PurposeAn important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and their effectiveness.MethodsThis was a qualitative review of RM effectiveness studies in the European Union electronic Register of Post‐Authorization Studies (EU PAS Register); data extracted included study design, population, sample size, data sources, drug information, RMMs, study period, indicators, and their reported effectiveness.ResultsOf the 872 records in the EU PAS Register, 19 studies evaluating the effectiveness of RMMs were included. Eleven were cross‐sectional surveys and 8 used secondary data sources. Eighty‐nine percent (17/19) evaluated additional RMMs (used when routine RMMs are considered insufficient), and 36% (7/19) evaluated changes in routine RMMs (applicable to all medicinal products). A total of 42 effectiveness indicators were identified: 18 process and 24 outcomes. Half of the indicators (21/42) were successful; 2% (1/42) indicators were partially successful; 17% (7/42) indicators were inconclusive. Effectiveness of the remaining 31% (13/42) indicators could not be determined owing to limited information. The United Kingdom was the most frequent country for the conduct of RM effectiveness studies.ConclusionsMost of the included studies evaluated additional RMMs. Half of the effectiveness indicators (process and/or outcome) were reported as successful. This review provides evidence to support the development of future guidance on the effectiveness of RM in Europe.
Purpose -The aim of this paper is to assess the monitoring standards of methylphenidate prescribed by general practitioners (GPs) against the NICE guidelines. Design/methodology/approach -The data on methylphenidate prescribing by GPs in Chorley and South Ribble were collected using a custom designed proforma from patient records held at GP surgeries and interviews with GPs. The data were then analysed using descriptive statistics. Findings -The study finds that the majority (96 per cent) of the subjects who were on methylphenidate prescription from GPs were monitored by specialist services. This included both the National Health Service and the private sector. Only 62.5 per cent had documentation on physical monitoring and psychosocial intervention. Practical implications -The results of the study showed that the monitoring of children on methylphenidate did not conform to the NICE guidelines. This highlighted the need for clear communication of responsibility of monitoring across the services. This is more important in regions where there are not optimal functioning child and adolescent mental health services. Originality/value -As far as the authors know this was the first audit of its kind assessing the standards of methylphenidate prescribing done by general practitioners.
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