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The American Journal of Tropical... May 2024This study investigated the quality of 13 essential medicines in the states of Enugu and Anambra, Nigeria. A total of 260 samples were purchased from licensed...
This study investigated the quality of 13 essential medicines in the states of Enugu and Anambra, Nigeria. A total of 260 samples were purchased from licensed pharmaceutical manufacturers and wholesalers and from vendors in pharmaceutical markets with unclear licensing status. Samples were analyzed for identity, content, and dissolution according to the United States Pharmacopeia (USP) 42 monographs. Forty-five samples of this study could be examined for authenticity with the Mobile Authentication Service scheme of the Nigerian National Agency for Food and Drug Administration and Control. Out of all samples, 25.4% did not comply with the USP 42 specifications. Strikingly, 21 out of 22 dexamethasone tablet samples (95%) were out of specification (OOS). Nine out of 19 glibenclamide samples (47%) failed dissolution testing, and 7 out of 17 cotrimoxazole samples (41%) failed assay testing. Medicines against noncommunicable diseases showed a slightly higher percentage of OOS samples than anti-infectives (21.2% versus 17.6%). The rates of OOS samples were similar in medicines stated to be produced in Nigeria, India, and China but were very different between individual manufacturers from each of these countries of origin. Therefore, prequalification of products, manufacturers, and suppliers are very important for quality assurance in medicine procurement. Unexpectedly, the total proportions of OOS samples were similar from licensed vendors (25.2%) and from markets (25.5%). Four samples (1.5%), all collected in markets, were clearly falsified and did not contain the declared active pharmaceutical ingredients. The proportion of falsified medicines was found to be lower than frequently reported in the media for Nigeria.
PubMed: 38740019
DOI: 10.4269/ajtmh.23-0837 -
Journal of Immunological Methods Jun 2024Quality control testing of the vaccine for lot release is of paramount importance in public health. A recent pandemic caused by the SARS-CoV-2 virus brought together all...
AIM
Quality control testing of the vaccine for lot release is of paramount importance in public health. A recent pandemic caused by the SARS-CoV-2 virus brought together all spheres of vaccine to combat the virus. The scientific advancement in the development of vaccines facilitated the scientists to develop the vaccine against SARS-CoV-2 in a record time. Thus, these vaccines should be stringently monitored for their safety and efficacy as per the latest WHO and national regulatory guidelines, and quality control evaluation of the product should be done at national control laboratories before releasing the product into the market as it assures the quality and safety of the vaccine.
METHODS
The SARS-CoV-2 exploited the ACE2 (Angiotensin Converting Enzyme 2) receptor, a surface protein on mammalian cells to gain entry into the host cells. The viral surface protein that interacted with the ACE2 receptor is the Spike protein of SARS-CoV-2. Thus, in the development of the vaccine and assessing its quality, the Spike protein of SARS-CoV-2 became an attractive immunodominant antigen. In National Institute of Biologicals, an apex body in the testing of biologicals in India, received the Adenovector (Adenovirus + vector) based COVID-19 vaccine, a finished product for quality evaluation. Due to the lack of a pharmacopeial monograph, the testing of the vaccine was done as per the manufacturer's specifications and methods. The routine assays of identification employed by the manufacturer do not reflect the expression of Spike protein which is required for the immune system to get activated. In this report, we showed the determination of Spike protein expression by immunoblotting and immunofluorescence for identification parameters in the quality testing of the COVID-19 vaccine. We determined the translation of the SARS-CoV-2 Spike gene cloned into an Adenovector.
RESULTS
The results from these experiments indicated the expression of Spike protein upon infection of mammalian cells with viral particles suggested that the expression of immunodominant Spike protein of SARS-CoV-2 may be employed by quality control laboratories as a parameter for identification.
CONCLUSION
The study suggested that the determination of the expression of Spike protein is pertinent to identifying the Adenovector based vaccines against COVID-19.
Topics: Spike Glycoprotein, Coronavirus; COVID-19 Vaccines; Humans; Quality Control; SARS-CoV-2; COVID-19; Angiotensin-Converting Enzyme 2; HEK293 Cells; Genetic Vectors; Adenoviridae; Animals
PubMed: 38703946
DOI: 10.1016/j.jim.2024.113680 -
Wiadomosci Lekarskie (Warsaw, Poland :... 2024Aim: To investigate and analyze legal conflicts in forensic dentistry of Ukraine.
