How to ensure the safe use of medication samples in ambulatory settings

Medication samples are often used in ambulatory settings (e.g., clinics, emergency departments). In rare circumstances, a sample medication may be used in an inpatient setting. For example, the physician may want the patient to continue use of a medication not available from the hospital pharmacy and authorizes the use of the patient’s supply.

The Joint Commission recently added a note to selected Elements of Performance (EPs) in the Medication Management (MM) standards to identify those that are applicable to sample medications in ambulatory settings, if the organization permits their use. However, in the rare circumstance of samples being used in the inpatient setting, all of the MM standards would apply, like any other medications used by inpatients.

Although The Joint Commission incorporated this change, the guidance is appropriate for compliance with the standards of other accreditation organizations (e.g., DNV, HFAP) as well as the CMS Conditions of Participation. Healthcare organizations should develop and implement policies and procedures to ensure the safe handling and use of samples including compliance with federal and state laws and regulations. Prescribers, staff, and pharmaceutical representatives should be oriented to the policies and monitored for compliance.

The following practices help ensure compliance with accreditation standards and the safe use of medication samples in the ambulatory setting.

Procurement and Storage

The pharmacy must be aware of all areas in the organization that use medication samples.

Medication area inspections must include checking samples to ensure proper storage, control, and compliance with health-system policies, laws and regulations, and accreditation standards.

  • Ensure the storage area is clean and organized. Environmental conditions (e.g., temperature, humidity) must be appropriate for the medications stored.
  • Organize and store samples separately (e.g., labeled bins) to minimize retrieval errors. Do not store multiple strengths of a medication in the same bin.
  • Safeguards to prevent errors with look-alike/sound-alike, high-alert, and hazardous medications identified by the organization (e.g., separation, Tall Man lettering, warning labels) must be implemented.
  • Ensure that non-drug items (e.g., chemicals, reagents, food, patient specimens) are not stored with medications to prevent contamination and/or confusion. Containers of chemicals and reagents can be confused with some medication containers (e.g., dropper bottles, ampules).
  • Ensure that expired, damaged, or unwanted samples are promptly removed and disposed of per organization policy and applicable laws and regulations. Sample medications in clinics and physician offices should not be sent to the pharmacy for disposal. These areas should contract with a reverse distributor for disposal since the individual prescribers are responsible for these medications.
  • Sample medications must be stored in a secure (e.g., locked) area that is only accessible to authorized personnel. Methods for securing samples include locked cabinets/drawers and automated distribution cabinets.
  • Pharmaceutical representatives should not be allowed unmonitored access to sample storage areas. Not only is this a security issue, but representatives often rearrange sample storage areas for their own benefit, disrupting the organization of the area which could result in retrieval errors.

Preparing and Dispensing

  • Sample medications must be dispensed in compliance with laws and regulations. State laws define who may dispense medications. Only persons licensed to dispense medications per laws and regulations may give samples to patients in outpatient settings such as clinics.
  • Prior to dispensing samples, the patient record must be reviewed for allergies, contraindications, and other medications the patient is taking for interactions and duplicate therapy.
  • Sample medications dispensed or administered must be documented in the patient's medical record.
  • Organizations that handle controlled substances samples must have the appropriate DEA registration and any required state licenses. Hospitals with off-site locations (e.g., clinics) must have a separate registration for each location.
  • Documentation must be maintained as required by laws and regulations (e.g., inventory records). Consider prohibiting provision of controlled substances samples.
  • Samples medications dispensed to patients to take at home must be packaged in child-resistant containers. Many samples are packaged in bottles with child-resistant caps or in unit-dose packages that meet child resistant requirements. Samples must not be removed from their original containers and repackaged.
  • Sample medications must be labeled in compliance with laws and regulations and accreditation standards. Samples should be labeled, at a minimum, with:
    • Drug name, strength, and amount
    • Expiration date
    • Directions for use
    • Any cautionary statements (e.g., “take with food”)
  • State laws and regulations may require additional information (e.g., patient’s name, prescriber’s name).
  • Maintain accountability controls that track the receipt and distribution of sample medications. A perpetual inventory is preferred. Methods for controlling samples include logs (manual or electronic) and automated dispensing cabinets.

Administering and Monitoring

  • Patient education must be provided and documented for each sample medication.
  • Adverse reactions and medication errors involving sample medications must be responded to and reported per the organization’s policies on adverse drug reactions and medication errors.
    • There must be a process to identify and retrieve recalled sample medications. An effective method to facilitate this process is to maintain a log (paper or electronic) that includes the patient’s name, date dispensed, drug name, dose, lot number, amount dispensed, and prescriber’s name for each sample medication dispensed.
    • A complete and current list of the patient’s medications must be maintained, including sample medications. The list must be reviewed for each admission or episode of care and updated as necessary.

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