Module 3 PubHealth

• Pharmacoepidemiology


  Study of uses and drug effects on population
• Pharmacoepidemiology


  the study of the use and effects/side effects of drugs in

  large numbers of people with the purpose of supporting the rational

  and cost-effective use of drugs in the population thereby improving

  health outcomes
• Hippocrates


  Father of

  modern

  medicine

  Coined the

  term

  'endemic
• John Snow


  Father of

  modern

  epidemiology

  ¨ Work in tracing

  the source of

  cholera

  outbreak in

  Soho, England
• Joseph Lister


  British Surgeon

  ¨ Discovered

  antiseptic

  (carbolic

  acid) as an

  antiseptic by

  applying Louis

  Pasteur's

  advances in

  microbiology
• Ronald Rose and his team


  Introduced

  mathematical

  methods in

  epidemiology
• 1906


  US government passed pure Food and Drug act in response to excessive adulteration and misbranding of food and drugs
• 1937


  people died from renal failure due as a result of the elixir

  sulfanilamide dissolved in diethylene glycol
• 1938


  Drug and Cosmetic Act was passed
• 1950-1960


  Thalidomide tragedy
• 1968


  UK established a committee on safety of medicines
• WHO


  established a bureau to collect and analyze information and similar national drug monitoring organizations
• 1962


  Kefauver-Harris Amendments
• 1960


  related field od drug utilization was developed along with the

  study of ADRs - considered to be the beginning of field of pharmacology
• International Society for Pharmacoeidemiology


  Established to obtain more data on risks and benefits of drugs in population and to discuss, develop an disseminate information
• Pharmacovigilance


  Is an area unique to pharmacoepidemiology and it is a type of continual monitoring of unwanted effects and other safety related aspects of drugs
• ¨ Randomized clinical trials

  ¨ Field trials

  ¨ Community intervention trials

  Experimental Pharmacoepidemiology studies
• ¨ Prospective cohort

  ¨ Retrospective cohort

  ¨ Case control

  ¨ Case series

  ¨ Case report

  ¨ Cross sectional

  ¨ Ecological

  ¨ Hybrid


  Nonexperimental pharmacoepidemiology studies
• ¨ Randomized

  ¨ Protocol-mandated visit and treatment schedule

  ¨ Treatment by protocol

  ¨ Restrictive entry

  ¨ Rigidly specified

  ¨ Prospective

  ¨ One primary objectiv

  Interventional/Clinical trial pharmacoepidemiology studies
• ¨ Non-randomized

  ¨ Routine care, no mandated visit and treatment schedule

  ¨ Broad entry criteria

  ¨ Naturalistic

  ¨ Prospective and/or retrospective

  ¨ Could state several objectives

  ¨ Little/no monitoring

  Observational Pharmacoepidemiology studies
• Randomized clinical trials


  Pharmacoepidemiology Studies (Experimental)Study patients with specific diseaseEx. Efficacy of alteplase and retaplase in prevention of MI
• Field trials


  Pharmacoepidemiology Studies (Experimental)Study subjects to prevent diseaseEx. Vaccination
• Community intervention trials


  Pharmacoepidemiology Studies (Experimental)Study communities to prevent diseaseEx. Fluoridation of water
• Prospective cohort


  Pharmacoepidemiology Studies (Non-Experimental)Observe group of patients treated with the same drug
• Retrospective cohort


  Pharmacoepidemiology Studies (Non-Experimental)Extract data from an existing repository to look at outcomes of exposed group
• Case control


  Pharmacoepidemiology Studies (Non-Experimental)Determine association between a drug and a rare event
• Case series


  Pharmacoepidemiology Studies (Non-Experimental)Reveal common experience of a number of patients following drug exposure
• Case report


  Pharmacoepidemiology Studies (Non-Experimental)Reveal the experience of a single patient following drug exposure
• Cross-sectional


  Pharmacoepidemiology Studies (Non-Experimental)Determine the prevalence of drug use in a patient population at a given time
• Ecological


  Pharmacoepidemiology Studies (Non-Experimental)Determine the association between drug use of a population or group and an event
• Pharmacology


  Study of the effects of drugs
• Clinical pharmacology


  Study of effects of drugs in humans
• Regulatory, Marketing, Legal, Clinical


  Reasons to perform Pharmacoepidemiology Studies
• Spontaneous reporting


  Source of Pharmacoepidemiology DataAll unsolicited reports of suspected AEsConfirmed by formal epedimiological studies
• Data mining


  Large complex databases
• Signal


  Previously unrecognized hazed

  - Known hazard more frequent or serious
• WHO, CIOMS, ICH


  Main agencies for global drug surveillance
• WHO-UMC and Eu Pharmacovigilance system


  Two international system for global drug surveillance
• Case control surveillance


  Uses case-control methodology to systematically evaluate and detect

  effects of medications and other exposures on the risk of serious illness

  o Non-prescription drugs and dietary supplements
• Prescription event monitoring


  Defined from prescription and followed-up for a defined period as to

  identify all adverse events occurring in the early post-treatment period