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The Food and Drug Administration (FDA) has long suffered from a lack of resources limiting their inspection capacity. They have fallen behind on proactive surveillance inspections of foreign manufacturing sites, relying instead on for-cause inspections after a problem has been discovered. Over-the-counter (OTC) products are especially vulnerable because the FDA considers them lower priority. This issue recently made big news after improperly manufactured OTC eye drops harmed users across the country, in some cases causing blindness. To prevent future harm to Americans, it is imperative that the FDA receives enough resources to keep up with their routine inspections. [ABSTRACT FROM AUTHOR]

Background and aims: Drugs sold on cryptomarkets are thought to have lower levels of adulteration and higher strength compared with those sourced off‐line. The present study aimed to determine whether cryptomarket and off‐line‐sourced 3,4‐methylenedioxy‐N‐methamphetamine (MDMA), cocaine, amphetamine, methamphetamine and lysergic acid diethylamide (LSD) differed in adulteration and strength. Design and setting: A between‐groups design was used to compare cryptomarket versus off‐line‐sourced drugs. Regression analyses controlling for year and service were conducted. Drug‐checking services were conducted in Spain (Energy Control) and the Netherlands (Drugs Information and Monitoring System). Cases: The cases comprised drug samples that underwent drug checking between 2016 and 2021 and were expected to contain MDMA (tablets; n = 36 065; powder: n = 6179), cocaine (n = 11 419), amphetamine (n = 6823), methamphetamine (n = 293) and LSD (n = 1817). Measurements Drugs were measured for (1) matching the advertised substance (i.e. containing any amount of the expected substance); (2) strength; (3) presence of adulteration; and (4) number of adulterants. Findings The expected drug was more likely to be identified when sourced from cryptomarkets versus off‐line for MDMA tablets [adjusted odds ratio (AOR) = 2.10, 95% confidence interval (CI) = 1.28–3.43], MDMA powder (AOR = 2.64, CI = 1.55–4.51), cocaine (AOR = 3.65, CI = 1.98–6.71) and LSD (AOR = 1.75, CI = 1.13–2.72). Cryptomarket‐sourced MDMA powder (β = 0.03, P = 0.012), cocaine (β = 0.08, P < 0.001) and methamphetamine (β = 0.15, P = 0.028) were statistically significantly higher in strength than substances from off‐line sources. Conversely, MDMA tablets (β = −0.01, P = 0.043) and amphetamine (β = −0.07, P < 0.001) from cryptomarkets were statistically significantly lower in strength than from off‐line sources. MDMA powder (AOR = 0.53, CI = 0.33–0.86) and cocaine (AOR = 0.66, CI = 0.55–0.79) were statistically significantly less likely to be adulterated if sourced from cryptomarkets. However, amphetamine (AOR = 1.54, CI = 1.25–1.90) and LSD (AOR = 1.31, CI = 1.00–1.71) were found to be more likely to be adulterated when purchased from cryptomarkets. Cocaine from cryptomarkets exhibited fewer adulterants (incidence rate ratio = 0.71, CI = 0.60–0.85). Conclusion: The relationship between on‐line drug market‐places and substance quality varies depending on both the specific substance and the dynamics of the cryptomarket. [ABSTRACT FROM AUTHOR]

International, cross-sectorial, and interdisciplinary efforts are providing opportunities to involve all stakeholders in shaping research and policy priorities. Coordinated approaches offer hope for arriving at sustainable control of African animal trypanosomosis (AAT). Strategic frameworks (e.g., the Progressive Control Pathway) have been developed that can provide coherence across international and national control efforts against AAT. A benzoxaborole compound is in development, providing the prospect of the first novel trypanocide in >60 years. Fundamental advances have improved the ability to work with clinically relevant trypanosome species, enhancing research capacity for identifying drug candidates, and understanding drug mechanisms of action and resistance. Improving integration of efforts across all stakeholder sectors will ensure that advances translate to meaningful strategies and impact in the field. A welcome resurgence in African animal trypanosomosis (AAT) research has resulted in advances in capabilities, foundational datasets, and understanding. Additionally, there is the prospect of the first new trypanocide in >60 years. However, it is vital to ensure that advances translate to improved and sustainable control in the field. A recent meeting, the Symposium on African Livestock Trypanosomes – Tanzania, convened stakeholders from across the spectrum of AAT research and control to ask how this can be achieved. Current constraints on progress were defined, as were critical gaps and opportunities that need addressing. There is a requirement and opportunity for the AAT research community to communicate, collaborate, and coordinate to maintain momentum and achieve the ultimate goal of sustainable AAT control. [ABSTRACT FROM AUTHOR]

This paper explores the socio cultural and institutional determinants of irresponsible prescription and use of antibiotics which has implications for the rise and spread of antimicrobial resistance (AMR). This study describes the patterns of prescription of antibiotics in a public facility in India and identifies the underlying institutional, cultural and social determinants driving the irresponsible use of antibiotics. The analysis is based on an empirical investigation of patients' prescriptions that reach the in-house pharmacy following an outpatient department (OPD) encounter with the clinician. The prescription analysis describes the factors associated with use of broad-spectrum antibiotics, and a high percentage of prescriptions for dental outpatient department prescribed as a precautionary measure. This paper further highlights the need for future research insights in combining socio-cultural approach with medical rationalities, to further explore questions our analysis highlights like higher antibiotic prescription, etc., Along with the recommendations for further research. [ABSTRACT FROM AUTHOR]

