1. COUNTRY ACTION PLAN for INTRODUCING AND IMPLEMENTING A PHARMACOVIGILANCE PROGRAMME IN KENYA Dorine Kagai and Wilfred Oguta Pretoria,2004

2. Starting Pharmacovigilance in Kenya Summary of plan ACTION Time frame Respo nsibilit y Draw plan of action2 wksDK/W O Prepare and make a presentation to the policy makers »Introducing pharmacovigilance »The importance of pharmacovigilance »How pharmacovigilance can work in Kenya »Situation the world over 2 wksDK/W O Identify funding

3. Summary plan cont. Prepare a budget for initiating and running system 2 wksDK/WO/M OH Design a model reporting form and test it 1-2 months DK/WO/M OH Identify the location of national pharmacovigilance centre. 1-2 months DK/WO/M OH/Other Develop training and educational material 2-3 months DK/WO/M OH/Other Embark on HCP training and public awareness 3-4 months DK/WO/M OH/Other Pilot test with a few centers in public sector as well as private sector offering ART and review response. 4-6 months DK/WO/M OH/Other

4. Summary plan cont. Expand as fast as system can cope continu ous DK/WO/MO H/Other Continue training of healthcare workers contino us DK/WO/MO H/Other Public awareness of need to report. Successful partnership with the media and use of IEC materials continu ous DK/WO/ MOH/Other Apply for membership to WHO- UMC. 2005DK/WO/MO H/Other Continue monitoring drugs continu ous DK/WO/MO H/Other

5. KEY ISSUES Definition Pharmacovigilance The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

6. Why should drugs be monitored? Every person is entitled to quality and safe medicines. -Very little information available on ADRs and experience with drugs used in Africa. Need to monitor and generate data -ADRs account for high percentage of hospital admissions thus increasing the burden on our already overstretched healthcare delivery systems -Pharmacovigilance can help detect counterfeits and substandard drugs. -Information collected before issue of market authorization not adequate. PV could assist in detecting less common, but sometimes severe ADRs. -to contribute to the assessment of benefit, harm, effectiveness and risk of medicines, -Assists in making regulatory decisions for rational and safe use of medicines -It helps save lives!

7. What, when, and how to report? Reporting to be done any time an SAE /ADR occurs. Spontaneous reporting. Report all suspected ADRs i.e. both serious reactions and others. Voluntary reporting Report as soon as possible. Within 2 weeks? Special investigation team will be necessary but may be costly. A centralized reporting system is preferable - initial PV targets ART and in specific centers. Can later be expanded. Forms should be filled in duplicate (original sent to PV centre and duplicate filed by reporter)

8. PROPOSED REPORTING FLOW Functions/activities of each individual in the plan defined. Structure based on centers already started on ART programme initially 10 centers and then expansion to meet the target for ART roll out. Also expansion to other PH programmes e.g. malaria and TB and later to include all drugs National PV Centre National Advisory Committee Nat. coordinator Healthcare worker at the clinics/hospitals Patients

9. Success factors Public awareness on need to report suspected ADRs Government support. Policy makers. Financing. Advocacy. Presence of national coordinator and an advisory committee Trained health care workers. The importance and need for pharmacovigilance. How to support. Reporting methods.

10. Success factors cont. Defined responsibilities in the reporting flow/pharmacovigilance system. Quality control of laboratories i.e. uniformity of standards and consistency of results/data. Free and open communication between public, HCP and policy makers. Ability to have free flow of information i.e. enquiries, feedback etc.

11. How to achieve success Involvement of all categories of healthcare professionals - ownership Ensuring reporting forms always available and facilitating reporting to make it easy Acknowledge receipt of reports Feedback Publication in …(journals, lay press etc)

12. How to achieve success cont… ADR monitoring and reporting issues in school and college curricula? Academic institutions Involvement of drug therapeutic committees Combining ADR monitoring into the public health programmes e.g. HIV/AIDS programme, malaria control Involving professional associations Involvement of patient associations e.g. People living with AIDS

13. How to achieve success cont… Introduction of telephone medical information service - Helpline Always advise patients to report any suspected ADR? Communication with DRA and policy makers. Proper use of data generated to improve safety and promote rational use of drugs Role of pharmaceutical companies in ADR monitoring? Interaction with pharmacovigilance centers in other countries

14. Resources required –Actual facility housing pharmacovigilance centre, –staffing, –training and development of training materials, –Requirements for sensitization, –Design and printing of forms, –cost of sending forms/reporting system,

15. Resources required cont. –follow-up and feedback systems, –computers, –advisory committee, –telephone and internet, e-mail, photocopier –furniture, –reference materials (may include subscription to journals, reference books etc) –logistics of monitoring and supervision –Post-marketing surveillance costs

16. Is pharmacovigilance feasible in Kenya? Yes. However, several challenges are anticipated Challenges may include It may require structural and policy changes. Political commitment New concept that would involve lots of sensitization and setting up new systems- professionals and DRA Attrition of health professionals Health systems do not allow for easy follow-up of patients. Patients jumping from one doctor to another (may be different with HIV)

17. Challenges cont. Financial commitment of funding agency (government or other partners) –Identification of funding agency and certainty of continued funding. Private sector control not easy e.g. may not like to follow the national guidelines and may be difficult to monitor/regulate.

18. Challenges cont. Many categories of prescribers. Standard of care? Adequate infrastructure and resources to monitor safety of ARV? Good laboratories? Properly equipped for quality controls and clinical monitoring Patients ability to pay for tests The need to treat ADRs even if ART is quite cheap infrastructure for proper causality assessment

19. Challenges cont. Extensive use of traditional medicine Expensive exercise.

20. Ahsante sana!