Sample Medication Management

It is common practice for physicians and providers to dispense free sample medications to patients. The benefits of dispensing sample medications are numerous:  it allows patients to try new medications on a trial basis; saves patients money on expensive medications; reduces non-adherence to medication regimens; expedites getting prescription medications into the hands of patients; and can strengthen the physician-patient relationship. But, as with most everything you do, there are risks.

As with any new medication, adverse reactions and/or side-effects are a possibility, but with sample medications there is no pharmacist safety net. Similarly, there is often no package insert or handout that provides patient education, instructions, or safety warnings. Therefore, it is solely incumbent upon the physician/provider to educate, instruct, and warn the patient about these things. The duty of care owed to patients is no less when dispensing sample medications than it is when writing prescriptions.

Moreover, sample medications require the same level of security and accountability as their prescription counterparts. Lack of proper storage, security safeguards, inventory documentation, and sample medication policies can lead to additional risks. Allowing access to the sample medication storage closet by staff can result in misuse and diversion of drugs to family and friends without up-to-date documentation and routine audits.

Finally, a lack of documentation relative to dispensed samples, including manufacturer, lot number, expiration date, and quantity can be problematic in the event of a drug recall.

To minimize these risks, do the following:

1. Familiarize yourself with all state and Federal laws and regulations relating to sample medications.
2. Have a written policy for handling and dispensing sample medications including storing, securing, logging, tracking, documenting, and dispensing.
3. Store sample medications per the manufacturers’ recommendations and monitor expiration dates.
4. Create a log documenting the name, manufacturer, quantity received, receipt date, lot number, expiration date, quantity dispensed, date dispensed, and name of the recipient.
5. Dispense sample medications only through licensed physicians/providers who have prescriptive authority.
6. Document in the patient’s medical record the intended purpose for the medication.
7. Provide patients with appropriate education, instructions, and safety warnings (including informed consent where applicable) specific to each medication dispensed and thoroughly document these discussions.
8. Document with specificity in the patient’s medical record each sample medication dispensed including the name, quantity, manufacturer, lot number, and any follow-up instructions.
9. Have a plan for notifying patients of manufacturer recalls.
10. Dispense sample medications to family, friends, and colleagues only when a medical record has been established for the patient and subject to any applicable ethical rules and regulations.
11. Label samples in accordance with state and federal guidelines.
12. Pharmaceutical representatives should not be allowed access to the storage area without staff being present.

If you have any questions, please contact SVMIC at 800.342.2239 or by email at ContactSVMIC@svmic.com.