EXAM 3

Prescription Drug or commercially packaged Legend Drug or Device. Any such label shall include all information required by Federal and State law or rule. (o5) “Product Labeling means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The following information is required by law* to be on the prescription container label of a drug dispensed pursuant to a prescription: 1. (FN) pharmacy name 2. (FN) pharmacy address 3. (FN) serial number of the prescription 4. (FN) date of filling 5. (FN) patient's name (a) 6. (FN) prescriber's name (b) 7. (FN) directions for use and any cautionary statements contained in the prescription 8. (FN) if central fill is used, a unique identifier of the central fill pharmacy (i.e., DEA registration number) in addition to the name and address of the pharmacy where the dispensing is to occur 9. (F) federal transfer warning for certain controlled substances (c) 10.(F) toll-free number for reporting side effects (d) 11.(N) name of the drug, device, or biological, unless instructed to omit by the prescriber (e) 12.(N) dosage form of the drug or biological 13.(N) strength of the drug or biological, if applicable 14.(N) quantity of drug, device, or biological in the container; except unit-dose containers 15.(N) pharmacy telephone number *FN = federal & Nebraska, F = federal, N = Nebraska (a) In Nebraska, the name of the owner and species of the animal if the prescription is for an animal. (b) In Nebraska, if the prescriber is a physician assistant (PA), the container label shall bear the name of the physician assistant and, if required for purposes of reimbursement, the name of the supervising physician. (c) The label of any controlled substance in Schedules II, III, and IV that is dispensed to a patient pursuant to a prescription, shall contain the following warning - CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. Therefore, a patient cannot transfer his/her controlled substance to any other person including a pharmacy, pharmacist, or prescriber. This requirement may also be satisfied with an auxiliary label on the container of the drug. This requirement does not apply to a Schedule V controlled substance or a noncontrolled substance. Many pharmacists have decided to be more stringent than federal law and place the transfer warning on the label of every dispensed prescription. 3

(-b-) if patient is an animal, include the last name of the owner, name of the animal, and animal species. (B) directions for use (-a-) directions for use as indicated by the prescriber and medication purpose/indication if included on prescription drug order 2 ; and (-b-) language should be simplified, avoiding unfamiliar words and medical jargon; when applicable, use numeric instead of alphabetic characters. (C) drug name X (-a-) if written for a brand name and a generic drug is dispensed, include phrase “Generic for [brand name];”and (-b-) include drug name suffixes, such as CD, SR, XL, XR, etc. (D) drug strength, expressed in the metric system whenever possible (E) “use by” date (-a-) date after which medication should not be used; not expiration date of medication or expiration date of prescription; and (-b-) format as – “Use by: MM/DD/YY.” (ii) Important information for patients – Must appear on the label but should not supersede critical information for patients and shall include: 3 (A) pharmacy name or dispensing practitioner’s entity name 4 ; (B) pharmacy telephone number 5 ; (C) prescriber name; (-a-) format as – “Prescriber: [prescriber name].” (D) “fill date” 6 ; (-a-) format as – “Date filled: MM/DD/YY.” (E) prescription number; (F) drug quantity; (-a-) format as – “Qty: [number].” (G) number of remaining refills; (-a-) format as – “Refills: [number remaining]” or “No refills,” using whole numbers only and managing partial fills through the pharmacy record keeping system; 2 Boards of pharmacy and licensees should recognize that “take as directed” may not provide sufficient information for the appropriate use of the medication. “Take as directed” is appropriate when specific directions are included on a unit-of-use package or dispensed package or in situations when directions are not able to be included on the label and the pharmacist presents directions to the patient and documents that such directions were given. “Take as directed” should not be used in lieu of patient counseling. It is understood that prescription drug orders often do not include the indication for use. 3 Information traditionally included on the patient label must continue to be maintained and safeguarded by the record-keeping system. Boards of Pharmacy should require that record-keeping systems prohibit any alteration or modification of these data unless an appropriate audit trail and justification exists. Record-keeping systems should also prohibit any deletion of information except in accordance with state and federal requirements for data management and retention. 4 Boards of Pharmacy should recognize that some pharmacies “do business as” a name other than the corporate name. 5 Include phone number of the dispensing pharmacy, recognizing that a pharmacy providing shared services may be involved in the filling process; Boards of Pharmacy should not require more than one telephone number on the label. 6 “Fill date” and “use by” date should be the only dates appearing on the prescription label. Other dates often found on labels, such as the original and expiration dates of the prescription drug order can be misunderstood by patients and clutter the label with unnecessary information. 6

such drug products and a pharmacist should use professional judgment in deciding whether or not to provide the PPI to a patient. Does a PPI have to be provided to a patient with a compounded drug product containing an estrogenic substance? No. That is because a compounded drug product is not an FDA-approved drug product and is not subject to the requirements of 21 CFR §310.515. From a risk management perspective, it would be wise to counsel a patient on the benefits and the risks of the estrogenic substance in order to reflect the required standard of care for FDA-approved drug products. The FDA requires a Medication Guide to be distributed with certain drug products that pose a serious and significant public health concern [21 CFR §208.1-§208.26]. A Medication Guide is intended to help prevent serious adverse effects and improve patient compliance (i.e., adherence). For example, a Medication Guide must be distributed with isotretinoin, warfarin (e.g., Coumadin®), quinine (i.e., Qualaquin®), varenicline (i.e., Chantix®), antidepressants ("to all patients of all ages"), NSAIDs ("even OTC NSAIDs if you dispense them as a prescription"), and a fentanyl transdermal system (e.g., Duragesic®). A comprehensive list of available Medication Guides may be found at the FDA's Center for Drug Evaluation and Research (CDER) website found at https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm When dispensing drug products that require a Medication Guide, it is important to keep in mind the following: 1. A Medication Guide must be distributed with each and every filling of a prescription (i.e., all new and refill prescriptions) for these drug products for outpatients. A special requirement does not exist for hospital inpatients or residents of a LTCF. 2. A prescriber can request that a Medication Guide is to be withheld from a patient. It would be wise to have such a request in writing. Also, such a request can be overridden by the patient. 3. The manufacturer or distributor must provide Medication Guides, or the means to produce Medication Guides, to the pharmacy. 4. “There are no provisions providing pharmacists with the option to distribute patient leaflets or written drug information produced by commercial vendors as a substitute when a Medication Guide is required for a particular drug.” Some pharmacists may inadvertently refer to a Medication Guide as a PPI and vice versa. Based on the summaries above, a Medication Guide is not a PPI and a PPI is not a Medication Guide. It is also important to note, that patient leaflets or written drug information other than a PPI or Medication Guide are referred to as consumer medication information (CMI). Written drug information also includes Vaccine Information Statements (VISs). VISs properly inform the adult vaccine recipient or the minor child’s parent or legal representative about the risks and benefits of each vaccine. A VIS must be given to patients prior to most vaccines being administered to them. While there are some exceptions (e.g., shingles), it is strongly recommended that a VIS be given to patients for such exceptions. Additional information about VISs may be found at http://www.immunize.org/vis/ . 9

premises for administration to multiple patients. These nonlegend drug products do not have to be labeled for a specific patient but can be administered to a patient only pursuant to a valid order from a prescriber. 3. Identify products which are subject to child-resistant packaging requirements and discuss specific exemptions and exceptions from child-resistant packaging requirements, including requests from patients and/or prescribers. Reference(s): #1 Required: Pharmacy Practice and the Law, pp. 179-181 (9 th Edition pp. 143-145) Required: Poison Prevention Packaging - A Guide For Healthcare Professionals – See Required Readings for this section in BlueLine The federal Poison Prevention Packaging Act (PPPA) of 1970 requires that hazardous household products (which include medications) must be sold in child- resistant packaging (with a few exceptions). Synonyms for child-resistant packaging include special packaging or safety packaging. Synonyms for non-child-resistant packaging include conventional, easy-open, flip-top, standard, non-complying, non-safety, or non-special packaging. Remember that when you are talking to patients about “child-resistant” containers (CRCs), be sure to call them just that. These kinds of containers are not “child-proof”; they are merely child-resistant. NOTE for your information: The PPPA is enforced by the U.S. Consumer Product Safety Commission ( http://www.cpsc.gov )  Link to CPSC full website Law link: https://www.ecfr.gov/cgi-bin/text-idx? SID=884f0845a363b1b62a1fcb54588052d6&mc=true&node=pt16.2.1700&rgn=div5 Why are child-resistant containers important?  Child-Resistant Containers Save Lives  What can happen if you don't follow the requirements The term "child-resistant packaging" is based on a statistical categorization. A container can be considered child-resistant if 80% of children under 5 years of age CANNOT open it and 90% of adults CAN open it. If you have a child really determined to open the container, he/she will find a way to open it and make themselves a part of the 20% of children under age 5 to whom the package is not resistant. The strategy behind this type of packaging is to frustrate the child for long enough so that he/she will go on to something 12

packaging on all future prescriptions. The pharmacist must find out from the patient if he or she wants non-child-resistant packaging for future prescriptions. Again, it is a very good idea to document, document, and document!!! Oral aspirin products must be in child-resistant containers, except when the manufacturer or distributor has multiple package sizes of a product in the same strength. For example, if Bayer Aspirin 325 mg tablets are sold in packages of 30, 50 and 100 tablets, one of those sizes can be marketed in a non-child-resistant package (and the other two sizes must be in child-resistant packaging). The non-child-resistant package must be marked: “This package for households without young children.” If the product comes in only one size, then special packaging must be used. This exception may also apply to other OTC products regulated under the PPPA. Can we reuse a child-resistant container on a refill? No. On refills, you must use a new container with one exception: any threaded container (screw top) can be reused but the lid must be replaced (e.g., on a liquid container). Most of the time it is so messy you will probably just use a new one anyway. What about drugs packaged in a blister or bubble pack? Some blister or bubble packs may be child-resistant, but not all are. There should be an indication in the labeling as to whether it meets CRC standards. All must pass a statistical test as to whether packaging meets CRC requirements. Remember that any drug can be repackaged by the pharmacist into a larger child-resistant container if necessary. Can a container that is easy-open in one position and child-resistant in another position (i.e., reversible or dual-purpose packaging) be used? Legally it is alright, but it has flaws. What if a patient with an Rx for Lomotil ® which has diphenoxylate 2.5 mg and atropine sulfate 0.025 mg reverts to the easy-open setting? This combination is extremely toxic and only takes a few tablets to harm a small child. Some pharmacists would not dispense it in this type of "two-way" container because they are concerned about being able to prove that the medication was dispensed in the correct (i.e., child-resistant) position in the event a child gains access to the contents of the vial. What about an inpatient in a hospital? There are no requirements to use child-resistant containers for such patients. What about patients in a long-term care facility/nursing home? No. What about a nursing home patient who wants to go home for the Thanksgiving weekend? This happens. You need to have a waiver because children might have the opportunity to get into their medications. This is really an easy law to deal with. It is there for the everyday practice of pharmacy to protect kids, and over the years, it has done its job. 15

packaging or in containers repackaged in compliance with state and federal laws, rules, and regulations relating to repackaging, labeling, and record keeping. Examples of a prescription medication distribution machine in Nebraska include ScriptPro and Parata filling systems. A prescription medication distribution machine may be operated only in a licensed pharmacy where a pharmacist dispenses medications to patients for self-administration pursuant to a prescription or in a long-term care automated pharmacy. When a cassette for a prescription medication distribution machine holds drugs reflecting different lot numbers and expiration dates, the shortest expiration date will apply and all dosage units remaining in the cassette must be removed from commerce in the event of a Class I or Class II recall. Drugs in an ADS are counted as pharmacy stock. So, inventory transferred to an automated medication distribution machine in a Nebraska hospital or to an automated medication distribution machine or prescription medication distribution machine in a Nebraska long-term care automated pharmacy is excluded from the 5% limit on total prescription drug sales revenue in section 71-7454 of Nebraska’s Wholesale Drug Distributor Licensing Act. The Automated Medication Systems Act in Nebraska allows for pharmacist remote order entry: 71-2445 (10) Pharmacist remote order entry means entering an order into a computer system or drug utilization review by a pharmacist licensed to practice pharmacy in the State of Nebraska and located within the United States, pursuant to medical orders in a hospital, long-term care facility, or pharmacy licensed under the Health Care Facility Licensure Act; In this regard: 71-2450 A pharmacist providing pharmacist remote order entry shall: (1) Be located within the United States; (2) Maintain adequate security and privacy in accordance with state and federal laws, rules, and regulations; (3) Be linked to one or more hospitals, long-term care facilities, or pharmacies for which services are provided via computer link, video link, audio link, or facsimile transmission; (4) Have access to each patient's medical information necessary to perform via computer link, video link, or facsimile transmission a prospective drug utilization review…; and (5) Be employed by or have a contractual agreement to provide such services with the hospital, long-term care facility, or pharmacy where the patient is located. 18

authentic prescription in Nebraska? Yes, as long as the prescription is within the legal scope of practice that would otherwise be applicable to that prescriber if he/she was licensed in Nebraska. Is a prescription from a foreign prescriber that is not licensed in any state in the United States an authentic prescription? The answer is “no” for most states, but could be “yes” in some states. For example, immigrants may come to Omaha with prescriptions from physicians in their home countries. In such cases, new prescriptions would have to be obtained from prescribers licensed in the United States. A pharmacy may be able to obtain new prescriptions from prescribers that are within local organizations (e.g., churches) that have sponsored the immigrants. Does a pharmacist who is the owner of a pharmacy and the owner of the drug products, a pharmacist-in-charge (PIC), or an employee pharmacist need a prescription for any legend drug product that he/she may need for his/her own personal use? Yes. According to federal and Nebraska law, a pharmacist can dispense legend drugs to himself/herself and to his/her family members, but such dispensing must always be pursuant to a valid prescription. In a 1995 Virginia case, a pharmacist was fined and sentenced to jail for refilling a cephalexin prescription for himself without an authorization and a Lomotil prescription for his wife without an authorization. In a 1999 Nebraska case, a husband and wife (both pharmacists) were found guilty of theft by deception for dispensing unauthorized prescriptions for the wife at the pharmacy where both were employed. Both pharmacists dispensed prescriptions without a doctor's authorization and charged the prescriptions to the pharmacy's insurance. The wife was found guilty of felony theft by deception and voluntarily surrendered her pharmacist license, was ordered three years of probation and to pay $16,500 in restitution to the pharmacy. The husband was found guilty of misdemeanor theft by deception. His license was suspended for one month and was ordered 18 months of probation. In addition, he had to pay $2,500 in restitution and civil penalties. A pharmacist should always pay close attention to prescriptions for certain drugs such as warfarin, methotrexate, colchicine, all fentanyl containing products, monoamine oxidase inhibitors, etc. The FDA has required the development of Risk Evaluation and Mitigation Strategies (REMS) for some high-risk drugs (e.g., clozapine [Clozaril], thalidomide, isotretinoin). For example, the iPLEDGE risk minimization action plan (RiskMAP) has been approved by the FDA for isotretinoin products. The program requires the registration of all participants in the healthcare system using isotretinoin products (i.e., wholesalers, prescribers, pharmacies, and patients) in order to ensure that no female patient starts isotretinoin therapy if pregnant and no female patient on isotretinoin therapy becomes pregnant. Before a male or female patient receives his/her isotretinoin prescription each month, the prescriber must counsel the patient and document in the iPLEDGE system that the patient has been counseled about the risks of isotretinoin. As part of the ongoing risk management program, it is crucial that a female patient of childbearing potential selects and commits to use two forms of effective contraception simultaneously for one month before, during, and for one month after isotretinoin therapy. She must have two negative urine or blood (serum) pregnancy tests before receiving the initial isotretinoin prescription. Lastly, a Medication Guide is required to be dispensed with all isotretinoin prescriptions. 21

Information about the iPLEDGE program may be found at its website ( https://www.ipledgeprogram.com/PatientInformation.aspx ) As discussed in a previous lesson, only a prescriber acting within his/her legal scope of practice can authorize the refilling of a prescription. According to federal law, a refill authorization cannot exceed five refills within six months from the date of issue for a Schedule III or IV controlled substance. According to federal law, there is no limit on the number of refills or time limit for a Schedule V controlled substance or noncontrolled substance. According to Nebraska law, a refill authorization cannot exceed five refills within six months from the date of issue for a Schedule III, IV, or V controlled substance. According to Nebraska law, there is no limit on the number of refills within twelve months from the date of issue for noncontrolled substances. If a prescription is written for #30 tablets (30-day supply) with five (5) refills, is it acceptable to initially dispense #90 tablets (90-day supply) with one (1) refill left? While there are no specific federal or Nebraska laws that address this particular scenario, it may be acceptable to use professional judgment on a case-by-case basis to dispense #90 tablets and give one refill for a drug product that is a noncontrolled substance without checking with the prescriber. However, it may not be acceptable to do this according to the law in some states or according to most third-party contracts. In addition, it would be very wise to check with the prescriber before doing that for any controlled substance prescription. Lastly, this should not be done for any drug product prescribed by a psychiatrist (or any prescriber for that matter) for a psychiatric patient without checking with the prescriber. Can additional refills be added to an existing or old prescription? According to federal and Nebraska law, additional refills can be added to an existing or old prescription without assigning a new prescription number. However, the additional refills cannot go beyond the original expiration date for the existing or old prescription (i.e., 12 months for a noncontrolled substance prescription in Nebraska or 6 months for a Schedule III, IV, or V controlled substance prescription in Nebraska) or beyond the total number of refills allowed by law for a given type of prescription. A problem with doing that is the documentation for the additional refill authorization(s) is usually lacking or lost (e.g., the date the additional refills were added). Therefore, many pharmacies have a policy in place that always requires a new prescription to be generated in such situations. That provides a much better audit trail for what actually occurred (i.e., the date of the additional refill authorization(s) by the prescriber). In today’s computerized world, it would be wise to always generate a new prescription rather than adding additional refills to an existing or old prescription. Some states may require that to be done as well. Can you refill a prescription for a Schedule II controlled substance in case of a true emergency? No. You can never refill a Schedule II controlled substance prescription. 28-414 A prescription for a controlled substance listed in Schedule II of section 28-405 shall not be refilled. 22

Considerable confusion can arise from a PRN or AD LIB refill authorization. Such refill authorizations are without limits and essentially mean the pharmacist has to use professional judgment in making a decision as to when to refill the prescription. While Nebraska and some other states recognize a PRN or AD LIB refill authorization, some states do not. Pharmacists working in states that do not recognize these refill authorizations have been charged with fraud by third party payers because they allegedly refilled prescriptions without valid authorizations. Therefore, they misbranded the drug product because they dispensed it without a valid prescription as required. The matter of PRN refill authorizations is discussed in the document “ Refills Shouldn’t Always Be Automatic ” found on the Introduction page for Selecting, Dispensing, and Distributing in BlueLine. In Nebraska: PRN refills are included in statutory language for III- V with the caution not to exceed 5 refills within 6 months after date of issuance and for non-controlled, legend drugs 71-2478 (h) number of authorized refills, including pro re nata or PRN refills What should a pharmacist do on a weekend when a patient needs a refill of a prescription for a maintenance drug that does not have any remaining authorized refills? The original prescriber is unavailable and the prescriber taking calls for the original prescriber cannot be reached. According to federal and Nebraska law, a pharmacist cannot refill the prescription without an authorization. However, a pharmacist can use professional judgment on a case-by-case basis to give the minimum amount necessary (i.e., a partial filling which is not a refill) of a maintenance noncontrolled substance in order to take care of the patient until an authorization can be obtained the following week. In addition, a pharmacist can use professional judgment on a case-by- case basis in a true emergency situation (which rarely occurs) to give the minimum amount necessary of a maintenance Schedule III, IV, or V controlled substance to take care of the patient until an authorization can be obtained the following week. If not a true emergency situation or whenever in doubt, the patient should be referred to an urgicenter or emergency room if the patient is out of refills and needs more of a Schedule III, IV, or V controlled substance. It is important to note, that it may not be acceptable to provide these partial fillings according to the law in some states or according to some third-party contracts. In addition, a request for reimbursement that is submitted in most of these situations should reflect the date of the actual authorization and not the date of the partial filling in case the pharmacy is audited. What should a pharmacist do on a weekend when a patient needs a refill of a prescription for a maintenance drug that does not have any remaining authorized refills, but the packaging of the drug product does not allow the dispensing of the minimum amount necessary (e.g., an ophthalmic drop or oral contraceptive)? Using professional judgment on a case-by-case basis, some pharmacists would dispense the item and obtain an authorization the following week. However, it may not be acceptable to do this according to the law in some states or according to some third-party contracts. In addition, a request for reimbursement that is submitted in most of these situations should reflect the date of the actual authorization and not the date of the partial filling in case the pharmacy is audited. 23

