Complexities in Drug Safety

Epidemiology and Pharmacoepidemiology in relation to Pharmacovigilance

Both epidemiology and pharmacoepidemiology are of great importance to contemporary pharmacovigilance practice globally.

This page provides brief definitions and explains their role within modern drug safety work, and if you are looking for more information on PrimeVigilance pharmacoepidemiology solutions to support increasing demand from regulators, please visit our Pharmacoepidemiology and Risk Management Solutions section.

Brief Definitions Of Epidemiology

Epidemiology is the scientific study of disease within the context of how it arises within any given “real life” population. It examines diseases as they arise within that population:

  • the number of patients affected
  • any common characteristics they share
  • their geographical location
  • any notable behavioural characteristics between patients
  • any notable characteristics of the environment in which the patients live
  • the number of new cases over a given period of time
  • any interventions which function to control the disease

The aim is to extend the knowledge base surrounding the disease: which groups in the population are affected; where do they live; and whether there are any identifiable causes. It ultimately aims to establish whether any conclusions can be drawn about why the disease arose, how its distribution developed. From this information, the conclusions can help to inform health care decisions which can better control the disease. The subject of epidemiology is naturally the subject of a vast body of global literature.

Brief Definitions Of Pharmacoepidemiology

Pharmacoepidemiology is the scientific study of the effects of the use of prescribed (and non-prescribed e.g. over-the-counter) drugs within a given population. It aims to examine all detectable effects, whether beneficial or adverse for patient’s health status. It looks at how the drugs are used by patients in real life: how they are prescribed by doctors and how they are consumed by patients in daily life.

Both disciplines are reliant on the use of statistical analyses of large populations rather than small groups of individuals to produce meaningful conclusions. This means they are not used as a way to investigate the clinical history of any one individual patient, rather to look at what is occurring in a larger group who may or may not share some common characteristics.

Applications Within Pharmacovigilance

Although not the subject of routine pharmacovigilance services, both epidemiology and pharmacoepidemiology are used on the resulting safety data in order to better understand its relevance to patients’ use of medicines in real life. Epidemiology information is included in what is known as the “Safety Specification” for each new medicine – this is part of the Risk Management Plan and describes what is known about the safety profile of the medicine, what is uncertain and what information is missing. Preparing the Risk Management Plan itself is considered one element of a pharmacovigilance service.

Specifically, epidemiological information about the disease that is to be treated by the medicine is critically important to understand what will be seen when the patient receives the medicine. For example, how old, what gender and in what ethnic groups does this disease occur? What other illnesses do these patients commonly have? What other medicines are they likely to take? How would the disease develop over time if untreated? All of this information may be the subject of epidemiological study and is described in the Safety Specification.

The Risk Management Plan includes a Pharmacovigilance Plan that aims to provide more and better information about the known risks associated with a medicine, as well as to fill the gaps in safety knowledge that were missing from clinical trials. Pharmacoepidemiology studies – generally registries in large populations of patients receiving the medicine after marketing – are used to follow up patients and find out how they fare with the passage of time. Other types of pharmacoepidemiology study may be used to investigate new safety signals that may arise after a medicine has been marketed.

Please note for brevity these brief descriptions are by no means comprehensive enough to constitute any type of reference document and cannot be interpreted as professional advice.

Reference And Suggested Further Lay Reading

1. Barton L. Cobert, MD. (2007). Manual of Drug Safety and Pharmacovigilance. Massachusetts: Jones and Bartlett.

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