Adverse drug reactions result in 250 000 UK admissions a year
BMJ 2006; 332 doi: https://doi.org/10.1136/bmj.332.7550.1109 (Published 11 May 2006) Cite this as: BMJ 2006;332:1109All rapid responses
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Although this statement is welcome the WHO itself unfortunately
promotes the use of inadequately tested medicines. I quote the recent
Cochrane review of MMR (2005:
"The design and reporting of safety outcomes in MMR studies, both pre
- and post marketing are largely inadequate"
and it goes on to remark:
"More attention needs to paid to the design and reporting of safety
outcomes in vaccine studies both pre and post marketing".
I urge the WHO to take note and act on its own advice.
Competing interests:
Autistic son
Competing interests: No competing interests
With the current worldwide interest in medicine safety and
regulation, the BMJ news item on adverse drug reactions (ADRs) is
significant. Of particular importance is the reference to the cost of
ADRs. The estimated annual expenditure of $870m towards ADR related
issues would be hard on any economy; needless to state, such figures
could seriously cripple countries with lesser resources.
The cost factor
should then be at least one of the reasons for all developing countries to
promote pharmacovigilance (PV). Started in 1968, the WHO Programme for
International Drug Monitoring has, to date, 79 countries as full members
to the programme; only 6 of these countries are from sub-Saharan Africa,
where PV is often still seen as a luxury profession. Yet in many of these
countries, treatment programmes are being expanded rapidly following the
release of significant funding for procuring medicines for treating
malaria, tuberculosis and HIV/AIDS. Not infrequently, several disease
control initiatives, involving the administration of several medicines,
are carried out among the same population, with little or no understanding
of how these various medicines could interact(1). Moreover, the conditions
and populations in which many of these medicines were tested often differ
radically from the conditions and populations of large-scale treatment
programmes(2). Recognizing this and conscious of the resource constraints
in introducing a fully-fledged 'generic' pharmacovigilance programme, WHO
is now seeking to roll-out a programme of 'disease-driven'
pharmacovigilance; disease programme managers are being trained to monitor
and manage adverse reactions to medicines in specific public health
programmes as a first step towards introducing pharmacovigilance into
countries. It is hoped that with time, individuals thus trained would
teach others the basics of ADR surveillance and help set-up nationwide
monitoring for all types of medicines. WHO has so far organized two
training workshops for introducing pharmacovigilance into malaria (5
countries) and HIV/AIDS programmes (8 countries) in sub-Saharan Africa. A
third workshop is being planned for HIV/AIDS programme managers in the
Caribbean(3).
In addition WHO is working together with the Forum for
collaborative HIV Research to co-ordinate cohort studies being undertaken
throughout the developing world to collect data on ADRs resulting from ARV
treatment(4). This is the first time that systematic data on such ADRs
will have been collected. Another aspect of work in WHO is to assist
Member States when there is a crisis, such as the recent cluster of
adverse drug reactions to one of the antimalarials used in Ghana. WHO
recruited an expert to review the case reports and is currently
investigating the quality of the suspected products. Adverse drug
reactions seriously affect all: men and women, young and old, rich and
poor. No one can afford to ignore pharmacovigilance because, if access to
medicines is a human right, then 'preventing 'avoidable' harm from
medicines is a professional and moral obligation.
References
1. Keith Alcorn and Theo Smart. How frequently are ARV side effects being
seen in resource-limited settings, and how are they dealt with? HIV &
Treatment in Practice #67, 13th April, 2006
2. Boffito M, Winston A, Owen A. Host determinants of antiretroviral drug
activity. Curr Opin Infect Dis 2005 Dec; 18(6):543-9.
3.Quality and Safety; Pharmacovigilance training courses
http://www.who.int/medicines/en/
4. Forum for Collaborative HIV Research. http://www.hivforum.org
Competing interests:
None declared
Competing interests: No competing interests
Does not this advice from the Government's MMR the Facts website
continue to stand medical ethics on its head?
"Q: "My son had a sever(e) reaction to the first MMR jab. Does this
mean that he is well protected from these diseases, or is a second dose
still necessary?"
"A: "If a child has responded to all the components of the vaccine
the first time, he will not have a problem being exposed to the viruses
again. It's like any one of us who is already immune meeting someone with
the disease - the infection can't get established.
"If he hasn't made protection to all three diseases after the first
time, then he would still be susceptible to those natural infections, and
still needs the 2nd dose.