Abstract Background Drug consumption rooms offer heroin and cocaine consumers a secure and hygienic environment including medical and social guidance. Despite the support and mentoring, only sparse information is available about how drug quality, drug prices and user expectations match at these locations. The present study reports analysis of these three parameters in two drug consumption rooms in Luxembourg. Methods Drug users were invited to participate in the project by handing in a few milligrams of the product they planned to consume for chemical analysis and filling out a short questionnaire about the price and their expectations. After consumption, they were asked to report the experienced effects. Drug quality was accessed using LC-Q-ToF and HPLC–UV, and a statistical analysis was carried out of the questionnaires that were correctly filled out. Results A total of 513 drug samples have been analyzed. Most consumers were looking for the relaxing/calming effects of heroin and the stimulating effects of cocaine, but they generally overestimated heroin potency and underestimated cocaine potency. No strong correlation based on Spearman’s ρ between drug user estimations, drug prices and drug quality was found. Conclusion To the best of our knowledge, this study is the first to combine drug analysis with heroin and cocaine user feedback about expectation, drug prices and drug effects. The analytical results were of great interest for users and the staff working at the drug consumption rooms. They may be a strong supplementary communication tool for health care workers when discussing effects and risks of highly toxic substance consumption.

This paper explores the socio cultural and institutional determinants of irresponsible prescription and use of antibiotics which has implications for the rise and spread of antimicrobial resistance (AMR). This study describes the patterns of prescription of antibiotics in a public facility in India and identifies the underlying institutional, cultural and social determinants driving the irresponsible use of antibiotics. The analysis is based on an empirical investigation of patients’ prescriptions that reach the in-house pharmacy following an outpatient department (OPD) encounter with the clinician. The prescription analysis describes the factors associated with use of broad-spectrum antibiotics, and a high percentage of prescriptions for dental outpatient department prescribed as a precautionary measure. This paper further highlights the need for future research insights in combining socio-cultural approach with medical rationalities, to further explore questions our analysis highlights like higher antibiotic prescription, etc., Along with the recommendations for further research.

The worsening of antibiotic resistance is a multifactorial process. One aspect of this is the counterfeiting of antibiotic medications. This is supposed to be particularly high in developing countries, including Nigeria. Therefore, the potency of some antibiotic drugs dispensed in community pharmacies in Gwale, Kano, Nigeria, was investigated in this case study. Three products, each from different manufacturers, with the active ingredients of ceftriaxone, gentamicin, ciprofloxacin, and metronidazole, respectively, were included in this study. By means of a disc-diffusion assay, the effect against the typed strains Staphylococcus aureus (ATCC 25923) and Escherichia coli (ATCC 25922) as well as Clostridium tetani isolated from soil was tested. Clinical isolates of S. aureus and E. coli were also used. While antibiotics, with the exception of ciprofloxacin-containing preparations against C. tetani, showed acceptable efficacy against the typed strains by comparison with the clinical science laboratory references, a predominant failure was observed with the clinical isolates. Thus, the investigated drug preparations can be considered of acceptable quality for the treatment of susceptible bacterial infections. This excludes counterfeits in the sampled preparations. However, the insufficient efficacy against clinical isolates further documents the severity of nosocomial bacteria. [ABSTRACT FROM AUTHOR]

Background: Drug consumption rooms offer heroin and cocaine consumers a secure and hygienic environment including medical and social guidance. Despite the support and mentoring, only sparse information is available about how drug quality, drug prices and user expectations match at these locations. The present study reports analysis of these three parameters in two drug consumption rooms in Luxembourg. Methods: Drug users were invited to participate in the project by handing in a few milligrams of the product they planned to consume for chemical analysis and filling out a short questionnaire about the price and their expectations. After consumption, they were asked to report the experienced effects. Drug quality was accessed using LC-Q-ToF and HPLC–UV, and a statistical analysis was carried out of the questionnaires that were correctly filled out. Results: A total of 513 drug samples have been analyzed. Most consumers were looking for the relaxing/calming effects of heroin and the stimulating effects of cocaine, but they generally overestimated heroin potency and underestimated cocaine potency. No strong correlation based on Spearman's ρ between drug user estimations, drug prices and drug quality was found. Conclusion: To the best of our knowledge, this study is the first to combine drug analysis with heroin and cocaine user feedback about expectation, drug prices and drug effects. The analytical results were of great interest for users and the staff working at the drug consumption rooms. They may be a strong supplementary communication tool for health care workers when discussing effects and risks of highly toxic substance consumption. [ABSTRACT FROM AUTHOR]

