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SOAHR 2005-089 DEPARTMENT OF COMMUNITY HEALTH
DIRECTOR’S OFFICE PHARMACY - GENERAL RULES
Filed with the Secretary of State on February 21, 2007
These rules become effective immediately upon filing with the Secretary of State unless adopted under sections 33, 44 or 45a(6) of 1969 PA 306. Rules adopted under these sections become effective 7 days after filing with the Secretary of State.
(By authority conferred on the director of the department of community health by sections 16145(3) and 17701 of 1978 PA 368, MCL 333.16145(3) and 333.17701 et seq. and Executive Reorganization Order
Nos. 1996-1, 1996-2, and 2003-01, being MCL 330.3101, 445.2001, and 445.2011)
October 11, 2006 R 338.471a, R 338.472, R 338.473, R 338.473a, R 338.473d, R 338.474a, R 338.475, R 338.479b and R
338.489, of the Michigan Administrative Code are amended as follows:
PART 1. GENERAL PROVISIONS
R 338.471a Definitions.
Rule 1a. As used in these rules:
(a) “Accredited college or school of pharmacy” means a college or school of pharmacy that is accredited by the accreditation council for pharmacy education, as provided in R 338.474(1)(a).
(b) "Board" means the board of pharmacy.
(c) "Code" means 1978 PA 368, MCL 333.1101.
(d) "Department" means the department of community health.
(e) “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 may not be rejected based on its validity.
(f) "Unconventional internship" means an educational program of professional and practical experience involving those pharmacy or
related pharmaceutical experiences which, by practical, on-the-job training, provide knowledge useful to the practice of the profession of pharmacy without meeting all of the criteria of a conventional internship.
R 338.472 Prescription drugs and devices; return or exchange for resale prohibited.
Rule 2. (1) For the protection of the public health and safety, prescription drugs or devices which have been dispensed and which have left the control of the pharmacist shall not be returned or exchanged for resale.
(2) Subrule (1) of this rule does not apply to a pharmacy operated by the department of corrections or under contract with the department of corrections or a county jail that has accepted a prescription drug for resale or redispensing, as provided under section 17766d of the code.
R 338.473 Intern licensure; eligibility; renewal; limitations.
Rule 3. (1) An applicant for a pharmacy intern license shall submit a completed application on a form provided by the department, together with the requisite fee. In addition to meeting the requirements of the code and the administrative rules promulgated pursuant thereto, an applicant shall establish that he or she is admitted to and actively enrolled in a professional program of study within an accredited college or school of pharmacy, as provided in R 338.474(1)(a).
(2) An intern shall engage in the practice of pharmacy only under the supervision of a pharmacist preceptor as defined in section 17708(1) of the code and only under the personal charge of a pharmacist.
R 338.473a Interns; eligibility; limited license; qualifications; supervision; notice of position change; duties; professional and practical experience; denial, suspension, or revocation of license.
Rule 3a. (1) An individual is eligible for intern licensure at the beginning of the first professional year of study in an accredited college or school of pharmacy.
(2) Upon application and payment of appropriate fees, a limited license shall be issued by the department to qualified applicants. The limited license shall remain active while the applicant is actively pursuing a degree in an accredited college or school of pharmacy and until licensure as a pharmacist or for not more than 1 year from the date of graduation from such college or school of pharmacy, unless extended by the board upon written request of the intern.
(3) An intern shall complete not less than 1,000 hours of internship experience, 500 hours of which shall be completed during the 18 months immediately preceding the examination for pharmacist licensure. An intern working in Michigan shall hold an intern license in order to earn the hours of internship experience required in Michigan. The minimum number of hours of internship experience may be satisfied by complying with any of the following provisions:
(a) Obtaining the minimum number of hours of experience under the personal charge of a qualified, approved preceptor.
(b) Completing a board-approved, structured practical experience program within the college or school of pharmacy curriculum.
(c) Through a combination of subdivisions (a) and (b) of this subrule.
(4) When eligible, a student shall apply for licensure as an intern.
(5) Hours of internship experience shall be computed from the date of board certification as a licensed intern. In computing the hours of internship experience, all of the following provisions shall apply:
(a) Experience shall be granted only upon verification by an approved pharmacy preceptor or other person previously approved by the board.
