The licensee is responsible for implementing policies and procedures for the control and appropriate use of all drugs within the RTF in accordance with all applicable state and federal regulations. The policies and procedures to implement this section must be developed, approved, and reviewed by a health care prescriber and the RTF administrator, and must be consistent with this chapter.

(1) Procurement. Timely procurement of drugs must be achieved in one or more of the following ways:

(a) A pharmacy licensed under chapter 18.64 RCW provides resident specific drugs by prescription order to the RTF;

(b) A prescriber purchases drugs from a licensed wholesaler and is responsible for the drugs;

(c) The RTF is listed as a hospital pharmacy associated clinic under a hospital pharmacy license in accordance with chapter 18.64 RCW and applicable rules adopted by the Washington state pharmacy quality assurance commission;

(d) The RTF holds a health care entity license under chapter 18.64 RCW and purchases drugs consistent with chapter 246-904 WAC; and

(e) The resident brings his or her prescribed medication with them to the RTF.

(2) Storage and security.

(a) Storage of drugs must include limits on access to drugs to those staff authorized to assist, administer, or dispense drugs and addresses security, safety, sanitation, temperature, light, moisture and ventilation, and hand washing facilities. All drugs must be stored in accordance with United States pharmacopoeia standards and designated storage locations are constructed in accordance with WAC 246-337-126.

(b) Automated drug dispensing devices (ADDDs). For the purposes of this section, an ADDD has the same meaning as defined in WAC 246-874-010. ADDDs may be used to store drugs if:

(i) The ADDD is leased or owned by a prescriber who maintains sole responsibility for the drugs;

(ii) The RTF holds a health care entity license under chapter 18.64 RCW and complies with chapters 246-874 and 246-904 WAC; or

(iii) The RTF is operated in connection with a licensed hospital and complies with chapter 246-874 WAC and rules of the pharmacy quality assurance commission governing hospital pharmacy associated clinics.

(3) Inventory of stock drugs. The licensee shall document:

(a) Receipt and disposal of all drugs;

(b) Inventory of legend drugs;

(c) Inventory of controlled substances biennially, including:

(i) Keep all controlled substance records for a minimum of two years;

(ii) Have two authorized staff verify shift counts of controlled substances when transfer of accountability occurs. If an ADDD is used, staff must follow the policies and procedures developed for the ADDD; and

(iii) Report to the Washington state pharmacy quality assurance commission if the controlled substance counts or inventory indicate disappearances or unaccounted for discrepancies of controlled substances in accordance with WAC 246-873-080 and 246-887-020, and 21 C.F.R. Sec. 1301.76(b).

(4) Prescribing and administering drugs.

(a) An organized system must be established and maintained that ensures accuracy in receiving, transcribing and implementing orders for medication administration that ensures residents receive the correct medication, dosage, route, time, and reason.

(b) An authorized health care prescriber shall sign all written orders for legend drugs, controlled substances and vaccines. Orders, including telephone or verbal orders for legend drugs, controlled substances and vaccines must be signed as soon as possible, but no later than seventy-two hours after the telephone or verbal order has been issued.

(c) If using electronic prescribing, prescribers shall comply with RCW 69.50.312, chapter 246-870 WAC, and 21 C.F.R. Sec. 1311(c).

(d) A prescriber shall approve the use of self-administered nonprescription drugs. Staff shall provide the nonprescription drugs according to prescriber instructions.

(e) A prescriber shall:

(i) Develop an approved list of nonprescription drugs acceptable for residents that includes the parameters of use for each drug; and

(ii) Review and approve the list annually.

(f) The licensee shall address the way(s) medications are administered including:

(i) Staff-administered medication in which licensed staff operating within their scope of practice remove the drug from the container and provide it to the resident for ingestion or otherwise administer the drug to the resident;

(ii) Observed self-administration of medication in which residents obtain their container of medication from a supervised and secure storage area, remove the dose needed, ingest or otherwise take the medication as directed on the label while being observed by staff;

(iii) Independent self-administration of medication in which residents obtain their container of medication from either a supervised and secure storage area or from their personal belongings, remove the dose needed, ingest or otherwise take the medication as directed on the label without being observed by staff; or

(iv) Involuntary antipsychotic medication administration consistent with WAC 388-865-0570.

(g) Medication administration errors, adverse effects, and side effects must be reported and addressed;

(h) The licensee shall develop a policy and procedure for:

(i) The use, receipt, storage and accountability for residents receiving methadone from an outpatient methadone clinic, if applicable; and

(ii) Drugs given to a resident on temporary leave from the RTF.

(5) Documentation. All medications administered, observed being self-administered, or involuntarily administered must be documented on the medication administration record, including:

(a) Name and dosage of the medication;

(b) Parameters of use;

(c) Date the medication order was initiated;

(d) Date the medication order was discontinued;

(e) Time of administration;

(f) Route;

(g) Staff or resident initials indicating medication was administered, or observed being self-administered;

(h) Notation if medication was refused, held, wasted or not administered or observed being self-administered;

(i) Allergies; and

(j) Resident response to medication when given "as needed."

(6) RTF staff must have available to them a current established drug reference resource.

(7) For the purposes of this section:

(a) Controlled substance has the same meaning as defined in RCW 69.50.101; and

(b) Legend drugs has the same meaning as defined in RCW 69.41.010.