Poor Quality Drugs Research Articles

Mapping the flow of veterinary antibiotics in Kenya.

To effectively regulate and reduce antibiotic use, in the livestock sector, a thorough understanding of the flow of veterinary antibiotics will help to identify key nodes in the chain for targeted interventions. The aim of this study was to understand the flow of antibiotics from import to end-user, and identify relevant governance mechanisms. A mixed methods approach was used to collect data in three Kenyan counties (Nairobi, Kiambu, and Kajiado). Focus group discussions (n = 23), individual interviews (n = 148), and key informant interviews (n = 10) were conducted. The key actors identified include primary wholesalers, secondary wholesalers, retailers, animal health service providers (AHSPs), and farmers. Kenya imports 100% of its veterinary antibiotics: primary wholesalers legally import antibiotics as finished pharmaceutical products (90%) or active pharmaceutical ingredients (10%) after approval by the Veterinary Medicines Directorate. Secondary wholesalers play a major role in the distribution of antibiotics (60% of antibiotics) from importers to farmers, AHSPs, and retailers. Some of the illegal sources of antibiotics include unlicenced/unauthorized middlemen and online platforms that sell directly to retailers, AHSPs, and farmers. Despite the presence of various laws and regulations governing the antibiotic value chain, implementation has been a challenge due to financial and human resource constraints. This contributes to over-the-counter sale of antibiotics without prescription, unlicensed businesses selling antibiotics, illegal importation, and presence of poor-quality drugs. There is a need to review the applicability of existing policies and address policy gaps (e.g., product containing antibiotic combinations, and use of human critically important antibiotics) to ensure the prudent sale and use of antibiotics, pharmacovigilance, antimicrobial use surveillance, and developing a business model that aligns with antibiotic stewardship. Additional interventions include awareness raising and capacity building of the different stakeholders along the antibiotic distribution chain to reduce antibiotic mis- and overuse.

Quality of veterinary anthelmintic drugs marketed in Gondar Zones, North West Ethiopia; presence of poor-quality medicines

The presence of poor-quality veterinary drugs hampers the effectiveness of animal health care systems. It may produce danger to human safety through animal-derived food products that are consumed by the people. Thus, this study assessed the quality of veterinary albendazole, fenbendazole and ivermectin boluses/tablets marketed in Gondar Zones, North West Ethiopia. A total of 42 samples were collected from all government veterinary clinics and private veterinary pharmacies in Gondar zones by mystery shoppers from October, 2020 to January, 2021. All samples were visually and physically inspected for proper labeling and packaging. Samples were evaluated based on Pharmacopoeias and manufacturers' methods for identification, assay, dosage uniformity, dissolution, disintegration, hardness, and friability tests. All samples passed the visual inspection criteria outlined in the joint WHO/FIP/USP checklist. In general, 80.95% (34/42) of the products examined were substandard failing one or more quality test parameters, including all albendazole (30/30) and fenbendazole (4/4) samples. However, all of the ivermectin samples (8/8) passed the quality test parameters investigated in this work. The study had indicated that low quality veterinary albendazole and fenbendazole products are incredibly common in the study sites. The most crucial quality features investigated as failure were friability and disintegration. Thus, regulations and enforcements that guarantee quality of veterinary anthelminthic medications should be strictly in place in the study area and in the country.

Survey Results on the Risk-Based Quality of Selected Medicines Available in ECOWAS Countries in Mali

