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Healthy Skepticism Library item: 3920

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Jureidini J.
Systematic checks can avert crisis from adverse drug reactions
The Australian Newspaper 2006 Apr 1,5744,18666410%255E23289,00.html


Ralph Fagotter’s Comments:

Only a tiny fraction of the adverse drug reactions ( ADRs) which patients report to their doctors in Australia are ever on-reported to the appropriate authorities.

Healhty Skepticism Chairman, Jon Jureidini, looks at the scandalous situation of Australia’s ADR reporting sytem.

Full text:

Systematic checks can avert crisis from adverse drug reactions

Jon Jureidini
April 01, 2006

THE health system is failing the community in monitoring an important
source of harm to patients – adverse effects from prescribed drugs. This
week has seen considerable publicity about the possible dangers of
stimulant medications typically prescribed for Attention Deficit
Hyperactivity Disorder (ADHD) in children.

Data obtained from the Therapeutic Goods Administration (TGA) showed
that 400 adverse drug reactions (ADRs) had been reported in patients
taking stimulants. While this figure sounds dramatic, it does not by
itself demonstrate that these drugs are dangerous.

Many of the ADRs might have had other causes, and two of the three
deaths occurred in the elderly. In February, an expert committee in the
US recommended labelling stimulants with a “black box” warning about
their heart attack and stroke risks, but other experts disagreed, and we
do not yet know whether these drugs are dangerous.

It is clear that stimulants act on the heart as well as the brain, and
increase both heart rate and blood pressure, with a potential risk of
heart attack and stroke. But there is another, perhaps more worrying
aspect to consider: rather than being concerned that 400 reports is too
many, we should be worried by how low that number is. This low number
highlights a problem well beyond the ADHD debate.

Doctors, regulators and the pharmaceutical industry do such a poor job
of collecting data about ADRs that the system cannot tell us how
dangerous a drug is. We probably could advise parents with confidence
about the safety or otherwise of drugs if we did a better job of
collecting and collating information.

Instead we are writing hundreds of thousands of prescriptions for
stimulant drugs, in spite of increasing doubts about their long-term
effectiveness, while doing too little to monitor potential harms.

The safety of drugs is established in two important ways. First, trials
used to establish efficacy in order to license a drug also carefully
monitor for ADRs. However, up to half of the important side effects of
drugs are not detected during this licensing phase, because drug trials
are brief (rarely more than a few months) and only involve a tiny and
unrepresentative fraction of the up to millions of diverse patients who
will ultimately be treated by a successfully marketed drug.

Many uncommon but important ADRs therefore are only recognised years
after the drug has begun to be so widely used that we cannot help but
notice harmful effects.

In recognition of the limited information about the harmful effects that
come from these licensing trials, pharmaceutical companies are
encouraged to carry out post-marketing surveillance to monitor for the
onset of important ADRs; however, recent research shows that drug
companies seem not to rate this responsibility very highly, only
spending a tiny 0.3 per cent of revenue on all aspects of post-marketing
surveillance (Health Affairs, 2006;25:429-436).

The second source of information is from doctors and pharmacists. In
Australia, doctors who suspect a drug may have caused an unexpected or
severe ADR, or that any ADR has occurred with a new drug, should
complete a brief prepaid letter and send it to the ADRAC branch of the
TGA. No individual report is expected to be very reliable. The system
relies on pooling many reports to find patterns likely to represent
effects of the drug.

For this technique to work, we need a high level of reporting.
Unfortunately doctors are notoriously poor at this task. My hospital
only notified about 120 ADRs to any drug last year, but was still rated
the third-best notifier of all major hospitals in Australia. Only a
handful of notifications were made by doctors, most being made by
hospital pharmacy staff who found that doctors had detected and
documented ADRs in hospital files but not gone on to report them.

Most medical care is provided by general practitioners, who do not have
access to vigilant pharmacists to make up for their shortfalls. Overall,
it is thought that less than 1 per cent of detected ADRs are reported.
Many more go undetected.

Like drug companies, regulators worldwide spend relatively little on
post-marketing surveillance, and do little to educate or cajole doctors
into better reporting. Three strategies appear promising. First,
regulators could employ specialist pharmacists to work with GPs and
others to help them improve their level and quality of ADR reporting, in
part by ensuring that doctors get better feedback about the outcome of
their reports.

Second, even a system with high levels of ADR reporting is vulnerable to
missing dangerous relationships, such as heart attacks from Vioxx or
strokes from postmenopausal hormone therapy, because these diseases are
relatively common for other reasons. To detect such links quickly would
require linking of multiple databases from hospitals, pharmacies and
doctors, an approach that has been used successfully in Canada (CMAJ,
2006;174:191-2). Finally, research has shown that consumer reporting of
ADRs can partly address under-reporting by health professionals.
Consumers are also more likely to report adverse reactions associated
with complementary medicines, which have much less stringent safety
testing than prescription drugs.

The Adverse Medicine Events (AME) Line operating out of Brisbane’s Mater
Hospital is a pilot project where clinical pharmacists provide a
national phone-in service for the general public to report suspected
ADRs. The AME Line has unfortunately not been funded beyond its pilot
phase, but consumers can still make ADR notifications on 1300 134237.

We cannot hope to detect which medicines are really doing us damage
without a methodical system in place to log adverse events. If someone
doesn’t show leadership on this crucial issue we are heading for another
Vioxx, or worse.

Dr Jon Jureidini is head of psychological medicine at the Women’s and
Children’s Hospital in Adelaide.


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Email a Friend influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.