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Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals

BMJ 1996; 313 doi: https://doi.org/10.1136/bmj.313.7056.530 (Published 31 August 1996) Cite this as: BMJ 1996;313:530

Rapid Response:

Reporting Adverse Drug Reactions

Before the proliferation of the thousands of "new" drugs over the
past 30 years, manufacturer monographs seemed to be more reliable as a
guide to early spotting of adverse drug reactions. Now, I am seeing far
more adverse drug reactions, many of which have been extremely dangerous,
sometimes potentially fatal. All of them contribute to non-compliance by
patients and serious financial losses to patients, insurance companies and
the medical system to correct the mistakes.

Each time I have seen a serious adverse drug reaction, I have looked
up the drug involved in the most recent information available at my local
pharmacy. I have been appalled to see that none of these reactions have
been listed in the monographs.

One of my friends nearly died because of a paradoxical reaction to
Parnate when her blood pressure fell below shock levels. Another was
rendered catatonic by Celexa. My own father suffered (fortunately
reversible) renal shutdown, leading to congestive heart failure, from a
"rare" reaction to Vanconase. These are only a few of the reactions I have
seen. I do not believe that any of the reactions I have seen are as "rare"
as the drug companies would like to believe. Drug companies have a vested
interest in marketing products with as few identified side effects as
possible, creating a conflict of interest.

In Canada, most major drugstore chains provide a drug information
sheet with each newly prescribed drug. While these are helpful in
identifying the more common adverse drug reactions, they are incomplete. I
believe this lack of full disclosure can be traced to the under-reporting
of adverse drug reactions by physicians and the consequent ignorance of
other physicians and pharmacists. I find that pharmacists are far more
careful to educate their customers about their prescriptions than are
doctors.

The statistics on the chart included with this article came as no
surprise to me. Patients are far more likely to report adverse drug
reactions than are doctors and should be encouraged to do so.

The problem lies in lack of education and not knowing how to report
and who to report to. Patients often forget to mention adverse effects to
their doctors and doctors rarely ask. The currently fashionable 10 minute
consultation does not allow enough time for detailed enquiries into side
effects from prescribed medications. Frequently, patients do not have
enough knowledge to spot the early signs of adverse drug reactions before
serious harm results.

There is also a psychological barrier to reporting that affects both
patients and doctors. Patients' reluctance to report drug reactions often
derives from being too polite and compliant; they don't want to risk
"insulting" the doctor who prescribed the drug by implying that the doctor
is lacking in knowledge and has prescribed the drug wrongly. Frequently,
doctors minimize the patient's concerns over minor side effects. Patients
are not in a position to determine if a minor side effect could lead to
more serious consequences. If any doctor has ever minimized a report by a
patient, that patient will be less likely to ever complain again about a
drug's effects.

Patients also fear that too many complaints could result in the
doctor's refusal to treat them anymore or in viewing them as
hypochondriacs. This does happen. The shortage of doctors here means a new
physician can literally pick and choose which patients they want to have
in their practice. I have seen a number of people who have complex
problems and unusual reactions to drugs dumped by their doctors. It can
take 1 - 2 years to find a new doctor.

Doctors frequently deny ever having seen or heard of their particular
adverse reaction. They also feel very guilty if the drug they have
prescribed either doesn't have the desired therapeutic effect or worse,
causes the patient problems.

Patients whose information is not taken seriously often react by
either feeling they are being viewed as "stupid" or by losing faith in the
doctor's competence. In either scenario, the doctor-patient relationship
is damaged and future interactions are jeopardized. Any patient who gets a
negative or dismissive reaction from a doctor is far more likely to edit
crucial information in the future, potentially endangering their own
lives.

The simplest method of improving the reporting of adverse drug
reactions would be to include an adverse drug reaction reporting card with
each new prescription written by a physician. Pharmacists could ask each
person presenting a new prescription whether they received a drug reaction
reporting card with the prescription and supply one stapled to the drug
information sheet if the patient had not been given one. The pharmacist
could also explain either verbally or via a clearly posted sign, the
importance of reporting drug reactions.

Adverse drug reaction cards should be returned to pharmacists, who
could help patients fill them in. This is a necessary step. Most patients
do not have the medical vocabulary to effectively describe their symptoms;
some cannot communicate well in written form (the current adult illiteracy
rate in Ontario is 38%); others need the pharmacist to ask related
questions to fully describe the problem.

Pharmacists collecting the drug reaction cards could send them off
weekly to an appropriate collecting centre. This should not be either a
government agency or the pharmaceutical companies - they all have too much
conflict of interest to be relied upon for impartial dissemination of the
results. I suggest instead that a separate body of pharmacists who have no
conflict of interest, compile, evaluate and report all drug interactions
to government agencies and all registered pharmacists and physicians. The
updating of this information could be done by email, removing the danger
of information being lost in the black hole of the postal service and
radically speeding up the process. There should also be a cross-referenced
data base of all pharmaceutical products (prescription and OTC) that
automatically checks for drug interactions.

Right now, pharmacists are the first line of defense against
iatrogenic illness. They are better at spotting potential drug
interactions than doctors are; a good pharmacist will call the doctor
before filling a prescription rather than risk a customer's well-being.
They are much better at educating patients, asking questions and assessing
the level of understanding. From observation, patients seem more
comfortable asking questions of pharmacists, perhaps because pharmacists
take more time with them.

Most of the funding should come from drug companies (It is their
products that are the potential problems. Just view it as post-marketing
research.) and insurance companies (They pay out for most of the
prescriptions and lose money if it doesn't work or another drug has to be
prescribed to clean up problems with the first drug. Just view this as a
loss prevention program.).

The process I have suggested for identifying and preventing both
adverse drug reactions and drug interactions may require some fine-tuning,
but the savings in terms of patient misery, improvements of safety and
cost-reductions to the health care system, drug insurance plans and
patients' wallets would make it worthwhile.

The biggest obstacle to this concept will probably come from the
pharmaceutical companies, but I hope there are enough caring, ethical
people out there who could make this a reality.

Sharon Williams

Competing interests:  
None declared

Competing interests: No competing interests

04 May 2003
Sharon J Williams
Retired Registered Nurse
n/a