Rafaella’s Literature Update

Ref. Jenkins D, Diallo C, Payne M. Detecting falsified oral contraceptives by visual assessment and diffuse reflectance spectroscopy (350-2500 nm): the need for supplementing traditional pharmacopeia techniques and the public health implications. Heliyon. 2022 Oct 1;8(10):e10837.

Dear Friends, 

Today I wish to share a contribution from David Jenkins and colleagues from FHI 360. For those of us professionally engaged with technical aspects of QA/QC, this will be very interesting! And for those who are not, it will be a great opportunity to learn about the complexities of QC/QA and, in particular, of detection of substandard and falsified medicines. And here I leave the word to David and colleagues …….

We want to share a new publication f[attached] from FHI 360 about product quality control testing on medical products to detect substandard and falsified medicines. 

For background, testing is usually performed using traditional pharmacopeia techniques. Pharmacopeias provide the standards for product quality and information on the test methods to evaluate compliance with the manufacturer’s specifications for the product. However, pharmacopeias sometimes include a limited set of techniques for testing. FHI 360’s Product Quality and Compliance (PQC) department has worked extensively to develop ways to assess products using different types of spectroscopy. Spectroscopic techniques can measure different interactions of light with a sample that can give information about the chemical and physical properties of the product. Advances in spectroscopy techniques can improve confidence in QC testing and sometimes reduce costs and resources required to perform testing. 

 As described in this paper, after visual assessments raised concerns about a specific sample of oral contraceptives in a Sub-Saharan African market, FHI 360 used diffuse reflectance spectroscopy (DRS) to confirm the product was falsified when traditional methods were unable to identify anything abnormal. Usually, traditional pharmacopeia techniques can be used to identify and characterize poor quality medications and then further analysis with spectroscopic assessments may be needed to provide a more information. However, in this case, traditional pharmacopeia procedures did not flag anything unusual with an oral contraceptive product that was flagged as potentially falsified. Instead, FHI 360 confirmed the product was falsified only through additional visual and spectroscopic assessments. 

 This paper is significant because it highlights the value of FHI 360’s work to develop and use spectroscopic techniques to supplement traditional techniques. In this case, our screening flagged that this product was falsified and we were able to raise awareness that it was circulating in the public market. Thus, the paper demonstrates the importance of using simple visual assessment and spectroscopic techniques (such as DRS) to screen a sample to supplement traditional pharmacopeia approaches and thereby minimize the risk of substandard and falsified medicines circulating in local markets in low- and middle-income countries.  

Just a last remark on the importance of detection of these products: as stated in the paper, “with this [falsified] sample being presented as another registered product’s brand name, the integrity of the regulatory oversight that the end users rely upon was compromised “, which “points to the continued need to further assist regulatory programs in the global market“.  Breaches of regulatory oversight are always dangerous to the public! 



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