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Therapeutics Information and Pharmacovigilance Centre

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Overview of TIPC TIPC is the Ministry of Health and Social Services Therapeutics Information and Pharmacovigilance Centre for the provision of unbiased and up-to-date therapeutics information for both the health care providers and the general public. The need for this medicine information centre in Namibia has long been established. The National Drug Policy (NDP) of 1998 actually recommends the establishment of a drug information center and an adverse reaction monitoring unit linked to the Medicines Control Council (MCC) to coordinate adverse reaction reporting and to manage data collection, analysis and dissemination. The Namibia Medicines and Related Substances Control Act, 2003 (Act. No. 13 of 2003) requires the reporting of Adverse Medicine Reactions (AMRs) by health professionals. Thus, a working group was formed under the leadership of the Ministry of Health and Social Services (MoHSS) to sets-up a center combining the twin functions of medicines information and pharmacovigilance. Therapeutics information TIPC was successfully launched in May 2008 with the general objective of TIPC is the Ministry of Health and Social Services Therapeutics Information and Pharmacovigilance Centre for the provision of unbiased and up-to-date therapeutics information for both the health care providers and the general public. The need for this medicine information centre in Namibia has long been established. The National Drug Policy (NDP) of 1998 actually recommends the establishment of a drug information centre and an adverse reaction monitoring unit linked to the Medicines Control Council (MCC) to coordinate adverse reaction reporting and to manage data collection, analysis and dissemination. The Namibia Medicines and Related Substances Control Act, 2003 (Act. No. 13 of 2003) requires the reporting of Adverse Medicine Reactions (AMRs) by health professionals. Thus, a working group was formed under the leadership of the Ministry of Health and Social Services (MoHSS) to sets-up a centre combining the twin functions of medicines information and pharmacovigilance. TIPC was successfully launched in May 2008 with the general objective of sensitizing healthcare professionals and the public of Namibia to the services of TIPC, which include answering queries on medicines and receiving AMR reports. sensitizing healthcare professionals and the public of Namibia to the services of TIPC, which include answering queries on medicines and receiving AMR reports. TIPC is the Ministry of Health and Social Services.

Know Your Medicines The centre responds to therapeutic enquiries using telephone, fax and e mail. The therapeutics information bulletin and the centre’s web page are used to proactively disseminate current therapeutic information. Our services for the general public emphasize on patient treatment literacy for medicines widely used in public health programs. Basic information about medicines use and medicine associated issuse are communicated to the general public by using the Namibian news paper every fortnight. Reports of adverse events from patients and health professionals are entered in to a database called vigiflow and this information is shared to the WHO international medicine monitoring centre in Uppsala , Sweden.

Mission of TIPC To improve the rational and safe use of medicines in Namibia. Pharmacovigilance system 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 Reaction

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 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. 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.

http://www.nmrc.com.na/tipc