Special Considerations for Using Drug Samples

Special Considerations for Using Drug Samples

In today’s climate of rising health insurance costs and more financial responsibility being placed on patients, many welcome free drug samples.  The patients avoid the co-pay, and frequently, get to sample a new drug that has improved features.  For these reasons, it builds rapport between doctor and patient.


The use of sample pharmaceuticals can also be beneficial to physicians. It provides an opportunity to determine effectiveness at no cost to the patient. And – that determination can be valuable feedback for the manufacturer as well.


But, even with all the benefits, providing drug samples in an “informal” manner can present problems for both doctor and patient.


It has long been settled that physicians should document all aspects of the care being rendered.  Prescriptions are part of that written record.  In the typical situation where drugs are prescribed, the physician identifies the drug and sets forth the rules for usage in a written document.  There may be multiple copies of that document maintained by the physician, patient and pharmacist.  Therefore, in the event there is every any question relative to what was to be taken and when, a written record exists to answer those issues.


In the context of drug samples, however, many physicians fail to recognize the potential problems associated with a more relaxed dispensation of those samples.  Often, the physician will grab the samples, hand them to the patient with oral instructions, and rely on documenting the chart as to what was said.  However, nothing exists that conclusively proves the patient was made aware and understood the purpose of the drug and its usage requirements.  This issue is exacerbated by the fact that many drug samples given to physicians do not contain instructions for use.


In that situation, the physician can have great difficulty defending a claim where the patient overdoses or otherwise misuses the narcotic.  Any such claim would invariably turn into a “he said/she said” situation, leaving a court to determine who was truthful.  In the event of a patient’s death as a result of using the drug, the dilemma is magnified, and the physician’s credibility will be viewed with greater scrutiny.


To properly manage the risks, the physician should be just as vigilant in documenting sample drug prescriptions, and disregard the fact that they are samples.  This means that dispensing the free samples should be accompanied by a written set of instructions to the patient, and ideally, a copy of those instructions that has been signed and dated by the patient should be placed in the patient’s file.  The patient’s chart should also be documented with the same instructions, and as to any informed consent issues that occurred relative to the subject drug.