Postmarketing surveillance
Encyclopedia
Postmarketing surveillance (PMS) is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance
. Since drugs are approved on the basis of clinical trials which involve relatively small numbers of people who have been selected for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population - and postmarketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
Postmarketing surveillance uses a number of approaches to monitor the safety of licensed drugs, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries and record linkage between health databases. These data are reviewed to highlight potential safety concerns in a process known as data mining
.
is the regulatory body which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance.
United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) jointly operate the Yellow Card Scheme
, which was one of the first examples of a Pharmacovigilance
scheme, aimed at mitigating Adverse Drug Reactions (ADRs)
United States: Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system called MedWatch
, to which doctors or the general public can voluntarily report adverse reactions to drugs.
Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
. Since drugs are approved on the basis of clinical trials which involve relatively small numbers of people who have been selected for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population - and postmarketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.
Postmarketing surveillance uses a number of approaches to monitor the safety of licensed drugs, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries and record linkage between health databases. These data are reviewed to highlight potential safety concerns in a process known as data mining
Data mining
Data mining , a relatively young and interdisciplinary field of computer science is the process of discovering new patterns from large data sets involving methods at the intersection of artificial intelligence, machine learning, statistics and database systems...
.
National Implementation
Canada: Health CanadaHealth Canada
Health Canada is the department of the government of Canada with responsibility for national public health.The current Minister of Health is Leona Aglukkaq, a Conservative Member of Parliament appointed to the position by Prime Minister Stephen Harper.-Branches, regions and agencies:Health Canada...
is the regulatory body which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance.
United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) jointly operate the Yellow Card Scheme
Yellow Card Scheme
The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Dr Bill Inman....
, which was one of the first examples of a Pharmacovigilance
Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
scheme, aimed at mitigating Adverse Drug Reactions (ADRs)
United States: Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system called MedWatch
MedWatch
MedWatch is the Food and Drug Administration’s reporting system for an adverse event or sentinel event, founded in 1993. An adverse event is any undesirable experience associated with the use of a medical product...
, to which doctors or the general public can voluntarily report adverse reactions to drugs.