E-drug: Survey of UK patient info leaflets on NSAIDs
----------------------------------------------------------
Last week my report on patient info leaflets with NSAIDs was published
[Pharmaceutical Journal 1999 (17 April); 262:559-561].
The abstract is below. The full text will be posted on the ISDB home page.
LEAFLETS WITH NSAIDs DON'T WARN USERS CLEARLY: A UK SURVEY
Objective - To examine how far Patient Information Leaflets (PIL) for
non-steroidal anti-inflammatory drugs (NSAIDs) explain their safe use and
warn about gastrointestinal side effects.
Design - Survey of PIL for 29 major NSAID preparations listed in the BNF.
Outcome measures - Does the PIL explain that:
[1] the NSAID relieves symptoms but does not influence the course of the
disease?
[2] the use of high doses or of the strongest drugs to obtain complete
relief increases the risk of serious adverse effects?
[3] if any 'stomach' symptom occurs, the patient should stop taking the
medicine or at least reduce the dose, and seek advice?
Results - [1] Only 4 of the 29 PIL clearly explained that the NSAID only
relieves symptoms.
[2] None of the PIL discouraged efforts by the patient to obtain complete
relief with the drug.
[3] 13 of the 29 PIL did not mention stopping the medicine if stomach
symptoms occurred; ten advised stopping only if serious symptoms occurred
(ie bleeding or severe stomach pain); six advised stopping, and seeking
advice if any stomach symptom occurred.
Conclusion - The information in PIL should be more complete, clearer, and
consistent for all NSAIDs. This requires urgent efforts by the Medicines
Control Agency and the manufacturers.
------------------------------
The commonest serious adverse effect of non-steroidal anti-inflammatory
drugs (NSAIDs) is upper gastrointestinal bleeding, which lands thousands of
mostly older people in hospital each year. 1 The risk varies up to 20-fold
with the type and dose of NSAID. How can we minimise it and help patients
to do so?
Del Favero concluded in a recent review: "The main way to reduce risks
from NSAIDs should � be to limit their use rather than attempt to lower the
relative risk further by co-prescription of other agents."2 We must
explain to patients that the risk is much higher with NSAIDs than with most
common medicines. They should understand three points concerning
symptomatic.
Andrew Herxheimer
Emeritus Fellow, UK Cochrane Centre
9 Park Crescent, London N3 2NL UK
Phone: +44 181 346 5470
Fax : +44 181 346 0407
e-mail: andrew_herxheimer@compuserve.com
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.