{"title":"Compliance with good storage practices in drug import warehouses in Syria.","authors":"Hasan Al-Hawasli, Anas Rajab","doi":"10.1177/09246479241304327","DOIUrl":"https://doi.org/10.1177/09246479241304327","url":null,"abstract":"<p><strong>Background: </strong>Ensuring the quality of pharmaceutical products is essential for effective healthcare delivery. Good storage practices (GSPs) play a crucial role in maintaining drug integrity and safety.</p><p><strong>Objectives: </strong>This study aimed to evaluate the adherence of Syrian drug import warehouses to GSP and identify key factors influencing compliance.</p><p><strong>Methods: </strong>A mixed-methods research design was employed, involving questionnaires and observations of drug import warehouses in Syria. Data were collected from June to August 2022. The first questionnaire assessed the reality of applying GSP, while the second explored perceived benefits and obstacles. The majority of respondents (>80%) had at least 6 years of working experience in the drug warehouse field.</p><p><strong>Results: </strong>Twenty-three public and private warehouses participated out of the 26 warehouses that were the subject of our study (88%). The study found that in Syria, a significant difference has been detected between existing requirements in drug import warehouses and the needed requirements for the successful implementation of GSP (<i>p</i> = 0.000). Key constraints to GSP implementation included a lack of a quality-oriented culture among warehouse owners (100%) and inadequate equipment (87%). Regarding the benefits of GSP application, respondents identified ensuring the quality of sensitive products (100%) and reducing waste and damage (96%) as the most important.</p><p><strong>Conclusions: </strong>To enhance GSP adherence, warehouses should prioritize staff training, adopt electronic data loggers, secure fuel for generators, obtain GSP certificates, and raise public awareness. Government agencies and international organizations should support these efforts and provide financial incentives.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":" ","pages":"9246479241304327"},"PeriodicalIF":0.9,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143459901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ehsan Ahsani-Estahbanati, Hossein Bevrani, Vladimir Sergeevich Gordeev, Leila Doshmangir
{"title":"Exploring factors affecting the severity of medical errors: A cross-sectional study in Iran.","authors":"Ehsan Ahsani-Estahbanati, Hossein Bevrani, Vladimir Sergeevich Gordeev, Leila Doshmangir","doi":"10.1177/09246479241300127","DOIUrl":"https://doi.org/10.1177/09246479241300127","url":null,"abstract":"<p><strong>Background: </strong>Medical errors are one of the most important factors affecting patient safety and the quality of health care services, and are affected by many factors.</p><p><strong>Objective: </strong>We aimed to investigate the relationship between hospital and medical error types, seasonality, and work shifts with the severity of medical errors (no harm, near miss, and harmful incident) in Iran's hospitals.</p><p><strong>Methods: </strong>We conducted a cross-sectional study in 39 hospitals in a province of Iran. Data were collected using voluntary reporting forms and analyzed using multiple logistic regressions.</p><p><strong>Results: </strong>Of 10,384 medical errors, 68.4% were no harm. Medical error type and hospital type had a significant relationship with the severity of medical errors. In terms of seasonality, all types of medical errors were more frequently reported during fall and winter as follows: no harm medical errors (28.4% and 28.3%), near miss (28.9% and 28.2%), and harmful incidents (31.0% and 26.5%). The incidence of errors in public non-educational (OR = 0.22, 95% CI: 0.17-0.30, <i>p</i><0.001) and public educational hospitals (OR = 0.27, 95% CI: 0.21-0.36, <i>p</i><0.001) has been significantly less as compared to other types of hospitals.</p><p><strong>Conclusion: </strong>Policymakers should pay attention to hospital types and common medical error types when developing evidence-based interventions and policies to decrease the medical error severity in Iranian and similar countries' context hospitals.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":" ","pages":"9246479241300127"},"PeriodicalIF":0.9,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143459990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Feeding tube safety: National guidance ignores the 'elephant in the room'.","authors":"Stephen J Taylor","doi":"10.1177/09246479241295560","DOIUrl":"https://doi.org/10.1177/09246479241295560","url":null,"abstract":"<p><strong>Background: </strong>National guidance attempts to prevent tubes remaining undetected and being used when misplaced in the respiratory tract. The 'elephant in the room' is that this guidance detects misplacement too late to prevent most pneumothoraces and pneumonias.