Pharmacy Law Review

1. Pharmacy Law Review Jesse C. Vivian Professor Department of Pharmacy Practice jessevivian.org

2. Professional Responsibility

3. Professional Responsibility

4. Sec. 17711A person shall not engage in the practice of pharmacy unless licensed or otherwise authorized by this article.

5. So, what does that mean?

6. “this article” Article 15 Occupations

7. Read the Definitions • What is a person? • Sec. 1106. "Person" means an individual, partnership, cooperative, association, private corporation, personal representative, receiver, trustee, assignee, or any other legal entity. It does not include a governmental entity unless specifically provided.

8. What does “engage” mean? No Public Health Code Definition, therefore, use ordinary meaning. http://www.dictionary.com/search?q=engage To obtain or contract for the services of; employ: engage a carpenter. To arrange for the use of; reserve: engage a room. To pledge or promise, especially to marry. To attract and hold the attention of; engross: a hobby that engaged her for hours at a time. To win over or attract: His smile engages everyone he meets. To draw into; involve: engage a shy person in conversation. To require the use of; occupy: Studying engages most of my time. To enter or bring into conflict with: We have engaged the enemy. To interlock or cause to interlock; mesh: engage the automobile's clutch. To give or take as security. ?????????

9. engage v.intr. To involve oneself or become occupied; participate: engage in conversation. To assume an obligation; agree. To enter into conflict or battle: The armies engaged at dawn. To become meshed or interlocked: The gears engaged

10. Practice of Pharmacy Sec. 17707 (5) "Practice of pharmacy" means a health service, the clinical application of which includes the encouragement of safety and efficacy in the prescribing, dispensing, administering, and use of drugs and related articles for the prevention of illness, and the maintenance and management of health. Professional functions associated with the practice of pharmacy include: (a) The interpretation and evaluation of the prescription. (b) Drug product selection. (c) The compounding, dispensing, safe storage, and distribution of drugs and devices. (d) The maintenance of legally required records. (e) Advising the prescriber and the patient as required as to contents, therapeutic action, utilization, and possible adverse reactions or interactions of drugs.

11. License Sec. 16106(2) "License," except as otherwise provided in this subsection, means an authorization issued under this article to practice where practice would otherwise be unlawful. License includes an authorization to use a designated title which use would otherwise be prohibited under this article and may be used to refer to a health profession subfield license, limited license, or a temporary license. For purposes of the definition of “prescriber” contained in section 17708(2) only, license includes an authorization issued under the laws of another state, or the country of Canada, to practice in that state,or the country of Canada, where practice would otherwise be unlawful, and is limited to a licensed doctor of medicine, a licensed doctor of osteopathic medicine and surgery, or another licensed health professional acting under the delegation and using, recording, or otherwise indicating the name of the delegating licensed doctor of medicine or licensed doctor of osteopathic medicine and surgery.

12. “otherwise authorized” Sec. 16171. Under the circumstances and subject to the limitations stated in each case, the following individuals are not required to have a license issued under this article for practice of a health profession in this state: (a) A student in a health profession training program, which has been approved by the appropriate board, while performing the duties assigned in the course of training.

13. “otherwise authorized” (c) An individual who by education, training, or experience substantially meets the requirements of this article for licensure while rendering medical care in a time of disaster or to an ill or injured individual at the scene of an emergency. (d) An individual who provides non-medical nursing or similar services in the care of the ill or suffering or an individual who in good faith ministers to the ill or suffering by spiritual means alone, through prayer, in the exercise of a religious freedom, and who does not hold himself or herself out to be a health professional. (e) An individual residing in another state or country and authorized to practice a health profession in that state or country who, in an exceptional circumstance, is called in for consultation or treatment by a health professional in this state. (f) An individual residing in another state or country and authorized to practice a health profession in that state or country, when attending meetings or conducting lectures, seminars, or demonstrations under the auspices of professional associations or training institutions in this state, if the individual does not maintain an office or designate a place to meet patients or receive calls in this state.

14. Sec. 17711. A person shall not engage in the practice of pharmacy unless licensed or otherwise authorized by this article.