"Reactions after the 2nd dose are essentially the same as after the
1st dose, but if they do occur they are even rarer. There are no new side
effects after the 2nd dose that do not occur after the 1st dose. The
advice is therefore that it is safe for your child to have the 2nd dose in
order that he is properly protected." [1]
I first highlighted this matter in these columns nearly two years ago
[2,3] but although the advice was temporarily removed [4] a policy
decision seems to have been made to reinstate it.
Good sense demands that we do not repeat a dose if there is a severe
adverse reaction, Dr Vivienne Nathanson - the BMA's Head of Ethic and
Science - insists that a yellow card must be filled in and submitted, but
here we are again: with vaccine it is different (apparently).
Obviously, if something had been done I would not be trying to detain
readers once again, but it has not and I am. Please can we have a single
standard, and an acknowledgement that what has happened is completely
unacceptable.
[1] http://www.mmrthefacts.nhs.uk/questions/question.php?id=79
[2] http://bmj.bmjjournals.com/cgi/eletters/328/7442/773#64165
[3] http://bmj.bmjjournals.com/cgi/eletters/325/7373/1134/a#78135
[4] http://bmj.bmjjournals.com/cgi/eletters/325/7373/1134/a#88802
Competing interests:
Autistic son
Competing interests: No competing interests
Adverse Events - a Canadian perspective.
3 July 2006
Dear Editor,
There are continuing concerns in the UK about drug reactions/adverse
events and their cost implications.[1] A recent BMA report was based on a
well designed, prospective study from 2004.[2] Adverse event issues
should really concern British doctors because Canadian research is being
used to promote the formation of regulation similar to that in the
“nuclear, aviation and railway industries.” [3]
Canadian concerns are based on the 2004 CMAJ {journal of the Canadian
Medical Association}original research article: "the Canadian Adverse
Events Study: the incidence of adverse events among hospital patients in
Canada." {CAES [4]}. The Study claims to show enormous risks to patients
in Canadian hospitals and concluded that there are many avoidable deaths.
This number is up to 10% of the total annual deaths in Canada. [4][5] In
comparison, the CAES was only a dual-level retrospective chart review of
charts from admissions in 2000 and it appears that the researchers drew
their conclusions in isolation to the full clinical picture.
Patient choice is integral to the delivery of health care and is not
'avoidable'. In the CAES E-appendix #3 I can find only 1 stated patient
choice out of the 255 listed cases.[6] There was no indication of the
presence or absence of any Personal Directive / Living Will.
The CAES cases are listed in E-appendix #3 & frequently did not
provide enough medical history for an adequate review.[6] Aggressive
treatment or investigation may have been futile. {For example Patient 44
of the 255 with adverse events, was stated as having palliative pancreatic
cancer. The researchers said that the patient did not have a ‘conclusive’
diagnosis - so was listed as having “Strong Evidence of Preventability.”
[6]}
No information was taken directly from the attending Physician.
Therefore conclusions are missing important aspects arising from the
Doctor/Patient relationship.
There are avoidable adverse events and all of us must strive to
minimise these dreadful occurrences. Nonetheless, it is simply ludicrous
to suggest that 10% of the total deaths in Canada are avoidable. It is
also ludicrous to think that patient care can be regulated like the
aviation industy. When planes fail they are scrapped. When patients are
no longer curable, we continue to strive for their comfort and quality of
life.
Yours sincerely,
Kevin Hay MRCPI CCFP FCFP
[1] Hitchen L. News: Adverse drug reactions result in 250 000 UK
admissions a year.
BMJ 2006;332:1109 (13 May), doi:10.1136/bmj.332.7550.1109
[2] Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ,
et al.
Adverse drug reactions as cause of admission to hospital: prospective
analysis of 18 820 patients.
BMJ 2004;329:15-19, doi:10.1136/bmj.329.7456.15
[3] Kondro W. News: “Independent federal safety board needed to
prevent adverse events”
CMAJ • June 6, 2006; 174 (12).
[4] Baker GR, Norton PG, Flintoft V, Blaise R, Brown A, Cox J, et al.
The Canadian Adverse Events Study: the incidence of adverse events
among hospital patients in Canada.
CMAJ 2004;170:1678-86.
[5] Statistics Canada: Deaths and death rate, by province and
territory (Number of deaths.)
[http://www40.statcan.ca/l01/cst01/demo07a.htm?sdi=deaths]
[6] E-Appendix 3: Brief description of clinical details of adverse
events occurring in 255 patients, by corresponding maximum degree of
preventability. Link to PDF file:
[http://www.cmaj.ca/cgi/content/full/170/11/1678/DC3]
Competing interests:
I am a doctor.
Competing interests: No competing interests