OBJECTIVE
Aim: To investigate and analyze legal conflicts in forensic dentistry of Ukraine.
PATIENTS AND METHODS
Materials and Methods: A comparative research method for determining the common and distinctive features of the legal regulation of forensic dental expertise as a subcluster in the legislation of Ukraine. The descriptive (monographic) method reveals the problematic aspects of forensic dental examination through the lens of local normative and general normative connotations. The structural-functional research method made it possible to systematize the peculiarities of forensic medical and forensic dental expert activity.
CONCLUSION
Conclusions: The analysis of legal conflicts made it possible to come to the following conclusions, that in Ukraine today there is no specific legal act that would regulate the aspects of performing dental activities. Forensic dental examination in Ukraine, in accordance with the legislation, is an examination of the actions and inactions of the dentist. The adoption of normative legal acts in the field of dental activity and forensic dental examination in Ukraine would make it possible to determine the specifics of establishing facts and circumstances that indicate a violation of the patient's rights.
Topics: Ukraine; Humans; Forensic Dentistry
PubMed: 38691805
DOI: 10.36740/WLek202403131 -
Hypertension (Dallas, Tex. : 1979) Jul 2024Guidelines recommend antihypertensive medication for adults with both stage 1 hypertension (systolic blood pressure, 130-139 mm Hg or diastolic blood pressure, 80-89...
Modeling the Impact of Biomarker-Guided Versus ASCVD Risk-Guided Drug Treatment in US Adults With Stage 1 Hypertension: The National Health and Nutrition Examination Survey, 1999 to 2004.
BACKGROUND
Guidelines recommend antihypertensive medication for adults with both stage 1 hypertension (systolic blood pressure, 130-139 mm Hg or diastolic blood pressure, 80-89 mm Hg) and 10-year atherosclerotic cardiovascular disease (ASCVD) risk ≥10%. Cardiac biomarkers could facilitate a more targeted approach to the treatment of stage 1 hypertension.
METHODS
We studied 1999 to 2004 National Health and Nutrition Examination Survey participants aged ≥20 years with untreated stage 1 hypertension without heart failure or ASCVD. We measured hs-cTnI (high-sensitivity cardiac troponin I), hs-cTnT (high-sensitivity cardiac troponin T) and NT-proBNP (N-terminal pro-B-type natriuretic peptide) in stored serum. We used the Pooled Cohort Equations to predict 10-year ASCVD risk. All participants had linked mortality follow-up through December 31, 2019.
RESULTS
Overall, 17.5% of US adults (32.2 million) had untreated stage 1 hypertension. Among these 32.2 million persons, 15.7% had ASCVD risk ≥10%, 5.6% had elevated hs-cTnI, 4.7% had elevated hs-cTnT, and 9.5% had elevated NT-proBNP. Among adults aged 65 to 79 years with untreated stage 1 hypertension, 80.5% had ASCVD risk ≥10%, 13.0% had elevated hs-cTnI, 15.2% had elevated hs-cTnT, and 29.4% had elevated NT-proBNP. Less than half of the adults aged ≥80 years with untreated stage 1 hypertension had elevated biomarkers. The cardiovascular disease mortality rates among all adults with untreated stage 1 hypertension and with either ASCVD risk ≥10%, elevated hs-cTnI, elevated hs-cTnT, or elevated NT-proBNP were 7.51, 7.74, 8.75, and 5.87 per 1000 person-years, respectively.
CONCLUSIONS
Cardiac biomarkers may be more selective for informing risk-based treatment decisions in stage 1 hypertension, particularly among adults aged ≥65 years.
Topics: Humans; Male; Female; Hypertension; Biomarkers; Nutrition Surveys; Middle Aged; United States; Antihypertensive Agents; Adult; Aged; Peptide Fragments; Risk Assessment; Natriuretic Peptide, Brain; Atherosclerosis; Troponin T; Troponin I
PubMed: 38690651
DOI: 10.1161/HYPERTENSIONAHA.123.22665 -
Medical Science Educator Apr 2024Many assessments in medical education involve measuring proficiency in a content area. Thus, proper content development (blueprinting) of tests in this field is of...
PROBLEM
Many assessments in medical education involve measuring proficiency in a content area. Thus, proper content development (blueprinting) of tests in this field is of primary importance. Prior efforts to conduct content review as part of assessment development have been time- and resource-intensive, relying on practice analysis and then on linking methods. This monograph explores a "rapid, cost-effective" approach to blueprinting that allows efficient assessment development with rigor. Our investigation seeks to explore an efficient and effective alternate method for creating a content design (blueprint) for medical credentialing and evaluation examinations by focusing directly on assessment requirements.
