From U London: Substandard drugs: a potential crisis for public health

Br J Clin Pharmacol. 2013 Nov 29. doi: 10.1111/bcp.12298. [Epub ahead of print]

Substandard drugs: a potential crisis for public health.

Johnston A, Holt DW.

Author information

• Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, UK.

Abstract

Poor quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsifieddrugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are more wide spread than falsified medications and represent a greater threat to health as they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals. This article will review the different aspects of substandard drug formulation that can occur (for example, pharmacological variability between drug batches or between generic and originator drugs; incorrect drug quantity; and presence of impurities). It will also discuss the possible means of addressing substandard manufacturing practices. A concerted effort is required on the part of governments, drug manufacturers, charities and healthcare providers to ensure that only drugs of acceptable quality reach the patient.