PROPOSED RULES
(Board of Pharmacy)
Original Notice.
Preproposal statement of inquiry was filed as WSR 98-14-119.
Title of Rule: Medication assistance in community-based settings.
Purpose: To establish uniform definitions across difference residential settings and to provide guidance to individuals, family members and caregivers on the subject of medication assistance.
Statutory Authority for Adoption: Chapters 69.41, 18.64 RCW.
Statute Being Implemented: RCW 69.41.085.
Summary: This rule allows nonhealth professionals to assist residents residing in community based settings with administration of their medications.
Reasons Supporting Proposal: This rule provides guidance to individuals, caregivers, family members and health professionals concerning medication assistance.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Don Williams, 1300 Quince Street S.E., Olympia, WA 98504, (360) 236-4828.
Name of Proponent: 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: This rule implements legislation enacted by the 1998 legislature. The legislature recognized that certain individuals residing in community-based settings may need assistance with administering their medication and amended the state law to allow nonhealth professionals to assist individuals with their medications under certain circumstances. These rules provide guidance to individuals, family members, caregivers and health professionals on the subject of medication assistance. It is anticipated that individuals who qualify for medication assistance will be able to remain in community based settings rather than skilled nursing facilities.
Proposal does not change existing rules. This is a new section.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
Economic Impact Analysis
This report contains two analyses: An economic impact analysis (EIA) and a small business economic impact statement (SBEIS). The EIA determines the economic impact of the rule on a typical business. The SBEIS addresses the impact of the rule on small businesses and whether the impact is disproportionate compared to large businesses. The SIC code assigned to this economic activity is 805 Nursing and Personal Care Facilities.
Purpose: This rule is intended to provide guidance to individuals and caregivers on the subject of medication assistance. The intent of this rule is to assure that the residents of this state receive the highest level of healthcare in a safe, effective and efficient manner.
Introduction: This rule implements legislation, SHB 2452, chapter 70, Laws of 1998. SHB 2452 amends chapter 69.41 RCW. This rule addresses the unmet health care needs of individuals residing in their own homes and in residential care facilities by allowing nonprofessional caregivers to assist individuals with the administration of their medications.
Background: Prior to the enactment of this legislation, individuals needing assistance with their medication(s) were required to be cared for in a skilled nursing facility regardless of their overall health status. The act of assisting an individual with their medication is considered "administration" of a medication. Under state law, only certain health professionals can administer medications (e.g., nurses, physicians, pharmacists, dentists).
The legislature recognized that some individuals residing in community-based settings (individual homes, adult family homes, boarding homes, assisted living centers, etc.) might need assistance taking their medication(s) due to physical or mental limitations. The legislation allows nonprofessional caregivers to assist individuals or residents with administering noninjectable medication(s). For many of these patients, the appropriate level of care is available in a community based facility, provided the patient can receive assistance with their medication. Caring for individuals in a community-based setting (as opposed to a skilled nursing facility) is a responsible use of health care resources and for most individuals improves quality of life.
Principle Components of the Regulation: WAC 246-888-010, describes the purpose of the rules. The purpose of the rules is to provide guidance to the individual/resident and the caregiver on medication assistance and administration.
WAC 246-888-020, describes the different levels of medication administration: Self administration with assistance, independent self administration and medication administration.
WAC 246-888-030, this section informs the reader how self-administration with assistance is initiated. A practitioner, in consultation with the individual (or his or her representative) and the facility decides if medication assistance is appropriate. No additional assessment or documentation of the individual’s needs are required, however, providers are encouraged to document their decision making.
WAC 246-888-040, informs the reader the practitioner may need to reassess the individual's status or situation if there is a change in the health status of the individual or resident.
WAC 246-888-050, this section describes what an enabler is and provides examples of enablers. This section also states that the common practice of "hand over hand" administration is prohibited.
WAC 246-888-060, describes how medications can be altered for self-administration with assistance. Examples include crushing the tablet, opening capsules and mixing the medication with foods or liquids, dissolving tablets in liquids, etc.
WAC 246-888-070, informs the reader that a pharmacist or other practitioner, acting within their scope of practice, must determine that it is safe to alter a medication and describes how to document the authorization.
WAC 246-888-080, describes other types of assistance the caregiver may provide, such as pouring a liquid medication into a calibrated spoon or cup.
WAC 246-888-090, informs the reader that oxygen is not covered under this rule.
WAC 246-888-100, informs the reader that these rules also apply to providing assistance to an individual or resident with a gastrostomy tube provided the physician has authorized the need for assistance.
WAC 246-888-110, informs the reader that they should be familiar with other rules specifically regulating their particular setting, i.e., rules adopted by the Department of Social and Health Services.
| Type of Facility | Number of Facilities | Potential Number of Persons Served | Average Number of Individuals per Facility |
| Assisted Living Centers | 2172 | 11,085 | 5.10 |
| Boarding Homes | 464 | 20,706 | 44.62 |
| Adult Family Homes | 2160 | 9,720 | 4.5 |
| Homes for Developmentally Disabled | 125 contracts | 3,000 | 24 |
Licensing Costs: None. Residential care facilities do not need to obtain additional licenses from the Department of Health or the Department of Social and Health Services to provide medication assistance. Practitioners are not required to obtain additional licenses either.
Other Costs: The only cost associated with this rule is related to record-keeping requirements. It should be noted that the record-keeping requirements contained in these rules are identical to rules already adopted by the Department of Social and Health Services, the agency that licenses these facilities so these do not represent an additional burden.