15. Rule 20

16. 17748The “long-arm” statute A pharmacy, manufacturer, or wholesale distributor of prescription drugs, whether or not located in this state but doing business in this state, shall be licensed by the board in accordance with this part. Licenses shall be renewed biennially. A pharmacy, manufacturer, or wholesale distributor may designate an individual to be the licensee for the pharmacy, manufacturer, or wholesale distributor and the licensee is responsible for compliance with this part.

17. Rule 20 (2) A pharmacist shall not fill a prescription order if, in the pharmacist's professional judgment, any of the following provisions apply: (a) The prescription appears to be improperly written. (b) The prescription is susceptible to more than 1 interpretation. (c) The pharmacist has reason to believe that the prescription could cause harm to the patient. (d) The pharmacist has reason to believe that the prescription will be used for other than legitimate medical purposes.

18. Logic: for a statement to be true, the opposite must also be true. Does that mean that if those 4 conditions are not present, the pharmacist SHALL fill all other prescriptions? Can a pharmacist refuse to fill a prescription for any reason or even for no reason? Is Professional Judgment subjective or objective?

19. Rule 20 (1) Professional responsibility A pharmacist has a professional responsibility for the strength, quality, purity, and the labeling of all drugs and devices dispensed under a prescription. In discharging this responsibility, a pharmacist shall utilize only those drugs and devices that are obtained from manufacturers and wholesale distributors licensed under section 17748 of the code or from other lawful channels of distribution.

20. Rule 20 (3) A prescription drug shall only be dispensed when the pharmacy is open and under the personal charge of a pharmacist. Sec. 17763. In addition to the grounds set forth in part 161, the disciplinary subcommittee may fine, reprimand, or place a pharmacist licensee on probation, or deny, limit, suspend, or revoke the license of a pharmacist or order restitution or community service for a violation or abetting in a violation of this part or rules promulgated under this part, or for 1 or more of the following grounds: (d) Permitting the dispensing of prescriptions by a pharmacist intern, except in the presence and under the personal charge of a pharmacist.

21. personal charge Sec. 17707 (1) "Personal charge" means the immediate physical presence of a pharmacist or dispensing prescriber.

22. Rule 20 (4) To encourage intended, positive patient outcomes, a pharmacist shall communicate, to the patient or the patient's caregiver, necessary and appropriate information regarding safe and effective medication use at the time a prescription is dispensed. As used in this subrule, "caregiver" means the parent, guardian, or other individual who has assumed responsibility for providing a patient's care. All of the following provisions apply to communicating medication safety and effectiveness information:

23. Shall Communicate (a) The information shall be communicated orally and in person, except when thepatient or patient's caregiver is not at the pharmacy or when a specific communication barrier prohibits oral communication. In either situation, providing printed material designed to help the patient use the medication safely and effectively satisfies the requirements of this subrule. (b) The information shall be provided with each prescription for a drug not previously prescribed for the patient. (c) If the pharmacist deems it appropriate, the information shall be provided with prescription refills. (d) The information shall be provided if requested by the patient or patient's caregiver or agent for any prescription dispensed by the pharmacy. This subrule does not require that a pharmacist provide consultation if a patient or a patient's caregiver refuses consultation. This subrule does not apply to prescriptions dispensed for administration to a patient while the patient is in a medical institution.

24. Important Distinctions Personal Charge §17707 (1) Supervision §16109(2) Delegation §16215 and Rule 20(5)

25. Supervision §16109(2) “the overseeing of or participation in the work of another individual by a health professional licensed under this article in circumstances where at least all of the following conditions exist: (a) The continuous availability of direct communication in person or by radio, telephone, or telecommunication between the supervised individual and a licensed health professional. (b) The availability of a licensed health professional on a regularly scheduled basis to review the practice of the supervised individual, to provide consultation to the supervised individual, to review records, and to further educate the supervised individual in the performance of the individual’s functions. (c) The provision by the licensed supervising health professional of predetermined procedures and drug protocol.”

26. Delegation Rule 20 (5) Pharmacist delegation of acts, tasks, or functions shall be in compliance with section 16215 of the code and under the personal charge of the delegating pharmacist, except as provided in R 338.486(3).

