FDA to put PILs for all approved drugs on web
The internet is becoming an essential source of information about
medicines |
Web-based patient information leaflets are to be provided for all approved drugs, the US Food and Drug Administration announced last week.
The move is part of the FDA’s wider drug
safety initiative, which
involves the formation of an independent “drug safety oversight
board” to oversee management of safety issues and to provide information
on emerging safety issues to health care providers and patients.
One of the board’s responsibilities will be to produce consumer-friendly
information sheets for patients and health care professionals available
in an easily accessible format. The aim is to allow patients and health
care professionals to make better-informed decisions about treatment
options.
The initiative will also include a Drug Watch web page that will communicate
the most up-to-date safety information to the public, even before the
FDA determines whether regulatory action is appropriate. This page will
contain links to the consumer and health care professional information
sheets, and issues highlighted on Drug Watch will also appear on the
information sheets.
Theo Raynor, head of the pharmacy practice and medicines management group
at the University of Leeds, told The Journal that this is a change of
direction for the FDA. “The US approach has been to allow third
parties to provide drug information … but the increasing focus on
safety for medicines has led the FDA to change tack and to take control.” He
adds that this development is a sign that despite there being a significant
proportion of the population who cannot access the internet, it is becoming
an essential part of providing information about medicines. |
The
Pharmaceutical Journal
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