Background and Objectives: Medicines are not ordinary commercial products. In most cases, consumers are unable to decide when and how to use drugs and weigh the potential benefits against the risks, because no drug is completely safe. The use of ineffective, poor quality and harmful drugs leads to treatment failure, exacerbation of disease, drug resistance and sometimes even death. It also contributes to reducing consumer confidence in health systems, healthcare providers, manufacturers and distributors of pharmaceutical products. Methods: The survey focused on establishments identified in cross-border areas selected by the ECOWAS PMS technical working group. These can be manufacturers, importers, central purchasing bodies, wholesalers, hospital distribution centers, health centers, retail outlets. It took place from September to November 2022 and aimed to conduct quality risk-based post-marketing survey of antimalarials, antibiotics and COVID-19 drugs circulating at selected distribution levels in Mali. Results: A total of 33 samples were taken and analyzed according to a risk-based protocol, of which 27 were compliant with a rate of 82% against 06 were non-compliant or 22%. Non-compliant drugs were from both the public and private sectors. We found that 79% of drugs were unregistered among which antimicrobials were the least registered drugs with a rate of 73% and came mainly from India and China. Conclusion: This study with its cross-border character allowed us to take samples in certain areas often not covered by routine PMS. It allowed us to detect 6 non-compliant products that were withdrawn from the market and regulatory measures were taken to ensure health and guarantee access to quality medicines for health and the well-being of populations.

) Quality Assessment of Some Brands of Ciprofloxacin and Levofloxacin Tablets Circulating in Karu Local Government Area of Nasarawa state, Nigeria.

Background: Circulation of poor-quality drugs has dire consequences on the health of consumers. Introduction of branded generics to ensure availability and affordability has shown potential for spread of poor-quality drugs. In this study, quality assessment of some commonly marketed ciprofloxacin (500 mg) and levofloxacin (500 mg) tablet brands in Karu Local Government Area (LGA) of Nasarawa State, Nigeria was evaluated. Methods: Five tablet brands including an innovator, of either drug were sourced from 5 different Pharmacies in the LGA. Tablets were coded A1-A5 and B1-B5 for ciprofloxacin and levofloxacin brands respectively. Physical assessment of the tablets was done. Physico-mechanical properties, uniformity of weight, friability and disintegration time were also evaluated using pharmacopeia methods. In vitro dissolution was carried out and the profiles statistically analyzed using the similarity and difference factors in comparison with the innovator products. Results: All the tablets had uniform weights within official specification, diameter was between 16.37 and 19.44 mm. Friability values were between 0.01 and 0.06 %; within specification. Disintegration time for ciprofloxacin and levofloxacin tablets was within 1.23 - 7.20 min and 3.19 - 12.90 min respectively; all met the specification. All (100 %) the ciprofloxacin brands met pharmacopeia requirement for drug release while only 60 % of the levofloxacin brands met this requirement. Comparatively A4 with f2 value of 41.62 % may not be interchangeable with the innovator brand while brands B2 and B4 with f2 values of 53.40 and 53.03 % respectively may be interchanged with the innovator brand or with each other. Conclusion:All the tablet brands were found to have good mechanical properties but only 75 % of the ciprofloxacin and 50 % of the levofloxacin tablet brands were found to be interchangeable with the innovator drug brands. This calls for concern as it brings to question the possible interchangeability of these brands with the innovator.

Physicochemical Equivalence and Quality Assessment of Various Brands of Gastro-Resistant Omeprazole Capsules in the Kumasi Metropolis.

The proliferation of counterfeit and poor-quality drugs is a major public health problem, especially in developing countries such as Ghana where there are inadequate resources to effectively monitor their prevalence. Most of these drugs, which are counterfeited, are drugs, which are in high demand and will reap huge profits for the unscrupulous people who engage in such activities. The introduction of Omeprazole as one of the first-line therapies in the management of peptic and duodenal ulcers in the treatment guidelines of Ghana has resulted in many generics being introduced onto the market. The pharmaceutical quality of fifteen randomly sampled Omeprazole capsule brands in the Kumasi metropolis was assessed using the innovator brand as a comparator to confirm their suitability for patient use and to provide data for drug regulatory agencies in Ghana concerning poor quality omeprazole brands. All the sampled brands complied with the official specifications for identification with good primary and secondary packaging characteristics. Ninety-four (94%) of the sampled brands passed the uniformity of weight test. All the brands (n = 16) representing 100% passed the disintegration tests. Sixty percent (60%) of the sampled brands passed the drug content test. Ten brands (66.7%) met the specification for in vitro dissolution test. From f2 analysis, the dissolution profiles of only five brands (31%) were similar to that of the reference brand which indicated that they could be used interchangeably in clinical practice. Conclusively, ten out of the fifteen sampled brands were of good quality and only five could be used as a substitute for the innovator. Thus, regulatory agencies will need to strengthen their postmarket surveillance to ensure that generic brands of good quality are allowed onto the market.

