Guidelines for Monitoring and Reporting Adverse Drug Reactions (ADRs). (Made Under Section 5 (C) of the Tanzania Food, Drugs and Cosmetics Act, 2003)
(2006; 33 pages)


Adverse Drug Reactions monitoring is a process of continuously monitoring of undesirable effect suspected to be associated with use of medicinal products. It facilitates collection of unbiased safety data observed during clinical practice in "real life" circumstances.

The guidelines have been developed to assist health care professionals on understanding the importance of ADRs monitoring, procedures of reporting an ADR and the four essential components of an ADRs case report to improve drug safety. The essential components include information about the patient, description of the adverse drug reactions, the suspected drug(s) and the reporter. The System of ADRs notification in Tanzania is a centralised reporting, whereby suspected case reports of ADR are reported by health care professionals and pharmaceutical manufacturers to TFDA. Public health programmes, such as Malaria, Human Immuno Deficiency Virus/Acquired Immuno Deficiency Syndrome (HIV/AIDS), Tuberculosis (TB) and Leprosy, Parasitic infections and vaccines should introduce ADR reporting in their programmes. This should include sensitizing health workers during seminars and trainings to report adverse drug reactions. Close collaboration between TFDA and these programmes is necessary.

It is mandatory for pharmaceutical manufacturers or product registrants to monitor their products in the market and report any suspected undesirable effects to TFDA...

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