Can a prescription be filled at a central location and subsequently be dispensed to the patient at a different location? Yes, according to federal and Nebraska law. “Centralized prescription filling means the filling by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order.” In a central fill pharmacy, a prescription cannot be received directly from a patient or prescriber or a filled prescription cannot be dispensed directly to a patient. So, the central fill pharmacy must transport a filled prescription back to the retail pharmacy that initially received the prescription, and the filled prescription would then be dispensed to the patient at the retail pharmacy. Prescriptions for Schedule II, III, IV, or V controlled substances may be transmitted electronically (including via facsimile) from a retail pharmacy to a central fill pharmacy. The retail pharmacy transmitting the prescription must: 1. Write “CENTRAL FILL” on the face of the original prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the pharmacist at the retail pharmacy that transmitted the prescription, and the date of transmittal; 2. Maintain the original prescription for a two years from the date the prescription was last refilled; 3. Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (i.e., private, common, or contract carrier) and the name of the retail pharmacy employee accepting delivery; and 4. Indicate in the information transmitted, the number of refills already dispensed and the number of refills remaining for a Schedule III, IV, or V controlled substance prescription. The central fill pharmacy receiving the transmitted prescription must: 1. Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and the DEA registration number of the retail pharmacy transmitting the prescription; 2. Keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the dates of filling or refilling of the prescription; and 3. Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e., private, common, or contract carrier). For electronic prescriptions (i.e., e-prescriptions or eRxs), the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the pharmacist at the retail pharmacy that transmitted the 24

prescription, and the date of transmittal must be added to the electronic prescription record. Remote Dispensing LB 731 was introduced, was passed by the Nebraska Legislature, and became law on July 19, 2018. In summary, LB 731 provides language that will allow remote dispensing to occur in Nebraska (see Neb. Rev. Stat. §71- 436.02). The purpose of the legislation is to provide access to pharmacies/pharmacists in rural and under-served areas of Nebraska. The remote pharmacy will be staffed by a certified pharmacy technician and owned by a supervising pharmacy (licensed and located in Nebraska - and no less than 10 driving miles from a pharmacy already in operation) to dispense medications. The pharmacist in charge (PIC) of the supervising pharmacy will also serve as the PIC for the remote dispensing pharmacy. A real-time audio/visual connection must be operational for dispensing to occur. If the real-time audiovisual communication system between the remote dispensing pharmacy and supervising pharmacy is not working, no remote dispensing can be completed at the remote dispensing pharmacy until the real-time audiovisual communication system is restored and working properly. The PIC can delegate tasks to a "virtual pharmacist", such as supervision, verification, DUR, patient counseling, etc., but the virtual pharmacist must be employed by the supervising pharmacy. When a prescription is being dispensed to a patient or caregiver, the pharmacist must attempt to counsel on all new prescriptions dispensed from a remote dispensing pharmacy and must offer to counsel on all refills. The ratio of technicians and pharmacist interns to pharmacists remains 3 to 1 as specified in Neb. Rev. Stat. §38- 2866.01. A separate license will be required for the remote dispensing pharmacy. Pharmacist interns may not work at a remote dispensing pharmacy unless they are at the location with a pharmacist (e.g. flu shot clinic). The definition of Pharmacist in Charge in Neb. Rev. Stat. §38-2833 was amended to include a remote dispensing pharmacy license as another pharmacy license type that requires a PIC designee and clarifies that the PIC does not have to be physically present in the remote dispensing pharmacy unless otherwise required by law. Several new definitions were added to the Pharmacy Practice Act and the Health Care Facility Licensure Act in regard to remote dispensing. The new definitions include: remote dispensing means dispensing that occurs using remote supervision in compliance with Neb. Rev. Stat. §71-436.02 (see Neb. Rev. Stat. §38-2843.02 and §71- 427.02); remote dispensing pharmacy means a pharmacy staffed by certified pharmacy 25

technicians in Nebraska is which remote dispensing occurs (see Neb. Rev. Stat. §38- 2843.03 and §71- 427.03); supervising pharmacy means a pharmacy licensed and located in Nebraska that owns and operates a licensed remote dispensing pharmacy (see Neb. Rev. Stat. §38-2843.04 and §71-427.04). The definition of verification in Neb. Rev. Stat. §38-2847 was amended to say that verification by a pharmacist of the work of a pharmacy technician may be done via real- time audiovisual communications systems for the purposes of remote dispensing. Remote dispensing pharmacy was added to the list of responsibilities for a pharmacist in charge in supervision and oversight of a pharmacy technician as stated in Neb. Rev. Stat. §38-2892. Statutes were amended to accommodate remote dispensing. Those updates include: amending the definition of pharmacy to include remote dispensing pharmacy in Neb. Rev. Stat. §71-425; and adding remote dispensing pharmacy to locations where prescription medication distribution machines may be used in Neb. Rev. Stat. §71-2448 In addition to adding language to allow remote dispensing, LB 731 changed existing statutes to allow a pharmacy technician to receive a refill authorization from a prescriber or prescriber’s agent (Neb. Rev. Stat. §38-2870 & §38-28,106 & §71-2483), as well as clarify that pharmacy technicians cannot perform tasks that require the “professional judgment” of a pharmacist. 38-28,106. Communication of prescription, chart order, or refill authorization; limitation. An employee or agent of a prescribing practitioner may communicate a prescription, chart order, or refill authorization issued by the prescribing practitioner to a pharmacist or a pharmacist intern except for an emergency oral authorization for a controlled substance listed in Schedule II of section 28-405. An employee or agent of a prescribing practitioner may communicate a refill authorization issued by the prescribing practitioner to a pharmacy technician. 71-2483. Communication authorized. An employee or agent of a prescribing practitioner may communicate a prescription, chart order, or refill authorization issued by the prescribing practitioner to a pharmacist or a pharmacist intern except for an emergency oral authorization for a controlled substance listed in Schedule II of section 28-405. An employee or agent of a prescribing practitioner may communicate a refill authorization issued by the prescribing practitioner to a pharmacy technician. Can a controlled substance be mailed to a patient? Yes. However, the "mailing” of an item is governed by United States Postal Service (USPS) regulations. Those regulations currently address the “mailing” of controlled substances (legend and nonlegend), but not the “mailing” of noncontrolled substances - see page 54 of the Pharmacist’s Manual (Revised 2010). At one time, narcotic Schedule II, III, IV, and V controlled substances (legend and nonlegend) could not be “mailed” through the USPS system to patients while nonnarcotic Schedule II, III, IV, and V controlled substances (legend and nonlegend) could be “mailed” through the USPS system to patients. However, narcotic Schedule II, III, IV, and V controlled substances (legend and nonlegend) could be “shipped” via a private carrier (e.g., UPS, FedEx) to patients. That was allowed because “shipping” via a private carrier is not considered “mailing” via the USPS. There is still confusion about this matter 26

today, because pharmacists do not make the distinction between “mailing” via the USPS system versus “shipping” via a private carrier. Narcotic and nonnarcotic controlled substances (legend and nonlegend) and noncontrolled substances (legend and nonlegend) may be mailed or shipped to patients today. However, it would be wise for a pharmacy to have internal control procedures in place that would require certain controlled substances to be mailed o r shipped via a secure method with confirmation of receipt by the patient or caregiver. Can a controlled substance be mailed or shipped to persons in other countries? Such a delivery or shipment is considered an export and is usually prohibited, i.e., "controlled substances that are dispensed pursuant to a legitimate prescription may not be delivered or shipped to individuals in countries without proper authorization." A federal law was passed in October of 2013 that addresses some emergency situations in schools. The School Access to Emergency Epinephrine Act allows “school personnel to stock and administer emergency supplies of epinephrine auto-injectors to treat life-threatening allergic reactions.” Nebraska regulations 92 NAC 59 (sometimes referred to as Rule 59), also address the emergency response to life-threatening asthma or systemic allergic reactions (anaphylaxis). Under this rule, a Nebraska pharmacy can provide an EpiPen or albuterol inhaler to a school for administration to a student in an emergency situation pursuant to a standing order signed by a minimum of one physician licensed to practice medicine in Nebraska. The EpiPen or albuterol inhaler does not have to be labeled for a specific patient, but must be labeled for "emergency use" along with the other information required by law. Can a pharmacist refuse to dispense a prescription? While federal law does not specifically address this matter, a Nebraska statute does: 38-2870(2)...The Pharmacy Practice Act shall not be construed to require any pharmacist or pharmacist intern to dispense, compound, administer, or prepare for administration any drug or device pursuant to any medical order. A pharmacist or pharmacist intern shall retain the professional right to refuse to dispense. It is important to emphasize, that a patient may claim he/she has been harmed if a pharmacist refuses to dispense a prescription. Therefore, care must be taken when making such a decision as one pharmacist learned when a lawsuit was filed ( http://drugtopics.modernmedicine.com/drugtopics/article/articleDetail.jsp?id=110810 ) A court case many years ago (Jones v. Walgreen Co.), established good reasons to refuse to fill or refill a prescription which included "the pharmacist may: 1. Not have the prescribed drug in stock 2. Suspect that the prescription is forged 3. Distrust his/her ability to fill the prescription (a) 4. (In the case of a refill) know that the refilling of the prescription violates the law 27

5. Believe that the prescription will be harmful to the patient due to an error on the part of the prescriber" (b) (a) This may occur with a prescription that needs to be compounded. Some pharmacists do not feel comfortable with compounding certain products and may refer the patient to a pharmacy that specializes in compounding. (b) Such a situation can be very difficult to deal with. Students are encouraged to ask their preceptors at work how they have handled specific situations in their practice. In any case, "it is imperative that the pharmacist refrain from making any comment to the patient as to the professional ability of the prescriber. An adverse comment could incur liability for slander." In more recent times, pharmacists have exercised "their religious, moral, and ethical beliefs" and have refused to fill or refill certain prescriptions. Some states have passed a specific law in this regard. For example, South Dakota has a conscience law that provides pharmacists with the "legal right to refuse to fill prescriptions for drugs used in abortion, suicide, or euthanasia." Some believe there is "a crisis at the pharmacy counter.” However, 77.5% of pharmacists in a 1997 national poll responded "yes" to the question "Should pharmacists have the right to refuse to provide medications for uses that conflict with their personal values?" In 2006, the APhA-ASP House adopted "Resolution 2006.3 - Professional Right to Refuse, which states 1. APhA-ASP recognizes a pharmacist's and student pharmacist's right to refuse to dispense a medication or provide a service for various reasons including, but not limited to, conscientious objection and clinical judgment. APhA-ASP also supports the establishment of systems that protect the patient's right to obtain legally prescribed and therapeutically appropriate treatment while reasonably accommodating the pharmacist's or student pharmacist's right to refuse. 2. APhA-ASP opposes legislation, regulation, and other policies that compromise a pharmacist's and student pharmacist's right to refuse." If you have religious, moral, or ethical beliefs that may impact how you will act in a given situation, it would be very wise for you to determine in advance if your employer has a specific policy in place that addresses such a situation. In addition, it would be very wise for you to check with your state Board of Pharmacy in advance for an interpretation of any statutes or regulations that may have a bearing on such a situation. Lastly, it would be very wise for you to check with your professional liability insurance carrier to determine in advance if you would be covered if a patient claims to be harmed in such a situation. Overall, “a pharmacist can be sued for making slanderous or false statements about a patient or prescriber. So, pharmacists that refuse to fill a prescription should explain their decisions in a friendly manner; cite professional judgment; and avoid making subjective statements about the patient and/or prescriber.” 28

6. Discuss the partial filling of controlled substance prescriptions. Reference(s): #1 Pharmacy Practice and the Law, pp. 260-261 & 264 (9 th Edition pp. 206-207, 209) #5 Statutes Relating to Pharmacy Practice Act, 28-414(5)(a&b) and 28-414.01(4) The partial filling of a prescription is where the quantity of drug dispensed to a patient is less than the quantity of drug requested by the prescriber on the face of the original prescription. It is very important to emphasize, that a partial filling of a prescription is not a refill of a prescription. According to federal law "the partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that: (a) Each partial filling is recorded in the same manner as a refilling, (b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and (c) No dispensing occurs after 6 months after the date on which the prescription was issued." Even though a partial filling is not a refill, the record for a partial filling of a Schedule III, IV, or V controlled substance is the same as for a refill (i.e., the date of filling, the initials of the dispensing pharmacist, and the quantity dispensed on the partial filling). The total quantity dispensed for all partial fillings cannot exceed the total quantity prescribed in the original prescription plus any authorized refill prescriptions. For example, a new prescription for diazepam 5 mg, #100, with 5 authorized refills, may be filled for a total of 600 tablets. This prescription may be filled a total of 6 times for 100 tablets within 6 months from the date of issue; filled for a total of 12 partial fillings for 50 tablets within 6 months from the date of issue; or filled for other combinations of partial fillings within 6 months from the date of issue provided no more than 600 tablets are dispensed. There is conflicting language in federal law on the refilling versus partial filling of a Schedule V controlled substance prescription. The matter was discussed with the DEA in 1997, but the DEA did not think there was a problem. According to federal law, you can refill a Schedule V controlled substance prescription forever as long as you have authorizations. However, according to federal law you cannot partially fill a Schedule V controlled substance prescription "after 6 months after the date on which the prescription was issued." Therefore, according to federal law, the six month window is applicable to refills of a Schedule III or IV controlled substance prescription and partial fillings of a 29

Schedule III, IV, or V controlled substance prescription. In Nebraska, the six month window is applicable to refills and partial fillings of a Schedule III, IV, or V controlled substance prescription. As of July 2016, federal law allows partial filling of Schedule II controlled substance prescriptions if state law does not prohibit it; the prescription is valid and legal; the patient or prescriber requests a partial filling; and the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. The remaining portion of a partially filled Schedule II controlled substance “shall be filled not later than 30 days after the date on which the prescription is written.” (9 th Edition pp. 206-207) Federal law continues to allow the partial filling of Schedule II prescriptions in emergency situations " if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription." For the partial filling of a Schedule II controlled substance prescription, there is a difference between filling and dispensing. While the remaining portion of an emergency Schedule II controlled substance prescription may be filled within 72 hours of the first partial filling, that second partial filling may actually be dispensed to the patient after the 72-hour period has passed. According to federal law, "a prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is "terminally ill'' or an "LTCF patient.'' A prescription that is partially filled and does not contain the notation "terminally ill'' or "LTCF patient'' shall be deemed to have been filled in violation of the Act. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication." According to federal law, the pharmacist does not need to notify the prescribing individual practitioner if the remaining portion is not or cannot be filled within the 60-day period for situations involving terminally ill patients or residents of a LTCF. 30

It is very important to note, that while it is acceptable to partially fill a Schedule II controlled substance prescription, it is never acceptable to refill a Schedule II controlled substance prescription. Nebraska law is identical to federal law with respect to the partial filling of Schedule II, III, IV, and V controlled substance prescriptions. 7. Discuss the dispensing of an approved drug product for an off label, unlabeled, or unapproved indication. Reference(s): #1 Pharmacy Practice and the Law, pp. 115-117, 132-136 & 156- 157 (9 th Edition pp. 89-91, 102-104, 119-121) The medical condition(s) for which a drug is initially approved in its NDA become part of the labeling for that product. Subsequent to receiving FDA approval for marketing, other uses for the drug product may be discovered. In order to include these new uses (indications) for the product in the product labeling, the manufacturer would have to file another NDA (as an amendment to the original) and receive approval to include the newly discovered indication in the package insert. In real-world practice, this does not usually happen. An unapproved indication could be one not found in the package insert (not in adequate information for use) or approved NDA. Or it could involve the frequency of usage or an administration route not listed on package insert. The prescriber can legally do this because it is considered within the art and science of medicine. The assigned readings in Pharmacy Practice and the Law provide excellent background and current information regarding the issue of unapproved uses for approved drugs, including:  the free speech issues involved in drug advertising and promotion  activities that manufacturers are permitted to engage in when discussing or promoting unapproved uses of approved medications (i.e., off-label uses)  explanation of key court decisions that have addressed this issue by striking a balance between free speech concerns, providing flexibility in treatment options for prescribers, and protection of the public Pharmacists can legally dispense drugs prescribed for off-label uses as long as labeling and other legal factors are met. However, it could increase your liability exposure. So, despite this practice being “technically” legal for a pharmacist to perform, consider the following thought in italics …  If you are not aware of an off-label use, you need to research it, buy into it, and believe it is medically acceptable. If you can’t accept the increased risk exposure and/or have therapeutic concerns about the use, you may have to consider not dispensing until you obtain more information. This can include inquiring further of the prescriber or checking with a drug information center. 31

Sometimes, clinical experience with successful off-label usage can result in research that is later used to support an amended NDA that includes the new indication. One such example is the beta blocker propranolol. In the past, an off-label use of propranolol was migraine prophylaxis. Today, we find migraine prophylaxis listed as an approved use. 8. Discuss when methadone and buprenorphine products can be dispensed. Reference(s): #1 Pharmacy Practice and the Law, pp. 229-232 & 366-368 (9 th Edition 182-184 & pp. 291-292) #5 Statutes Relating to Pharmacy Practice Act, 28-412(1)-(6) and 28-470 Manufacturer's Info for Health Care Professionals http://www.suboxone.com/hcp/ Information about buprenorphine-based narcotic addiction treatment (SAMHSA) http://buprenorphine.samhsa.gov/ Buprenorphine Quick Start Guide https://www.samhsa.gov/sites/default/files/quick-start-guide.pdf Qualify for Nurse Practitioners (NPs) and Physician Assistants (PAs) Waiver (SAMHSA) https://pcssnow.org/medications-for-opioid-use-disorder/waiver- training-for-nurses/ https://pcssnow.org/medications-for-opioid-use-disorder/waiver- training-for-pas/ Methadone (a Schedule II narcotic) can be dispensed in the outpatient pharmacy setting (i.e., as a prescription) but it can only be for analgesic purposes. Methadone CANNOT be prescribed to either maintain or detoxify an addict. Some pharmacists think they can’t fill methadone for a terminal patient because the patient is not in a narcotic treatment program, but physicians can prescribe methadone as an analgesic and pharmacists can dispense it. If methadone is dispensed as an analgesic, must the Rx say ‘for pain’? There is no requirement to do this in either federal or Nebraska law. In a narcotic treatment program, methadone is dispensed for administration, and these are not prescriptions , they are orders for administration . These treatment programs deal with detoxifying and maintaining opiate addicts. If a physician has methadone in his/her office, s/he can administer it one day at a time only and for no more than 3 days before a patient must go into a treatment program. The physician can obtain methadone from a pharmacy registrant using a paper DEA Form 222 and then have the addict come in daily for 3-days maximum administration of methadone. In an inpatient hospital setting, if the patient is 32

only there as an addict the hospital can dispense for administration to the patient one day at a time with the same 3-day maximum. However, if the patient is in the hospital for treatment of another condition such as diabetes, the hospital can maintain and detoxify without the 3-day time limitation. Methadone is usually used in the hospital setting for terminal cancer patients as an analgesic. Voluntary restrictions (effective January 1, 2008), established by the manufacturers of methadone hydrochloride 40mg dispersible tablets, limit distribution of this strength and formulation of methadone to hospitals and to facilities authorized for the detoxification and maintenance treatment of opioid addiction. For additional information and background concerning these voluntary restrictions, see the document “ DEA Methadone Advisory ” located on the Introduction page of Selecting, Dispensing & Distributing in BlueLine. See the Manufacturer's Info for Health Care Professionals for pharmacists, and click on the Information About Buprenorphine link if you are interested in information about another form of narcotic addiction treatment from SAMHSA. Suboxone is buprenorphine + naloxone to detoxify and maintain patients with opioid use disorders. The Drug Addiction Treatment Act of 2000 (DATA) allows for narcotic addiction treatment outside a methadone treatment program. The website also has information such as the drug label, patient leaflet, and information for pharmacists. What is the pharmacist’s role in assuring the safe use of this product? You must make sure a physician is in compliance with DATA (the treatment act mentioned above). The requirements for office-based use of the new agents by physicians include special training criteria for providing appropriate care, either subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties or subspecialty board certification in addiction medicine or at least 8 hours of authorized training on the treatment or management of opioid-dependent patients AND must have the capacity to provide or to refer patients for necessary ancillary services, such as psychosocial therapy. There is also a new mechanism in place to allow you to determine whether physicians meet these requirements listed above. For prescribers who have met the requirements for prescribing buprenorphine-containing products, DEA issues a unique ID number that is verifiable by contacting 1-866-BUP-CSAT. Buprenorphine was rescheduled from Schedule V to Schedule III. As discussed earlier, because these drugs were rescheduled, every pharmacy had to inventory them to determine what they had on hand. Opioid Treatment In April of 2021 Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder (OUD) provided an exemption that allowed eligible physicians, physician assistants, nurse practitioners, and other providers that are state licensed and registered by the DEA to prescribe controlled substances, an exemption from certain statutory certification requirements related to training, counseling and other ancillary services, that is psychosocial services. 33

The exemption allows practitioners to treat patients with buprenorphine without certifying as to their capacity to provide counseling and ancillary services. This exemption specifically addresses reported barriers to the training requirement. Providers still must submit an application designated as a “Notice of Intent” in order to prescribe buprenorphine for the treatment of OUD. (Link: https://www.federalregister.gov/documents/2021/04/28/2021-08961/practice- guidelines-for-the-administration-of-buprenorphine-for-treating-opioid-use-disorder ) This exemption does not include the use of any Schedule II drugs (e.g., methadone) used for the treatment of OUD. The Opioid Treatment Program Directory helps people find local treatment programs by state. Learn more about finding help and treatment services for mental and/or substance abuse issues. How can a pharmacist verify if a physician has a waiver to prescribe buprenorphine (Subutex® or Suboxone®) for the treatment of opioid addiction? The SAMHSA Buprenorphine Physician Locator web site ( https://www.samhsa.gov/medication-assisted-treatment/physician-program- data/treatment-physician-locator ) lists the physicians in each State who have DATA 2000 waivers. A physician listed on the site can be considered to have a valid DATA 2000 waiver. Note, however, that the site does not list every physician with a valid waiver, only those who have agreed to be listed on the site. Physicians with valid waivers may choose not to be listed on the site. A pharmacist desiring to verify that a physician who is not listed on the site has a valid DATA 2000 waiver can contact SAMHSA by phone at 301-443-0457 or by e-mail at nreuter@samhsa.gov . Pharmacists should convey their DEA registration number with these requests. There is also an online method for pharmacists to verify a practitioner’s buprenorphine prescribing authority: Buprenorphine Practitioner Verification for Pharmacists https://www.samhsa.gov/bupe/lookup-form Is there a limit on the number of patients a practitioner may treat with buprenorphine at any one time? Yes. DATA 2000, as amended in December 2006, specifies that an individual physician may have a maximum of 30 patients on opioid therapy at any one time for the first year. One year after the date on which a physician submitted the initial notification, the physician may submit a second notification of the need and intent to treat up to 100 patients. A 2016 Final Rule now allows prescribers who have been authorized to prescribe buprenorphine for 100 patients for 1 year can now apply to increase the number of patients they can treat with buprenorphine to 275. 34

