NL-EDQM study HARM caused by falsified medicinal products Bastiaan Venhuis

1. NL-EDQM studyHARMcaused by falsified medicinal productsBastiaan Venhuis Harm caused by falsified medicinal products

2. The current NL situation Falsified products with on the black market • Substandard, impure, wrong active…. Lack of information on harm • Pharmacovigilance virtually no data • Poisons information institutes limited data, poorly accessible • Hospitals et cetera limited data - Medical community is unfamiliar with the problem - What signals to look for? - How to report? Harm caused by falsified medicinal products

3. The NL-EDQM study • Assessment of the current situation • Methodology for detecting signals • Monitoring signals of health damage Harm caused by falsified medicinal products

4. Goal • To describe the exposure and level of harm • To show the relevance to the medical community • An internationally harmonized methodology • Provide tools for governments to respond to changes: • Alert specific medical professions based on trends in seizures • Alert enforcement based on hospital reports • Monitor effects of changes in the health system Harm caused by falsified medicinal products

5. Approach • Assessment of the current situation • Literature review for signals of harm • A study to exposure • Methodology • What signals to look for? • Where to find such signals? • Harmonized methodology for CoE countries • Monitoring • Harmonized monitoring system • Specific medical professions are asked to report cases Harm caused by falsified medicinal products

6. Scientific literature • Literature on harm caused by falsified medicines (1970 – pres.) • Systematic search of MEDLINE and EMBASE databases • Limited to countries with a developed health system Looking for: • Number of cases • Number of victims • Product types • Reasons for discovery Harm caused by falsified medicinal products

7. Scientific literature Results • 73 incidents • 4501 persons hospitalized • 175 deaths Primarily caused by: Counterfeit gentamycin Counterfeit heparin Slimming herbs Victims: General symptoms Unwitting Unwilling to be frank Cases uncovered because of severity or scale Harm caused by falsified medicinal products

8. Exposure study (1), (2011 - 2012) • 3 - 5 year data on seized products • Data from RUF, S, UK, B, CH, It, Isr, NL • Data currently coming in • To identify: leading symptoms product types geographic differences vulnerable groups expected harm Harm caused by falsified medicinal products

9. Exposure study (2), (2012) • Sewage epidemiology • Approaches the actual exposure • Feasible for medicines* and drugs of abuse • Thus far not applied to monitor use of illicit medicines • Method • Using incoming water at Sewage Refinement Plants • Measure levels of interest • Calculate use per 1000 inhabitants • Compare with official sales *ED drugs in waste water of 9 EU cities (Nieto et al. 2010) Harm caused by falsified medicinal products

10. Methodology (2011 – 2012) • Study design depends on outcome exposure study • Medical experts to draw up a TRIGGER list • priapism ED-drugs Libido • eye-disorders ED-drugs Libido • psychosis Sibutramine Slimming • suicide Rimonabant Obesity • lack of efficacy Counterfeit Any product • Describe WHERE in the medical system these complaints would surface Harm caused by falsified medicinal products

11. Monitoring (2012 - ) • Pilot study in the participating countries on identification and quantification of harm • Harmonized methodology • Tailored to a country specific health system • Optimization, validation, implementation Harm caused by falsified medicinal products

12. Conclusions • We know very little about the current level of harm • To asses the level of harm the following is needed: • Asses the anticipated harm based on exposure • Describe signals and signal receivers • Involve the medical community • A harmonized international pilot-study into the identification and quantification of harm. • All support is welcome! Harm caused by falsified medicinal products