Regulatory decisions. Emphasis on safety issues

Effective post-marketing surveillance of drugs calls for an approach tuned to the individual problem. In Sweden, the combined use of spontaneous adverse drug reaction (ADR) reporting data and different registers has yielded much valuable information on safety problems with different drugs. However, the raw data must be interpreted with care and often be supplemented by in-depth studies. The advantage with registers is that they comprise the whole or a random sample of the population and that the reporting routines are fairly simple. Since much of the information is collected primarily for other purposes (like health care planning or budgeting) the cost of the information is low. The potential of spontaneous ADR reporting for detecting new rare ADRs is exemplified by the zimeldine case. Limitations of the system besides low and selective reporting are that the physicians must suspect the clinical manifestation to be drug-induced and that patient compliance is unknown. The greatest disadvantage with the patient- and disease-oriented registers is the frequent inaccuracy of the diagnoses and the delay in the appearance of the data. Improved education and more resources for updating the registers are required. The ICD-code should be adapted to the needs of drug monitoring. Since the registers contain sensitive information about individual patients, the confidentiality of the data must be secured. As a logical complement to these sources of information, systems for case control studies, to be adopted ad hoc when problems arise, should be instituted. Moreover, for certain kinds of long term drug reactions, record-linkage systems are probably the only means to disclose risks (e.g. of cancer) after long term drug exposure. In this respect, the computerisation of Swedish pharmacies offers unique possibilities for the retrieval of prescription data on individual patients.