Therapeutics Information and Pharmacovigilance Centre (TIPC): is the MOHSS official centre for provision of unbiased therapeutic information and pharmacovigilance services to health care workers and the general public in namibia .

Monitoring Adverse Drug Reactions (ADR)

Adverse Drug Reactions (ADR): is a noxious and unintended response to a medicine, 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 medicine use. ADRs as a result of prescription, non-prescription, biological (including blood products), complementary medicines (including herbals) and radiopharmaceutical medicine products are monitored. Drug abuse, medicine overdoses, Medicine interactions and unusual lack of therapeutic efficacy are also considered to be reportable as ADRs.

Report: 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 reactions : Regardless of their severity i.e. not consistent with product information or labeling; or
• Serious adverse medicine reaction: is defined as " a noxious and unintended response to a medicine, 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 or the other outcomes listed above, whether expected or not, are considered to be serious.
• Reactions to new medicines: Reactions to recently marketed medicines (on the market for less than five years) regardless of their nature or severity.

How to report : The form can be obtained from the pharmacy, nurse offices, therapeutic committee and departments of your health institutions. Electronic copy is also available at the MCC website. Fill in the reporting form as completely as possible, using a separate form for each patient and fax, mail or e-mail it to TIPC.
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 identifiers is kept strictly confidential.

Follow-up information for an ADR that has already been reported: Any follow-up information for an AMR that has already been reported can be sent on another AMR form, or it can be communicated by telephone, fax or e-mail to TIPC at Central Windhoek Hospital. So that the information can be matched with the original report, indicate that it is a follow-up report, the date of the original report and the unique TIPC id number if known. It is very important that follow-up reports are identified and linked to the original report.

Where to send the report : Adverse reactions for medicine products that are marketed in Namibia are monitored by the TERAPUTICS INFORMATION AND PHARMACOVIGILLANCE CENTRE at the Windhoek Central Hospital. Send these ADR reports to the address on the ADR Reporting Forms.

For more information on the TIPC, additional copies of ADR reporting forms or to report an ADR contact

Therapeutics Information and pharmacovigilance centre Windhoek Central Hospital Private Bag: 13198 Windhoek, Namibia Tel. 061 203 2312 Fax: 061 226631, e-mail: info@tipc.com.na