§ 715.17. Medication control.
(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.
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