The DATA 2000 waiver ID number to be placed on prescriptions for buprenorphine products used to treat narcotic addiction is in addition to the prescriber's regular DEA registration number. This DATA 2000 waiver ID number is the same as the prescriber's DEA registration number with one change. The first letter of the DEA registration number is changed to an "X". For example, if the prescriber's DEA registration number is AS4789636, the prescriber's DATA 2000 waiver ID number would be XS4789636. However, prescriptions for buprenorphine products used to treat pain, do not require the “X” version of the prescriber’s DEA registration number. Most states have provided for better access to naloxone, an opioid antagonist, to reverse the effects of an opioid overdose. In the spring of 2015, the Nebraska Legislature passed a statute (LB 390) that included better access to naloxone: 28-470(2) A family member, friend, or other person who is in a position to assist a person who is apparently experiencing or who is likely to experience an opioid- related overdose, other than an emergency responder or peace officer, is not subject to actions under the Uniform Credentialing Act, administrative action, or criminal prosecution if the person, acting in good faith, obtains naloxone from a health professional or a prescription for naloxone from a health professional and administers the naloxone obtained from the health professional or acquired pursuant to the prescription to a person who is apparently experiencing an opioid- related overdose. 28-470(5)(d) Heath professional means a physician, physician assistant, nurse practitioner, or pharmacist licensed under the Uniform Credentialing Act; Naloxone Dispensing Pharmacists need to know how to provide to naloxone to patients in compliance with Nebraska law. On May 27, 2015, LB 390 was signed into law authorizing the expanded access to naloxone, a life-saving drug used to reverse the effects of an opioid overdose. Although the language in Neb. Rev. Stat. §28-470 is now in question, pharmacists can provide naloxone to patients via a prescription, a collaborative practice agreement, and the Nebraska Naloxone Standing Order signed by the Interim Chief Medical Officer at the Nebraska Department of Health and Human Services (pursuant to Neb. Rev. Stat. §38-2840). The Nebraska Naloxone Standing Order can be found: http:// dhhs.ne.gov/publichealth/PDMP/ Pages/NaloxoneResources.aspx . Authority to Prescribe Naloxone Expanded to Nurse Practitioners (NPs) and Physician Assistants (PAs) On July 22, 2016, President Obama signed the Comprehensive Addiction and Recovery Act (CARA) into law as Public Law 114-198. One of CARA’s important provisions expands access to substance use treatment services and overdose reversal medications— including the full spectrum of services from prevention to medication-assisted treatment (MAT) and recovery support—by extending the privilege of prescribing buprenorphine in 35

office-based settings to qualifying nurse practitioners (NPs) and physician assistants (PAs) until Oct. 1, 2021. NPs and PAs who have completed the 24 hours of required training may seek to obtain a DATA 2000 waiver for up to 30 patients by completing the Waiver Notification Form. Effective February 27, 2017 , SAMHSA will only accept electronic submissions of the NOI. 9. Discuss the substitution of an equivalent generic product for the trade-name or brand-name product originally prescribed. Reference(s): #1 Pharmacy Practice and the Law, pp. 165-170 (9 th Edition pp. 132-136) #5 Statutes Relating to Pharmacy Practice Act, 38-28,108 to 38- 28,116 While federal law does not address the pharmacist’s substitution of a biogeneric/biosimilar product or generic product for the trade-name or brand-name product originally prescribed, the FDA does provide several important publications (i.e., Purple Book and Orange Book) to assist the pharmacist in making such substitutions. The Purple Book (Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/ap provalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm ) is applicable to biotech drugs that are derived from living organisms, such as proteins, and often produced using recombinant DNA technologies. At the present time, very few products are listed in this publication. Some states will allow substitution with a biogeneric/biosimilar product only if the FDA has deemed it to be interchangeable with the brand-name product for the specific indication and if the prescribing doctor allows the substitution. At the present time, Nebraska does not address substitution with a biogeneric/biosimilar product. 38-28,109 Drug product selection; purposes of act Nebraska Revised Statute The purposes of the Nebraska Drug Product Selection Act are to provide for the drug product selection of equivalent drug products or interchangeable biological products and to promote the greatest possible use of such products. 38-28,116 Drug product selection; rules and regulations Nebraska Revised Statute (1) The department may adopt and promulgate rules and regulations necessary to implement the Nebraska Drug Product Selection Act upon the joint recommendation of the Board of Medicine and Surgery and the Board of Pharmacy. (2) The department shall maintain a link on its web site to the current list of all biological products that the federal Food and Drug Administration has determined to be interchangeable biological products. 36

38-2825.02 Interchangeable biological product means a biological product that the federal Food and Drug Administration: (1) Has licensed and has determined meets the standards for interchangeability pursuant to 42 U.S.C. 262(k)(4), as such section existed on January 1, 2017, or as set forth in the Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations published by the federal Food and Drug Administration, as such publication existed on January 1, 2017; or (2) Has determined is therapeutically equivalent as set forth in the Approved Drug Products with Therapeutic Equivalence Evaluations of the federal Food and Drug Administration, as such publication existed on January 1, 2017. 42 U.S.C. 262(k)(4) “Biological product” defined In this section: (1) The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. (2) The term “biosimilar” or “biosimilarity‘’, in reference to a biological product that is the subject of an application under subsection (k), means-- (A) that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and (B) there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product. (3) The term “interchangeable” or “interchangeability', in reference to a biological product that is shown to meet the standards described in subsection (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. (4) The term “reference product” means the single biological product licensed under subsection (a) against which a biological product is evaluated in an application submitted under subsection (k). (k) Licensure of biological products as biosimilar or interchangeable (1) In general Any person may submit an application for licensure of a biological product under this subsection. (2) Content (A) In general (i) Required information An application submitted under this subsection shall include information demonstrating that-- (I) the biological product is biosimilar to a reference product based upon data derived from-- (aa) analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; (bb) animal studies (including the assessment of toxicity); and (cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product; (II) the biological product and reference product utilize the same mechanism or mechanisms of action for the condition or conditions of use prescribed, recommended, or 37

suggested in the proposed labeling, but only to the extent the mechanism or mechanisms of action are known for the reference product; (III) the condition or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; (IV) the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product; and (V) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent. (ii) Determination by Secretary The Secretary may determine, in the Secretary's discretion, that an element described in clause (i)(I) is unnecessary in an application submitted under this subsection. (iii) Additional information An application submitted under this subsection-- (I) shall include publicly-available information regarding the Secretary's previous determination that the reference product is safe, pure, and potent; and (II) may include any additional information in support of the application, including publicly-available information with respect to the reference product or another biological product. (B) Interchangeability An application (or a supplement to an application) submitted under this subsection may include information demonstrating that the biological product meets the standards described in paragraph (4). (3) Evaluation by Secretary Upon review of an application (or a supplement to an application) submitted under this subsection, the Secretary shall license the biological product under this subsection if-- (A) the Secretary determines that the information submitted in the application (or the supplement) is sufficient to show that the biological product-- (i) is biosimilar to the reference product; or (ii) meets the standards described in paragraph (4), and therefore is interchangeable with the reference product; and (B) the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (4) Safety standards for determining interchangeability Upon review of an application submitted under this subsection or any supplement to such application, the Secretary shall determine the biological product to be interchangeable with the reference product if the Secretary determines that the information submitted in the application (or a supplement to such application) is sufficient to show that-- (A) the biological product-- (i) is biosimilar to the reference product; and (ii) can be expected to produce the same clinical result as the reference product in any given patient; and (B) for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. The Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm is applicable to conventional, easy to replicate, chemical-based drug compounds or small-molecule drugs. As noted in 38

its title, it only includes approved drug products but not unapproved drug products (e.g., phenazopyridine as a pre-1938 drug). Nebraska is an Orange Book state. So, both the generic drug product and brand-name drug product must have the same FDA bioequivalency rating (e.g., AA, AB, AB1, AB2, AB3, AN, AO, AP, or AT) before drug product selection can take place. Drug product selection cannot take place in Nebraska if either drug product is B-rated (e.g., B*, BC, BD, BE, BN, BP, BR, BS, BT, or BX) or not rated by the FDA. Definitions for the various ratings, along with ratings for drug products which have received FDA approval for safety and effectiveness, may be found in the Orange Book. Drug products are listed under the name of the applicant for an NDA (new drug application) or ANDA (abbreviated new drug application), which may or may not be the name of the manufacturer or distributor. Therefore, in some cases a pharmacist may have to check with the manufacturer or distributor in order to determine the name of the applicant. Most every state has a drug product selection law that allows a pharmacist to substitute a generic small-molecule drug product for the brand-name drug product originally prescribed. However, such drug product selection laws vary from state to state. For example, a state may have a positive formulary, a negative formulary, or no formulary at all. A positive formulary includes those drug products for which substitution is allowed, while a negative formulary includes those drug products for which substitution is not allowed (e.g., narrow therapeutic index drugs like digoxin or levothyroxine). Nebraska is a positive formulary state. In Nebraska, "drug product select means to dispense, without the practitioner's express authorization, an equivalent drug product in place of the brand-name drug product contained in a medical order of such practitioner." This means that a pharmacist can legally substitute a generic drug product for a trade-name or brand-name drug product without the prescriber’s express authorization as long as the generic drug product meets certain statutory requirements. It is important to note that not all generic drug products on the market today are acceptable for use in drug product selection in Nebraska. In Nebraska, a generic drug product is acceptable for use in drug product selection if: 1. it is chemically equivalent to the prescribed brand-name drug product (a) 2. it is bioequivalent to the prescribed brand-name drug product (b) 3. it is marked with an identification code or monogram directly on the dosage unit, if it is in solid dosage form 4. its product container is labeled with an expiration date 5. its manufacturer, distributor, or packager provides reasonable services to accept the return of drug products that have reached their expiration date 6. its manufacturer, distributor, or packager maintains procedures for the recall of unsafe or defective drug products (a) Based on Nebraska statutes, "chemically equivalent means drug products that contain amounts of the identical therapeutically active ingredients in the identical strength, quantity, and dosage form and that meet present compendial standards" (i.e., USP-NF). Note that 39

both the trade-name or brand-name drug product and the generic drug product must be the same dosage form (e.g., tablet, capsule). (b) Based on Nebraska statutes, "bioequivalent means drug products: 1. that are legally marketed under regulations promulgated by the federal Food and Drug Administration 2. that are the same dosage form of the identical active ingredients in the identical amounts as the drug product prescribed 3. that comply with compendial standards and are consistent from lot to lot with respect to purity of ingredients, weight variation, uniformity of content, and stability 4. for which the federal Food and Drug Administration has established bioequivalent standards or has determined that no bioequivalence problems exist" Some specific examples may be of help in understanding the drug product selection process in Nebraska: 1. Pamelor â (nortriptyline HCl) 25 mg cap is AB rated. Can a generic nortriptyline HCl 25 mg cap that is AB rated be substituted for Pamelor? Yes* 2. Diabeta â (glyburide) 1.25 mg tablet is AB2 rated. Can a generic glyburide 1.25 mg tablet that is AB1 rated be substituted for Diabeta â ? No** 3. If a brand name drug tablet is not rated in the Orange Book, can a generic tablet of the same strength that is unrated be substituted for the brand name drug? No** *This is drug product selection as allowed by Nebraska statute. **The prescriber must be contacted to obtain an authorization to dispense a generic drug product, unless the prescriber has indicated orally or in writing in some manner that generic substitution, or words of similar meaning, is acceptable (e.g., the prescriber has checked a box or circled "generic is allowed" on the prescription). The FDA has given some products an AB1, AB2, AB3, or AB4 rating. Can you substitute a drug product with an AB1 rating for a product with an AB4 rating? No. You can only substitute an AB1 rated drug product for an AB1 rated drug product. Otherwise, the prescriber should be contacted before substituting in such situations. If the prescription is written for by generic name (e.g., glyburide), with no mention of the brand name (e.g., Diabeta®), then there is no “drug product selection” occurring and the prescription can be filled with any FDA- approved generic product of the same active ingredient, strength and dosage form. Is a drug product that is B-rated or unrated by the FDA, a bad drug product? No. It simply means that they cannot be used in the drug product selection process in Nebraska (i.e., "without the practitioner's express authorization"). However, they can be dispensed with the express authorization of the prescriber. What should the pharmacist do if a prescriber writes a prescription generically for Ampicillin 500 mg cap instead of using a trade name? This is not a drug product 40

selection situation. The pharmacist should use professional judgment and dispense an acceptable product for the prescription. In Nebraska, the pharmacist may not drug product select if the prescriber specifies in a written (i.e., paper or electronic) prescription or communicates in an oral prescription (1) no drug product selection (NDPS), (2) dispense as written (DAW), (3) brand medically necessary (BMN), (4) no generic substitution, or words or notations of similar import to indicate that drug product selection is not permitted. In such situations, the pharmacist must contact the prescriber if the patient insists or if an insurance company or Medicaid requires that a generic drug product be dispensed. In Nebraska, the patient or designated representative or caregiver of such patient may instruct the pharmacist that drug product selection is not to be done: 38-28,111(1) A pharmacist may drug product select except when (b) A patient or designated representative or caregiver of such patient instructs otherwise. According to a Nebraska statute on drug product selection: 38-28,115(2) It is unlawful for any employer or such employer's agent to coerce a pharmacist to dispense a drug product against the professional judgment of the pharmacist or as ordered by a prescribing practitioner. The pharmacist should not assure or guarantee a patient that a generic is "exactly the same thing" as the trade-name or brand-name drug product. In reality, it may not be "exactly the same thing." However, the patient can be assured that it is the same chemical or active ingredient in the same dosage form, most likely manufactured/distributed by a different company, possibly in a different color and/or shape that according to the FDA should provide the same results. At one time, Nebraska had a statute which required that the generic drug product dispensed on all refills had to be from the same distributor and manufacturer as that dispensed on the initial filling. If that could not be done, a new prescription had to be obtained from the practitioner. However, that Nebraska statute was repealed. The use of "authorized generics" has caused confusion for some prescribers and pharmacists. 'It is important to note that authorized generics are not generic drugs, and are not listed in the Food and Drug Administration's (FDA) Orange Book of approved generic equivalents. They are brand name drugs in generic bottles, priced to take market share from the true generic." "Authorized generics result from brand pharmaceutical companies 'authorizing' a third party to sell the brand product disguised as a generic as soon as the first true generic begins to enjoy its...exclusivity." 10. Discuss when formularies can be established. 41

Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-28,112(3)(b) In Nebraska, a hospital can establish a formulary: 38-28,112(3) Nothing in this section shall (a) ... or (b) prohibit any hospital from developing, using, and enforcing a formulary. Drug formularies or drug policies and procedures for a hospital, are usually established through its Pharmacy and Therapeutics Committee (P & T Committee). If a practitioner (e.g., an MD) wants to have privileges within a hospital, he/she must agree to abide by the decisions of a hospital's P & T Committee. In this manner, pharmacists in a hospital may be able to therapeutically substitute or generically substitute certain drug products (e.g., B- rated or unrated) as long as such substitutions have received prior approval through the hospital's P & T Committee. Similarly, pharmacists in a hospital may be able to change the dosage form of a drug product without a specific order from a practitioner (e.g., an MD) as long as such changes have received prior approval through the hospital’s P & T Committee. 11. Discuss when a prescriber may legally dispense a prescription drug. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-2850(1) The ability of a prescriber to dispense a prescription drug to a patient varies from state to state. In Nebraska, the overall process of dispensing a prescription drug product includes the receipt of an oral or written prescription; interpreting, evaluating, verifying, and clarifying the prescription; selecting, repackaging, and labeling a drug product; keeping appropriate records; conducting a prospective drug utilization review; making a verbal offer to counsel the patient; etc. The Nebraska statute that pertains to the dispensing of prescription drugs by a Nebraska prescriber (i.e., practitioner) is as follows: 38-2850 As authorized by the Uniform Credentialing Act, the practice of pharmacy may be engaged in by a pharmacist, a pharmacist intern, or a practitioner with a pharmacy license. The practice of pharmacy shall not be construed to include: (1) Practitioners, other than veterinarians, certified nurse midwives, certified registered nurse anesthetists, nurse practitioners, and physician assistants, who dispense drugs or devices as an incident to the practice of their profession, except that if such practitioner engages in dispensing such drugs or devices to his or her patients for which such patients are charged, such practitioner shall obtain a pharmacy license. 42

According to this statute, some practitioners (i.e., prescribers) in Nebraska can dispense drug products without having to be licensed as a pharmacist. In addition, he/she does not have to obtain a license for a pharmacy if the dispensing is as an incident to the practice of his/her profession. At this time, there is confusion as to what "as an incident to the practice of his/her profession" actually means. A practitioner must obtain a license for a pharmacy if he/she dispenses drug products to his/her patients and charges the patients in some manner for the drug products. Each practitioner may dispense only to his/her patients and not to another practitioner's patients and such dispensing cannot be delegated to any other person. It is important to note, that any practitioner (i.e., prescriber) in Nebraska may distribute prescription drug samples that fall within his/her legal scope of practice to patients. A prescription drug sample will be labeled by the manufacturer, packager, or distributor as "sample, not for sale", "professional sample, not for sale", or words or notations of similar import. Only an MD, DO, DDS/DMD, DPM, and OD can obtain a license for a pharmacy in Nebraska in order to dispense drug products to his/her patients and charge the patients in some manner for the drug products. 12. Discuss the requirements relating to patient profiles, prospective drug use review, and patient counseling. Reference(s ): #1 Pharmacy Practice and the Law, pp. 306-313 (9 th Edition pp. 241- 247) #5 Statutes Relating to Pharmacy Practice Act, 38-2830 and 38- 2869(1)(a-b) & (2)(a-e) Optional Reading OBRA ’90 at Sweet Sixteen: A Retrospective Review by Jesse C. Vivian, BS Pharm., JD and Joseph L. Fink III, BS Pharm., JD ( US Pharm. 2008; 33(3):59-65.) http://www.uspharmacist.com/content/t/generic_medications,medicaid/c/1 0126/ This is about OBRA 90: Omnibus Budget Reconciliation Act of 1990 (OBRA 90) Up until the passage of OBRA 1990 (Public Law 101-508), federal law in the pharmacy arena was concerned primarily with drug product safety. OBRA 90, while not explicitly usurping the police powers of the states, required that in order to be eligible for federal matching dollars, each state participating in the Medicaid program would have to establish state standards for the following practice activity areas: Maintaining Proper Patient Records (i.e., patient profiles) 43

Pharmacists must make reasonable efforts to obtain, record, and maintain at least the following patient information: patient name, address, telephone number, age, gender, individual history where significant (including disease state or states, known allergies and/or drug reactions, and a comprehensive list of medications and relevant devices), and pharmacist comments relevant to the patient's drug therapy. Prospective Drug Utilization Review (ProDUR) Prior to dispensing a prescription, an evaluation of the patient record must be performed in order to detect potential therapy problems such as: therapeutic duplication; drug- disease contraindications; drug-drug reactions (including serious interactions with OTC medications); incorrect drug dosage or duration of drug treatment; drug-allergy interactions; and evidence of clinical abuse/misuse. Patient Counseling A requirement that pharmacists must offer to counsel regarding matters that are, in the pharmacist’s professional judgment, significant, which include but are not limited to: name and description of the medication, route of administration, dose, dosage form, and duration of therapy. Additionally, such standards must require pharmacists to discuss special precautions and directions, common severe side effects or interactions and therapeutic contraindications that may be encountered (including how to avoid them and what to do if they occur), proper storage, techniques for self-monitoring drug therapy, what to do if a dose is missed, and refill information. To avoid establishing two legal standards of care – one for Medicaid patients and another for non-Medicaid patients – states generally adopted standards to meet the OBRA 90 criteria while extending the standards to benefit all pharmacy patients, not just Medicaid patients (Catizone, et al., NABP Survey of Pharmacy Law, 1993). Pharmacy practice changed radically with OBRA 90 and became more patient-focused. Recall that at the federal level, OBRA 90 only pertained to Medicaid patients – not Medicare patients. You should know the difference between Medicare and Medicaid. Medicare was established by Title 18 of the Social Security Act and deals primarily with the elderly or disabled. It is mostly administered by the federal government. Medicaid was established by Title 19 of the Social Security Act and is usually for the economically disadvantaged. It involves federal and state dollars, and is administered on the state level. Let’s take a look at OBRA 90 from the state perspective… As we just mentioned, individual states came up with OBRA 90 equivalents to apply not just to Medicaid patients but to all patients that come into a pharmacy. An equivalent law usually: 1. requires a patient record be kept (i.e., patient profiles) 44

2. requires prospective drug utilization review (ProDUR) 3. mandates an offer to counsel (i.e., does NOT mandate patient counseling, just that the offer be made to counsel). Let’s take a closer look at these from the perspective of a pharmacist licensed in Nebraska: 38-2869 (1)(a) Prior to the dispensing or the delivery of a drug or device pursuant to a medical order to a patient or caregiver, a pharmacist shall in all care settings conduct a prospective drug utilization review. Such prospective drug utilization review shall involve monitoring the patient-specific medical history described in subdivision (b) of this subsection and available to the pharmacist at the practice site for: (i) Therapeutic duplication; (ii) Drug-disease contraindications; (iii) Drug-drug interactions; (iv) Incorrect drug dosage or duration of drug treatment; (v) Drug-allergy interactions; and (vi) Clinical abuse or misuse. (b) A pharmacist conducting a prospective drug utilization review shall ensure that a reasonable effort is made to obtain from the patient, his or her caregiver, or his or her practitioner and to record and maintain records of the following information to facilitate such review: (i) The name, address, telephone number, date of birth, and gender of the patient; (ii) The patient's history of significant disease, known allergies, and drug reactions and a comprehensive list of relevant drugs and devices used by the patient; and (iii) Any comments of the pharmacist relevant to the patient's drug therapy. 45

(c) The assessment of data on drug use in any prospective drug utilization review shall be based on predetermined standards, approved by the board. (2)(a) Prior to the dispensing or delivery of a drug or device pursuant to a prescription, the pharmacist shall ensure that a verbal offer to counsel the patient or caregiver is made. The refusal of the verbal offer to counsel must be documented. The counseling of the patient or caregiver by the pharmacist shall be on elements which, in the exercise of the pharmacist's professional judgment, the pharmacist deems significant for the patient. Such elements may include, but need not be limited to, the following: (i) The name and description of the prescribed drug or device; (ii) The route of administration, dosage form, dose, and duration of therapy; (iii) Special directions and precautions for preparation, administration, and use by the patient or caregiver; (iv) Common side effects, adverse effects or interactions, and therapeutic contraindications that may be encountered, including avoidance, and the action required if such effects, interactions, or contraindications occur; (v) Techniques for self-monitoring drug therapy; (vi) Proper storage; (vii) Prescription refill information; and (viii) Action to be taken in the event of a missed dose. (b) The patient counseling provided for in this subsection shall be provided in person whenever practical or by the utilization of telepharmacy which is available at no cost to the patient or caregiver. (c) Patient counseling shall be appropriate to the individual patient and shall be provided to the patient or caregiver. (d) Written information may be provided to the patient or caregiver to supplement the patient counseling provided for in this subsection but shall not be used as a substitute for such patient counseling. If written information is provided, it shall also include all information found on the prescription label. (Repealed, 2007 ) (e) A verbal offer to counsel is not required when: (i) The pharmacist, in his or her professional judgment, determines that patient counseling may be detrimental to the patient's care or to the relationship between the patient and his or her practitioner; 46

