Changing Paradigms in Drug Safety Management: A Review of Emerging e‐Health Approaches. Pharmaceutical Sector Paper, No. 1, June 2013 Victor Igharo Introduction oor access to safe drugs/medicines contribute to thousands of deaths, complications and suffering both in urban and rural settings. Most of the problems being encountered in the healthcare delivery system in Nigeria centres around the herculean task of improving patient access to quality healthcare products and services, improving safety of medicines and lowering overall healthcare costs. In addition to the shortfall of drugs and health commodities, a major threat to health and wellbeing is the proliferation of fake and counterfeit medicines. While there are generally less than adequate and reliable data on the mortality or morbidity arising from the consumption of counterfeit drugs in Nigeria, pockets of submissions have been recorded on the impact of fake and adulterated/substandard pharmaceutical products. This paper will identify the factors to be considered in view of the changing paradigms in drug safety and the application of modern e-health approaches to address the underlying factors. Drug Safety versus Patient Safety bout 1.6 billion people do not have access to safe medicines. Lack of access to safe medicines contributes to thousands of deaths, complications and suffering both in urban and rural settings. Safe Medicines comprises drugs and other health commodities used internally or externally for prevention, treatment of diseases or symptoms, lessening of pain or for diagnostic purposes which when used appropriately will elicit the desired therapeutic response while otherwise might result in adverse reactions or worsen the pre-existing disease condition. The safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines, report their harmful effects, and provide accurate information for their safe use. Adverse Drug Reactions (ADRs) which are Unintended, harmful reactions to medicines are among the leading causes of death in many countries. The majorities of adverse drug reactions (ADR) are preventable and in some countries ADR-related costs, such as hospitalization, surgery and lost productivity, exceed the cost of the medications. 1 Several discourses have brought to the fore several issues bothering on the safety of medicines in Nigeria. These include drug counterfeiting and adulteration practices, healthcare control systems, drug consumption patterns and pharmacovigilance architecture. Drug Counterfeiting and adulteration Drug counterfeiting has become a ‘’billion dollar’’ industry. In 2006, the WHO launched the global IMPACT (International Medicinal Products Anti-Counterfeiting Taskforce) initiative which created five working groups; 2 [8] P A