Affiliation: Drug Safety Research Unit
- Prescription-event monitoring and reporting of adverse drug reactionsE Heeley
Drug Safety Research Unit, Bursledon Hall, SO31 1AA, Southampton, UK
Lancet 358:1872-3. 2001..Our results should not be extrapolated to calculate incidence rates of adverse drug reactions in the community from spontaneous reports...
- Automated signal generation in prescription-event monitoringEmma Heeley
Drug Safety Research Unit, Bursledon Hall, Southampton, United Kingdom
Drug Saf 25:423-32. 2002..However, with both methods it is important to perform signal generation at multiple levels in the dictionary and with careful selection of the comparator group...
- Relative risk of vaginal candidiasis after use of antibiotics compared with antidepressants in women: postmarketing surveillance data in EnglandLynda Wilton
Drug Safety Research Unit, Southampton, United KingdomUniversity of Portsmouth, Portsmouth, United Kingdom
Drug Saf 26:589-97. 2003..Aim: To determine the relative risk of vaginal candidiasis following the use of antibiotics compared with antidepressants in prescription-event monitoring (PEM) studies...
- Impact analysis of signals detected from spontaneous adverse drug reaction reporting dataPatrick Waller
Patrick Waller Limited, Consultancy in Pharmacovigilance and Pharmacoepidemiology, Southampton, UK
Drug Saf 28:843-50. 2005..A computer program has been written to facilitate the process and reduce error. Further work is required to test the feasibility and value of impact analysis in practice...
- Testing and implementing signal impact analysis in a regulatory setting: results of a pilot studyEmma Heeley
Post Licensing Division, Medicines and Healthcare products Regulatory Agency, London, UK
Drug Saf 28:901-6. 2005..This paper describes a pilot project whereby impact analysis was simultaneously introduced into practice in a regulatory setting and tested in comparison with the existing approach...
- Chronic atrial fibrillation: Incidence, prevalence, and prediction of stroke using the Congestive heart failure, Hypertension, Age >75, Diabetes mellitus, and prior Stroke or transient ischemic attack (CHADS2) risk stratification schemeStephan Rietbrock
General Practice Research Database, Medicines and Health Care Products Regulatory Agency, London, United Kingdom
Am Heart J 156:57-64. 2008..The aim of the study is to estimate the incidence and prevalence of chronic AF (cAF) in the United Kingdom and test the accuracy of the CHADS2 score for stroke prediction...