27. §16215 (1) A licensee who holds a license other than a health profession subfield license may delegate to a licensed or unlicensed individual who is otherwise qualified by education, training, or experience the performance of selected acts, tasks, or functions where the acts, tasks, or functions fall within the scope of practice of the licensee's profession and will be performed under the licensee's supervision. An act, task, or function shall not be delegated under this section which, under standards of acceptable and prevailing practice, requires the level of education, skill, and judgment required of a licensee under this article.

28. §16215 (2) Except as otherwise provided in this subsection, a licensee under part 170 or 175 shall delegate an act, task, or function that involves the performance of a procedure that requires the use of surgical instrumentation only to an individual who is licensed under article 15. This subsection does not apply if the unlicensed individual is 1 or more of the following and if the procedure is directly supervised by a licensed physician or osteopathic physician who is physically present during the performance of the procedure or if the unlicensed individual is performing acupuncture: (a) A student enrolled in a school of medicine or osteopathic medicine approved by the Michigan board of medicine or the Michigan board of osteopathic medicine and surgery. (b) A student enrolled in a physician's assistant training program approved by the joint physician's assistant task force created under part 170.

29. §16215 (3) A board may promulgate rules to further prohibit or otherwise restrict delegation of specific acts, tasks, or functions to a licensed or unlicensed individual where the board determines that the delegation constitutes or may constitute a danger to the health, safety, or welfare of the patient or public. (4) To promote safe and competent practice, a board may promulgate rules to specify conditions under which, and categories and types of licensed and unlicensed individuals for whom, closer supervision may be required. (5) An individual who performs acts, tasks, or functions delegated pursuant to this section does not violate the part which regulates the scope of practice of that health profession.

30. …under personal charge.. except as provided in R 338.486(3) R 338.486 "Medical institution" and "pharmacy services" defined; pharmacy services in medical institutions. Rule 16(3) Pharmacy personnel who assist the pharmacist by performing delegated functions in the care of inpatients shall be supervised by a pharmacist who is on the premises of the medical institution.

31. Delegation Rule 20(5) A pharmacist who delegates acts, tasks, or functions to a licensed or unlicensed person shall do all of the following: (a) Determine the knowledge and skill required to safely and competently complete the specific act, task, or function to be delegated. (b) Before delegating an act, task, or function, make a determination that the delegatee has the necessary knowledge and skills to safely and competently complete the act, task, or function. (c) Provide written procedures or protocols, or both, to be followed by the delegatee in the performance of the delegated act, task, or function. (d) Supervise and evaluate the performance of the delegatee. (e) Provide remediation of the performance of the delegatee if indicated. Note: Inclusive, all 5 requirements

32. Rule 20 (6) A delegating pharmacist shall bear the ultimate responsibility for the performance of delegated acts, tasks, and functions performed by the delegatee within the scope of the delegation. “while a task may be delegable, the responsibility associated with the proper performance of it is never delegable”

33. 333.7333a Electronic monitoring system.Sec. 7333a. Replaces OPP

34. Michigan Automated Prescription System The MAPS program replaced the Official Prescription Program (OPP) effective January 1, 2003.  MAPS requires electronic reporting of all controlled substances in schedules 2 through 5 dispensed by pharmacies, physicians and veterinarians.

35. MAPS Controlled substance samples and those administered to patients are exempt from reporting.  Also exempt are controlled substances dispensed by a physician in a health facility or agency licensed under article 17 for no more than a 48 hour supply

36. MAPS The MAPS program does not require the physician to use security paper or serialized forms for prescribing controlled substances.  The Department will not supply serialized prescription forms after January 1, 2003.