Quality of Antimalarial Drugs in East Africa: A Systematic Review.

BackgroundThe use of poor quality drugs will have multiple consequences with an extended hazard of growing drug-resistant strains.PurposeThe review aimed to provide the quality status of antimalarial drugs in East Africa.Data SourcePubMed, Scopus, Web of Science, and Google Scholar were searched from September 5 to September 12, 2021.Study SelectionThe review included articles available as original research targeted at evaluating the quality of antimalarial drugs. For inclusion, data on at least one of the following quality control parameters were required: packaging and labeling, hardness, friability, weight variation/uniformity of weight, disintegration, dissolution, and assay/percentage purity. Mendeley citation manager version 1.19.4 was used to avoid duplication and organize references, and titles and abstracts were primarily used for screening.Data ExtractionThe sample collection site, drug name, and the quality control parameters tested were retrieved from the selected studies.Data synthesis Totally, 300 antimalarial drug samples from Ethiopia, Kenya and Tanzania were included in this review. No antimalarial drug tested failed the identification and disintegration test. However, 15.93% (36/226), 5.00% (15/300), and 1.90% (3/158) of antimalarial samples failed the dissolution, assay and mass uniformity test, respectively. Moreover, amodiaquine and sulfadoxine/pyrimethamine samples failed dissolution and assay tests. In addition, amodiaquine samples failed the mass uniformity test. However, artemether/lumefantrine and quinine passed all quality control parameters tested. Overall, 19.67% (59/300) of antimalarial drug samples did not meet at least one quality control parameter. And the higher faller rate was reported for sulfadoxine/pyrimethamine accounting for 52.86% (37/70).ConclusionsAn unneglected amount of antimalarial drug failed to meet at least one quality control parameter. Strengthening pharmaceutical management systems, including post-marketing surveillance, and providing the resources required for medication quality assurance, are recommended.

A Comprehensive Study on Counterfeit Medicine and its prevention in India through its Regulatory Approach

A counterfeit medication is one which is intentionally and false mislabeled with relevance identity or source. Counterfeiting applies to both brand and generic products which incorporate items with wrongs ingredients, without active ingredients, with inadequate active ingredients. Worldwide, each nation is that the survivor of substandard or spurious drugs, which end in life threatening issues, loss of consumer and manufacturer and loss in trust on health system. Internationally, the trade in counterfeit drug is of the quickest developing grey economies – after narcotics, terrorism, and arm trade.
 In term of revenues, India Is world’s leading in generic companies. India has the notoriety of being a significant producer of the world's counterfeit drugs. Counterfeit drugs structure 10% of the counterfeit drugs in line with the world Health Organization (WHO). As Per BASCAP-"Drug industry is that the premier falsified industry in India".
 The point of this enumerative review was to clarify the effect of poor-quality drugs with their outcomes on public health and also the preventive measures taken by the Indian drug administrative framework by CDSCO. India should adopt the technologies present in other countries to combat counterfeit medicine.

POSB244 Regional Variation in Uptake of Recommended Cancer Treatments in England (2018-2020) - An Osimertinib Case Study