</p><p><strong>Objective: </strong>Review risks of undetected and detected respiratory or oesophageal tube misplacements and how 'in-procedure' methods of determining tube position might reduce them.</p><p><strong>Methods: </strong>Tube misplacement risk was compared for different methods of checking tube position. Data were obtained from UK NHS England (NHSE), a literature search between 1986 and 12/07/2024 using CINAHL, Embase, Medline and Emcare and from a local database.</p><p><strong>Results: </strong>Post-procedure pH or X-ray checks on tube position have failed to prevent a rising incidence of undetected respiratory misplacements (NEVER events) (0.013%). Worse, current checks cannot prevent the 0.52% of placements that lead to in-procedure pneumothorax, constituting 97% of lung complications. In addition, pH may fail to prevent aspiration risk from oesophageal misplacement. Conversely, pneumothorax-risk would be reduced to 0.021% by using a supplementary mid-procedure CO<sub>2</sub> check or to 0.005% with expert guided tube placement (both <i>p</i> < 0.0001). Guided tube placement can additionally pre-empt oesophageal-related complications, but its safety is expert-dependent, with higher rates of undetected misplacement and pneumothorax in low-use Cortrak centres (0.10%) than expert centres (0%, <i>p</i> < 0.009).</p><p><strong>Conclusion: </strong>The high health burden from feeding tube-related complications could be almost eliminated if regulatory authorities recommended a mid-procedure CO<sub>2</sub> check for respiratory placement or expert guided tube placement, alongside mandates for the necessary training.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":" ","pages":"9246479241295560"},"PeriodicalIF":0.9,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Adverse outcome detection of childhood administered thimerosal-free HibTITER<sup>®</sup>.","authors":"Karl Jablonowski, Brian Hooker","doi":"10.1177/09246479241292017","DOIUrl":"https://doi.org/10.1177/09246479241292017","url":null,"abstract":"<p><strong>Background: </strong>Haemophilus influenzae type b (HIB) is a gram-negative pathogenic bacterium that mostly impacts the pediatric and geriatric population, sometimes resulting in permanent sequelae or death.</p><p><strong>Objective: </strong>In this study we set out to discover adverse outcomes from the thimerosal-free HibTITER<sup>®</sup> vaccine derived from a Florida Medicaid dataset spanning from January 2003 to June 2007 (<i>n</i> = 277,484).</p><p><strong>Methods: </strong>HIB vaccinated children were isolated from the Florida Medicaid dataset. Using other HIB vaccines as the control, we analyzed diagnoses for statistically significant adverse outcomes related to the HibTITER<sup>®</sup> vaccine (only the strictest <i>p</i>-value of <0.0001 was used in analyzing this dataset). We simultaneously and independently examined the statistical significance of symptoms reported to VAERS related to HIB vaccines to corroborate our findings (<i>p</i>-value significance was reported at <0.05, <0.001, and <0.0001).</p><p><strong>Results: </strong>The study revealed 19 individual ICD-9 codes positively associated (<i>p</i>-value<0.0001 post Bonferroni correction) with recipients of the HibTITER<sup>®</sup> vaccine within 30-days of vaccination. Of these conditions, 14 have VAERS corroborators. The diseases span severity from mild to life-threatening and areas of respiration (e.g., asthma), gastrointestinal, otolaryngologic (e.g., common cold), dermatologic, generalized infections (e.g., tuberculosis), and other conditions.</p><p><strong>Conclusion: </strong>Incidence of 19 different medical conditions was significantly higher compared to the control group who received other HIB vaccine formulations. These results were corroborated using the VAERS database, and have profound medical implications for the estimated 35 million Americans between the ages of 16 and 33 who received the vaccine.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"35 4","pages":"301-307"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Patient safety, pharmacovigilance and liability through the current vaccine crisis, disaster in pharmaceutical promotion and various global patient safety concerns.","authors":"Liliya Eugenevna Ziganshina","doi":"10.1177/09246479241299268","DOIUrl":"https://doi.org/10.1177/09246479241299268","url":null,"abstract":"","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"35 4","pages":"299-300"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pharmaceutical product recall and educated hesitancy towards new drugs and novel vaccines.","authors":"Peter Rhodes, Peter I Parry","doi":"10.1177/09246479241292008","DOIUrl":"https://doi.org/10.1177/09246479241292008","url":null,"abstract":"<p><p><b>Background:</b> Of many pharmaceutical products launched for the benefit of humanity, a significant number have had to be recalled from the marketplace due to adverse events. A systematic review found market recalls for 462 pharmaceutical products between 1953 and 2013. In our current and remarkable period of medical history, excess mortality figures are high in many countries. Yet these statistics receive limited attention, often ignored or dismissed by mainstream news outlets. This excess mortality may include adverse effects caused by novel pharmaceutical agents that use gene-code technology.