Differences in drug quality between South Africa and Germany

Lehmann, Andreas; Hofsäss, Martin A.; Dressman, Jennifer B.

doi:10.1111/jphp.12985

Cited by 3 publications

(2 citation statements)

References 25 publications

(64 reference statements)

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“… 15 Here, samples of difficult-to-make drug products were procured and tested directly by the FDA. Drug sampling studies are needed because such studies in other countries, especially developing countries, have shown serious issues with drug quality, 16 , 17 , 18 , 19 often associated with counterfeiting. 20 Beyond this study, the FDA regularly samples drugs for surveillance and other reasons and takes action when occasionally finding substandard products from all regions.…”

Section: Discussionmentioning

confidence: 99%

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

et al. 2020

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Key Points Question Are there substantive differences in the major quality attributes of difficult-to-make pharmaceutical products manufactured throughout the world and marketed in the US? Findings In this quality improvement study, all of 252 drug product samples met the US market standards for the major quality attributes of dosage unit uniformity and dissolution, although there was evidence of differences in the consistency of these attributes among regions and manufacturers. Meaning These findings suggest that difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the US.

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Section: Discussionmentioning

confidence: 99%

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

et al. 2020

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“….]" 15 or with the capacity of local regulators to detect insufficient standards. Harming is not the primary intent of such practices, but the primary intent (cutting costs) implies accepting the risk of harming.…”

Section: From Who Definitions To National Legislationsmentioning

confidence: 99%

Legal Uncertainty—The Gray Area around Substandard Medicines: Where Public Health Meets Law

Olliaro¹,

Olliaro

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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A vicious circle links lack of equitable access to health to the supply of poor-quality medicines, which amount to one-tenth of medicines available in low-and middle-income countries. The WHO introduced a new, public health-focused definition of substandard and falsified (SF) medicines, which offers opportunities for governments to broaden the scope of interventions to combat poor-quality medicines. At the same time, translating it into legal and regulatory measures may be challenging because this definition is not free of ambiguity (in that, there is a gray area between intentionally falsified and unintentional substandard medicines), and some countries may not have appropriate regulatory mechanisms/jurisdictions in place. The focus of the article is to consider what a public health-informed legal and regulatory environment could look like in light of WHO's SF definition and propose appropriate measures to put it into effect. We present a "legal levers matrix" that may assist legislators and policymakers evaluate the adequacy of measures (i.e., criminal, civil, and administrative mechanisms) to address the problem of poor-quality medicines, particularly in terms of their configuration. In addition, this matrix underscores the importance of fostering dialogue between medical/public health and the legal/regulatory communities and to develop alternative/complementary solutions, including regulatory strengthening and nonpunitive actions. Substandard and falsified medicines arise from the interplay between societies, economies, and behaviors: effective regulation is necessary to disincentivize the production and/or supply of SF medicines, whereas health systems should strive to provide affordable medicines to all levels of society.

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Comparative evaluation of acetaminophen form (I) in commercialized paracetamol brands

et al. 2023

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Differences in drug quality between South Africa and Germany

Abstract: Important differences in quality were detected between some German and South African products. To preclude drug products of poor or doubtful quality from entering the market in South Africa, countermeasures are needed.

Cited by 3 publications

References 25 publications

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

Legal Uncertainty—The Gray Area around Substandard Medicines: Where Public Health Meets Law

Comparative evaluation of acetaminophen form (I) in commercialized paracetamol brands

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