Pharmacovigilance Programme of India(PVPI)

Pharmacovigilance has been defined by the World Health Organization (WHO) as the science and activities relating to the detention ,assessment ,understanding and prevention of adverse effects or any other medicine related issues.
WHO established its programme for international drug monitoring in response to the Thalidomide tragedy happened in the year of 1961.Latter WHO decided to start pharmacovigilance programme at the country level .

Pharmacovigilance programme in India
The central drugs standard control organisation (CDSCO) New Delhi,under aegis of Ministry of Health and Family Welfare ,Government of India initiated a national wide pharmacovigilance programme in July 2010 with AIIMS New Delhi as National coordination Centre (NCC)for monitoring ADRs in the country for safe -guarding public health by ensuring the safety of medical products.The NCC was shifted from AIIMS ,New Delhi to Indian Pharmacopoeia Commision (IPC) Ghaziabad on 15th April 2011.

National coordination centre (NCC)

Indian pharmacopoeia commision (IPC) is an autonomous institution of the Ministry of Health and Family welfare .Government of India and functioning as National coordination centre for pharmacovigilance programme of India.The main responsibility of NCC is to monitor all the adverse reaction of medicine being observed in Indian population and to develop and maintain its own pharmacovigilance database for patient safety .NCC IS participating in the WHO International drug monitoring programme and collaborating with the  WHO-Uppsala monitoring centre ,Sweden.India is the world's sixth country recognised by the World Heath Organization as a WHO -Collaborating Centre for Pharmacovigilance  in public heath programme and regulatory services. 

ADR monitoring centres (AMCs)

Effective communication channels are the key to successful functioning of any organization. The use of information communication technology at NCC-PvPI & across 250 ADR monitoring centre (AMC) working under its umbrella is a beautiful role model for government bodies in India .

SCOPE AND OBJECTIVES

1.  To create a nation-wide system for patient safety reporting.
2.  To identify and analyse new signals from the reported cases.
3.  To analyse the benefit-risk ratio of marketed medications.
4.  To generate evidence based information on safety of medicines.
5.  To support regulatory agencies in the decision-making process on use of medications.
6.  To communicate the safety information on use of medicines to various stakeholders to prevent/ minimise the risk.
7.  To emerge as a National Centre of Excellence for Pharmacovigilance activities.
8. To collaborate with other national centres for the exchange of information and data management.
9. To provide training and consultancy support to other National Pharmacovigilance Centres across the globe.
10. To promote rational use of medicines.

Short term goals 

1)To develop and implement pharmacovigilance system in India.

2)To start initially all MCI approved medical colleges  in the programme covering north,south,east and west of India.

3)To encourage healthcare professionals in reporting of ADRs to drug,vaccines(Adverse event following immunization) ,medical devices (Materiovigilance) and blood products(Haemovigilance).

4)To collect case reports and maintained as data.

Long term goals
1)To expand pharmacovigilance programme to all hospitals (govt & private) centres of public health programme located across India.
2)To develop and implement electronic reporting system (e-reporting)
3)To develop reporting culture in health professionals .
4)To make ADR reporting mandatory for healthcare professionals.

ADR REPORTING IN PvPI

What is meant by Adverse drug reaction (ADR)  

An adverse drug reaction is defined as any noxious ,unintentional and undesired effect of a drug,which occurs at doses normally used in humans for prophylaxis,diagnosis or therapy.None of the drug is free from adverse effects.It is therefore important for prescribers to be aware of adverse effects of drugs in various therapeutic categories and of relative merits of different drugs in the same therapeutic category before prescription,and also when shifting the treatment modalities such as from first line drug  to second line drugs .Reporting and monitoring of ADRs is important .The quality of data generated on ADRs helps in taking appropriate regulatory decision.

The reporting of ADRs in india is done under the Pharmacovigilance programme of India. The spontaneous reporting of ADRs is the need of the hour .All the stakeholders are encouraged to report suspected ADRs to their ADR monitoring centre .This will help to generate valid evidence base and identification of potential signals.

Who can Report?

All healthcare professionals including doctors,pharmacist,nurses ,lab technicians and others including consumers may report a suspected adverse drug reaction. Pharmaceutical companies may send report on adverse drug reaction for their product directly to the national coordination centre (NCC-PvPI).

