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Sample Medications

PDF Version of BQA 04-029 (PDF, 36 KB)

DATE: December 27, 2004 BQA Memo 04-029 

TO: Adult Family Homes AFH – 12, Adult Day Care ADC – 08, Community Based Residential Facilities CBRF – 15, Residential Care Apartment Complexes RCAC - 12

FROM: Kevin Coughlin, Chief, Assisted Living Section

Via: Cris Ros-Dukler, Director, Bureau of Quality Assurance

ISSUE

Can residents in assisted living facilities use sample medications?

BACKGROUND

Sample medications are those that manufacturers generally provide directly to physicians. These medication samples are primarily used as starter supplies when patients are started on a new medication. More often, however, physicians use these sample medications for patients who have difficulties affording medications. In some cases, the sample medications are used beyond that of a starter supply and for ongoing needs.

Medication samples are not typically packaged and labeled by pharmacies. State law does exempt sample medications dispensed by physicians from the labeling requirements found in Wis. Stat. § 450.11. However, physicians must keep the sample medication in the original manufacture’s packaging. The challenge for assisted living programs is that the sample packaging may not meet the regulations or provide adequate information to safely administer these sample medications.

RESPONSE

Residential Care Apartment Complexes (RCACs): Residents who administer and control their own medications may use sample medications as directed by their physicians. When the RCAC is responsible for medication management, it is recommended that the registered nurse responsible for medication management work with a pharmacist to set up some guidelines for the use of these samples. Guidelines usually include maintaining samples in original packaging, obtaining written instructions from the physician, etc. Medication setup for RCACs follow BQA memo 04-006.

Adult Day Care (ADCs): Participants who administer their own medications may use sample medications as directed by their physicians. However, adult day care program standards require medications to remain in original packaging when day care staff administer medications (Standards I.F.(3)(c) (PDF, 59 KB). Therefore, adult day care staff who administer medications to participants need to ensure that the sample medications remain in the sample packaging received from the physicians. Since labeling and information may be somewhat lacking when sample products are used, ADC staff may need to make specific requests to obtain written information about the medication and may need to consult with the physicians about the use of the sample drug (Standards I.F.(3)(d)&(e) (PDF, 59 KB). Medication setup follows BQA memo 04-006.

Adult Family Homes (AFHs): Residents who administer and control their own medications can use sample medications as directed by their physicians. If AFH staff is administering sample medications, the medications must be sent to the facility in the original sample packaging from the physicians. Medication setup follows BQA memo 04-006.

Community Based Residential Facilities (CBRFs): Residents who administer and control their own medications can use sample medications as directed by their physicians. If CBRF staff is administering sample medications, the medications must be sent to the facility in the original sample packaging provided by the physicians. Medication setup follows BQA memo 04-006. If the CBRF does not have a nurse on staff, then the sample medications must be in unit dose or unit time packaging from the physician or pharmacist. Pharmacists, at their discretion, may repackage sample medications that have been dispensed from a physician to meet the CBRF’s unit dose packaging requirements.

The following chart summarizes the use of sample medications.

Use of Sample Medications in Assisted Living

Facility Type

ADC

AFH

CBRF

RCAC

Super- vised

Not Super- vised

Residents/Tenants/Participants: Self-administer: Samples can be used and packaged as they wish.

Y

Y

Y

Y

Y

Facility staff administer: sample medications can be used

Y

Y

Y

Y

Y

Sample medication set up when staff administer- BQA memo 04-006 applies

Y

Y

Y

Y*

Y

*Unit dose packaging by a pharmacist is required unless physician-dispensed sample is already in unit dose packaging.

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