English — reviewed original text

Republic of Namibia Ministry of Health and Social Services Namibia Medicines National Guidelines for Regulatory Council Medicine Safety Surveillance Therapeutics Information and Pharmacovigilance Centre | TIPC October 2011 UNITY LIBERTY JUSTICE Know YOUR medicines

• Advise the NMRC on all other issues related to medicines safety in Namibia NMRC • Take regulatory decisions based on the recommendations of the Clinical Committee • Communicate the regulatory decisions taken to the HCRs and all other relevant bodies by using official letters and other means of communication 6. Scope of Pharmacovigilance and Medicine Safety Surveillance Activities PhV is concerned with the safety of medicines, medical devices, complementary medicines (which includes traditional and herbal medicines), vaccines, blood products, and other biologicals. It is also relevant in the detection of substandard medicines, medication errors, lack of efficacy, and off-label use of medicines. Information on other issues, such as acute and chronic poisoning, medicine related mortality, abuse and misuse of medicines, and interactions with other medicine and food, can also be obtained from PhV activities. 6.1. Types of AMRs An AMR is a noxious and unwanted reaction that occurs at a dose used in humans for diagnosis, treatment or prophylaxis of diseases or medical conditions. Many unwanted effects (side effects) are medically trivial. It is therefore convenient to retain the term side effects for minor effects, which are related to the pharmacological properties of the medicines. There are two principal types of AMRs— 1) Type A (augmented) is related to the principal action of the medicine • Will occur in everyone • Dose related 21

11.Tools for Medicine Safety Surveillance Activities Several tools have been developed or adopted by TIPC for PhV activities that standardize medicine safety surveillance in Namibia. These tools have harmonized Namibia’s medicines safety practices with international practices for better information sharing and collaboration. Some of the tools that are critical for the functioning of such activities include the safety yellow form, patient reporting form, therapeutics information request form, WHO causality assessment tool, AE severity grading, AE avoidability scale, algorithm for categorizing medication error, Vigiflow®, medicines or therapeutics information databases and others. Safety Yellow Form The AMR reporting form (annex 2), also called the safety yellow form, is the tool for reporting all suspected adverse reactions by health care professionals. Efforts have been made to make it simple and user friendly. An electronic version is available on the NMRC website. It can be used to report any suspected AMR and therapeutic ineffectiveness for all conventional, biological, complementary, i.e. alternative and traditional/herbal medicines, as well as cosmetics, nutritional and dietary supplements and medical devices. Patient Adverse Reaction Reporting Form/Safety Yellow Card The Patient Adverse Reaction Reporting Form, also called the Safety Yellow Card, is a simplified form (annex 6) that patients and those not in the health care profession can use to report any suspected AMR, medicinal product problem, medication error and therapeutic ineffectiveness for all medicines including conventional, biological, complementary, i.e. alternative and traditional/herbal medicines, as well as cosmetics, nutritional and dietary supplements and medical devices. 57

health services, and intersectoral initiatives whose primary purpose is to protect the public from harm related to the use of medicines New medicines: refers to the medicines with preparations of new chemical entities, compounding medications of new therapeutic activities, or new route of administration of old chemical entities; furthermore, the medical preparation, which is in the new dosage form, new dose, new dose per unit, or new route of administration that is still under the safety monitoring period, is monitored with an end date that is the same as the first preparation of the same component New chemical entities (NCE) or new molecular entity (NME): according to the US Food and Drug Administration, a medicine that contains no active moiety that has been approved by FDA in any other application submitted Periodic safety update report (PSUR): an update of the worldwide safety experience of a product obtained at defined times post registration Pharmacovigilance (PhV): the science and activities relating to the detection, assessment, understanding, and prevention of AEs or any other possible medicine-related problems; recently, its concerns have been widened to include herbals, traditional and complementary medicines, blood products, biologicals, vaccines and medical devices Serious AE: any untoward occurrence that is life threatening or fatal, causes or prolongs hospital admission, causes persistent incapacity or disability, causes misuse or dependence, and causes a congenital anomaly or birth defect. Signal: refers to reported information on a possible causal relationship between an AE and a medicine, the relationship being unknown or incompletely documented previously; usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information Side effect: any unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmacological proprieties of the medicine 68