Current through Register Vol. 35, No. 18, September 24, 2024
A. In hospitals where there is not a
pharmacy, prelabeled, prepackaged medications shall be stored in and
distributed from a drug storage area or automated medication management system,
which is under the supervision of a pharmacist.
B. The pharmacist-in-charge shall have the
responsibility for the procurement and storage of all drugs.
C. All medications, with the exception of
those for emergency use, shall be issued for inpatients use pursuant to the
review of the physician's order or direct copy thereof, prior to dispensing. If
the pharmacy is closed when the order is written, the pharmacist shall review
the order within 24 hours.
D. A
medication profile for all inpatients and outpatients shall be maintained and
used. The medication profile shall serve as the distribution record for
inpatient medications. Dangerous drug distribution records, for inpatient use,
must include the following information:
(1)
the patient's name and room (or bed) number;
(2) the name, strength, quantity and dosage
form of the drug distributed;
(3)
the name of the technician filling the drug order and pharmacist responsible
for checking the technician's work; or
(4) the name of the pharmacist or pharmacist
intern filling the drug order;
(5)
the date filled; and
(6) the date
and amount of unwanted/ unused drug returned to the pharmacy stock;
(7) records for schedule II controlled
substances must be kept separate; and
(8) schedule III-V must be kept separate or
if stored with non-controlled records, readily retrievable.
E. Floor stock dangerous drug
distribution records must include the following:
(1) name, strength, dosage form, and quantity
of the drug distributed;
(2) date
of filling;
(3) a name of
technician filling the drug order and the supervising pharmacist; or
(4) the name of the pharmacist or pharmacist
intern filling the drug order;
(5)
the destination location of the drug in the hospital; and
(6) the date and quantity of unwanted/ unused
drug returned to the pharmacy's stock;
(7) schedule II controlled substance records
must be kept separate from all other records; and
(8) schedule IV controlled substance records
must either be kept separate from other non-controlled substances records or
are readily retrievable.
F. Dangerous drug distribution records,
inpatient and floor stock, and medication profiles may be stored electronically
if such system is capable of producing a printout of all the required
information and the information is retrievable within 72 hours upon demand. The
pharmacist stating that it is a true and accurate record must certify the
printout. Hospitals utilizing automated drug distribution must comply with
Subsection M of
16.19.7.11
NMAC in lieu of the above. Hospital pharmacies are subject to all applicable
state and federal record keeping requirements when a prescription from a
licensed practitioner is filled.
G.
A distribution system for controlled substances shall be maintained including
perpetual inventory of all schedule II controlled substances. All schedule II
controlled substances that are stored in the pharmacy will be kept in a locked
storage area in the pharmacy.
H.
Drug storage and preparation areas within the facility shall be the
responsibility of the pharmacist-in-charge. All areas shall be inspected on a
monthly basis and documented by a pharmacist, intern or technician.
I. All pharmacy preparations of sterile
products shall be performed in accordance with the sterile products
regulations, 16.19.36 NMAC.
J.
Floor stock drugs, including those issued from automated medication management
systems, shall be limited to drugs for emergency use and routinely used items
as listed in the pharmacy policy and procedure manual and approved by the
pharmacy and therapeutics committee. Floor stock drugs shall be supplied in
individual doses unless the bulk container cannot be individualized. Dangerous
drug floor stock must be reviewed by the pharmacist or pharmacist intern on a
routine basis to insure appropriate use.
K. Where such committees exist, the
pharmacist-in-charge or designated pharmacist shall be a voting member of the
pharmacy and therapeutics committee or its equivalent.
L. Medications dispensed in the emergency
room will be dispensed only by a licensed pharmacist, a licensed pharmacist
intern or a licensed practitioner and shall comply with the following:
(1) a record shall be kept of all medications
dispensed from the emergency room of a hospital; the record shall include:
(a) the date the drug was
dispensed;
(b) name and address of
the patient;
(c) name of the
prescribing physician;
(d) the name
of the drug;
(e) the strength of
the drug;
(f) the quantity of drug
dispensed;
(g) initials of the
person recording the information if not a physician;
(2) a separate record shall be kept for
schedule II controlled substances;
(3) the following will be recorded in the
patient's medical chart:
(a) the name of the
drug(s) prescribed;
(b) the
strength of the drug;
(c) the
quantity of the drug dispensed;
(4) when medications are prescribed by the
physician and dispensed to the patient in the emergency room of the hospital
the dispensing label shall contain the following information:
(a) the name of the patient;
(b) the name of the prescribing
physician;
(c) name of the
drug;
(d) strength of the
drug;
(e) quantity of the
drug;
(f) name and address of the
hospital;
(g) date the drug is
dispensed;
(h) directions for
use;
(i) expiration date of
medication.
