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Medication Setup in Assisted Living - REVISED

PDF Version of BQA 04-006 (PDF, 84 KB)

DATE: March 11, 2004 BQA Memo 04-006 - Replaces BQA 03-009

TO: Adult Family Homes AFH – 02, Adult Day Care ADC – 02, Community Based Residential Facilities CBRF – 02, Residential Care Apartment Complexes RCAC - 02

FROM: Kevin Coughlin, Chief, Assisted Living Section

Via: Susan Schroeder, Director, Bureau of Quality Assurance

ISSUE

Who may set up medications that will be administered by unlicensed assisted living staff or adult day care staff to residents, tenants or participants?

ASSUMPTIONS

Medication setup by personnel other than a physician or pharmacist involves medications that have already been dispensed by a pharmacist or physician and meet prescription-labeling requirements under Wis. Stat. § 450.11(4).

Medication setup means the placing of medications into another container - like a medication planner - for easier administering at a later time. Medication setup does not include the preparing and immediate administering of the medication by the person who prepared it.

BEST PRACTICE

The Wisconsin Patient Safety Institute has published a practice guideline entitled Maximizing Patient Safety in the Medication Use Process (exit DHFS; PDF, 1100 KB). This guideline recommends that the best demonstrated practice is to dispense the medication in specialized packaging and labeling for the elderly, individuals with disabilities and other special patient populations.

Each manipulation of a medication creates an opportunity for medication errors to occur. Even when medication setup is done with the best intentions, taking the medication out of one container and placing it into another creates a situation that increases the possible number of errors. Decreased handling of the medication lessens the potential for errors that may occur between the manufacturer/distributor and the person who receives the medication. Therefore, it is highly recommended that pharmacists dispense the medication in the specialized packaging needed for medication planners or medication cards.

However, current assisted living regulations and adult day care standards may allow others to set up medications in different packages than those in which the medications were dispensed from pharmacies. The following analysis addresses the regulations or standards that affect medication setup. It is highly recommended that all providers consult with a pharmacist for alternative packaging solutions if medication set up is being considered.

ANALYSIS

Adult Day Care (ADC)

Standard I.F. (3)(c)—Over-the-counter and prescription medications shall remain in the original labeled containers and be stored in a locked, safe place.

Medication Administration by Adult Day Care Staff

Prior to this memo, the Bureau of Quality Assurance (BQA) did not issue any blanket waivers to this certification standard. If ADC staff are administering medications, then they need to take the medications out of the original package provided by the pharmacy. Labeling is done by the pharmacy, as required by pharmacy regulations.

If the adult attending the day care resides in a community-based residential facility (CBRF), Residential Care Apartment Complex (RCAC), adult family home (AFH), or another BQA regulated facility, then the adult day care can accept and use the medications that were set up in that facility. Another acceptable practice is to have the CBRF, RCAC, AFH or nursing home send the original packaged medications provided by the pharmacy. An alternative is to ask the pharmacy to supply two packages: one for use in the ADC and one for use at the CBRF, RCAC, AFH or the nursing home. If the ADC has a nurse, it is acceptable for the nurse to review the medications to determine their usability given the packaging. If the nurse feels the medication’s packaging integrity is compromised, the nurse may decide the medications are unusable and require the medications to come in a package provided by the pharmacy. ADC nurses who control and administer medications are encouraged to consult with a pharmacist regarding appropriate packaging and storage alternatives.

The individual service plan will indicate that the participant is responsible for medication management. The participant can set up and label medications as they wish.

Adult Family Homes (AFH):

Wis. Admin. Code § HFS 88.07(3)(a)—Every prescription medication shall be securely stored, shall remain in its original container as received from the pharmacy and stored as specified by the pharmacist.

The Bureau of Quality Assurance (BQA) has not issued any blanket waivers of this regulation. If AFH staff are administering medications, they need to take the medications out of the original package provided by the pharmacy. Labeling is done by the pharmacy, as required by pharmacy regulations under Wis. Stats. ch.450.

The code suggests that original packaging would be required for residents who self-administer medications. However, after reviewing regulations on residents rights and individual service plans, it is possible that if residents are responsible for their own medications, they could, on their own, setup medications or have family members assist them. The labeling can be determined by the resident or family, but it is recommended that the facility know which medications are being taken, and in what dosage, so that this information can be given to emergency personnel or others, as necessary.

