Medical Product Problems : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

An adverse event is any undesirable experience a patient has using a medical product. Serious adverse events — the ones FDA is primarily interested in — include death, life-threatening situations, initial or prolonged hospitalization, and situations requiring medical intervention to prevent permanent damage, disability, and congenital anomaly. Congenital anomalies include birth defects, miscarriage and stillbirth, or birth with cancer or some other serious disease.

The identity of patients involved in MedWatch reports is confidential and legally protected. The identity of the reporter may be shared with the manufacturer unless the reporter requests otherwise.

"Physicians should report when there is a suspicion that the drug or device may be related to a serious adverse effect; they are not expected to establish the connection or even wait until evidence seems compelling," Kessler wrote in a recent Journal of the American Medical Association article.

"On the other hand, the FDA does not want providers to report every adverse reaction observed; this would not be practical for the practitioner or useful to FDA," Kessler continued.

Problems should also be reported when there is concern about the quality, performance or safety of any medication or device. Product quality problems may occur during manufacturing, shipping or storage. These problems include contamination, defective components, poor packaging or product mix-up, questionable stability, and labeling concerns.

The agency's MedWatch central unit receives all the reports initially. From there, it is determined what type of product is involved. Within one working day of receipt of a report, it is in the hands of the appropriate program in the center responsible for the particular product.

"We were receiving about 100,000 reports each year of adverse events with drugs," Anello says. "Several thousand of those are serious and unlabeled [not listed in the product labeling] reactions. Not every one of those reports establishes cause-and-effect relationships. We have a staff of epidemiologists who assess the causes [of the reaction] and also the public health importance of these reported adverse events."

Once an adverse event or product problem is identified, FDA can take any of the following actions:

Labeling Changes — Adverse events often prompt FDA to require the manufacturer to add new information to the product's package insert.

Boxed Warnings — are reserved for the most serious adverse events. FDA can require that warnings be placed in a prominent position on the product's packaging to ensure its continued safe use.

Product Recalls and Withdrawals — are among the most serious actions FDA can advise a company to take. Recalls involve the firm's removal of a product from the market and may require taking the product off the market permanently.

Medical and Safety Alerts — are used to provide important safety information about a product to health professionals, trade, and media organizations.

Sharing Information

Communicating FDA actions that resulted from MedWatch reports to health professionals is another primary goal of the new program.

"Already we have about 70 health-care organizations that have signed up to be our partners," Kennedy says. "They're doing news and journal articles, distributing forms, publishing print ads, public service announcements."

These organizations have also agreed to help disseminate information about the safety actions the agency has taken.

FDA also reports back to health-care professionals through "Dear Doctor" and "Dear Health Professional" letters, FDA Medical Bulletin, and press releases and journal articles.

"The plans are for us to provide whatever information comes out back to the health professional," Kennedy says. "We're certainly not able to individualize responses, although if a significant problem is discovered, we might look back at the reports used in discovering the problem and write to those who reported it."

What Does MedWatch Mean to You?

The MedWatch program will provide different benefits to different people.

For health professionals, the MedWatch program will help educate and inform practitioners of the need for adverse event reporting. It will also quickly correct product problems and remove defective or dangerous products from distribution.

But the greatest beneficiary will be the general public. "MedWatch will help identify problems earlier so that we [FDA] can prevent the continued occurrence of that problem," Kennedy says.

Simply put, MedWatch is expected to make medical products safer for consumers by ensuring the safety of products on the market and enabling faster removal from the market of those that cause problems.

As Kessler told the health professionals, "What MedWatch is all about is preventing illness and death. It is about someone in my family, in your family, someone anywhere in this country who will escape illness or even death because a health professional filed a report. And it is about every patient who will suffer because a report was not filed."

Vaccine Reporting

MedWatch doesn't include vaccines.

In 1986, Congress passed the National Childhood Vaccine Injury Act, requiring health-care practitioners and vaccine manufacturers to report serious adverse events with certain vaccines.

The Vaccine Adverse Event Reporting System (VAERS) began Nov. 1, 1990, collecting all vaccine reports for FDA and the national Centers for Disease Control and Prevention.

Congress passed the act after realizing litigation against manufacturers was driving up vaccine costs and motivating some companies to stop vaccine production.

Anyone — consumers, parents, manufacturers, and health-care providers — can submit a VAERS form, but patients or their representatives are encouraged to also consult their doctors.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.