Post marketing product risk analysis

Product safety is followed up by monitoring public health risk associated with the use of food, drugs, herbal drugs, cosmetics and medical devices. Such health risks are food-borne diseases and adverse reactions due to drugs, cosmetics and medical devices.

1.       Monitoring of adverse drug reactions

Adverse Drug Reactions (ADRs) monitoring is a systematic reporting and evaluation of certain or all adverse reactions to drugs.  It provides for systematic inferences on likely chains of causation linking drugs and adverse reaction within a population. It includes the experimental drugs. The science of  detection, assessment and prevention of Adverse Drug Reactions is known as Pharmacovigilance.

The objectives of monitoring ADRs are:

1. To detect the adverse drug reactions as early as possible, especially serious, unknown and infrequent reactions.
2. To establish the frequency and incidence of the adverse reactions both the well recognized and newly discovered reactions.
3. To identify all factors that may induce and /or influence the development of adverse drug reactions (e.g. racial factors, drug interactions, irrational drug use, etc) or affect the severity or incidence.
4. To analyse and disseminate information needed in drug prescribing and regulation.

All suspected adverse reactions should be reported whether known or unknown, serious or not including minor ones. Reports on the new drugs are of great interest because they make easier to monitor the performance of these drugs in the country for any suspected adverse drug reactions.

The National Centre for ADRs monitoring is under the Tanzania Food and Drugs Authority (TFDA), with offices near EPI-Mabibo, Dar es Salaam. The Centre evaluates the reports and feedbacks its findings to the healthcare professionals and the general public. Reported information is also communicated to the World Health Organisation (WHO).

All health care providers including doctors, dentists, pharmacists and nurses can report ADRs. All affected consumers are encouraged to report ADRs directly to their healthcare professionals and zonal Drug Information centers situated at Bugando, Muhimbili, KCMC, and Mbeya Referral Hospitals. The reports should be sent to Director General, TFDA, P.O. Box 77150, Dar es Salaam, fax +255 22 2450793.  Adverse drug reaction forms may be obtained from TFDA, offices of Regional Medical Officers or Regional Pharmacists and healthcare facilities. They are also available online

(Click here to fill ADR reporting form online)

The reporting form (yellow form) should be used to report cases of ADRs. It contains the following elements:

1.     Patient information including Patient identifier, Age/Date of birth, Sex, Weight and relevant medical history.

2.     Description of the adverse reaction including date of onset.

3.     Suspected drug(s): name (including brand name, if known), dosage, route, start and stop dates, and reasons for use.

4.     Treatment given for the reaction(s).

5.     Other relevant history, including pre-existing medical conditions

6.     Outcome of reactions

7.     Name, date, signature and address of the reporter.

Note: adverse effects due to herbal drugs and cosmetics can be reported using the same form, for the time being. 

2.      Monitoring of food-borne diseases

TFDA is working hard to improve a system for monitoring and collecting information related to food-borne diseases.