Current through Register Vol. 54, No. 12, March 23, 2024
(a) A narcotic
treatment program shall comply with applicable Federal and State statutes and
regulations regarding the storing, compounding, administering and dispensing of
medication.
(b) A narcotic
treatment program shall develop policies and procedures regarding verbal
medication orders, including the issuing and receiving of orders, identifying
circumstances when orders are appropriate and documenting orders, in accordance
with applicable Federal and State statutes and regulations.
(c) A narcotic treatment program shall
develop and implement written policies and procedures regarding the medications
used by patients which shall include, at a minimum:
(1)
Administration of
medication.
(i) A narcotic treatment
physician shall determine the patient's initial and subsequent dose and
schedule. The physician shall communicate the initial and subsequent dose and
schedule to the person responsible for the administration of medication. Each
medication order and dosage change shall be written and signed by the narcotic
treatment physician.
(ii) An agent
shall be administered or dispensed only by a practitioner licensed under the
appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who
are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient
permitted at a dispensing station at any given time.
(v) Each patient shall be observed when
ingesting the agent.
(vi)
Administering and dispensing shall be conducted in a manner that protects the
patient from disruption or annoyance from other individuals.
(2)
Drug storage
areas. A narcotic treatment program shall develop and implement
written policies and procedures regarding storage of medications and access to
the medication storage area. Agents shall be stored in a locked safe that has
been approved by the DEA under
21 CFR
1301.72 and
1301.74 (relating to physical
security controls; and other security controls).
(3)
Inspection of storage
areas. A narcotic treatment program shall inspect all drug storage
areas and the dispensing station at least quarterly to ensure that the areas
are maintained in compliance with Federal, State and local laws and
regulations. A narcotic treatment program shall develop and implement written
policies and procedures regarding who performs the inspections, how often, and
in what manner the inspections are to be documented. The policies and
procedures shall include the following:
(i)
Disinfectants and drugs for external use shall be stored separately from oral
and injectable drugs.
(ii) Drugs
requiring special conditions for storage to insure stability shall be properly
stored.
(iii) Outdated and
contaminated drugs shall be removed and destroyed according to Federal and
State regulations.
(iv)
Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable
drugs shall be stored in accordance with Federal and State
regulations.
(4)
Method for control and accountability of drugs. A narcotic
treatment program shall develop and implement written policies and procedures
regarding who is authorized to remove drugs from the storage area and the
method for accounting for all stored drugs. An agent or other drug prescribed
or administered shall be documented on an individual medication record or sheet
in a manner sufficient to maintain an accurate accounting of medication at all
times and shall include:
(i) The name of the
medication.
(ii) The date
prescribed.
(iii) The
dosage.
(iv) The
frequency.
(v) The route of
administration.
(vi) The date and
time administered.
(vii) The name
of the person administering the medication.
(viii) The take-home schedule, if
applicable.
(5)
Security of all substances. A narcotic treatment program shall
develop and implement written policies and procedures to minimize the
likelihood of loss, theft or misuse of an agent or another controlled substance
as well as a plan of action if a loss, theft or misuse does occur. In the event
of loss, theft or misuse, the Federal and State statutes and regulations
regarding reporting shall be followed.
(6)
Inventories. A narcotic
treatment program shall conduct monthly inventories of agents and other
controlled substances stored. Each inventory record shall include:
(i) The date the inventory was
conducted.
(ii) The time of day it
was conducted.
(iii) The name and
amount of each product on hand at the time of the inventory.
(iv) The name of the individual conducting
the inventory.
(7)
Drug reactions and medication errors. A narcotic treatment
program shall report any adverse drug reaction or medication error to a
narcotic treatment physician immediately and initiate corrective action. The
narcotic treatment program shall record the reaction or error in the drug
administration record and the clinical chart, and shall inform each person who
is authorized to administer medication or supervise self-medication of the
reaction or error.