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

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?

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

Pilot project of ten countries Australia, Canada, Denmark, Germany, Ireland, Netherlands, New Zealand, Sweden, United Kingdom, USA

WHO Programme for International Drug Monitoring HQ WHO Collaborating Centre, Uppsala National Centres

Safety saves Mary Caroline Shanthi

Pharmacovigilance in WHO Exchange of Information Policies, guidelines, normative activities Country support Collaborations 9/16/2018

Exchange of Information 24th WHA (1971) Resolution WHA 24.56 Need for a system of collection and dissemination of information on results of safety and effectiveness trials of new drugs and on their registration in the countries, for possible use of data by health authorities of countries importing these drugs

Exchange of Information INTERNATIONAL INFORMATION SYSTEM National Information Officers (WHO Liaison Officers) WHO Pharmaceuticals Newsletter WHO Restricted List Updates

Exchange of Information Ad hoc “Drug Alerts” WHO Drug Information International Conference of Drug Regulatory Authorities (ICDRA) www.who.int/medicines/edmtopics.shtml 9/16/2018

Policies, Guidelines and Normative Activities The Importance of Pharmacovigilance (2002) Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002) Pharmacovigilance in public health Safety monitoring of herbal medicines Expert Advisory Committee 9/16/2018

Country Support Strengthen spontaneous reporting systems Establish active surveillance component in public health programmes Work with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre) Ongoing Regional projects: “Implementation and Development of Pharmacovigilance in Newly Independent States of Eastern Europe”, since 2000 (National pharmacovigilance systems established in all 8 participating countries) 9/16/2018

Partnerships within WHO Malaria HIV/AIDS Patient Safety Leprosy (UK Thalidomide) Poisons and Chemicals Safety Traditional Medicines

Challenges Awareness and Advocacy Public Health Programmes Geriatrics (Access improves longevity !!) Paediatrics (Learning from SSRIs) DTC advertising and Internet sales Pregnancy Patient Safety

Challenges Patient Safety Pregnancy Fast Track & High Through-put Products Counterfeit Drugs

Solutions Guidelines and Standards: PV in HIV/AIDS, Malaria, Paediatrics…. Global Alliance for Patient Safety Electronic discussion groups Advocacy material Training Tools Databases

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.

Backstage … Gaynor, Laura, Lisa

Thank You Merci beaucoup !