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Importance of Pharmacovigilance

Published Date : July 04, 2018


Pharmacovigilance is the process of collecting, detecting, assessing, monitoring and deterring drugs of detrimental effects. It is also referred to as drug safety. The data necessary for assessments are collected from various sources procured from patients and health care providers and medical literature. Local drug regulatory authority demands the submission of adverse event data received by any pharmaceutical company for the marketing of a pharmaceutical product. This is applicable in most of the countries.

Significance of pharmacovigilance:

Pharmacovigilance agreements (PVAs) furnish the necessary information related to terms and conditions for an efficient Pharmacovigilance to take place. Hence, pharmacovigilance plays a crucial role in the prevention of adverse effects that may come to any patient during the usage of a pharmaceutical product. Enterprises of various types are asked to mandatorily perform comprehensive drug safety and pharmacovigilance audit to efficiently analyze their agreement with regulations, guidance and worldwide laws.

Adverse Event (AE) reporting:

Adverse event reporting is a common activity implicated in pharmacovigilance that often consumes enormous amount of resources for government agencies, drug related authorities, and other drug related departments in various pharmaceutical enterprises. The report may encompass various assessments that are acquired from patients, health care professionals and other essential forms of intermediaries. It is quintessential for pharmaceutical companies from different parts of the world to perform adverse event reporting and these reports also furnish sufficient data to firms and drug related authorities that play a pivotal role in creating a risk-benefit profile of a drug through appropriate assessment procedures.

Assessment of complications:

The complication of any drug is categorized based upon various factors. The determination of seriousness is essential to distinguish the detrimental quality of pharmaceutical drugs. The following are the various factors that determine the seriousness of any drug:

ü The drug is of life-threatening variety.

  • The usage of a specific drug resulting in the hospitalization of a patient.
  • Any pharmaceutical product that causes prolongation of hospitalization period.
  • The usage results in considerable incapacity or disability.
  • The usage could result in birth defect (congenital anomaly).

ü The usage is otherwise medically significant, but is serious due to the consideration of treatment to deter any one of the preceding criteria.

Reporting methods and risk management:

There are various reporting methods implicated in pharmacovigilance process. The common reporting methods encompass expedited reporting, clinical trial reporting, spontaneous reporting, aggregate reporting, and other potential reporting methods. Risk management forms an essential branch in pharmacovigilance studies wherein the assessment of the risks involved is performed and consequently efficient ways of managing such risks are mapped out.