How is pharmacovigilance contributing to clinical research?

Mon Mar 1, 2021

Pharmacovigilance plays a crucial role in clinical research through monitoring, the discovery of interactions and various assessments and its effects are analyzed. Pharmaceutical and biotechnological medicines are built to treat, prevent or cure diseases.

What is Pharmacovigilance system?

Pharmacovigilance system includes collecting, monitoring, researching, assessing and evaluation health-related information from doctors, nurses, pharmacists to comprehend adverse drug reaction.
However, there are also risks factors in particularly adverse drug reactions (ADRs) that can cause serious harm to patients. Thus, for safety and security in medication ADRs, continuous monitoring is required for each medicine throughout its life cycle. While the development of drug components such as pre-marketing which includes early stages of drug design, clinical trials, and post-marketing surveillance, the role of Pharmacovigilance is integral. PV is typically concerned with the detection, assessment, understanding and prevention of adverse drug reactions.
Pharmacogenetics and pharmacogenomics are an imperative part of clinical research. Variation in the human genome is the reason for variable response to drugs and susceptibility to diseases. The entire sections are determined for early drug discovery to PV. In addition, PV has traditionally transformed in spontaneous mining reports that are submitted to national surveillance systems. The research focuses on shifting toward the use of data generated from platforms outside the traditional frameworks such as electronic medical records, biomedical literature, and patient-reported data in health forums.

Advance program in pharmacovigilance

PV or Pharmacovigilance was officially introduced in 1961, December. In 1968, the WHO promoted a programme for international drug monitoring for centralizing the world data on ADRs (Adverse Drug Reaction).

Necessary steps in an Advance program in pharmacovigilance:

Pharmacovigilance comprises of

  • Safety data management
  • Signal detection and decision making maintaining all safety issues
  • Actions, including regulatory for protecting public health
  • Informing all concerned parties

Safety Data Management

A serious adverse event for molecules can be generated during preregistration and post-marketing phase. It can occur while clinical trials and can be reported spontaneously. The unexpected adverse vent can arise during the life-cycle of a product, that might put the users into risks and curtail the life of the product. The single way to manage this load is by using the latest software and automation system.

The steps of data management systems are the following:

  • Data collection and verification
  • Coding of adverse reaction descriptions
  • Coding of drugs
  • Casualty assessment
  • Timely reporting to authorities
  • Scope of Pharmacovigilance system and prospect

    It is essential to meet the challenges of increasing range and potency in pharmaceutical discipline and biological medicines that includes vaccines. However, the risk of harm is less if medicines are used by well-informed health workers and patients who can understand and share the responsibility for using a particular drug.
    If any adverse effects appear for any new associations with a particular drug, they must be analyzed and communicated effectively. Vaccines and biological medicine require a modified system of safety monitoring. It is frequently administered to safeguard the health of children. This can be applied mainly to vaccines used within the national immunization programs. In many countries, those exposed to a particular vaccine represent the entire birth cohort; thus, a sizeable part of the whole population. People’s expectations of safety are high, and they are unwilling to countenance even a small risk of the adverse event.

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