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[e-drug] Differences in Drug Datasheets (3)

E-DRUG: Differences in Drug Datasheets (3)

Andrew Herxheimer and some others did work in this area a number of years
ago I believe looking at the difference in data sheets for NSAIDs. I think
that this work was published in Pharmaceutical Journal. If Andrew is on this 
discussion group perhaps he could fill in more details.

[the moderator has copied an editorial by Andrew below, it is from BMJ 1998]

Joel Lexchin
Joel Lexchin MD
121 Walmer Rd.
Toronto ON
Canada M5R 2X8
Tel: 416-964-7186
Fax: 416-736-5227
E mail: joel.lexchin@utoronto.ca

BMJ 1998;316:492 (14 February) 

Many NSAID users who bleed don't know when to stop 
Uncomprehending "adherence" is dangerous  

Upper gastrointestinal bleeding and perforation are common and serious adverse 
effects of non-steroidal anti-inflammatory drugs. About a third of all ulcer 
bleeding in older people is associated with these drugs1 2; the same may apply 
to perforation. The most important predisposing influences are the type and 
dose of drug (and use of two non-steroidal anti-inflammatory agents together), 
which can increase the risk up to 20-fold. Other risk factors include prior 
ulcer,3 anticoagulants, systemic corticosteroids,4 smoking,5 alcohol 
consumption,6 and old age.1 3 Some of these are independent, so that treatment 
with non-steroidal anti-inflammatory drugs increases an already high risk. As 
we look for ways of lowering the risk of bleeding in patients using non-steroid 
anti-inflammatory drugs, an ingenious investigation from Newcastle offers a new 

Wynne and Long studied 50 consecutive patients admitted to hospital with an 
acute gastrointestinal bleed who had taken any of four commonly used 
non-steroidal anti-inflammatory drugs in the preceding three days and 100 
controls from local practices?matched for age, sex, drug, and dosage?who had 
not bled.6 All patients were visited at home by a nurse to assess their 
knowledge of their arthritis treatment. The nurse asked whether the patients 
had received any information about possible side effects of the drug, if so 
from where, and what they had been advised to do if side effects occurred. She 
asked the index patients, "Did you have any stomach problems, such as 
indigestion or pain before your stomach bleed?" and the controls, "Have you had 
any stomach problems, such as indigestion or pain?" The nurse also asked the 
patients to estimate how much of the prescribed dose they actually took and, if 
it was less than prescribed, why so. 

It turned out not only that the patients who had bled into the gut knew less 
about the side effects of their drugs or what to do when they occurred than did 
the controls but also that they stuck more closely to the prescribed dosage. 
Fewer index patients (16%) than controls (41%) remembered having been told of 
the potential side effects or about what to do if they developed an adverse 
effect (4% v 21%). "Full compliance" was commoner among the index patients 
(96%) than among the controls (70%). Furthermore, 18 (36%) of the index 
patients had had epigastric pain before the bleed and all but two had continued 
to take the drug, whereas only 15 (15%) of the controls had had dyspepsia, of 
whom 10 had reduced their intake. 

Perhaps this study should be interpreted cautiously: it was fairly small; 
patients with a complication may be more likely to claim that they were 
inadequately warned; and dyspepsia is widely accepted to be a poor guide to 
ulceration?though this has not been critically examined in relation to use of 
non-steroidal anti-inflammatory drugs. Nevertheless, it looks as if ignorance 
about side effects led to failure to recognise warning symptoms and to 
inappropriate compliance. Ten of the 16 patients who had pain but continued 
their drug and bled might not have bled if they had stopped the drug at once. 
Ten bleeds fewer out of 50 would be a useful reduction. 

As the authors say, we need effective methods of increasing patients' knowledge 
and understanding of side effects?and this applies not only to non-steroidal 
anti-inflammatory drugs. In particular we must try to ensure that patients and 
doctors share the same goals in medicine taking and move from compliance to 
concordance.7 8 Establishing what works best will take time and effort. But for 
a start, whenever doctors, pharmacists, and nurses see a patient who is using a 
non-steroidal anti-inflammatory drug they could check whether the patient 
understands two things. Firstly, they should understand that the drug is for 
symptomatic relief and should be used only when arthritic pain or inflammation 
is troublesome. Some patients with severe rheumatoid arthritis may have to take 
the drug all the time, but most others do not. Prescribers and patients should 
not aim at complete relief by using high doses because this increases the risk 
of damaging the gut; they should accept partial relief. Secondly, they should 
know that stomach pain or indigestion is a signal to stop taking the drug if 
possible; if this is not possible, they and the doctor should consider whether 
to reduce the dose. 

Of 21 patient information leaflets for oral non-steroidal anti-inflammatory 
drugs, nine tell the patient to stop taking the drug if such symptoms occur; 
the others say "tell your doctor" or something similar.* The points about 
symptomatic relief and using moderate doses whenever possible are almost 
completely absent. The Medicines Control Agency should insist that the leaflets 
are clear and consistent on these points. 

Andrew Herxheimer, Adviser a

a Health Action International?Europe, 9 Park Crescent, London N3 2NL 

*I did the survey in spring 1997 and I thank Andrew King and David Scott for 
obtaining leaflets not in the ABPI Compendium of Patient Information Leaflets 

1. Somerville K, Faulkner G, Langman M. Non-steroidal anti-inflammatory drugs 
and bleeding peptic ulcer. Lancet 1986;i:462-4. 
2. Faulkner G, Prichard P, Somerville K, Langman MJS. Aspirin and bleeding 
ulcers in the elderly. BMJ 1988;297:1311-3. 
3. Laporte J-R, Carné X, Vidal X, Moreno V, Juan J. Upper gastrointestinal 
bleeding in relation to previous use of analgesics and non-steroidal 
anti-inflammatory drugs. Lancet 1991;337:85-9. 
4. Piper OM, Ray WA, Daugherty JR, Griffin MR. Corticosteroid use and peptic 
ulcer disease: role of non-steroidal anti-inflammatory drugs. Ann Intern Med 
5. Henry D, Dobson A, Turner C. Variability in the risk of major 
gastrointestinal complications from non-steroidal anti-inflammatory drugs. 
Gastroenterology 1993;105:1078-88. 
6. Wynne HA, Long A. Patient awareness of the adverse effects of non-steroidal 
anti-inflammatory drugs (NSAIDs). Br J Clin Pharmacol 1996;42:253-6. 
7. Mullen PD. Compliance becomes concordance. BMJ 1997;314:691-2.[Free] 
8. Marinker M. From compliance to concordance: achieving shared goals in 
medicine taking. BMJ 1997;314:747-8.[Free] 

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