Pharmacovigilance Dr. SURENDRA.S.AKASH MD

We define an adverse drug reaction as "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product." ADVERSE DRUG REACTION 12.09.2018

The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems Pharmacovigilance

Aims of Pharmacovigilance To improve patient care and safety To improve public health and safety To contribute to the assessment of benefit, harm, effectiveness and risk of medicines To promote understanding, education and clinical training Aims of Pharmacovigilance

Who are the partners? Government Industry Hospitals and academia Medical and pharmaceutical associations Poisons information centres Health professionals Patients Consumers Media WHO Who are the partners?

1986 - a formal adverse drug reaction (ADR) monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. In 1989, under the aegis of the Drug Controller of India, six regional centres were set up in Mumbai, New Delhi, Calcutta, Lucknow, Pondicherry and Chandigarh. History

12.09.2018

In 1997, India joined the WHO Programme for International Drug Monitoring managed by the Uppsala Monitoring Centre, Sweden. Of the six centres, only the centres in Mumbai and New Delhi were active, yet spontaneous reporting of ADRs was poor.

Recognising the need for improved ADR monitoring in India, the Government of India sent a proposal to the World Bank for funding. The World Bank approved the proposal with an annual grant of $US 0.1 million for 5 years and the National Pharmacovigilance programme was launched in November 2004. History

Why do we need pharmacovigilance?

1959 / 61– Epidemia de focomelia por Talidomida (4. 000 – 10 1959 / 61– Epidemia de focomelia por Talidomida (4.000 – 10.000 casos no mundo, com 15% de mortos)

Reason 1: Humanitarian concern – Insufficient evidence of safety from clinical trials Animal experiments Phase 1 – 3 studies prior to marketing authorization Reason 1:

Examples of product recalls due to toxicity MEDICINE YEAR Examples of serious and unexpected adverse events leading to withdrawal of medicine Thalidomide 1965 Phocomelia Practolol 1975 Sclerosing peritonitis Terfenadine 1997 Torsade de pointes Rofecoxib 2004 Cardiovascular effects Veralipride 2007 Anxiety, depression, movement disorders Rosiglitazone 2010 Nimesulide 2011 Hepatotoxicity Examples of product recalls due to toxicity

Reason 2 Medicines are supposed to save lives Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005 Reason 2

More than 3% of all deaths seem to be caused by adverse reactions to medical drugs, according to new research.

Warfarin, Insulin and Digoxin are the most Dangerous drugs in the elderly. Do we believe that?

ADRs are expensive !! 6.5% of admissions are due to ADRs Reason 3

Cost of drug related morbidity and mortality exceeded $177 Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000 (Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc) ADR related cost to the country exceeds the cost of the medications themselves Cost of ADRs in the US?

Promoting rational use of medicines and adherence Reason 4:

Prescription problems

Ensuring public confidence Reason 5

According to a fact sheet by WHO(May-2010) about the rational use of medicines ,more than 50 percent of all medicines are not correctly prescribed ,dispensed, and sold: and more than 50 percent patients take their drugs incorrectly.

Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical Reason 6

Not reporting a serious unknown reaction is unethical valid for everyone patient health professional manufacturer authorities

ADR FORM

ADR FORM

What to report? The programme particularly solicits reports of: • All adverse events suspected to have been caused by new drugs and ‘drugs of current interest' (List published by CDSCO {Central Drugs Standard Control Organization} from time to time) What to report?

• Reactions to any other drugs which are suspected of significantly affecting a patient's management, including reactions suspected of causing: • Death • Life-threatening (real risk of dying) • Hospitalization (initial or prolonged) • Disability (significant, persistent or permanent) • Congenital anomaly • Required intervention to prevent permanent impairment or damage.

WHO Programme for International Drug Monitoring

National PVig Programme

PSG INSTITUTE,TAMILNADU AIIMS newdelhi Travancore Medical college Ministry of Health India UMC Sweden WHO-HQ Geneva

12.09.2018

12.09.2018

SEND NOT ONLY QUANTITY BUT…. SO….WHAT IS OUR ROLE?

HOW? Monitor clinical status of patients Identify the correct ADRs not side effects Get more information Investigate at hospital level Help practitioners to fill-up the forms Keep patient’s record if more information needed HOW?

Pharmacovigilance looks at all available information to assess the safety profile of a drug. Pharmacovigilance should also take the benefit of the drug in account. Pharmacovigilance is required for systematically identifying and correlating drugs and side-effects and taking corrective actions, especially for the product launching first time in India. CONCLUSION

THANKYOU

Tegaserod is reported to increase the risk of heart attacks by 10 times, while the use of gatifloxacin in elderly patients may increase risk of developing serious hyperglycemia 17 times compared with other anti-biotics