The Pharmacovigilance Reference Manual is a comprehensive document that introduces key pharmacovigilance concepts and provides guidance for detecting, managing, and reporting medicine-related problems. It is designed to help all health workers contribute to the continuous surveillance of the safety and effectiveness of medicines and related products used in disease prevention, diagnosis, and treatment. Pharmacovigilance is the systematic science of detecting, monitoring, researching, assessing, and evaluating adverse effects and other medicine-related problems reported by healthcare providers and patients. Its purpose is to identify new safety information and prevent harm, ensuring the rational and safe use of effective medicines. Its scope is broad and covers adverse drug reactions, interactions, medication errors, misuse, overdose, treatment failures, resistance, and product-quality issues such as poor packaging, expired or counterfeit products, and lack of efficacy. The main objectives outlined in the document are (i) ensure the rational and safe use of effective medicines, through continuous monitoring of the safety and efficacy of medicines, vaccines, biological, herbal and traditional products, by actively identifying new information about potential risks and hazards, and by preventing harm to patients through early detection of adverse drug reactions; (ii) detect, assess, understand and prevent adverse effects and all medicine-related problems, establishing a pharmacovigilance system to collect and evaluate data from health workers and patients, while also monitoring a broad range of medicine-related issues such as adverse drug reactions, drug interactions, medication errors, overdose and abuse, treatment failures and drug resistance, as well as product quality problems including expired, counterfeit or poorly packaged medicines and products lacking efficacy; (iii) equip health workers with skills for detection, management and reporting of medicine-related problems, providing clear guidelines in the manual on how to detect adverse events, how to manage adverse drug reactions, and how to correctly report suspected reactions, along with training health workers in the principles and procedures of drug safety monitoring and reporting; (iv) promote active participation of health professionals in pharmacovigilance activities, encouraging health workers to report all suspected adverse events—including serious or unexpected reactions, lack of efficacy and product quality defects and support them with tools such as the Adverse Drug Event (ADE) reporting form and a structured reporting pathway from health facilities to the National Pharmacovigilance Unit; (v) support continuous improvement of patient care and public health, building national databases of adverse drug reactions to inform evidence-based regulatory decisions, using pharmacovigilance findings to guide actions such as updates to product information, recalls or withdrawals, and maintaining surveillance systems that monitor drug resistance in diseases such as malaria, HIV and tuberculosis. Chapter 8 highlights the widespread global use of herbal and traditional medicines and stresses the need to assess their safety and efficacy. Adverse reactions from herbal products may arise from the herb itself, through predictable effects, overdose, interactions, or allergic responses, or from problems in manufacturing, such as misidentification, contamination, substitution, adulteration, or poor labeling. Patient characteristics and long-term or heavy use can increase the risk of adverse events. The chapter emphasizes that adverse reactions from herbal medicines must be reported just like those from pharmaceuticals.
Zambia · 2006-05-01