37. MAPS Reporting of controlled substances dispensed is required by the 15th of the month following the month the controlled substances are dispensed.Questions regarding the MAPS program should be directed to mapsinfo@michigan.gov

38. DEPARTMENT OF CONSUMER AND INDUSTRY SERVICESDIRECTOR’S OFFICECONTROLLED SUBSTANCES Filed with the Secretary of State on December 30, 2002. These rules take effect 7 days after filing with the Secretary of State. (By authority conferred on the director of the department of consumer and industry services by 1978 PA 368 and Executive Reorganization Order No. 1996-2, MCL 333.7201, 333.7301, 333.7333, 333.7333a, 333.16145, and 445.2001) R 338.3101, R 338.3102, R 338.3104, R 338.3161,R 338.3162, R 338.3164, R 338.3165, R 338.3166, R 338.3167, and R 338.3168 of the Michigan Administrative Code are amended, and R 338.3162b, R 338.3162c, R 338.3162d, and R 338.3162e are added to the Code as follows:

39. PART 1. GENERAL PROVISIONSR 338.3101 Definitions; A to E. Rule 1. As used in these rules: (a) “Act” means 1978 PA 368, MCL 333.1101 et seq. (b) “Deleterious drug” means a drug, other than a proprietary medicine, that is likely to be destructive to adult human life in quantities of 3.88 grams or less. (c) “Department” means the Department of Consumer and Industry Services. (d) “Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. An electronic signature also is a unique identifier protected by appropriate security measures such that it is only available for use by the intended individual and ensures non-repudiation so that the signature could not be rejected based on its validity.

40. R 338.3102 Definitions; I to P.Rule 2. (1) As used in these rules: (a) "Inventory” means all stocks in finished form of a controlled substance that is manufactured or otherwise acquired by a licensee, whether in bulk or commercial containers or contained in pharmaceutical preparations in the possession of the licensee. (b) “Licensee” means a person who is licensed pursuant to section 7303 of the act. (c) “Michigan automated prescription system (maps) claim form” means a form, to be determined by the department, that is in the format and includes the information as specified by the american society for automation in pharmacy (asap) and contains the information specified in R 338.3162b. (d) "National drug code number (ndc)” means an 11-digit, 3-segment number that identifies the labeler/vendor, product, and package size and is assigned to each drug product listed under section 510, registration of producers of drugs and devices, of the federal food, drug, and cosmetic act. (e) “Officer” means a state, county, or local law enforcement officer who has a duty to enforce the laws of this state.

41. R 338.3102 Definitions; I to P.Rule 2. (1) As used in these rules: (f) “Patient identifier” includes the following information about a patient: Full name. (ii) Address, including zip code. (iii) Date of birth. (iv) Any of the following: (A) Social security number. (B) Driver’s license number. (C) State-issued identification number. (v) If a patient is an animal, any of the following: (A) The owner’s social security number. (B) The owner’s driver’s license number. (C) The owner’s state-issued identification number.

42. R 338.3102 Definitions; I to P.Rule 2. (1) As used in these rules: (g) “Prescriber” or “practitioner” means any of the following individuals who are licensed to prescribe by the laws of this state: (i) A dentist. (ii) A doctor of medicine. (iii) A doctor of osteopathic medicine and surgery. (iv) A doctor of podiatric medicine and surgery. (v) A veterinarian. (2) As used in part 5 of these rules: (a) “Medical institution” means an inpatient health facility which is licensed or approved by the state and which directly or indirectly provides or includes pharmacy services. (b) “Pharmacy services” means the direct and indirect patient care services associated with the practice of pharmacy.

43. R 338.3104 Definitions; R, S.Rule 4. As used in these rules: (a) “Readily retrievable” means a record which is kept in such a manner that it can be separated from all other records within 48 hours and in which a listed controlled substance shall be marked with an asterisk, redlined, or in some other manner be visually identifiable apart from the other substances listed in the record. (c) “Sign” means to affix a signature manually in the same manner as signing a check or legal document or to use an electronic signature, as defined in subdivision (d) of R 338. 3101. Stamped signatures are not valid for any controlled substance prescription.

44. PART 6. DISPENSING AND ADMINISTERING PRESCRIPTIONSR 338.3161 Prescriptions.Rule 61 (1) A prescription that is issued for a controlled substance shall be dated and signed when issued and shall contain all of the following information: (a) The full name and address of the patient for whom the substance is being prescribed. (b) The prescriber's drug enforcement administration (dea) registration number, printed name, address, and professional designation. (c) The drug name, strength, and dosage form. (d) The quantity prescribed. For a prescription received in writing, the prescription shall contain the quantity in both written and numerical terms. A written prescription is in compliance if it contains preprinted numbers representative of the quantity next to which is a box or line the prescriber may check. (e) The directions for use. (f) In addition, if the prescription is for an animal, then the species of the animal and the full name and address of the owner.

