Reporting of Adverse Drug Reactions (ADRs)
Reporting of Adverse Drug Reactions (ADRs) and Adverse Events Following Immunization (AEFI) in Tanzania
Adverse drug reactions (ADRs) and Adverse Events Following Immunization (AEFI) may affect the full benefits of new medicines in treatment of diseases of public health importance and are major cause of death and hospitalization in developed countries. Reporting them aids regulatory decision making regarding medicines. There are four (4) major reporting mechanisms for reporting ADRs/AEFIs). These are;
Paper based Reporting of ADR/AEFI
The paper-based ADR/AEFI reporting system has been in practice in Tanzania since 1987. It involves use of TMDA yellow forms to report any untoward experience associated with the use of medicine.
Despite its importance, technological changes have attracted use electronic reporting mechanisms such as website reporting; Unstructured Supplementary Service Data (USSD) and Toll Free number. These systems were introduced in the country to assist improve the number of ADR reported to the National Regulatory Authority.
On-line Reporting of ADR/AEFI
Reporting of ADR/AEFI by Text Message
Apart from the on-line reporting system for ADR/AEFI, the Unstructured Supplementary Service Data (USSD) system was also introduced in the country in the year 2018. Records from the Tanzania Communication Regulatory Authority (TCRA) shows majority of mobile phone users use the ordinary phones and therefore have access to USSD services.
Please send us a simple short text message to report any suspected Adverse Drug Reaction by just dialing *152*00# and follow the instructions
Reporting of ADR/AEFI by Toll Free Number
Another simplest way of reporting ADRs/AEFIs is to contact TMDA by phone call through Toll Free number 080011 0084. This method is free of charge.
Please call us to report any suspected ADRs/AEFI by just dialing 080011 0084.
How to access the reporting forms
Adverse drug reaction forms may be obtained from TMDA headquarters, Zonal Drug Information Centres, offices of Regional Medical Officers or Regional Pharmacists and healthcare facilities.
How to report
Suspected adverse reactions for drugs marketed in Tanzania should be reported using a standardized form which is postage pre-paid and self-adhesive. It contains the following elements
- Patient information including Patient identifier, Age/Date of birth, Sex, Weight and relevant medical history.
- Description of the adverse reaction including date of onset.
- Suspected drug(s): name (including brand name, if known), dosage, route, start and stop dates, and reasons for use.
- Treatment given for the reaction(s).
- Other relevant history, including pre-existing medical conditions
- Outcome of reactions
- Name, date, signature and address of the reporter.
All sections of the form should be dully filled prior submission. A separated form should be used for each patient.