Patient self‐monitoring: A challenging approach to pharmacoepidemiology

This paper reports the development over the past 10 years of an innovative patient self‐monitoring method of (1) signalling possible adverse drug reactions (ADRs) and unexpected beneficial drug reactions, and (2) providing incidence estimates and relative risks. The system's validity has been well documented in a series of published papers. There is no other existing postmarketing surveillance method that can obtain early reliable and accurate patient reports about possible side‐effects. We thought that, having successfully developed and validated the method, both the US Food and Drug Administration (FDA) and the pharmaceutical industry would recognize the need to support its application as an important complementary approach to existing postmarketing surveillance methods. Despite our repeated requests, however, neither FDA nor industry has shown any interest in helping to sustain this research, in part because pharmacoepidemiologists tend to focus on the detection of serious ADRs as defined and diagnosed by physicians, but also because it has become patently clear that the US pharmaceutical industry does not want its new drugs to be monitored for possible ADRs. Thus there is virtually no systematic attention being paid to the possible importance of less serious ADRs as inferred from accurate patient reports of behavioural and subjective symptoms — which, especially with CNS‐acting drugs, may often be essential for obtaining reliable ADR profiles.