M. Automated Pharmacy Systems.
(1) General Statement: Automated devices for
storage and distribution of floor stock or patient profile drugs or both, shall
be limited to licensed health care facilities and shall comply with all the
following provisions. Written policies and procedures, approved by the
appropriate health care facility committee, shall be in place to ensure safety,
accuracy, security, and patient confidentiality. Personnel allowed access to an
automated dispensing device shall have a confidential access code that records
the identity and electronic signature of the person accessing the
device.
(2) Security/Access: The
control of access to the automated device must be controlled by the
pharmacist-in-charge. Proper identification and access control, including
electronic passwords or other coded identification, must be limited and
authorized by the pharmacist-in-charge. The pharmacist-in-charge must be able
to stop or change access at any time. The pharmacist-in-charge must maintain a
current and retrievable list of all persons who have access and the limits of
that access. Review of user access reports shall be conducted at least
quarterly as established by policy and procedures to ensure that persons who
are no longer employed at the facility do not have access to the
system.
(3) Records: The records
kept by the automated drug delivery system must comply with all state, federal,
and board requirements. Records must be maintained by the pharmacy and be
readily retrievable. Records may be retained in hard copy or an alternative
data retention system may be used where current technology allows.
(4) Automated Drug Distribution: An automated
medication management system shall be under the control of the
pharmacist-in-charge. If used for storage and dispensing of doses scheduled for
administration, there shall be a procedure by which orders for a drug are
reviewed and approved by the pharmacist before the drug may be withdrawn from
the automated dispensing device. There shall be written procedures for downtime
in the event of system malfunction or otherwise inoperable. A downtime log
shall be maintained and include:
(a) date of
transaction;
(b) patient;
(c) drug/dose;
(d) quantity of transaction;
(e) nurse signature;
(f) beginning count;
(g) ending count;
(h) wasted amount;
(i) witness signature, if needed;
and
(j) prescriber (for controlled
substances only).
(5)
Quality Assurance: The pharmacist-in-charge shall be responsible for developing
and implementing a quality assurance program which monitors total system
performance. Quality monitors shall include:
(a) the proper loading/refilling of the
device, including proof of delivery;
(b) the proper removal, return or waste of
drugs;
(c) processes for recording,
resolution, and reporting of discrepancies; and
(d) processes for conducting periodic audits
to assure compliance with policies and procedures.
(6) Records: Transaction records: At the time
of any event involving the contents of the automated device, the device shall
automatically produce on demand, a written or electronic record showing:
(a) the date and time of
transaction;
(b) the type of
transaction;
(c) the name,
strength, and quantity of medication;
(d) the name of the patient for whom the drug
was ordered;
(e) the name or
identification code (electronic signature) of the person making the
transaction;
(f) the name of the
attending, admitting or prescribing practitioner; and
(g) the identity of the device
accessed.
(7) Delivery
Records: A delivery record shall be generated on demand for all drugs filled
into an automated dispensing device which shall include:
(a) date;
(b) drug name;
(c) dosage form
(d) strength;
(e) quantity;
(f) identity of device; and
(g) name or initials of the person filling
the automated dispensing device.
(8) Filling: There shall be policies and
procedures in place, utilizing either manual, bar coding or other electronic
processing means of item identities as current technology allows, to ensure
pharmacist verification of accuracy in the filling and refilling of the
automated device. A delivery record of medications filled into an automated
pharmacy system shall be maintained and shall include identification of the
person filling the device.
(9)
Labeling/Packaging: Drugs filled into automated dispensing devices shall be in
manufacturers' sealed, original packaging or in repackaged containers in
compliance with the requirements of the board regulations relating to packaging
and labeling.
N.
Outsourcing of Pharmaceutical Services: A hospital pharmacy may contract or
enter into an agreement with another licensed pharmacy/pharmacist to provide
pharmaceuticals and/or other pharmacist services under the following
conditions:
(1) the contract pharmacy is
licensed by the board of pharmacy;
(2) the pharmacist providing the services by
the contracted pharmacy shall be licensed as a pharmacist in this
state;
(3) the contract is
incorporated into the pharmacy's policy and procedure manual and complies with
the requirements of 16.19.7 NMAC;
(4) the contracted pharmacy/pharmacist must
have complete access to the patient's profile in order to perform a drug
regimen review;
(5) the contracted
pharmacy/pharmacist must have access to the licensed practitioners of the
hospital;
(6) records of all
pharmaceuticals transferred from the contracted pharmacy to the hospital
pharmacy comply with the requirements;
(7) documentation of the services provided by
the contracted pharmacy/pharmacist.
