1. STRUCTURE AND PROCESS OF PERIODIC SAFETY UPDATE REPORTING SYSTEM MEDICINES IN KENYA KIOGORA MWITI GATIMBU REG NO.U51/64042/2013 M.PHARM-EPIVIGIL 24 TH NOVEMBER, 2014

2. Outline Introduction Rationale Objectives Methodology Results Conclusion Acknowledgements

3. Introduction Periodic safety update report(PSUR) is a document that Marketing Authorization Holders(MAHs) submit to regulatory authority to evaluate medicinal products safety data for a particular interval of time. PSURs owe its origin to the Council of International Organization of Medical sciences(CIOMS) guideline of 1992.

4. Introduction This guideline became widely accepted in all International Conference for Harmonization(ICH) regions. ICH brings together regulatory authorities of Europe, Japan and USA to discuss scientific and technical aspect of product registration. PSUR aim is to provide an update of world wide safety experience of specific medicinal products.

5. Rationale for study of PSURs ADRs are a public health concern - Aim to protect health of population. For early detection of ADRs pharmacovigilance (PV)is of essence. PSURS form part of tools used in PV reporting. The study aimed at analyzing the content, process and structure of PSURs to find out whether they are able to collect relevant information for regulatory action.

6. Objectives Broad objective To assess the structure, content and process of periodic safety update reports in Kenya Specific objectives To examine the content of PSURs in Kenya. To explore the organizational structure of PSURs in Kenya. To examine the processes of PSURs in Kenya.

7. Methodology A cross-sectional qualitative study of documentary material. Scotts adapted version of Leavitt’s Diamond model.

8. Methodology Descriptive interviews with key informants at PPB,Kenya. A universal sampling was done.

9. Methodology Data was abstracted from the PSURs by use of a PSUR review tool and key informant interview tool. Descriptive and univariate analysis was done on all the variables. The data was analyzed using stata version 10.0

10. Results

11. Submitted documents marked as PSURs All documents labeled as PSURs dated between January, 2013 to January, 2014 were eligible for inclusion in the study. A total 120 documents were identified for review. However, 31 documents were excluded because of being in a poor physical condition. A further 57 documents were excluded because, though they had been filed as PSURs, they did meet the minimum criteria for PSURs

12. Type of document submittedTotal Periodic safety update reports(PSURs) 32 Safety update 2 Global data sheet 2 Amendment package insert update 2 Package insert update 8 Prescribing information update 23 Amendment for prescribing information 9 Core safety risk management plan 2 Worldwide pharmaceutical operation 1 Periodic benefit risk evaluation 1 Application to spc 1 Package leaflet 3 Summary bridging report 1 Core data sheet 1 PSUR assessment 1

13. Exposure number calculation method

14. Studies and other information

15. Overall safety components

16. Process of PSUR reporting Marketing authorization holders(MAHs),submit 2 hard copies. A soft copy A cover letter is signed and a copy is retained at the department. They are coded and entered in an excel sheet awaiting assessment and review.

17. Conclusion PPB had a well laid structure for PSUR reporting. Lacked harmonized format for capturing information. Non mandatory requirement by the regulatory authority to submit PSURs. No regular PSURs reviews.

18. Conclusions Nearly half of reviewed PSURs reported drug interactions. 50% of PSURs reviewed had potential safety concerns. Nearly two-thirds reported medication errors and medicine abuse and misuse. Local MAHs do not submit PSURs

19. Recommendations Urgent need for policies on PSURs. PV team to develop and implement structured PSURs review tools. The board to employ adequate staff to facilitate regular PSURs reviews for timely detection of signals. The regulatory authority to develop comprehensive guidelines and SOPs on PSURs.

20. Recommendations Local MAHs to submit PSURs to the regulatory authority. To set aside funds to facilitate regular reviews.

21. Acknowledgements I wish to acknowledge the contribution and guidance of my supervisors; Dr George Osanjo Dr James Riungu Dr Wesley Ronoh My course coordinator Dr Faith Okalebo Pharmacovigilance team at the PPB.

22. THANK YOU THANK YOU