What is Pharmacovigilance?

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What is Pharmacovigilance?

Most of you might have heard this term during many incidences. Are you wondering what actually the Pharmacovigilance is? You are at the right place. This article will tell you all about Pharmacovigilance. Continue reading ...

Defining Pharmacovigilance:

Pharmacovigilance can be defined as the process of evaluating as well as improving the safety of drugs. In other words, it can be called as the practice of using the scientific methods for tracking, recording and analyzing the effects of various pharmaceutical goods. This is also known as 'Drug Safety'. (1), (2), (3)

Terminologies Involved:

In this unique field of pharmacological science, there are some terminologies which are important to be known and understood. Those terms are:

- Adverse Drug Reaction

- Adverse event

- Benefits

- Causal relationship

- Clinical trial

- Control group

- Dechallenge and Rechallenge

- Effectiveness

- Efficacy

- Event

- Harm

- Implied causality

- Individual Case Study Report

- Life-threatening

- Phase

- Risk

- Risk factor

- Signal

- Temporal relationship

- Triage (3)

Why Pharmacovigilance?

As you are aware, before a drug is marketed, any experience of the drug's safety as well as efficacy is limited to its use in the clinical trials. However, it is to be noted that the conditions under which the patients and medicines are being studied in these clinical trials do not necessarily reflect the way in which the drugs are being used in the hospital settings and general practice after they are marketed.

When a drug is released into the market, there will be a great deal that is still unrevealed about the safety of the particular product. Different medicine brands might differ in the way in which they are being produced and the ingredients that are used. And, some adverse reactions may not be seen until a larger population has received the drug. Therefore, it is important that the safety of all the medicines is monitored all through their marketed life which is known as Pharmacovigilance. (4), (5)

What does the Pharmacovigilance Process Involve?

Pharmacovigilance is the process which would involve:

- Monitoring the use of pharmaceutical drugs in daily practice in order to identify the adverse effects which are unrecognized previously.

- Monitoring the use of pharmaceutical drugs in daily practice in order to identify the changes in the patterns of adverse effects.

- Assessing the risks as well as benefits of the pharmaceutical drugs in order to determine the action to be taken if necessary for improving the safe use.

- Providing information to the patients as well as healthcare professionals in order to optimize the safe and effective use of the pharmaceutical drugs.

- Monitoring the impact of any action that has been taken in the past. (4)

Primary Objectives of Pharmacovigilance:

The primary objectives of Pharmacovigilance process are as follows:

- Early detection of the unrevealed safety problems.

- Detection of the increases in frequency of safety problems.

- Identification of the risk factors.

- Quantification of the risks.

- Preventing the patients from getting affected unnecessarily. (6)

- Improving patient care as well as safety in relation to the use of pharmaceutical drugs.

- Improving public health and safety in relation to the use of pharmaceutical drugs. (7)

Steps Involved in Pharmacovigilance Process:

Following are the steps that are involved in the Pharmacovigilance process:

Detecting and Reporting an adverse drug reaction: An ADR form will be filled out with the patient and reaction details. And, this would form the basis for data entry.

- Spontaneous Reporting: This is the most common form of reporting. Here, the healthcare professionals would identify and report any suspected ADR to the Pharmacovigilance centers or to the manufacturers.

- Mandatory Reporting: Here, the manufacturers will be required to submit the reports they receive from the healthcare professionals to the respective national authority in the form of 'Periodic Safety Update Report' wherein a regulatory document that is prepared by the 'Marketing Authorization Holder' will be submitted to the agency. This report would include information on all ADRs irrespective of the reporting country. In addition, this report would also include scientific evaluation of the risk-benefit balance.

What is Signal Detection in Pharmacovigilance?

This is relatively new term in the pharmacological field which was previously called as 'Unknown Safety Information'. As per the 'World Health Organization', signal detection is defined as the reported information on any possible causal association between a drug and an adverse event in which the relationship being unclear or not fully documented previously.

Regulatory Actions Taken:

Following are the regulatory actions that are taken on the basis of ADR reports:

Summary of Product Characteristics: This is the basis of information for the healthcare professionals on how to use the pharmaceutical product safety and efficacy.

Patient Information Leaflets: This is drawn up in accordance with the 'Summary of Product Characteristics'.

Changes in Classification:

- From over-the-counter to prescription only medicines

- From renewable to non-renewable

- Special medical prescriptions

- Restricted prescriptions

Marketing Authorization withdrawal

Batch recall based on the clustering of ADRs (7)

Improving Pharmacovigilance:

Following are the ways to improve Pharmacovigilance process:

- Increasing the awareness among healthcare professionals and the public about the importance of Pharmacovigilance.

- Developing and promoting an effective channel for adverse drug reaction reporting. For example: online reporting system.

- Coordinating all the parties that are involved in Pharmacovigilance reporting under a platform.

- Setting up a centralized database for the safety reports in order to facilitate the systematic follow up as well as detailed analyses.

- Improving the communication among the stakeholders in the reporting of adverse events such as:

- The regulator

- The healthcare providers

- Manufacturers (6)

Pharmacovigilance in India:

Although the western countries have seen major achievements in the Pharmacovigilance, India is yet to catch up. The National Pharmacovigilance Program was inaugurated during November 2004 and became operational during January 2005. This program was overseen by 'National Pharmacovigilance Advisory Committee' which was based in 'Central Drugs Standard Control Organization'. This program was then renamed as 'Pharmacovigilance Program of India' and became operational during July 2010. (8)


(1) http://www.haiweb.org/19072009/19July2009FactsheetTheEuropeanCommission'sProposalforaPharmacovigilanceDirective.pdf

(2) http://www.safemedicines.org/what-is-pharmacovigilance.html

(3) http://en.wikipedia.org/wiki/Pharmacovigilance

(4) http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/Pharmacovigilance/index.htm

(5) http://www.who.int/medicines/areas/quality_safety/safety_efficacy/S.AfricaDraftGuidelines.pdf

(6) http://www.pmda.go.jp/english/events/1st_indonesian-japanese_symposium/6_Important_of_Pharmacovigilance_for_Manufacture.pdf

(7) http://www.slideshare.net/tulasiraman/pharmacovigilance-23894909

(8) http://www.chemtech-online.com/P&B/vijay_march13.html

About the Author

Tharani Rajamanickam's picture

I am Tharani. I have Bachelors degree in Biotechnology. I am passionate about the healthcare and medical industry and continue to explore, learn and share and I bring in a wealth of knowledge and expertise to help you keep updated with current trends and developments. I have gained a lot of experience in clinical field by working in clinical trials arena. Stay tuned..

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