Clinical Research & PharmacovigilancePharmacovigilance

Basics of Pharmacovigilance: A Quick Overview

The Indian Pharmaceutical industry is growing at a rate of 12-14% per annum. Now, India is emerging as a destination for Drug Discovery and Development and is a Global Hub for Clinical Trials. Rapid growth in pharmaceutical entities and clinical trials has thrown up challenges of monitoring Adverse Drug Reactions (ADRs) over the global population.
It is true that all medicines have side effects and it is important to monitor both known and unknown side effects of medicines to determine new information available for their safety profile. This safety profile is accessed with the help of Pharmacovigilance program. Hence, it is very important to have a standardized and robust Pharmacovigilance and drug safety monitoring program.

Let us look at what “Pharmacovigilance” is? In simple language – Pharmacovigilance is the pharmacological science related to the detection, assessment, understanding and prevention of long term adverse effects, and short term side effects of medicines. The process of collecting the information about a drug starts right from the beginning of the clinical trials i.e. from phase I before the approval of the drug and continues even after its approval to be marketed. Many drug regulatory agencies around the world have made post marketing surveillance studies mandatory. Good Pharmacovigilance identifies the risks and risk factors in the shortest possible time so that the chances of ADRs (Adverse Drug Reaction) and AEs (Adverse Events) can be avoided or minimized.

WHO established the Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. 134 countries were part of the WHO PV programme by the end of 2010, and it aims to enhance patient care and patient safety in relation to the use of medicines and support public health programs by providing reliable and balanced information for effective assessment of the risk -benefit ratio of the drug.
It is important for all the pharmaceutical companies who are involved in the mass production of medicines to implement quality systems, as these medicines are used by patients of different genera. Many patients are likely to use several other drugs, even herbal and traditional medicines along with the prescribed drug. Pharmacovigilance not only monitors ADRs associated with modern medicines but also ADRs occurring in combination with traditional and herbal medicines.
ADRs can be location specific, i.e., one drug can cause ADRs in one country or region but may not produce any harmful effects in the other region/country. Pharmacovigilance proves to be an important monitoring system for the safety of medicines not only globally but in individual countries as well. This is achieved with the support of doctors, pharmacists, nurses, other health professionals and by the patient itself.

All the continents / regions in the world have their own Pharmacovigilance systems based on the WHO guidelines. Few of them are summarized below:-
Pharmacovigilance System in Europe:- EMA (European Medicines Agency) and NCAs (National Competent Authorities) coordinate and conduct the Pharmacovigilance program in Europe. EMA is responsible for maintaining and developing the Pharmacovigilance database comprising all suspected and unexpected serious ADRs that are observed in the European region. In Europe Pharmacovigilance system is known as EudraVigilance which includes separate but alike database of human and veterinary reaction.
Pharmacovigilance System in United States:- In US Pharmacovigilance has a multi facet approach and comprises of three branches: FDA (Food and Drug Administration) ; the pharmaceutical manufacturers; and the academic/non-profit organizations like RADAR and Public Citizen. The reports on ADRs are received by the US FDA and appropriate actions for drug safety are taken thereafter.
Pharmacovigilance System in India: – National Pharmacovigilance Program (NPP) was launched by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Govt. of India, in November 2004, based on the WHO recommendations made in the document titled “Safety Monitoring of Medicinal Products – Guidelines for Setting Up and Running a Pharmacovigilance Centre”. The National Pharmacovigilance Programme for India is sponsored by the World Health Organization (WHO) and is funded by the World Bank. The country is divided into zones and region for operational efficiency. CDSCO, New Delhi is at the top of the hierarchy followed by two zonal Pharmacovigilance centers viz., Seth GS Medical College, Mumbai and AIIMS, New Delhi. The NPP collects, collate, analyze and monitors data to identify any unexpected or suspected ADRs which is then further reported to WHO International Drug Monitoring Programme for international collaboration on drug safety.
The core of data generating system of international Pharmacovigilance program is spontaneous reporting. These reports generally faces a drawback that they are often under reported, as they are submitted voluntarily and relies on the healthcare professionals and consumers to identify and report any suspected ADRs to their National Pharmacovigilance Center or to the manufacturer. Good safety monitoring encourages healthcare practitioners to take full responsibility for the medicines they use, hence it is important to train the health professionals for diagnosis, management and prevention of ADRs. It helps to improve the clinical effectiveness and increases the confidence with which they and their patients use medicines.
Pharmacovigilance program has helped in identifying the safety profile of many drugs and also many drugs have been withdrawn from the market after their ADRs were observed in the larger population. Awareness for reporting ADRs needs to be incorporated into the system for creating safety profile for all medicines in use or would be coming into use in nearing future.

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