Dispensing Sample Medications: Risk Management Strategies

Debra Kane Hill, MBA, RN, Senior Patient Safety Risk Manager, The Doctors Company

Dispensing free sample medications to patients is commonplace in medical and dental offices. With safeguards in place, it can contribute to improved clinical results and generate goodwill between the practitioner and the patient.

Free sample medications are convenient for patients—particularly those who lack financial or transportation resources—and can improve timeliness and compliance with medication regimens. Sample medications also allow patients to try new and sometimes costly prescriptions on a trial basis to determine if they are effective and without unwanted side effects.

Potential Issues

Sample medications, if not carefully managed, can create issues that place patients and the practice at risk. Failure to control access to the sample drug closet can result in unauthorized individuals using sample medications without supervision. Additionally, sample medications, which are usually newer to the market, can have unforeseen side effects. Because they are brand-name medications, they are sometimes 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 individuals without thorough medical or dental evaluation. Allergies and contraindications might also be overlooked. In an office setting, the safety checks normally performed by pharmacists are often removed from the process of dispensing. Inadequate policies can result in patient harm and compromised regulatory compliance, creating considerable liability for the practitioner.

Sample Medication Misuse

Without safeguards, staff, patients, and others with building access can divert samples to themselves, friends, and family without the provider’s knowledge and proper management. Consider the following scenarios involving sample medication misuse.

• Offices allowed drug representatives to have full access to the sample closet without supervision, giving them free access to samples from other companies.
• Drug representatives gave sample medications to office staff or the practitioner without documentation or practice accountability.
• Office staff sold or bartered sample medications with other practices. In one case, ob/gyn practice staff traded birth control pills for cosmetic samples with dermatology practice staff 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 a 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.
• A person who was homeless was found helping himself to the sample drug closet located near the practice’s unlocked back door.
• A patient was found filling her purse with sample medications while waiting in the exam room to see the provider.

To comply with state and federal pharmaceutical regulations, providers must maintain an accounting of sample medications, both when they are received and when they are dispensed.

Avoiding Risky Situations

Failure to implement safeguards creates significant liability. We have observed the following unsafe situations 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 or in areas that are not routinely monitored).
• 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 when dispensed according to state and federal guidelines, resulting in patient medication errors.
• Inattention to expiration dates.
• Incomplete patient instructions or failure to provide written instructions in a language the patient can understand.
• Incomplete patient assessment and monitoring.
• Incomplete documentation in the patient’s health record, including failure to list sample medication on the patient’s medication list.

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. Practitioners have the same duty of care to patients receiving sample medications as they have to patients receiving prescriptions.

Consider implementing the following safety guidelines for drug samples in your practice:

Practice Policies and Procedures

• Develop detailed policies and procedures that address sample medication inventory, storage, access, tracking, documentation, and patient care management.

Drug Storage and Access

• Store, secure, and track samples to prevent inappropriate access and loss.
• Allow only designated clinicians and staff to access the drug closet.
• 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.
• Follow state and federal guidelines for disposing of expired medications. Maintain logs in administrative files.

Drug Dispensing

• Never allow staff to provide samples to anyone without provider orders, provider supervision, and patient record documentation. Give sample medications only when prescribed by a licensed provider with prescriptive authority.
• Label samples with prescribing information as required by law.

Patient Record Documentation

• Document any dispensed samples in the patient record. Include the name of the drug, strength, lot number, manufacturer, instructions provided, and discussion of potential side effects.
• Provide written patient education regarding the medication, and document in the patient’s record.
• Obtain and document informed consent from the patient when appropriate, e.g., for the type of medication, possible side effects, or the patient’s first use of the medication.

Administrative Logs

• Maintain administrative records to log a sample medication’s receipt into the practice and to track its inventory and access. Creating a separate log for each medication simplifies the tracking process. Include the drug name, dosage, manufacturer, lot number, expiration date, date and quantity received by the practice, and by whom.
• Maintain administrative records to log a sample medication that is dispensed (separate from the patient record). 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 date dispensed, patient name, drug name, dosage, lot number, expiration date, quantity dispensed, and by whom.
• Establish a system for identifying and managing drug recalls. (For more information, see the FDA drug recall guidance.)
• Assign administrative staff to review logs routinely for any inconsistencies.

Creating a system for dispensing sample medications can be a significant undertaking, but it provides many benefits for the practice and the patient. 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.