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| Drug Safety and Medicine |
Drug Safety and Medicine in General
Drug Safety is also known as Pharmacovigilance.
Drug safety is, the pharmacological science related to the
compilation, detection, evaluation, monitoring, and avoidance of serious
adverse events, adverse events with medicinal products or pharmaceutical
products.
Meaning of Pharmacovigilance:
- Pharmakon (Greek word for drug)
- Vigilare (Latin word for to keep watch).
Drug safety or Pharmacovigilance heavily focuses on adverse
drug reactions. Patients who are participating in clinical trials experience
adverse events following the administration of new investigational product.
Once the medicine is marketed, the patients complain about the harmful effects
of drug. All these adverse events and harmful effects caused by medicines are
collected, monitored and prevented with Drug safety or Pharmacovigilance.
These adverse events can be categorized into fatal events,
serious adverse events and non serious events. Also, special consideration is
taken about the adverse events caused during pregnancy, breast feeding and in
special population (children’s and old people, patients with renal and hepatic
dysfunctions.
Adverse drug reactions (ADR):
The ADRs are defined as any response to a drug which is
harmful and unintended, including lack of effectiveness of a particular drug.
Serious adverse events (SAE):
The outcome of the SAEs is as follows
- SAE results in death, or is life-threatening;
- SAE requires inpatient hospitalization or prolongation of
existing hospitalization;
- SAE results in persistent or significant disability or
incapacity;
- SAE results in a congenital anomaly (birth defect); or is
otherwise
- SAE can be "medically significant" —This criteria
it does not meet above criteria, but is considered serious because this
criteria requires treatment/intervention
The following organizations play a key joint role in the
global oversight of Pharmacovigilance:
- The International Council on Harmonization (ICH)
- The World Health Organization (WHO)
The Council for International Organizations of Medical
Science (CIOMS)
This blog provides information about the drug safety or
Pharmacovigilance and the latest updates in medicine.
