If you’re a medical assistant with questions about handing sample medications or drugs to patients, consider the following situation a CMA (AAMA) in Texas brought to my attention:
I am a CMA (AAMA) employed in a large, multispecialty clinic. I received an order from one of our licensed providers to distribute packets of sample medications to a patient. Is this legal in my state [Texas]? I thought only pharmacists and their staff were permitted to dispense medications.
To answer the question accurately, we have to define some terms. Note the following definitions from the Texas Pharmacy Act:
Sec. 551.003. DEFINITIONS. In Chapters 551-566:
(1) “Administer” means to directly apply a prescription drug to the body of a patient by any means, including injection, inhalation, or ingestion, …
(16) “Dispense” means to prepare, package, compound, or label, in the course of professional practice, a prescription drug or device for delivery to an ultimate user or the user ‘s agent under a practitioner ‘s lawful order.
(17) “Distribute” means to deliver a prescription drug or device other than by administering or dispensing.
Also, note the following from the Texas Occupations Code:
§157.002.General Delegation of Administration and Provision of Dangerous Drugs
(a) In this section:
(1) “Administering” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other means.
(2) “Provision” means the supply of one or more unit doses of a drug, medicine, or dangerous drug.
(b) A physician may delegate to any qualified and properly trained person acting under the physician’s supervision the act of administering or providing dangerous drugs in the physician’s office, as ordered by the physician, that are used or required to meet the immediate needs of the physician’s patients. The administration or provision of the dangerous drugs must be performed in compliance with laws relating to the practice of medicine and state and federal laws relating to those dangerous drugs.
According to these definitions, “distributing” a drug is not the same as “dispensing” a drug.
Under the laws of most every state, physicians are permitted to distribute/provide sample medications to their patients. (This is also generally the case with nurse practitioners and physician assistants, although the laws vary from state to state.)
The laws of many states explicitly or implicitly permit physicians to assign to knowledgeable and competent medical assistants working under their direct/on-site supervision the distributing or providing of sample medications to patients of the physician.
In the scenario described, the CMA (AAMA) is being asked by a delegating licensed provider to distribute/provide sample medications to patients, not to dispense medications.
It is my legal opinion that, if there is a likelihood of significant harm to a patient if the sample medication is selected or distributed improperly, the delegating provider must verify the identity and the dosage of the sample medication before it is distributed to the patient by the medical assistant.