Section R. 338.587 - Prescription refill records; manual systems; profile systems; automated pharmacy data systems; nonapplicability to medical institution service; record confidentiality; and accessRule 87.
(1) A pharmacist shall record prescription refills using only 1 of the systems described in subrule (2), (3), or (4) of this rule and in compliance with the provisions of subrule (2), (3), or (4) of this rule, as applicable.(2) A pharmacy may utilize a manual system of recording refills if the system complies with both of the following criteria: (a) The amount and date dispensed must be entered on the prescription in an orderly fashion and the dispensing pharmacist initials the entry. If the pharmacist only initials and dates the prescription, then the full-face amount of the prescription must be considered dispensed.(b) If the drug that is dispensed is other than the brand prescribed or if the prescription is written generically, then the name of the manufacturer or supplier of the drug dispensed must be indicated on the prescription.(3) A pharmacy may utilize a uniform system of recording refills if the system complies with all of the following criteria: (a) Records must be created and maintained in written form. All original and refill prescription information for a particular prescription appears on single documents in an organized format. The records are subject to inspection by the board or its agents.(b) The following information for each prescription must be entered on the record: (i) The prescription number.(ii) The patient's name and address.(iii) The prescriber's name.(iv) The prescriber's DEA number, if appropriate.(v) The number of refills authorized.(vi) The "dispense as written" instructions, if indicated.(vii) The name, strength, dosage form, quantity, and name of the manufacturer of the drug prescribed, and the drug dispensed originally and after each refill. If the drug dispensed is other than the brand prescribed or if the prescription is written generically, then the name of the manufacturer or supplier of the drug dispensed must be indicated.(viii) The date of issuance of the prescription.(ix) The date and identifying designation of the dispensing pharmacist for the original filling and for each refill. If a pharmacy technician performs final product verification, the identification of the delegating pharmacist and pharmacy technician must be recorded.(c) Prescription entries must be made on the record when the prescription is first filled and at each refill, except that the format of the record may be organized so that information already entered on the record may appear for a prescription or refill without reentering the information. The dispensing pharmacist is responsible for the completeness and accuracy of the entries and shall initial the record each time a prescription is filled or refilled.(d) The information required by subdivision (b) of this subrule must be entered on the record for all prescriptions filled at a pharmacy, including nonrefillable prescriptions. This requirement is in addition to the requirements set forth in R 338.586.(4) A pharmacy may utilize a uniform automated data processing system of recording refills if the system complies with all of the following criteria: (a) All information that is pertinent to a prescription must be entered on the record, including all of the following information: (i) The prescription number.(ii) The patient's name and address.(iii) The prescriber's name.(iv) The prescriber's DEA number, if appropriate.(v) The number of refills authorized.(vi) Whether the drug must be dispensed as written.(vii) The name, strength, dosage form, quantity, and name of the manufacturer of the drug prescribed and the drug dispensed originally and after each refill. If the drug dispensed is other than the brand prescribed or if the prescription is written generically, then the name of the manufacturer or supplier of the drug dispensed must be indicated.(viii) The date of issuance of the prescription.(ix) The date and identifying designation of the dispensing pharmacist for the original filling and for each refill. If a pharmacy technician performs final product verification, the identification of the delegating pharmacist and pharmacy technician must be recorded.(b) Prescription entries must be made on the record when the prescription is first filled and at each refill, except that the format of the record may be organized so that information already entered on the record may appear for a prescription or refill without reentering the information. The dispensing pharmacist is responsible for the completeness and accuracy of the entries. A pharmacy shall keep the original prescription record on site for 5 years. Two years after the date of the prescription's issue date, a pharmacy may make an electronic duplicate of the original non-controlled paper prescription, which becomes the original prescription. The records are subject to inspection by the board or its agents. A procedure must be established to facilitate inspections.(c) The required information must be entered on the record for all prescriptions filled at the pharmacy, including nonrefillable prescriptions. This requirement is in addition to the requirements set forth in R 338.586.(d) The recording system must provide adequate safeguards against improper manipulation, the alteration of records, and the loss of records.(e) The recording system must have the capability of producing a printout of all original and refilled prescription data, including a prescription-by-prescription and refill-by-refill audit trail for any specified strength and dosage form of a controlled substance by either brand or generic name or an audit trail of controlled substance prescriptions written for a particular patient or by a particular practitioner. A printout of an audit trail or other required information must be made available to an authorized agent of the board on request. The prescription data must be maintained for 5 years. Data older than 2 years must be provided within 72 hours of the time the request is first made by the agent. Prescription data for the most current 2 years must be readily retrievable on site and available for immediate review.(f) If the automated data processing system is inoperative for any reason, then the pharmacist shall ensure that all refills are authorized and that the maximum number of refills is not exceeded. When the automated data processing system is restored to operation, the pharmacist shall enter the information regarding prescriptions filled and refilled during the inoperative period into the automated data processing system within 48 hours.(g) A pharmacy shall make arrangements with the supplier of data processing services or materials to ensure that the pharmacy continues to have adequate and complete prescription and dispensing records if the relationship with the supplier terminates for any reason. A pharmacy shall ensure continuity in the maintenance of records.(h) The automated data processing system must be an integrated system that complies with all of the requirements of these rules.(5) This rule does not apply to pharmacy services provided in a medical institution.(6) Records that are created under subrule (2), (3), or (4) of this rule are subject to the same requirements regarding confidentiality and access that apply to original prescriptions.Mich. Admin. Code R. 338.587
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024