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Prescribing Drugs: Michigan Law For PAs Handouts and Lecture Notes are online at:

Michigan Academy of Physician Assistants September 30, 2005 Jesse C. Vivian, BS Pharm, JD Professor of Pharmacy Practice Room 2144 Applebaum Voice:(313) 577-5389 Fax: (313) 577-5369 E-Mail: jessevivian@wayne.edu Web: http://jessevivian.net. Prescribing Drugs: Michigan Law For PAs

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Prescribing Drugs: Michigan Law For PAs Handouts and Lecture Notes are online at:

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  1. Michigan Academy of Physician AssistantsSeptember 30, 2005Jesse C. Vivian, BS Pharm, JDProfessor of Pharmacy PracticeRoom 2144 ApplebaumVoice:(313) 577-5389 Fax: (313) 577-5369E-Mail: jessevivian@wayne.eduWeb: http://jessevivian.net Prescribing Drugs: Michigan Law For PAs Handouts and Lecture Notes are online at: PAprescribinghandout.doc PAprescribinghandout.xml PAprescribinghandout.htm PAprescribinghandout.ppt

  2. Prescribing Law Sources Excerpts from Michigan Pharmacy Law: A Guide to the Statutes and Regulations, 3rd Edition (2004) Published by The Michigan Pharmacists Association, Lansing, MI 48906

  3. Question: Who can prescribe what under Michigan Laws and Regulations? Note: Federal Law defers to State law on prescribing authority

  4. Distinguish: • Independent Prescribing authority From • Dependant Prescribing Authority

  5. Distinguish: • RDs from • FDs

  6. Who can prescribe what under Michigan Laws and Regulations? The answer, depends upon whether the focus of the question is on • practitioners licensed by the state of Michigan to prescribe federal legend drugs or, • practitioners authorized to prescribe under the laws of other states (or even Canada) when the prescription is presented to a Michigan pharmacy. • The other critical factor depends on whether the prescription is for a controlled substance or a non-controlled federal legend drug.

  7. No Rule is a Good RuleunlessThere are Exceptions

  8. Executive Order No. 2005-24 • On September 20, Governor Granholm signed Executive Order No. 2005-24 giving Michigan licensed Pharmacists and Pharmacies discretionary authority to dispense prescription drugs to victims of Hurricane Katrina where there are no records available. • STATE OF DISASTER: TEMPORARY SUSPENSION OF REQUIREMENTS RELATING TO PRESCRIPTION DRUGS

  9. Executive Order 2005-24 1. Subdivision (e) of Section 17763 of the Public Health Code 1978 PA 368, MCL 333.17763(e), and associated state regulations are suspended.  Pharmacies and pharmacists licensed in this state may, in the exercise of their professional judgment, refill controlled substance prescriptions issued by licensed physicians in the States of Alabama, Louisiana, and Mississippi.

  10. Executive Order 2005-24 2. Subsection (1) of Section 17751 of the Public Health Code, 1978 PA 368, MCL 333.17751(1) and associated state regulations are suspended.  Pharmacies and pharmacists licensed in this state may, in the exercise of their professional judgment, fill or dispense up to a 30-day supply of a non-controlled substance prescription for which a patient from the States of Alabama, Louisiana, or Mississippi affected by Hurricane Katrina does not have a refill prescription.

  11. Executive Order 2005-24 3. Those portions of Subsection (4) of Section 7333 and Subdivision (1)(a) of Section 7405 Public Health Code, 1978 PA 368, MCL 333.7333(4) and 333.7405(1)(a) related to the prohibition against refilling prescriptions for controlled substances without a refill prescription and associated state regulations are suspended.  Pharmacies and pharmacists licensed in this state may, in the exercise of their professional judgment, refill schedule 3, 4, and 5 controlled substance prescriptions for up to a 30-day supply without a refill prescription.

  12. Executive Order 2005-24 • The Department of Community Health is responsible for coordinating the implementation of this Order. • This Order is effective until the expiration of the State of Disaster declared under Executive Order 2005-21, including any extensions of the State of Disaster.

  13. Independent Prescribers Licensed health practitioners expressly authorized to prescribe federal legend drugs (within the scope of practice permitted by their license) as a “prescriber” in Michigan. Include: • dentists • veterinarians • doctors of podiatric medicine and surgery • optometrists • doctors of medicine • doctors of osteopathic medicine and surgery.