Rationale: To ensure that quality medicines are available to the populace. Aim and Objective: To provide a new perspective for drug sampling and testing using a risk‐based approach globally, and provide a reference for improving the efficiency of the drug sampling and testing programme in China. Method: This study used a combination of theoretical analysis and problem analysis. First, we analysed the high‐risk drugs that should be given attention to theoretically in the drug sampling testing programme based on the healthcare reform in China. Second, this study leveraged on data on the sampling and testing of drugs extracted from self‐constructed data by the China Food and Drug Administration (CFDA). The integrated and structured data sets were used to conduct an innovative analysis that identifies the actual content of the drug sampling and testing programme and contrasts them with the theoretical content to understand the problems. This study used quantitative and qualitative approaches for data analysis. Results: Following analysis, we discovered that there is still a big gap between the reality of drug sampling and testing in China and the ideal state of the objective requirements of healthcare reforms. The major sources of risk are the retail pharmacies or hospital pharmacies in the distribution chain of drugs; however, the CFDA sampled mostly drugs from drug manufacturers. Additionally, the CFDA did not sample adequate essential medicines, bid‐winning drugs (especially those with large price drops in centralized procurement), biological products and other high‐risk drug varieties. The high‐risk drugs produced by companies or enterprises with a history of noncompliance, especially bid‐winning enterprises in centralized procurement, were not sampled. Conclusion: We suggest that the major content of drug sampling and testing in China should focus on the link of drug utilization, varieties of drugs with large price drops in centralized procurement and bid‐winning enterprises with a history of noncompliance. [ABSTRACT FROM AUTHOR]

The worsening of antibiotic resistance is a multifactorial process. One aspect of this is the counterfeiting of antibiotic medications. This is supposed to be particularly high in developing countries, including Nigeria. Therefore, the potency of some antibiotic drugs dispensed in community pharmacies in Gwale, Kano, Nigeria, was investigated in this case study. Three products, each from different manufacturers, with the active ingredients of ceftriaxone, gentamicin, ciprofloxacin, and metronidazole, respectively, were included in this study. By means of a disc-diffusion assay, the effect against the typed strains Staphylococcus aureus (ATCC 25923) and Escherichia coli (ATCC 25922) as well as Clostridium tetani isolated from soil was tested. Clinical isolates of S. aureus and E. coli were also used. While antibiotics, with the exception of ciprofloxacin-containing preparations against C. tetani, showed acceptable efficacy against the typed strains by comparison with the clinical science laboratory references, a predominant failure was observed with the clinical isolates. Thus, the investigated drug preparations can be considered of acceptable quality for the treatment of susceptible bacterial infections. This excludes counterfeits in the sampled preparations. However, the insufficient efficacy against clinical isolates further documents the severity of nosocomial bacteria.

Grapiprant is a new analgesic and anti-inflammatory drug belonging to the piprant class, approved in 2016 by the FDA Veterinary Medicine Center for the treatment of pain and inflammation associated with osteoarthritis in dogs. It acts as a highly selective antagonist of the EP4 receptor, one of the four prostaglandin E2 (PGE2) receptor subtypes. It has been shown to have anti-inflammatory effects in rat models of acute and chronic inflammation and clinical studies in people with osteoarthritis. The current state of knowledge suggests the possibility of using it in oncological therapy. The manuscript presents the development of conditions for the identification and quantitative determination of grapiprant by thin-layer chromatography with densitometric detection. The optimal separation of the substance occurs using silica gel 60F254 chromatographic plates and the mobile phase containing ethyl acetate-toluene-butylamine. Validation (according to ICH requirements) showed that the developed method is characterized by straightness of results in a wide concentration range with the limit of detection of 146.65 µg/mL. The %RSD values of the precision and accuracy confirm the sensitivity and reliability of the developed procedure. Next, the method was used for quantification of grapiprant in a pharmaceutical preparation, and for stability studies under various environmental conditions. Additionally, the mass studies were carried out on the stressed samples using the UPLC-MS/MS method. The degradation products were primarily characterized by comparing their mass fragmentation profiles with those of the drug. The results indicated a potential degradation pathway for grapiprant. [ABSTRACT FROM AUTHOR]

Introduction. The publication is devoted to the role of laboratory research in ensuring the quality of domestic medicines and is a review and analysis of regulatory documents and current publications on this topic.Text. A number of different types of laboratories are involved in Drug life cycle and ensuring their effectiveness and safety. Today there are a large number of regulations governing laboratory research. Common to all types of laboratories and regulatory documents is the need to organize an effective quality management system (QMS) for the drug life cycle laboratories. The aim of this review is to analyze approaches to regulating the quality of laboratory research of domestic drugs and to consider the most effective QMS model, which is fundamental for all types of laboratories in the life cycle of drugs.Conclusion. The laboratory research quality system serves as a basic tool for achieving the ultimate goal - the clinical value of drugs and is designed to ensure that risks for patients are minimized. At the same time, each stage of the drug life cycle provides a solution to a specific problem on the way to this goal, which must be taken into account when building a QMS in each type of laboratory. The range of regulatory documents and external assessment systems (accreditation, certification, inspection control, etc.) in the field of domestic laboratory research is quite diverse. In this regard, it is advisable for the laboratory to build a harmonious QMS based on priorities in accordance with the goals and objectives. The most effective method for building such a system is an integrated management system model.

Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities. [ABSTRACT FROM AUTHOR]

Amodiaquine (AQ) is a commonly used antimalarial drug, and N-desethyl-AQ (N-DEAQ) is an active metabolite of AQ. Given the significance of drug quality in the management of malaria cases, this study aims to develop antibody-based assays for the detection and quantitation of AQ without the need for sophisticated equipment. Two monoclonal antibodies (mAbs) against AQ, designated as JUN7 and TE7, were selected, which showed 72.7% and 9.5% cross-reactivity to N-DEAQ, respectively. These mAbs showed <0.1% cross-reactivity to other commonly used antimalarial drugs. An indirect competitive enzyme-linked immunosorbent assay (icELISA) based on JUN7 showed a 50% inhibitory concentration (IC50) of 0.16 ng/mL and a working range of 0.06–0.46 ng/mL. A lateral flow immunoassay (LFIA) based on JUN7 was also developed with a working range of 2.58–30.86 ng/mL. The icELISA and LFIA were applied for the quantification of AQ in commercial drugs, and the results were comparable to those determined using high-performance liquid chromatography. In addition, a combination dipstick for simultaneous, qualitative analysis of AQ and artesunate was developed. All immunoassays based on JUN7 can be applied for quality control of AQ-containing artemisinin-based combination therapies. As TE7 showed low cross-reactivity to N-DEAQ, an icELISA based on TE7 was developed with an IC50 of 0.38 ng/mL and a working range of 0.14–1.67 ng/mL. The TE7 icELISA was applied for the study of pharmacokinetics of AQ in rat serum after intragastric administration, and the results were consistent with those of previous studies. [ABSTRACT FROM AUTHOR]

Abstract Background Anti-malarial drugs play a critical role in reducing malaria morbidity and mortality, but their role is mediated by their effectiveness. Effectiveness is defined as the probability that an anti-malarial drug will successfully treat an individual infected with malaria parasites under routine health care delivery system. Anti-malarial drug effectiveness (AmE) is influenced by drug resistance, drug quality, health system quality, and patient adherence to drug use; its influence on malaria burden varies through space and time. Methods This study uses data from 232 efficacy trials comprised of 86,776 infected individuals to estimate the artemisinin-based and non-artemisinin-based AmE for treating falciparum malaria between 1991 and 2019. Bayesian spatiotemporal models were fitted and used to predict effectiveness at the pixel-level (5 km × 5 km). The median and interquartile ranges (IQR) of AmE are presented for all malaria-endemic countries. Results The global effectiveness of artemisinin-based drugs was 67.4% (IQR: 33.3–75.8), 70.1% (43.6–76.0) and 71.8% (46.9–76.4) for the 1991–2000, 2006–2010, and 2016–2019 periods, respectively. Countries in central Africa, a few in South America, and in the Asian region faced the challenge of lower effectiveness of artemisinin-based anti-malarials. However, improvements were seen after 2016, leaving only a few hotspots in Southeast Asia where resistance to artemisinin and partner drugs is currently problematic and in the central Africa where socio-demographic challenges limit effectiveness. The use of artemisinin-based combination therapy (ACT) with a competent partner drug and having multiple ACT as first-line treatment choice sustained high levels of effectiveness. High levels of access to healthcare, human resource capacity, education, and proximity to cities were associated with increased effectiveness. Effectiveness of non-artemisinin-based drugs was much lower than that of artemisinin-based with no improvement over time: 52.3% (17.9–74.9) for 1991–2000 and 55.5% (27.1–73.4) for 2011–2015. Overall, AmE for artemisinin-based and non-artemisinin-based drugs were, respectively, 29.6 and 36% below clinical efficacy as measured in anti-malarial drug trials. Conclusions This study provides evidence that health system performance, drug quality and patient adherence influence the effectiveness of anti-malarials used in treating uncomplicated falciparum malaria. These results provide guidance to countries’ treatment practises and are critical inputs for malaria prevalence and incidence models used to estimate national level malaria burden.

Grapiprant is a new analgesic and anti-inflammatory drug belonging to the piprant class, approved in 2016 by the FDA Veterinary Medicine Center for the treatment of pain and inflammation associated with osteoarthritis in dogs. It acts as a highly selective antagonist of the EP4 receptor, one of the four prostaglandin E2 (PGE2) receptor subtypes. It has been shown to have anti-inflammatory effects in rat models of acute and chronic inflammation and clinical studies in people with osteoarthritis. The current state of knowledge suggests the possibility of using it in oncological therapy. The manuscript presents the development of conditions for the identification and quantitative determination of grapiprant by thin-layer chromatography with densitometric detection. The optimal separation of the substance occurs using silica gel 60F254 chromatographic plates and the mobile phase containing ethyl acetate-toluene-butylamine. Validation (according to ICH requirements) showed that the developed method is characterized by straightness of results in a wide concentration range with the limit of detection of 146.65 µg/mL. The %RSD values of the precision and accuracy confirm the sensitivity and reliability of the developed procedure. Next, the method was used for quantification of grapiprant in a pharmaceutical preparation, and for stability studies under various environmental conditions. Additionally, the mass studies were carried out on the stressed samples using the UPLC-MS/MS method. The degradation products were primarily characterized by comparing their mass fragmentation profiles with those of the drug. The results indicated a potential degradation pathway for grapiprant.

