Section 338.480a. Prescription refill records; manual systems; profile systems; automated data processing systems; nonapplicability to inpatient medical institution service; record confidentiality and access.

a. (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 is in compliance with both of the following criteria:

(a)        The amount and date dispensed shall be entered on the prescription in an orderly fashion and the dispensing pharmacist shall initial the entry.

If the pharmacist only initials and dates the prescription, then  the  full face amount of the prescription shall be deemed 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 shall be indicated on the prescription.

(3)     A pharmacy may utilize a uniform system of recording refills if  the system is in compliance with all of the following criteria:

(a)     Records shall be created and maintained in written form. All original and refill prescription information for a particular   prescription  shall appear on single documents in an organized format. The pharmacy shall preserve the records for 5 years. The records are subject to inspection by the board or its agents.

(b)     All of the  following  information  for  each  prescription shall 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  federal  drug  enforcement   administration  number,       if appropriate.

(v)     The number of refills authorized.

(vi)     The "dispense as written" instructions, if indicated.

(vii)      The name, strength, dosage form, and quantity of the drug prescribed and the drug dispensed originally and  upon  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 shall 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.

(c)     Prescription entries shall be made on the record  at   the  time  the prescription is first filled and at the time of 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 shall 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 338.480.

(4)         A  pharmacy  may  utilize  a   uniform  automated  data   processing  system   of recording refills if the system is in compliance with all of the following criteria:

(a)     All information that is pertinent to a prescription shall 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  federal  drug  enforcement   administration  number,       if appropriate.

(v)     The number of refills authorized.

(vi)     Whether the drug must be dispensed as written.

(vii)      The name, strength, dosage form, and quantity of the drug prescribed and the drug dispensed originally and  upon  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 shall 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.

(b)     Prescription entries shall be made on  the  record  at   the  time  the prescription is first filled and at the time of 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. The pharmacy shall preserve the records on-site for 5 years. The records are subject to inspection by the board or its agents. A procedure shall be established to facilitate inspections.

(c)     The required information shall 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 338.480.

(d)       The recording system shall provide adequate safeguards against improper manipulation, the alteration of records, and the loss of records.

(e)       The recording system shall have the capability of producing a printout of all original and refilled prescription data, including a prescription-by- prescription and refill-by-refill audit trial 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 shall be made available to an authorized agent of the board upon request. The prescription data shall be maintained for 5 years. Data older than 16 months shall be provided within 72 hours of the time the request is first made by the agent. Prescription data for the most current 16 months shall 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 assure 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 assure continuity in the maintenance of records.

(h)      The automated data processing system shall be an integrated system that is capable of complying with all of the requirements of these rules.

(5)     This rule does not apply to inpatient medical institution service.

(6)     Records that are created under subrule (3) or (4) of this rule are subject to the same requirements regarding confidentiality and access that apply to original prescriptions.

History:  1992 AACS; 1998-2000 AACS.