An agenda for UK clinical pharmacology: Pharmacoepidemiology

Abstract

Current concerns over the safety of medicines once they have been marketed mean that pharmacoepidemiology is of increasing importance. There are three main areas in which further research is needed.1 To improve the methods used to make causal inference of effects of medicines and to raise the quality of the reporting and critical appraisal tools, so that the strengths and weaknesses of the new methods can be judged. 2 To apply the methods in areas where randomized trials cannot easily be done, such as in pregnancy. 3 To use electronic health records as fully as possible, using linkage between different databases, ensuring the data are of as high quality as possible.Public health and public perceptions mean that much of pharmacoepidemiology must be done using non-industry funding sources.

Relevance of pharmacoepidemiology to Nepal

“…Antihistamines were the most prescribed drug category followed by NSAIDs. 7 Shankar PR et al, 2007 24 To study prescribing patterns of fluoroquinolones among hospitalised patients Inpatients enrolled during a period of five months and prescribed with fluoroquinolone were analysed Fluoroquinolone utilisation was 7.76 DDD/100 bed-days and contributed to 36.7% of the total drug costs and ciprofloxacin was the most prescribed fluoroquinolone. 8 Shankar PR et al, 2010 4 To study drug utilisation in older inpatients…”

“…7 This concept has since evolved to be a tool for monitoring real world situations such as after drugs are marketed for use. 8 The application of PE is important in health systems and has been beneficial in reducing drug-related problems in areas of use, as well as in the approval and ultimately for the promotion of rational use of drugs.…”

Calidad de la prescripción de verapamilo de liberación convencional en pacientes con hipertensión arterial

“…Es de importancia resaltar que intervenciones farmacoepidemiológicas y de farmacovigilancia de este tipo ayudan a identificar rápida y eficazmente pacientes con prescripciones potencialmente inapropiadas y asociadas a riesgo con la posibilidad de intervenir rápidamente, brindando herramientas adecuadas para la mejor prescripción de medicamentos 19 .…”

Importance of feasibility assessments before implementing non‐interventional pharmacoepidemiologic studies of vaccines: lessons learned and recommendations for future studies

“…In addition, reliable risk estimates for very rare (incidence range: <1 to 10/100,000 person-years) safety outcomes cannot usually be provided by pre-licensure clinical studies. Pharmacoepidemiologic (PE) studies are often seen as the best option to deliver evidence of safety post-licensure 13 . It is challenging to design sufficiently robust PE studies to generate reliable evidence on rare safety outcomes in real-life settings.…”

“…Regardless of the data source, the study design should consider the adequacy of the sample size (i.e. power), minimization/control of bias and confounding, accuracy of exposure information, and degree of specificity of the outcome assessment 13 . These aspects are challenged by ever-increasing expectations with respect to the quality of research voiced by the scientific community, the regulatory agencies, vaccine recommending bodies, and the public at large.…”