INTRODUCTION

The Therapeutics Information and Pharmacovigilance Centre (TIPC) serves as the administrative and technical division of the Namibia Medicines Regulatory Council (NMRC), entrusted with the responsibility of pharmacovigilance to ensure the safe and rational utilization of medicines. Pharmacovigilance primarily involves the investigation and monitoring of adverse events (AEs) that occur following the use of medicinal products, including vaccines, commonly referred to as Adverse Events Following Immunization (AEFIs). The essential role of post-marketing pharmacovigilance lies in the monitoring of rare incidents and the long-term safety of drugs, particularly in specific populations and situations that are typically not included in pre-marketing studies. Central to this is the importance of appropriately gathering and reporting safety data to furnish information for clinical and regulatory decision-making. Pharmacovigilance plays a crucial role in maintaining the safety of medicines for their intended use. Ensuring the rational and safe utilization of medications encompasses the identification and prevention of medication errors. These errors can transpire at any point along the drug delivery process, ranging from prescription to drug administration.

PHARMACOVIGILANCE

Suspected adverse events to medicines, should be reported using the Adverse Medicine Reaction (Safety Yellow Form) must be completed and sent to the TIPC by fax or email. Adverse events can also be reported telephonically. Alternatively, the eReporting tool found at https://vigiflow-eforms.who-umc.org/na/named can be used.

Actual or "near errors" can occur when prescribing, repacking, dispensing or administering a medicine. They should be reported using the Medication Error Form. TIPC guarantees confidentiality of information received and respects reporters' wishes as to the level of detail included in the report.

Problems of quality defect that occur during manufacturing, shipping or storage of prescription or over-the-counter products shall be reported to the marketing authorization holder or to the inspectorate of the NMRC on the Pharmaceutical Product Quality Form.

• All suspected reactions to new medicines
• Unknown or unexpected medicines
• Serious adverse medicine reactions
• Unexpected therapeutic effects
• All suspected medicine interactions
• Product quality issues
• Treatment failure
• Medication error

• Healthcare workers
• Health facility therapeutics committees
• Holder of Certificate of Registration
• Public health programmes
• Patients and care givers