Recommendation from the National Institute for Health & Care Excellence (NICE) provides critical validation for drugs launching in England. Commissioners have a statutory responsibility to fund, but uniform patient access is not automatic. This analysis assessed whether current regulation is sufficient to ensure timely adoption of a key new treatment. The Innovation Scorecard 2018-2020 was analysed, and tyrosine kinase inhibitors (TKIs) were identified as under-utilised (∼124,000 actual daily dose (ADD)/quarter) versus NICE expectations (∼300,000 ADD/quarter). Osimertinib, indicated for advanced EGFR+ NSCLC, was selected for further study. Technology appraisal guidance (TA653+TA654) and relevant guidelines were reviewed. NICE-reported actual regional uptake (ADD/100,000 standardised population) was compared to published global data, and oncology pharmacists and clinical leads in two low-uptake regions were interviewed to explore NICE guidance implementation processes and barriers. Regional variation in osimertinib utilisation was observed, with Midlands and North East & Yorkshire predominantly in the lowest 20%. Annual purchase data showed that Clatterbridge (33,481), Royal Marsden (16,540) and Christie (13,805) NHS Foundation Trusts led acquisition, with 19 Trusts 500-1958; 33 300-499; and 47 <299 ADD/100,000 finished consultant episode (FCE) day hospital care. Potential barriers to adoption included treatment positioning, patient identification, biopsy, accessibility of genetic testing, poor data quality and Cancer Drugs Fund restrictions. Osimertinib utilisation was driven by London and the Northwest, with only modest uptake at other oncology centres over the study period. National adoption of osimertinib increased in Q3 2020 and will likely accelerate following the May 2021 approval of adjunctive use in early-stage patients. However, data suggest that usage was at the lower end of expectation for 3 years, potentially denying some patients access to important new treatment. NHS Trust implementation of NICE guidance appears to be inconsistent, and structured equitable frameworks are required to ensure timely access for all eligible patients.

Quality of Active Pharmaceutical Ingredients Present on Algerian Soil: Control of Impurities of Ciprofloxacin, Metronidazole and Fluconazole

The medicine quality is defined by its aptitude to meet certain requirements declared by the regulatory authorities. Among these, impurities control which constitutes the major fear of pharmaceutical manufacturers in efficiency and safety terms. Nowadays, in many developing countries, the presence of poor quality drugs is common, for this reason, an increased control should be instituted including impurities which represent a serious public health problem threatening the efficacy and the safety medicines, because of their nocuous repercussions on health. The objective of this study is to verify that impurities in certain APIs: Ciprofloxacin, Metronidazole and Fluconazole actually collected on Algerian soil meet the impurity requirements. An observational experimental study was carried out from 1st December 2013 to 31st December 2017, on impurities control in the APIs of Ciprofloxacin, Metronidazole and Fluconazole medicines registered in the Algerian Medicines Nomenclature and marketed in Algeria. All samples collected were analyzed to detect, quantify and evaluate impurties for rigorous control of three categories of impurties, such as: Organic related-impurities analysis by High-Pressure Liquid Chromatography with UV Detector (HPLC-UV), Elemental-impurities analysis by Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) and Residual Solvents-impurities analysis by Headspace Gas Chromatography with Flame Ionization Detection (HS-GC-FID). 18 samples collected from 11 laboratories among 27 requested. 22% of non-conformities were detected, including 5.5% Indian origin, 5.5% Spanish origin, 5.5% French origin and 5.5% Chinese origin. These non-conformity cases are due to the high rate of degradation product-impurity for C5 sample, Cobalt-impurity and Nickel-impurity contents exceeding the required limits for C4 and M3 samples respectively, Methanol-impurity and Toluene-impurity contents exceeding the authorized limits for M2 and F3 samples respectively. This study concluded that samples non-compliance rate is high because of certain impurities detection exceeding the safety standards. So, we interpellate the health authorities to ensure the APIs impurities control before being put into the manufacturing process in order to prevent the potentially serious health problems that are difficult to control.

Quality Evaluation of Ethambutol Hydrochloride Tablet Batches Available in Governmental Health Facilities of Jimma Town, Southwest Ethiopia.

