Sample Medications

Physicians’ attitudes toward the use of free sample medications vary considerably. Many believe that offering free samples to patients is a great service, especially for indigent patients. Another benefit is the easy availability of medication to immediately begin a course of therapy. But when a medical practice’s management of samples (or any other medications) becomes too informal, the laxity can put the patient, the physician, and the office staff at risk.

Drug samples often flow from drug rep to office staff to physician without documentation or accountability. The liability risk issues include, but are not limited to, the following:

  • Incomplete patient monitoring
  • Lack of appropriate tracking (and the problem of theft this can facilitate)
  • Improper labeling
  • Inattention to expiration dates

The Joint Commission requires that medical institutions have a policy and procedure related to the control of drug samples and that such samples be handled with the same level of accountability and security as other prescription medications. In addition, physicians who dispense medications must follow applicable state pharmaceutical laws and regulations.

Physicians have the same duty of care to patients receiving samples as they do to patients being given prescriptions. Consider the following guidelines when handling drug samples:

  • Store, secure, and track samples to prevent needless access and loss.
  • Document the dispensing of samples in the patient’s medical record.
  • Obtain and document informed consent from the patient, if appropriate for that medication.
  • Label samples with prescribing information.
  • Review samples regularly for expiration dates.
  • Maintain records so patients can be contacted in the event the medication is recalled.

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

J7492 6/10

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