(ii) The patient is a patient or resident of a health care facility or health care service licensed under the Health Care Facility Licensure Act to whom prescription drugs or devices are administered; PATIENT PROFILES: Nebraska law is identical to federal law with respect to patient profiles (although as we mentioned the federal standards only deal with Medicaid patients, while the Nebraska standards extend these provisions to all patients in the state). The provisions of section 38-2869 above outline some of the information the pharmacist should make a reasonable effort to obtain from the patient (e.g., name, address, telephone number, date of birth, gender, etc.). The pharmacist is not required to personally obtain this information from the patient. He/she can allow a pharmacy technician to collect all the basic information, but the pharmacy technician cannot interpret the significance of this information. Only the pharmacist can interpret the information. A good addition to the information suggested would be the patient’s occupation. For example: If the patient is a truck driver or a construction worker and you are dispensing diphenhydramine (or any other drug that will or may cause drowsiness), the patient should be counseled not to drive or operate machinery due to the danger involved while drowsy. DRUG UTILIZATION REVIEW: Nebraska law is identical to federal law with respect to drug utilization review (although as we mentioned the federal standards only deal with Medicaid patients, while the Nebraska standards extend these provisions to all patients in the state). Prospective DUR must be done in all care settings prior to the dispensing or the delivery of a drug or device pursuant to a medical order to a patient or caregiver. This includes each new and refill prescription. DUR is in many ways the essence of pharmacy practice today. It is the act of reviewing a patient’s drug therapy to look for therapeutic duplication, drug-disease contraindications, drug interactions, incorrect dosage or duration of drug treatment as well as reviewing for drug-allergy interactions and clinical abuse/misuse. When performed as intended, the DUR process is a great quality control and safety procedure in the drug use process from the patient’s perspective. Can you delegate this DUR function to a pharmacy technician? No. Can a pharmacist intern do DUR? Yes. DUR also usually involves pharmacy software. So, when you get a positive interaction screen that pops up, a pharmacy technician CANNOT override this screen. Only a pharmacist exercising his/her professional judgment is allowed to make the decision to override a DUR warning. DUR and the issues that surround it could be the area of greatest potential civil liability for pharmacists. Another possible item (i.e., optional but a good idea) you should screen for during the DUR process: drug-prescriber contraindication. Can an oncologist prescribe a cardiac medication? Legally, yes, physicians have unlimited prescribing authority; but this may be a red flag. For example, an Alabama Supreme Court case involved a prescription from an oncologist who was writing for tamoxifen but somehow a mix-up occurred and the prescription was filled with Tambocor â , an antiarrhythmic heart medication. Although an oncologist has every legal right to prescribe Tambocor â , the court ruled that the pharmacist should have caught this error because he should have at least asked why the 47

doctor was prescribing this heart medication – not because it was illegal from a scope-of- practice perspective, but because it was unusual for an oncologist to be prescribing a cardiac medication. This might have alerted the physician to the fact that this was not the drug he/she intended to prescribe. This is why it is important to know what the specialty of the prescriber is and know his/her prescribing habits. As pharmacists, we are not in the business of second-guessing every prescription or order for medication that we see, but it doesn’t hurt to do a little detective work once in a while!! The combination of sound professional knowledge, astute judgment and a little common sense can go a long way in protecting our patients and in reducing our liability exposure. PATIENT COUNSELING: There are differences between Nebraska and federal requirements. OBRA 90 requires that an offer be made to discuss the prescription with each Medicaid recipient or caregiver. This offer is applicable to all prescriptions – both new and refill. Pharmacies could have a sign posted saying if you have questions, ask the pharmacist. This is considered an offer to counsel from the federal perspective. Or you could put a note in the sack saying the same thing – even for those who can’t read or don’t understand English. This meets OBRA 90 requirements from the federal perspective. Also, the pharmacy technician can make the offer but should not simply say, “You don’t want to talk to the pharmacist, do you?” It is not appropriate to make the offer in a manner that encourages refusal. If the offer to counsel is accepted, then either the pharmacist or pharmacist intern can do the counseling but the pharmacy technician cannot.  In Nebraska, this scenario is a little bit different. Look at reference #5, 38-2869 subsection 2(a): Prior to dispensing, the pharmacist shall ensure that a verbal offer to counsel the patient is made. A sign would not be adequate under Nebraska law, although it is acceptable under federal law for Medicaid patients. The pharmacy technician can still make the offer, but the offer must be verbal. Subsection 2(a) (i-viii) outlines some items that could be covered in counseling. You don’t have to cover every one of these but must use your professional judgment as to what you cover on each prescription. For instance, you probably want to cover more on an initial prescription versus on a refill. You probably only want to cover common side effects, not all the side effects covered in the package insert, which usually includes lots and lots of side effects. An example of a common side effect is drowsiness with diphenhydramine. You should always warn the patient about such dramatic side effects.  In Nebraska, patient counseling is not required, but a verbal offer to counsel the patient must occur prior to dispensing each new or refill prescription. Ideally, the interaction between pharmacy personnel and patient during this offer should be documented to protect the pharmacist. In the event that an error is made in filling a prescription and the matter comes before the Board, the Board will likely look at the documentation and take into consideration whether the offer was made and refused or not made at all. The Board's position is that patient counseling performed correctly and appropriately, can help pharmacists detect incorrectly filled prescriptions and other mistakes before they can harm the patient. A patient’s refusal of counseling must be documented. 48

Practice Tip: When a patient comes in for a refill, you have an excellent opportunity to determine if s/he is experiencing any side effects or problems with the medication. These may or may not be clinically significant, but you won’t know until you ask – a good patient care and risk management technique. An open-ended question like “How has the medication been working for you?” is a good start. A useful follow-up question could be “Have you been experiencing any problems or side-effects while using this medication?” You may uncover an unanticipated problem that saves both you and your patient a lot of grief in the long run!! Reference #5, 38-2869(2)(a), requires that a patient's refusal of counseling is documented. Reference #5, 38-2869(2)(d), refers to written information that may be provided to supplement patient counseling – a great tool for reinforcing the verbal counseling – but, remember, written material does not and cannot replace patient counseling. 13. Discuss privileged and confidential patient information. Reference(s) : #1 Pharmacy Practice and the Law, pp. 313-324 (9 th Edition pp. 247- 256) #5 Statutes Relating to Pharmacy Practice Act, 38-2868(1)(a-d) Summary of the HIPAA Privacy Rule - April 11, 2003 – see Additional Readings document linked on Selecting and Dispensing BlueLine introduction page. The complete administrative rules implementing HIPAA http://www.hhs.gov/ocr/privacy/hipaa/administrative/privacyrule/index.ht ml HIPAA as the actual federal law in its entirety http://aspe.hhs.gov/admnsimp/pl104191.htm HIPAA Frequently Asked Questions http://www.hhs.gov/ocr/privacy/hipaa/faq/index.html Readings from the CMS HIPAA Security Series Required: #1: Security 101 for Covered Entities at: https://www.hhs.gov/hipaa/for- professionals/security/guidance/index.html Optional: #2: Administrative Safeguards at: https://www.hhs.gov/hipaa/for- professionals/security/guidance/index.html In this section, you will find educational materials to help you learn more about the HIPAA Security Rule and other sources of standards for safeguarding electronic protected health information 49

(e-PHI). Optional: #3: Physical Safeguards at: https://www.hhs.gov/hipaa/for- professionals/security/guidance/index.html Optional: #4: Technical Safeguards at: https://www.hhs.gov/hipaa/for- professionals/security/guidance/index.html Optional: #5: Organizational, Policies & Procedures & Documentation Requirements at: https://www.hhs.gov/hipaa/for- professionals/security/guidance/index.html Optional: HIPAA Security Requirements: Final Rule as Published in the Federal Register http://www.gpo.gov/fdsys/pkg/FR-2003-02-20/pdf/03-3877.pdf HIPAA Privacy Rule Prior to the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this issue was addressed exclusively by state law. New stringent (federal) requirements have come out about patient confidentiality. These are the federal HIPAA regulations. Prior to HIPAA, Nebraska law (reference #5 at 38-2868) outlined the four circumstances under which you could release patient information to: 1. the patient or the caregiver of the patient or others authorized by the patient or his or her legal representative 2. a physician treating the patient 3. other physicians or pharmacists when, in the professional judgment of the pharmacist, such release is necessary to protect the patient’s health or well being 4. other persons or governmental agencies authorized by law to receive such information HIPAA regulations have expanded upon these and where more strict take precedence over Nebraska law. (Note: For those who practice in other states with requirements more stringent than HIPAA, you need to know and follow the law in that state). Employees also need training in order to abide by HIPAA standards, and the federal government requires documentation that employees have completed this training. Release of information requires documentation under HIPAA requirements. In general, when making a decision to release information, you need to ask “what is the person’s need to know the information.” Also, you need to ask “if they have a signed release from the patient before giving out the information.” After the passage of HIPAA in 1996, the Department of Health and Human Services began the (often lengthy) process of developing administrative rules for the implementation of a 50

federal law. For HIPAA, this process culminated with the issuance of the Final Rule, effective April 14, 2003. During the intervening years there was a great deal of public comment and input into the development of what became the Final Rule. The following links to government websites concerning HIPAA are optional for this course, but are recommended for deeper understanding of HIPAA and presented here so that you have them available as references. You might want to consider downloading and saving some of these in their pdf versions and keeping them on your hard drive and/or printing them out. Health Insurance Portability and Accountability Act of 1996 (HIPAA) Resources: · Click the following link to see the US Department of Health and Human Services, Office of Civil Rights (OCR) Summary of the HIPAA Privacy Rule https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html · The HIPAA Security Requirements: Final Rule as Published in the Federal Register are very lengthy, you might consider just checking the summary. · And, click the following to see HIPAA as the actual federal law in its entirety (optional) The rules implementing this federal statute became effective as of April 14, 2003. This statute and its rules established, for the first time, federal standards for protecting the privacy and security of patients’ “protected health information” or PHI. These standards include, but are not limited to, how patient protected health information must be stored, under what conditions it may be released, and to whom it may be released. This law has sweeping implications for pharmacies and pharmacists alike. The HIPAA privacy rules are designed to strike a balance between maintaining the flow of patients’ health information among those persons and entities necessary for providing health care to patients while simultaneously maintaining privacy for individuals. Essentially, this combination of statute and implementing regulations increases privacy and security for private information by establishing a “need to know” basis for who may have access to someone’s protected health information and to what extent they may have that access. Further, it establishes requirements for security of storage and for transmission of protected health information by anyone who has access to the information. Pharmacy managers in all settings are responsible for making sure that their pharmacy staff members and pharmacy policies and procedures are in compliance with HIPAA. The following is from a list of Frequently Asked Questions on the US Health & Human Services website. Question : Generally, what does the HIPAA Privacy Rule require the average provider or health plan to do? Answer : For the average health care provider or health plan, the Privacy Rule requires activities, such as: 51

· Notifying patients about their privacy rights and how their information can be used (and keeping a record of your having notified them). · Adopting and implementing privacy procedures for its practice, hospital, or plan. · Training employees so that they understand the privacy procedures. · Designating an individual to be responsible for seeing that the privacy procedures are adopted and followed. · Securing patient records containing individually identifiable health information so that they are not readily available to those who do not need them. Responsible health care providers and businesses already take many of the kinds of steps required by the Rule to protect patients’ privacy. Covered entities of all types and sizes are required to comply with the Privacy Rule. To ease the burden of complying with the new requirements, the Privacy Rule gives needed flexibility for providers and plans to create their own privacy procedures, tailored to fit their size and needs. The scalability of the Rule provides a more efficient and appropriate means of safeguarding protected health information than would any single standard. For example: · The privacy official at a small physician's practice may be the office manager, who will have other non-privacy related duties; the privacy official at a large health plan may be a full-time position, and may have the regular support and advice of a privacy staff or board. · The training requirement may be satisfied by a small physician's practice providing each new member of the workforce with a copy of its privacy policies and documenting that new members have reviewed the policies; whereas a large health plan may provide training through live instruction, video presentations, or interactive software programs. · The policies and procedures of small providers may be more limited under the Rule than those of a large hospital or health plan, based on the volume of health information maintained and the number of interactions with those within and outside of the health care system. HIPAA establishes federal standards for protecting the privacy and security of patients’ protected health information (PHI). HIPAA privacy rules are designed to strike a balance between maintaining the flow of patients’ PHI among those persons and entities necessary for providing health care to patients while simultaneously maintaining privacy for individuals. It establishes requirements for security of storage and for transmission of PHI by anyone who has access to the information. In the day-to-day operation of a pharmacy, a pharmacist manager in all settings needs to understand and comply with the requirements for the following areas: 1) Who is covered by the Privacy Rule? 52

The Privacy Rule considers health plans, health care providers and health care clearinghouses as covered entities. “Every health care provider, regardless of size, who electronically transmits health information in connection with certain transactions, is a covered entity” (US Department of Health & Human Services, Office of Civil Rights, May 2003). This definition includes pharmacies. 2) What information is protected? According to the Department of Health and Human Services Office of Civil Rights, “The Privacy Rule protects all ‘individually identifiable health information’ held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule calls this information "protected health information” (PHI). Further, the Privacy Rule states that “individually identifiable health information” is information, including demographic data, which relates to the: · individual’s past, present or future physical or mental health or condition, · provision of health care to the individual, or · past, present, or future payment for the provision of health care to the individual, and that identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual. Individually identifiable health information includes many common identifiers (e.g., name, address, birth date, Social Security Number). (US Department of Health & Human Services, Office of Civil Rights, May 2003). 3) What must the Covered Entity do to protect information? The following areas summarize what a pharmacy manager (a person who also may be the “privacy officer”) must be aware of: · Employee Training Employees of the pharmacy must be trained in HIPAA rules and procedures as a condition of employment. Newly hired personnel must receive training before being allowed to work with PHI. This training must be documented as having been completed and repeated if necessary for employees who do not perform up to the standard. At a minimum, the training must include making clear to employees: 1) how, to whom, to what extent, and under what circumstances, PHI may be released, and 2) that patients’ PHI must not be included in casual conversations with others – even in conversations with other health care providers if they are not involved in the patient’s care. Also, employee access to PHI must be restricted to what is necessary in the performance of their duties. 53

· Notice of Privacy Practices Under the HIPAA Privacy Rules, all covered entities are required to provide patients with a “notice of privacy practices.” The covered entity must provide this notice to all patients and it must be written in understandable language. The privacy officer, most likely the pharmacy manager, is responsible for documenting patient signatures acknowledging receipt of the notice, documenting the reasons for any patient refusals of the notice, or any patient refusals to sign in acknowledgment of having received the notice. The covered entity must maintain records of these documents for six years. Again, the importance of maintaining well-organized and easily retrievable records cannot be overemphasized. · Business Associates A business associate is a person or organization, other than a member of a covered entity's workforce, that performs certain functions or activities on behalf of, or provides certain services to, a covered entity that involve the use or disclosure of individually identifiable health information. Business associate functions or activities on behalf of a covered entity include claims processing, data analysis, utilization review, and billing. Business associate services to a covered entity are limited to legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, or financial services. However, persons or organizations are not considered business associates if their functions or services do not involve the use or disclosure of protected health information, and where any access to protected health information by such persons would be incidental, if at all. A covered entity can be the business associate of another covered entity. When a covered entity uses a contractor or other non- workforce member to perform "business associate" services or activities, the Rule requires that the covered entity include certain protections for the information in a business associate agreement (in certain circumstances governmental entities may use alternative means to achieve the same protections). In the business associate contract, a covered entity must impose specified written safeguards on the individually identifiable health information used or disclosed by its business associates. Moreover, a covered entity may not 54

contractually authorize its business associate to make any use or disclosure of protected health information that would violate the Rule (US Department of Health & Human Services, Office of Civil Rights, May 2003). A pharmacy manager and/or privacy officer (in consultation with legal counsel) should tailor the pharmacy’s relationships with business associates via the business associate contract. The goals of an appropriately constructed business associate contract are to minimize the business associate’s exposure to protected health information (PHI) while clearly establishing what uses of the PHI by the business associate are permitted. The privacy officer should have a clear idea of what business associates plan to do with any PHI that they obtain and should make sure that any subcontractors have similar agreements. The privacy officer should monitor the business associate for any violations of the contract. In fact, the contract should stipulate that it is the responsibility of the business associate to report unauthorized disclosures of PHI. Finally, the privacy officer is responsible for the disposition of any PHI released to the business associate and should make sure that after it has been used by the business associate, PHI is either returned, held securely, or destroyed. · Patient Authorization Required for Release of PHI A pharmacy, as a covered entity, needs to obtain a patient’s written authorization for any disclosure or use of PHI that is not for treatment, payment or health care operations. This authorization cannot be used as a pre-condition for benefits eligibility, payment or treatment. The authorization document must be written in plain and specific language and it may allow use and disclosure of protected health information by the covered entity. An example of a disclosure of PHI that would require a written authorization by a patient is disclosure of PHI to a drug manufacturer for its marketing purposes. All authorizations must specify what information may be disclosed and must identify the person(s) disclosing and receiving the information, must specify an expiration date for the authorization document, and must state that a patient has the right to revoke the authorization in writing. Patient authorization for the release of PHI is not required for circumstances such as situations where the pharmacist reports spousal abuse or child neglect, becomes involved in legitimate law enforcement situations (including compliance with worker’s compensation laws), is avoiding a threat to health or safety, or is reporting an adverse drug reaction to the FDA. · Circumstances Where PHI May be Released without Explicit Patient Authorization Protected Health Information may be released without explicit patient authorization under certain circumstances defined in the law and rules. These circumstances (with examples) include: treatment (as when a pharmacist discusses a patient’s 55

condition with the patient’s physician), payment (as when a claim for payment is submitted to a third-party payer), regular healthcare operations (as with the transfer of PHI among departments within a hospital), and when the information has been “de-identified” . Protected Health Information is considered to be de-identified when the following data elements have been removed: · Patient’s name, Social Security Number, telephone and/or fax numbers · Patient’s town, street address, and/or zip code (State of residence need not be removed) · Any dates of service (except year) · Medical record number, health plan number, account number and/or prescription number · Any vehicle identifiers (e.g., license plate number) · Medical device identifiers and/or serial numbers · Patient’s website URL, computer IP address, and/or email address · Biometric identifiers · Photo images (identifiable) · Any other unique characteristic or code Remember, though, that de-identification of information is not necessary between covered entities involved in the patient’s care. De-identification is also not necessary between a covered entity and a business associate with which the covered entity has a business associate contract. 56

The HIPAA law and HIPAA rules have created considerable confusion for many pharmacy managers who have wondered about how this change may affect normal operations in their pharmacies. For example, questions arise regarding situations like when a neighbor is picking up a prescription for a patient. (Yes, the pharmacist may release the prescription to the neighbor and counsel that neighbor as the patient’s “agent”.) In response to these sorts of questions, the HIPAA Frequently Asked Questions database listed in the References for this section provides answers to many common questions about how HIPAA is applied in a wide variety of healthcare practice situations. Finally, here's another important point to consider, regardless of the state where you may practice eventually. An October 1999 Nebraska Board of Pharmacy bulletin addressed the safe disposal of empty medication vials and confidential information. These items must be properly destroyed because they contain confidential medical information. Pharmacies cannot just throw such items out in the dumpster. Dumpsters can be combed to obtain confidential information. Discarded prescription containers might be fraudulently used to obtain refills or to obtain information about one of your patients. This is an issue that was being addressed by a number of individual states even prior to the enactment of HIPAA. (Hint: Sometimes the simplest way to deal with this situation is to give the old empty vial back to the patient and let him/her dispose of it.) HIPAA Security Rule HIPAA Security Standards are designed to protect the security of electronic PHI (i.e., EPHI) throughout the following phases: transmission, storage and disposal. The required reading, #1: Security 101 for Covered Entities clearly explains the rationale for implementation of the HIPAA Security Standards and helps draw the distinction between Privacy and Security . One way to think about this difference is to use a bank as an example. A bank keeps your account information private by not telling anyone else about your bank balance while also keeping your funds secure by not letting someone else have access to them without your permission. It wouldn't make much sense to have privacy with no security when it comes to your money, and the rationale for HIPAA Security Standards follows the same logic. Requiring that Covered Entities maintain the privacy of EPHI without standards for maintaining security would make as much sense as a bank without security. Page 4 of Security 101 for Covered Entities also puts this comparison into context: "The Privacy Rule sets the standards for, among other things, who may have access to PHI, while the Security Rule sets the standards for ensuring that only those who should have access to EPHI will actually have access." 57

Selling Nonlegend Controlled Substances and Other Nonlegend Products Objective: At the conclusion of this lesson, the student should be able to: 1. discuss the over-the-counter sale of nonlegend Schedule V controlled substances; ephedrine, pseudoephedrine, and phenylpropanolamine products; emergency contraceptives; syringes and needles; poisons; hazardous substances; and acetone-based products. 1. Discuss the over-the-counter sale of nonlegend Schedule V controlled substances; ephedrine, pseudoephedrine, and phenylpropanolamine products; emergency contraceptives; syringes and needles; poisons; hazardous substances; and acetone-based products. Reference(s): #1 Pharmacy Practice and the Law, pp. 279, 234-235, 146-148, & 144-145 8 th Ed pp. 220-221, 186-187, 112-113, 110-111 9 th Ed #5 Statutes Relating to Pharmacy Practice Act, 28-414.01(1); 28-456(1)(a-e), 28-456.01(1)&(2), & 28-405 Schedule IV (g) 58

(2)(A)-(E) & (i-ii); 28-439 & 28-442(1)&(2); 71-2501 to 71- 2503 & 71-2507 to 71-2510; and 28-419 to 28-424 Schedule V Controlled Substances https://www.deadiversion.usdoj.gov/21cfr/21usc/812.htm According to federal law, "a controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that: (a) Such dispensing is made only by a pharmacist, and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist); (b) Not more than 240 cc (8 ounces) of any such controlled substance containing opium, nor more than 120 cc (4 ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period; (c) The purchaser is at least 18 years of age; (d) The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish suitable identification (including proof of age where appropriate); (e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser; and (f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or local law." According to federal law, “pharmacist means any pharmacist licensed by a state to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State." In addition, an electronic record of OTC sales is 59

allowed, as long as the record and purchaser’s signature are captured and can be reproduced for law enforcement purposes. According to Nebraska law, all controlled substances are legend and can only be dispensed pursuant to an oral or written prescription (i.e., they cannot be sold over-the- counter to a patient for self treatment). Ephedrine (EPH), Pseudoephedrine (PSE), and Phenylpropanolamine (PPA) Products According to federal law, the following requirements must be followed for the over-the- counter (OTC) sale of single and multi-ingredient ephedrine, pseudoephedrine, and phenylpropanolamine drug products: 1. 3.6 gram daily "sales" limit to the same purchaser (i.e., each person per day) 2. 9.0 gram 30-day "purchase" limit to the same purchaser (i.e., each person over 30 days) 3. all non-liquid forms must be sold in blister packs or unit dose packets or pouches 4. products must be placed behind a counter or in a locked cabinet 5. 7.5 gram 30-day "sales" limit for mobile sellers (such as kiosks in airports) 6. 7.5 gram 30-day "purchase" limit for mail-service pharmacy 7. seller must maintain a written or electronic logbook* which must identify the product name, quantity sold, names and addresses of purchasers, and dates and times of sales** (this requirement does not apply to sales of 60 mg or less of pseudoephedrine) 8. purchasers must present a photo ID and sign the logbook (this requirement does not apply to sales of 60 mg or less of pseudoephedrine) 9. mail-service pharmacy must verify patient's identification before shipping product 10.sellers must self-certify to the U.S. Attorney General that their sales personnel have been trained as required by regulations 60

