Voluntary Reporting of Adverse Drug Reactions
by Health Professionals

What to Report (ADR Reporting Guideline)
An adverse drug reaction (ADR) is a noxious and unintended response to a drug, at a dose intended for the diagnosis, treatment or prevention of a disease or the modification of an organic function. This includes any undesirable patient effect suspected to be associated with drug use. ADRs as a result of prescription, non-prescription, biological (including blood products), complementary medicines (including herbals) and radio pharmaceutical drug products are monitored. Drug abuse, drug overdoses, drug interactions and unusual lack of therapeutic efficacy are also considered to be reportable as ADRs.

ADR reports, for the most part, are only suspected associations. A temporal or possible association is sufficient for a report to be made. Reporting an ADR does not imply a causal link.

ADRs that should be reported include all suspected adverse drug reactions, which are:

• Unexpected, regardless of their severity i.e. not consistent with product information or labeling; or
• Serious, whether expected or not; or
• Reactions to recently marketed drugs (on the market for less than five years) regardless of their nature or severity.

What is a serious reaction?
Serious adverse drug reaction is defined as "a noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, life-threatening or results in death". ADRs that require significant medical intervention to prevent one of the other outcomes listed above are considered to be serious.

How to report
To report a suspected ADR for drug products marketed in Ethiopia, Health Professionals should complete a copy of the ADR Reporting Form. This form may be obtained from the pharmacy, nurse offices and departments of your health institutions.

Fill in the sections that apply to the report as completely as possible, using a separate form for each patient. The success of the program depends on the quality and accuracy of the information sent in by the reporter.

Confidentiality
Any information related to the reporter and patient identity is kept strictly confidential.

Follow-up information for an ADR that has already been reported
Any follow-up information for an ADR that has already been reported can be sent on another ADR form, or it can be communicated by telephone, fax or e-mail to ADR monitoring and promotion control division at the drug administration and control authority. So that this information can be matched with the original report, indicate that it is a follow-up information, the date of the original report and the report case number if known. It is very important that follow-up reports are identified and linked to the original report.

Where to send the report or to obtain more information

The Adverse Drug Reaction Monitoring and Promotion Control Division at the Drug Administration and Control Authority monitor adverse reactions for drug products that are marketed in Ethiopia. Send these ADR reports to the addresses on the ADR Reporting Form.

For more information on the ADR monitoring program, additional copies of ADR reporting forms or to report an ADR, physicians, pharmacists and other Health Professionals are invited to contact:

Drug Administration and Control Authority of Ethiopia
Planning and Drug Information Department
Adverse Drug Reaction Monitoring and Promotion Control Division
P.O. Box 5681,
Addis Ababa, Ethiopia                    
Fax 52 12 92
E-mail daca@telecom.net.et