Improving the constant weight rates of weighing bottles and evaporation dishes is beneficial to drug quality control. When different quantities of weighing bottles were dried under the same conditions, the greater the quantity is, the lower the constant weight rate will be. When quantities are controlled to be the same, weighing bottles that have been cooled for 50 minutes have higher constant weight rates than those cooled for half an hour. Without being affected by other factors, weighing bottles’ constant weight rates are higher when the bottles are dried at the temperature of 180 °C than 105 °C. The rate increases when the bottled are dried for 8 hours instead of 5 hours. After soaking for 48 hours in the solution of 2% HNO3 + 6% HCl, the weighing bottles and evaporating dishes gain higher constant weight rates. Being more efficient, faster, economical and practical, this experiment has improved the method to increase constant weight rates of weighing bottles and evaporating dishes, without the need of auxiliary equipment, and thus increased the accuracy of drug weighing results. [ABSTRACT FROM AUTHOR]

Materials related to features of microbiological analysis of the purity of soft dosage forms are presented. Possible requirements for microbiological quality parameters of various soft dosage forms are analyzed. The applicability of a direct inoculation technique to obtain reliable quantitative determinations of microorganisms is proven using gel, ointment, and suppositories as examples. The accuracy (Kgr 75 – 107%) and intralaboratory precision (CV 2 – 6%) are calculated and fall within the required limits. The specificity of the method is considered for a particular working range established according to recommendations of the RF State Pharmacopoeia, i.e., up to 250 CFU/dish for bacteria and up to 50 CFU/dish for yeasts and molds. Features of microbiological analysis of the quality of patches and transdermal therapeutic systems are studied. The possibilities and limitations of a membrane filtration technique are shown using 83 series of 18 items meeting regulatory requirements as examples. [ABSTRACT FROM AUTHOR]

Background: Control of the quality of pharmaceutical and healthcare products in the market is mandatory to ensure the safety and efficacy of the delivered product to the final consumers. The United States Food and Drug Administration (FDA) is providing a continuous and comprehensive updated list for various healthcare issues including drug recalls. Methods: This study provides a multidimensional analysis using statistical process control (SPC) tools to evaluate the risk associated over a 3-year period (2016–2018). Results: The study showed a simple implementation of the combination of SPC tools, which demonstrated that the major contributors to recalls are microbiological quality issues, problems with product compositions, and packaging defects. Months that contributed by more than 60% of the total recalls were from May to August, November, and December. Conclusion: The general trend of drug recall rates is increasing yearly, which should be a warning signal for the regulatory agencies to take preventive measures to control and prevent excessive cases of recalls.

Abstract Background Diminazene diaceturate (DA) and isometamidium chloride hydrochloride (ISM) are with homidium bromide, the main molecules used to treat African Animal Trypanosomosis (AAT). These drugs can be purchased from official suppliers but also from unofficial sources like local food markets or street vendors. The sub-standard quality of some of these trypanocides is jeopardizing the efficacy of treatment of sick livestock, leading thus to economic losses for the low-resource farmers and is contributing to the emergence and spread of drug resistance. The objective of this study was to assess the quality of trypanocidal drugs sold in French speaking countries of West Africa. In total, 308 drug samples including 282 of DA and 26 of ISM were purchased from official and unofficial sources in Benin, Burkina Faso, Côte d’Ivoire, Mali, Niger and Togo. All samples were analysed at LACOMEV (Dakar, Senegal), a reference laboratory of the World Organisation for Animal Health, by galenic inspection and high performance liquid chromatography. Results The results showed that 51.90% of the samples were non-compliant compared to the standards and were containing lower quantity of the active ingredient compared to the indications on the packaging. The non-compliances ranged from 63.27% in Togo to 32.65% in Burkina Faso (61.82% in Benin, 53.84% in Mali, 50% in Côte d’Ivoire, 47.36% in Niger). The rates of non-compliance were not statistically different (P = 0.572) from official or unofficial suppliers and ranged from 30 to 75% and from 0 to 65% respectively. However, the non-compliance was significantly higher for ISM compared to DA (P = 0.028). Conclusions The high non-compliance revealed in this study compromises the efficacy of therapeutic strategies against AAT, and is likely to exacerbate chemoresistance in West Africa. Corrective actions against sub-standard trypanocides urgently need to be taken by policy makers and control authorities.

Commercial viability of any drug product may often bring pain for patients who otherwise wait for their drug to improve their quality of life and breath. Dryness of drug products like thyroxin, warfarin, phenobarbitone, salbutamol inhalers, morphine etc. from the market leave patient on the mercy of nature. The heart wrenching healthcare professional burst out when lifesaving drugs are not available due to any reason. Voice of civil society rises in community where care of others is felt as a moral responsibility beside capitalism and/or socialism. It is also observed and quite possible that quality defects may create similar situations of drug shortage. Manufacturing facility or its control may go out unwittingly due to knowledge limitation. A quality defect that impacts delivery and performance of drug and/or carries harmful potential has always been a matter of top priority. In both cases, ability to detect, report and assess defines presence and thickness of protection wall for the public. Power to predict uncertainty and taking measures well in time is a challenge for industry and regulators to maintain uninterrupted supply of quality drugs.

