by Debra Kane Hill, MBA, RN, Senior Patient Safety Risk Manager, The Doctors Company, Part of TDC Group

Provided by OSMA’s exclusively endorsed medical liability insurance partner, The Doctors Company (TDC).

Dispensing free sample medications to patients, a common practice in medical and dental offices, can provide many benefits for both patients and practitioners. Dispensing sample medications can, however, create risks and patient safety issues—especially for offices that take a casual approach toward the sample medication supply.

Benefits

With safeguards in place, sample medications can contribute to improved patient outcomes 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

Failure to control access to the sample drug supply can result in unauthorized individuals using sample medications without supervision. Because samples are usually brand-name medications that are newer to the market, they may have unforeseen side effects or be more costly for the patient in the long-term once the sample supply is depleted.

Practices lacking a formal system for managing sample medications might inadvertently provide medications to patients without proper instructions or labeling or distribute medications to individuals without thorough assessment. Allergies and contraindications might also be overlooked, and necessary patient record documentation may be omitted. In an office setting, the safety checks normally performed by pharmacists are often removed from the dispensing process—including required labeling, instructions, and evaluation for contraindications with other medications or medical conditions. The lack of a formal system 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 office access can divert samples to themselves, friends, and family without the practitioner’s knowledge and proper management. Consider the following scenarios involving sample medication misuse:

• Office staff 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 family member for a chronic cough for several months with various antibiotics from the sample medication closet. The family member received no medical evaluation, and the practice physician was entirely unaware of this activity. The family member was later diagnosed with lung carcinoma, 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 practitioner.
• A medical assistant accidentally retrieved the wrong medication from the sample medication closet and handed it directly to the patient.
• A patient’s allergies were not checked when the sample medication was dispensed. The patient took the medication, went into anaphylactic shock, and was admitted to the hospital on life support.

Risky Situations

We have observed the following unsafe situations in offices that have no formal sample medication policies in place:

• Failure to follow 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 exam rooms 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 according to state and federal guidelines, resulting in patient medication errors (including potential confusion by family members, who might take the unlabeled medication in error).
• Inattention to expiration dates.
• Incomplete patient instructions or failure to provide written instructions in a language the patient can understand. Verbal instructions are easily confused or forgotten.
• Incomplete patient assessment and monitoring.
• Incomplete documentation in the patient’s health record, including failure to list a 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

• Implement detailed policies and procedures that address sample medication inventory, storage, access, tracking, documentation, and patient care management.
• Provide and document training for your staff.

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 supply.
• Organize medications by drug type when setting up sample medication storage. Never place 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 list of confused drug names and strategies for reducing dispensing errors.)
• 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 practitioner orders, practitioner supervision, and patient record documentation. Give sample medications only when prescribed by a licensed practitioner with prescriptive authority.
• Label samples with prescribing information and instructions 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 the education 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 of a medication recall. 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 tracking and dispensing sample medications can be a significant undertaking, but it provides many benefits for the practice and the patient.

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The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Reprinted with permission. ©2024 The Doctors Company (thedoctors.com).