Paper based system for submission of adverse drug reaction

TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

PAPER BASED SYSTEM FOR SUBMISSION OF ADVERSE DRUG REACTION

Introduction

All drugs even if taken appropriately may associate with adverse drug reactions ranging from mild to severe form and fatal reactions. Some of the reactions are predictable and therefore can be avoided but some of them are not predicted. The feedback of how fair the registered medicines and licensed vaccines are doing to the market is important for the TMDA to continue make informed decision every time. There are forms for reporting of all suspected Adverse Drug Reactions (ADRs) and Adverse Events Following Immunizations (AEFIs) distributed to health facilities. The yellow forms were designed to collect safety reports of medicines and vaccines by health care personnel while the green forms are for consumers reporting of suspected ADRs and AEFIs.

Why reporting of Adverse Drug Reactions and Adverse Events Following Immunization

The system for reporting of Adverse Drug Reactions and Adverse Events Following Immunization was established in order to;

  1. Detect the adverse drug reactions as early as possible, especially serious, unknown and infrequent reactions.
  2. Establish the frequency and incidence of the adverse reactions both the well recognized and newly discovered reactions.
  3. 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. Analyze and disseminate information needed in drug prescribing and regulation.
What to report

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.

Who should report

All health care providers including specialists, doctors, dentists, pharmacists and nurses can report ADRs and AEFIs. All affected consumers are encouraged to report ADRs directly to their healthcare professionals and zonal Drug Information centers. The reports should be sent to the Director General, TMDA, P.O. Box 1253, Dodoma, fax +255 22 2450793 email adr@tmda.go.tz .

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

  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.

All sections of the form should be dully filled prior submission. A separated form should be used for each patient.

For further information contact TMDA
Click here to get guidelines for Monitoring and reporting Adverse Drugs Reactions (ADRs)
Adverse Reaction Reporting Tool