The State Pharmacopoeia of the Russian Federation is a collection of general monographs and pharmacopoeial monographs. It should be reissued at least once in 5 years. The next scheduled edition of the State Pharmacopoeia of the Russian Federation is planned for publication in 2015. It will include both first developed in national and, in some cases, global pharmacopoeial analysis general and pharmacopoeial monographs, and updated revised general and pharmacopoeial monographs. The implementation of the general and pharmacopoeial monographs of the mentioned edition of the State Pharmacopoeia of the Russian Federation will significantly increase the level of national pharmacopoeial analysis and ensure its compliance with international standards.

Background: Anti-malarial drugs play a critical role in reducing malaria morbidity and mortality, but their role is mediated by their effectiveness. Effectiveness is defined as the probability that an anti-malarial drug will successfully treat an individual infected with malaria parasites under routine health care delivery system. Anti-malarial drug effectiveness (AmE) is influenced by drug resistance, drug quality, health system quality, and patient adherence to drug use; its influence on malaria burden varies through space and time. Methods: This study uses data from 232 efficacy trials comprised of 86,776 infected individuals to estimate the artemisinin-based and non-artemisinin-based AmE for treating falciparum malaria between 1991 and 2019. Bayesian spatiotemporal models were fitted and used to predict effectiveness at the pixel-level (5 km × 5 km). The median and interquartile ranges (IQR) of AmE are presented for all malaria-endemic countries. Results: The global effectiveness of artemisinin-based drugs was 67.4% (IQR: 33.3–75.8), 70.1% (43.6–76.0) and 71.8% (46.9–76.4) for the 1991–2000, 2006–2010, and 2016–2019 periods, respectively. Countries in central Africa, a few in South America, and in the Asian region faced the challenge of lower effectiveness of artemisinin-based anti-malarials. However, improvements were seen after 2016, leaving only a few hotspots in Southeast Asia where resistance to artemisinin and partner drugs is currently problematic and in the central Africa where socio-demographic challenges limit effectiveness. The use of artemisinin-based combination therapy (ACT) with a competent partner drug and having multiple ACT as first-line treatment choice sustained high levels of effectiveness. High levels of access to healthcare, human resource capacity, education, and proximity to cities were associated with increased effectiveness. Effectiveness of non-artemisinin-based drugs was much lower than that of artemisinin-based with no improvement over time: 52.3% (17.9–74.9) for 1991–2000 and 55.5% (27.1–73.4) for 2011–2015. Overall, AmE for artemisinin-based and non-artemisinin-based drugs were, respectively, 29.6 and 36% below clinical efficacy as measured in anti-malarial drug trials. Conclusions: This study provides evidence that health system performance, drug quality and patient adherence influence the effectiveness of anti-malarials used in treating uncomplicated falciparum malaria. These results provide guidance to countries' treatment practises and are critical inputs for malaria prevalence and incidence models used to estimate national level malaria burden. [ABSTRACT FROM AUTHOR]

With proliferating efforts to regulate the quality of cannabis on legalized markets, and recent discussions about drug quality assessment by darknet buyers, it seems timely to explore definitions of the quality of cannabis among consumers. An inductive analysis of in-depth interviews with people who had used cannabis in the past 12 months was conducted, which focused on the respondents' subjective definitions and assessments of the quality of cannabis. The data are drawn from convenience samples in four localities (Florida [United States], Czechia, Spain, and New South Wales [Australia]) where cannabis was illegal or decriminalized. The findings suggest that the respondents across all four localities used a range of visual and sensory indicators to assess the quality of cannabis. For many respondents, these were independent indicators of the quality of cannabis suggesting that cannabis was not merely an "experience" good. For others, visual and sensory assessments were used as indirect indicators of quality in that they represented the effect of the cannabis. The desired effect was more complex than simple potency (strength) and several respondents preferred mild and not-sedating cannabis. Across the four localities, the respondents also included "proxy" indicators of the safety of cannabis in their definitions of quality. In other words, high-quality cannabis was defined as not causing excessive intoxication or physical harm. Altogether, cannabis was a specific "credence" good when its quality was seen as a result of cultivation techniques, production location, or producers' (profit) motivations - depending on the locality. These findings suggest that cannabis policies that regulate the cultivation process can be relevant to people who use cannabis. Given that consumers take the safety of cannabis into consideration when assessing its quality, their involvement in the development of quality standards is warranted. Consumer-led self-regulation should also be considered in policies that seek to regulate cannabis supply. [ABSTRACT FROM AUTHOR]

Many life-saving drugs are still inaccessible and unaffordable in low- and middle-income countries, particularly in Sub-Saharan Africa. This contributes to poor health outcomes, wider health and socioeconomic inequities, and higher patient spending on healthcare. While resource limitations facing national regulatory authorities (NRAs) contribute to the problem, we believe that (1) fragmented and complex drug regulations, (2) suboptimal enforcement of existing regulations, and (3) poorly designed disincentives for non-compliance play a larger role. These “unintended consequences” that are a direct result of our current regulatory regimes limit competition, keep drug costs high, and lead to shortages and the proliferation of illegitimate and unregistered drugs. While NRAs can gain a lot from increased investment in their work, regulatory harmonization and innovation can arrest and reverse the regulatory failures we still see today and improve medicine access in Africa. Unfortunately, harmonization initiatives in Sub-Saharan Africa have made modest impact and have done so slowly. We encourage greater attention and investment in harmonization and other downstream functions of NRAs. We also urge increased participation of national governments–particularly executive agencies in health and the treasury—and patient advocacy groups in advancing harmonization across the subcontinent.

