Exceptions to the Rule: A Pharmacy Law Presentation Eric Roath, Pharm.D. Director of Professional Practice Michigan Pharmacists Association Objectives 1. Identify basic legal frameworks that govern the practice of pharmacy in the state of Michigan. 2. Identify specific cases in which the legal requirements for certain prescriptions, providers or scenarios deviate from conventional regulations. 3. Identify most common regulatory violations cited in pharmacy audits and inspections. DISCLAIMER Please Note: MPA does not provide legal advice, but rather our interpretation of the Public Health Code and how the Board of Pharmacy is currently enforcing the provisions. For legal advice, we recommend that you contact an attorney. 1
Word of the Hour: Appears in the latest edition of PLUS > 300 times Summary of Common Exceptions Licensure and Training Controlled Substances Prescriptive Authority Dispensing Prescription Validity Compounding Pharmacy Patient Specific Prescriptions Commercially Available Products Repackaging Technology and Automation Sources of Regulatory Authority Michigan Public Health Code Board of Pharmacy Administrative Rules Federal Food Drug and Cosmetic Act DEA Code of Federal Regulations United States Pharmacopeia and National Formulary 2
Licensure and Training Pharmacy technicians must be licensed to work in a pharmacy as of October 1, 2015 when they are enrolled in an approved training program. Pharmacy Technicians (Proposed) R 338.3655 Approved pharmacy technician programs. The following programs offer exemption from licensure while the technician is enrolled in the program: (a) A pharmacy technician program that is accredited by the accreditation council for pharmacy education (ACPE). (b) A pharmacy technician program that is offered by a pharmacist education program that is accredited by the accreditation council for pharmacy education (ACPE). (c) A comprehensive curriculum based pharmacy technician education and training program conducted by a school that is licensed pursuant to the Proprietary Schools Act, 1943 PA 148, MCL 395.101 to 395.103. (d) A pharmacy technician training program utilized by a pharmacy or employer that includes specific training in the functions, specified in MCL 333.17739(1), required to assist the pharmacist in the technical functions associated with the practice of pharmacy Pharmacy Technicians What employer based pharmacy technician program exams are approved by the board? Rite Aid Corporation Meijer Inc. Omnicare, Inc. CVS Health The Kroger Co. of Michigan Walgreen Company SpartanNash, Inc. Pharmacy Services Inc. (Program without exam) 3
Pharmacy Technicians Proposed CE Requirements: 5 hours of live CE 1 hour of pain and symptom management 1 hour of patient safety 1 hour of pharmacy law 20 hour total to renew Identifying victims of human trafficking C.S. Prescriptive Authority Nurse Practitioners may not prescribe Schedule II medications under limited circumstances in which they actually are permitted to prescribe under delegation. C.S. Prescriptive Authority R 338.2305 (5) A delegating physician may delegate the prescription of schedule 2 controlled substances only if all of the following conditions are met: (a) The delegating physician and nurse practitioner or nurse midwife are practicing within a health facility as defined in section 20106(d), (g), or (i) of the code; specifically, freestanding surgical outpatient facilities, hospitals, and hospices. (b) The patient is located within the facility described in subdivision (a) of this subrule. (c) The delegation is in compliance with this rule. (6) A delegating physician may not delegate the prescription of schedule 2 controlled substances issued for the discharge of a patient for a quantity for more than a 7 day period. 4
C.S. Dispensing Schedule V controlled substances require a prescription or medical order to be dispensed to a patient for certain medications which are classified as Schedule V Exempt. C.S. Dispensing R 338.3167 Dispensing schedule 5 substances without prescriptions. (1) A pharmacist may, without a prescription, dispense a controlled substance listed in schedule 5 which is not a prescription medication as determined under the federal food, drug, and cosmetic act, 21 U.S.C. 301 to 392, if all of the following provisions are met: (a) The dispensing pharmacist has determined it is to be used for a medical purpose. (b) Not more than 240 cc (8 ounces) or 48 solid doses of a substance containing opium or more than 120 cc (4 ounces) or 24 solid doses of any other substance listed in schedule 5 are distributed at retail to the same purchaser in any single 48 hour period. (c) The purchaser is at least 18 years of age. (d) The pharmacist requires a purchaser not known to the pharmacist to furnish suitable identification, including proof of age where appropriate. C.S. Dispensing R 338.3167 Dispensing schedule 5 substances without prescriptions. (2) If a pharmacist dispenses a controlled substance listed in schedule 5, then he or she shall affix to the container in which the substance is dispensed a label that shows the date, [the pharmacist s] name, and the name and address of the place of practice in which the substance is dispensed. (3) The pharmacist shall maintain a record of the dispensing of controlled substances listed in schedule 5. The record shall be immediately retrievable and may be maintained in the same manner as required for schedule 5 prescription medication. The record shall contain all of the following information: (a) The name and address of the patient. (b) The name and address of the purchaser if different from the patient. (c) The name and quantity of substance purchased. (d) The date purchased. (e) The name or initials of the pharmacist or pharmacy intern who dispensed the substance. (f) The medical purpose for which the medication is being used as determined by the pharmacist. 5
Schedule II controlled substances may only be issued pursuant to a written or electronic prescription for certain circumstances in which alternative dispensing arrangements can be made. (d) In the case of an emergency situation a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner); (d) In the case of an emergency situation a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in 1306.05, except for the signature of the prescribing individual practitioner; 6
