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How to stay out of trouble with your drug samples

Ambulatory Safety Monitor, August 4, 2005

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Pharmaceutical sales representatives come into healthcare settings with all sorts of sample drugs, but those single-sized packets of Zoloft, Lipitor, and even aspirin can get you into trouble with the Joint Commission on Accreditation of Healthcare Organizations's (JCAHO) standard MM.2.20 if they're not dealt with properly. Timothy O'Kelley, risk manager at Deaconess Hospital in Oklahoma City, says that while he was at a former employer, emergency room physicians failed to audit their inventory of samples, and the recalled drug Fen-phen was accidentally given to a patient in the ER department. Fortunately, the patient had no serious side effects. Incidents like this could happen in any healthcare setting.

In The Compliance Guide to the JCAHO's Medication Management Standards, published by HCPro, Inc., author Michael R. Hoying, RPh, MS, director of pharmacy at Fairview Hospital in Cleveland, suggests that your sample drug policy address the documentation, storage, usage, and auditing of sample inventory (click the boxes below to see where you could improve your policy):

Documentation
A physician signs for all samples
Pharmaceutical sales representative documents the lot number and expiration date
A staff member or pharmaceutical sales representative logs samples, noting drug, strength, quantity per pack, and total number of packs

Storage
Staff store drugs in a locked cabinet
Approved staff supervise sample drugs at all times
Sample drugs are not stored within any pharmacy in the organization

Usage
Restricted from inpatients
Restricted to the emergency department and outpatient areas
Use of free samples for indigent patients
Used as trial medications for new therapies
Used to educate physicians in training

Audit inventory
Samples evaluated for expiration monthly
Samples expiring within two months are removed and disposed
Recalled samples are immediately removed and disposed of

Some facilities dangerously store these pesky packets in unlocked "help yourself drawers" for employee use. Remember, if a JCAHO surveyor stumbles upon a stash of samples, it could result in a performance improvement request. As always, your policy is only as good as the staff following it, so educate your staff regularly about the importance of respecting sample drugs.

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