Carolyn Buppert, NP, JD

Disclosures

December 28, 2005

Question

Who can legally dispense drugs from the sample closet? Can licensed practical nurses (LPNs), medical assistants (MAs), and registered nurses (RNs) do this?

Response from Carolyn Buppert, NP, JD

To answer this question, we need to look at state pharmacy laws and state law on scope of practice of LPNs, MAs, and RNs.

Pharmacy Law

State Pharmacy Practice Acts are quite specific about who may dispense medications. However, these laws tend to exempt physicians and other authorized prescribers when the prescribers supply their patients with drugs.

For example, the New York Pharmacy Practice Act says:

This article shall not be construed to affect or prevent...any physician...or other licensed health care provider legally authorized to prescribe drugs under this title who is not the owner of a pharmacy, or registered store, or who is not in the employ of such owner, from supplying his patients with such drugs as the physician...or other licensed health care provider legally authorized to prescribe drugs under this title deems proper in connection with his practice, provided, however, that all such drugs shall be dispensed in a container labeled with the name and address of the dispenser and patient, directions for use, and date of delivery, and in addition, such drug shall bear a label containing the proprietary or brand name of the drug and, if applicable, the strength of the contents, unless the person issuing the prescription specifically states on the prescription in his own handwriting, that the name of the drug and the strength thereof should not appear on the label; provided further that if such drugs are controlled substances, they shall be dispensed pursuant to the requirements of article thirty-three of the public health law. (NY Education Law, Article 137, Section 6807.)

I could find no state where the pharmacy law specified who could dispense samples from a physician's office sample closet. It appears that the handling of pharmaceutical samples by physician offices is unregulated.

I queried a pharmaceutical representative -- someone who provides physician offices with pharmaceutical samples -- about whether her company issues any guidance for physicians about how the company's samples are dispensed. She knew of no such directives.

Scope of Practice: MAs

State law varies greatly on the regulation of MAs. There is no online compilation of the law on scope of practice of MAs. Some states' laws give physicians the authority to delegate what they want to whom they want, and leave it up to a physician employer to determine what an MA does. Some states, such as California and Maryland, have published regulations giving MAs the legal authority to dispense medications. In states where physicians do not have the legal authority to delegate tasks requiring licensure to unlicensed individuals, and where there is no scope of practice for MAs, an MA who dispensed medications would be breaking the law.

To answer the question, we would need to research each state's law to determine whether physicians can delegate their authority to dispense to MAs, whether there is any state law regulating the practice of MAs, and whether that law authorizes the dispensing of medications.

Scope of Practice: LPNs

The scope of practice of LPNs is covered by each state's Nurse Practice Act.[1] Check your state's Board of Nursing Web site to determine whether dispensing of medications is within the scope of practice of LPNs.

Scope of Practice: RNs

The scope of practice of RNs is covered by each state's Nurse Practice Act.[1] Check your state's Board of Nursing Web site to determine whether dispensing of medications is within the scope of practice of RNs.

Other Legal Considerations

Even if an MA, LPN, or RN has the legal authority to dispense medications, there must be an order from an authorized prescriber for the sample medication for a specific patient, and state law may require that specific labeling be done. See NY law above. Furthermore, principles of risk avoidance would call for applying the same standard of care with samples as with medications provided by pharmacists. Therefore, physician offices that dispense samples would need to be sure that the pharmacist's patient education function be fulfilled by office staff and that the samples are kept secure from patients and staff who are not authorized to prescribe and dispense.

Furthermore, accreditation organizations such as JCAHO may have requirements for handling of samples.

Related Resources

  • Antalis JS. Sample medications: some ideas to promote safety. Available here. Accessed December 14, 2005.

  • Backer EL, Lebsack JA, Van Tonder RJ, Crabtree BF, The value of pharmaceutical representative visits and medication samples in community-based family practices. Available here. Accessed December 14, 2005.

  • Tache S, Chapman S. What a medical assistant can do in your practice. Available here. Accessed December 14, 2005.

  • McCarty M. The lawful scope of a medical assistant's practice. Available here. Accessed December 14, 2005.

  • Sanchez LT, Fromson J. Handling of drug samples requires careful consideration. Available here. Accessed December 14, 2005.

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