WSR 04-08-097

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed April 6, 2004, 2:38 p.m. ]

     Original Notice.

     Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

     Title of Rule: WAC 246-888-010, 246-888-020, 246-888-030, 246-888-040, and 246-888-070, medication assistance.

     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 also set standards for medication assistance in these settings.

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

     Statute Being Implemented: Chapter 69.41 RCW.

     Summary: The proposed amendments clarify that the rule only applies to controlled substances and legend drugs, simplifies the practice of medication assistance while maintaining prescriber involvement, and allows medication assistance with prefilled insulin syringes.

     Reasons Supporting Proposal: The proposed amendments implement legislation, HB 1753, enacted in 2003 and promote public health.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Donald Williams, 310 Israel Road S.E., Tumwater, WA 98504-7863, (360) 236-4825.

     Name of Proponent: Washington State Department of Health, Board of Pharmacy, governmental.

     Rule is not necessitated by federal law, federal or state court decision.

     Explanation of Rule, its Purpose, and Anticipated Effects: Chapter 246-888 WAC, Medication assistance, rules allow for medication assistance in community-based care settings or in-home settings for individuals who may need assistance with self-administering their medications. The proposed amendments implement legislation enacted during the 2003 legislative session. The amendments will simplify the practice of medication assistance while maintaining prescriber involvement, allow medication assistance with prefilled insulin syringes (assistance with the administration of any other intravenous and/or injectable medication continues to be excluded from the rule), and clarify that the rule only applies to legend drugs and controlled substances. It is anticipated that the proposed amendments will have the potential to improve the quality of life of individuals who may need assistance with their medications.

     Proposal Changes the Following Existing Rules: Amends WAC 246-888-010, 246-888-020, 246-888-030, 246-888-040, and 246-888-070, medication assistance. Changes include:
• Clarify that the rule only applies to legend drugs and controlled substances;
• Correct a wrong WAC citation;
• Repeals WAC 246-888-040 relating to a change in the individual's situation;
• Simplify the practice of medication assistance while maintaining prescriber involvement; and
• Allow medication assistance with prefilled insulin syringes (assistance with the administration of any other intravenous and/or injectable medication continues to be excluded from the rule).

     No small business economic impact statement has been prepared under chapter 19.85 RCW. Proposed amendments are explicitly and specifically dictated by statute and will not impose more than a minor cost on businesses or an industry.

     RCW 34.05.328 does not apply to this rule adoption. Proposed amendments are explicitly and specifically dictated by statute.

     Hearing Location: Mirabeau Park Hotel, 1100 North Sullivan Road, Spokane, WA 99037, on June 11, 2004, at 1:00 p.m.

     Assistance for Persons with Disabilities: Contact Lisa Salmi by June 1, 2004, TDD 833-6388 [1-800-833-6388] or (360) 236-4828.

     Submit Written Comments to: Lisa Salmi, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, e-mail Lisa.Salmi@doh.wa.gov, fax (360) 586-4359, by June 1, 2004.

     Date of Intended Adoption: June 11, 2004.

February 26, 2004

D. H. Williams

Executive Director

OTS-6374.3


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 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. 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
246-888-050 246-888-040
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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