Background The availability of poor-quality drugs on the drug market might favor the ineffectiveness of the drug and/antimicrobial resistance. Aim To evaluate the quality of similar batches of ethambutol hydrochloride tablets available in different governmental health facilities of Jimma town, southwest Ethiopia. Methods The World Health Organization checklist was used to inspect the storage area of health facilities and check medicines for the sign of counterfeit. The test was conducted as per the United States Pharmacopeia on six similar batches of ethambutol hydrochloride sampled from different governmental health facilities. Data were analyzed using SPSS version 20, and one-way ANOVA was used for comparing the dissolution profile and weight variation of batches. Results Three health facilities did not comply with the storage area specifications for pharmaceuticals. No batches have shown any sign of counterfeit. All of the tablet batches tested complied with USP specifications for weight variation, percentage purity, and dissolution test. Conclusions and Recommendation. The entire tablet batches complied with the World Health Organization specification for packaging and labelling of pharmaceuticals. All tablet batches complied with the test for weight variation, purity of drug substance, and dissolution. Since some health facilities did not comply with at least one specification for storage of pharmaceuticals, regulatory agencies and stack holders are advised to inspect the health facilities to ensure appropriate storage of pharmaceuticals in health facilities.

Bold measures to accelerate malaria elimination

In the Greater Mekong subregion, intense drug pressure and indiscriminate use of poor-quality antimalarial drugs has led to the emergence of antimalarial resistance to all widely used drugs, including the artemisinin derivatives. 1 Hamilton WL Amato R van der Pluijm RW et al. Evolution and expansion of multidrug-resistant malaria in southeast Asia: a genomic epidemiology study. Lancet Infect Dis. 2019; 19: 943-951 Summary Full Text Full Text PDF PubMed Scopus (112) Google Scholar The malaria community remains divided as to the magnitude of this threat. Malaria cases in the Greater Mekong subregion continue to fall, giving some authorities confidence that current activities will achieve elimination targets within the next few years. Counter-arguments highlight the potential for parasites to evolve under prolonged, intense drug pressure, possibly resulting in widespread resistance to all available antimalarial drugs and the prospect of resurgent, untreatable malaria. Paradoxically, the solution might be promoting wider use of antimalarial drugs, to expedite parasite elimination before resistance evolves further. Mass drug administration for the acceleration of malaria elimination in a region of Myanmar with artemisinin-resistant falciparum malaria: a cluster-randomised trialIn this low-transmission setting, the substantial reduction in P falciparum prevalence resulting from support of community case management was accelerated by MDA. In addition to supporting community health worker case management and LLIN distribution, malaria elimination programmes should consider using MDA to reduce P falciparum prevalence rapidly in foci of higher transmission. Full-Text PDF

Prevalence of Substandard Amoxicillin Oral Dosage Forms in the National Capital District of Papua New Guinea.

.Antibiotics are commonly reported as being substandard or falsified in low- to middle-income countries, having potential to contribute to the development of antimicrobial resistance and drug-resistant infections. Amoxicillin, used to treat a number of infections and listed by the WHO as an essential medicine, presented as a good drug candidate for this study. We aimed to measure the prevalence of substandard and falsified amoxicillin oral products (tablets, capsules, and suspensions) in the National Capital District of Papua New Guinea (PNG). These oral products were surveyed in 2018 and 2019 from retail pharmacies, private and public health facilities, and the Area Medical Store, representing more than 90% of licensed medicine outlets. The product packaging was visually inspected, and the samples were analyzed for amoxicillin content using a validated high-performance liquid chromatography method. Although no falsified products were identified, 15% of the 190 products analyzed contained substandard amounts of amoxicillin. Quality varied with the dosage form (P = 0.002), with capsules exhibiting the lowest incidence of substandard content (4% in 2019) and tablets collected in 2018 experiencing the highest failure rate (50%). Suspension (40%) quality was compromised by failure to achieve homogeneity on reconstitution. A higher incidence of substandard content (P = 0.002) was associated with one major retail group. Routine testing of medicines by resource-poor countries is often unachievable, leading to the circulation of poor quality drugs, which is a global public health concern. Our study highlighted that substandard amoxicillin oral products are indeed prevalent in the NCD of PNG.

