Current through Register Vol. 24-18, September 15, 2024
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.
Statutory Authority: Chapter 71.12 RCW. 05-15-157, §
246-337-105, filed 7/20/05, effective
8/20/05.