Quality and safety monitoring through effective post-marketing surveillance

1. Quality and safety monitoring through effective post-marketing surveillance Dr. Klara Tisocki EC-TA HSPSP National Health Staff Meeting Bohol Tropics March 4-6, 2008

2. Overview Medicine quality and safety Quality requirements in context of RA9502 Common problems of medicines quality safety Strategies to ensure access to good quality, safe medicines Potential policy options for regulatory interventions for the Philippines

3. True or False ? Quality testing of finished products in an accredited laboratory can ensure quality All generics must be tested for bioequivalence in humans Counterfeit medicines are the greatest risk to health systems Once EMEA, US FDA, BFAD etc. registers a drug product, we know for sure it is safe. Pharmacovigilance requires reporting of all adverse drug events and medication errors to BFAD

4. FALSE, FALSE, FALSE, FALSE, FAlSE Quality testing is not enough! GMP + GDP + GSD + correct administration is a MUST to achieve and maintain quality Bioequivalence in humans is NOT needed for ALL generics Clear scientific criteria is available for what needs BE ASEAN BE guidelines (WHO, FDA, EMEA similar) Counterfeit are dangerous but substandard poor quality medicines are far more common ( causing Rx failure, Drug resistance, ADRs, extra cost ) Drug Safety - Clinical trials cannot measure all potentiol safety problem - need for continuos safety monitoring ADR reporting is focused on learning about unknown ADRs and take corrective action whenever is possible

5. Building Blocks to meet Health System Goals