What is Pharmacovigilance?


Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Pharmacovigilance involves reporting these events to ensure that they are communicated to health care professionals who will then inform the patients. This involves monitoring patients for adverse reactions when they receive treatment therapeutically or prophylactically.

The main goals of PV are:

  • to detect new signals about a treatment;
  • to identify any causal relationship between an adverse reaction and a treatment;
  • to take appropriate action if necessary, such as updating warnings on product labelling;
  • to gather information from healthcare professionals, patients and consumers that can help us evaluate whether treatments are working effectively when used in clinical practice;

Pharmacovigilance involves more than just reporting adverse drug reactions (ADRs). It also includes risk management and coordination of a patient’s care.

As a multidisciplinary field of science, pharmacovigilance focuses on the overall safety of healthcare products as well as the risk-benefit relationship for patients and other stakeholders to ensure safe and effective drugs are administered.

The fields of pharmacology, epidemiology, clinical pharmacology, clinical research, pharmacoeconomics, and regulatory affairs are all interlinked with each other to ensure that there is an appropriate balance between benefits and risks when treatment is used in humans. Beyond reporting adverse drug reactions (ADRs), PV also considers both physical and mental health needs throughout a patient’s lifetime as a result of monitoring possible side effects caused by a treatment.

The most common reasons for discontinuing a drug are related to adverse drug reactions (ADRs).

ADRs are a common reason for discontinuing a drug, and it has been found that ADRs are more likely to occur in people taking multiple drugs concurrently. Pharmacovigilance not only helps to protect against serious side effects but it also allows you to make informed decisions about your health care.

In older people, drugs interact with each other more frequently and cause more severe ADRs than in younger people.

As you age, your body becomes more vulnerable to side effects from medications. Older adults are more likely to be taking multiple medications, as well as drugs with a narrow therapeutic index. For example, if you take an antihypertensive medication (a blood pressure lowering drug), your doctor may prescribe another drug for the same condition in order to prevent falls or treat acute heart failure. The risk of adverse reactions increases when these two medications are taken concurrently with other medicines that shave similar properties or function in the body.

Understanding pharmacovigilance can help you feel better about participating in a clinical trial.

Enrolling onto clinical trials is often a stressful process for patients. Information regarding side effects and efficacy of a treatment can be largely unknown until the trial is completed. However, understanding the intentions of pharmacovigilance can help ease the emotional worries associated with participating. The process of pharmacovigilance can be broken down into three key steps:

  • Monitoring the safety of drugs before and after they are approved for use.
  • Detecting side effects early through monitoring in order to prevent harm to patients
  • Treating adverse events and communicating them to health care providers, researchers, and regulatory agencies.

For a patient, this means that there is continuous monitoring and discussion within the research and drug development community in order to ensure that a drug is a safe and effective treatment option.


Through active and passive monitoring, researchers and healthcare professionals proactively aid in the investigation of developing safe and effective drugs. Hence, pharmacovigilance is a vital part of medical research that ultimately aims to improve the quality of life for patients.

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