Ability of primary care health databases to assess medicinal products discussed by the European Union Pharmacovigilance Risk Assessment Committee (CAPs and NAPs in primary EHDs)

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Population studied

• Short description of the study population:
  Patients receiving at least one prescription for each substance (or class of substances) during the entire lifespan of each database until August 31, 2018
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  819175

Study design details

• Main study objective:
  To measure the extent to which exposure to different categories of medicines, including centrally authorised products (CAPs) and nationally authorised products (NAPs), discussed by the Pharmacovigilance Risk Assessment Committee (PRAC) in a 3-month period (September-November 2019) was adequately covered in four electronic primary care health databases in their entire lifespan until 31 August 2018
• Outcomes:
  Number of prescriptions Number of patients exposed
• Data analysis plan:
  Descriptive analyses include the number of substances without any prescription per database, authorisation type and duration of authorisation in 3 categories (<2 years, 2-5 years, >5 years), and the median (with range) number of prescriptions and patients available per database, authorisation type and duration of authorisation. To estimate the number of substances for which each database could meaningfully assess adverse events, we calculated the numbers of patient exposures required to detect a statistically significant adverse event associated with a range of theoretical relative risks (RR) for CAPs and NAPs in different frequency categories. This was based on a hypothetical comparison of two proportions using a 2-sided Fisher exact test with α = 0.05, power = 0.90 and equal numbers of patients exposed to the drug of interest and a comparator. Effect sizes of a doubling and a four-times increase in events rate against a hypothetical comparator were used

Documents

Study publications

Flynn R, Hedenmalm K, Murray-Thomas T, Pacurariu A, Arlett P, Shepherd H, Myles…