ADR related questions received by a telephone medicines information service and ADRs received by a spontaneous ADR reporting system: a comparison regarding patients and drugs

Abstract

A telephone medicines information service (telephone service) has been available in the Netherlands since 1990. Patients can anonymously and free of charge ask a pharmacist all kinds of questions related to medication use. An analysis of the questions (n=7541) received by this service in 1994 showed that 28% of the questions predominantly related to adverse drug reactions (ADRs). A comparison was made between questions concerning ADRs received by the telephone service and suspected ADRs reported to the regionalized ADR reporting system LAREB regarding characteristics of the associated patients and medicines. In both systems approximately two out of three patients were women. LAREB received relatively more reports concerning patients of 60 years and older, whereas the telephone service received relatively more questions from patients aged 20–40 years. For most classes of medicines the observed proportion of encounters at both systems differed from the expected proportion estimated by the number of prescriptions in the same year. Antidepressants in particular were more frequently encountered at both systems than expected. There were clear differences between the telephone service and LAREB regarding the classes of medicines encountered. Reports of suspected ADRs submitted to LAREB more frequently involved antibiotics, antirheumatic products, anti‐asthmatics, antihypertensives and topical antifungals, whereas questions concerning ADRs received by the telephone service significantly more frequently concerned drugs acting on the central nervous system (anxiolytics/hypnotics/sedatives, antidepressants and antipsychotic drugs) and corticosteroids. We are setting up further studies to investigate whether telephone services can serve as an additional tool in postmarketing surveillance for identifying potential drug safety issues. © 1997 John Wiley & Sons, Ltd.

Impact of a Policy Change on Pharmacists’ Reporting of Adverse Drug Reactions

“…Previous studies have noted that altering the working definition of an ADR, either alone or in concert with modifications to reporting infrastructures, can significantly change the rates at which ADRs are both detected and subsequently reported. 16,[40][41][42] The pharmacists' self-identified ADR reporting rate remained consistent at about 45% in both survey periods, and accuracy of respondents' recall was supported by independently generated workload data. Given the substantial number of considerations that must be taken into account when deciding to report suspected ADRs, 43 this rate appears reasonable.…”

“…10,14,15 Surveillance of ADRs in medication users outside the hospital setting may be especially helpful, as such individuals may have fewer confounding factors to complicate the assessment of causality. Surveillance in outpatients may also detect ADRs in different drug categories, 16 such as herbal and natural health products. 17,18 ADR reports obtained directly from patients may also provide earlier signals of adverse effects and can capture humanistic outcomes that may be overlooked or downplayed by health professionals.…”

First French Experience of ADR Reporting by Patients After a Mass Immunization Campaign with Influenza A (H1N1) Pandemic Vaccines

“…In particular, few comparative studies (patient vs professional reports) have been retrieved. [25][26][27][28][29] In 2009, a Dutch study by Van Hunsel et al [27] assessed patient reports following a television programme on the benefits and risks of statins. Some differences were observed in the category of ADRs, according to the primary SOC and Preferred Term, but no difference was observed in the level of seriousness.…”

“…In these papers, various methodologies of data collection or analysis are encountered (format of patient 'forms', postal questionnaire and telephone interview). [24,25,[27][28] In particular, some comparative analysis between patient and HCP reports were based on different data sources and/ or different data collection methodologies. [25,28] In the present study, the integration of patient participation as part of an existing system, with no substantial difference in data collection, treatment or encryption processes, ensures a satisfying comparability between patient and HCP reports.…”