The quality of traditional Chinese medicine preparations is directly related to the safety of patients. Among the various factors, the process and corresponding critical equipment are critical factors influencing the quality of the preparations. To improve the quality of traditional Chinese medicine preparations, this article summarizes and analyzes the problems in the process links and corresponding critical equipment in the manufacturing process of traditional Chinese medicine preparations. Furthermore, a critical quality attribute evaluation system is established based on safety and effectiveness combined with the drug properties, preparation process, and preparation characteristics, providing a basis for the process and equipment improvements aimed at quality enhancement.

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Synopsis: The present study details MSI's mechanisms for determining abortifacient quality. These can be applied more widely to other key SRH and ancillary medicines. [ABSTRACT FROM AUTHOR]

Background: Diminazene diaceturate (DA) and isometamidium chloride hydrochloride (ISM) are with homidium bromide, the main molecules used to treat African Animal Trypanosomosis (AAT). These drugs can be purchased from official suppliers but also from unofficial sources like local food markets or street vendors. The sub-standard quality of some of these trypanocides is jeopardizing the efficacy of treatment of sick livestock, leading thus to economic losses for the low-resource farmers and is contributing to the emergence and spread of drug resistance. The objective of this study was to assess the quality of trypanocidal drugs sold in French speaking countries of West Africa. In total, 308 drug samples including 282 of DA and 26 of ISM were purchased from official and unofficial sources in Benin, Burkina Faso, Côte d’Ivoire, Mali, Niger and Togo. All samples were analysed at LACOMEV (Dakar, Senegal), a reference laboratory of the World Organisation for Animal Health, by galenic inspection and high performance liquid chromatography. Results: The results showed that 51.90% of the samples were non-compliant compared to the standards and were containing lower quantity of the active ingredient compared to the indications on the packaging. The noncompliances ranged from 63.27% in Togo to 32.65% in Burkina Faso (61.82% in Benin, 53.84% in Mali, 50% in Côte d’Ivoire, 47.36% in Niger). The rates of non-compliance were not statistically different (P = 0.572) from official or unofficial suppliers and ranged from 30 to 75% and from 0 to 65% respectively. However, the non-compliance was significantly higher for ISM compared to DA (P = 0.028). Conclusions: The high non-compliance revealed in this study compromises the efficacy of therapeutic strategies against AAT, and is likely to exacerbate chemoresistance in West Africa. Corrective actions against sub-standard trypanocides urgently need to be taken by policy makers and control authorities. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To examine differences in drug product quality between products marketed in developed countries and in developing countries. Methods: The quality of drug products marketed in both Germany and South Africa by the same pharmaceutical company was compared. A fixed‐dose combination tablet containing amoxicillin/clavulanic acid, and mometasone furoate nasal spray were selected to represent generic medicines requiring prescriptions, while skin lightening products (legally obtained and/or confiscated) were selected to represent pharmaceutical products that are available without a prescription. Pharmacopoeial tests included assay, content uniformity, and where applicable, dissolution in addition to a visual examination of the packaging. Key findings: Some differences between the product marketed in Germany and in South Africa were detected for the amoxicillin tablet formulations, although all samples still complied with regulatory requirements. The mometasone nasal spray product marketed in South Africa delivered a higher dose than was declared on the label. The composition of the skin lightening products conformed qualitatively with labelling, but in some South African samples alarmingly high amounts of hydroquinone were found. Conclusions: 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. [ABSTRACT FROM AUTHOR]

Summary: Objective: Epilepsy is a major public health issue in low‐ and middle‐income countries, where the availability and accessibility of quality treatment remain important issues, the severity of which may be aggravated by poor quality antiepileptic drugs (AEDs). The primary objective of this study was to measure the quality of AEDs in rural and urban areas in 3 African countries. Methods: This cross‐sectional study was carried out in Gabon, Kenya, and Madagascar. Both official and unofficial supply chains in urban and rural areas were investigated. Samples of oral AEDs were collected in areas where a patient could buy or obtain them. Pharmacological analytical procedures and Medicine Quality Assessment Reporting Guidelines were used to assess quality. Results: In total, 102 batches, representing 3782 units of AEDs, were sampled. Overall, 32.3% of the tablets were of poor quality, but no significant difference was observed across sites: 26.5% in Gabon, 37.0% in Kenya, and 34.1% in Madagascar (P = .7). The highest proportions of substandard medications were found in the carbamazepine (38.7%; 95% confidence interval [CI] 21.8‐57.8) and phenytoin (83.3%; 95% CI 35.8‐99.5) batches, which were mainly flawed by their failure to dissolve. Sodium valproate was the AED with the poorest quality (32.1%; 95% CI 15.8‐42.3). The phenobarbital (94.1%; 95% CI 80.3‐99.2) and diazepam (100.0%) batches were of better quality. The prevalence of substandard quality medications increased in samples supplied by public facilities (odds ratio [OR] 9.9; 95% CI 1.2‐84.1; P < .04) and manufacturers located in China (OR 119.8; 95% CI 8.7‐1651.9; P < .001). The prevalence of AEDs of bad quality increased when they were stored improperly (OR 5.4; 95% CI 1.2‐24.1; P < .03). Significance: No counterfeiting was observed. However, inadequate AED storage conditions are likely to lead to ineffective and possibly dangerous AEDs, even when good‐quality AEDs are initially imported. [ABSTRACT FROM AUTHOR]

