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Elements of Plan

Elements of Plan. Why should drugs be monitored? What should be monitored? All drugs? Only ARVs? Which reports to be investigated? All suspected ADRs, clusters ? Unexpected? Unusual? Significantly affecting compliance? Who should monitor? Roles and responsibilities.

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Elements of Plan

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  1. Elements of Plan • Why should drugs be monitored? • What should be monitored? All drugs? Only ARVs? Which reports to be investigated? All suspected ADRs, clusters ? Unexpected? Unusual? Significantly affecting compliance? • Who should monitor? Roles and responsibilities. Consider the functions and activities of each individual/organization in your proposed reporting flow Can the proposed reporting flow be adapted to your country setting?

  2. Elements of plan (cont.) • How should monitoring occur? Spontaneous monitoring? Cohort studies? Registries? Is this system feasiblein your country? Should it be modified/simplified? 5.When should you be encouraging reporting of events or reactions? What should be the timelines for submitting initial reports, investigations reports, aggregate reports?

  3. Elements of plan (cont.) • How do you manage non-serious ADRs? Should you encourage reporting of serious events/reactions only or include non-serious as well? 7. What are the resources available? Based on resources, size of country and nature of public health structures 8. What are the critical success factorsto achieve the system and its objectives? How can these critical success factors be achieved in your country?

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