delegation, On the Job, Scope of Practice

Distributing vs. Dispensing Drugs

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.

12 thoughts on “Distributing vs. Dispensing Drugs”

  1. In Arizona the physician must write on the sample box how the patient is to take the medication. This also must be entered in the patient chart and the CMA must sign it as well with lot number This should also be entered on the office sample log as to what. Medication, lot number and direction for the patient.

    1. Thank you for your excellent help with this, Mary! Don

      Donald A. Balasa, JD, MBA
      Chief Executive Officer, Legal Counsel
      American Association of Medical Assistants
      Ph: 800/228-2262 | Fax: 312/899-1259 | http://www.aama-ntl.org
      The CMA (AAMA): Health Care’s Most Versatile Professional®

  2. Cudos to Arizona!
    In my experience as a provider, if I’m starting a patient on a med or changing to a different dose, I personally give the samples to the patient along with an explanation and instructions. That’s my responsibility, not the staff person’s. The staff can reinforce and clarify understanding of those instructions, but ultimately, the buck (as it were) stops with me.

  3. In my experience, when it came to drug samples, the provider gave them to the patient. I am in Washington State. I have been looking to see if there are any medical assistant specific laws addressing this and there doesn’t seem to be any. I do know we have some pretty clear definitions of what it means to administer medications, but not giving out samples.

    1. Thank you for your comment. I agree that the state laws governing distributing/providing sample medications are generally not specific.

      Donald A. Balasa, JD, MBA
      Chief Executive Officer, Legal Counsel
      American Association of Medical Assistants
      Ph: 800/228-2262 | Fax: 312/899-1259 | http://www.aama-ntl.org
      The CMA (AAMA): Health Care’s Most Versatile Professional®

    1. Thank you for your question. I have just reviewed the Indiana law and it is my legal opinion that it permits physicians to assign to knowledgeable and competent unlicensed professionals such as medical assistants working under their direct/onsite supervision in outpatient settings the providing/distributing of sample medications to a patient—as specifically ordered by the physician in regard to a specific patient.

      Keep in mind my statement in my post, however:
      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.

      I hope this is helpful.

      Donald A. Balasa, JD, MBA
      Chief Executive Officer, Legal Counsel
      American Association of Medical Assistants
      Ph: 800/228-2262 | Fax: 312/899-1259 | http://www.aama-ntl.org
      The CMA (AAMA): Health Care’s Most Versatile Professional®

      1. where did you find this information? I am trying to find Indiana’s state law on medical assistants administering medications.

        1. Thank you for your question. Go to http://www.aama-ntl.org and click below “State Scope of Practice Laws” on the left side of the homepage. You will be able to find the medical assisting law of all states, including Indiana. Note the following from my legal opinion letter in the Indiana section:

          According to 25-22.5-1-2, Section 2(a) of the Indiana statutes, the provisions relating to the unlawful or unau­thorized practice of medicine or osteopathic medicine shall not apply to:

          (20) an employee of a physician or group of physicians who performs an act, a duty, or a function that is customarily within the specific area of practice of the employing physician or group of physicians, if the act, duty or function is performed under the direction and supervision of the employing physician or a physician of the employing group within whose area of practice the act, duty or function falls. An em­ployee may not make a diagnosis or prescribe a treatment…An employee may not administer medica­tion without the specific order of the employing physician of the employing group.
          It is my legal opinion that this language authorizes physicians to delegate a reasonable scope of clinical and administrative tasks (including venipuncture/phlebotomy, administering intramuscular, intradermal, and subcu­taneous injections [including immunizations/vaccinations], conveying information verbatim as directed by the delegating physician, transmitting verbatim the physician’s prescription/medication orders as directed by the delegating physician after review and approval by the physician) to knowledgeable and competent unlicensed professionals such as medical assistants working under their authority in outpatient settings. Tasks which con­stitute the practice of medicine, or which state law permits only certain health care professionals to perform, or which require the exercise of independent professional judgment or the making of clinical assessments, evalua­tions, or interpretations, however, may not be delegated to unlicensed professionals such as medical assistants.

          I hope this is helpful.

          Donald A. Balasa, JD, MBA
          Chief Executive Officer, Legal Counsel
          American Association of Medical Assistants
          Ph: 800/228-2262 | Fax: 312/899-1259 | http://www.aama-ntl.org
          The CMA (AAMA): Health Care’s Most Versatile Professional®

  4. Hello,

    I work as a C.M.A. in C.T. and I send electronic orders for medication, I send referrals, do prior authorization for medications, and triage calls. It was just brought to my attention that a CMA can send prescriptions and possibly cant give advise. If we are under the physician’s guidance and if they want us to refill or send Rx based on results are we legally allowed to do this.

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