Spontaneous Reporting Schemes

There is widespread agreement that spontaneous reporting schemes are here to stay. They are economical and embrace the entire population of patients and reporters. However, it is important to treat all such reports as hypotheses. Some will almost certainly be causally linked with the suspect drug, whereas others will turn out not to be so. With the increase in acceptance of reports from pharmacists and nurses in addition to doctors, 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 spontaneous reports. In so doing, there is a danger that the output from any review could be made available without the benefit of careful clinical and pharmacological 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 anecdotal 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 analysis by trained, experienced observers. Such people are in short supply; nevertheless, they are extremely valuable in the context of logical interpretation of spontaneous reporting schemes.

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 quality information, is to be encouraged. These schemes are best developed in New Zealand and by the Drug Safety Research Unit in Southampton. The present author believes 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 United Kingdom at present where there is a severe epidemic of concern about confidentiality of medical information within the public psyche. 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 pharmaco-vigilance issues.

The problem becomes particularly acute when we observe the controversy about patient con fidentiality in the United Kingdom at the present time. The regulatory authority for prescribers (the General Medical Council (GMC)) has been extremely legalistic in its approach to patient confidentiality. Led by its President, a distinguished retired general practitioner, the GMC has been draconian in its emphasis of the need for total patient confidentiality. Whilst at first sight this seems entirely reasonable and laudable, the areas of research referred to above could be seriously damaged by such an approach: in particular, observational 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 practice records) to form a relevant patient record. In the absence of adequate anonymous patient registration numbers to bring these records together, names and addresses may be required solely to coordinate such information. If this can only be undertaken by receiving individual patient consent, an unknown proportion 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. Moreover, in the case of prospective databases involving literally millions of patient-years of observations, the practicalities of obtaining patient approval to use names and addresses 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 practical ways of achieving the desired end of maintaining quality research into drug safety and into cancer surveillance whilst fulfilling the need for confidentiality for all patients. I 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 information 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 names and addresses 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. Any breach of this confidentiality would be dealt with severely by fines or suspension of a licence to practice. To this writer's knowledge, 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. The value of such systems is proportional both to their duration in existence and to their continuity. Any breach in either of these two areas could have serious long-term consequences for the value of their work.

Although I have addressed the confidentiality issue early in this review, it applies to all pharmacovigilance work. Briefly, anonymised records should be the usual type of information used by pharmacovigilators and pharmacoepidemiologists; however, there are times when, for the public good and because anonymised information is not readily available, named records will be required for linkage purposes. With suitable safeguards in place and enforced, such records should become a part of participation in NHS treatment and at the same time participation in future research in this crucial area.

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