Issue 22
The risks and benefits of an Rx-to-OTC
switch. The case of over-the-counter H2-blockers
A paper by Oster in Medical Care back in 1990 looked
at this important topic. They are writing in a USA context but the findings appear to be
of interest to us in the UK.
In recent years, many new over-the-counter (OTC)
medications have resulted from the granting of OTC status to drug entities that previously
were available only by prescription (Rx). While the benefits to consumers of Rx-to-OTC
switches may be substantial, they also involve some degree of risk, as usage typically
expands and physician supervision diminishes. Osters study explored the balance of
benefits and risks. The study used the technique of decision analysis to examine drug
regulatory policy.
Histamine H2 receptor antagonists (H2-blockers),
which were available only by prescription, were presented as a case study and were
examined to determine how OTC availability of these agents would be likely to alter the
patterns, effectiveness, and risks of self-treatment for acid-peptic disorders.
In the USA about 5.7 million persons experience an
episode of dyspepsia during any given quarter, of whom 3.5 million self-medicate with
antacids. Study results indicate that OTC availability of H2-blockers would:
Increase the proportion of persons
with dyspepsia who self-medicate from 61.8% currently to 64.1%;
Increase the proportion of persons who experience
complete relief of their symptoms while self-medicating from 37.9% to 43.2%;
Result in 14 additional cases of serious
haematological disorders and an additional 22,000 instances of minor side effects per
quarter, but cause the overall rate of side effects among persons who self-medicate to
decline
Cause an additional 300 persons per quarter with
gastric cancer to self-medicate before seeking professional care, but cause no change in
the median time between onset of symptoms and the decision to seek such care
Decrease by 277,000 the number of persons per
quarter who seek professional care for dyspepsia.
On balance, results suggest that OTC H2-blockers may
be a relatively safe and effective means of self-care for acid-peptic disorders, and may
substantially reduce the number of patient encounters with the medical care system for
minor gastrointestinal complaints.
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Evidence based on call
A team of clinicians at the Centre for
Evidence-Based Medicine in Oxford,
has set up "Evidence-Based On-Call" to meet the challenge of providing
clinically relevant evidence-based advice at the bedside.
The Oxford team will use high-quality techniques to
search the literature for the best journal articles on specific on-call problems. EBOC has
developed an internet authorising tool allowing clinicians with EBM experience to create
one-page summaries of these articles.
These summaries, known as critically-appraised topics or CATs, will
be added to a central electronic database to create clinical guidelines.
Clinicians from all specialities and at all levels
of experience may participate in Evidence-Based On-Call.
The group are looking for contributors and
reviewers:
Their website at
http://cebm.jr2.ox.ac.uk/eboc/eboc.html gives a sample guideline and some CATs. Contact
Chris Ball at:
EBOC Office, Cairns Library, Level 3 Academic
Street, John Radcliffe Hospital
Oxford, OX3 9DU, UK.Telephone: +44 (0)1865 221945 email: cmball@eboc.u-net.com
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Systematic reviews
Andrew Booth has recently given a useful outline of
what makes a systematic review.
He suggests there are four components to the review
that make it systematic:
1. The literature search
2. The selection of the materials
3. The appraisal
4. The synthesis
A bona fide systematic review is only such if all
elements have been done systematically - the methodology is not therefore study dependent
(i.e. not necessarily RCTs only). The considerations that come into play are as follows:
1. All systematic reviews should give evidence of
the widest possible strategy for identifying studies. This is done by listing all
databases searched, strategies where available, performing funnel plots to look for
publication bias etc.
With a qualitative review one obviously cannot prove
that one has a statistically valid sample so one would look for the presence of data
saturation - i.e. to search the literature persistently until you no longer find any new
types of models. Citation searching is particularly important in this context.
2. Selection of materials should be done according
to an a priori (i.e. up front) set of criteria. This includes a precise definition of
studies to be included. Selection of criteria after retrieving articles is
methodologically suspect.
3. Similarly criteria for appraisal should be existing
systems/checklists rather than formulating your own.
4. The added value of the review, when done
systematically, is in bringing together comparable studies and commenting on commonalties
and differences. Guidance on how to do this for qualitative studies is found in a useful
publication Metaethnography (full ref in Cochrane Review Methodology Database).
If your review meets the above then it is arguably a
systematic review. If not then you could describe it according to those characteristics
that it possesses, e.g. a systematic search and qualitative review, systematic search and
concept analysis etc.
Often the problem lies in the synthesis if you are
trying to analyse different sorts of studies - this will only be possible if you have
subgroups of similar enough studies. "The mixing of diverse studies can make for a
strange fruit salad: mixing apples and oranges may seem reasonable enough but when
sprouts, turnips or even an old sock are added it can cast doubt on the meaning of any
aggregate estimates".
This comes from the context of meta-analysis but the
same principles apply.
The paper "What is meta-analysis?" has a
very useful companion "What is a systematic review?". Both are available from
the Bandolier site as downloadable documents in the "What is ....." series.
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