<b>Objective:</b> To examine key pharmaceutical product withdrawals and derive lessons that inform the current use of gene-based COVID-19 vaccines.<b>Methods:</b> Selective narrative review of historical pharmaceutical recalls and comparative issues with recent COVID-19 vaccines.<b>Results:</b> Parallels with past drug withdrawals and gene-based vaccines include distortion of clinical trial data, with critical adverse event data absent from high-impact journal publications. Delayed regulatory action on pharmacovigilance data to trigger market withdrawal occurred with Vioxx (rofecoxib) and is apparent with the gene-based COVID-19 vaccines.<b>Conclusion:</b> Public health requires access to raw clinical trial data, improved transparency from corporations and heightened, active pharmacovigilance worldwide.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"35 4","pages":"317-333"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vittorio Bolcato, Giuseppe Basile, Luca Bianco Prevot, Giovanni Fassina, Silvia Rapuano, Enrico Brizioli, Livio P Tronconi
{"title":"Telemedicine in Italy: Healthcare authorization profiles in the modern medico-legal reading.","authors":"Vittorio Bolcato, Giuseppe Basile, Luca Bianco Prevot, Giovanni Fassina, Silvia Rapuano, Enrico Brizioli, Livio P Tronconi","doi":"10.1177/09246479241301640","DOIUrl":"https://doi.org/10.1177/09246479241301640","url":null,"abstract":"<p><strong>Background: </strong>The ruling n. 38485, 20 June 2019, of the Italian Supreme Court, III criminal section, addressed by the perspective of the law the very sensitive and new issue of telemedicine.</p><p><strong>Objective: </strong>This commentary deals with the issue of authorization of telemedicine activities by the health authority, starting from the Italian Court of Criminal Cassation, III section, decision n. 38485/2019. The case law explored the authorization of a health point, which carries out telemedicine services.</p><p><strong>Methods: </strong>Starting from the perspective discussed by Italian health regulations, the paper examines how the health act could be defined, with the possibilities offered by telecommunications, and how it now relates legally to the physical place where it takes place.</p><p><strong>Results: </strong>Even if telemedicine opens the way to virtual spaces of health practice, the Ministry of Health Italian Guidelines pose functional and logistical issues to guarantee users' safety and health care system accountability. Then, functional requirements for health legitimate practice, and their continuous monitoring, together with the responsibilities of the service centers, health professionals and health facilities, are discussed.</p><p><strong>Conclusion: </strong>The questioning of States' health law, in a broad health system such as that of the Europe, characterized by autonomous health regulations, is extremely important for cross-border health policy with telemedicine, as overall regulatory compliance in health care is the ground criterion for risk prevention and patient safety, to be properly verified.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"35 4","pages":"337-343"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Febuxostat induced Stevens Johnson syndrome: A case report.","authors":"Jaspreet K Sidhu, Deepti Chopra","doi":"10.1177/09246479241292014","DOIUrl":"https://doi.org/10.1177/09246479241292014","url":null,"abstract":"<p><p><b>Background:</b> Febuxostat is a novel non-purine selective xanthine oxidase inhibitor with superior ability to lower serum urate levels than allopurinol.<b>Case Report:</b> We report a case of Stevens Johnson syndrome following febuxostat administration.<b>Conclusion:</b> This case report underlines the necessity of recognising this major mucocutaneous adverse reaction and the need for cautious medication usage.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"35 4","pages":"334-336"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muhammad Kiddeer, Abdul Basit, Tawseef Ahmad, Imran Masood
{"title":"Needle stick injuries and post-exposure prophylaxis practices among healthcare personnel working at tertiary care hospitals in Punjab, Pakistan.","authors":"Muhammad Kiddeer, Abdul Basit, Tawseef Ahmad, Imran Masood","doi":"10.1177/09246479241302295","DOIUrl":"https://doi.org/10.1177/09246479241302295","url":null,"abstract":"<p><strong>Background: </strong>Healthcare workers face a high risk of blood-borne infections due to needlestick injuries, especially in developing countries like Pakistan.</p><p><strong>Objective: </strong>This study aims to evaluate the prevalence of needlestick injuries, reporting practices, and post-exposure prophylaxis measures among healthcare personnel in tertiary care hospitals in Punjab.