Current through Register Vol. 30, No. 38, September 20, 2024
A. The limited-service pharmacy permittee
shall ensure that the limited-service correctional pharmacy complies with the
standards for area, personnel, security, sanitation, equipment, drug
distribution and control, administration of drugs, drug source, quality
assurance, investigational drugs, and inspections as set forth in
R4-23-608,
R4-23-609(A) through (D) and (F) through (H), R4-23-610(A), R4-23-611,
R4-23-612, R4-23-653(E), R4-23-658(B) through (E), R4-23-659, and
R4-23-660.
B. The
pharmacist-in-charge of a limited-service correctional pharmacy shall authorize
only pharmacists, interns, pharmacy technicians, pharmacy technician trainees,
compliance officers, drug inspectors, peace officers, and correctional officers
acting in their official capacities, other persons authorized by law, support
personnel, and other designated personnel to be in the limited-service
correctional pharmacy.
C. When no
pharmacist will be on duty in the correctional facility, the
pharmacist-in-charge shall arrange, before there is no pharmacist on duty, for
the medical staff and other authorized personnel of the correctional facility
to have access to drugs in remote drug storage areas or, if a drug is not
available in a remote drug storage area and is required to treat the immediate
needs of a patient, in the limited-service correctional pharmacy.
1. The pharmacist-in-charge shall, in
consultation with the appropriate committee of the correctional facility,
develop and implement procedures to ensure that remote drug storage areas:
a. Contain only properly labeled drugs that
might reasonably be needed and can be administered safely during the
pharmacist's absence,
b. Contain
drugs packaged only in amounts sufficient for immediate therapeutic
requirements,
c. Are accessible
only with a physician's written order,
d. Provide a written record of each drug
withdrawn,
e. Are inventoried at
least once each week, and
f. Are
audited for compliance with the requirements of this rule at least once each
month.
2. The
pharmacist-in-charge shall, in consultation with the appropriate committee of
the correctional facility, develop and implement procedures to ensure that
access to the limited-service correctional pharmacy when no pharmacist is on
duty conforms to the following requirements:
a. Is delegated to only one nurse, who is in
a supervisory position;
b. Is
communicated in writing to medical staff of the correctional
facility;
c. Is delegated only to a
nurse who has received training from the pharmacist-in-charge in proper methods
of access, removal of drugs, and recordkeeping procedures; and
d. Is delegated by the supervisory nurse to
another nurse only in an emergency.
3. When a nurse to whom authority to access
the limited-service correctional pharmacy is delegated removes a drug from the
limited-service correctional pharmacy, the nurse shall:
a. Record the following information on a
form:
i. Patient's name,
ii. Name of the drug and its strength and
dosage form,
iii. Dose
prescribed,
iv. Amount of drug
removed, and
v. Date and time of
removal;
b. Sign the
form recording the drug removal;
c.
Attach the original or a direct copy of a physician's written order for the
drug to the form recording the drug removal; and
d. Place the form recording the drug removal
conspicuously in the limited-service correctional pharmacy.
4. Within four hours after a
pharmacist in the limited-service correctional pharmacy returns to duty
following an absence in which the limited-service correctional pharmacy was
accessed by a nurse to whom authority had been delegated, the pharmacist shall
verify all records of drug removal according to
R4-23-402.
D. When no pharmacist will be on
duty in the correctional facility, the pharmacist-in-charge shall arrange,
before there is no pharmacist on duty, for the medical staff and other
authorized personnel of the correctional facility to have telephone access to a
pharmacist.
E. The limited-service
pharmacy permittee shall ensure that the limited-service correctional pharmacy
is not without a pharmacist on duty for more than 96 consecutive
hours.
F. In addition to the
requirements of R4-23-671, the limited-service pharmacy permittee shall secure
the limited-service correctional pharmacy as follows:
1. Permit no one to be in the limited-service
correctional pharmacy unless a pharmacist is on duty except:
a. As provided in subsection (C)(3) when a
pharmacist is not on duty; or
b. A
pharmacy technician or pharmacy technician trainee may remain to perform duties
in
R4-23-1104(A),
when a pharmacist is on duty and available in the correctional facility but
temporarily absent from the pharmacy, provided:
i. All controlled substances are secured in a
manner that prohibits access by persons other than a pharmacist;
ii. Activities performed by a pharmacy
technician or pharmacy technician trainee while the pharmacist is temporarily
absent are verified by the pharmacist immediately upon returning to the
pharmacy;
iii. Any drug measured,
counted, poured, or otherwise prepared and packaged by a pharmacy technician or
pharmacy technician trainee while the pharmacist is temporarily absent is
verified by the pharmacist immediately upon returning to the pharmacy;
and
iv. Any drug that has not been
verified by a pharmacist for accuracy is not dispensed, supplied, or
distributed while the pharmacist is temporarily absent from the pharmacy;
and
2.
Provide keyed or programmable locks to all areas of the limited-service
correctional pharmacy.
G. The pharmacist-in-charge of a
limited-service correctional pharmacy shall ensure that the written policies
and procedures for pharmacy operations and drug distribution within the
correctional facility include the following:
1. Physicians' orders, prescription orders,
or both;
2. Authorized
abbreviations;
3. Formulary
system;
4. Clinical services and
drug utilization management including:
a.
Participation in drug selection,
b.
Drug utilization reviews,
c.
Inventory audits,
d. Patient
outcome monitoring,
e. Committee
participation,
f. Drug information,
and
g. Education of pharmacy and
other health professionals;
5. Duties and qualifications of professional
and support staff;
6. Products of
abuse and contraband medications;
7. Controlled substances;
8. Drug administration;
9. Drug product procurement;
10. Drug compounding, dispensing, and
storage;
11. Stop orders;
12. Pass or discharge medications;
13. Investigational drugs and their
protocols;
14. Patient
profiles;
15. Quality management
procedures for:
a. Adverse drug
reactions;
b. Drug
recalls;
c. Expired and
beyond-use-date drugs;
d.
Medication or dispensing errors;
e.
Drug storage; and
f. Education of
professional staff, support staff, and patients;
16. Recordkeeping;
17. Sanitation;
18. Security;
19. Access to remote drug storage areas by
non-pharmacists; and
20. Access to
limited-service correctional pharmacy by non-pharmacists.