DRUG SAFETY AND MEDICINE IN GENERAL

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:

1. The International Council on Harmonization (ICH)
2. 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.