</p><p><strong>Methods: </strong>A cross-sectional study was conducted from May to July 2019. Data were collected from healthcare personnel working in teaching hospitals across six randomly selected cities of Punjab. Data were collected from 600 healthcare personnel using a pretested, self-administered questionnaire, employing stratified random sampling to ensure representative sampling. Descriptive statistics were applied, and differences in needlestick injuries across demographic segments were assessed using the Mann-Whitney U and Kruskal-Wallis H tests.</p><p><strong>Results: </strong>Among the 600 respondents, 533 returned the complete questionnaire, yielding a response rate of 88.8%. The majority of respondents were female (<i>n</i> = 341, 64.2%). The mean years of service was 5.58 (±5.78), with most participants falling in the 0.5-5 years category (<i>n</i> = 338, 66.4%). The prevalence of self-reported needlestick injuries in the last six months was 35.25%. Most injuries occurred during sampling (n = 95, 35.85%), followed by recapping (<i>n</i> = 63, 23.77%). Reporting of needlestick injuries to the respective department was poor, with only 82 (21.87%) injuries reported. The frequency of needlestick injuries differed significantly across profession, working department, and education categories (<i>p</i> < 0.05). Sanitary staff were more likely to sustain needlestick injuries during garbage collection and waste handling. Post-exposure screening for blood-borne infections was received by 79 (42.93%) individuals, and post-exposure prophylaxis (PEP) was administered to 67 (36.41%).</p><p><strong>Conclusion: </strong>The high prevalence of needlestick injuries among healthcare personnel occurred primarily during sampling and recapping. Reporting of NSIs was inadequate, and post-exposure testing and prophylaxis practices were substandard. Enhanced policies and protocols are necessary for effective NSI surveillance and the administration of pre- and post-exposure prophylaxis.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":"35 4","pages":"308-316"},"PeriodicalIF":0.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143460051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muhammad Kiddeer, Abdul Basit, Tawseef Ahmad, Imran Masood
{"title":"Needle stick injuries and post-exposure prophylaxis practices among healthcare personnel working at tertiary care hospitals in Punjab, Pakistan.","authors":"Muhammad Kiddeer, Abdul Basit, Tawseef Ahmad, Imran Masood","doi":"10.3233/JRS-240010","DOIUrl":"https://doi.org/10.3233/JRS-240010","url":null,"abstract":"<p><strong>Background: </strong>Healthcare workers face a high risk of blood-borne infections due to needlestick injuries, especially in developing countries like Pakistan.</p><p><strong>Objective: </strong>This study aims to evaluate the prevalence of needlestick injuries, reporting practices, and post-exposure prophylaxis measures among healthcare personnel in tertiary care hospitals in Punjab.</p><p><strong>Methods: </strong>A cross-sectional study was conducted from May to July 2019. Data were collected from healthcare personnel working in teaching hospitals across six randomly selected cities of Punjab. Data were collected from 600 healthcare personnel using a pretested, self-administered questionnaire, employing stratified random sampling to ensure representative sampling. Descriptive statistics were applied, and differences in needlestick injuries across demographic segments were assessed using the Mann-Whitney U and Kruskal-Wallis H tests.</p><p><strong>Results: </strong>Among the 600 respondents, 533 returned the complete questionnaire, yielding a response rate of 88.8%. The majority of respondents were female (n = 341, 64.2%). The mean years of service was 5.58 (±5.78), with most participants falling in the 0.5-5 years category (n = 338, 66.4%). The prevalence of self-reported needlestick injuries in the last six months was 35.25%. Most injuries occurred during sampling (n = 95, 35.85%), followed by recapping (n = 63, 23.77%). Reporting of needlestick injuries to the respective department was poor, with only 82 (21.87%) injuries reported. The frequency of needlestick injuries differed significantly across profession, working department, and education categories (p < 0.05). Sanitary staff were more likely to sustain needlestick injuries during garbage collection and waste handling. Post-exposure screening for blood-borne infections was received by 79 (42.93%) individuals, and post-exposure prophylaxis (PEP) was administered to 67 (36.41%).</p><p><strong>Conclusion: </strong>The high prevalence of needlestick injuries among healthcare personnel occurred primarily during sampling and recapping. Reporting of NSIs was inadequate, and post-exposure testing and prophylaxis practices were substandard. Enhanced policies and protocols are necessary for effective NSI surveillance and the administration of pre- and post-exposure prophylaxis.</p>","PeriodicalId":45237,"journal":{"name":"INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142141358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}