Why to Report?

The health and safety of Indian population is a matter of national concern. Occurrence of ADR constitutes a significant economic burden on the patient and the government.As a prudent and vigilant healthcare professionals (HCPs), it is the responsibility of HCPs to report adverse drug reactions associated with use of medicines to safeguard the health of patients. India has a vast population that exhibits genetic and ethnic variability, there also exists a vast variation in disease prevalence. The data so generated will help to make vital policy decisions regarding safe use of medicines in Indian population.

What to Report?

In order to foster the culture of reporting, PvPI encourages reporting of all types of suspected ADRs- irrespective of whether they are known or unknown, serious or nonserious,frequent or rare and regardless of an established causal relationship to PvPI.

Although Pharmacovigilance is primarily concerned with pharmaceutical medicines and vaccines, adverse reactions associated with drugs used in traditional medicine (e.g. herbal remedies), medical devices, contrast media and other pharmaceuticals are also monitored. Special areas of interest include outcomes associated with the drug use during pregnancy, lactation period, and in paediatric and geriatric populations. In addition, reporting of lack of efficacy of medicines and suspected pharmaceutical defects are also recommended to report. Reporting of ADRs encountered with overdose, abuse, off-label use, misuse or occupational exposure is not currently included in the purview of PvPI.

How and Whom to Report?

All healthcare professionals (clinicians, dentists,pharmacists, nurses, etc.) can report adverse drug reactions using the ‘Suspected Adverse Drug Reaction Reporting Form’.Pharmaceutical companies can use this form to send their Individual Case Safety Reports .

METHODS  OF ADR REPORTING

Suspected ADR form

Reporters may fill the red colored ‘Suspected Adverse Drug Reaction Reporting Form’ available on the official website of IPC (www.ipc.gov.in ) or the CDSCO (www.cdsco.nic.in) to report any ADR.Reporters may submit the ADR form to the nearest AMC or directly to NCC of PvPI or mail the duly filled form to pvpi@ipcindia.net or pvpi.ipcindia@gmail.com

Helpline Number

Patients/Consumers/Healthcare Professionals may report suspected ADRs associated with the use of medicinal products to NCC-PvPI via toll-free helpline 1800-180-3024 from 9:00 A.M. to 5:30 P.M. on working days. 

Mobile Application

An android mobile application for Adverse Drug Reaction (ADR)reporting was launched on 22nd May 2015. It is a joint venture of IPC (NCC) and NSCB Medical College, Jabalpur. It is expected that this application will provide a platform for the private healthcare professionals to report ADRs. The mobile application includes inbuilt functions and features for reporting ADRs such as customization of reporter details, auto-entry of drug details and WHO algorithm based causality assessment.Download the app from https://play.google.com/store/

Medicines Side Effect Reporting Form (For Consumers)

The form ensures direct participation of patients/ consumers in PvPI and this in turn helps

in safeguarding the health of Indian population. The blue colored form is now available in ten local languages i.e. Hindi, Bengali, Gujarati, Kannada, Malayalam, Marathi, Assamese, Oriya,Tamil and Telugu. This channel of reporting ADR may be regarded as a mechanism for consumer empowerment in healthcare sector.The form available on the official website of IPC (www.ipc.gov.in).Reporters may submit the ADR form to the nearest AMC or directly to NCC of PvPI or mail the duly filled form to pvpi@ipcindia.net or pvpi.ipcindia@gmail.com

The reporter is free to choose his own choice to report the Adverse Drug Reactions.

Benefits of ADR reporting

• Generation of drug safety data based on Indian population.
• Evidence based regulatory decisions can be taken.
• Educational initiatives to healthcare professionals for improving safe use of medicines.
• Benefit risk ratio can be assessed.
• Updation on patient information leaflet -new ADRs ,new warnings,new contraindications   dose alteration etc
• Population specific safety data can be generated - paediatrics,geriatrics,pregnancy and lactation .
• Rational and safe use of medicines can be achieved.
• Public confidence can be enhanced.
• Close monitoring of medicines ,vaccines,medical devices and blood products.