Medication Samples and Safety Concerns for Physician Practices

The use of medication samples in clinical practice needs to be re-evaluated to keep patients safe.

In a 2012 study, researchers found that up to 14% of medication samples in prescribers’ offices were expired.¹ Of the estimated $16 billion in medication samples given out per year, the authors estimate approximately $2.2 billion in medication samples is wasted each year. Additionally, these outdated medications could prove detrimental if they are provided to patients or if used personally by the physician or office staff.

The lack of organization, inventory control, and storage space for samples in office closets may be major contributing factors to such a high percentage of expired medications. In addition, some drug companies may send medication samples to clinicians who never actually distribute them in their practice; these medications sit in the physician’s closet until they are discarded.

Inadequate systems also may exist for distributing sample medications to patients. For example, samples are frequently dispensed without computer screening for drug interactions, duplicate therapy, allergies, or contraindications, and without an independent check by a second individual. Patient education may be limited or narrow in scope,² and drug recalls may be overlooked. Medication samples also may have problematic or confusing labeling and lack specific patient labeling (eg, patient name, directions for use, warning labels).

The use of medication samples in clinical practice should be reevaluated in order to keep patients safe. In fact, a safer alternative to dispensing medication samples from physician practices is the use of medication vouchers; manufacturers should consider distributing vouchers that prescribers can give to patients to redeem at community pharmacies for a free trial of a medication. If distribution of medication samples continues, practitioners should follow a standardized approach to reduce the risk of medication errors. Below are some risk-reduction strategies physician practices and pharmacies should consider:

• Avoid giving medication samples for long-term use unless they are part of a program that includes pharmacy review and dispensing.³
• Store medication samples in accordance with manufacturers’ labeling and in locked cabinets away from patient and staff traffic.
• As samples are received, have staff enter each into a logbook, listing the drug name and expiration date.
• Establish policies that indicate who is responsible to monitor storage, inspect for outdated product, maintain the log, and ensure that safety measures are followed.
• Check the expiration date and visually examine the medication sample package before giving it to the patient.³
• When patients are given samples, the following information should be communicated on an attached label: Patient name Reason for the medication Amount that should be taken Frequency of administration Special precautions for use Any significant side effects
• If a sample medication needs to be reconstituted, the amount of water to be added by the patient should be indicated on the label.
• Medication samples should be treated like new prescriptions with respect to screening for drug interactions, duplicate therapy, allergies, and contraindications.
• When counseling patients, ask to view any medication sample that has been provided and ensure that the patient understands how to use the medication properly.
• Enlist the help of your patients by telling them to notify you whenever medication samples have been provided so that you can perform these important checks.

Dr. Gaunt is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/ Ambulatory Care Edition.

References:

• Evans K, Brown S. Many sample closet medications are expired. J Am Board Fam Med. 2012;25(3):394-395. www.jabfm.org/content/25/3/394.full. Accessed July 2013.
• Aseeri MA, Miller DR. Patient education and counseling for drug samples dispensed at physicians’ offices. J Am Pharm Assoc. 2006;46(5):621-623.
• National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). Recommendations for avoiding medication errors with drug samples. www.nccmerp.org/council/council2008-01.html. Published 2008.Accessed July 2013.