*A written logbook must be bound. All logbooks must be kept a minimum of two years after the date on which the entry is made. **The DEA suggests that retailers treat the logbook as if it is subject to all HIPAA requirements and that retailers should "make some attempt to ensure that customers can only see their own information." It is important to note, that PPA products are currently not approved for any sales for human use in the United States. According to federal law, retailers must train all individuals who deliver these products to purchasers and cashiers who receive payments to ensure that these persons understand the applicable requirements. Training certification consists of the following: 1. retailers must certify that all retail store employees who conduct such sales transactions have been trained 2. retailers must maintain certifications and records to confirm employee training (each employee must sign an acknowledgment that he/she has received the training, which is kept in his/her personnel file) 3. certifications must state that the retailer understands the legal requirements and agrees to comply with them 4. separate certifications are required for each place of business 5. DEA will establish certification criteria through the regulatory process, but must provide for self-certifications 6. state and local officials will have access to certifications 7. retailers will be able to submit self-certifications over an internet website to be established by DEA and receive an acknowledgement of that submission Lastly, retail stores should take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of these products, including asking job applicants whether they have been convicted of any crime involving or related to these products or controlled substances. If loss or theft of these products occurs, an oral report should be made to the local DEA Diversion Field Office. In addition, a written report must be filed within 15 days after the pharmacist becomes aware of the loss or theft. A written report should include the DEA registration 61

number (if applicable), name, business address, date of loss, type of loss, and a description of the circumstances of the loss (e.g., in-transit, theft from premises). It is important to note, that all single-entity and most combination ephedrine products are Schedule IV controlled substances (i.e., legend drugs) in Nebraska. Primatene tablets and Bronkaid Dual Action Caplets (but not their generic equivalents) are currently exceptions to this scheduling and can be sold as OTC products in Nebraska. However, OTC sales of these two brand-name drug products in Nebraska are subject to the federal law requirements listed above. In addition to the federal requirements listed above, the following Nebraska requirements must be followed for the over-the-counter (OTC) sale of single and multi-ingredient pseudoephedrine products and for the over-the-counter (OTC) sale of Primatene Tablets and Bronkaid Dual Action Caplets: 1. retail employees selling such products and the customers purchasing them must be 18 years of age or older 2. solid dosage units must be packaged in blister packs, each blister containing not more than two dosage units, or if the use of blister packs is technically infeasible, in unit dose packets or pouches. Lastly, Primatene Tablets and Bronkaid Dual Action Caplets cannot be "marketed, advertised, or represented in any manner for the indication of stimulation, mental alertness, euphoria, ecstasy, a buzz or high, heightened sexual performance, or increased muscle mass" in Nebraska. These federal and Nebraska requirements for OTC sales do not apply to ephedrine or pseudoephedrine products dispensed pursuant to an oral or written prescription. Emergency Contraceptives There is confusion with regard to the over-the-counter (OTC) sale of morning-after emergency contraceptives. Based on a US court order, Plan B One Step is “now available in the United States to all women of child-bearing age as an over-the-counter product without age or point-of-sale restrictions.” The FDA subsequently provided the same access to the generic equivalents of that product. At this time, the status (i.e., legend versus nonlegend) of the 2-pill Plan B is not clear. Therefore, its labeling must be checked in order to verify its status. It is possible, that some states may have passed a law that is more stringent than federal law with regard to emergency contraceptives. Nebraska has not done that. There is some evidence that products “containing levonorgestrel are completely ineffective for women weighing more than 176 pounds and begin to lose effectiveness in women weighing more than 165 pounds.” 62

Syringes and Needles In Nebraska, syringes and needles may be sold over-the-counter (OTC) to patients for their legitimate use. This includes a pharmacist selling "hypodermic syringes or needles for the prevention of the spread of infectious diseases." The possession of syringes or needles for other than a legitimate use may be viewed as possession of drug paraphernalia. It is important to note, that states other than Nebraska may require a prescription for syringes or needles, or may restrict the purchase of syringes or needles over-the-counter to a pharmacy. Poisons There are requirements in Nebraska for the over-the-counter sale (OTC) of poisons (e.g., mineral acids, such as hydrochloric acid, sulfuric acid, and boric acid): 1. it shall be unlawful for any person, other than a duly registered pharmacist, to sell or dispense poisons… 2. it shall be unlawful for any person in this state to sell or deliver any poison to any minor under eighteen years of age or to any person known to be of unsound mind or under the influence of intoxicants. 3. such OTC sales of poisons in Nebraska must be recorded in a Poison Register which contains the date of sale, the name and address of the purchaser, the name and quantity of the poison, the purpose for which it is purchased, and the name of the dispenser. The Poison Register shall be signed by the person to whom the poison is delivered. An electronic register is allowed, as long as the record and purchaser’s signature are captured and can be reproduced for law enforcement purposes. The Poison Register must be preserved for at least two years after the last entry. It is recommended that poisons be sold only in their original container as labeled with all of the required cautions and warnings. Hazardous Substances The Federal Hazardous Substances Act is applicable to products stocked in some pharmacies. "A hazardous substance can be defined as a substance or a mixture of substances that can cause injury or illness through handling and that can cause potential danger, especially to children, if misused." Examples of hazardous substances include bleach, cleaning fluids, antifreeze, drainpipe cleaners, etc. It is recommended that hazardous substances be sold only in their original container as labeled with all of the required cautions and warnings. Acetone-based Products Some pharmacies stock various types of model kits (e.g., airplane, car, ship) for sale. Along with those model kits, acetone-based glues are frequently stocked. Those acetone- based glues have been misused (e.g., inhaled). The following Nebraska statutes are applicable to such products: 63

28-419 No person shall breathe, inhale, or drink any compound, liquid or chemical containing...acetone... ethyl alcohol…or any other substance for the purpose of inducing a condition of intoxication, stupefaction, depression, giddiness, paralysis, inebriation, excitement, or irrational behavior, or in any manner changing, distorting, or disturbing the auditory, visual, mental or nervous processes. For the purposes of section 28-419 to 28-424, any such condition so induced shall be deemed an intoxicated condition. 28-420 No person shall knowingly sell or offer for sale, deliver or give to any person any compound, liquid or chemical or any other substance which will induce an intoxicated condition as defined in section 28-419, when the seller, offerer or deliverer knows or has reason to know that such compound is intended for use to induce such condition. 28-421 The provisions of sections 28-419 to 28-424 shall not apply to the use or sale of such substances…when such use or sale is administered or prescribed for medical or dental purposes, nor shall the provisions of sections 28-419 to 28-424 apply to the use or sale of alcoholic liquors… 28-422 Every person selling or offering for sale at retail any of the substances as defined in section 28-419, shall maintain a register in which are recorded the date of each sale, the quantity sold, and the name and address of the purchaser. The record of each sale shall be available for inspection by any peace officer for at least one year. 64

Registration and Enforcement Objectives: At the conclusion of these lessons, the student should be able to: 1. identify various federal and Nebraska registrations and licenses for a pharmacy. 2. discuss possible pharmacy inspections by federal and Nebraska personnel, including warrant procedures. 1. Identify various federal and Nebraska registrations and licenses for a pharmacy. Reference(s) : #1 Pharmacy Practice and the Law, 8th edition pp. 211-219, 268- 270, 271-272, 385-387; 9 th edition pp. 168-174, 212-215, 305- 307 #5 Statutes Relating to Pharmacy Practice Act, 38-2872 to 38-2889 and 71-432 to 71-437 #7 Regulations Governing Licensure of Pharmacies, 8-003 to 8-005 Federal registrations/licenses: According to federal law, facilities in which traditional pharmacy practice is occurring and human drug preparations are compounded pursuant to prescriptions for individual patients do not have to register with the FDA but must be licensed as a pharmacy in the state where they are located. However, facilities in which traditional pharmacy practice is not occurring and human drug preparations are compounded without prescriptions for individual patients may voluntarily elect to register with the FDA as an outsourcing facility. It is important to emphasize, that an outsourcing facility is allowed to sell compounded drug preparations in bulk to hospitals and physician practices without prescriptions for 65

individual patients. While an outsourcing facility is not required to be licensed as a pharmacy in the state where it is located, it can elect to do so. If manufacturing is occurring in a traditional pharmacy, the traditional pharmacy must obtain a federal registration for manufacturing from the FDA. As a manufacturer, the traditional pharmacy then becomes subject to inspection by the FDA and is required to be in compliance with the FDA's Current Good Manufacturing Practices (CGMPs). A traditional pharmacy does not need to register as a manufacturer if only activities defined as compounding are occurring in the pharmacy. Federal law ( 21CFR §207.10 ) states clearly the exemption from registration as a manufacturer for traditional pharmacies (subparagraph "a") and for hospitals (subparagraph "b") in which manufacturing is not occurring. Also, if a traditional pharmacy is registered as a manufacturer, and manufacturing activities involve controlled substances, further registration with the DEA as a manufacturer of controlled substances is required by federal law ( 21CFR § 1301.13 ). A DEA registration is required for each pharmacy in which pharmacists are dispensing controlled substances, with appropriate schedules approved. Such registration is valid for 3 years. If a pharmacy moves to a new address or physical location, but ownership remains the same, an updated DEA registration certificate reflecting the respective change must be obtained. If the name of the pharmacy is changed, but ownership remains the same, an updated DEA registration certificate reflecting the new name must be obtained. It is the pharmacy's responsibility to notify the DEA about these changes before their effective date. In the situations mentioned above, the DEA registration number does not change. It is NOT necessary to notify the DEA when there is a change in the pharmacist- in-charge. If a change of ownership occurs, the registration of the seller is terminated and the new owner must file a new application for registration with the DEA. As a result, a new DEA registration number will be assigned to the pharmacy and a new DEA registration certificate will be issued. The appropriate forms are online Instructions for DEA 224 application. https://www.deadiversion.usdoj.gov/drugreg/reg_apps/224/224_instruct.htm are available The National Provider Identifier (NPI) is a Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification Standard. The NPI is a unique identification number for covered health care providers. Covered health care providers and all health plans and health care clearinghouses must use their NPI in the administrative and financial transactions adopted under HIPAA. The NPI is a 10-digit number. An “entity type code” of 1 is issued to health care providers who are individual human beings (e.g., dentists, nurses, pharmacists, physicians) while an “entity type code” of 2 is issued to health care providers other than individual human beings (e.g., hospitals, nursing homes, pharmacies). Does a pharmacist need an NPI in the daily practice of pharmacy? No. However, a pharmacist can apply for and obtain an NPI if he/she is billing separately or independently for services provided (e.g., immunizations, MTM). It is important to note, that a pharmacy must have an NPI for billing purposes. 66

The federal Ryan Haight Online Pharmacy Consumer Protection Act was enacted to address rogue internet pharmacies. The Act prohibits the delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. On the basis of the broadly drafted definition of an online pharmacy in the Act, it is possible for a pharmacy that provides Internet access to customers to be deemed an online pharmacy and to be required to modify its existing retail pharmacy registration. “Pharmacies participating in Internet drug activity should take steps to inquire whether they are compliant with the new DEA obligations. Pharmacies should also check with state boards of pharmacy to ensure that they have proper licensure and permits when engaging in the dispensing and shipping of drugs over the Internet.” An extensive summary of this Act’s major provisions may be found on pages 97-104 of the Pharmacist’s Manual (Revised 2020). The federal Clinical Laboratory Improvement Act (CLIA) was enacted to improve clinical laboratory testing procedures. An example of where a pharmacy can run afoul of this law is in the area of blood glucose monitoring. You need this waiver if you as the pharmacist are the one who will be pricking the patient’s finger and putting the droplet of blood on the test strip. One can avoid registration under CLIA for this kind of procedure by having the patient perform the procedure on himself/herself. The CLIA waiver will be issued in the name of the pharmacy, with someone (e.g., the pharmacist) being named as the laboratory director. A CLIA waiver is good for two years. A separate CLIA waiver is required for each state in which you perform such tests. For example, if you are working at pharmacies in Omaha, NE and in Council Bluffs, IA, a separate CLIA waiver would be required for each state that you perform tests in - even if you are not performing such tests on a regular basis. What about disposal of hazardous waste that accumulates from the performance of such a procedure on the pharmacy premises? It is hazardous medical waste and must be disposed of properly. Questions about CLIA waivers (August 23, 2005): ( At the pharmacy where I work ) we have a CLIA waiver that is registered in the pharmacy manager's name here. If we do health fairs or travel to other stores to do HA1c and cholesterol checks, is our CLIA waiver good for those? If not, how would we go about covering ourselves for these? Answers Received from Nebraska Department of Health and Human Services (August 30, 2005): "Regarding off-site health fairs, it is recommended that a laboratory which participates in a health fair at the same location/address at least annually, apply and maintain a CLIA waived certificate for that location/address. If the health fair(s) locations vary and there is no plan to provide services on a continuing basis at the same address, it is not practical and the state does not require a CLIA certificate. The CLIA certificate in essence states that the holder takes responsibility for the testing, i.e., accuracy, performance, etc." 67

Nebraska licenses/permits: Every pharmacy in Nebraska must have a pharmacy license if prescriptions are to be dispensed to patients. The only exception is an inpatient hospital where prescriptions cannot be dispensed to outpatients. If just one prescription is dispensed to an outpatient, then a pharmacy license is required. The key here is that medications administered to inpatients in a hospital are pursuant to chart orders. As mentioned in a previous lesson, such chart orders are not prescriptions. 71-470 Hospital pharmacy; license, when required; designate pharmacist in charge; duties; inspections provided requirements specific to licensure Neb Rev Stat updated law for the practice of pharmacy in hospitals. One aspect that is controversial because of the DQSA is compounding in one hospital and sending that drug to another with the same hospital network. The FDA has indicated that this could occur if the affiliated hospitals were within 1 mile of each of the hospitals. If the two hospitals were beyond that limit FDA contends that this could happen only if the compounding hospital pharmacy was licensed as an outsourcing facility. In Nebraska 71-470 (1) , provides that “Compounding in a hospital pharmacy may occur for any hospital which is a part of the same health care system under common ownership or which is a member of or an affiliated member of a formal network or partnership agreement.” This allows compounded preparations made in one CHI hospital to be sent to another CHI hospital. Thus, the controversy exists. Other new aspects of statute - 71-470 (2) requires hospital pharmacies to designate a pharmacist licensed in the state as being the pharmacist in charge and responsible for the practice of pharmacy and medication use procedure in such hospital. It also provides for the inspection of the practice of pharmacy in any hospital licensed in the state to be inspected by pharmacy inspectors. 71-470 (3) holds the designated pharmacist in charge responsible for the establishment and implementation of policies and procedures for the practice of pharmacy and medication use in that hospital. The process to obtain a pharmacy license to operate a pharmacy in Nebraska consists of two stages. The first stage consists of obtaining a provisional pharmacy license based on the results of the Department’s review of the applicant’s signed application. A provisional license will be issued if the Department determines that the pharmacy has substantially complied with the requirements for licensure under the Health Care Facility Licensure Act and that the operation of the pharmacy does not pose an imminent danger of death or physical harm to the persons served by the pharmacy. The provisional license: 1. is valid for a period of up to one year 2. is not renewable 68

3. may be converted to a regular license upon a showing that the pharmacy has fully complied with the requirements for licensure. The second stage consists of obtaining a regular pharmacy license based on the results of an initial on-site inspection by a pharmacy inspector. A regular pharmacy license will be issued if the Department determines that the pharmacy has fully complied with the requirements for licensure under the Health Care Facility Licensure Act and that the operation of the pharmacy does not pose an imminent danger of death or physical harm to the persons served by the pharmacy. The Department may deny a regular pharmacy license when an applicant fails to meet the requirements for licensure, including: 1. failing an inspection 2. having had a license revoked within the two-year period preceding an application 3. any of the grounds listed in regulations A regular pharmacy license: 1. expires on July 1 of each year 2. is issued only for the premises and persons named in the application and is not transferable or assignable. Change of ownership (sale, whether of stock, title, or assets, lease, discontinuance of operations) or change of premises terminates the license. If there is a change of ownership and the pharmacy remains on the same premises, an inspection is not required. The new owner(s) must apply for a new pharmacy license. If there is a change of premises, the owner(s) must apply for a new pharmacy license and the pharmacy must pass an inspection as specified in regulations. The Department must be notified: 1. in no later than one business day when there is a change in the pharmacist-in- charge (a) 2. in writing in not less than 30 days before a pharmacy is sold, leased, or moved to new premises 3. in writing in no less than 5 working days when there is a change in the name of the pharmacy 4. by the heirs or executor of the estate no later than 30 days after the death of the licensee 5. in writing by electronic mail, facsimile, or postal service no later than 24 hours of any change in environment which will adversely affect the potency, efficacy, safety or security of the drugs, devices or biologicals in the pharmacy. The notification may be made by telephone if the event has affected the licensee’s capacity to communicate. 69

(a) If a pharmacist-in-charge (PIC) is going to be absent for 3 weeks or so, does the PIC title/duty need to be handed over to the pharmacist filling in? According to the Nebraska Department of Health and Human Services, Licensure Unit - “If a PIC is out on medical leave for 8 weeks or less, the facility does not need to designate a new PIC. However, during the time that the PIC is out, he/she would still need to be available if issues should arise. If they are unable to fulfill this requirement, the facility would need to designate someone to be PIC until the regular PIC returns. The amendment process would need to be followed just the same as though it were a permanent designation.” In some special situations in Nebraska, a delegated dispensing permit is allowed. For example, such a permit is allowed for dispensing that occurs in public health clinics and dispensing that occurs through dialysis drug or device distributors. In these situations, a pharmacist is allowed to delegate to another person the act of dispensing only those drugs or devices in an approved limited formulary. In addition, persons dispensing in these situations must meet training standards approved by the Nebraska Department of Health and Human Services. In public health clinics, only contraceptives and other drugs from a very limited formulary to treat STDs can be dispensed with a delegated dispensing permit. Controlled substances cannot be included in the formulary. Such drugs can only be dispensed pursuant to a prescription written onsite by a practitioner. Only prescriptions for oral contraceptives can be refilled. Dialysis drug or device distributors operate solely on the authority of applicable statutes. Peritoneal dialysis patients have a large number of legend dialysate solutions and legend devices delivered to their homes. The pharmacist may delegate the dispensing of these legend products through a dialysis drug or device distributor under the authority of the applicable statute. In hospital emergency rooms, hospital personal are allowed to dispense without a delegated dispensing permit and pharmacist oversight is not required. This authority is based on a 2005 Declaratory Order issued by the Nebraska Health and Human Services Director of Regulation and Licensure (i.e., the Raymond Ruling). This Order was the basis for hospitals' practice of allowing the ED practitioners with prescription authority to dispense from the hospital pharmacy a small supply of prescription drugs to see the emergency department patient through until he/she can access a commercial pharmacy to fill a prescription . Unfortunately, there is considerable confusion about that Declaratory Order. In addition, it does not require such dispensed drugs to be properly packaged and labeled as required by law. A letter to the Nebraska Hospital Association ( dated August 19, 2015) on the Introduction page for Registration and Enforcement should help to clarify this matter. Hospital pharmacists have the opinion that the Raymond Declaratory Order might not be relevant since it appears to have been replaced when 71-475 was enacted. They interpret this law to include patients treated in the hospital’s emergency department. It provides the health care practitioner a means to have the drug labeled without having a pharmacist directly do so. 70

71-475 Drug; provided to patient upon discharge; records; label; documentation Nebraska Revised Statute (1)(a) When administration of a drug occurs in a hospital pursuant to a chart order, hospital personnel may provide the unused portion of the drug to the patient upon discharge from the hospital for continued use in treatment of the patient if: (i) The drug has been opened and used for treatment of the patient at the hospital and is necessary for the continued treatment of the patient and would be wasted if not used by the patient; and (ii) The drug is: (A) In a multidose device or a multidose container; or (B) In the form of a liquid reconstituted from a dry stable state to a liquid resulting in a limited stability. (b) A drug provided to a patient in accordance with this subsection shall be labeled with the name of the patient, the name of the drug including the quantity if appropriate, the date the drug was provided, and the directions for use. (2)(a) A licensed health care practitioner authorized to prescribe controlled substances may provide to his or her patients being discharged from a hospital a sufficient quantity of drugs adequate, in the judgment of the practitioner, to continue treatment, which began in the hospital, until the patient is reasonably able to access a pharmacy. (b) The pharmacist-in-charge at the hospital shall maintain records of the drugs provided to patients in accordance with this subsection which shall include the name of the patient, the name of the drug including the quantity if appropriate, the date the drug was provided, and the directions for use. (3) If a drug is provided to a patient in accordance with this section: (a) The drug shall be kept in a locked cabinet or automated medication system with access only by a licensed health care practitioner authorized to prescribe, dispense, or administer controlled substances; (b) Prior to providing the drug to the patient, a written or electronic order shall be in the patient’s record; (c) The process at the hospital shall be under the direct supervision of the prescriber; (d) If the label is prepared by a nurse, the prescriber shall verify the drug and the directions for the patient; (e) When possible, the directions for the patient shall be preprinted on the label by the pharmacist; (f) The label shall include the name of the patient, the name of the drug including the quantity if appropriate, the date the drug was provided, and the directions for use; (g) A written information sheet shall be given to the patient for each drug provided; and (h) Documentation in a readily retrievable format shall be maintained each time a drug is provided to a patient from the hospital pharmacy’s inventory which shall include the date, the patient, the drug, and the prescriber. Confusion may continue because the DHHS’s Hospital Pharmacy Quality Assurance Report (HPQAR) #26 has the Declaratory Order as a provision to be addressed. Pharmacies located outside of Nebraska frequently deliver, mail or ship prescriptions to patients in Nebraska. In Nebraska, the Mail Service Pharmacy Licensure Act is applicable to those pharmacies: 71