APPROACH
We employed a two-phase process to propose a method. Phase 1 involved a 1-day direct meeting of content experts/practitioners. Phase 2 involved a corroboration survey sent to a wider group of content experts/practitioners. The rapid blueprinting method was applied to developing eleven blueprints (five for medical specialty certification; five for health professions certification; and one for in-training assessment).
OUTCOMES
The methods we used resulted in effective, well-balanced, operational examinations that successfully implemented the resulting blueprints in item writing assignments and test development. Assessments resulting from the use of the rapid blueprinting method also generated psychometrically sound inferences from the scores. For example, the assessments resulting from this methodology of test construction had KR-20 reliability coefficients ranging from .87 to .92.
NEXT STEPS
This approach leveraged the effectiveness and feasibility of the rapid blueprinting method and demonstrated successful examination designs (blueprints) that are cost- and time-effective. The rapid blueprinting method may be explored for further implementation in local assessment settings beyond medical credentialing examinations.
PubMed: 38686150
DOI: 10.1007/s40670-024-02006-y -
Scientific Reports Apr 2024Chronic obstructive pulmonary disease (COPD) has a high prevalence and a major impact on health-related quality of life (HRQL). COPD exacerbations are an important cause... (Observational Study)
Observational Study
Chronic obstructive pulmonary disease (COPD) has a high prevalence and a major impact on health-related quality of life (HRQL). COPD exacerbations are an important cause of morbidity and mortality, affecting cardiovascular risk, and are associated with poorer health status. The aim of this study was to assess the association between cardiovascular risk (CVR) and HRQL, according to exacerbator or non-exacerbator phenotype. We undertook a cross-sectional, observational, descriptive study of 107 patients with COPD. Patients with two or more moderate exacerbations or one severe exacerbation in the previous year were considered as exacerbators. The CVR was calculated with the Framingham scale and SCORE (Systematic Coronary Risk Evaluation) and the HRQL was assessed with the generic questionnaire Short Form-36 Health Survey (SF-36), the St George Respiratory Questionnaire (SGRQ) and the COPD Assessment Test (CAT). Statistical analysis was done with SPSS version 26.0 for Windows. The SF-36 and the SGRQ showed lower values for the exacerbator phenotype, indicating a poorer quality of life. The CAT questionnaire showed values above 10 for the exacerbator phenotype, and lower values in the non-exacerbator group. After categorizing the sample according to their median age (65 years), we found a greater deterioration in HRQL in patients under 65 years of age according to the SF-36, the SGRQ and the CAT. We also detected differences in HRQL between non-exacerbator patients with a high CVR according to the Framingham (≥ 20%) and SCORE (≥ 5%) scales compared to those without this risk. A tendency towards worse HRQL was observed in non-exacerbator patients with a high CVR, which was statistically significant for the SGRQ impact domain on the SCORE scale. The CAT also showed a worse quality of life in non-exacerbator patients with a high CVR, which was significant in the Framingham model (Framingham high risk 8.41 vs non-high risk 6.05, p < 0.01). These differences were not observed in exacerbator patients. Our findings confirm that a high CVR influences HRQL in patients with COPD, especially in non-exacerbator patients with a high CVR, measured according to the SGRQ and the CAT.
Topics: Humans; Pulmonary Disease, Chronic Obstructive; Quality of Life; Male; Female; Aged; Middle Aged; Phenotype; Cross-Sectional Studies; Cardiovascular Diseases; Surveys and Questionnaires; Heart Disease Risk Factors; Risk Factors
PubMed: 38678074
DOI: 10.1038/s41598-024-60406-x -
Pharmaceuticals (Basel, Switzerland) Apr 2024In the present work, an efficient isocratic HPLC method was developed for the precise and accurate estimation of vitamin D in tablet form. The chromatographic conditions...
