WSR 04-18-095

PERMANENT RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed September 1, 2004, 8:28 a.m. , effective October 2, 2004 ]


Purpose: The rules recognize that individuals residing in community-based care settings or in-home settings may need assistance self-administering their legend drugs and controlled substances due to physical or mental limitations. The rules set the standards for medication assistance in these settings.

Citation of Existing Rules Affected by this Order: Repealing WAC 246-888-040; and amending WAC 246-888-010, 246-888-020, 246-888-030, and 246-888-070.

Statutory Authority for Adoption: Chapter 69.41 RCW, RCW 18.64.005.

Adopted under notice filed as WSR 04-08-097 on April 6, 2004.

Changes Other than Editing from Proposed to Adopted Version: The proposed version of the rule was amended to clarify that the rule only applies to assistance with legend drugs and controlled substances.

An administrative correction was also made to recodify WAC 246-888-040 to 246-888-045.

A final cost-benefit analysis is available by contacting Lisa Salmi, P.O. Box 47863, Olympia, WA 98504, phone (360) 236-4828, fax (360) 586-4359, e-mail Lisa.Salmi@doh.wa.gov.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 1, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 1, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 1, Repealed 0.

Date Adopted: June 11, 2004.

George Roe

Board Chair

OTS-6374.5


AMENDATORY SECTION(Amending WSR 00-01-123, filed 12/17/99, effective 1/17/00)

WAC 246-888-010   Purpose.   The legislature recognizes that individuals residing in community-based care settings or ((their own homes,)) in-home settings may need assistance self-administering their ((medications,)) legend drugs and controlled substances, due to physical or mental limitations.

Community-based care settings include: Community residential programs for the developmentally disabled, certified by the department of social and health services under chapter 71A.12 RCW; adult family homes licensed under chapter 70.128 RCW; and boarding homes licensed under chapter 18.20 RCW. Community-based care settings do not include acute care or skilled nursing facilities.

In-home settings include: An individual's place of temporary and permanent residence, but does not include acute care or skilled nursing facilities, and does not include community-based care settings. The following rules provide guidance to the individual/resident and caregiver on medication assistance and administration.

[Statutory Authority: RCW 18.64.005 and 69.41.085. 00-01-123, 246-888-010, filed 12/17/99, effective 1/17/00.]


AMENDATORY SECTION(Amending WSR 00-01-123, filed 12/17/99, effective 1/17/00)

WAC 246-888-020   What is self-administration with assistance and how is it different from independent self-administration or medication administration?   Self-administration with assistance means assistance with legend drugs and controlled substances rendered by a nonpractitioner to an individual residing in a community-based care setting or ((his/her own home)) an in-home care setting. It includes reminding or coaching the individual to take their medication, handing the medication container to the individual, opening the medication container, using an enabler, or placing the medication in the hand of the individual/resident. The individual/resident must be able to put the medication into his or her mouth or apply or instill the medication. The individual/resident does not necessarily need to state the name of the medication, intended effects, side effects, or other details, but must be aware that he/she is receiving medications. Assistance may be provided with prefilled insulin syringes. Assistance is limited to handing the prefilled insulin syringe to an individual/resident. Assistance with the administration of any other intravenous and/or injectable medication is specifically excluded. The individual/resident retains the right to refuse medication. ((Assistance with the administration of intravenous and injectable medications are specifically excluded.)) Self-administration with assistance shall occur immediately prior to the ingestion or application of a medication.

Independent self-administration occurs when an individual/resident is independently able to directly apply a legend drug or controlled substance by ingestion, inhalation, injection or other means. In licensed boarding homes, self-administration may include situations in which an individual cannot physically self-administer medications but can accurately direct others per WAC ((246-316-300)) 388-78A-300. These regulations do not limit the rights of people with functional disabilities to self direct care according to chapter 74.39 RCW.

If an individual/resident is not able to physically ingest or apply a medication independently or with assistance, then the medication must be administered to the individual/resident by a person legally authorized to do so (e.g., physician, nurse, pharmacist). All laws and regulations applicable to medication administration apply. If an individual/resident cannot safely self-administer medication or self-administer with assistance and/or cannot indicate an awareness that he or she is taking a medication, then the medication must be administered to the individual/resident by a person legally authorized to do so.

[Statutory Authority: RCW 18.64.005 and 69.41.085. 00-01-123, 246-888-020, filed 12/17/99, effective 1/17/00.]


AMENDATORY SECTION(Amending WSR 00-01-123, filed 12/17/99, effective 1/17/00)

WAC 246-888-030   How is self-administration with assistance initiated in a community-based care setting or an in-home setting?   An individual/resident ((or his or her representative from)) who resides in a community-based care setting or an in-home setting or his or her representative may request self-administration with assistance. ((The practitioner consults with the individual or his or her representative and the facility in making the decision. A practitioner considers such factors as the physical and mental limitations of the individual and the setting or environment in which the individual resides, for purposes of determining whether or not the individual can safely self-administer with assistance. Practitioners include: A physician, osteopathic physician, podiatric physician, dentist, licensed practical nurse, registered nurse, advanced registered nurse practitioner, and a pharmacist. Refer to chapter 69.41 RCW for a complete listing of authorized practitioners.)) A nonpractitioner may help in the preparation of legend drugs and controlled substances for self-administration where a practitioner has determined and communicated orally or by written direction that such medication preparation assistance is necessary and appropriate.

No additional separate assessment or documentation of the needs of the individual/resident are required in order to initiate self-administration with assistance. It is recommended that providers document their decision making process in the health record of the individual or resident health record.

[Statutory Authority: RCW 18.64.005 and 69.41.085. 00-01-123, 246-888-030, filed 12/17/99, effective 1/17/00.]


AMENDATORY SECTION(Amending WSR 00-01-123, filed 12/17/99, effective 1/17/00)

WAC 246-888-070   Can all medications be altered to facilitate self-administration?   A pharmacist or other practitioner practicing within their scope of practice must determine that it is safe to alter a ((medication)) legend drug or controlled substance. If the medication is altered, and a practitioner has determined that such medication alteration is necessary and appropriate, the determination shall be communicated orally or by written direction. Documentation of the appropriateness of the alteration must be on the prescription container, or in the individual's/resident's record.

[Statutory Authority: RCW 18.64.005 and 69.41.085. 00-01-123, 246-888-070, filed 12/17/99, effective 1/17/00.]


REPEALER

     The following section of the Washington Administrative Code is repealed:
WAC 246-888-040 What if there is a change in the individual's situation?

NEW SECTION


The following sections of the Washington Administrative Code are recodified as follows:

Old WAC Number New WAC Number
246-888-050 246-888-045
246-888-060 246-888-050
246-888-070 246-888-060
246-888-080 246-888-070
246-888-090 246-888-080
246-888-100 246-888-090
246-888-110 246-888-100

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