Pharmacovigilance Requirements in Namibia
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. An electronic copy is also available at the NMRC 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.
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.
Therapeutics Information and Pharmacovigilance Centre
Room 21, Basement Area, Windhoek Central Hospital. Windhoek.
Tel: 061 203 2312
Fax: 061 22 66 31/ 088 618 776