Practice Tips

Many physician offices accept sample medications from pharmaceutical drug representatives and dispense them to their patients. Providing sample medications to patients in a safe manner requires significant administrative effort. When a practice dispenses sample medications to its patients, it must follow state and federal pharmacy regulations. The physician’s office should have detailed policies and procedures that address the following areas when accepting and distributing sample medications to assure they meet their responsibility to patients and regulatory systems. Processes that do not screen for drug interactions, duplicate therapy, allergies, or contraindications with the sample medication can pose patient safety risks.

Accepting Samples

A staff member should document all sample medications received from pharmaceutical drug representatives on a drug inventory log. A staff member should accompany drug representatives when they access sample medication areas.

Storage and Documentation

• The practice should have a process for the storage, handling, removal, and distribution of samples. A specific staff position should be assigned responsibility for monthly inspections of sample medications.
• Store sample medications in a locked area inaccessible to unauthorized persons. Any medications in patient exam rooms should be stored in a locked cabinet. The storage area should not be subject to extreme temperatures.
• Lighting in the storage room should allow for easy reading of medication names and dosages.
• Organize samples by drug or drug group with labels facing out.
• Place medications with similar names and similar packaging in separate areas.
• Rotate stock, so the oldest medications are dispensed first.
• Separate the medications by route of administration.
• Store medications according to the manufacturer’s instructions.
• Check medications monthly for outdates, deterioration, and appropriate location. Inspect all medication storage areas, including refrigerators.
• Medication refrigerators should only be used for medication storage and should not contain food or beverages.
  • Refrigerator temperatures must be monitored daily.
  • Refrigerators containing vaccines may require twice-daily temperature checks.
  • Practices should have mechanisms to alert staff if refrigerator or freezer temperatures are out of range when the office is closed.
  • Staff should have emergency instructions on appropriate actions to take if temperatures are out of range.
• The REFRIGERATOR/FREEZER TEMPERATURE LOG can be used to record medication refrigerator temperatures. Temperature logs should be maintained for five years.
• The DRUG INVENTORY AND DESTRUCTION LOG can be used to document receipt and destruction of sample medications. Inventory logs provide your office practice with a method to track the sample medications you dispense and identify those that have expired and require disposal. Discard expired sample medications following federal, state, and local laws. Contact your state or federal Department of Environmental Services for advice on medication disposal to prevent unauthorized use by staff or others of discarded medications.

Access

• Store sample medications in a secured location and limit access to specified personnel.
• Employees should not be allowed to access or request free samples. Obtaining medications without a prescription can lead to adverse events for which the practice could be held liable.

Dispensing

• Only pharmacists, physicians, and advance practice providers with prescribing authority may dispense medications. When an office practice dispenses sample medications, it must follow state and federal pharmacy regulations.
• Any requests for refills of sample medications require approval from a provider with prescribing authority.
• The provider should discuss the administration, storage, potential interactions, and side effects of the medication with the patient. Providers should document all discussions regarding allergies, side effects, dosage, special procedures for taking medications, and other related issues in the patient’s medical record.
• When retrieving sample medications, the authorized clinical 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
• Label all medications with the following:
  • Patient’s name
  • Medication name
  • Dosage
  • Frequency or time
  • Route
  • Form, i.e., liquid, tablet, drops
  • Date dispensed
  • Lot number
  • Prescribing provider’s initials
• A double-check of the patient’s name and second identifier, i.e., date of birth should occur when providing the patient with the medication.
• The patient should receive written information about the medication, including instructions on how to take the medication in a manner they can understand. Place a copy of the written instructions in the patient’s medical record. Be sure instructions include the physician’s name, the patient’s name, the date dispensed, the name and strength of the drug, address, and telephone number of the practice.
  • The PATIENT INSTRUCTIONS FORM provides the medication information patients may need after leaving the practice, as patients may not remember verbal instructions. The form provides a place for patient/guardian signature acknowledging receipt of the medication information. It provides an outline to assure all the necessary drug information, patient instructions, and patient education have been documented and provided to the patient. Retain a copy of the form in the patient’s medical record.
• The PATIENT DISTRIBUTION LOG can be used to track medication and lot number of sample medications dispensed to patients. Use of this log will simplify the process of identifying patients who have received a medication whose lot number has been recalled or has had other warnings or issues associated with it.
• Document sample medications provided to patients in the patient’s medical record. Include the medication’s name, date, dose, frequency, route, form, date dispensed, lot number, and written authorization by the provider.

Resources

U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control - National Take Back Initiative
http://www.deadiversion.usdoj.gov/drug_disposal/takeback/

Maine Department of Public Safety, Maine Drug Enforcement Agency
http://www.maine.gov/dps/mdea/index.htm

New Hampshire Department of Environmental Services - Medicine Disposal Information for New Hampshire
https://www.des.nh.gov/sites/g/files/ehbemt341/files/documents/2020-01/nh-drug-box-locations.pdf

Report to the Vermont Legislature, Statewide Drug Disposal Program in Vermont
https://www.healthvermont.gov/alcohol-drugs/services/prescription-drug-disposal