1. 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.,

• 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