Pharmacoepidemiology is a synthetic field of knowledge for studying the use and effects of drugs on large groups of people.
In order to study the use and effects of drugs on large groups of people, pharmacoepidemiology involves a methodological apparatus of such remote areas of knowledge as pharmacology and epidemiology .
Thus, pharmacoepidemiology can be called a science that connects pharmacology and epidemiology. There are other areas of study that are unique to pharmacoepidemiology, for example, activities known as pharmacovigilance.
Content
Pharmacology
As a field of knowledge, he studies the effects of drugs on any living system, and clinical pharmacology studies the effects of drugs specifically on humans. One of the objectives of clinical pharmacology is to conduct a risk-benefit assessment of the effect of a drug on patients.
Carrying out such studies required to assess the likelihood of beneficial effects in populations, or determine the likelihood of adverse, adverse actions in populations and other parameters associated with the use of the drug may benefit from the use of epidemiological methodology.
In other words, pharmacoepidemiology can be defined as the application of an epidemiological method to pharmacological issues.
Epidemiology
Epidemiology is a field of knowledge that studies the distribution and determinants of diseases in populations.
Epidemiological studies are divided into two main types:
- Descriptive epidemiology characterizes the disease being recorded and / or its influence and includes the calculation of the frequency, that is, the occurrence of the disease and its prevalence in space, time and in the studied groups. Such descriptive studies do not use control groups, they are only able to put forward hypotheses without testing them. As a rule, studies of drug use fall under the category of descriptive studies.
- Analytical epidemiology itself involves two types of studies:
- observational studies, such as case-control studies and cohort studies, group studies,
- and experimental studies involving clinical trials of the type of randomized clinical trials. Analytical studies compare the group exposed to the drug with the control group and are usually planned as hypothesis testing studies.
Pharmacoepidemiology benefits from using the above methodology, developed in general epidemiology. She can further develop it for applications unique to pharmacoepidemiology.
Pharmacovigilance
Pharmacovigilance is a type of continuous monitoring of undesirable actions and other related safety aspects of drugs that are already on the market. In practice, pharmacovigilance is based solely on spontaneous reporting systems that allow health care professionals and others to report to the central unit about adverse reactions to the effect of the drug. The aforementioned central unit then combines messages from many sources to create an informational safety profile of a drug, based on one or more messages from one or more health care professionals.
- On April 1, 2019, the Federal Service for the Supervision of Public Health will launch an updated database of side effects of drugs [1] .
Implications for Health
Pharmacoepidemiology is a theoretical and methodological basis for organizing a service for monitoring drug safety, pharmacovigilance in drug manufacturing companies or holders of registration certificates.
Pharmacovigilance in the Russian Federation is carried out by the Federal Service for Supervision in the Sphere of Health and Social Development . Pharmacovigilance in the European Union is carried out by EudraPharm ; similar facilities exist in the USA and as part of WHO .
- Pharmacoepidemiology. Journal "Clinical Pharmacy"
- Pharmacovigilance. Journal "Clinical Pharmacy"
- Pharmacoepidemiology. Journal "High-quality clinical practice"
- Drug safety. Journal "High-quality clinical practice"