The question of whether or when you should dispense expired medications to patients has both legal and practical implications. The short answer is that you should never dispense expired medications to anyone.

You need to be aware of the expiration dates of medications and contact lenses that you sell to your patients, as well as medications, contact lenses and solutions that you might use in the course of an ophthalmic examination.

You should also ensure that the samples you give to patients haven't expired. Keep in mind that it's illegal in most states to sell samples to patients.

Even if there's no clinical reason why a drug couldn't be used by a patient after its expiration date, you could be held liable for dispensing expired medications.

If a patient has an adverse reaction to a treatment or an expired drug -- even if that reaction isn't based solely on the drug being expired -- a lawsuit by that patient against you would almost certainly include a claim that you were negligent to dispense a medication that had passed its expiration date.

In addition to liability resulting from a patient lawsuit, state laws might forbid you from dispensing medications that have passed their expiration dates.

Put in a monitoring system

Monitoring should be part of your compliance plan and may be related to either state or OSHA regulations and/or inspections. But each practice must institute its own system for monitoring medications, even if it's not mandated. This system requires a person who's in charge, a strict monitoring schedule, set monitoring procedures and the recording of complete, documented results for each monitoring operation. Dispensed samples should be documented by date, patient name and the name of the medication. You should also have a safe system for discarding outdated medications that's in strict accordance with local law. Recognizing that medications can be kept in many sites throughout your ophthalmology office (storage spaces, examining rooms, surgical rooms and contact lens areas) it's important to cover all areas where medications may be present.

You should monitor the location of all medications, and carry out regular, documented evaluations of their expiration dates. When you receive new medications or solutions, it's important to put the newest medications in the back and move the older ones forward.

Because many eye drops and contact lens solutions are normally left on counters so you can get to them quickly, patients may, while waiting, actually pick up some bottles and notice the expiration dates. In addition to being illegal, the presence of expired medications makes a poor impression on the patient. Inadvertent use of expired drugs, solutions or contact lenses usually occurs due to lack of a good monitoring routine.

The dangers are real

In ophthalmology, especially with respect to injectables and eye drops, sterility is the key. If a pharmaceutical is old, either because a patient has opened the medication or for some other reason, bacteria can breed in the container and make the drug dangerous.

Be as meticulous in your management of medications as you are in the delivery of other aspects of your ophthalmic care. As in the case of many other areas of risk management, having a specific plan and adhering to it is the way to avoid potential problems.

Jeffrey D. Weinstock, Esq., is an attorney with Sachs, Sax and Klein, P.A., in Boca Raton, Fla. He practices healthcare and corporate law. Risk Manager provides a general summary of legal issues and should not be construed as personal legal advice. Application of these principals varies according to individual situations