Get Informed Consent for Risky Drugs

By Johnson, Lee J. | Medical Economics, November 2, 2007 | Go to article overview

Get Informed Consent for Risky Drugs


Johnson, Lee J., Medical Economics


Malpractice Consult

Media coverage of the medication litigation of recent years (think Fen-Phen, Vioxx, and Celebrex) attests to the liability associated with prescribed medications. While the big pharmaceutical companies may be the main targets of this litigation, doctors are being sued as well, sometimes as co-defendants.

To protect yourself, be sure to meet your informed consent responsibilities. Informed consent is the conversation that you have with your patient about recommended procedures and pharmaceuticals. Historically, consent derives from the theory of assault and battery, which focuses on unconsentedto touching. That's why informed consent has long been associated with surgery.

The laws regarding informed consent are evolving, though, and physicians are increasingly expected to have informed consent conversations with patients about any recommended treatments that carry material risks. These include certain office procedures, especially invasive ones such as sigmoidoscopy and endoscopy. Informed consent requirements may also apply to medications you prescribe if they have significant risks or side effects.

Some states have adopted a "reasonable patient" rule in which you're required to provide whatever information a reasonable patient would need to make an informed decision. Other states have rules that indicate you must provide whatever information a reasonable physician in your specialty would be expected to supply.

In approving a drug for over-the-counter sale, the FDA is implying that the average consumer can understand the drug's risks. Prescription drugs, however, typically carry greater risk than the average patient is expected to understand. As such, the FDA relies on clinicians to evaluate and explain those risks.

Your informed consent responsibilities-and potential liability-are greatest when you prescribe:

* painkillers

* narcotics and other controlled substances

* off-label uses of drugs

* drugs that have been recalled or placed on alert

Informed refusal means that a competent adult patient, after getting a rundown of risks and benefits, has the right to dedine treatments. …

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