Quality of Different Brands of Metronidazole Benzoate Oral Suspensions Available at Jimma Town, Southwest Ethiopia: Pharmaceuticals Quality Study

Background: Poor quality drugs include substandard and counterfeit medicines. Poor quality antibiotics selectively kill the susceptible strain and leaves resistant strain to multiply. Metronidazole is a broad spectrum antibiotic whose effectiveness depends up on a dose administered to the patient. Objective: The aim of the study is to assess the quality of different brands of metronidazole Benzoate oral suspension available in Jimma town, West Ethiopia. Methods: Cross-sectional study was conducted in Jimma town, West Ethiopia from Feb 08 – Mar 28, 2018. The assay result of all the seven brands of Metronidazole Benzoate oral suspensions was entered to statistical package for social sciences software version 24.0 for windows. Then, one way analysis of variance was performed using Tukey test to determine whether there exists significant difference in assay result of the brands (p&lt;0.05). Result: All the seven Metronidazole benzoate oral suspensions assessed in this study passed British Pharmacopoeia 2013 specification of identity test of the drug. All the brands passed the assay test and total aerobic microbial count specification United States Pharmacopoeia 2015. The highest percentage of drug content was obtained for Metrolag, 105.56%, while the least content for Mizel, 93.12%. However, statistical comparison of drug contents at 95% confidence interval indicates that there is significant difference in drug content within and among the seven brands of Metronidazole benzoate oral suspensions (p&lt;0.05). The pH of all the brands was with in United States Pharmacopoeia 2015 specification limit.

Assessment of the pharmaceutical equivalence and in vitro dissolution studies of amlodipine tablets marketed in Northern Nigeria

The extensive supply of poor quality and/or counterfeit drug products in many developing countries has made it vital to frequently carry out suitable tests to assess bioequivalence (BE) in a cost-effective manner. This study was intended to assess the pharmaceutical equivalence and dissolution profile of amlodipine 5mg tablets marketed in Jos and Kaduna metropolis. Ten brands of Amlodipine 5mg tablets were obtained from different community pharmacies and evaluated for different quality control parameters such as percent drug content, friability, hardness, thickness, weight uniformity, disintegration time, and dissolution. The results showed that brands F and I failed the test for percent drug content while the rest of the brands passed it. In addition, all the brands passed the disintegrationand friability test while Brands C, F and I did not pass the hardness test. The dissolution profiles of all the brands were similar to the innovator brand at pH 6.8, whereas at pH 1.2, only four brands (B, E, H and I) had similar dissolution profile to the innovator. This study serves to justify for the assessment of in vitro parameters of commercially available amlodipine generics which may aid the prescribers’ decision making.&#x0D; Keywords: Amlodipine; Jos; Tablet properties, Dissolution profile

The view of recent medical graduates on ethical consideration of prescription writings in Bangladesh

Prescription writing reflects the competency as well as the quality of medical education of the physician. This study was done to evaluate opinion of recent medical graduates towards ethical aspects of prescription writing. This descriptive study was conducted on recent medical graduates of 7 medical colleges in Bangladesh from January’18-June’19. Data were collected by a pretested self administered semi-structured questionnaire. Only descriptive statistics were computed by collected data. The study included 308 recent medical graduates having average age at commencement of internship was 24.2 years with male predominant (53.2%). Majority of the respondents thought that prescription should be written in block letter or be printed (70.1%) and there was possibility for selling wrong medicine due to bad handwriting (77.6%). Majority of the recent medical graduates thought that generic names were not difficult to remember (82.8%), there was every possibility of selling poor quality drugs of the same generic names by the pharmacists (87.7%) and physicians should not use generic name in prescriptions (56.5%). Furthermore, most of them (92%) felt a need for a mandatory educational qualification for the pharmacists. Most participants opined that pharmacists should have a minimum educational qualification to prevent the errors in dispensing. The findings of this study might be helpful to reinforcement the law to avoid the errors related to medical professionalism and ethical aspects of prescription writing in the medical education.&#x0D; Bangladesh Journal of Medical Education Vol.12(1) 2021: 16-21&#x0D;

Quality of Drug in Health Facilities: A Cross-sectional Study.

