Regulating Sample Medications

September 1, 2006

We are currently trying to streamline our process for receiving and dispensing sample medications. The clinical staff logs them on a form that tells the date received, amount received, lot number, expiration date, receiving physician, the date given out, the patient’s name, amount dispensed, dispensing physician, and amount remaining. We then audit them monthly. It is also documented on the patients’ charts when they receive samples (date, dose, amount, directions, and expiration date). We are not JCAHO-accredited, but we are associated with a hospital that is. What are the correct guidelines for sample drugs?

Question: We are currently trying to streamline our process for receiving and dispensing sample medications. The clinical staff logs them on a form that tells the date received, amount received, lot number, expiration date, receiving physician, the date given out, the patient's name, amount dispensed, dispensing physician, and amount remaining. We then audit them monthly. It is also documented on the patients' charts when they receive samples (date, dose, amount, directions, and expiration date). We are not JCAHO-accredited, but we are associated with a hospital that is. What are the correct guidelines for sample drugs?

Answer: The JCAHO has some recommendations on this subject. Go to www.jointcommission.org, search the term "sample medications," and click on the first item that pops up.

Your system sounds comprehensive, but here are some key points regarding storage that you did not mention:

  • Store samples under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and safety according to manufacturers' specifications and relevant laws and regulations (e.g., USP and OSHA requirements).



  • JCAHO recommends storing samples by therapeutic class rather than alphabetically, since this reduces the danger of a serious dispensing error. In any case, throwing all samples of various types into a drawer is not acceptable.



  • Make sure samples of prescription or legend drugs are secure. You don't want staff pilfering them after making self-diagnoses.

    Also, ask your state medical board for information on any state regulations.