45. PART 6. DISPENSING AND ADMINISTERING PRESCRIPTIONSR 338.3161 Prescriptions.Rule 61 (2) A written prescription for a controlled substance in schedules 2 to 5 shall be written with ink or an indelible pencil, or prepared using a printer and shall be signed by the prescriber. (3) An agent of the prescriber may prepare a prescription for the signature of the prescriber, but, pursuant to the act, the prescriber is liable if the prescription does not conform to these rules. A pharmacist who dispenses a controlled substance pursuant to a prescription not prepared in the form required by these rules is liable pursuant to the act.

46. PART 6. DISPENSING AND ADMINISTERING PRESCRIPTIONSR 338.3161 Prescriptions.Rule 61 (4) If the controlled substance prescription or order in a medical institution is issued pursuant to delegation under R 338.2304, R 338.2305, R 338.108a, or R 338.108b, then the printed name of the delegatee, the licensure designation, the delegating prescriber, and the signature of the delegatee shall be on the written prescription. In medical facilities, orders shall contain the signatures of the delegatee and the printed name of the delegating prescriber. (5) A prescription shall not be issued by a prescriber to obtain a stock of a controlled substance for the purpose of dispensing or administering the substance to patients.

47. R 338.3162 Dispensing by pharmacists; delivery of controlledsubstances. Rule 62 (1) A controlled substance shall be dispensed by a pharmacist or a pharmacy intern in the presence, and under the immediate supervision, of a pharmacist. (2) A pharmacist may require identification of individuals to whom controlled substances are delivered. (3) Except as provided by R 338.3162a, a pharmacist may dispense a controlled substance which is listed in schedules 3 to 5 and which is a prescription drug pursuant to the provisions of the federal food, drug, and cosmetic act of 1991, 21 U.S.C. §201.100(b)(i) et seq., only pursuant to a written, electronically transmitted, or oral order of a prescriber that contains all of the required information under R 338.3161, except that the signature of the prescriber is not required if the controlled substance is obtained pursuant to an oral order.

48. R 338.3162 Dispensing by pharmacists; delivery of controlledsubstances. Rule 62 (4) If an oral order for a controlled substance listed in schedules 3 to 5 is transmitted by the prescriber’s agent under delegation, then all of the following shall be recorded on the prescription generated at the pharmacy: (a) The information required by R 338.3161. (b) The transmitting agent’s identity. (c) The individual who received the prescription at the pharmacy. (5) Only an order that is issued in the usual course of professional treatment or in the course of legitimate and authorized research is a prescription.

49. R 338.3162b Electronic system for monitoring schedules 2, 3, 4, and5 controlled substances.Rule 62b. (1) A pharmacist, dispensing prescriber, and veterinarian licensed under Part 177 who dispenses a prescription drug which is a controlled substance listed in schedules 2 to 5 or a pharmacy licensed by the state that dispenses in this state or dispenses to an address in this state a controlled substance listed in schedules 2 to 5 shall report to the department or the department’s contractor by means of an electronic data transmittal process the following information for each prescription of a schedules 2 to 5 controlled substance prescription dispensed:

50. R 338.3162b Electronic system for monitoring schedules 2, 3, 4, and5 controlled substances.Rule 62b. (a) The patient identifier, as defined in R 338.3102 (f). (b) The name of the controlled substance dispensed. (c) The metric quantity of the controlled substance dispensed. (d) The national drug code number (ndc) of the controlled substance dispensed. (e) The date of issue of the prescription. (f) The date of dispensing. (g) The estimated days of supply of the controlled substance dispensed. (h) The prescription number assigned by the dispenser. (i) The dea registration number of the prescriber and the dispensing pharmacy. (j) The Michigan license number of the dispensing pharmacy. (2) A pharmacist, dispensing prescriber, or veterinarian may presume that the patient identification information provided by a patient or a patient’s representative is correct