Michigan Administrative Code
Department - Licensing and Regulatory Affairs
Bureau of Professional Licensing
Board of Pharmacy
Board of Pharmacy - Controlled Substances
Part 5 - RECORDS
Section R. 338.3154 - Medication records in medical institutions
Universal Citation: MI Admin Code R. 338.3154
Current through Vol. 24-16, September 15, 2024
Rule 54.
(1) A patient's chart must constitute a record of medications ordered for, and actually administered to, a patient of medical institutions.
(2) Medication records are required for all controlled substances listed in schedules 2, 3, 4, and 5. At a minimum, these records must include all of the following information:
(a) The number of doses of controlled
substances purchased.
(b) The
number of doses dispensed to individual patients or distributed to nursing
stations or both.
(c) The number of
doses administered.
(d) The number
of doses dispensed, but not administered, to the patient.
(3) If the controlled substance is not dispensed to an individual patient, all of the following provisions must be complied with:
(a) Medication records for
those controlled substances listed in schedules 2, 3, 4, and 5 must be
maintained.
(b) Distribution of a
controlled substance to a nursing unit may not be more than 25 doses per
container.
(c) A distribution
record for each multiple of 25 doses must be used to account for delivery to a
nursing unit. The record must include all of the following information:
(i) The name and dose of the controlled
substance.
(ii) The quantity of the
substance.
(iii) The date of
delivery.
(iv) The location of the
nursing unit.
(v) The name of the
distributing pharmacy and address if it is a different location from the
medical institution.
(vi) Name of
distributing pharmacist.
(vii) The
name of the individual on the nursing unit who receives the
substance.
(d) A proof of
use record must be maintained to account for all doses of an administered
substance. The record must include all of the following:
(i) The name of the substance.
(ii) The dose administered.
(iii) The date and time a dose was
administered.
(iv) The name of the
patient.
(v) The signature of the
individual who administered the dose.
(e) This subrule does not apply to automated
devices.
(4) A controlled substance that is maintained at a nursing unit must be stored in a securely locked cabinet or medication cart that is accessible only to an individual who is responsible for the administration or distribution of the medication.
(5) If a controlled substance is dispensed from an automated device, documentation of all of the following must be maintained on-site in the pharmacy responsible for the automated device for 2 years for review by the department, an agency, or the board.
(a) The name and address of the
pharmacy responsible for the operation of the automated device.
(b) The manufacturer name and model number of
the automated device.
(c) The name
and address of the facility where the automated device is located.
(d) The contents of the automated
device.
(e) The quality assurance
policy and procedure to determine continued appropriate use and performance of
the automated device that includes all of the following quality assurance
documentation for the use and performance of the automated device:
(i) Use of monitors that alert the user if
the wrong medication is filled or removed for administration to a
patient.
(ii) Use of security
monitors that include an alert for unauthorized access, patients not in the
system, system security breaches, and controlled substance audits.
(iii) Corrective measures to address issues
and errors identified in the internal quality assurance program.
(f) The policy and procedure for
system operation that includes all of the following:
(i) Safety.
(ii) Security systems and procedures that
include prevention of unauthorized access or use and comply with federal and
state regulations.
(iii)
Accuracy.
(iv) Patient
confidentiality.
(v)
Access.
(vi) Type of controlled
substances.
(vii) Data retention or
archival.
(viii)
Definitions.
(ix) Downtime
procedures.
(x) Emergency
procedures.
(xi) Operator
inspections.
(xii) Installation
requirements.
(xiii)
Maintenance.
(xiv) Medication
security.
(xv) Medication
inventory.
(xvi) Staff education
and training.
(xvii) System set-up
and malfunction.
(xviii) List of
medications qualifying for emergency dose removal without pharmacist prior
review of the prescription or medication order.
(xix) The use of the automated device that
includes a requirement that a pharmacist review a prescription or medication
order before system profiling or removal of medication from the automated
device for immediate patient administration, except in the following situations
where a pharmacist shall review the orders and authorize further dispensing
within 48 hours:
(A) The automated device is
being used as an after-hours cabinet for medication dispensing in the absence
of a pharmacist under R 338.486(4)(j).
(B) The system is being used in place of an
emergency kit under R 338.486(4)(c).
(C) The system is being accessed to remove
medication required to treat the emergent needs of a patient under 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.
(g) The
automated device must maintain transaction data that includes all activity
regarding access to the contents of the automated device.
(h) The pharmacy responsible for the
automated device shall maintain records related to access to the automated
device. The records must be readily retrievable and must include all of the
following information:
(i) The unique identity
of the device.
(ii) Identification
of the individual accessing the automated device.
(iii) The type of transaction.
(iv) The name, strength, dosage form, and
quantity of the drug accessed.
(v)
The name of the patient.
(vi) The
identification of the pharmacist checking for the accuracy of the medications
stocked or restocked in the automated device.
(vii) Any information the pharmacist
considers necessary.
(i)
For medication removed from the automated device for on-site patient
administration, the automated device must document all of the following
information:
(i) The name of the
patient.
(ii) The date and time
medication was removed from the automated device.
(iii) The name, initials, or other unique
identifier of the individual removing the drug.
(iv) The name, strength, and dosage form of
the drug. The documentation may be on paper or completed
electronically.
(j) If
the pharmacist delegates the stocking of the automated device, technologies
must be in place and utilized to ensure that the correct drugs are stocked in
their appropriate assignment utilizing bar-coding or another a board-approved
error prevention technology.
(k)
The automated device must provide a mechanism for securing and accounting for
controlled substances removed from the automated device return bin. Controlled
substances must not be returned directly to the automated device for immediate
reissue or reuse. Controlled substances removed from the automated device may
not be reused or reissued, except as indicated in R 338.486(7).
(l) The automated device must provide a
mechanism for securing and accounting for wasted or discarded
medications.
(6) An individual who is responsible for administering a controlled substance or a portion thereof shall record the quantity, disposition, and an explanation of the destruction of the controlled substance on the proper accountability record. If the institution has a policy that reflects current practice standards and delineates the method of destruction, an explanation would only be required if policy was not followed.
Disclaimer: These regulations may not be the most recent version. Michigan may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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