Abstract: Background and aim: Cryptomarkets—on‐line, anonymous market‐places for illicit goods and services that specialize mainly in drugs—account for a small but rapidly growing share of the illicit drug market in many countries. Policy responses so far are based generally on the assumption that their rise will only increase drug harms. In this contribution for debate, we question this assumption. Methods: We provide a narrative review of the emerging literature connected to drug cryptomarkets. We use MacCoun & Reuter's formula to understand the effect of population‐level increases in use on total harm as depending on the level of harm associated with each unit of use. We then consider the potential for cryptomarkets to increase or decrease the harms and benefits related to each unit of drug use, with specific attention to the quality of drugs sold and the non‐drug‐related harms and benefits for customers. Results: It is likely that cryptomarkets will increase both the amount and the range of substances that are sold. However, we argue that the effects on harms will depend upon whether cryptomarkets also increase the quality and safety of products that are sold, provide harm‐reducing information to consumers and reduce transactional conflict involved in drug purchasing. Conclusions: There is an emerging and rapidly growing evidence base connected to the macro and micro harms and benefits of cryptomarkets for drug users. Future researchers should use appropriately matched comparative designs to establish more firmly the differential harms and benefits of sourcing drugs both on‐ and off‐line. While it is unlikely that the on‐line drug trade can be eradicated completely, cryptomarkets will respond to regulation and enforcement in ways that have complex, and sometimes unanticipated, effects on both harms and benefits. [ABSTRACT FROM AUTHOR]

Fake and substandard medicines are a significant problem in developing nations, and a growing problem in developed ones too. There have been assessments of basic medicine quality from many countries and regions across the world but almost none in Central and South America. Over the past decade, as part of our research, we have collected over ten thousand samples of medicines from 22 cities in emerging markets, but the only one from the Latin region was Sao Paolo in Brazil. We have now rectified this gap, at least for one critical medicine, the broad spectrum antibiotic ciprofloxacin. Using original, self-collected data from ten countries in Latin America, we test whether the 687 Ciprofloxacin treatments pass the Global Pharma Health Fund e.V. Minilab® protocol to identify substandard or counterfeit medicines. In terms of quality, 93 percent of drugs were good quality. Within the drugs that failed the quality test, the majority were substandard rather than fake. About 26 % of the poor quality drugs were fake, with zero active pharmaceutical ingredient (API), while the rest were substandard, with less than 80 % API. In line with results from our earlier studies, we find that products that were locally registered, as well as those with SRA or WHO pre-qualification, were more likely to pass the test. A new finding in this paper is that corruption is a key predictor of poor quality drugs. Less corrupt countries had higher levels of passing drugs. [ABSTRACT FROM AUTHOR]

Eleven Achillea collina Becker accessions of different origin were tested in open field plots during three years for their phenological, morphological, productional features and active material content in Budapest, Hungary. Among the tested plant materials European selected cultivars, Hungarian cultivated stocks and populations from wild growing habitats were investigated. Concerning flowering time, two types (early and late) were distinguished. Flowering time of the less abundant late type, represented by Hungarian variety ‘Azulenka’ and ‘Gb22’, started approximately 2 weeks later than that of the early flowering type. Plant height and length of flowering horizon varied only slightly among taxa, and increased after the first year of cultivation. The proportion of useful plant organs in the drug was stable. Biomass and drug production of the investigated genotypes was variable, late flowering types providing higher yields. Essential oil, proazulene, total phenolic and flavonoid content varied on a large scale among accessions and years. Results demonstrate the high intraspecific variability of A. collina and also the role of valuable genotypes in drug production. Selected cultivars may provide stable and good yields and drug quality under particular environmental conditions, while genotypes of wild origin may be valuable sources of future breeding programs.

This retrospective descriptive study aimed to evaluate and compare the quality analysis of generic drugs available in Songklanagarind Hospital drugs list. One thousand six hundred and sixty eight samples of the quality analysis of the generic drugs data were collected during the period of October 1, 1990 to September 30, 2010 from the electronic database called “Hospital Information System”. Data were analysed using descriptive statistics of frequency, percentage and average, and using chi-square test for independence testing between the result of the quality analysis of drug and dosage form, pharmacological group, standard testing, type of sampling drug and the source of drug manufacturing. The results revealed that 1,534 samples (92.0%) of the analyzed products met the Pharmacopoeia standards, while 134 samples (8.0%) were substandard with respect to dissolution. The quality of the generic drugs were statistically significantly associated with the source of drug manufacturing. (p