the fenoterol story pharmacoepidemiology jean fran ois boivin 5 november 2010 n.
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The fenoterol story Pharmacoepidemiology Jean-François Boivin 5 November 2010

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The fenoterol story Pharmacoepidemiology Jean-François Boivin 5 November 2010

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  1. The fenoterol story Pharmacoepidemiology Jean-François Boivin 5 November 2010 1

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  9. 9 Lancet – 29 April 1989 – Pages 917 - 922

  10. Source of cases New Zealand National Asthma Mortality Survey 5 – 45 years old Source of controls Hospitalized asthma patients 10

  11. Sources of data, asthma treatment Cases: General practioner questionnaires completed for the National Asthma Mortality Survey Controls: Hospital record notes 11

  12. Drug A B SEVERE ASTHMA + Death RR = 0.5 - 1000 10 MILD ASTHMA + Death RR = 0.5 - TABLE 4 A cohort study 100 100 ALL PATIENTS + 202 8 Death RR = 2.5 - 898 102 1100 110 12

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  14. Source of cases Death from asthma • National Health Statistics Centre Hospitalized in 12 months before death Source of controls Hospitalized for asthma 14

  15. Source of data, asthma treatment Medical record notes 15

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  17. 17 NEJM 1992; 326: 501-506

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  19. Saskatchewan data bases Saskatchewan Drug Plan Deaths Hospital discharge diagnoses Procedure codes ( e.g.: intubation) Doctor billing codes Use of health services • Hospitalizations • Doctor visits 19

  20. x x 10 prescriptions of asthma drugs death • death certificates • coroner’s reports • autopsy reports • hospital discharge summaries x x 10 prescriptions alive 20

  21. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 10 years x x 10 prescriptions alive 20

  22. Death rate in study cohort? 1 death 22 person – years ? 1 death 20 person –years ? 21

  23. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 10 years x x 10 prescriptions alive 22

  24. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 2 years 10 years x x x 10 prescriptions allergy treatment death 22

  25. 1 year 10 years x x 10 prescriptions of asthma drugs death 1 year 2 years 8 years x x x 10 prescriptions allergy treatment death 22

  26. 1 death 8 person – years ? Death rate, allergy treatment 1 death 10 person – years ? 1 death 11 person – years ? 23

  27. Pharmaco-surveillance: Vaccines 24

  28. Example: Time-trend studies Percentage of Children Receiving Measles-Mumps-Rubella (MMR) Immunization in Second Year of Life and Caseload of Children With Autism, by Year of Birth, California, 1980-1994 JAMA. 2001;285:1183-1185 Time Trends in Autism and in MMR Immunization Coverage in California 25

  29. Polio vaccine: Cutter incident Wyeth 26

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  43. Questions that can be studied with a case -crossover design (Rothman 2002, page 89) Exposure varies from time to time • coffee • exercise One cannot study • blood group • low weight at birth 40

  44. Case cross-over studies Exposure triggers a short-term effect • asthma • sudden death One cannot study • lung cancer • osteoporosis 41

  45. Case cross-over studies Disease must have abrupt onset • allergic reaction • myocardial infarction • car accident One cannot study • multiple sclerosis • hypercholesterolemia 42

  46. Case cross-over studies Effect of exposure must be brief • anxiety in traffic • distraction on cell phone • panic during earthquake One cannot study • sedentarity • personality disorder 43

  47. N Engl J Med 2000; 343: 1355-61 44

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  49. N Engl J Med 2004; 351: 1721-30 46

  50. N Engl J Med 1997; 336: 453-8 47