Mich. Admin. Code R. 338.587 - Prescription refill records; manual systems; profile systems; automated pharmacy data systems; nonapplicability to medical institution service; record confidentiality; and access
Rule 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.
Notes
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