  14. Dependent Prescribing Authority Dependent prescriptive authority is limited to specific situations and types of drugs. Only Michigan licensed “doctors of medicine” (MDs) and “doctors of osteopathic medicine and surgery” (DOs) are allowed to delegate prescribing authority, They may delegate this authority only to another “licensed health professional acting under the delegation and using, recording or otherwise indicating the name of the delegating licensed doctor of medicine or doctor of osteopathic medicine and surgery.”

  15. Licensed Physician’s Assistants (PAs) November 1999, MD & DO Boards adopt rules for PAs Permitted to prescribe most federal legend drugs — but ONLY IF the PA is acting within the defined parameters of authority delegated by a supervising MD or DO.

  16. Pharmacist’s Request • Do not be surprised if a pharmacist asks to obtain a copy of the prescriber’s delegation protocol to a PA. • Especially for Controlled Substances.

  17. Governing Regulations make provisions for the licensing boards to “promulgate rules for the delegation by a supervising physician to a physician’s assistant the function of prescribing drugs.” with the exception of controlled substances, which are discussed below, those boards had not promulgated any rules yet (04/14/2005)

  18. General Rule for PA PrescribingNon-Controlled Substances In the absence of any applicable rules, the statutes state that “a supervising physician may delegate the prescription of drugs other than controlled substances ------ along with “other procedures and protocols necessary to promote consistency with federal and state drug control and enforcement laws.”

  19. Rx Format If a PA does prescribe a Non-Controlledfederal legend drug, the prescription must indicate both the PA’s name and the supervising physician’s name. Otherwise, the prescription may be treated as if it originated with the MD or DO.

  20. Regulations • Rules 338.2304/338.2305 (Medicine) and Rules 338.108a/338.108b (Osteopathic) have identical requirements for physicians who elect to delegate the prescribing of controlled substances to the physician’s assistants, nurse practitioners, or nurse midwives they supervise

  21. Department of Community Health Opinion “Since the prescribing is accomplished through delegation from the physician, a separate Michigan Controlled Substance or DEA license is not required.” “Physician’s assistants, nurse practitioners and nurse midwives are not independently tracked. Prescriptions are recorded under the individual physician’s DEA number.”

  22. R 338.108a (R 338.2304). Delegation of prescribing of controlled substances to physician’s assistants; limitation. Rule 8a (Rule 4) (1) A physician who supervises a physician’s assistant under sections 17548 and 17549 (17048 and 17049) of the code may delegate the prescription of controlled substances listed in Schedules 3 to 5 to a physician’s assistant if the delegating physician establishes a written authorization that contains all of the following information: (a) The name, license number, and signature of the supervising physician. (b) The name, license number, and signature of the physician’s assistant. (c) The limitations or exceptions to the delegation. (d) The effective date of the delegation.

  23. Rule 8a: More Conditions (2) A delegating physician shall review and update a written authorization on an annual basis from the original date or the date of amendment, if amended. A delegating physician shall note the review date on the written authorization. (3) A delegating physician shall maintain a written authorization in each separate location of the physician’s office where the delegation occurs. (4) A delegating physician shall ensure that an amendment to the written authorization is in compliance with subrule (1)(a) to (d) of this rule.

  24. Rule 8a: Schedule 2 Rx (5) A delegating physician may delegate the prescription of Schedule 2 controlled substances only if all of the following conditions are met: (a) The supervising physician and physician’s assistant 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.

  25. Rule 8a: Schedule 2 Rx (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.

  26. Questions • You may obtain the complete text of the rules through the Internet using the following Bureau of Health Professions Web address at http://www.michigan.gov/healthlicense. • This website is maintained by the Office of Regulatory Reform and contains all of the administrative rules for the Department of Consumer and Industry Services. Scroll to the Board of Medicine or Board of Osteopathic Medicine and click on General Rules. • Please direct questions to the Bureau of Health Professions at (517) 241-9427.

  27. Rule 8a: More Conditions (7) A delegating physician shall not delegate the prescription of a drug or device individually, in combination, or in succession for a woman known to be pregnant with the intention of causing either a miscarriage or fetal death.

  28. Rx Contents Name and Address of the MD or DO or Name and address where PA is located Patient’s Name (and address) Name of Drug: Brand or Generic name Dosage Form (capsules tablets, liquids) Quantity (numeric and alphabetical if CS) Directions for Use (“Sig” qd, bid,qid) Refills if any (“prn” caution) Signed by PA

  29. Questions

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