UK doctors ignore adverse drug reactions -- "citizen medicine" fills the gap

[Altostrata]

A UK study shows doctors frequently ignore patient reports of adverse drug reactions, although there is a reporting system available. UK statistics show emergency room visits for ADRs have increased by nearly 77% in 10 years -- twice the rate of the increase in prescriptions -- while ADRs are killing hundreds of thousands in Europe, too.

 

Citizen medicine and why we must try it

15 June 2011 by Janet Krska and Tony Avery NewScientist.com

 

YOU are a doctor somewhere in the western world. During surgery

hours, a patient complains of a strange reaction to a medicine....

 

No sooner have you reassured patient X, told him to continue taking

the medicine, and made a new appointment, than patient Y is

recounting her story....

 

Later, you ponder these odd symptoms, or as professionals call them,

suspected Adverse Drug Reactions. You won't find these ADRs in any

textbooks, but you are not a doctor who sets much store by patient

accounts of bad reactions to their medicines anyway.

 

You are, however, very aware your patients may stop taking the

drugs, which could make matters worse. What to do? After all, a big

part of your job is to walk the tightrope between the healing and

the harm of our modern pharmacopeia. But it all takes time.

 

Had you had time to keep up with your reading, you might have

noticed in the UK's Royal Society of Medicine's journal a paper

showing 557,978 ADR-associated admissions to hospital--up by 76.8

per cent over the decade from 1999 to 2008. ADRs, said the society,

have a major impact on public health.

 

Just days ago, too, The Lancet ran a letter from top researchers and

doctors to the UK's prime minister and health secretary, stating:

"[ADRs] have reached epidemic proportions... increasing at twice the

rate of prescriptions. [in 2008 the] European Commission estimated

adverse reactions kill 197,000 EU citizens annually, at a cost of

EUR79 billion."

 

When you next see your patients, you try to reassure them. Had you

believed in their symptoms, you would have reported them to the

authorities. In the UK that is the Medicines and Healthcare products

Regulatory Agency (MHRA), a government agency responsible for

ensuring medicines and medical devices work and are acceptably safe.

Similar systems work across the European Union. And if you were a

doctor in one of the 46 countries with a patient reporting system,

you might have suggested your patients submit their own reports.

 

Once a report reaches one of these bodies, it is electronically

recorded so safety issues can be detected and action taken to update

both the patient information leaflet (PIL), legally required for

medicines in the EU, and the summary of product characteristics

(SPC), which gives more details of the medicine, including what it

is licensed for. Depending on the severity of the problem,

manufacturers may decide to withdraw or modify their drugs, or

reflect the drug reactions in SPCs and PILs.

 

While many ADRs are identified during clinical trials before drugs

reach the market, many others depend on pharmacovigilance systems -

in which our fictional doctor is not playing a full part. The

reports made to our doctor are about real drugs, based on real

patients' stories cited in our recent evaluation of patients'

reports of ADRs using the UK Yellow Card system.

 

Yellow Card reporting was set up in 1964 in the wake of the

thalidomide disaster. From the start, it was seriously underused

because patients were felt to be unreliable sources of information -

and few felt the pharmaceutical industry needed challenging.

 

Direct patient reporting was first considered in the UK after

benoxaprofen, a non-steroidal anti-inflammatory, was withdrawn in

1983. Sixty-one people, mostly elderly, died and 3500 adverse drug

reports were received by the Committee on Safety of Medicines. But

it was rejected in favour of encouraging patients to consult their

doctors in the hope that these professionals would report more ADRs.

The levels failed to increase significantly.

 

Support for patient reporting grew slowly. There was scepticism and

speculation that it was merely a sop to consumer pressure. But by

October 2005, patients or their representatives were finally allowed

to add their voices to those of professionals, and use Yellow Cards

to report ADRs by post, telephone or the internet.

 

Five years on, ADRs are still seriously under-reported by doctors

and health professionals. It is estimated that over 90 per cent of

ADRs are not reported by doctors and health professionals, so it is

helpful that patients can boost the number of reports. After a slow

start, patient reporting has gathered momentum. Between 2005 and

2009 the MHRA received 10,000 patient reports compared with 56,000

from healthcare professionals.

 

Our research involved studying patient reports and asking what

patients thought of the process. We compared patient reports with

those of health professionals. Five years into the UK system, we

think that our findings should worry regulators everywhere.

 

First, few people (doctors or patients) know that direct patient

reporting actually exists. Some who do know are ambivalent about its

value, which means important information that could save lives is

not taken seriously. For example, patients tended to record more

suspected ADRs per report, more suspect drugs, and used more, often

very emotive, words to describe their experiences than health

professionals. Even so, similar proportions of reports from both

groups contained at least one reaction that the MHRA considered

"serious". And 44.8 per cent of patient reports indicated that a

suspected ADR was bad enough to affect everyday life.

 

Withdrawal symptoms also loomed large. One patient wrote: "... the

effect wrecked my life, my body, my mind. I have been unable to work

for 18 months... Personality change is the most unbearable effect -

aggression, irritability, depersonalised feelings. The information

on the PIL was not adequate..."

 

Equally important were the "signals", new information on possible

causal relationships between an ADR and a drug. It turned out that

patients were as likely as health professionals to note reactions

not already listed, so they were a potential source of extra

information.

 

Patients also explained how they set about identifying a suspected

ADR. Roughly 75 per cent said there was an association in time--in

other words, they took a medicine and shortly afterwards something

happened, sometimes reliably, over and over again. Others said

health professionals had told them their symptoms were associated

with the suspect drug, while others found data from the PIL, or

other sources, including the internet.

 

The fact that patients are trying to evaluate their experience and

match it with external evidence is important and should help allay

the fears of those who feel patients are not up to the job of

accurately identifying ADRs.

 

As for the future of patient reporting, the scale of ignorance is a

big problem. Only 8.5 per cent of 2000 people we surveyed had heard

of it. Almost half of those who sent in a Yellow Card learned about

the scheme from pharmacies rather than from doctors or other

healthcare professionals.

 

Patients felt this lack of awareness typified the ambivalence and

dismissiveness that had dogged the system from the start. Some said

successful reporting needs to be independent of professionals to

ensure patients are heard accurately--or at all. As one wrote: "I

feel if I told my doctor about my side effect, he would belittle

it... I would feel I was making too much fuss, whereas my experience

was not wrong... I feel scared of my [doctor's] response."

 

ADRs are such a problem that if patient reporting has a big role to

play in improving medicine safety, we need to know fast. We need to

explore how much notice regulators take of patient reporting, the

best way to use patient reports, whether patients and regulators see

the same ADR as equally serious--and what would happen after a big

campaign to publicise reporting.

 

Profile

 

Janet Krska is professor of pharmacy practice at Liverpool John

Moores University, UK. Tony Avery is a GP and professor of primary

healthcare at the University of Nottingham, UK. Their research on

patient ADR reporting features at a conference in London on 24 June,

more at: http://primm.eu.com

 

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