title: The influence of primary care prescribing rates for new drugs on spontaneous reporting of adverse drug reactions.
abstract: BACKGROUND
  Adverse drug reaction (ADR) reporting makes a vital contribution to pharmacovigilance, although the factors that influence the reporting rate remain unclear. The aim of this study was to investigate whether the variation in the rate of reporting of suspected ADRs in different regions of Scotland was explained by differences in local prescribing practice and to quantify the extent of this influence.
  
  
  METHODS
  Population and primary care prescribing data were obtained for ten geographical areas based on the 15 administrative regions of the National Health Service in Scotland. All reports of suspected ADRs received from within Scotland for 2000 and 2001 were available from the regional monitoring centre (Committee on Safety of Medicines, Scotland). The primary analysis was based on 14 medications that appeared in the 'top ten' list for the frequency of reported ADRs for either year. Reporting rates for each area were expressed both in terms of population (reports per million people) and in terms of estimated exposure to those medications in primary care (reports per 1000 prescriptions). For each analysis, the Pearson correlation coefficient between reporting and prescribing data was calculated using SPSS software.
  
  
  RESULTS
  The 'top ten' medications accounted for 1715 of 2817 (60.9%, 95% CI 59.1, 62.7) ADR reports but only 2.2 million out of a total of 128 million primary care prescriptions (1.7%). Although there was a 3-fold geographical variation in the per-population ADR reporting rate, there was a close correlation between local reporting of ADRs and prescribing of the index medications (p = 0.66, p = 0.04, respectively). This implies that 44% of the observed variation in reporting rate can be attributed to variation in prescribing within the same population.
  
  
  CONCLUSIONS
  Spontaneous ADR reporting in Scotland over the 2 years studied was highly concentrated on a small number of medications that were under intensive surveillance. Although there was a 3-fold variation in reporting rates from individual geographic areas when corrected for the size of the population, primary care prescribing data showed nearly half of this local variation in reporting rates could be explained by differences in prescribing. This study highlights the importance of considering prescribing practice when interpreting spontaneous ADR reporting data.
authors.affiliation: Information Services Division (National Health Service, Scotland), Edinburgh, UK.
authors.forename: Richard C
authors.initials: RC
authors.lastname: Clark
authors.forename: Simon R J
authors.initials: SR
authors.lastname: Maxwell
authors.forename: Sheena
authors.initials: S
authors.lastname: Kerr
authors.forename: Melinda
authors.initials: M
authors.lastname: Cuthbert
authors.forename: Duncan
authors.initials: D
authors.lastname: Buchanan
authors.forename: Doug
authors.initials: D
authors.lastname: Steinke
authors.forename: David J
authors.initials: DJ
authors.lastname: Webb
authors.forename: Nicholas D
authors.initials: ND
authors.lastname: Bateman
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D016642:Bupropion / Q000009:adverse effects / Q000627:therapeutic use; D000069287:Capecitabine; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use; D000077144:Clopidogrel; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D016903:Drug Monitoring / Q000379:methods / Q000706:statistics & numerical data; D011307:Drug Prescriptions / Q000145:classification / Q000706:statistics & numerical data*; D017723:Drug Utilization Review / Q000706:statistics & numerical data*; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D011320:Primary Health Care / Q000379:methods*; D012606:Scotland; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D018687:Antidepressive Agents, Second-Generation; D000964:Antimetabolites, Antineoplastic; D052246:Cyclooxygenase 2 Inhibitors; D007783:Lactones; D022401:Meningococcal Vaccines; D010975:Platelet Aggregation Inhibitors; D013450:Sulfones; D016642:Bupropion; D015283:Citalopram; C116926:rofecoxib; D003841:Deoxycytidine; D000069287:Capecitabine; D000077144:Clopidogrel; D013988:Ticlopidine; D005472:Fluorouracil