Jenkins David, Diallo Cherif, Payne Michael
Product Quality and Compliance, FHI 360, 2810 Meridian Parkway, Suite 160, Durham, NC 27713, USA.
Heliyon. 2022 Oct 1;8(10):e10837. doi: 10.1016/j.heliyon.2022.e10837. eCollection 2022 Oct.
Substandard and falsified pharmaceuticals can present a major health risk, particularly for low- and middle-income countries. In a Sub-Saharan African market, United States Agency for International Development (USAID) staff found an oral contraceptive product (0.15 mg levonorgestrel/0.03 mg ethinyl estradiol) labeled with a logo (and brand name) visually matching one historically used by USAID but purportedly manufactured by an unauthorized source. Additional assessment was conducted to determine if more evidence of falsification was present to better understand the public health impact.
Relative to a control, the suspect sample was assessed visually for tablet features and with United States and International Pharmacopeia methods for levonorgestrel/ethinyl estradiol tablets. Diffuse reflectance spectra (350-2500 nm) were collected to further characterize the sample.
Although the suspect sample aligned with pharmacopeia tests, visual examination of tablet characteristics and diffuse reflectance spectroscopy (350-2500 nm) assessments supported the tablets were not the same as control samples, confirming the suspect sample was falsified. These results raised concerns for the overall regulatory oversight available for the market with uncertainty regarding the true clinical bioequivalence levels (although adequate dissolution levels were observed).
Comprehensive characterization of suspect pharmaceuticals from the field can often be required depending on the nature of the sample and can have dramatic implications for understanding the public health risks to the end user within the local market. Simple visual assessment and spectroscopic techniques to screen a sample can help to supplement traditional pharmacopeia approaches.
Proper characterization of suspect pharmaceuticals is necessary to best understand their potential public health impact. Situations can occur where traditional pharmacopeial techniques may not adequately characterize a sample. Visual assessments and diffuse reflectance spectroscopy can be supplemented to provide a more holistic analysis.
不合格和伪造药品会带来重大健康风险，对低收入和中等收入国家而言尤其如此。在撒哈拉以南非洲市场，美国国际开发署（USAID）工作人员发现一种口服避孕药（0.15毫克左炔诺孕酮/0.03毫克炔雌醇），其标签上的标识（和品牌名称）在视觉上与USAID过去使用的一个标识相符，但据称是由未经授权的来源生产的。进行了进一步评估，以确定是否存在更多伪造证据，以便更好地了解其对公众健康的影响。
相对于对照品，对可疑样品的片剂特征进行了目视评估，并采用美国和国际药典方法对左炔诺孕酮/炔雌醇片剂进行了评估。收集了漫反射光谱（350 - 2500纳米）以进一步表征样品。
尽管可疑样品符合药典测试，但对片剂特征的目视检查和漫反射光谱（350 - 2500纳米）评估表明这些片剂与对照样品不同，证实可疑样品是伪造的。这些结果引发了对该市场整体监管情况的担忧，因为真正的临床生物等效性水平存在不确定性（尽管观察到了足够的溶出度水平）。
根据样品的性质，通常需要对实地可疑药品进行全面表征，这对于了解当地市场终端用户面临的公共健康风险可能具有重大影响。简单的目视评估和光谱技术可用于筛选样品，有助于补充传统的药典方法。
正确表征可疑药品对于充分了解其潜在的公共健康影响至关重要。在某些情况下，传统的药典技术可能无法充分表征样品。可以补充目视评估和漫反射光谱法以提供更全面的分析。