(b) The board may grant internship experience gained in unconventional internship programs. Up to 400 hours of internship experience may be granted for such unconventional education experiences.
(c) A maximum of 40 hours of internship experience shall be granted per calendar week served by the intern.
(d) A maximum of 16 hours of non-college-sponsored internship experience shall be granted per calendar week while the intern is a full-time student in a college or school of pharmacy, except during authorized vacation periods.
(e) The board may grant credit for internship experience obtained through practice as an intern in another jurisdiction if the experience was comparable to the minimum standards set forth in these rules.
(f) The board may accept experience as a licensed pharmacist in another jurisdiction as the equivalent of internship experience.
(6) An intern shall be supervised by an approved pharmacist preceptor and shall, at all times, practice only under the personal charge of a pharmacist. The intern shall be responsible for verifying board approval of his or her pharmacy preceptor.
(7) Within 30 days, an intern also shall notify the board if he or she is no longer actively enrolled in a pharmacy degree program at an accredited college or school of pharmacy.
(8) Interns shall complete and submit such forms or examinations, or both, as deemed necessary by the board.
(9) Interns shall receive professional and practical experience in at least all of the following areas:
(a) Pharmacy administration and management.
(b) Drug distribution, use, and control.
(c) Legal requirements.
(d) Providing health information services and advising patients.
(e) Pharmacists' ethical and professional responsibilities.
(f) Drug and product information.
(10) Interns shall keep abreast of current developments in the internship program and the pharmacy profession.
(11) The board may deny, suspend, or revoke the license of an intern or may deny hours of internship for failure to comply with pharmacy law or rules relating to pharmacy practice or internship.
R 338.473d Graduates of a non-accredited college or school of pharmacy; requirements; internship. Rule 3d. (1) An applicant who is a graduate of a non-accredited college or school of pharmacy may be granted an intern license to comply with the requirements of R 338.473a(3) upon making application, payment of appropriate fees, and providing evidence of successful completion of the Foreign Pharmacy Graduate Examination Committee certification program administered by the National Association of Boards of Pharmacy, Foreign Pharmacy Graduate Examination Committee, 1600 Feehanville Dr., Mount Prospect, IL 60056.
(2) An intern license issued in accordance with this rule is valid for not more than 2 years from the date of issuance, unless extended by the board upon written request by the intern.
R 338.474 Pharmacist licensure; eligibility; examination.
Rule 4. (1) An applicant for licensure as a pharmacist shall submit a completed application on a form provided by the department, together with the appropriate fee. In addition to meeting the requirements of the code and the administrative rules promulgated pursuant thereto, an applicant shall comply with all of the following requirements:
(a) Have completed the requirements for a degree in pharmacy from an accredited college or school of pharmacy education approved by the board or successfully completed the Foreign Pharmacy Graduate Examination Committee certification program administered by the National Association of Boards of Pharmacy, Foreign Pharmacy Graduate Examination Committee, 1600 Feehanville Dr., Mount Prospect, IL 60056. The board adopts by reference the standards of the Accreditation Council for Pharmacy Education, 20 North Clark St., Suite 2500, Chicago, IL 60602. The standards are set forth in the documents entitled “Standards and Guidelines for Accreditation of Professional Degree Programs in Pharmacy”, 8th edition, January 1995; and, the “Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree”, adopted June 14, 1997, of the Accreditation Council for Pharmacy Education. Copies of the standards are available at no cost
from the Council’s website at http://www.acpe-accredit.org/standards. Copies of the guidelines also are available for inspection and distribution at cost from the Michigan Board of Pharmacy, Department of Community Health, 611 West Ottawa, P.O. Box 30670, Lansing, MI 48909.
(b) Have completed a program of internship pursuant to these rules.
(c) Pass a jurisprudence examination, approved by the board, which measures an applicant’s knowledge of the rules and regulations governing the practice of pharmacy with a scaled score of not less than 75.
(d) Pass an examination, approved by the board, which measures an applicant's theoretical and practical knowledge of pharmacy with a scaled score of not less than 75.
(2) An applicant who has not achieved a passing score on either of the examinations identified in subrule (1)(c) and (d) of this rule after 6 attempts may be reexamined only after meeting the requirements set forth in R 338.474a.
R 338.474a Licensure; reexamination.
