US FDA announced its updating of the rules regarding package inserts to make them easier to understand. (file photo)
BEIJING, Jan. 19 (Xinhuanet) -- The US Food and Drug Administration (FDA) will change its requirements for the lengthy package inserts that are included with most prescription drugs.
Health professionals welcome the update, saying that it was long overdue.
"Current package inserts are often copious, written in a very small type and buried in numerous pages. All too often, this is confusing, even to physicians," said Dr. Bruce Cronstein, director of the division of clinical pharmacology at the New York University School of Medicine. "The FDA improvement will simplify getting drug information to physicians and give them a better understanding of the ingredients."
The change is similar to the food-label update of several years ago which was meant to help consumers better understand the nutritional content of their food purchases. In this case, the revamped package inserts are intended to help physicians, pharmacists and patients better understand the benefits and risks of the drugs.
The most noticeable changes are a table of contents; inclusion of the date of initial product approval; a new "highlights" section, which lists the most pertinent benefits and risks for a drug; and a toll-free number and Internet reporting of adverse effects.
Drug manufacturers will also be required to include a "list of all substantive recent changes made within the year," according to an FDA press release.
The change was prompted by the increase in medical errors, the release stated. Enditem
(Agencies)
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