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Drug regulation terms -- a dictionary

Special to The Times

“Black box” warnings. “Dear Doctor” letters. Confused yet? Read on for an insider’s guide to drug regulation lingo.

Professional label:Such alabelfor a prescription drug is not the label consumers see on the vial they bring home from the pharmacy. The professional label comprises many pages of information about the drug and how it should be prescribed and used, its side effects, any warnings the Food and Drug Administration has issued about it and results of clinical studies.

“This is professional information for physicians,” says Dr. Paul Seligman, director of the safety policy and communications staff at the FDA. “It is not part of the information that’s routinely handed out to patients.” (Patients can ask to see it, however.)

Black box warning: Any warnings the FDA issues for a drug are printed on the professional label. The strongest possible warning is a black box warning, named for the black border that surrounds it. Such a warning is meant to be the 800-pound gorilla of FDA safety advisories: hard to miss. “When we think a warning is particularly important and requires special attention for safe use of a drug, we put a box around the warning to highlight it so it can be seen better,” Seligman says.

The FDA may decide to require a black box warning if evidence shows that a drug can cause serious, even life-threatening, risks. “This is generally given when the FDA has half a mind to take the drug off the market but doesn’t want to because of the good it does for some patients,” says Dr. Frances Richmond, director of the School of Pharmacy Regulatory Science program at USC. “It’s used when a drug has a very rare but very serious effect. If it has a very serious but common effect, the drug is withdrawn.”

Medication guides: Sometimes the FDA requires paper handouts or pamphlets for drugs. These guides are regulated by the FDA and are intended especially for patients to help them avoid serious problems. They must be given out, not just with every new prescription but with every refill too.

“We require medication guides when we feel it’s particularly important for consumers to understand a serious risk in weighing decisions about taking the drug,” Seligman says.

If the FDA also requires a black box warning on the drug, it’s highlighted in the guide. Of the thousands of drugs on the market, 460 come with medication guides.

Medication guides are useful when a drug has side effects that the patient may be able to mitigate or avoid, Richmond says. For other drugs, nothing a patient does can make any difference. But side effects for other drugs may be out of the patient’s control. “Then you don’t really need a medication guide. You need a good doctor.”

Consumer medication information: Don’t confuse the medication guide with the consumer medication information sheet that, by law, comes with all prescription drugs. This should provide useful information about the drug, including proper ways to take and store it, precautions and warnings that have been issued about it, and symptoms of bad reactions it might cause. These sheets are prepared by pharmacies and are not regulated by the FDA.

Dear Doctor letter: Such a letteris written and sent by a drug manufacturer to tell doctors about newly discovered dangers associated with a drug the manufacturer produces. The FDA can require manufacturers to send these letters, in which case it must approve the content. If the FDA has required a black box warning on the drug, that warning is highlighted in the Dear Doctor letter. The Health Care Notification Network -- a new system funded by drug and device manufacturers -- was launched in May for sending these letters by e-mail.

Advisory committees: These independent outside experts make recommendations to the FDA about some black box warning decisions but not all. Such committees are more likely to be involved when decisions regard a class of drugs, rather than a single drug, and when decisions are predicted to be controversial.


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