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Distribution of Sample Medications in the Practice Setting
Rose B. Moore, CPC, CCP

Many physician offices accept sample medications from pharmaceutical drug representatives and dispense them to their patient population. The distribution of sample medication allows patients a "trial run" on a new medication without financial expense. Although the samples are free-of-charge, this does not lessen the physician's continuing responsibility to the patient. The physician's office should have a detailed policy and procedure that addresses the following areas in accepting and distributing sample medications.

Storage
1. All sample medications should be stored in a locked room in a location inaccessible to patients. Medications should not be stored in exam rooms where patients are left unattended.
2. The storage area should not be subject to extreme temperatures. All refrigerators containing medications should have daily temperature checks. Logs of these checks should be kept.
3. Lighting in the storage room should allow easy reading of medication names and dosages.
4. Samples should be well-organized by drug or drug group. Medications with similar names should be located in separate areas.
5. All medications in the practice should be checked monthly for outdates, deterioration and appropriate location. Include all areas in which medications are stored including refrigerators.
   A specific person should be assigned responsibility for the monthly inspection.
   A log should be kept indicating that the medications have been inspected.
   Expired sample medications should be discarded in accordance with federal, state and local laws. Contact your state or the federal Department of Environmental Services for advice on medication disposal.
6. It is recommended that an inventory of sample medications be maintained. A form should reflect the names of patients who received medications, including the lot number. It may be helpful to use an inventory sheet for each type of sample medication.

These sample logs are intended to provide your office practice with a methodology to track the sample medications that you dispense as well as aid you in identifying those that have expired and require disposal. The Inventory Inspection Log [PDF] allows you to check all expiration dates at a glance to streamline your review and discard process. The Patient Distribution Log [PDF] is a means to keep track of the lot numbers of the medications given to each patient. Use of this log will simplify the process of identifying your patients that have received a medication whose lot number has been recalled or has had other warnings or issues associated with it.

Access
1. Access to sample medications should be limited to specified medical personnel only.
2. Employees should not be allowed to access or request free samples. Self-medication can lead to adverse events of which the practice could be held liable.

Dispensing
1. Only pharmacists, physicians and mid-level providers with prescribing authority may actually dispense medications.
2. At times patients request refills of their sample medications. Sample medications can only be dispensed after a physician or mid-level provider with prescribing authority (physician assistant or nurse practitioner) has authorized the refill. This information should be noted in the patient's record.
3. When retrieving sample medications, the authorized medical professional should:
   review the provider's order/authorization
   double check the name of the medication on the package
   confirm the expiration date of the medication
   verify the patient's allergies to medications
4. All medications should be labeled with the following:
   Patient's Name
   Medication Name
   Dosage
   Frequency or Time
   Route
   Form, i.e., liquid, tablet, drops
   Date Dispensed
   Lot Number
5. The provider should discuss with the patient the administration, storage, and side effects of the medication. This discussion, as well as the patient's understanding, should be documented in the patient's record.
6. A double check of the patient's name and second identifier, i.e., date of birth, should occur when providing the patient with the medications.
7. Documentation of the provision of sample medications should be placed in the patient's medical record to include the name of the medication, date, dose, frequency, route, form, date dispensed, lot number and written authorization by the provider.

All physician practices that distribute sample medications should ensure mechanisms are in place for secure storage, patient distribution and education, appropriate record-keeping and regular monitoring. A detailed policy and procedure should support this process.