1. 1 Pharmacovigilance & the New National Adverse Drug Reaction (ADR) Reporting System Michael Bonett, Quality Assessor Post-Licensing Directorate Medicines Authority

2. 2 The science and activities relating to the detection, assessment, understanding and prevention of adverse effects of medicinal products. (Source: The Importance of Pharmacovigilance, WHO 2002) What is Pharmacovigilance (PhV)?

3. 3 Why is PhV necessary? Information collected during the pre-marketing phase of a medicinal product is inevitably incomplete with regards to a complete safety profile of a medicinal product; Data from clinical trials is limited by their size and duration; Animal testing is insufficiently predictive of human safety.

4. 4 Development of ADR reporting system New national ADR reporting system developed by the Medicines Authority (MA) System launched on 4 th May 2004 Targeted Healthcare Professionals (HCPs) include: doctors, dentists, pharmacists ADR reporting card developed for the use of HCPs

5. 5 What ADRs to Report? Legal obligation to report serious or unexpected ADRs (L.N.22 of 2004) All suspected ADRs of new drugs and vaccines Non-serious ADRs of established drugs and vaccines ADRs which occur in children and elderly All suspected ADRs of herbal medicinal products

6. 6 How to report ADRs?

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8. 8 What is done with data collected? Validation (criteria for valid report fulfilled) Processing (input of reports into database) Acknowledgement of all local ADR reports Scientific evaluation (medical and pharmaceutical assessors) Transmission of data (WHO/EMEA) Regulatory action (if necessary) Communication (Drug Safety Bulletin, DDLs)

9. 9 Progress so far Number of reports received: 9 Reporters include consultant doctor (1), hospital pharmacists (5), community pharmacists (2) One report from a pharmaceutical company Guidance Notes for HCPs First issue of the Drug Safety Bulletin Maintenance of MA website

10. 10 Future plans Regular information sessions for HCPs Increasing ADR reporting rate by HCPs Dissemination of ADR reporting card within several primary healthcare institutions Inclusion of other HCPs e.g. nurses in the ADR reporting scheme

11. 11 On-going monitoring of the safety of medicinal products through ADR reporting by HCPs is an essential component of pharmacovigilance Provision of ADR reports and the evaluation of the safety data provided ensures availability of complete, up-to-date drug safety information Reporting of ADRs by HCPs will enable the MA to effectively regulate the safety of medicinal products, hence safeguarding public health Summary and Conclusions

12. 12 Thank you for your attention! We look forward to receiving ADR reports from you. Please visit our website at: http://www.health.gov.mt/mru Email: postlicensing.mru@gov.mtpostlicensing.mru@gov.mt Tel. No.: +356-23439135