When a drug is withdrawn

May 20, 2005

If a drug is withdrawn tell any patients who are currently taking it to stop.

Q Recently, several pain medications have been withdrawn from the market after questions were raised about their safety. What are my legal obligations to my patients regarding these drugs? Do I face any malpractice risk?

Claims against physicians could include the following allegations: failure to inform a patient about the drugs' potential risks, failure to adequately monitor a patient for adverse side effects, and failure to discontinue the drugs once those side effects were noted. Even if your patient received the drug from another physician, you could face liability if you don't check for side effects.

If a drug is voluntarily withdrawn by its manufacturer, or if the FDA orders its withdrawal, you must stop prescribing the drug immediately and contact any patients who are currently taking it, or who have taken it in the past, asking them to stop taking the drug and to come in for an exam and a new prescription. Those at high risk for the drugs' adverse side effects should be sent certified letters with return receipt requested, strongly urging them to come in for an exam. Be sure to keep copies of those letters and documentation of phone calls in each patient's chart.

In your letter, stick to factual information about the drug and its potential side effects. Don't speculate about the quality of the drug, whether FDA action was warranted, or the possibility of litigation. Conclude with something like this: "Your health and well-being are important to me. I encourage you to contact my office or a physician of your choice to schedule an appointment for a medical evaluation."

Patients who have been taking high-dosage Cox 2 inhibitors for a long time, for instance, should be screened for any risk factors that predispose them to stroke or heart attack. Ask those patients to come in for an exam and a discussion or possibly an ECG or a referral to a cardiologist. Document those discussions, and any tests or referrals.

Tell these patients about alternative pain medications, including their risks and benefits. When prescribing pain medications for the first time, document the initial exam and discussion, why you chose the drug you did, and get the patient's informed consent. When taking a new patient's history, ask about prior use of suspect or withdrawn drugs. If necessary, provide appropriate follow-up care.

The author, who can be contacted at lj@bestweb.net
, is a healthcare attorney in Mt. Kisco, NY, specializing in risk management issues.

This department deals with questions on common professional liability issues. We cannot, however, offer specific legal advice. If you have a general question or a topic you'd like to see covered here, please send it to Malpractice Consult, Medical Economics, 5 Paragon Drive, Montvale, NJ 07645-1742. You may also fax your question to us at 973-847-5390 or e-mail it to memalp@advanstar.com
.