(d) In the case of an emergency situation a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and (4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The prescription shall have written on its face Authorization for Emergency Dispensing, and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7 day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing. (4) For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner. 7
(e) A prescription prepared in accordance with 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with 1304.04(h) of this chapter. (f) A prescription prepared in accordance with 1306.05 written for Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with 1304.04(h). (g) A prescription prepared in accordance with 1306.05 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it shall be maintained in accordance with 1304.04(h). 8
Compounding: Patient Specific Rxs A pharmacy may only compound a medication pursuant to a patient specific prescription for facilities registered as an Outsourcing Facility with the FDA. Compounding: Patient Specific Rx 21 USC 353a: (2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and (B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between (i) the licensed pharmacist or licensed physician; and (ii)(i) such individual patient for whom the prescription order will be provided; or (II) the physician or other licensed practitioner who will write such prescription order. Compounding: Commercially Available Products A pharmacy may not compound a copy of a commercially available product for under limited circumstances. 9
Compounding: Commercially Available Products Sec. 17748c. Except for pharmaceuticals on the Michigan pharmaceutical product list maintained by the department of community health, a pharmacist shall not compound a pharmaceutical that is commercially available unless 1 of the following requirements is met: (a) The commercially available pharmaceutical is modified to produce a significant difference, in the professional judgment of the prescriber, between the compounded pharmaceutical for the patient and the comparable commercially available pharmaceutical. Compounding: Commercially Available Products Sec. 17748c. Except for pharmaceuticals on the Michigan pharmaceutical product list maintained by the department of community health, a pharmacist shall not compound a pharmaceutical that is commercially available unless 1 of the following requirements is met: (b) The commercially available pharmaceutical is not available from normal distribution channels in a timely manner to meet the patient s needs and the dispensing of the compounded pharmaceutical has been approved by the prescriber and the patient. A pharmacist who compounds a commercially available pharmaceutical as provided in this subdivision shall maintain documentation of the reason for the compounding. Repackaging Repackaging is a function relegated specifically to manufacturers for repackaging done under specific circumstances and purposes. 10
Repackaging 333.7106 (2) Manufacture means the production, preparation, propagation, compounding, conversion, or processing of a controlled substance, directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis. It includes the packaging or repackaging of the substance or labeling or relabeling of its container Repackaging Exemption #1: Unit Dose Packaging Example: (b) A prescription drug that is repackaged into a unit dose package or a unit of issue package by the pharmacy, dispensed, and returned to that pharmacy in that unit dose package or unit of issue package may be returned to stock, but it shall not be repackaged. A unit dose package or unit of issue package prepared by the pharmacist and returned to stock shall only be redispensed in that same unit dose package or unit of issue package and shall only be redispensed once. A pharmacist shall not add unit dose package drugs to a partially used unit of issue package. Repackaging Exemption #2: Customized Medication Packaging Example: R 338.479c (1) In place of dispensing 2 or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient s caregiver, or a prescriber, provide a customized patient medication package (CPMP). A CPMP is a package which is prepared by a pharmacist for a specific patient and which contains 2 or more prescribed solid oral dosage forms. The CPMP is designed and labeled to indicate the day and time or period of time that the contents within each CPMP are to be taken. The person who dispenses the medication shall instruct the patient or caregiver on the use of the CPMP. 11
Technology and Automation Automated dispensing machines for prescription medications are not permitted under state law within certain types of facilities and under certain circumstances. Technology and Automation R 338.489 (2) An automated device may be used only in the following locations: (a) A pharmacy. (b) A hospital. (c) A county medical care facility. (d) A hospice. (e) A nursing home. (f) Other skilled nursing facility as defined in 1978 PA 368, MCL 333.20109. (g) An office of a dispensing prescriber. QUESTIONS? 12
ASSESSMENT QUESTIONS 1. Which of the following regulatory policy sets impact the practice of pharmacy in the state of Michigan: a. Michigan Public Health Code b. Board of Pharmacy Administrative Rule Sets c. The Food Drug and Cosmetic Act d. All of the above 1. Which of the following regulatory policy sets impact the practice of pharmacy in the state of Michigan: a. Michigan Public Health Code b. Board of Pharmacy Administrative Rule Sets c. The Food Drug and Cosmetic Act d. All of the above 13
2. True or false: A nurse practitioner may never issue a prescription for a Schedule 2 controlled substance. a. True b. False 2. True or false: A nurse practitioner may never issue a prescription for a Schedule 2 controlled substance. a. True b. False 3. True or false: You may only dispense a codeine cough syrup preparation if the patient has a prescription. a. True b. False 14
3. True or false: You may only dispense a codeine cough syrup preparation if the patient has a prescription. a. True b. False 4. True or false: A registered nurse may sign off on a written controlled substance prescription for a physician as an alternative to having the physician sign the prescription. a. True b. False 4. True or false: A registered nurse may sign off on a written controlled substance prescription for a physician as an alternative to having the physician sign the prescription. a. True b. False 15