In the present work, an efficient isocratic HPLC method was developed for the precise and accurate estimation of vitamin D in tablet form. The chromatographic conditions comprised an L3 silica column (5 µm in particle size, 4.6 mm × 250 mm) with a mobile phase n-hexane/ethyl acetate (85:15 /) with a flow rate of 2.0 mL/min and a detection wavelength of 292 nm. The new methodology was validated for accuracy, precision, specificity, robustness, and quantification limits according to an official monograph of USP/BP and ICH guidelines. The peak areas of the six replicates of the homogeneous sample were recorded. The mean value obtained was 67,301, and the relative standard deviation (RSD) was 0.1741. The linearity and range were in the acceptable bounds, i.e., 0.999, which was calculated using regression line analysis. The results show that the method is truly acceptable as the RSD, as the flow rate was 0.81%, while for the mobile phase composition, it was 0.72%, which lies in the acceptable range. The limit of detection (LOD) and the limit of quantification (LOQ) values were 0.0539 µg/mL and 0.1633 µg/mL, respectively. The % RSD of the intra and inter-day precision of the method was deemed acceptable according to the international commission for harmonization guidelines. The developed method has potential to be used for the detection and quantification of vitamin D during routine analysis for tablets in dosage form.
PubMed: 38675464
DOI: 10.3390/ph17040505 -
Central European Journal of Public... Mar 2024The study aims to present a historical review and analysis of the establishment and development of undergraduate public health (PH) education in Bulgaria from 1878 until...
OBJECTIVE
The study aims to present a historical review and analysis of the establishment and development of undergraduate public health (PH) education in Bulgaria from 1878 until 2019.
METHODS
А search and selection of historical documents was performed, including laws, rules, regulations, government plans, programmes, scientific publications from periodical medical press, journals, specialized monographs, and books. A retrospective analysis of the normative documents related to the organization of the sanitation and public health activities, and to the provision of professional undergraduate education of the public health workforce in Bulgaria has been carried out. The required competences and tasks of the specialists exercising public health control services were extracted.
RESULTS
The development in the public health educational activities were followed in three consecutive periods: the newly independent state (1878-1944); the socialist state (1945-1990); the democratizing state (1990-2019). The development of organized PH activities began after the liberation of Bulgaria in 1878. The historical analysis reveals a direct link between the major socioeconomic changes in the country and the organization of PH undergraduate education which passed through dynamic transformations. The professional education in the sphere of PH started with the training of feldshers, followed by sanitary feldsher and sanitary health inspectors performed in secondary vocational medical schools during the socialist period, reaching the stage of undergraduate university PH education provided by medical colleges associated with universities in the third period.
CONCLUSION
Despite the continuous development in the organization of undergraduate PH education in Bulgaria, its content is still not fully compatible with the basic European PH services and actions. There is a growing need for wider standardization and integration of undergraduate PH education in the EU so that the specialty can reach the status of a regulated health profession similar to medicine, nursing, and others.
Topics: Bulgaria; Humans; History, 20th Century; History, 19th Century; History, 21st Century; Education, Medical, Undergraduate; Education, Public Health Professional; Public Health; Retrospective Studies
PubMed: 38669158
DOI: 10.21101/cejph.a7928 -
Journal of Fungi (Basel, Switzerland) Mar 2024Over the past two decades, numerous novel species have been identified within , primarily in and . A recent monograph has revealed that these two genera exhibit a...
Over the past two decades, numerous novel species have been identified within , primarily in and . A recent monograph has revealed that these two genera exhibit a distinct preference for freshwater habitats, particularly in southern China. However, further investigation into the distribution and diversity of the two genera in Guangdong and Guizhou Provinces remains insufficient. In this study, we conducted an analysis of four intriguing cheiroid hyphomycetes collected from flowing rivers in these two regions. Through morphological and phylogenetic analyses incorporating combined LSU, SSU, ITS, and sequence data, we have identified them as a novel species in ( sp. nov.), two novel species in ( sp. nov. and sp. nov.), and one previously documented species (). Specifically, the identification of is primarily based on its distinct morphology, characterized by complanate, cheiroid, and brown to dark brown conidia, with a hyaline, short, and atrophied appendage arising from the apical cell of the outer row. In addition, the morphological distinctions between and are further clarified based on our new data. This study also highlights a few phylogenetic matters regarding .
PubMed: 38667930
DOI: 10.3390/jof10040259 -
Prehospital and Disaster Medicine Apr 2024This editorial monograph explores the advances and pitfalls of the common forms of purposeful sampling. Purposeful sampling is a common research design in qualitative...
This editorial monograph explores the advances and pitfalls of the common forms of purposeful sampling. Purposeful sampling is a common research design in qualitative research.
Topics: Humans; Qualitative Research; Research Design
PubMed: 38647214
DOI: 10.1017/S1049023X24000281