There is widespread agreement that spontaneous reporting schemes are here to stay.
SPONTANEOUS REPORTING SCHEMES
There
is widespread agreement that spontaneous reporting schemes are here to stay.
They are econom-ical and embrace the entire population of patients and
reporters. However, it is important to treat all such reports as hypotheses.
Some events will almost certainly be causally linked with the suspect drug,
whereas others will turn out not to be so. With secu-lar trends in widening the
reporter base to include nurses, pharmacists, other health professionals and
now patients, the balance may vary somewhat from region to region and from one
group of reporters to another. It is important that standardised procedures are
adopted to review and analyse all such sponta-neous reports. In so doing, there
is a danger that the output from any review could be made available with-out
the benefit of careful clinical and pharmacologi-cal expertise and input with
serious consequences to all concerned. The rule here is to appreciate that the
raw information from spontaneous reporting schemes are anecdotes – no more and
no less. They have to be treated as such. Sophisticated analyses of anecdo-tal
data are justified if great care is taken with the subsequent interpretation,
otherwise more harm could arise than good. Careful review of all reported
suspect reactions to a particular medicine may point to a sub-population at
especial risk. Such reviews can rarely be automated, but require careful,
time-consuming analy-sis by trained, experienced observers. Such people are in
short supply; nevertheless, they are extremely valu-able in the context of
logical interpretation of spon-taneous reporting schemes. Signal detection can
now be enhanced by advances in information technology, including techniques for
interrogation and analysis of databases of spontaneous reports.
The
development of Augmented Spontaneous Reporting Schemes whereby potential
reporters are contacted about details of outcomes after specific medicines have
been prescribed in the hope that they will respond in greater numbers and with
better qual-ity information is to be encouraged. These schemes are best
developed in New Zealand and by the Drug Safety Research Unit in Southampton
(United King-dom). The present authors believe that these schemes should be
encouraged and developed further in the coming decade. They are not without
their problems, however. This is especially so in the United King-dom at present
where there is a severe epidemic of concern within the public psyche about
confidentiality of medical information. Whilst no one would disagree with the
need to maintain confidentiality when dealing with information on illness, and
all would support the need for great care in this area, nonetheless there are
circumstances in which the need to link information from several different
sources is necessary to ensure appropriate interpretation of the data. This is
most marked in the case of cancer registry data, but is also a clear feature of
many pharmacovigilance issues.
The
problem becomes particularly acute when we observe the controversy about
patient confidentiality in the United Kingdom at the present time. The
regu-latory authority for prescribers (the General Medical Council) has been
rigid in its emphasis of the need for total patient confidentiality. Whilst at
first sight this seems entirely reasonable and laudable, observa-tional
research could be seriously damaged by such an approach: in particular, studies
such as cancer registries and drug safety monitoring studies are uniquely
vulnerable since both require coordination of disparate data sources (e.g.
demographic data, drug prescription data, hospital records and general
prac-tice records) to form a relevant patient record. In the absence of
adequate anonymous patient
registration numbers to bring these records together, identifiable information
may be required solely to coordinate such information. If this can only be
undertaken by receiv-ing individual patient consent, an unknown propor-tion of
patients (possibly up to 30%) will for one reason or another be unable or
unwilling to give such permission. Thus the value of the resulting data set is
dramatically reduced as it no longer constitutes a random sample from the
population. Warlow and colleagues have recently demonstrated this consent bias
in observational research (Al-Shahi, Vousden and Warlow, BMJ 2005; 331: 942–5).
In a follow-up study of patients with intracranial arterio-venous malforma-tions,
outcomes were clearly different between those who did and did not give consent.
Moreover, in the case of prospective databases involving literally millions of
patient-years of observations, the practi-calities of obtaining patient
approval to use identifi-able information solely to permit record linkage with
the objective of furthering public health objectives of potential benefit to
all people in the land seem at first sight almost insurmountable as well as
being prohibitively expensive. Are we then to cease this type of research?
Surely the answer to this must be a resounding ‘No’! We must find other more
prac-tical ways of achieving the desired end of maintain-ing quality research
into drug safety and into cancer surveillance whilst fulfilling the need for
confidential-ity for all patients. We would suggest that a reasonable position
to adopt would be one in which it was a recognised duty on patients receiving
treatment in the National Health Service to accept that their informa-tion
would be used for routine monitoring purposes, including disease incidence and
prevalence studies and studies into the safety of medicines. Such studies will
require records to be linked across several areas, and identifiers may be
needed for this purpose. At all times such confidential information would be
kept to the minimum necessary and would be used solely for this purpose. Data
can be protected by coding and restriction at various levels in the
capture-and-research process. Any breach of this confidentiality would be dealt
with severely by fines or suspension of a licence to practise. As far as we
know, there is no record of any confidential information being placed in the
public domain from such data sets. Thus the obsessive concentration on
confidentiality to the exclusion of all other facets of this issue is likely to
do substantial harm to world-class research if the issue of post hoc anonymisation cannot be
adequately and economically addressed.
In
summary, anonymised records should be the usual type of information used by
pharmacovigi-lators and pharmacoepidemiologists; however, there are times when,
for the public good and because anonymised information is not readily
available, iden-tifiable data will be required for linkage purposes. With
suitable safeguards in place and enforced, the public can be reassured that
such records can and should become a part of participation in NHS treatment,
including public health monitoring and research.
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