Patients may consider sample medications a bonus at any outpatient setting for reasons of convenience or cost savings.

However, sample medications create liability for physicians and healthcare organizations while unsuspecting patients face increased safety risks. Dispensing sample medications requires consistent use of a medication management system with policies and staff education to mitigate potential risk. Standards and best practices should be considered when determining whether to accept the liability that exists when storing and dispensing sample medications. For instance, The Joint Commission (JCAHO) standards  apply to sample medications dispensed in ambulatory care centers. State laws also apply and physician extenders may or may not have prescribing authority.

With so much at stake for healthcare organizations and patients, it’s an important decision when determining whether to maintain and distribute sample medications in a healthcare organization.

Important risks to consider regarding sample medications include the following:

• Allergic and adverse reactions without a proper method to track
• Violation of state laws or JCAHO regulations
• Issues with the Board of Medicine or even a lawsuit related to expiration dates or recalls
• Inappropriate distribution due to unauthorized access
• Confusion and safety issues due to lack of documentation

If your organization determines that the benefits outweigh the risks for sample medication distribution, there are several steps you may take to reduce your exposure to liability and increase patient safety.

Here are some helpful tips for maintaining and distributing sample medications:

• Obtain written advice from your malpractice insurer
• Create written guidelines for appropriate sample medication distribution
• Track inventory to prevent unauthorized removal
• Ensure storage that is consistent with guidance for temperature
• Dispose of expired medications on a regular basis
• Lock the sample closet or at least choose a spot with high visibility
• Create a protocol for contacting patients who have received recalled medication
• Document in the patient’s record including medication type, dosage, lot number, and expiration date
• Keep in mind that state laws apply regarding scope of practice (only those with prescribing authority may actually dispense medication)
• An appropriate provider must review the patient’s chart to ensure there are no contraindications

Healthcare compliance programs require management and protocols. Documentation is a recommended method to mitigate many compliance risks and the risks associated with sample medications is no exception. JCAHO recommends maintaining a log for sample medication distribution to include lot number, date of dispensing, and who received the medication. First Healthcare Compliance offers a downloadable sample log.