Physicians Grapple With Questions of Duty When Drugs Are Withdrawn

When Merck & Co. Inc. withdrew rofecoxib, sold as VIOXX, from the market last fall, the announcement stirred up a host of questions about patient notification. FPs volleyed comments back and forth on an AAFP e-mail discussion list.

One physician wrote that the withdrawal raised the question of who was responsible for good care. Another wrote, "It stands to reason that the pharmacies that fill prescriptions are best positioned to pull up who has actually filled Rxs for a drug and notify these people at the current phone number and address."

"Why don't the insurance companies notify everyone? They have every patient's medication purchase history on file anyway," reasoned a third FP. "I'm dragging my feet on printing out a few hundred letters and paying the postage," said a fourth, adding, "Is this our job? Do we really put ourselves in that much legal jeopardy if we do not specifically notify everyone ourselves?"

FP Report set about finding the answers to these questions.

The first call went to the FDA. Crystal Rice, public affairs specialist, said the agency does not regulate physician practice; rather, it makes information available to physicians.

"The FDA approves medicines and monitors their safety profiles. FDA strongly encourages discussion about medicines -- their benefits versus any potential risks -- between physician and patient," she said.

Next contact: the American Pharmacists Association. Susan Winckler, R.Ph., vice president of policy & communications, said pharmacists have a responsibility to notify patients when a drug is recalled or withdrawn.

In the VIOXX withdrawal last fall, Winckler said many pharmacists reviewed their prescription databases to ascertain who had received VIOXX in the past 60 days. "Pharmacists then either generated a letter or a phone call to those patients informing them of the withdrawal and recommending that they talk to their doctor about an alternative."

The patient may hear from both the pharmacist and the physician, said Winckler, "but in this instance, the redundancy is appropriate."

Do insurers have a responsibility to the patient? "Insurance companies commonly play a role in alerting patients and physicians," said Susan Pisano, vice president of communications for America's Health Insurance Plans. That's because insurers are able to identify patients through claims data.

FP Report turned to AAFP Past President Richard Roberts, M.D., J.D., of Madison, Wis., for a medicolegal perspective. He said the underlying legal principles are "reliance" and "loss of a chance."

"Patients rely on us to look out for their health, especially when we were the ones who prescribed the medication in question. We have a duty to notify them, when we can reasonably do so, in order for them to not ‘lose the chance' to avoid injury," said Roberts.

Notifying 600 patients within 24 hours could be considered unreasonable, he continued. "But if a physician has only one patient on a medication that later is found to be dangerous, and the physician could easily notify that patient, then the physician has a duty (ethical obligation) to notify the patient."