Poor quality drugs result minor to detrimental effect on human health. The drug should be of standard quality and should be used appropriately in order to meet its therapeutic efficacy. This study aims to assess the quality of drug in Nepal. A cross sectional study was conducted in randomly selected 88 health facilities in Nepal from 10th April to 30th June 2016. Selective medicines were collected from both private licensed pharmacies and selected public health facilities. Face to face interview with health facility in-charge of selected health facilities was carried out along with the direct observation of the medicine storage room. The collected medicine samples were dispatched to two laboratories for in-vitro analysis. The labels of the collected medicine were analyzed. The obtained data were entered in Epidata version 3.1, cleaned in Microsoft excel 2007 and analyzed in SPSS version 20. Out of 172 brands, nine brands of medicines were found substandard. Information regarding storage conditions, direction for use and category of the drug were lacking in the label of some brands of medicines. Some selected health facilities were found not meeting major requirements for drug storage: protection from sunlight, moisture, heat, well ventilation and proper sanitation. Few drugs were found to be substandard in Nepalese market from both public and private sectors. Adequate labeling and proper storage condition of medicines in health facilities were lacking.

&lt;p&gt;In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia&lt;/p&gt;

BackgroundThe use of ineffective and poor quality drugs endangers therapeutic treatment and may lead to treatment failure. For desired therapeutic effect, drugs should contain the appropriate amount of active pharmaceutical ingredient and the required physical characteristics.AimThe aim of this study was to evaluate quality as well as physicochemical bioequivalence of different brands of furosemide tablets marketed in Bahir Dar, Northwest Ethiopia.MethodsFive different brands of furosemide tablets were purchased from community pharmacies in Bahir Dar city, Northwest Ethiopia. The quality control parameters of furosemide tablets were determined by identification, weight variation, disintegration, assay and dissolution tests and the results were compared with USP and BP pharmacopoeial standards. Difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements.ResultsIdentification test results revealed that all samples contained the stated active pharmaceutical ingredients. The results of weight variation tests indicated that all samples complied with USP specification limits. The active pharmaceutical ingredients quantitative assay showed that all the brands of furosemide tablets were between the 90% and 105% limit of label claim. Similarly, all samples fulfilled disintegration time (i.e., ≤30 min) and dissolution tolerance limits (i.e., Q ≥80% at 60 min). Hence, none of the samples were found to be counterfeit and/or substandard. Difference factor (f1) values were <15 and similarity factor (f2) values were >50 for all the tested brands of furosemide tablets.ConclusionThis study revealed that all the furosemide brands met the quality specification of weight variation, hardness, friability, dissolution, disintegration and assay. The study also indicated similarity in the dissolution profile of the brands of furosemide tablets with the innovator product. Hence, all of these generic brands could be substituted with the innovator product in clinical practice.

Development and application of a spectrophotometric method in quality evaluation of benzimidazole anthelminthics in Nairobi city county

BackgroundNeglected tropical diseases (NTDs) are a group of communicable diseases which are prevalent in the tropics affecting more than one billion people. Treatment and prevention of these infections is very costly to developing economies. Helminthiases are classified among NTDs. The communities afflicted are poor and have limited access to essential resources for their livelihood. Poor-quality drugs for NTDs may lead to death or prolonged treatment without achieving the desired results. The limited resources used in purchasing poor-quality drugs will therefore be wasted instead of being put to good use.Most of the methods available for the analysis of benzimidazole anthelminthics utilize high-performance liquid chromatography. They are therefore time consuming, require sophisticated and expensive equipment, utilize rare and expensive reagents and solvents, and call for skilled personnel. A simple, rapid, and inexpensive ultraviolet spectrophotometric method of analysis would therefore come in handy especially in the analysis of many samples as occurs during post-authorization market surveillance for quality.ResultsThe suitable solvent for the spectroscopic analysis was established as 0.1 M methanolic HCl. The wavelength of analysis was set at 294 nm. Upon validation, the method was found to have good linearity. The range over which linearity was established was way beyond the 80 to 120% of the working concentration specified by the ICH. The method exhibited good precision.Out of 32 commercial samples analyzed, five (15.6%) did not comply with compendial specifications. Intra-brand batch variation was also observed. Out of three batches of product A002T analyzed, one did not comply with compendial specifications.ConclusionA major limitation in the analysis of benzimidazole anthelminthics is the lack of reliable, simple, rapid, and low-cost methods of analysis with high throughput. The developed method serves to fill this gap. It can be used in the analysis of raw materials and finished products. It can also be used in the establishment of the quality of products prior to registration. The method will prove very useful in post-market surveillance of quality of benzimidazole anthelminthics.

