What is Pharmacovigilance?

Pharmacovigilance refers to the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and other drug-related safety problems. Related to this general definition, the underlying objectives of pharmacovigilance are to prevent harm from adverse reactions in humans that arise from the use of health products within or outside the terms of marketing authorization and in relation to the life cycle of these health products.

The main goal of pharmacovigilance is thus to promote the safe and effective use of health products, in particular by providing timely information about the safety of health products to patients, healthcare professionals, and the public. Pharmacovigilance is, therefore, an activity contributing to the protection of patients and maintaining public health.

Many other issues are also of relevance to pharmacovigilance-related activities and include medication errors, lack of efficacy reports, off-label use, acute and chronic poisoning, assessment of drug-related mortality, abuse and misuse of health products, and adverse interactions of medicines with chemicals and other drugs.

The pharmacovigilance approach can be clinical, epidemiological, experimental (e.g., to reproduce an adverse effect in animals to better understand the mechanism involved for human protection), or diagnostic (e.g., imputable methods).

The ultimate goal of pharmacovigilance is to accurately characterize and optimize the benefit/risk ratio of a health product throughout its life cycle.

Medicines and vaccines have transformed the prevention and treatment of diseases. In addition to their benefits, medicinal products may also have side effects, some of which may be undesirable and/or unexpected. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine-related problem.

All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. However, the clinical trial process involves studying these products in a relatively small number of selected individuals for a short period of time. Certain side effects may only emerge once these products have been used by a heterogeneous population, including people with other concurrent diseases, and over a long period of time.

What is pharmacovigilance in clinical research?

Pharmacovigilance begins with clinical trials that provide data on the benefits and risks of a drug. The aim of pharmacovigilance in clinical research is to determine if the benefits outweigh the risks; if they do, drug manufacturers take steps to gain approval to market the new drug.

Phase I, II, and III clinical trials are needed before a drug company can apply for a new medicine’s market authorization. In these studies, the principal investigator is the main point of contact at the trial site. They are responsible for the conduct of the research and then feed it back to the sponsor (the pharma company).

During clinical trials, the investigator collects and analyzes data on serious adverse events (SAEs), determining whether the drug in question caused the SAEs. If they conclude that the negative side effects were causal, they are categorized as adverse drug reactions (ADRs).

The investigator shares this data with the pharmaceutical company responsible for the drug’s R&D (research and development). This is assessed by the pharmaceutical company’s in-house PV team and the patient files undergo medical review. The PV team determines if the drug is sufficiently safe and effective to progress to the next phase of clinical research or to submit an application to the regulatory authority for approval to go to market.

These regulatory authorities have the final word as to whether the drug’s safety and efficacy profile is acceptable.

If approved, Phase IV clinical trials may be conducted by the drug company to provide additional data on the safety profile and efficacy of a drug. These studies are beneficial as they provide data in a less controlled environment, representative of how patients are using the drug.

What is pharmacovigilance outside of clinical research?

Pharmacovigilance data from clinical research is limited due to study restrictions. PV data from clinical research poorly identifies:

• Potential drug interactions
• Long-term risks
• Risks that come from higher doses
• Dangers that come from drug misuse or abuse

For this reason, ongoing PV from healthcare professionals and consumers is necessary to update the potential risks of medications. The drug company may facilitate postmarketing drug safety surveillance (a specific type of Phase IV study) to monitor the “real world” effectiveness and safety of the product as it is not possible to anticipate all possible adverse effects of a drug based on preapproval studies. Numerous approaches can be adopted such as; spontaneous reporting systems, drug registries, electronic health records.

Why is pharmacovigilance important?

Pharmacovigilance is central to drug safety. PV analysis conducted in Phase I, Phase II, and Phase III clinical trials gives drug companies data on the safety profile of the drug. This data can be used for further R&D if necessary or can be submitted to regulatory authorities to allow new markets to be accessed.

Both PV practices in clinical research and those done through medical professionals and consumers offer valuable insights into the safety profile of pharmaceutical medications.

When a new adverse reaction is identified, the list of side effects on the label must be updated. At times, PV data can lead to the removal of a drug from the market (drug recall) due to dangerous side effects.