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Evidence builds: lack of focus on human factors allows error-prone devices

From the July 14, 1999 issue

Sample medications: Safe management is a difficult but necessary process

PROBLEM: Samples medications are often available in hospital outpatient units, clinics, and physician offices. Most often, they are dispensed without computer screening for drug interactions, duplicate therapy, allergies, contraindications, etc., and without another practitioner’s check. For example, in one incident recently reported to USP-ISMP, a patient was given REZULIN (troglitazone) samples without a warning that the drug could decrease effectiveness of her prescribed oral contraceptive. Company representatives routinely distribute both formulary and non-formulary drugs with which staff may be unfamiliar. Too often, pharmacy oversight is lacking. Education and drug recalls may be overlooked, and unsecured storage may allow easy access to over-the-counter (OTC) and prescription drugs. A survey published in JAMA (Westfall JM et al. Personal use of drug samples by physicians and office staff. 1997; 278:141-3) showed that office staff frequently take samples for personal use.

SAFE PRACTICE RECOMMENDATION: Safe management of drug samples in clinical settings is a difficult process, especially in large teaching hospitals. Even when drug samples are prohibited, it’s likely they will find their way into facilities. Unlike the formulary and drug distribution processes in hospitals, pharmacists often have little control over sample drug distribution and use. It seems that the entire process is influenced by the pharmaceutical industry and reimbursement concerns. Yet, several hospitals have achieved some measure of safety with sample use. To that end, we have listed strategies used in other facilities for consideration. 1) Have pharmacy maintain oversight authority of pharmaceutical representatives’ visits by scheduling all appointments hospital-wide. Instruct representatives about the rules governing sample drugs and require them to sign an agreement to abide by them. If another department, such as materials management, schedules appointments, have them routinely send pharmacy a list of areas where representatives have visited. 2) Only accept samples of medications that are currently on the drug formulary. 3) Have the pharmacy store sample drugs and provide physicians with internal vouchers to prescribe from sample supplies, at no cost to the patient. 4) Store samples that must remain in patient care areas in locked cabinets away from traffic. 5) As samples are received, have staff enter each into a logbook, listing the drug name and expiration date. Log in the patient’s name and medical record number when samples are dispensed. 6) Have physicians write an order in the medical record when samples are administered or sent home with the patient. Send a copy of the order to the pharmacy for order screening. Document all sample drugs administered in the patient’s medical record. 7) Have pharmacy staff periodically visit units to assure secure storage, inspect samples for dating, implement safety measures, and educate practitioners about the danger involved in using samples without pharmacy oversight and clinical order screening. 8) For those with office practices, consult with a local pharmacist to establish safety measures such as a logbook, monitoring drug storage and expiration dates, and providing staff with pertinent drug information. Also, educate patients when samples are dispensed.

While all approaches above may not seem feasible, consider targeting a single unit where samples are heavily used to test one or more of these strategies. After fine-tuning, spread the strategies to other high-use areas. In the end, this difficult issue will only be solved when the pharmaceutical industry is forced to recognize the risk that samples present to patients, and then make safety their first priority. Meanwhile, we continue to urge companies to provide prescribers with vouchers for sample starter supplies.


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