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发帖数: 25265 | 1 Postmarketing surveillanceFrom Wikipedia, the free encyclopediaJump to:
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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.[1] These data are reviewed to highlight
potential safety concerns in a process known as data mining.
[edit] National ImplementationCanada: 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.
[2]
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.[3]
[edit] Footnotes1.^ McNeil JJ, Piccenna L, Ronaldson K, et al. (2010). "The
Value of Patient-Centred Registries in Phase IV Drug Surveillance". Pharm
Med 24 (5): 281-288. http://adisonline.com/pharmaceuticalmedicine/Fulltext/2010/24050/The_Value_of_Patient_Centred_Registries_in_Phase.2.aspx.
2.^ "Post-marketing Pharmacosurveillance in Canada". Health Canada. 2005. http://www.hc-sc.gc.ca/hcs-sss/pubs/pharma/2005-pharma-surveill-can/ref-can_3_4-eng.php. Retrieved 2010-07-27.
3.^ "Post-marketing Surveillance". U.S. FDA/CDER. 2004. http://www.fda.gov/cder/regulatory/applications/Postmarketing/surveillancepost.htm.
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: Postmarketing surveillanceFrom Wikipedia, the free encyclopediaJump to:
: navigation, search
: 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
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