Pharmacovigilance Shanthi Pal M Pharm Ph D Quality

Pharmacovigilance Shanthi Pal, M. Pharm, Ph. D Quality Assurance and Safety of Medicines WHO 1 World Health Organization

Objectives • To discuss the need for pharmacovigilance • To present WHO’s role in promoting pharmacovigilance 2 World Health Organization

Medicine Safety • To undergo treatment you have to be very healthy, because apart from your sickness you have to stand the medicine. Molière 3 World Health Organization

Pharmacovigilance What IS this? 4 World Health Organization

Vigilance Vigilare = to watch alert watchfulness forbearance of sleep; wakefulness watchfulness in respect of danger; care; caution; circumspection the process of paying close and continuous attention 5 World Health Organization

Pharmacovigilance • The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems 6 World Health Organization

Pharmacovigilance Major Aims • early detection of unknown safety problems • detection of increases in frequency • identification of risk factors • quantifying risks • preventing patients from being affected unnecessarily Rational and Safe use of Medicines 7 World Health Organization

Why Pharmacovigilance? 8 World Health Organization

Why Pharmacovigilance? • Post-marketing Topics Unexpected adverse reactions Interactions Dependence Long-term efficacy, Resistance Risk factors Quality (Counterfeit) Cost assessment 9 World Health Organization

Why Pharmacovigilance? • Adverse Drug Reactions are the 4 th to 6 th largest cause of mortality in the USA (Lazarou J. et al. , 1998) 10 World Health Organization

Why Pharmacovigilance? The percentage of hospital admissions due to drug related events in some countries is about or more than 10%. • UK Study : 10. 1 % (Bhalla et al, 2003) • French study : 10. 3 % prevalence of ADRs (Imbs et al, 1999) 11 World Health Organization

Why Pharmacovigilance? Economic impact Drug related morbidity and mortality expenses exceeded US$ 177. 4 billion in the USA in 2000 (Ernst & Grizzle, 2001) 12 World Health Organization

Some Examples Medicine 13 ADR Thalidomide Amidopyrine Clioquinol Congenital malformations Agranulocytosis Myeloneuropathy (SMON) Statins Oral Contraceptives Rhabdomyolyis Thromboembolism World Health Organization

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WHO Programme for International Drug Monitoring (HQ) • • 15 Policy Exchange of Information Technical support to countries Advisory Committee on Safety of Medicinal Products World Health Organization

Exchange of Information • • 16 WHO Pharmaceuticals Newsletter WHO Drug Alerts WHO Drug Information WHO Restricted Pharmaceuticals List (Vigimed - electronic exchange) (Uppsala Reports) (Signal) World Health Organization

Technical support to countries • Technical guidelines on all aspects of pharmacovigilance (Several publications and documents) • Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ) 17 World Health Organization

Training courses for Public Health Programmes • Introducing Pharmacovigilance into Malaria Programmes- Zambia 2003 • Introducing Pharmacovigilance into HIV/AIDS Programmes – South Africa 2004 18 World Health Organization

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WHO Collaborating Centre (Uppsala Monitoring Centre) ADR database • No of reports: more than 3 million • Each year increase ~250, 000 / year • Top 5 reporting countries • • • 20 USA United Kingdom Germany Australia Canada World Health Organization

WHO Collaborating Centre (Uppsala Monitoring Centre) ADR Reports • Analysis • Data mining (BCPNN) • Output – Feedback to National Centres – Signal documents – Ad hoc research results 21 World Health Organization

Future challenges • • • 22 Raise awareness Monitor all medicines Address broader safety concerns Integrate work throughout WHO Improve training activities World Health Organization

In conclusion …. • The work of WHO in the area of safety monitoring of medicines is necessary if we are to achieve the mission of EDM: • Medicines should be Available, Affordable, Safe and Properly used. 23 World Health Organization

Thank you ' A blue fly, if it clings to the tail of a thoroughbred horse, can travel ten thousand miles '. 24 World Health Organization