Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online

Merczel, Sára; Vida, Róbert György; Tasi, Tamás; Fittler, András; Botz, Lajos

doi:10.1016/j.jsps.2023.04.018

Cited by 3 publications

(1 citation statement)

References 33 publications

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“…According to the World Health Organization, 1 in 10 health products in low to middle-income countries is estimated to be falsified (World Health Organization, 2018). Some studies revealed impurities, higher doses, and wide dose variations between medicinal products and online supplements (Merczel et al, 2023;Venhuis et al, 2014).…”

Section: Introductionmentioning

confidence: 99%

Assessing knowledge and practice of online medication purchasing: A pilot study

Haestuti,

Puspita,

Nida

2024

Pharm Educ

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Background: Online Medication Purchasing (OMP) has emerged as a growing concern because of the risk of receiving falsified products and the irrational use of medicines. Despite the government regulation about OMP, more is needed to know whether the residents are aware of this regulation. Objective: The study aimed to determine the level of knowledge & practice of OMP and to estimate the factors correlated to it. Method: A pilot project was conducted in the Wanasari village, Cibitung district, Bekasi. A validated questionnaire determined the sociodemographics, knowledge, and practice of 92 participants regarding OMP. A multivariate logistic regression was performed to measure the predictors of OMP knowledge. Result: The study showed that slightly over half of the participants have adequate knowledge of OMP (58.7%). Nevertheless, poor knowledge predominantly emerged regarding legal access to antibiotics and controlled medicines. Adequate knowledge of OMP increased for participants with higher education (OR:20.202; 95%CI:3.488-117.020; p = 0.001) and being active workers (OR:8.365; 95%CI:1.974-35.435; p = 0.004). Conclusion: Education and employment determine OMP knowledge. This study confirms that educational interventions are required to promote good OMP practice and protect health customers from the adverse effects of falsified medications.

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Section: Introductionmentioning

confidence: 99%

Assessing knowledge and practice of online medication purchasing: A pilot study

Haestuti,

Puspita,

Nida

2024

Pharm Educ

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Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study

Ashraf,

Mackey,

Vida

et al. 2024

J Med Internet Res

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Background Over the past 4 decades, obesity has escalated into a global epidemic, with its worldwide prevalence nearly tripling. Pharmacological treatments have evolved with the recent development of glucagon-like peptide 1 agonists, such as semaglutide. However, off-label use of drugs such as Ozempic for cosmetic weight loss has surged in popularity, raising concerns about potential misuse and the emergence of substandard and falsified products in the unregulated supply chain. Objective This study aims to conduct a multifactor investigation of product quality and patient safety risks associated with the unregulated online sale of semaglutide by examining product availability and vendor characteristics and assessing product quality through test purchases. Methods We used a complex risk and quality assessment methodology combining online market surveillance, search engine results page analysis, website content assessment, domain traffic analytics, conducting targeted product test purchases, visual quality inspection of product packaging, microbiological sterility and endotoxin contamination evaluation, and quantitative sample analysis using liquid chromatography coupled with mass spectrometry. Results We collected and evaluated 1080 links from search engine results pages and identified 317 (29.35%) links belonging to online pharmacies, of which 183 (57.7%) led to legal pharmacies and 134 (42.3%) directed users to 59 unique illegal online pharmacy websites. Web traffic data for the period between July and September 2023 revealed that the top 30 domains directly or indirectly affiliated with illegal online pharmacies accumulated over 4.7 million visits. Test purchases were completed from 6 illegal online pharmacies with the highest number of links offering semaglutide products for sale without prescription at the lowest price range. Three injection vial purchases were delivered; none of the 3 Ozempic prefilled injection pens were received due to nondelivery e-commerce scams. All purchased vials were considered probable substandard and falsified products, as visual inspection indicated noncompliance in more than half (59%-63%) of the evaluated criteria. The semaglutide content of samples substantially exceeded labeled amounts by 28.56%-38.69%, although no peptide-like impurities were identified. The lyophilized peptide samples were devoid of viable microorganisms at the time of testing; however, endotoxin was detected in all samples with levels ranging between 2.1645 EU/mg and 8.9511 EU/mg. Furthermore, the measured semaglutide purity was significantly low, ranging between 7.7% and 14.37% and deviating from the 99% claimed on product labels by manufacturers. Conclusions Glucagon-like peptide 1 agonist drugs promoted for weight loss, similar to erectile dysfunction medications more than 2 decades ago, are becoming the new blockbuster lifestyle medications for the illegal online pharmacy market. Protecting the pharmaceutical supply chain from substandard and falsified weight loss products and raising awareness regarding online medication safety must be a public health priority for regulators and technology platforms alike.

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Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study (Preprint)

Ashraf,

Mackey,

Vida

et al. 2024

Preprint

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BACKGROUND Over the past 4 decades, obesity has escalated into a global epidemic, with its worldwide prevalence nearly tripling. Pharmacological treatments have evolved with the recent development of glucagon-like peptide 1 agonists, such as semaglutide. However, off-label use of drugs such as Ozempic for cosmetic weight loss has surged in popularity, raising concerns about potential misuse and the emergence of substandard and falsified products in the unregulated supply chain. OBJECTIVE This study aims to conduct a multifactor investigation of product quality and patient safety risks associated with the unregulated online sale of semaglutide by examining product availability and vendor characteristics and assessing product quality through test purchases. METHODS We used a complex risk and quality assessment methodology combining online market surveillance, search engine results page analysis, website content assessment, domain traffic analytics, conducting targeted product test purchases, visual quality inspection of product packaging, microbiological sterility and endotoxin contamination evaluation, and quantitative sample analysis using liquid chromatography coupled with mass spectrometry. RESULTS We collected and evaluated 1080 links from search engine results pages and identified 317 (29.35%) links belonging to online pharmacies, of which 183 (57.7%) led to legal pharmacies and 134 (42.3%) directed users to 59 unique illegal online pharmacy websites. Web traffic data for the period between July and September 2023 revealed that the top 30 domains directly or indirectly affiliated with illegal online pharmacies accumulated over 4.7 million visits. Test purchases were completed from 6 illegal online pharmacies with the highest number of links offering semaglutide products for sale without prescription at the lowest price range. Three injection vial purchases were delivered; none of the 3 Ozempic prefilled injection pens were received due to nondelivery e-commerce scams. All purchased vials were considered probable substandard and falsified products, as visual inspection indicated noncompliance in more than half (59%-63%) of the evaluated criteria. The semaglutide content of samples substantially exceeded labeled amounts by 28.56%-38.69%, although no peptide-like impurities were identified. The lyophilized peptide samples were devoid of viable microorganisms at the time of testing; however, endotoxin was detected in all samples with levels ranging between 2.1645 EU/mg and 8.9511 EU/mg. Furthermore, the measured semaglutide purity was significantly low, ranging between 7.7% and 14.37% and deviating from the 99% claimed on product labels by manufacturers. CONCLUSIONS Glucagon-like peptide 1 agonist drugs promoted for weight loss, similar to erectile dysfunction medications more than 2 decades ago, are becoming the new blockbuster lifestyle medications for the illegal online pharmacy market. Protecting the pharmaceutical supply chain from substandard and falsified weight loss products and raising awareness regarding online medication safety must be a public health priority for regulators and technology platforms alike.

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Quality of dorzolamide hydrochloride and timolol maleate containing eye drops distributed online

Cited by 3 publications

References 33 publications

Assessing knowledge and practice of online medication purchasing: A pilot study

Assessing knowledge and practice of online medication purchasing: A pilot study

Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study

Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study (Preprint)

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