Mission
Safeguard the health of the Indian population by ensuring that the benefits of medicines outweighs the risk associated with its use
Vision
To Improve patient safety and welfare in Indian population by monitoring the drug safety and thereby reducing the risk associated with use of medicines
Benefits
• Generation of drug safety data in Indian population
• Evidence based regulatory decisions
• Medicines benefit-risk assessment
• Promoting rational use of medicines
Main Objectives
• To create a nation-wide system for patient safety reporting
• To identify and analyse new signal from the reported cases
• To support regulatory agencies in the decision-making process on use of medication
• To emerge as a national centre of excellence for Pharmacovigilance
What is Pharmacovigilance?
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.
What is an Adverse Drug Reaction (ADR)?
A response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or treatment of disease, or for the modification of physiological function.
IMA – PvPI Initiative
No medicinal product is completely devoid of risk. Therefore, it is essential to have a monitoring system to ensure patient safety.
IMA – PvPI Initiative
Ministry of Health and Family Welfare, Government of India, launched a nationwide Pharmacovigilance programme of India (PvPI) to monitor the safety of medicines in Indian population. Indian Pharmacopoeia commission (IPC) is functioning as National Coordination Centre (NCC) to collate ADR reports and recommend Central Drug Standards Control Organisaiton (CDSCO) for regulatory intervention.
Who can Report?
All healthcare professionals (Clinicians, dentists, pharmacists, nurses and non-healthcare professionals including consumers etc.) can report ADRs.
Why to Report?
As a healthcare professional it is a moral responsibility to report adverse reactions associated with pharmaceutical products to safeguard public health.
What to Report?
PvPI encourages reporting of all types of suspected adverse reactions with all pharmaceutical products irrespective of whether they are known or unknown, serious or non-serious and frequent or rare.
How and whom to Report?
• A reporter who is not a part of ADR monitoring centres (AMCs) can fill the ‘Suspected Adverse Drug Reaction Reporting Form’ and send to the nearest AMC or directly to the NCC.
• Or can directly mail the form to [email protected] or [email protected]
• Or can also call on Helpline number 1800-180-3024 to report ADR. ADR reporting form and contact details of AMCs can be downloaded from the official website www.ipc.gov.in
What will happen to reported
Adverse Drug Reaction form?
The information obtained from your reported ADR form will be entered into the national adverse drug reaction safety database and will be analysed by expert reviewers. This will be helpful in identifying and reducing the risks associated with drug thus, promotes the safe use of medicines.
Will reporting have any negative
Consequences on the healthcare
Professionals or the patient?
• Submission of an ADR report does not have any legal implication on the reporter
• Confidentiality of the reporter and patient will be maintained
• The information is only meant for better understanding of medicines used in India and to safeguard the health of Indian Population
IMA – PvPI Initiative
ADRs reporting is to evaluate benefits risk ratio of a medicine and there by ensuring safe use of medicines.
Benefits
• 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-paediatric, geriatric pregnancy and lactation
• Rational and safe use of medicines can be achieved
• Public confidence can be enhanced
Why Pharmacovigilance is important in India?
• Safety of more than 1.27 billion population is a concern
• Vast genetic and ethnic variability
• Variation in disease prevalence and use of multimodal practices
• Drug manufacturing processes
• Poor compliance by patients in adhering to the dosage regimen
• Some of the studies revealed that ADRs in India are leading to hospitalization and constitutes a significant economic burden on patient.