Rule 4a. An applicant may take the examinations required by these rules on 6 separate occasions. An applicant who has not received a passing score on an examination after 6 attempts shall not take the examination a seventh or subsequent time, unless the applicant can demonstrate to the board that the applicant has complied with all of the following:
(a) Has enrolled as a student in a pharmacy education program approved by the board.
(b) Has taken courses which would provide a thorough review of those areas failed on the applicant's most recent examination.
(c) Has submitted certification to the board from the pharmacy education institution that the courses have been satisfactorily completed.
R 338.475 Licensure by endorsement; examination.
Rule 5. An applicant for licensure by endorsement shall submit a completed application on a form provided by the department, together with the requisite fee. In addition to meeting the requirements of the code and administrative rules promulgated pursuant thereto, an applicant shall satisfy both of the following requirements:
(a) Pass an examination, approved by the board, which measures an applicant’s knowledge of the rules and regulations governing the practice of pharmacy with a scaled score of not less than 75.
(b) Satisfy those requirements in existence in this state at the time he or she was licensed in another state.
R 338.479b Noncontrolled prescriptions.
Rule 9b. (1) A prescriber who issues a prescription for a noncontrolled legend drug shall date and sign the prescription and shall ensure that the prescription contains all of the following information:
(a) The full name of the patient for whom the drug is being prescribed.
(b) The prescriber’s printed name and address.
(c) The drug name and strength.
(d) The quantity prescribed.
(e) The directions for use.
(f) The number of refills authorized.
(2) A prescriber shall ensure that a prescription is legible and that the information specified in subrule (1)(c) to (f) of this rule is clearly separated.
(3) A prescriber shall not prescribe more than the following on a single prescription form as applicable:
(a) For a prescription prescribed in handwritten form, up to 4 prescription drug orders.
(b) For a prescription prescribed on a computer-generated form or a preprinted list or produced on a personal computer or typewriter, up to 6 prescription drug orders.
(4) A prescriber shall not add handwritten drugs to a preprinted form and shall clearly designate which drugs are to be dispensed.
(5) A prescriber shall not prescribe a controlled and noncontrolled substance on the same prescription form.
(6) A prescription is valid for 1 year from the date the prescription was issued.
(7) A prescriber shall clearly indicate the total number of drugs prescribed for each prescription.
(8) A noncontrolled substance prescription may be transmitted electronically from the prescriber to the pharmacy of the patient’s choice, and shall occur by utilizing a system that includes the following:
(a) A combination of technical security measures such as, but not limited to, those listed in R 164.312 under Subpart C – Security Standards for the Protection of Electronic Protected Health Information of 45 CFR Part 164 that implements the federal Health Insurance Portability and Accountability Act of 1996, to ensure all of the following:
(i) Authentication of an individual who prescribes or dispenses.
(ii) Technical non-repudiation.
(iii) Content integrity.
(iv) Confidentiality.
(b) An electronic signature as defined in R 338.471a(e). An electronic signature is valid only when it is used to sign a prescription that is transmitted electronically from a prescriber to a pharmacy.
(c) Appropriate security measures to invalidate a prescription if either the electronic signature or prescription record to which it is attached or logically associated is altered or compromised following transmission by the prescriber. The electronic prescription may be reformatted to comply with industry standards provided that no data is added, deleted, or changed.
(9) The electronic prescription shall meet any other requirements of the federal Health Insurance Portability and Accountability Act.
(10) The electronic prescription shall permit the prescriber to instruct the pharmacist to dispense a brand name drug product provided that the prescription includes both of the following:
(i) The indication that no substitute is allowed, such as“dispense as written” or “DAW”.
(ii) The indication that no substitute is allowed and that it is a unique element in the prescription.
(11) If the prescription is transmitted electronically, the prescriber shall generate and transmit the prescription in a format that can be read and stored by a pharmacy in a retrievable and readable form. The electronic prescription shall identify the name of the pharmacy intended to receive the transmission, and shall include the information identified in subrule (1) of this rule.
(12) The electronic prescription shall be preserved by a licensee or dispensing prescriber for not less than 5 years. A paper version of the electronic prescription shall be made available to an authorized agent of the board upon request. A secured copy shall be retained for a minimum of 1 year by the transaction service vendor for record-keeping purposes and shall be shared only with the parties involved in the transaction except as otherwise permitted by state or federal law.