71-2407(1) Any person operating a mail service pharmacy outside of the State of Nebraska shall obtain a mail service pharmacy license prior to shipping, mailing, or in any manner delivering dispensed prescription drugs…into the State of Nebraska. (2) To be qualified to hold a mail service pharmacy license, a person shall: (a) Hold a pharmacy license or permit issued by and valid in the state in which the person is located and from which such prescription drugs will be shipped, mailed, or otherwise delivered; (b) Be located and operating in a state in which the requirements and qualifications for obtaining and maintaining a pharmacy license or permit are considered by the Department of Health and Human Services, with the approval of the Board of Pharmacy, to be substantially equivalent to the requirements of the Health Care Facility Licensure Act; (c) Designate the Secretary of State as his, her, or its agent for service of process in this state; and (d) Employ on a full-time basis at least one pharmacist who holds a current unrestricted pharmacist license issued under the Uniform Credentialing Act who shall be responsible for compliance by the mail service pharmacy with the Mail Service Pharmacy Licensure Act. The mail service pharmacy shall notify the department when such pharmacist is no longer employed by such pharmacy. 2. Discuss possible pharmacy inspections by federal and Nebraska personnel, including warrant procedures. Reference(s): #1 Pharmacy Practice and the Law, 8th edition pp. 178, 223-228, 64-66 9 th edition pp. 142, 177-181, 48-50 #5 Statutes Relating to Pharmacy Practice Act, 28-414.03(1)&(2); 28-417(1)(c) & (d); and 28-428(1)(a)- (e), (2), & (3) #7 Regulations Governing Licensure of Pharmacies, 8-004 According to federal law, facilities in which traditional pharmacy practice is occurring and human drug preparations are compounded pursuant to prescriptions for individual patients are not subject to FDA inspections and CGMP requirements. However, they are regulated by a state board of pharmacy and are subject to state inspections. Facilities in which traditional pharmacy practice is not occurring and human drug preparations are compounded without prescriptions for individual patients that have voluntarily elected to register with the FDA as an outsourcing facility are regulated by the FDA and are subject to similar oversight as traditional manufacturers. They must pay a fee, report adverse events 72

associated with their drug preparations, comply with CGMP requirements, and be subject to routine inspections by the FDA. If an outsourcing facility elects to be licensed as a pharmacy in a state, it would also be regulated by the state board of pharmacy and be subject to state inspections. If manufacturing is occurring in a traditional pharmacy, the traditional pharmacy must be registered with the FDA, be subject to their inspections, and abide by CGMP requirements (current good manufacturing practices). U.S. Occupational Safety and Health Administration (OSHA) Inspections: Is the pharmacy a safe place to work for employees? This is especially a concern if chemotherapeutic agents are being prepared to be administered or dispensed to patients. Likewise, if glucose monitoring is being conducted, employees should be trained in universal precautions when dealing with blood and/or bodily fluids. Other governmental and non-governmental agencies with which you may come into contact include: 1) the U.S. Environmental Protection Agency (EPA) concerning the disposal of environmentally toxic waste materials; 2) The Joint Commission (a non- governmental organization abbreviated as TJC, formerly the Joint Commission on Accreditation of Healthcare Organizations or JCAHO); 3) the U.S. Centers for Medicare and Medicaid Services (CMS, formerly the Health Care Financing Administration or HCFA) regarding reimbursement issues for Medicaid & Medicare patients; 4) the U.S. Nuclear Regulatory Commission (NRC) or Agreement State status for a nuclear pharmacy; 5) the Office of Inspector General: https://oig.hhs.gov/ within the U.S. Department of Health and Human Services (an agency that places an emphasis on detection of fraud and abuse); and 6) the U.S. Drug Enforcement Administration (DEA) may conduct a controlled substances accountability audit. To avoid problems with any of these entities, the best protection and most proactive approach is to follow the letter of all applicable laws and to make sure all record keeping is complete, accurate, and up-to-date. In Nebraska, inspections of pharmacies include: 1. opening inspections 2. initial on-site inspections 3. annual inspections 4. re-inspections 5. compliance inspections The Department will conduct an opening inspection (i.e., review) of an application for the purpose of issuing a provisional pharmacy license. The Department will conduct an announced initial on-site inspection within 60 days of the issuance of a provisional pharmacy license. The pharmacist-in-charge must be present for the initial on-site inspection. All pharmacies are subject to an annual inspection to determine whether a pharmacy fully complies with all applicable requirements. The inspection may occur by a self- inspection or by an on-site inspection. 73

A pharmacy can conduct a self-inspection by completing the Pharmacy Quality Assurance Report (PQAR). https://dhhs.ne.gov/licensure/Documents/PharmQAR.pdf The PQAR is due one year from the date of the initial on-site inspection and annually thereafter within 30 days of its due date. The PQAR must be accompanied by a signed statement from the pharmacist-in-charge verifying that all information in the PQAR is accurate, complete, and correct. At a minimum, the PQAR must provide information on the following: 1. standards for the operations of the pharmacy such as staffing requirements; storage requirements; record keeping requirements; dispensing requirements; controlled substance dispensing requirements for emergency situations; and disaster preparedness and management. 2. Physical plant standards such as equipment, facilities, and utilities; shelving, counters, floor, inventory, fixtures, equipment, and utensils; and reference materials. 3. Sterile compounding requirements (if applicable). 4. Non-sterile compounding requirements (if applicable). The PQAR will not fulfill the annual inspection requirement when: 1. the Department has determined, based on the review of the PQAR, that the pharmacy is not in compliance with the Health Care Facility Licensure Act, the Prescription Drug Safety Act, or applicable regulations; 2. the pharmacy failed to submit a PQAR; 3. the pharmacy is randomly selected as part of the 25% of licensed pharmacies chosen for inspection; or 4. five years have elapsed since the pharmacy was subjected to an on-site inspection. When the Department determines, based upon the criteria specified in regulations, that the PQAR does not fulfill the annual inspection requirement, a pharmacy inspector will conduct an on-site inspection to determine compliance with the Health Care Facility Licensure Act, the Prescription Drug Safety Act, and applicable regulations. The Department may conduct a re-inspection (i.e., subsequent on-site inspection) to determine if a pharmacy licensee is in full compliance with all applicable statutes and regulations. It is important to note, that an unannounced on-site inspection may be conducted at any time the Department deems necessary to determine compliance after a regular pharmacy license has been issued. According to 175 NAC 8 004.02(B) Compliance Inspection “an unannounced inspection may be conducted of the facility or service anytime the Department deems necessary, including, the passage of five years without an inspection. Hospital PQAR Deadline May 1 st The Hospital Pharmacy Quality Assurance Report (HPQAR) and annual inventory are due on May 1 annually. DHHS will accept the HPQAR between March 15 and June 74

15th annually. https://dhhs.ne.gov/licensure/Documents/HospitalHPQARform.pdf Hospitals will be notified by the Department as to whether or not they are in compliance with regulatory requirements. Completed PQARs are to be sent to the Office of Acute Care Facilities at: DHHS.acutecarefacilities@nebraska.gov or by FAX at 402-742-8319. In Nebraska: 28-417(1) It shall be unlawful for any person: (a) ...; (b) …; (c) To refuse or fail to make, keep, or furnish any record, notification, order form, statement, invoice, or information required under the Uniform Controlled Substances Act; (d) To refuse any entry into any premises for inspection authorized by the act; Section 28-428(1)(a)-(e), (2), & (3) in Nebraska Statutes Relating to Pharmacy Practice Act (Reference #5) describes an administrative inspection of controlled premises. If during an on-site inspection, a pharmacy inspector sees something that makes him or her want to come back (e.g., look into controlled substances), this subsequent inspection requires an administrative inspection warrant. Where does the inspector go to get that warrant? S/he goes to a judge who can issue an administrative inspection warrant. A pharmacy inspector can serve the warrant on controlled premises portion of the pharmacy. The Inspector has free access to all records required under law. However, the law does not allow for inspection of financial or pricing data found in the pharmacy. If the inspectors find a forged prescription and the inspector wants to take the original prescription, can they take it? Yes, as long as they give you a receipt for it. Under such circumstances it is advisable to photocopy the prescription and then place the photocopy in your Rx files with the following attached: 1) the receipt from the inspector, and 2) a note documenting that the original prescription document was given to the inspector pursuant to a warrant. There are three pharmacy inspectors in the state of Nebraska. Upon arrival at a pharmacy for an inspection, the pharmacy inspector should always provide proper identification and state the purpose of the inspection. 75

Pharmacist Licensure, Practice of Pharmacy, Pharmacist Interns, Pharmacy Technicians, etc. Objectives: At the conclusion of these lessons, the student should be able to: 1. Discuss situations where Nebraska licenses or registrations may be denied, limited, suspended, revoked, or renewal refused, or have other disciplinary measures taken. 2. Define the practice of pharmacy in Nebraska and discuss pharmaceutical care. 3. Discuss the equipment and reference material requirements for operating a pharmacy in Nebraska. 4. Discuss the use of pharmacy technicians in Nebraska. 5. Discuss the responsibilities of a pharmacist-in-charge (PIC) in a Nebraska pharmacy. 76

6. Discuss the requirements of pharmacist interns in Nebraska. 7. Discuss the requirements for obtaining and renewing a license to practice pharmacy in Nebraska. 8. Discuss continuing competency requirements for Nebraska pharmacists. 9. Discuss the requirements of the Emergency Box Drug Act in Nebraska. 10. Discuss the Licensee Assistance Program (LAP) in Nebraska. 11. Discuss the composition of the Nebraska Board of Pharmacy. 12. Discuss the qualifications of a pharmacy inspector in Nebraska. 13. Discuss miscellaneous statutes and regulations applicable to the practice of pharmacy in Nebraska. These lessons only cover Nebraska laws. However, the laws in other states may cover some of the same areas. 1. Discuss situations where Nebraska licenses or registrations may be denied, limited, suspended, revoked, or renewal refused, or have other disciplinary measures taken. Reference(s): #6 Statutes Relating to Uniform Credentialing Act, 38-178 and 38-179 #8 Regulations Governing the Practice of Pharmacy, 128-008 As found in section 38-178 for Nebraska - a credential to practice a profession (e.g., pharmacist's license, pharmacist intern’s registration) may be denied, refused renewal, or have other disciplinary measures taken against it...on any of the following grounds: (1) Misrepresentation of material facts in procuring or attempting to procure a credential; (2) Immoral or dishonorable conduct evidencing unfitness to practice the profession in this state; (3) Abuse of, dependence on, or active addiction to alcohol, any controlled substance, or any mind-altering substance; (4) Failure to comply with a treatment program or an aftercare program, including, but not limited to, a program entered into under the Licensee Assistance Program...; 77

(5) Conviction of (a) a misdemeanor or felony under Nebraska law or federal law, or (b) a crime in any jurisdiction which, if committed within this state, would have constituted a misdemeanor or felony under Nebraska law and which has a rational connection with the fitness or capacity of the applicant or credential holder to practice the profession; (6) Practice of the profession (a) fraudulently, (b) beyond its authorized scope, (c) with gross incompetence or gross negligence, or (d) in a pattern of incompetent or negligent conduct; If you refill a prescription without a prescriber's authorization, you could be charged with the practice of medicine (i.e., practicing beyond your authorized scope). (7) Practice of the profession while the ability to practice is impaired by alcohol, controlled substances, drugs, mind-altering substances, physical disability, mental disability, or emotional disability; (8) Physical or mental incapacity to practice the profession as evidenced by a legal judgment or a determination by other lawful means; (9) Illness, deterioration or disability that impairs the ability to practice the profession; (10) Permitting, aiding, or abetting the practice of a profession or the performance of activities requiring a credential by a person not credentialed to do so; A pharmacist could be disciplined if he/she allows a pharmacy technician to carry out acts, tasks, or functions beyond what they are legally allowed to do. (11) Having had his or her credential denied, refused renewal, limited, suspended, revoked, or disciplined in any manner...by another state or jurisdiction based upon acts by the applicant or credential holder similar to acts described in this section; (12) Use of untruthful, deceptive, or misleading statements in advertisements; (13) Conviction of fraudulent or misleading advertising or conviction of a violation of the Uniform Deceptive Trade Practices Act; (14) Distribution of intoxicating liquors, controlled substances, or drugs for any other than lawful purposes; (15) Violations of the Uniform Credentialing Act or the rules and regulations relating to the particular profession; (16) Unlawful invasion of the field of practice of any profession regulated by the Uniform Credentialing Act which the credential holder is not credentialed to practice; 78

(17) Violation of the Uniform Controlled Substances Act or any rules and regulations adopted pursuant to the act; (18) Failure to file a report required by section 38-1,124 or 38-1,125; Section 38-1,124(3) requires a copy of any report of loss or theft of a controlled substance to the DEA (i.e., a completed DEA Form 106) to be provided to the department. The mandatory reporting requirements in section 38-1,125, may be the most difficult statute to comply with in the State of Nebraska. A summary of the applicable regulations (172 NAC 5, Regulations Governing Mandatory Reporting by Health Care Professionals, Facilities, Peer and Professional Organizations and Insurers) provides guidance with regard to that statute. See the document “ Summary of Mandatory Reporting Requirements ” linked on the Introduction page for “Pharmacist Licensure…” A report must be based on first-hand knowledge (i.e., not hearsay) and must be submitted in writing within thirty days of an occurrence. It may be wise to consult with an attorney before reporting someone under these requirements. While pharmacist interns are not required to report on anyone, "a pharmacy technician shall report first-hand knowledge of facts giving him or her reason to believe that any person in his or her profession, or any person in another profession under the regulatory provisions of the department, may be practicing while his or her ability to practice is impaired by alcohol, controlled substances, or narcotic drugs." A pharmacist is required to report on a pharmacist intern or pharmacy technician where applicable. It is important to note, that another state may have different requirements with regard to mandatory reporting for pharmacists, pharmacist interns, or pharmacy technicians. (19) Failure to maintain the requirements necessary to obtain a credential; (20) Violation of an order issued by the department; (21) Violation of an assurance of compliance entered into under section 38-1,108; (22) Failure to pay an administrative penalty; (23) Unprofessional conduct as defined in section 38-179; or (24) Violation of the Automated Medication Systems Act. As found in section 38-179 for Nebraska – For purposes of section 38-178, unprofessional conduct means any departure from or failure to conform to the standards of acceptable and prevailing practice of a profession or the ethics of the profession, regardless of whether a person, consumer, or entity is injured, or conduct that is likely to deceive or defraud the public or is detrimental to the public interest, including, but is not limited to: (1) ...; 79

(2) Division of fees, or agreeing to split or divide the fees, received for professional services with any person for bringing or referring a consumer other than (a) with a partner or employee of the applicant or credential holder or his or her office or clinic, (b) with a landlord of the applicant or credential holder pursuant to a written agreement that provides for payment of rent based on gross receipts, (c) with a former partner or employee of the applicant or credential holder based on a retirement plan or separation agreement...; (3) Obtaining any fee for professional services by fraud, deceit, or misrepresentation, including but not limited to, falsification of third-party claim documents; Medicare and Medicaid fraud are areas where pharmacists have had problems. You need to know acceptable billing practices for Medicare and Medicaid. A Nebraska pharmacist was convicted of Medicaid fraud because he was charging more for Medicaid prescriptions than regular cash-paying customers were paying for the same prescriptions. As a result, he was unable to fill any Medicaid prescriptions for a year which really hurt his pharmacy financially. Another Nebraska pharmacist lost his pharmacist license and served time in prison for the same type of billing fraud. He eventually sold his three pharmacies and was unable to become licensed again as a pharmacist. After signing a third-party contract, you must follow all of the requirements of that contract. (4) Cheating on or attempting to subvert the credentialing examination; (5) Assisting in the care or treatment of a consumer without the consent of such consumer or his or her legal representative; (6) Use of any letters, words, or terms, either as a prefix, affix, or suffix, on stationery, in advertisements, or otherwise, indicating that such person is entitled to practice a profession for which he or she is not credentialed; (7) ...; (8) Knowingly disclosing confidential information except as otherwise permitted by law; (9) Commission of any act of sexual abuse, misconduct, or exploitation related to the practice of the profession of the applicant or credential holder; (10) Failure to keep and maintain adequate records of treatment or service; Under Nebraska law, a pharmacist is required to make a reasonable effort to obtain certain information and to maintain patient profiles for all patients in all care settings. (11) Prescribing, administering, distributing, dispensing, giving, or selling any controlled substance or other drug recognized as addictive or dangerous for other than a medically accepted therapeutic purpose; 80

A dangerous drug includes all legend drugs. Does this requirement mean you cannot dispense an approved drug for an off label, unlabeled, or unapproved use? No, because an off label, unlabeled, or unapproved use may be considered a medically accepted therapeutic purpose. 12) ...; (13) Failure to comply with any federal, state, or municipal law, ordinance, rule, or regulation that pertains to the applicable profession; (14) Disruptive behavior, whether verbal or physical, which interferes with consumer care or could reasonably be expected to interfere with such care; and (15) Such other acts as may be defined in rules and regulations. Nothing in this section shall be construed to exclude determination of additional conduct that is unprofessional by adjudication in individual contested cases. 38-179 … Unprofessional conduct means any departure from or failure to conform to the standards of acceptable and prevailing practice of the profession or the ethics of the profession, regardless of whether a person, patient, or entity is injured, or conduct that is likely to deceive or defraud the public or is detrimental to the public interest. Unprofessional conduct includes but is not limited to acts set out in Neb. Rev. Stat. Section 38-179 and the following: (1) Receipt of fees on the assurance that an incurable disease can be permanently cured; (2) Division of fees, or agreeing to split or divide the fees, received for professional services with any person for bringing or referring a consumer other than (a) with a partner or employee of the applicant or credential holder or his or her office or clinic, (b) with a landlord of the applicant or credential holder pursuant to a written agreement that provides for payment of rent based on gross receipts, (c) with a former partner or employee of the applicant or credential holder based on a retirement plan or separation agreement, or (d) by a person credentialed pursuant to the Water Well Standards and Contractors’ Practice Act; (3) Obtaining any fee for professional services by fraud, deceit, or misrepresentation, including, but not limited to, falsification of third-party claim documents; 81

(4) Cheating on or attempting to subvert the credentialing examination; (5) Assisting in the care or treatment of a consumer without the consent of such consumer or his or her legal representative; (6) Use of any letters, words, or terms, either as a prefix, affix, or suffix, on stationery, in advertisements, or otherwise, indicating that such person is entitled to practice a profession for which he or she is not credentialed; (7) Performing, procuring, or aiding and abetting in the performance or procurement of a criminal abortion; (8) Knowingly disclosing confidential information except as otherwise permitted by law; (9) Commission of any act of sexual abuse, misconduct, or exploitation related to the practice of the profession of the applicant or credential holder; (10) Failure to keep and maintain adequate records of treatment or service; (11) Prescribing, administering, distributing, dispensing, giving, or selling any controlled substance or other drug recognized as addictive or dangerous for other than a medically accepted therapeutic purpose; (12) Prescribing any controlled substance to (a) oneself or (b) except in the case of a medical emergency (i) one’s spouse, (ii) one’s child, (iii) one’s parent, (iv) one’s sibling, or (v) any other person living in the same household as the prescriber; (13) Failure to comply with any federal, state, or municipal law, ordinance, rule, or regulation that pertains to the applicable profession; (14) Disruptive behavior, whether verbal or physical, which interferes with consumer care or could reasonably be expected to interfere with such care; and (15) Such other acts as may be defined in rules and regulations. Nothing in this section shall be construed to exclude determination of additional conduct that is unprofessional by adjudication in individual contested cases. Unprofessional conduct is also addressed in Nebraska regulations: 128-008. UNPROFESSIONAL CONDUCT . Unprofessional conduct includes those acts set out in Neb. Rev. Stat. § 38-179 and this chapter. (A) Refusal to cooperate or furnish requested information during a licensing or discipline; EFFECTIVE NEBRASKA DEPARTMENT OF 11-03-2020 HEALTH AND HUMAN SERVICES 172 NAC 128 (B) Any departure from or failure to conform to the ethics of the pharmacy profession, which code of ethics were adopted by the membership of the American Pharmacists Association on October 27, 1994 by a pharmacist; 82

(C) Misrepresenting one’s credentials in an application submitted to a healthcare facility, insurance company, or prospective employer; (D) Refusal to provide professional service to a person because of such person’s race, color, religion, sex, ancestry, age, familial status, disability, or national origin; (E) Refusal to undergo a competency evaluation as required by the Board of Pharmacy pursuant to Neb. Rev. Stat. § 38-1,112; (F) Failure by a pharmacist to ensure a verbal offer to counsel is made, unless specifically exempt as provided in Neb. Rev. Stat. § 38-2869(2)(e); (G) Willfully or negligently violating the confidentiality between pharmacy personnel and a patient, except as allowed by law; (H) Except as otherwise permitted by law, dispensing, selling, administering, distributing, ordering, or giving to a person, known by the pharmacist to be an addict or any person previously drug dependent, any drug legally classified as a controlled substance; (I) Exercising undue influence on the patient in such a manner as to exploit the patient for the financial gain of the pharmacist or of a third party, which includes, but is not limited to, the promotion or sale of services, goods, drugs, devices, or biologicals; (J) Refusal to allow access to the records appropriate to practice pharmacy in a facility and required to be kept as set out in 175 NAC 8; (K) Return of dispensed drugs or devices to saleable stock, unless specifically allowed by law; (L) Dispensing, selling, or administering anabolic steroids to a person for other than therapeutic purposes; (M) Practicing pharmacy under a false or assumed name; (N) Lack of appropriate direction, collaboration, or supervision of any person employed by, supervised by or assigned to the pharmacist; (O) Claiming credit for any continuing competency activities not actually participated in and earned; or (P) Any false or misleading statement on a pharmacy self-inspection form. Code of Ethics for Pharmacists (adopted by the membership of the American Pharmacists Association October 27, 1994) Preamble Pharmacists are health professionals who assist individuals in making the best use of medications. This Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the fundamental basis of the roles and responsibilities of pharmacists. These principles, based on moral obligations and virtues, are established to guide pharmacists in relationships with patients, health professionals, and society. I. A pharmacist respects the covenantal relationship between the patient and pharmacist. Considering the patient-pharmacist relationship as a covenant means that a pharmacist has moral obligations in response to the gift of trust received from society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust. II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner. 83

A pharmacist places concern for the well-being of the patient at the center of professional practice. In doing so, a pharmacist considers needs stated by the patient as well as those defined by health science. A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and a compassionate spirit, a pharmacist focuses on serving the patient in a private and confidential manner. III. A pharmacist respects the autonomy and dignity of each patient. A pharmacist promotes the right of self-determination and recognizes individual self-worth by encouraging patients to participate in decisions about their health. A pharmacist communicates with patients in terms that are understandable. In all cases, a pharmacist respects personal and cultural differences among patients. IV. A pharmacist acts with honesty and integrity in professional relationships. A pharmacist has a duty to tell the truth and to act with conviction of conscience. A pharmacist avoids discriminatory practices, behavior or work conditions that impair professional judgment, and actions that compromise dedication to the best interests of patients. V. A pharmacist maintains professional competence. A pharmacist has a duty to maintain knowledge and abilities as new medications, devices, and technologies become available and as health information advances. VI. A pharmacist respects the values and abilities of colleagues and other health professionals. When appropriate, a pharmacist asks for the consultation of colleagues or other health professionals or refers the patient. A pharmacist acknowledges that colleagues and other health professionals may differ in the beliefs and values they apply to the care of the patient. VII. A pharmacist serves individual, community, and societal needs. The primary obligation of a pharmacist is to individual patients. However, the obligations of a pharmacist may at times extend beyond the individual to the community and society. In these situations, the pharmacist recognizes the responsibilities that accompany these obligations and acts accordingly. VIII. A pharmacist seeks justice in the distribution of health resources. When health resources are allocated, a pharmacist is fair and equitable, balancing the needs of patients and society. Overall, a pharmacist has nothing to be concerned about as long as he/she knows the law and always practices within the law. 2. Define the practice of pharmacy in Nebraska and discuss pharmaceutical care. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-2837(1) & (2); 38-2831(1) & (2); and 38-2850 Pharmacists must know their legal scope of practice and always practice within that legal scope of practice, which can vary from state to state. The practice of pharmacy in Nebraska is defined as follows: 84

