Pharmacy – Medication Samples

The MGH/MGPO Medication Samples, Vouchers, Discount Cards – Restricted Use Policy prohibits (with limited exceptions) the storage and distribution of the following in MGH/MGPO practices:

• Medication samples
• Drug discount, savings, and copay cards; drug coupons and vouchers

The MGH Department of Pharmacy Quality Compliance and Regulatory Affairs (QCRA) team conducts a quarterly medication management audit to evaluate practices’ adherence to this medication management policy.

Per the audit report, medication samples, vouchers, coupons and drug discount cards together held the second least compliant medication management standard/adherence to policy in 2018 (Q1–Q3).  During an external regulatory audit, such as the Joint Commission survey, this would result in a citation and requirement for an action plan and follow-up if found.

During the quarterly audits to assess adherence to policies, the QCRA team provides education on MGH standards regarding medication samples and drug discount/copay cards. It also provides resources such as policy documents. Pharmacy QCRA also monitors the “approved medication sample locations” to ensure their adherence to MGH/MGPO policy.

Practices should not allow pharmaceutical marketing personnel to drop off medication samples, drug discount/copay cards, etc., nor request them to be mailed/dropped off at the practice location.

Discount cards, copay cards, or vouchers for select medications and pre-authorization services are only to be provided by MGH outpatient pharmacies (Main Campus – Wang Lobby, Revere Health Center Pharmacy and MG West Waltham Outpatient Pharmacy). These discount carts, copay cards, and vouchers may never be distributed from practices themselves.

Exceptions for Perceived Medical Necessity

If there is a perceived medical necessity for having samples, a clinic practice director may use the Sample Medication Request form (linked file opens in Word) to submit a formal petition for an exception to the Pharmacy and Therapeutics Safety Committee (PTSC).

The request must include a detailed rationale for having the specific medication available as a sample. All such requests will be reviewed by the PTSC, which must issue consensus support for the petition prior to acceptance of the drug by the practice.

If approved, the practice must comply with the Medication Samples, Vouchers, Discount Cards – Restricted Use Policy. According to this policy, the following requirements must be met:

1. The physician who receives approval to dispense the sample medication is responsible for ensuring that samples are not being used for personal use or for use by family members, long-term maintenance therapy or in lieu of an assistance program. Patients who require financial assistance for medications should be referred to Patient Financial Services (ext. 42099).
2. All sample medications must be stored in secured lockable areas with limited access.
3. The physician may dispense only a limited supply of the medication for short-term use by the patient. There must be an order written in the medication list portion of the patient’s electronic medical record. For every medication dispensed, the following must be recorded:
   • Dose
   • Strength
   • Amount of the medication
   • Comment section – state “Sample Use”
4. Any product dispensed must be labeled with the drug name and strength, date dispensed, patient and practitioner names, lot number, quantity, expiration date, and directions for use.
5. The prescribing practitioner must educate and advise the patient about the drug, how to monitor its effects, and what to do should an adverse effect occur.
6. Patient-specific medication information, approved by PTSC Policy and Compliance Subcommittee, must be provided by the practice if the patient is given medication to take after they leave the practice.
7. Record keeping must be completed by using Sample Inventory Management Sheet (SIMS). Lot number of the medication must be recorded on the SIMS to ensure that prescribing practitioners can recall practice-dispensed medications whenever needed.

• Forms and templates compiled by the MGH Pharmacy and Therapeutics Safety Committee – includes a Sample Request Form
• Medication Samples, Vouchers, Discount Cards – Restricted Use Policy
• Contact for Department Pharmacy Quality Compliance and Regulatory Affairs:
  • Hari Koirala, CPhT, MS
    Quality Assurance & Compliance Specialist
    Department of Pharmacy
    Email: hkoirala@partners.org
    Phone: (617) 643-9130