How to achieve international action on falsified and substandard medicines

Substandard/Counterfeit Antimicrobial Drugs

“…Substandard medicines have not been defined uniformly (18). Substandard drugs are "genuine medicines which have not passed the standards and quality testing protocols set for them" (19)(20)(21)(22).…”

“…Counterfeit medicines are a type of substandard drugs. There is no international consensus regarding the definition of counterfeit medicines (18), and the WHO defines them as "drugs that are deliberately and fraudulently mislabeled with respect to identity and/or source" (12).…”

“…In most cases, it is not known if the wrong concentration of the active component in a drug is the result of fraud, even after chemical analysis of a drug (59). In 2011, the WHO proposed the use of the term "substandard/spurious/falsely labeled/falsified/counterfeit drugs" (SSFFC) (59); this is ambiguous (18) since it cannot differentiate the different causes of poor drug quality (counterfeit versus substandard), which need to be addressed using different approaches. In this article the term "substandard/counterfeit" drug is used when the cause for the poor-quality drug has not been determined.…”

“…The data reflect the regulatory oversight in countries where the counterfeit antimicrobials have been studied (73). Since pharmaceutical companies and regulatory authorities have not published most of their data on counterfeit antibiotics (18,73), published prevalence studies may provide useful epidemiology data (73).…”

The Medicines Quality Database: a free public resource

“…3 The problem of poor quality medicines is particularly widespread and potentially more devastating in lowincome countries. [4][5][6][7] It is therefore extremely important to strengthen such countries' capacity for quality assurance (QA) and quality control (QC) of medicines. However, many low-income countries lack the resources to develop appropriate regulatory frameworks and the necessary QA and QC systems.…”