PHARMACOVIGILANCE PLAN FOR TANZANIA

1. PHARMACOVIGILANCE PLAN FOR TANZANIA PREPARED BY EMMA & MARY 10TH SEPTEMBER 2004

2. PLAN Justification for monitoring of drugs. • To make sure that drugs for the public health use are of acceptable quality, safety and efficacious. • All drugs circulating in the market are supposed to be monitored. Reports to be investigated • Every report need a follow up because they play part and parcel of safety monitoring of drugs.

3. Cont…. • The following reports need to be investigated: clusters, Unexpected, Unusual and non compliance reports. Investigation should be on: • Group of individuals affected. • Quality of the products. • Outcome of the treatment. • Frequency of occurrence of the ADR including causal relationship.

4. Cont…. Roles and responsibilities in monitoring. • Tanzania Food and Drugs Authority The roles of the authority is to monitor safety of all drugs in the country. The system of collecting information (reports) is in place. From sentinel centres and from healthcare providers to TFDA.

5. Cont…… • The plan is to encourage patients to report to TFDA and zonal offices (to be established). • Manufacturers and product registrants have the responsibility of monitoring their products and send reports to TFDA. • Feedback reports from TFDA will be sent to all including the media depending on circumstances. In addition… • All health workers have the responsibility of monitoring proper management of drugs at their capacity (reporting of suspected quality problems and drug administration).

6. cont… Monitoring Processes Spontaneous monitoring: • Is in place for all registered pharmaceuticals products and those registered for study. Cohort studies: • Will be a priority especially with ART Programme. Registries: • If record keeping system is improved, monitoring using registries will be incorporated.

7. Reporting of events or reactions • As soon as the patients are using the drugs the reporting on adverse reactions will continue to be encouraged. • With ARVs and drugs which are on studies the reporting on adverse events and adverse reactions is encouraged.

8. What should be the timelines for submitting; Initial reports, • Three days after filling of the forms, these should be posted. Investigations reports, • As soon as possible when the investigation is still on progress. Aggregate reports? • Bi annual.

9. How do you manage non-serious ADRs? • Both serious and non serious ADRs are encouraged to be reported. 7. What are the resources available? Based on resources, size of country and nature of public health structures • There is drug regulatory authority. • Functional Pharmacovigilance centre. • Organized health systems in place. • Government commitment on Public health programs.

10. 8. What are the critical success factorsto achieve the system and its objectives? • Inadequate human resource, five more people need to be recruited. • Financial resource is not adequate to perform all the pv activities. • Infrastructure and equipment need to be improved • More support is needed from the upper to the lower level. • Technical support to conduct more activities eg research.

11. TRAINING STRATEGIES • Training of TOTs (Regional Health Management Teams). • Facilitators from the PV centre and TFDA. • Training Curriculum preparation. • Preparation of Training materials • Meeting of the facilitators and experts to agree on the training materials and curriculum.

12. Curriculum Contents: • Introduction: The definition of pharmacovigilance Importance of pharmacovigilance in Public health. Magnitude of the adverse effects of drugs • The importance of monitoring adverse drugs reactions.

13. Contents cont… • The pharmacological basis of adverse drug reactions and classification of ADR based on etiology. • How to recognize ADR • Principle of efficient reporting. When and what to report. How to report. • Ways of improving ADR monitoring and reporting • Communication on feedback of the reports.

14. Curriculum cont… Each session will consist of thirty participants with four facilitators. • Training methods Participatory, Role plays and Group discussion Number of hours for the training: The training session is expected to take 3 days or a total of 24 hours.

15. Training Schedule • Training will be conducted in the six zones which will consist of four regions each with seven participants. (TOT). These training will be covered within three months. • Sensitization of the trained professionals will be done on quarterly basis. • During annual professionals meetings there will be a session to remind health workers the importance of ADR reporting.

16. Training of TOTs • The objective of Training in general is to ensure that health workers are well educated on the importance of safety monitoring of drugs as well as to increase the reporting of adverse drug reactions. • Trained TOT will help in training other health workers in their respective regions.

17. To the community….. • The use of media will be of emphasis: • Different communication channels will be used, leaflets, posters, radios, magazines etc. • To the retail pharmacies, the pharmacists will be encouraged to sensitize their customers on reporting of adverse reactions they encounter. • The objective of sensitizing communities is to raise their awareness on the harmful effects drugs can cause.