1. Pharmacoepidemiology

1.2. Applications and contributions of pharmacoepidemiology

Some examples of applications and contributions of pharmacoepidemiology are:

  • Prediction of the magnitude (frequency and size) of the likely effects of the medicine, both intended and unintended.
  • Development of measurement scales to capture patient-reported outcomes (PRO)  that are linked to efficacy and safety measures.
  • Design of clinical efficacy trials.
  • Development of an expected safety profile.
  • Development of risk management plans and post-marketing safety studies.
  • Reassurance about medicines safety

  • Supplementing the information available from premarketing studies – better quantitation of the incidence of known adverse and beneficial effects, e.g.,

    • in patients not studied prior to marketing (e.g., the elderly, pregnant women);
    • as modified by other medicines and other illnesses;
    • relative to other medicines used for the same indication

    • New types of information not available from premarketing studies
      • discovery of previously undetected adverse and beneficial effects (e.g., uncommon, delayed, or rare effects)
      • formulation of therapeutic guidelines
      • finding material for possible new indications
      • understanding how the medicine is being utilised in routine clinical practice
        • describe the characteristics of patients who receive the medicine
        • patterns of medicines prescribing (the appropriateness of use)
        • medication adherence and persistence patterns,
        • identification of predictors for medication use.
        • evaluation of effects of medicines overdose in everyday use
      • determine the frequency and distribution of medicines use outcomes in a population (“Real-world data” (RWD) and “Real-world evidence” (RWE), focussing on
        • what is being used (assessment of specific medicines being used in certain situations)
        • how it is being used (assessment of the patterns of use, including how much, where and when, and by whom);
        • why it is being used (assessment of the reasons for medicines-taking behaviours and the functions that medicines serve in society)

    • Facilitate pharmaco-economic evaluation
    • Inform interventions or public health policy decisions that may need to be developed