The following tasks must be accomplished in order to provide medication assistance:
| Task | Time | Cost |
| (1) Document the patient’s ability to receive assistance self-administering their medication. | .25/hour | 2.50* |
| (2) Document the authorization of the practitioner for the patient to receive assistance self-administering their medication. | .25/hour | 2.50* |
| (3) Document the appropriateness of altering a medication, if necessary. | .25/hour | 2.50* |
| Total | 7.50 per individual |
Because this rule is new, the exact number of individuals affected by this rule is not known. Not all individuals residing in community-based facilities will require medication assistance.
The affect of this rule should result in an overall decrease in health care expenses. Below is an example of the average per day cost for care in a skilled nursing facility and community-based facilities. The cost of care in a community-based setting is significantly reduced from that of a skilled nursing facility.
| Type of Facility | Per Day Cost |
| Skilled Nursing Facility | $115.50 |
| Adult Residential Care | $29.31 |
| Enhanced Adult Residential Care | $47.87 |
| Assisted Living Center | $57.86 |
| Activity | Freq-uency | Time Involved | Hourly Rate | Travel Exp. | Total |
| Tele-phone calls | 72 calls per year | 24 hours | $31.54 | None | $756.96 |
| Educational Presen-tations | 2 | 10 hours | $31.54 | $24.80 | $340.20 |
| Total | 34 hours | $63.09 | $24.80 | $1097.16 |
(B) The Size Distribution of Affected Parties: RCW 19.85.020 defines a small business as one that employs less than 50 individuals. All businesses in this industry category employ less than 50 employees, so all qualify as a small business. Therefore, there is no disproportionate cost to small business from this rule.
(C) Cost Comparison of Large and Small Businesses: No cost comparison was performed because all businesses in this industry are small by definition.
(D) Steps Taken by the Agency to Reduce the Costs of the Rule on Small Businesses: Since all business' in this industry are small and there is no disproportionate impact to small business, DOH has no obligation to mitigate costs. It should be noted that the only costs associated with this rule are related to record-keeping requirements. The same record-keeping requirements are already mandated by the Department of Social and Health Services, the agency that licenses these facilities.
(E) Involvement of Small Businesses in the Development of the Rule: The Department of Health solicited information from representatives of boarding homes, adult family homes, and assisted living centers in preparing this impact statement. The department also received data during public meetings and in written comments. Comments on the rule were also received from several governmental agencies and other organizations representing the industry.
(F) Industries Required to Comply with the Rule: An estimated 4921 facilities will be required to comply with the rules.
A copy of the statement may be obtained by writing to Lisa Salmi, Department of Health, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863.
RCW 34.05.328 does not apply to this rule adoption.
Hearing Location: Tacoma Sheraton Inn, 1320 Broadway Plaza, Tacoma, WA, on October 22, 1999, at 10:15 a.m.
Assistance for Persons with Disabilities: Contact Lisa Salmi by October 1, 1999, TDD (800) 833-6388, or (800) 525-0127.
Submit Written Comments to: Lisa Salmi, fax (360) 586-4359, by October 10, 1999.
Date of Intended Adoption: October 22, 1999.
August 23, 1999
D. H. Williams
Executive Director
OTS-2815.2
MEDICATION ASSISTANCE
The legislature recognizes that individuals residing in community-based settings or their own homes, may need assistance self-administering their medications, legend drugs and controlled substances, due to physical or mental limitations. The following rules provide guidance to the individual/resident and caregiver on medication assistance and administration.
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Self-administration with assistance means assistance rendered by a nonpractitioner to an individual residing in a community-based setting or his/her own home. 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. 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. These regulations do not limit the rights of people with functional disabilities to self direct care according to 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.
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An individual/resident or his or her representative from a community based setting 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.
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.
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If there is a change in the health status of the individual/resident, medications, physical or mental limitations, or environment, the practitioner may need to be re-involved in the process.
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Enablers are physical devices used to facilitate an individual's/resident's self-administration of a medication. Physical devices include, but are not limited to, a medicine cup, glass, cup, spoon, bowl, prefilled syringes, syringes used to measure liquids, specially adapted table surface, straw, piece of cloth or fabric.
An individual’s hand may also be an enabler. The practice of "hand-over-hand" administration is not allowed. Medication administration with assistance includes steadying or guiding an individual’s hand while he or she applies or instills medications such as ointments, eye, ear and nasal preparations.
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Alteration of a medication for self-administration with assistance includes, but is not limited to, crushing tablets, cutting tablets in half, opening capsules, mixing powdered medications with foods or liquids, or mixing tablets or capsules with foods or liquids. Individuals/residents must be aware that the medication is being altered or added to their food.
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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, documentation of the appropriateness of the alteration must be on the prescription container, or in the individual’s/resident’s record.
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A nonpractitioner can transfer a medication from one container to another for the purpose of an individual dose. Examples include: Pouring a liquid medication from the medication container to a calibrated spoon or medication cup.
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Under state law, oxygen is not a medication and is not covered under this rule. While oxygen is not considered a medication under state law, oxygen does require an order/prescription from a practitioner.
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If the prescription is written as an oral medication via "g-tube," and if a practitioner has determined that the medication can be altered, if necessary, for use via "g-tube," the rules as outlined for self-administration with assistance would also apply.
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You should be familiar with the rules specifically regulating your residential setting. The department of social and health services has adopted rules relating to medication services in boarding homes and adult family homes.
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