Quality Assurance and Safety of Medicines Pharmacovigilance Shanthi Pal, M.Pharm, PhD Quality Assurance and Safety of Medicines WHO

Objectives To discuss the need for pharmacovigilance To present WHO’s role in promoting pharmacovigilance

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

Pharmacovigilance What IS this?

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

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

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

Why Pharmacovigilance?

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

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

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)

Why Pharmacovigilance? Economic impact Drug related morbidity and mortality expenses exceeded US$ 177.4 billion in the USA in 2000 (Ernst & Grizzle, 2001)

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

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

Exchange of Information WHO Pharmaceuticals Newsletter WHO Drug Alerts WHO Drug Information WHO Restricted Pharmaceuticals List (Vigimed - electronic exchange) (Uppsala Reports) (Signal)

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)

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

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 USA United Kingdom Germany Australia Canada

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

Address broader safety concerns Integrate work throughout WHO Future challenges Raise awareness Monitor all medicines Address broader safety concerns Integrate work throughout WHO Improve training activities

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.

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