Dispensing free sample medications to patients is a common practice in medical offices. With safeguards in place, it is a practice that can contribute to improved clinical results and generate goodwill between the physician and the patient.
Free sample medications are convenient for patients—particularly those who lack financial or transportation resources—and they can improve compliance with medication regimens. Free sample medications also allow patients to try new prescriptions on a trial basis to determine if they are effective and without unwanted side effects.
If not carefully managed, however, sample medications can create issues that place patients and the practice at risk. Sample medications, which are newer to the market, can have unforeseen side effects. Because they are brand-name medications, they are generally more costly for the patient on a long-term basis once the sample supply is depleted.
If a practice lacks a formal system for managing sample medications, it might inadvertently provide medications to patients without proper instructions or labeling, or it might distribute medications to nonpatients without a thorough medical evaluation. These actions can result in patient harm and compromised regulatory compliance, creating considerable liability for the physician.
Sample Misuse Scenarios
Taking a casual approach to pharmaceutical representatives can create liability issues for the practice. In addition, when access to the sample drug closet is open to all without careful accounting, staff can freely access samples to divert to friends and family without the physician’s knowledge and proper medical management. Consider the following scenarios involving sample medication misuse:
- Drug representatives gave sample medications to office staff or the physician without documentation or practice accountability.
- Some offices allowed drug representatives to have full access to the sample closet without supervision, giving them free access to samples from other companies.
- Office staff sold or bartered sample medications with other practices. In one case, an ob/gyn practice traded birth control pills for cosmetic samples with a dermatology office in the same building.
- A medical assistant “treated” her own uncle for a chronic cough for several months with various antibiotics from the sample medication closet. The uncle received no medical evaluation by the physician, and the practice physician was entirely unaware of this activity. The uncle was later diagnosed with small-cell carcinoma of the lung, and the family reported the physician to the medical board for negligence and lack of supervision.
Failure to implement simple safeguards can create significant liability. We’ve seen the following risky practices in offices that have no formal sample medication policies in place:
- Failure to recognize applicable state and federal regulations governing sample medications.
- Lack of record keeping (e.g., no logs) for medications received and dispensed.
- Inability to track drug recalls (e.g., not documenting lot numbers).
- Improper storage system (e.g., inattention to manufacturers’ storage recommendations or storing samples alphabetically—which can result in medication errors).
- Improper storage location (e.g., storing samples in clinical care areas that are accessible to patients).
- Failure to secure sample medications under lock and key—which can result in theft and misuse by patients and staff.
- Failure to label sample medications in accordance with state and federal guidelines. This can result in medication errors in the home or the wrong person taking the drug by accident.
- Inattention to expiration dates.
- Incomplete patient instructions or failure to provide written instructions in a language the patient can understand.
- Incomplete patient monitoring.
- Incomplete documentation in the patient’s medical record.
Patient Safety Strategies
Sample medications must be handled with the same level of accountability and security as other prescription medications—as required by the standard of care, federal and state pharmaceutical laws and regulations, and accrediting organizations. Physicians have the same duty of care to patients receiving sample medications as they have to patients receiving prescriptions.
Consider the following patient safety guidelines when handling drug samples:
- Develop detailed policies and procedures that address sample medication inventory, storage, tracking, documentation, and patient care management.
- Store, secure, and track samples to prevent inappropriate access and loss.
- Never allow staff to provide samples to anyone without provider orders and medical supervision. Sample medications should only be given when prescribed by a licensed provider with prescriptive authority.
- Group medications by drug type when setting up a sample medication closet. Never store sample medications in alphabetical order or next to drugs that have look-alike and sound-alike (LASA) names. (See the Institute for Safe Medication Practices for a current LASA list.)
- Assign staff to monitor and document safe storage per manufacturers’ recommendations and to check medications for expiration. Dispose of expired medications properly. Maintain logs in administrative files.
- Document the patient’s medical record with any dispensed samples. Include the name of the drug, strength, lot number, manufacturer, instructions provided, and discussion of potential side effects.
- Provide patient education regarding the medication. Obtain and document informed consent from the patient, when appropriate.
- Label samples with prescribing information as required by law.
- Maintain administrative records to log a sample medication’s receipt into the practice and to track its inventory and access. This allows the practice to identify patients in the event a medication is recalled. Creating a separate log for each medication simplifies the tracking process. Include the drug name, manufacturer, lot number, expiration date, date and quantity received, patient name/identifier, ordering physician, date and quantity dispensed, and by whom.
- Establish a system for identifying and managing drug recalls.
- Assign administrative staff to review logs routinely for any inconsistencies.
For assistance with implementing sample medication safeguards in your practice, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.