An Analytic Investigation of the Drug Formulation-Based Recalls in the USA: See More Beyond the Literal.

High numbers of drug recalls persist despite the tremendous time and effort invested by pharmaceutical organizations and regulatory bodies such as the Food and Drug Administration (FDA) to ensure the quality of safe and effective medicines for the patient. It is imperative to better understand the underlying risk factors of drug formulation-based recalls to best protect the patient from poor quality drugs. Increased knowledge of underlying factors of formulation risk can also help inform the future design and development of drugs. In this study, we used a text mining technique with Python to parse the data and examine drug recalls from the aspect of administration route, dosage form, release mechanism, market type, pharmacologic class, and excipients. Observational analysis of the recalls revealed both high- and low-risk factors for the formulation-based recalls. Higher risk, or an increased probability of a formulation-based recall, was associated with factors such as extended release mechanism, capsule dosage form, oral route of administration, and an increased number of excipients, while lower risk of formulation-based recalls was associated with other factors including the new drug application market type, immediate release mechanism, and solution dosage form. In addition, the factors did not work independently, and we observed interactions among variables. For example, the release mechanism modified the effect of market type, administration route, and dosage form. This study will help inform the future design of quality drug products by pharmaceutical organizations and assist risk-based oversight by regulatory organizations, such as FDA, to ensure patient safety.

Predictors of Payment Methods for Health Care, Perception and Use of the National Health Insurance Scheme among Pregnant Women in Nigeria

Objective: To determine the predictors of payment methods for health care, perception and use of National health insurance scheme (NHIS) among pregnant women in a low income country. Methods: An adapted, pretested, semi-structured, interviewer administered questionnaire was used to collect data from 770 pregnant women attending antenatal care (ANC) services in the two selected tertiary health institutions in south-east Nigeria. All consenting pregnant women attending ANC in the facilities irrespective of age and reason for visit were included. Data analysis was by SPSS version 25. Logistic regression model was used to predict the factors influencing perception and use of NHIS. Statistical significance was accepted when P- value was <0.05. Results: Up to 70.9% of the respondents pay for health care out of their pockets for health services while only 20.0% use the NHIS. Fifty-two percent practice a monthly budget while 67.0% were aware of NHIS. The women had varied perceptions and concerns about NHIS which ranged from inability of the scheme to cover healthcare costs, and reduce hardships from high cost of health care to use of poor quality drugs. Eight (5.2%) of the 154 women that registered with the scheme had never used it. There were statistically significant association between level of education (x2= 107.7, p<0.001), respondents’ occupation (x2=49.6, p<0.001), respondents’ spouse occupation (x2=103.3, p<0.001), monthly income (x2=55.0, p<0.001) as well as age of the respondent (x2=8.2, p=0.004) and the awareness of NHIS in both facilities. Respondents aged less than 39 years were 0.46 times less likely to use NHIS compared to those 39 years and above (AOR=0.46, p< 0.022, 95%CI = 0.236 –0.900). Use of NHIS was significantly associated with educational level (x2=19.0, p<0.001) and occupation of spouse (x2=24.0, p<0.001) in both facilities. There was a significant difference in the method of use of NHIS between the two hospitals (x2=14.83, p<0.001). Conclusion: Majority of pregnant women still pay for health care by out-of-pocket method and awareness about the NHIS was fair and a good number of the women were willing to enrol in the scheme if offered the opportunity. Significant predictors for NHIS use were maternal age, occupation of spouse and income.