38-2837(1) Practice of pharmacy means (a) the interpretation, evaluation, and implementation of a medical order, (b) the dispensing of drugs and devices, (c) drug product selection, (d) the administration of drugs or devices, (e) drug utilization review, (f) patient counseling, (g) the provision of pharmaceutical care, (h) medication therapy management, and (i) the responsibility for compounding and labeling of dispensed or repackaged drugs and devices, proper and safe storage of drugs and devices, and maintenance of proper records. (2) The active practice of pharmacy means the performance of the functions set out in this section by a pharmacist as his or her principal or ordinary occupation. A pharmacist in Nebraska can administer drugs to patients (e.g., flu vaccine) unless prohibited by a facility’s internal policy (e.g., hospital, LTCF). Note also, that a registered and properly supervised pharmacist intern has essentially the same scope of practice as a pharmacist. However, a pharmacist intern cannot supervise or verify the work of a pharmacy technician or another pharmacist intern. In 2015, the Nebraska legislature passed a statute that permits an insurer to contract with a licensed pharmacist for pharmacist professional services: 44-313(1)(a) Insurer means any insurer offering any individual or group sickness and accident insurance policy or subscriber contract delivered, issued for delivery, or renewed in this state and any hospital, medical, or surgical expense-incurred policy, except for policies that provide coverage for a specified disease or other limited-benefit coverage, and any self-funded employee benefit plan to the extent not preempted by federal law; and (b) Pharmacist professional services means professional services provided to patients by licensed pharmacists as allowed by law. (2) On and after January 1, 2016, an insurer may contract with a licensed pharmacist for pharmacist professional services. Nothing in this section shall prohibit an insurer from contracting with a licensed pharmacist who is not employed or associated with a pharmacy. Nothing in this section shall require a licensed pharmacist to contract with an insurer for pharmacist professional services. Pharmaceutical care in Nebraska is defined as: 38-2831(1) Pharmaceutical care means the provision of drug therapy by a pharmacist for the purpose of achieving therapeutic outcomes that improve a patient's quality of life. Such outcomes include (a) the cure of disease, (b) the elimination or reduction of a patient's symptomatology, (c) the arrest or slowing of a disease process, or (d) the prevention of a disease or symptomatology. (2) Pharmaceutical care includes the process through which the pharmacist works in concert with the patient and his or her caregiver, physician, or other professionals in designing, implementing, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient. 85

Can a Nebraska pharmacist enter into a practice agreement (sometimes referred to as a collaborative agreement) with a practitioner who has independent prescribing authority to provide pharmaceutical care according to written protocols? Yes. Such practice agreements could address various disease state management programs and various vaccination programs. 38-2836.01 Practice agreement, defined Nebraska Revised Statute Practice agreement means a document signed by a pharmacist and a practitioner with independent prescribing authority, in which the pharmacist agrees to design, implement, and monitor a therapeutic plan based on a written protocol. 38-2867.03 Pharmacist; practice agreement; notice; contents; form; pharmacist intern participation Nebraska Revised Statute (1) A pharmacist may enter into a practice agreement as provided in this section with a licensed health care practitioner authorized to prescribe independently to provide pharmaceutical care according to written protocols*. The pharmacist shall notify the board of any practice agreement at the initiation of the agreement and at the time of any change in parties to the agreement or written protocols. The notice shall be given to both the Board of Pharmacy and the board which licensed the health care practitioner. The notice shall contain the name of each pharmacist participating in the agreement and each licensed health care practitioner authorized to prescribe independently participating in the agreement and a description of the therapy being monitored or initiated. (2) A copy of the practice agreement and written protocols shall be available for review by a representative of the department. A copy of the practice agreement shall be sent to the Board of Pharmacy upon request by the board. (3) A practice agreement shall be in writing. Each pharmacist participating in the agreement and each licensed health care practitioner authorized to prescribe independently participating in the agreement shall sign the agreement and the written protocols at the initiation of the agreement and shall review, sign, and date the documents every two years thereafter. A practice agreement is active after it is signed by all the parties listed in the agreement. (4) A practice agreement and written protocols cease immediately upon (a) the death of either the pharmacist or the practitioner, (b) the loss of license to practice by either the pharmacist or the practitioner, (c) a disciplinary action limiting the ability of either the pharmacist or practitioner to enter into practice agreement, or (d) the individual decision of either the pharmacist or practitioner or mutual agreement by the parties to terminate the agreement. (In Nebraska, pharmacist interns are allowed to participate in a practice agreement) (5) A pharmacist intern may participate in a practice agreement without expressly being mentioned in the agreement if the pharmacist intern is supervised by a pharmacist who is a party to the agreement. In Nebraska, some activities are not considered the practice of pharmacy: 86

38-2850 As authorized by the Uniform Credentialing Act, the practice of pharmacy may be engaged in by a pharmacist, a pharmacist intern, or a practitioner with a pharmacy license. The practice of pharmacy shall not be construed to include: (1) Practitioners, other than veterinarians, certified nurse midwives, certified registered nurse anesthetists, nurse practitioners, and physician assistants, who dispense drugs or devices as an incident to the practice of their profession, except that if such practitioner engages in dispensing such drugs or devices to his or her patients for which such patients are charged, such practitioner shall obtain a pharmacy license; (2) ...; (3) Medical representatives, detail persons, or persons known by some name of like import, but only to the extent of permitting the relating of pharmaceutical information to health care professionals; (4) Licensed veterinarians practicing within the scope of their profession; (5) Certified nurse midwives, certified registered nurse anesthetists, nurse practitioners, and physician assistants who dispense sample medications which are provided by the manufacturer and are dispensed at no charge to the patient; (6) Optometrists who prescribe or dispense eyeglasses or contact lenses to their own patients, including contact lenses that contain and deliver ocular pharmaceutical agents as authorized under the Optometry Practice Act, and ophthalmologists who prescribe or dispense eyeglasses or contact lenses to their own patients, including contact lenses that contain and deliver ocular pharmaceutical agents. (7) Registered nurses or licensed practical nurses employed by a hospital who administer pursuant to a chart order, or procure for such purpose, single doses of drugs or devices from original drug or device containers or properly labeled repackaged or prepackaged drug or device containers to persons registered as patients and within the confines of the hospital; The RN or LPN that is authorized to procure drugs or devices after hours from a hospital inpatient pharmacy should provide accurate documentation of such activity. The documentation should include the patient's name, patient's room number, drug, strength (if applicable), quantity, date, time, and signature of the nurse. It would be wise for another RN or LPN to verify the drugs or devices that were procured in such situations. Lastly, it is believed that a copy of the patient's chart order and the original or properly labeled repackaged or prepackaged drug or device container should be made available for a pharmacist to review when the hospital inpatient pharmacy opens again. (8) Persons employed by a facility where dispensed drugs and devices are delivered from a pharmacy for pickup by a patient or caregiver and no dispensing or storage of drugs or devices occurs; and 87

(9) ...; (10) A person accredited by an accrediting body who, pursuant to a medical order, (a) administers, dispenses, or distributes medical gas or medical gas devices to patients or ultimate users or (b) purchases or receives medical gas or medical gas devices for administration, dispensing, or distribution to patients or ultimate users. (11) …. 3. Discuss the equipment and reference material requirements for operating a pharmacy in Nebraska. Reference(s): #7 Title 175 Chapter 8 Health Care Facilities and Services Regulations Licensure Pharmacies, 008.01 – 008.03 At one time, Nebraska regulations were very specific as to the equipment required in a pharmacy (e.g., a certain number of spatulas, a mortar and pestle, a certain number of graduates). However, current Nebraska regulations are not as specific: 008. PHYSICAL PLANT STANDARDS. A licensee must meet the requirements set out in this chapter. 008.01 ACCESS BY PHARMACIST. The licensee must provide the appropriate staff access to all equipment, facilities, and utilities appropriate for the accurate, efficient, and safe provision of the clinical services available in that pharmacy. 008.02 CONDITIONS. The licensee must assure the prescription department, including shelving, counters, floor, inventory, fixtures, equipment, and utensils are maintained in a clean, orderly, and sanitary manner that supports the scope of pharmacy services provided at the site. 008.03 REFERENCE MATERIAL. The licensee must provide the appropriate staff access to all reference material appropriate for the accurate, efficient, and safe practice of pharmacy. These references materials must be up to date, in either printed or electronic form, and available at all times while the practice of pharmacy is occurring. 88

It is important to note, that the availability of the Orange Book (with its equivalence evaluations) or an equivalent reference is necessary in order to properly carry out drug product selection in a Nebraska pharmacy. 4. Discuss the use of pharmacy technicians in Nebraska. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-2836; 38-2890 to 38-2897; 38-2845; 38-2847; 38-2866.01; and 38-2867(3) #8 Regulations Governing The Practice of Pharmacy, 128-003.03 and 128-006.03 A pharmacy technician does not replace the pharmacist. However, he/she can be a tremendous asset in assisting the pharmacist in the practice of pharmacy. In Nebraska, a pharmacy technician is defined as follows: 38-2836 Pharmacy technician means an individual registered under sections 38- 2890 to 38-2897. 38-2890(1) All pharmacy technicians employed by a health care facility licensed under the Health Care Facility Licensure Act shall be registered with the Pharmacy Technician Registry created in section 38-2893. In order to be employed as a pharmacy technician in such a health care facility, a pharmacy technician (a) shall be certified by a state or national certifying body which is approved by the board (i) by January 1, 2017, if he or she was registered with the Pharmacy Technician Registry on January 1, 2016, or (ii) within one year after being registered with the Pharmacy Technician Registry, if he or she was so registered after January 1, 2016, and (b) upon being so certified, shall maintain current certification during the time he or she is so registered. (2) To register as a pharmacy technician, an individual shall (a) be at least eighteen years of age, (b) be a high school graduate or be officially recognized by the State Department of Education as possessing the equivalent degree of education, (c) have never been convicted of any nonalcohol, drug-related misdemeanor or felony, (d) file an application with the Division of Public Health of the Department of Health and Human Services, and (e) pay the applicable fee. Regulatory requirements 172 NAC 128 003.03 PHARMACY TECHNICIAN REGISTRATION. To obtain a pharmacy technician registration an individual must submit a complete application provided by the Department and provide documentation demonstrating that the applicant meets the requirements of Neb. Rev. Stat. § 38- 2890 89

172 NAC 128 006. IDENTIFICATION REQUIREMENTS. Each individual must be properly identified as set out in Neb. Rev. Stat. § 38-124, and this chapter 006.03 PHARMACY TECHNICIAN Each pharmacy technician must be identified as a pharmacy technician while performing the duties of a pharmacy technician. The definition of a pharmacy technician and the requirements to become a pharmacy technician can vary from state to state. Can a person that has a misdemeanor MIP or DUI conviction become a pharmacy technician in Nebraska? Yes, because an alcoholic beverage is not defined as a drug in Nebraska statutes or regulations. Therefore, an MIP or DUI is not a drug-related conviction in Nebraska. In Nebraska, a statute is very clear as to what a pharmacy technician can or cannot do when assisting a pharmacist in the practice of pharmacy: 38-2891(1) A pharmacy technician shall only perform tasks which do not require professional judgment and which are subject to verification to assist a pharmacist in the practice of pharmacy. (2) The functions and tasks which shall not be performed by pharmacy technicians include, but are not limited to: (a) Receiving oral medical orders from a practitioner or his or her agent; (b) Providing patient counseling; (c) Performing any evaluation or necessary clarification of a medical order or performing any functions other than strictly clerical functions involving a medical order; (d) Supervising or verifying the tasks and functions of pharmacy technicians; (e) Interpreting or evaluating the data contained in a patient's record...; (f) Releasing any confidential information maintained by the pharmacy; (g) Performing any professional consultations; and (h) Drug product selection, with regard to an individual medical order, in accordance with the Nebraska Drug Product Selection Act. (3) The director shall, with the recommendation of the board, waive any of the limitations in subsection (2) of this section for purposes of a scientific study of the role of pharmacy technicians approved by the board. Such study shall be based upon providing improved patient care or enhanced pharmaceutical care. Any such waiver shall state the length of the study and shall require that all study data and 90

results be made available to the board upon the completion of the study. Nothing in this subsection requires the board to approve any study proposed under this subsection. According to an old Nebraska statute on pharmacy technicians, "Receiving oral medical orders or oral authorizations to refill prescriptions from a practitioner or his or her agent" were not allowed. According to the revised Nebraska statute on pharmacy technicians as presented above, "Receiving oral medical orders from a practitioner or his or her agent" is still not allowed. However, the revised Nebraska statute no longer prohibits a pharmacy technician from receiving "oral authorizations to refill prescriptions from a practitioner or his or her agent" as long as new information about a prescription is not included with the refill authorization. Certified Pharmacy Technician Validation LB 74 changed the practice of certified pharmacy technicians working within the confines of a hospital in Nebraska allowing tech-check-tech within the workflow. The basis for the law changes were the successful pilot projects, as permitted by the Nebraska Board of Pharmacy, at several Nebraska hospitals. Certified pharmacy technicians may validate the work of another certified pharmacy technician in the process of preparing medications for administration within the hospital. The validation process must include the use of bar code technology or radio frequency identification, or other similar technology to ensure the accuracy of the medications. The medications being validated by certified pharmacy technicians must be prepackaged by the manufacturer or prepackaged and verified by a pharmacist. All of these activities must be outlined in policies and procedures established by the hospital’s pharmacist in charge. Because the law now refers to “validation” of the work between certified pharmacy technicians, a definition of validation was added to the Pharmacy Practice Act. Validation means the action of a certified pharmacy technician checking the accuracy and completeness of the acts, tasks, or functions undertaken by another certified pharmacy technician as provided in 38-2891.01. Additionally, the definition of supervision was updated to recognize the certified pharmacy technician validation process. Supervision means the personal guidance and direction by a pharmacist of the performance by a pharmacy technician of authorized activities or functions subject to (1) verification by such pharmacist or (2) validation by a certified pharmacy technician subject to section 38-2891.01. Supervision of a pharmacy technician may occur by means of a real-time audiovisual communication system. Pharmacists and pharmacy technician must remember that the ratio of pharmacists to pharmacy technicians did not change. The effective date for LB 74 was September 1, 2019. 38-2870 (3) Except as otherwise provided in section 28-414 and 28-414.01, a practitioner or the practitioner’s agent may transmit a medical order to a pharmacist or pharmacist intern and an authorized refill to a pharmacist, pharmacist intern, or pharmacy technician by the following means : (a) In writing, (b) orally, (c) by facsimile transmission of a written medical order or electronic transmission of a medical order signed by the practitioner, or 91

(d) by facsimile transmission of a written medical order or electronic transmission of a medical order which is not signed by the practitioner. Such an ussigned medical order shall be verified with the practitioner. Pharmacy technicians may be offended when they are told that they cannot use professional judgment. What do you mean when you say we cannot use judgment? It is important to note, that there is a difference between judgment and professional judgment. Professional judgment is acquired through education, training, clinical rotations/clerkships, experience, and licensing. It requires professional judgment to conduct a prospective drug utilization review, and this cannot be delegated to a pharmacy technician. It requires professional judgment to counsel a patient on the proper use of medications, and this cannot be delegated to a pharmacy technician. Does it require professional judgment to enter something into a computer? No. Can you verify what has been entered into a computer? Yes. Does it require professional judgment to count tablets and capsules? No. Can you verify what has been counted? Yes. Always keep in mind, a pharmacy technician cannot do a task if it requires professional judgment or if it cannot be verified. In Nebraska: 38-2892(1) The pharmacist in charge of a pharmacy or hospital pharmacy employing pharmacy technicians shall be responsible for the supervision and performance of the pharmacy technicians. (2) Except as otherwise provided in the Automated Medication Systems Act, the supervision of pharmacy technicians at a pharmacy shall be performed by the pharmacist who is on duty in the facility with the pharmacy technicians or located in pharmacies that utilize a real-time, online data base and have a pharmacist in all pharmacies. The supervision of pharmacy technicians at a hospital pharmacy shall be performed by the pharmacist assigned by the pharmacist in charge to be responsible for the supervision and verification of the activities of the pharmacy technicians. In Nebraska, supervision of a pharmacy technician is defined as follows: 38-2845 Supervision means the personal guidance and direction by a pharmacist of the performance by a pharmacy technician of authorized activities or functions subject to verification by such pharmacist. Supervision of a pharmacy technician may occur by means of a real-time audiovisual communication system. In Nebraska: 38-2867(3) It shall be unlawful for any person to coerce or attempt to coerce a pharmacist…to supervise any pharmacy technician for any purpose or in any manner contrary to the professional judgment of the pharmacist. In Nebraska, verification is defined as follows: 92

38-2847 Verification means the confirmation by a supervising pharmacist of the accuracy and completeness of the acts, tasks, or functions undertaken by a pharmacy technician to assist the pharmacist in the practice of pharmacy. Verification shall occur by a pharmacist on duty in the facility, except that if a pharmacy technician performs authorized activities or functions to assist a pharmacist and the prescribed drugs or devices will be administered to persons who are patients or residents of a facility by a credentialed individual authorized to administer medications, verification may occur by means of a real-time audiovisual communication system. It is important to note, that verification must take place before the medication is dispensed. In Nebraska: 38-2866.01 A pharmacist may supervise any combination of pharmacy technicians and pharmacist interns at any time up to a total of three people. A pharmacist intern shall be supervised at all times while performing the functions of a pharmacist intern which may include all aspects of the practice of pharmacy unless otherwise restricted. This section does not apply to a pharmacist intern who is receiving experiential training directed by the accredited program in which he or she is enrolled. It is important to emphasize, that a pharmacist intern who is receiving experiential training directed by the accredited program in which s/he is enrolled (e.g., an introductory pharmacy practice experience [IPPE], advanced pharmacy practice experience [APPE], or other experiential training activities) is not considered in the ratio. So, the ratio of pharmacy technicians to one pharmacist in any pharmacy in Nebraska shall not exceed: 1. one pharmacy technician to one pharmacist, if two pharmacist interns who are not receiving experiential training are also being supervised by the pharmacist 2. two pharmacy technicians to one pharmacist, if one pharmacist intern who is not receiving experiential training is also being supervised by the pharmacist 3. three pharmacy technicians to one pharmacist, if only pharmacist interns receiving experiential training are also being supervised by the pharmacist A pharmacy clerk, who is not performing the duties of a pharmacy technician, is also not considered in the ratio. Each pharmacy technician must be identified as a pharmacy technician while performing the duties of a pharmacy technician. 93

A pharmacy technician may be disciplined: 38-2894(1) A registration to practice as a pharmacy technician may be denied, refused renewal, removed, or suspended or have other disciplinary measures taken against it by the department, with the recommendation of the board, for failure to meet the requirements of or for violation of any of the provisions of subdivisions (1) through (17) and (19) through (24) of section 38-178 and sections 38-2890 to 38-2897 or the rules and regulations adopted under such sections. Pharmacy technicians in Nebraska are eligible to participate in the Nebraska Licensee Assistance Program (LAP): 38-2894(4) Pharmacy technicians may participate in the Licensee Assistance Program... In Nebraska: 38-2895(1) If a pharmacy technician performs functions requiring professional judgment and licensure as a pharmacist or performs functions without supervision and verification and such acts are known to the pharmacist supervising the pharmacy technician or the pharmacist in charge or are of such a nature that they should have been known to a reasonable person, such acts may be considered acts of unprofessional conduct on the part of the pharmacist supervising the pharmacy technician or the pharmacist in charge pursuant to section 38-178, and disciplinary measures may be taken against such pharmacist supervising the pharmacy technician or the pharmacist in charge pursuant to the Uniform Credentialing Act. A Nebraska statute requires "mandatory reporting" by a pharmacy technician only in certain circumstances: 38-2897 Duty to report impaired practitioner; immunity. (1) The requirement to file a report under subsection (1) of section 38-1,125 shall not apply to pharmacist interns or pharmacy technicians, except that a pharmacy technician shall, within thirty days after having first-hand knowledge of facts giving him or her reason to believe that any person in his or her profession, or any person in another profession under the regulatory provisions of the department, may be practicing while his or her ability to practice is impaired by alcohol, controlled substances, or narcotic drugs, report to the department in such manner and form as the department may require. A report made to the department under this section shall be confidential. The identity of any person making such report or providing information leading to the making of such report shall be confidential. 5. Discuss the responsibilities of a pharmacist-in-charge (PIC) in a Nebraska pharmacy. 94

Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-2833 and 38- 2867.02(1)&(2) #7 Title 175 Chapter 8 Health Care Facilities and Services Regulations Licensure Pharmacies, 8-005.03 In Nebraska, a pharmacist-in-charge (PIC) is defined as follows: 38-2833 Pharmacist in charge means a pharmacist who is designated on a pharmacy license or designated by a hospital as being responsible for the practice of pharmacy in the pharmacy for which a pharmacy license is issued or in a hospital pharmacy and who works within the physical confines of such pharmacy or hospital pharmacy. It is important to emphasize, that the PIC of a Nebraska pharmacy is responsible for everyone (e.g., other pharmacists, pharmacist interns, pharmacy technicians, pharmacy clerks) and everything that is done in a pharmacy every hour of every day the pharmacy is open. While the PIC does not have to actually be in the pharmacy at all times, he/she is responsible for the day to day functioning of the pharmacy. In Nebraska: 8-005.03 The licensee must notify the Department within 1 business day when there is a change in the pharmacist-in-charge. According to a current Nebraska regulation, each pharmacy registered with the DEA to handle controlled substances must complete a controlled substances inventory whenever there is a change in the pharmacist-in-charge. Such inventory must contain all of the information required in the annual inventory and the original copy of this inventory must be maintained in the pharmacy for five years. However, changes to that regulation have been proposed. With regard to a hospital pharmacy in Nebraska: 38-2867.02(1) Beginning January 1, 2017, the pharmacist in charge of a hospital pharmacy shall develop and implement policies and procedures to ensure that a pharmacist reviews all medical orders prior to the first dose being administered to a patient in the hospital. The policies and procedures may provide for either a pharmacist onsite or the use of telepharmacy to comply with this requirement. (2) This section does not apply to the following situations: (a) When the practitioner controls the ordering, dispensing, and administration of the drug, such as in the operating room, endoscopy suite, or emergency room; or (b) When time does not permit the pharmacist’s review, such as (i) a stat order meaning a medical order which indicates that the medication is to be given immediately and only once or (ii) 95

when the clinical status of the patient would be significantly compromised by the delay resulting from the pharmacist’s review of the order. 6. Discuss the requirements for pharmacist interns in Nebraska. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-2834 and 38-2854(1)-(3) #6 Statutes Relating to Uniform Credentialing Act, 38-129 #8 Regulations Governing the Practice of Pharmacy, 128- 003.02, 128-006.02 128-007 In Nebraska, a pharmacist intern is defined as follows: 38-2834 Pharmacist intern means a person who meets the requirements of section 38-2854. 38-2854(1) A pharmacist intern shall be (a) a student currently enrolled in an accredited pharmacy program, (b) a graduate of an accredited pharmacy program serving his or her internship, or (c) a graduate of a pharmacy program located outside the United States which is not accredited and who has successfully passed equivalency examinations approved by the board. Intern registration based on enrollment in or graduation from an accredited pharmacy program shall expire not later than fifteen months after the date of graduation or at the time of professional licensure, whichever comes first. Intern registration based on graduation from a pharmacy program located outside of the United States which is not accredited shall expire not later than fifteen months after the date of issuance of the registration or at the time of professional licensure, whichever comes first. 172 NAC 128 Practice of Pharmacy and Credentialing of Pharmacy Personnel 003.02 PHARMACIST INTERN REGISTRATION. To obtain a pharmacist intern registration an applicant must meet the requirements of Neb. Rev. Stat. § 38-2854 and submit one of the following: (A) Documents from an educational institution showing current enrollment in an accredited pharmacy program; (B) Official transcript from an accredited pharmacy program; or (C) Copy of the Foreign Pharmacy Graduate Examination Committee (FPGEC) Certification given by National Association of Boards of Pharmacy (NABP) (2) A pharmacist intern may compound and dispense drugs or devices and fill prescriptions only in the presence of and under the immediate personal supervision 96

of a licensed pharmacist. Such licensed pharmacist shall either be (a) the person to whom the pharmacy license is issued or a person in the actual employ of the pharmacy licensee or (b) the delegating pharmacist designated in a delegated dispensing agreement by a hospital with a delegated dispensing permit. (3) Performance as a pharmacist intern under the supervision of a licensed pharmacist shall be predominantly related to the practice of pharmacy and shall include the keeping of records and the making of reports required under state and federal statutes. The department, with the recommendation of the board, shall adopt and promulgate rules and regulations as may be required to establish standards of internship. 172 NAC 128 Practice of Pharmacy and Credentialing of Pharmacy Personnel 006. IDENTIFICATION REQUIREMENTS. Each individual must be properly identified as set out in Neb. Rev. Stat. § 38-124, and this chapter 006.02 PHARMACIST INTERN. Each pharmacist intern must be identified as a pharmacist intern while performing the duties of a pharmacist intern. 007. SUPERVISION OF PHARMACIST INTERN. A pharmacist intern must be supervised as set out in Neb. Rev. Stat. §§ 38-2854 and 38-2866.01. This supervision must be provided by a pharmacist who possesses a Nebraska pharmacist license which is free from disciplinary measures at the time of supervision unless the pharmacist intern is receiving experiential training directed by the accredited pharmacy program in which he or she is enrolled. 007.01 ONE OR MORE SUPERVISORS. Nothing in this chapter will be construed to prohibit 1 pharmacist intern or 1 pharmacy technician from being supervised by more than 1 pharmacist at any time. 007.02 PHARMACIST INTERN. A pharmacist intern must not supervise another pharmacist intern nor a pharmacy technician. 007.03 COMPLIANCE. In the case of a pharmacist intern, the result of failure to comply with any of these standards may be revocation of any credential issued on the basis of such pharmacist internship As noted above, the requirement for pharmacist supervision does not apply to pharmacist interns who are receiving experiential training directed by the accredited pharmacy program in which s/he is enrolled (e.g., a pharmacist intern who is completing an academic or research APPE can be supervised by someone who is not a pharmacist). It is important to emphasize, that "a pharmacist intern may compound and dispense drugs or devices and fill prescriptions only in the presence of and under the immediate personal supervision of a licensed pharmacist" and that “a pharmacist intern must be supervised at all times while performing the functions of a pharmacist intern, which may include all 97

aspects of the practice of pharmacy, unless otherwise restricted.” It is the Board of Pharmacy's opinion "that out-of-sight or hearing is not immediate personal supervision.” There is some concern that this provision of the law is not being met and that pharmacist interns are not being properly supervised. Several compounding errors have been made by pharmacist interns in Nebraska and inadequate supervision may have been a contributing factor. In Nebraska, a registered and properly supervised pharmacist intern has essentially the same legal scope of practice as a pharmacist. Even though a pharmacist intern may legally be able to do something (e.g., administer flu vaccine), the pharmacist supervising a pharmacist intern may not allow that to be done until the pharmacist intern has the appropriate knowledge and skill to do so (e.g., completion of a pharmacy-based immunization delivery course). If in doubt, a pharmacist intern must always clarify a given situation with his/her supervising pharmacist. In Nebraska, pharmacist interns are allowed to participate in a practice agreement: 38-2867.03(5) Pharmacist interns may participate in a practice agreement without expressly being named in the agreement if they are supervised by a pharmacist who is named in the agreement. Since a pharmacist intern in Nebraska has a legal scope of practice, he/she must follow all applicable pharmacy practice laws and can be disciplined. He/she is expected to act as a professional person in all settings, with everyone that he/she interacts with, and in all of his/her communications. A DWI/DUI (i.e., driving while intoxicated) while enrolled in a pharmacy program could have a negative impact on someone’s application to become licensed as a pharmacist after graduation. A key difference between a pharmacist intern and a pharmacy technician is that a pharmacist intern can carry out a task that requires professional judgment (e.g., counsel a patient) while a pharmacy technician cannot carry out a task that requires professional judgment (e.g., counsel a patient). A pharmacy student may apply to become a registered pharmacist intern in Nebraska as soon as he/she is enrolled in an accredited pharmacy program. The student must furnish "satisfactory evidence to the department that he/she is of good character and has attained the age of nineteen years (see section 38-129). In addition, he/she must provide proof of citizenship, lawful permanence, and/or immigration status. Once registered, pharmacist interns must always have their registration card with them when functioning as pharmacist interns in Nebraska. A pharmacist intern must notify the Nebraska Department of Health and Human Services Regulation and Licensure of any change in enrollment, address, or name. Each pharmacist intern must be identified as a pharmacist intern while performing the duties of a pharmacist intern. A pharmacist intern cannot supervise or verify the work of a pharmacy technician or another pharmacist intern. 98

In Nebraska: 38-2866.01 Pharmacist; supervision of pharmacy technicians and pharmacist interns Nebraska Revised Statute A pharmacist may supervise any combination of pharmacy technicians and pharmacist interns at any time up to a total of three people. A pharmacist intern shall be supervised at all times while performing the functions of a pharmacist intern which may include all aspects of the practice of pharmacy unless otherwise restricted. This section does not apply to a pharmacist intern who is receiving experiential training directed by the accredited pharmacy program in which he or she is enrolled. It is important to emphasize, that a pharmacist intern who is receiving experiential training directed by the accredited program in which s/he is enrolled (e.g., an introductory pharmacy practice experience [IPPE], advanced pharmacy practice experience [APPE], or other experiential training activities) is not considered in the ratio. Except in an accredited school or college of pharmacy experiential training program (e.g., a clerkship or rotation experience), the ratio of pharmacist interns to one pharmacist in any pharmacy in Nebraska shall not exceed: 1. one pharmacist intern to one pharmacist, when two pharmacy technicians are also being supervised by the pharmacist 2. two pharmacist interns to one pharmacist, when one pharmacy technician is also being supervised by the pharmacist 3. three pharmacist interns to one pharmacist, when no pharmacy technicians are being supervised by the pharmacist 7. Discuss the requirements for obtaining and renewing a license to practice pharmacy in Nebraska. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-2851(1)-(2); 38-2855 to 38-2865; 38-2845; and 38-2854(2) #6 Statutes Relating to Uniform Credentialing Act, 38-124; 38- 129; 38-142(1)-(3); and 38-144(1)-(3) #8 Regulations Governing the Practice of Pharmacy, 128-003 and 128-007 In the State of Nebraska: 38-2851(1) To be eligible to take the pharmacist licensure examination, every applicant must present proof of graduation from an accredited pharmacy program. A graduate of a pharmacy program located outside of the United States and which is not accredited shall be deemed to have satisfied the requirement of 99

being a graduate of an accredited pharmacy program upon providing evidence satisfactory to the department, with the recommendation of the board, of graduation from such foreign pharmacy program and upon successfully passing an equivalency examination approved by the board. (2) Every applicant for licensure as a pharmacist shall (a) pass a pharmacist licensure examination approved by the board, (b) have graduated from a pharmacy program pursuant to subsection (1) of this section, and (c) present proof satisfactory to the department, with the recommendation of the board, that he or she has met one of the following requirements to demonstrate his or her current competency: (i) within the last three years, has passed a pharmacist licensure examination approved by the board; (ii) has been in the active practice of the profession of pharmacy in another state, territory, or the District of Columbia for at least one year within the three years immediately preceding the application for licensure; (iii) has become board certified in a specialty recognized by the Board of Pharmacy Specialties or its successor within the seven years immediately preceding the application for licensure; (iv) is duly licensed as a pharmacist in some other state, territory, or the District of Columbia in which, under like conditions, licensure as a pharmacist is granted in this state; or (v) has completed continuing competency in pharmacy that is approved by the Board of Pharmacy. At the present time, a Nebraska regulation requires an applicant to be of good character and not less than twenty-one years of age in order to become licensed as a pharmacist. This age requirement is greater than that required in section 38-129 (i.e., nineteen years). A proposal has been made to change that regulation to reflect the nineteen years required in section 38-129. A pharmacist licensed in a state other than Nebraska, may want to transfer his or her license to the State of Nebraska. This transfer process is also referred to as reciprocity or obtaining a reciprocal license based on a license by examination in another state. A licensed pharmacist shall make his/her current credential available upon request (i.e., a pharmacist does not have to have his/her license posted in a pharmacy). At one time, a sign with the names of all pharmacists regularly employed in a pharmacy had to be located near the front door of the pharmacy. However, that regulation was repealed. In Nebraska: 128-003.07 No one, other than a duly licensed pharmacist, is allowed to use the following terms or designations or any other terms, designations, or letters implying licensure as a pharmacist in this state or in any other jurisdiction: 1. pharmacist, 2. registered pharmacist, R.P., or R.Ph., 3. pharmacist-in-charge, 4. licensed pharmacist, or 5. natural pharmacist, herbal pharmacist 100

In Nebraska, a license to practice pharmacy expires on January 1st of each even- numbered year. If the renewal fee and/or the completed renewal form are postmarked or submitted in person after the expiration date, a penalty fee will be assessed and one may not practice until the license is renewed. If one continues to practice he/she will be subject to an administrative penalty of $10.00 per day up to a maximum of $1,000.00. A pharmacist should not allow his/her license to expire or lapse: 38-142(2) At least thirty days before the expiration of a credential, the department shall notify each credentialed person at his or her last address of record. If a credentialed person fails to notify the department of his or her desire to have his or her credential placed on inactive status upon its expiration, fails to meet the requirements for renewal on or before the date of expiration of his or her credential, or otherwise fails to renew his or her credential, it shall expire. When a person's credential expires, the right to represent himself or herself as a credentialed person and to practice the profession in which a credential is required shall terminate. Any credentialed person who fails to renew the credential by the expiration date and desires to resume practice of the profession shall apply to the department for reinstatement of the credential. It is possible for a pharmacist licensed in Nebraska, to place his/her license on inactive status: 38-142(3) When a person credentialed pursuant to the Uniform Credentialing Act desires to have his or her credential placed on inactive status, he or she shall notify the department of such desire in writing. The department shall notify the credentialed person in writing of the acceptance or denial of the request to allow the credential to be placed on inactive status. When the credential is placed on inactive status, the credentialed person shall not engage in the practice of such profession, but he or she may represent himself or herself as having an inactive credential. A credential may remain on inactive status for an indefinite period of time. In Nebraska, a temporary educational permit (TEP) may be issued to a graduate of an accredited pharmacy program who is not licensed as a pharmacist but who is "serving in a supervised educational program or in an approved graduate pharmacy education program conducted by an accredited hospital or clinic in the State of Nebraska or by an accredited school or college of pharmacy in the State of Nebraska." Several key points about a TEP are as follows: 1. the holder of a TEP is not a licensed pharmacist and cannot engage in the practice of pharmacy outside of the assigned training program or outside the confines of the accredited hospital or clinic or the accredited school or college (see section 38- 2856) 2. since the holder of a TEP is not a licensed pharmacist, he/she cannot supervise and/or verify the work of a pharmacist intern or pharmacy technician [see sections 38-2854(2) and 38-2845] 101

3. the duration of a TEP cannot exceed one year, but it can be renewed for no more than five one-year periods (see section 38-2859) Most individuals elect to become licensed as a pharmacist in Nebraska because of the significant disadvantage presented in Item #2 above. END OF MATERIAL FOR EXAM #3 8. Discuss Continuing Competency Requirements for Nebraska pharmacists. Reference(s): #6 Statutes Relating to Uniform Credentialing Act, 38-145(1)-(4) and 38-146(2) #8 Regulations Governing the Practice of Pharmacy, 128-006 Many states require continuing education credits before a pharmacist can renew his/her license to practice pharmacy. In Nebraska, each professional board in Nebraska was directed to establish continuing competency requirements for persons seeking renewal of a credential. Continuing competency activities may include, but not be limited to, any one or a combination of continuing education, board certification in a clinical specialty area, professional certification, professional portfolio, or testing. Nebraska pharmacists are required to complete thirty (30) hours of acceptable continuing education every two years. Credit earned in excess of the thirty (30) hour requirement cannot be carried over into subsequent periods. Some states require a portion of the continuing education hours to be in specific areas of interest (e.g., HIV, law). Some states require the pharmacist to actually be in attendance at a lecture or conference. Nebraska does not have either of these requirements at this time. However, all continuing education hours for Nebraska pharmacists must be from providers approved by the Nebraska Board of Pharmacy: 128-006 Continuing Competency 128-006.01 General Requirements for Licensee On or before January 1 of each even-numbered year, every Pharmacist who is licensed in the State of Nebraska must as a condition for renewal of his/her license: 128-006.01A Complete 30 hours of acceptable continued education during the preceding 24 month period, no more hours than the total number of acceptable hours offered in Nebraska will be required during this period. 128-006.01A1 The Board of Pharmacy has approved the following providers of continuing education: 1. The Accreditation Council for Pharmacy Education (ACPE); 2. The Nebraska Council on Continuing Pharmaceutical Education; or 102

3. Other providers demonstrating the same quality standards as those established in the Criteria for Quality of ACPE. 128-006.01B Be responsible for maintaining in his/her personal files certificates or records of credit from acceptable continuing education activities attended . In lieu of continuing education, it has been proposed that achieving or maintaining certification through the Board of Pharmacy Specialties (BPS) or the National Certification Board for Diabetes Educators (NCBDE) could also be used to satisfy the continuing competency requirements in Nebraska. A sample of licensee renewal applications may be randomly selected for audit of continuing competency. Licensees selected for audit are required to produce documentation of his/her continuing competency activities listed on his/her renewal application. Failure to comply with an audit may be grounds for non-renewal of a license. In Nebraska, the department may waive continuing competency requirements in certain situations: 38-146(2) The department may waive continuing competency requirements, in whole or in part, upon submission by a credential holder of documentation that circumstances beyond his or her control have prevented completion of such requirements. Such circumstances shall include, but not be limited to: (a) the credential holder has served in the regular armed forces of the United States during part of the credentialing period immediately preceding the renewal date; (b) the credential holder was first credentialed within the credentialing period immediately preceding the renewal date; or (c) other circumstances prescribed by rules and regulations adopted and promulgated under the appropriate practice act. 128-006.02 Wavier of Continuing Competency The Department, on recommendation of the Board, may waive the continuing competency requirements, in whole or in part, for any two year license or for the period of time when a licensee submits documentation that circumstances beyond his/her control prevented the completion of such requirements. 128-006.02A Such circumstances will include situations in which the licensee: 1. Holds a Nebraska pharmacist license but has not practiced in Nebraska during the 24 months immediately preceding the license renewal date; or 2. Has been in the service of regular armed forces of the United States during any part of the 24 months immediately preceding the license renewal date; or 3. Has been suffering from a serious or disabling illness or physical disability which prevented completion of the required number of continuing education hours during the 24 months immediately preceding the license renewal date; or 4. Has been first licensed in Nebraska within 24 months immediately preceding the renewal date. 103

128-006.02B Application for Wavier of Continuing Competency: Any licensee who seeks wavier of continuing competency requirements, in part or in total, for any two year licensing period must apply to the Department. The Department, on the recommendation of the Board, may waive continuing competency requirements in part or in total for any two year period. 9. Discuss the requirements of the Emergency Box Drug Act in Nebraska. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 71-2411 to 71- 2417 and 38-2808.01 The DEA has a policy which allows individual state licensing and regulatory boards to approve the storage of controlled substances in emergency kits at long-term care facilities (LTCF) that are not registered with the DEA. In Nebraska, "emergency box drugs means drugs required to meet the immediate therapeutic needs of patients when the drugs are not available from any other authorized source in time to sufficiently prevent risk of harm to such patients by the delay resulting from obtaining such drugs from such other authorized source." The supplying pharmacy and the medical director and quality assurance committee of the LTCF shall jointly determine the drugs by identity and quantity to be included in an emergency box. An emergency box shall not contain multiple dose vials, shall not contain more than ten drugs which are controlled substances, and shall contain no more than a total of fifty drugs. Drugs in an emergency box in a LTCF: 1. are owned by the supplying pharmacy 2. can include Schedule II, III, IV, or V controlled substances 3. can be removed from the emergency box for administration to a patient only pursuant to a prescription 4. are exempt from the labeling requirements for a specific patient 5. shall be in the original manufacturer's or distributor's containers or shall be repackaged by the supplying pharmacy and shall include the manufacturer's or distributor's name, lot number, drug name, strength, dosage form, NDC number, route of administration, and expiration date on a typewritten label. Any drug which is repackaged shall contain on the label the calculated expiration date. For purposes of the Emergency Box Drug Act, calculated expiration date has the same meaning as in section 38-2808.01 (i.e., "the expiration date on the manufacturer's, packager’s, or distributor’s container or one year from the date the drug is repackaged, whichever is earlier"). _______________________________________________________________________ 10. Discuss the Licensee Assistance Program (LAP) in Nebraska. 104

Reference(s): #6 Statutes Relating to Uniform Credentialing Act, 38-175(1)-(5) In Nebraska, the Licensee Assistance Program (LAP) is "limited to providing education, referral assistance, and monitoring of compliance with treatment for abuse of, dependence on, or active addiction to alcohol, any controlled substance, or any mind-altering substance and shall be limited to voluntary participation by credential holders. Participation in the program shall not preclude the investigation of alleged statutory violations which could result in disciplinary action against the person's credential or criminal action against the person." 11. Discuss the composition of the Nebraska Board of Pharmacy. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-2849 #6 Statutes Relating to Uniform Credentialing Act, 38-161 to 38- 163 The Nebraska Board of Pharmacy consists of five members (four actively practicing pharmacists and one public member) who are residents of the State of Nebraska. One of the pharmacists must be a hospital pharmacist. Board members can serve two consecutive five-year terms for a total of 10 years. The purpose of the Nebraska Board of Pharmacy "is to protect the health, safety, and welfare of the public as prescribed in the Uniform Credentialing Act." Duties of the Nebraska Board of Pharmacy include, but are not limited to: 1. setting the minimum standards of proficiency and competency for a credential 2. providing recommendations related to the issuance or denial of credentials, disciplinary action, and changes in legislation 3. providing the department with recommendations on regulations to carry out the Uniform Credentialing Act 12. Discuss the qualifications of a pharmacy inspector in Nebraska. Reference(s): #5 Statutes Relating to Pharmacy Practice Act, 38-28,101 "Only a licensed pharmacist who is or who has been engaged in the active practice of pharmacy shall be appointed by the department to serve as a pharmacy inspector with the consent and approval of the board." 105

13. Discuss miscellaneous statutes and regulations applicable to the practice of pharmacy in Nebraska. Reference(s): #7 Regulations Governing Licensure of Pharmacies, 8-006 In Nebraska, a pharmacy must be prepared to deal with various disasters: 8-006.07 The licensee must establish and implement disaster preparedness plans and procedures to protect the potency, efficacy, safety, and security of the drugs, devices, or biologicals in the pharmacy in instances of natural (tornado, flood, etc.) or other disasters, disease outbreaks, interruption of utility services, or other similar situations. Such plans and procedures must address and delineate: 1. How the pharmacy will provide for the storage of drugs, devices, and biologicals at the proper temperature; 2. How the pharmacy will provide for the disposal of drugs, devices, and biologicals if the pharmacy determines their potency, efficacy, or safety has been adversely affected; 3. How the pharmacy will secure the drugs, devices, and biologicals from the public; and 4. How the pharmacy will maintain patient records and inventory records. In Nebraska, a pharmacy is required to report to the Nebraska Parkinson's Disease Registry: 186 NAC 4-004.02 The pharmacist in charge of each pharmacy located within the state or doing business in the state must report dispensation of drugs that are included on the list of drugs to be reported for Parkinson's disease issued by the Department each January. The report will be filed on a semi-annual basis. The report for the months of January through June must be due on or before the following July 31st, and the report for the months of July through December must be due on or before January 31st of the following year. Data to be reported to the Department for each individual resident of this state to whom the pharmacist has dispensed drugs as specified on the list of drugs required to be reported for Parkinson's disease...are as follows: 1. Name; 2. Address; 3. Social security number; 4. Name of the prescribing physician; and 5. Address of the prescribing physician. It is important to note that: 1. "Any pharmacist required to make reports under the Parkinson's Disease Registry Act is immune from liability, civil, criminal, or otherwise, that might result from divulging such information; and 106

2. State reporting requirements "trump" HIPAA. In other words, HIPAA allows for state mandated reporting requirements." In Nebraska, suspected abuse or neglect must be reported as required in sections 28- 711 and 28-372: 28-711(1) When any physician, any medical institution, any nurse, any school employee, any social worker, the Inspector General…, or any other person has reasonable cause to believe that a child has been subjected to child abuse or neglect or observes such child being subjected to conditions or circumstances which reasonably would result in child abuse or neglect, he or she shall report such incident or cause a report of child abuse or neglect to be made to the proper law enforcement agency or to the department on the toll-free number established ... 28-372(1) When any physician, psychologist, physician assistant, nurse, nursing assistant, other medical, developmental disability, or mental health professional, law enforcement personnel, caregiver or employee of a caregiver, operator or employee of a sheltered workshop, owner, operator, or employee of any facility licensed by the department, or human services professional or paraprofessional not including a member of the clergy has reasonable cause to believe that a vulnerable adult has been subjected to abuse, neglect, or exploitation or observes such adult being subjected to conditions or circumstances which reasonably would result in abuse, neglect, or exploitation, he or she shall report the incident or cause a report to be made to the appropriate law enforcement agency or to the department. Any other person may report abuse, neglect, or exploitation if such person has reasonable cause to believe that a vulnerable adult has been subjected to abuse, neglect, or exploitation or observes such adult being subjected to conditions or circumstances which reasonably would result in abuse, neglect, or exploitation. 28-371 Vulnerable adult shall mean any person eighteen years of age or older who has a substantial mental or functional impairment or for whom a guardian has been appointed under the Nebraska Probate Code. The toll-free number for the above reports is 800-652-1999. 107