(13) An electronic signature that meets the requirements of this rule shall have the full force and effect of a handwritten signature on a paper-based written prescription.
(14) This rule does not apply to inpatient medical institutions.
R 338.489 Automated devices.
Rule 19. (1) An automated device means a device designed for the specific purpose of selling, dispensing, or otherwise disposing of any drug or device ordered by a prescription.
(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.
(3) An automated device designed for the specific purpose of selling, dispensing, or otherwise disposing of any drug or device ordered by a prescription, as defined in the code, and located within a licensed pharmacy shall be used only by a pharmacist or other pharmacy personnel under the personal charge of a pharmacist.
(4) If an automated dispensing device is used in a dispensing prescriber’s office, the device shall be used only to dispense medications to the dispensing prescriber’s patients and only under the control of the dispensing prescriber. A pharmacy shall not own, control, or operate an automatic dispensing device in a dispensing prescriber’s office.
(a) If a dispensing prescriber delegates the stocking of the device, then technologies shall be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board- approved error prevention technology that complies with R 338.3154.
(b) A dispensing prescriber operating an automated device is responsible for all medications that are stocked and stored in that device as well as removed from that device.
(c) If any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility shall be maintained by the dispensing prescriber for review by an agent of the board. This documentation shall include at least all of the following information:
(i) Manufacturer name and model.
(ii) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.
(iii) Policy and procedures for system operation that addresses at a minimum all of the following:
(A) Accuracy.
(B) Patient confidentiality.
(C) Access.
(D) Data retention or archival records.
(E) Downtime procedures.
(F) Emergency procedures.
(G) Medication security.
(H) Quality assurance.
(5) An automated device that is to be used for the furnishing of medications for administration to registered patients in any hospital, county medical care facility, nursing home, hospice, or any other skilled nursing facility, as defined in 1978 PA 368, MCL 333.20109, shall be supplied and controlled by a pharmacy that is licensed and located in this state. The use of an automated device in these locations is not limited to the provisions of subrule (3) of this rule. If a pharmacist delegates the stocking of the device, then technologies shall be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that complies with R 338.3154. Each such device shall comply with all of the following provisions:
(a) A pharmacy operating an automated device is responsible for all medications that are stocked and stored in that device as well as removed from that device.
(b) If any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility shall be
maintained by the pharmacy for review by an agent of the board. The documentation shall include at least all of the following information:
(i) Name and address of the pharmacy responsible for the operation of the automated device.
(ii) Name and address of the facility where the device is located.
(iii) Manufacturer name and model number.
(iv) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.
(v) Policy and procedures for system operation that address at a minimum all of the following:
(A) Accuracy.
(B) Patient confidentiality.
(C) Access.
(D) Data retention or archival records.
(E) Downtime procedures.
(F) Emergency procedures.
(G) Medication security.
(H) Quality assurance.
(I) Ability to provide on demand to an agent of the board a list of medications qualifying for emergency dose removal without pharmacist prior review of the prescription or medication order.
(6) Records and electronic data kept by automated devices shall meet all of the following requirements:
(a) All events involving access to the contents of the automated devices shall be recorded electronically.
(b) Records shall be maintained for 5 years by the pharmacy and shall be retrievable on demand for review by an agent of the board. The records shall include all of the following information:
(i) The unique identity of device accessed.
(ii) Identification of the individual accessing the device.
(iii) The type of transaction.
(iv) The name, strength, dosage form and quantity of the drug accessed.
(v) The name of the patient for whom the drug was ordered.
(vi) Identification of the pharmacist responsible for the accuracy of the medications to be stocked or restocked in the device.
(7) Policy and procedures for the use of the automated device shall include a requirement for pharmacist review of the prescription or medication order before system profiling or removal of any medication from the system for immediate patient administration. This subrule does not apply to the following situations:
(a) The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided in R 338.486(4)(i).
(b) The system is being used in place of an emergency kit as provided in R 338.486(4)(c).
(c) The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R 338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order.
(d) In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and authorize any further dispensing within 48 hours.
(e) The device is located in a dispensing prescriber’s office.
(8) A copy of all policies and procedures related to the use of an automated device shall be maintained at the pharmacy responsible for the device’s specific location or at the dispensing prescriber’s office and be available for review by an agent of the board.
