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On the use of substandard medicines in hematology: An emerging concern in the Middle East and North Africa region

Published:November 24, 2017DOI:https://doi.org/10.1016/j.ejim.2017.08.003
      Generic drugs (generics) are vital to the sustainability of health care systems, especially in developing areas with low resources. Ensuring benefit to patients through the approval and delivery of generics that meet quality standards remains essential. Generics are expected to be bioequivalent and interchangeable with the innovator's drug product's reference formulation. Aside from certain instances were such generics are found to be spurious, falsely-labelled, falsified, or counterfeit; all would have passed local regulatory approvals in manufacturing and importing countries before becoming available for patient prescription. Unfortunately, regulatory standards do not always entail that such generics have met all necessary quality specifications, and the availability of ‘substandard’ generics with compromised safety or efficacy is emerging as a global healthcare concern. Several factors have been identified that explain this rising concern, ranging from poor manufacturing practices (e.g. use of impure materials in drug synthesis, inadequate quality control or assurance, incorrect storage, inappropriate packaging) to negligence in enforcement or complete absence of appropriate regulatory approval standards. Thus, generics which may have passed local regulatory authority approval may still be far from meeting international quality standards. Increased harmonization and enforcement of strict regulatory, manufacturing and supply chain standards are thus becoming a global priority in an increasingly interconnected world [
      • Yang Y.T.
      • Nagai S.
      • Chen B.K.
      • Qureshi Z.P.
      • Lebby A.A.
      • Kessler S.
      • et al.
      Generic oncology drugs: are they all safe?.
      ,
      • Johnston A.
      • David W.H.
      Substandard drugs: a potential crisis for public health.
      ].

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