Control Samples

May 1, 2004

We currently provide pharmaceutical samples to many of our needy patients. We always document the "sampling" in the chart. However, I've been hearing a lot of talk about physician offices being held to the strict guidelines of a dispensing pharmacy when dispensing drugs in this manner. How careful do we need to be?

Question: We currently provide pharmaceutical samples to many of our needy patients. We always document the "sampling" in the chart. However, I've been hearing a lot of talk about physician offices being held to the strict guidelines of a dispensing pharmacy when dispensing drugs in this manner. How careful do we need to be?

Answer: I know of several practices that have stopped giving samples because they accidentally gave out expired samples and their patients contacted an "authority" - the state board of medicine, in one case. Another practice stopped keeping samples in-house after an employee sued over a sample that she took from the sample closet to which she had an adverse reaction.

Of course, the more cases there are like these, the more pressure there is to be regimented in the dispensing. Still, most practices continue to just distribute samples freely.

Of course, the process is up to you, but we would recommend the following:

  • Don't dispense to employees, or, if you do, follow the same steps that you would for patients.
  • Contact your malpractice carrier and get its advice - in writing - about your policies and procedures.
  • Lock the sample closet.
  • Require that expired samples be disposed of monthly. Have proper disposal.
  • Document any samples you give out in the patient's chart.
  • Consider your process if a drug was recalled - how would you identify patients who had been given samples of this drug? Many practices identify patients by pulling an applicable ICD-9 code from the billing system and reviewing those patients' charts. (For example, if a migraine medication were recalled, the billing system would be run for all patients who had a diagnosis of "migraine." Then their charts would be pulled to see if they had been given that drug). An EMR makes this process simple.



My hope is that physicians can implement some limited procedures before adverse outcomes occur - and the system has to be dismantled.