Maintaining Drug Quality Standards

Abstract Medicines are manufactured, sold, distributed, and dispensed across the globe today, bringing enormous benefits for patients. However, this globalisation has also increased the spread and prevalence of medicines that are unsafe or may be ineffective. Substandard medicines, according to the WHO, are “products whose composition and ingredients do not meet the correct scientific specifications and which are consequently ineffective and often dangerous to the patient”. Substandard drugs are able to gain approval in countries that do not have robust regulatory standards for drug quality. Legitimate generic medicines meet accepted regulatory standards, typically through bioequivalence evaluation with rigorous identity and quality testing verified by a stringent regulatory evaluation process. These quality drugs provide a vital and cost-effective way to meet the pharmaceutical needs of patients around the world. Substandard medicines can arise due to the lack of scientific expertise of the manufacturer, problems with the manufacturing processes and/or quality and testing system deficiencies. The negative consequences of substandard drugs are serious and can contribute to significant mortality and morbidity due to treatment failure, toxicity or promotion of drug resistance. The theoretical scientific concerns regarding comparability between different versions of drugs containing the same active ingredient (originator, generic or substandard) have been borne out in investigations of the purity and clinical performance of specific copies relative to the originator drug. These studies can reveal insight into the extent to which substandard drugs have become available around the world and the impact they can have on healthcare. This presentation will present an overview of the healthcare issues that arise due to substandard drugs. The presentation will give examples of clinical and technical issues that give rise to substandard drugs and the potential impact of these formulations on individual patients and healthcare systems.