Residential Care Apartment Complex (RCAC):

Wis. Admin. Code § HFS 89.23(2)(a)2.c.—Nursing services: health monitoring, medication administration and medication management.

Wis. Admin. Code § HFS 89.23(4)(a)2. Nursing services and supervision of delegated nursing services shall be provided consistent with the standards contained in the Wisconsin Nurse Practice Act. Medication administration and medication management shall be performed by or, as a delegated task, under the supervision of a nurse or pharmacist.

Setting up medication is a nursing service under the "medication management" provision of Wis. Admin. Code § HFS 89.23(4)(a)2.

If RCAC staff who are not Registered Nurses (RN) are administering medications, this administration should be included in the service agreement under nursing services. This service requires RN delegation. A RN may delegate the act of setting up of medication to a licensed practical nurse (LPN). The RN may also delegate this activity to other qualified staff. There are no specific requirements for labeling. However, it is recommended that the facility, at a minimum, have the resident’s name on the package, name of the medication, strength of the medication and instructions for use. The RCAC should maintain the original packaging received from the pharmacy until all the medication is gone.

When the tenant assessment indicates that the tenant is capable of and responsible for medication management, the tenant may set up and label medications as he or she wishes.

Community Based Residential Facilities (CBRF)

Wis. Admin. Code § HFS 83.33(3)2. When prescription and over-the-counter medications are controlled by the CBRF, the CBRF shall ensure that all of the following are met:

Wis. Admin. Code § HFS 83.33(3)2.a. All prescription medications shall have a label permanently attached to the outside of the container, which identifies the information required under Wis. Stat. § 450.11(4).

Wis. Admin. Code § HFS 83.33 (3)(b)2.b. Medications shall be stored in their original containers and not transferred to another container except by a practitioner or other appropriately licensed person.

Wis. Admin. Code § HFS 83.33(3)(e)4. If the staff member is not supervised, as required under subd. 3. [i.e., under the general or direct supervision of an appropriately licensed person, a pharmacist or the prescribing practitioner], the resident’s prescription medication shall be packaged by a pharmacist in unit dose or unit time packets, a blister pack, multi-day pill holder or similar device. Each packet, pack, holder or similar device shall be labeled by the pharmacist under the provisions of Wis. Stat. § 450.11(4).

Without RN supervision, as defined under Wis. Admin. Code § HFS 83.33(3)(e)3.a. to d. In this situation, a pharmacist must do all packaging and labeling. Wis. Admin. Code § HFS 83.33(3)(e)4.

With RN supervision, as defined under Wis. Admin. Code § HFS 83.33(3)(e)3.a. to d. In this situation, medications must be obtained from a pharmacy and the pharmacist must label the medications appropriately pursuant to Wis. Stat. § 450.11(4). However, § HFS 83.33(3)(b)2.b. suggests that medications may be removed from their original package. The only persons allowed to transfer the medications are practitioners or appropriately licensed persons, who are defined as either a pharmacist, RN or LPN. Those facilities where staff are administering medications under supervision of a nurse may have a RN or LPN set up medications in a medication planner. Although there are currently no regulations for labeling these set up medications, it is recommended that at least the resident’s name, medication name, medication strength and instructions for use be placed on the medication planner. It is also recommended that the original container, with the pharmacy label intact, be kept until all the medication is depleted so that the facility can show compliance with § HFS 83.33(3)(b)2.a. In addition, keeping the original container allows for easy checking of the set up medications.

In any case where the CBRF is not controlling medications and residents are taking their own medications, residents may set up medications for themselves or have family members do it. No labeling is required, but the CBRF must have a list of medications the resident is taking, in what dosage, so that this information can be given to emergency personnel or others, as may be necessary.

All Providers

For use during unplanned or non-routine events or activities, staff may place single doses of medications into packages for the resident or resident’s guardian to administer. Planned or routine events are subject to the set up provisions as stated within this memo. It is highly recommended that all providers consult with a pharmacist for alternative packaging solutions for planned or routine events.

The following table on page 6 is a quick reference for the analysis contained in this memo.

Medication Setup in Assisted Living

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