A discussion paper(3)

All the proposals were designed to improve the identification of adverse drug reactions rather than evaluate effectiveness, but this element could have been added. It is included in prescription-event monitoring in a limited way by asking physicians whether the drug was effective or not . Although effectiveness was not their main focus, an examination of the 1977 proposals is useful because they exhibit issues that would affect a present-day conditional release scheme. ventolin inhaler

Each scheme involved the registration of patients by a central monitoring agency, but the proposers of the schemes had no distinct opinion as to who should bear the responsibility of running it. Three suggestions were made: the pharmaceutical industry, the Committee on Safety of Medicines and an independent agency. Only the independent agency had definite advantages . The establishment of organizations that are free of governmental and industrial influences to monitor drug effects has been proposed in both the United Kingdom and the United States . The Drug Safety Research Unit, which runs prescription-event monitoring, was deliberately set up as an independent unit associated with a university and funded by the pharmaceutical industry on a purely sponsorship basis, not a contractual one. Similarly, the Intensive Medicines Monitoring Programme is part of the Centre for Adverse Reactions Monitoring located at the University of Otago . The organizational and funding aspects of a conditional release scheme are the first issues that should be considered (Table 1).

TABLE 1 Issues to be considered for a conditional release drug approval program

Who would do the coordination and evaluation work and who would pay for it?
How would patients be identified and who would register them?
Would all new drugs be monitored and for how long?
What data would be reported and evaluated and who would do the reporting?

In Inman’s and Dollery and Rawlins’ methods, the prescribing physician would register the patient, while in Lawson and Henry’s scheme , the dispensing pharmacist would perform this task. If physicians register patients, their prescribing habits and patient selection criteria would likely be different from normal, leading to the study patients being unrepresentative of the larger population that would eventually be exposed to the drug. Compliance could also be affected if patients became aware from physicians that they were receiving a new drug that was under evaluation.