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Keywords:

  • adverse drug reactions;
  • pharmacovigilance;
  • prescribing;
  • spontaneous reporting

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT

• Under-reporting of adverse drug reactions to regulatory authorities is common, and there is concern about falling numbers of general practitioner reports.

• Although previous work has suggested high prescribers are less interested in pharmacovigilance, a recent examination of reporting to the Yellow Card scheme has suggested ADR reporting is correlated with high prescribing rates.

• This study aimed to examine influences on the reporting of ADRs to the Yellow Card scheme in primary care.

WHAT THIS STUDY ADDS

• High prescribing rates within primary care are correlated with low ADR reporting rates.

• Several Primary Care Trust characteristics related to general practitioners, such as increased proportions of single-handed general practitioners and larger list sizes, are associated with low ADR reporting rates.

AIM(S) To examine Primary Care Trust (PCT) demographics influencing general practitioner (GP) involvement in pharmacovigilance.

METHODS PCT adverse drug reaction (ADR) reports to the Yellow Card scheme between April 2004 and March 2006 were obtained for the UK West Midlands region. Reports were analysed by all drugs, and most commonly reported drugs (‘top drugs’). PCT data, adjusted for population size, were aggregated. Prescribing statistics and other characteristics were obtained for each PCT, and associations between these characteristics and ADR reporting rates were examined.

RESULTS During 2004–06, 1175 reports were received from PCTs. Two hundred and eighty (24%) of these reports were for 14 ‘top drugs’. The mean rate of reporting for PCTs was 213 reports per million population. A total of 153 million items were prescribed during 2004–06, of which 33% were ‘top drugs’. Reports for all drugs and ‘top drugs’ were inversely correlated with the number of prescriptions issued per thousand population (rs=−0.413, 95% CI −0.673, −0.062, P < 0.05, and r=−0.420, 95% CI −0.678, −0.071, P < 0.05, respectively). Reporting was significantly negatively correlated with the percentages of male GPs within a PCT, GPs over 55 years of age, single-handed GPs within a PCT, the average list size of a GP within a PCT, the overall deprivation scores and average QOF total points. ADR reports did not correlate significantly with the proportion of the population over 65 years old.

CONCLUSIONS Some PCT characteristics appear to be associated with low levels of ADR reporting. The association of low prescribing areas with high ADR reporting rates replicates previous findings.