Search

Substandard and falsified medicines are often reported worldwide. An accurate and rapid detection method for falsified medicines is needed to prevent human health hazards. Raman scattering spectroscopy has emerged as a non-destructive analysis method for the detection of falsified medicines. In this laboratory study, Raman spectroscopy was performed to evaluate the applicability of the ultra-compact Raman scattering spectrometer (C13560). Principal component analysis (PCA) was also performed on the Raman spectra. This study analyzed tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) tablets. We tested the standard product and products purchased from the internet (genuine or falsified). For Cialis and Levitra, all falsified tablets were identified by the Raman spectra and PCA score plot. For Viagra, the Raman spectra of some falsified tablets were almost comparable to the standard tablet. The PCA score plots of falsified tablets were dispersed, and some plots of falsified tablets were close to the standard tablet. In conclusion, C13560 was useful for the discrimination of falsified Cialis and Levitra tablets, whereas some falsified Viagra tablets had Raman spectra similar to that of the standard tablet. The development of detection methods that can be introduced in various settings may help prevent the spread of falsified products.

Background: substandard and falsified medicines (SFMs) are a threat to public health. The availability of SFMs in Myanmar was reported by the World Health Organization (WHO) in 1999, but there have been few systematic surveys on falsified medicines in Myanmar since then. The aim of this study is to examine the extent of SFMs for sale in Myanmar. Methods: target medicines were tablets of candesartan, metformin, and pioglitazone, and infusions of ciprofloxacin and levofloxacin. Samples were collected from hospitals, pharmacies, and wholesalers located in the Mandalay region in 2015. We carried out observation testing, authenticity investigation, and quality testing to search for SFMs, and analyzed the relationship between SFMs and the price and store type. Results: There were no falsified medicines found in the authenticity check, though there remained a problem due to low response rates from manufacturers and regulatory authorities. In the quality test, some tablets of metformin and pioglitazone made in India failed the dissolution test. Conclusions: although no serious problems were found, some substandard medicines were detected. Regular surveys to monitor SFMs are therefore recommended, together with further regulatory guidance to improve conditions in all medicine manufacturers, distributors, and pharmacies.

Medicine falsification is a global issue. Viagra, an erectile dysfunction therapeutic (EDT) medicine consisting primarily of sildenafil citrate, is the most commonly falsified medicine worldwide. Recently falsified EDTs have been reported multiple times in developing countries. The globalization of falsified EDTs has become a concern. In the present study, we selected sildenafil citrate tablets as an indicator and examined samples from a developing country, Cambodia, to investigate the availability of falsified sildenafil tablets in Cambodia and verify the current globalization status of falsified medicines from the standpoint of a developing country. Six samples of the originator Viagra, and 68 samples of generic sildenafil products were purchased from private drug outlets and wholesalers in Phnom Penh, Svay Rieng, and Battambang. The samples’ manufacturers were contacted to authenticate the samples. The quantities and dissolution rates of active ingredients were measured by a high-performance liquid chromatography system with photodiode array. Five generic samples were strongly suspected to be falsified medicines because of their extremely low quality; however, there was little distribution and no falsified medicine alleged to be produced by the originator of Viagra, which charges high prices. That finding indicates that falsification reflects local economic circumstances.

Studies concerning patient demands are mainly conducted at hospitals and pharmacies, whereas few surveys have been conducted on drug stores. The demand for drug stores is estimated to be increasing with growing needs for self-medication. Thus, conducting a customer survey at drug stores is thought to be valuable. The aim of the current study was to clarify the structure of customers’ demands for drug stores. The survey was conducted on 190 customers of 19 drug stores in Japan. The questionnaire consisted of 24 items using a 9-point Likert scale. The IBM SPSS Statistics version 23 (IBM Japan, Tokyo, Japan) and Amos version 5 (IBM Japan, Tokyo, Japan) were utilized to perform factor analysis. Gender did not influence the response to each question. Factor analysis showed that the structure of customers’ demands consisted of three factors: (1) an explanation about medicine, (2) staff’s manners, and (3) location of drug stores. Because fit indices suggested a good fit, this three-factor solution was adopted as the final factor structure. This study demonstrated the structure of customers’ demands for drug stores, with the potential for use in promotion of self-medication.

Many poor-quality medicines are supplied to patients mainly in developing countries. No systematic survey on counterfeit medicines has been conducted in Myanmar since 1999. The purpose of this study was to investigate the current situation of substandard or counterfeit medicines in Myanmar. Samples of oral medicines, cefuroxime axetil (CXM), donepezil hydrochloride (DN) and omeprazole (OM), and injections, ceftriaxone sodium (CTRX), and gentamicin sulfate (GM), were collected from pharmacies, hospitals, and wholesalers in Yangon, Myanmar in 2014. Authenticity and quality were verified. There were 221 (94%) foreign medicines among 235 collected samples. Five samples of GM and 1 DN sample were not registered with the Food and Drug Administration, Myanmar. In quality analysis, 36 samples out of 177 (20.3%) did not pass quantity tests, 27 samples out of 176 (15.3%) did not pass content uniformity tests, and 23 out of 128 samples (18.0%) did not pass dissolution tests. Three of the unregistered GM samples failed in both identification and microbial assay tests. Counterfeit GM is being sold in Yangon. Also, the quality of OM is a matter of concern. Poor-quality medicines were frequently found among the products of a few manufacturers. Regular surveys to monitor counterfeit and substandard medicines in Myanmar are recommended.