INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

Background: 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.Objective: To examine key pharmaceutical product withdrawals and derive lessons that inform the current use of gene-based COVID-19 vaccines.Methods: Selective narrative review of historical pharmaceutical recalls and comparative issues with recent COVID-19 vaccines.Results: 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.Conclusion: Public health requires access to raw clinical trial data, improved transparency from corporations and heightened, active pharmacovigilance worldwide.

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background: Febuxostat is a novel non-purine selective xanthine oxidase inhibitor with superior ability to lower serum urate levels than allopurinol.Case Report: We report a case of Stevens Johnson syndrome following febuxostat administration.Conclusion: This case report underlines the necessity of recognising this major mucocutaneous adverse reaction and the need for cautious medication usage.

Background: Healthcare workers face a high risk of blood-borne infections due to needlestick injuries, especially in developing countries like Pakistan.

Objective: 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.

Methods: 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.

Results: 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%).

Conclusion: 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.

Background: Healthcare workers face a high risk of blood-borne infections due to needlestick injuries, especially in developing countries like Pakistan.

Objective: 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.

Methods: 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.

Results: 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%).

Conclusion: 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.

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background: The implementation of modified, all-oral shorter regimens for treatment of rifampicin-resistant tuberculosis has started in Armenia since August 2020 under the conditions of operational research.

Objective: This study aims to evaluate the safety and effectiveness of shorter regimens.

Methods: We evaluated cumulative incidence rates of serious adverse events, adverse events of grade 3 and greater and events resulting in treatment modifications or suspension for 52 study participants.

Results: A new, different pattern of adverse events emerged compared with the previous evaluations of drug safety of treatment for rifampicin-resistant tuberculosis. Arthralgia (23.1%) and peripheral neuropathy (21.2%) took leading positions among the adverse events resulting in modifications of treatment. Some adverse events of interest (prolonged QT interval, elevated liver enzymes and anemia) remained relevant for the patients receiving new combinations of anti-TB drugs. The other adverse events (impaired hearing, acute kidney injury and hypokalemia) lost their significance for safety surveillance of rifampicin-resistant tuberculosis treatment. One unexpected serious adverse event (lymphoproliferative skin lesion) brought to a "failed treatment" outcome. The other serious adverse event was anemia.

Conclusion: The shorter regimens proved to be safe and effective for treatment of rifampicin-resistant tuberculosis, but proper follow-up of adverse events is necessary.

Background: Medication errors are known to cause adverse drug reactions, hospital admissions and mortality. In most resource-poor settings, medication errors occur but are undocumented.

Objective: This study sought to investigate medication errors in a diabetic clinic at Komfo Anokye Teaching Hospital (KATH), Ghana.

Methods: The research combined both qualitative and quantitative data collection methods. The quantitative aspect involved retrospectively reviewing patient folders over two years (1st January 2019 to 31st December 2021). Patients' folders were reviewed to identify possible medication errors. The qualitative arm explored underlying factors and experiences related to medication errors through interviews with healthcare workers. Ten healthcare professionals at KATH were interviewed using an interview guide.

Results: A total of 264 patients' folders were retrieved. The majority (23.11%) of the patients were between 18 and 25 y.o., and there were more females (52.27%) than males. About 60% of the patients had diabetes and hypertension comorbidity. The overall prevalence of medication errors was 18.18%. The most prevalent type of medication error identified was wrong drug formulation (n = 19, 39.58%). About 47.92% of the medication errors resulted in adverse events and this was predominantly caused by antidiabetic drugs (47.83%) and anti-hypertensive drugs (34.78%). Patients in the age category of 26-35 y.o. [aOR: 0.31, CI: 0.11-0.90] had reduced odds of medication errors whilst patients with comorbidity of diabetes and hypertension [aOR: 5.95, CI: 2.43-14.60] had an increased odds of medication errors. Large patient population, low staff numbers and inadequate knowledge of drugs by healthcare workers were factors that contributed to medication errors.

Conclusion: Medication errors was moderately high in this diabetic clinic, and the errors led to a number of adverse events. Age, diabetes and hypertension comorbidity, large patient population, low staff numbers, and inadequate knowledge about drugs were identified as factors that influenced medication errors.

Background: Understanding knowledge and attitudes of health care professionals (HCPs) towards adverse drug reaction (ADR) reporting can inform educational interventions promoting ADR reporting.

Objective: To explore knowledge, attitudes, practice, and barriers of local HCPs towards ADR reporting.

Methods: Focus groups involving HCPs from different settings were organized to help develop a questionnaire. The questionnaire was validated and disseminated to pharmacists, physicians, dentists and nurses practicing in Malta. A review of ADR reports reported in Malta from 2004 to 2021 was carried out to contextualise questionnaire findings.

Results: Overall, HCPs (n = 374) had good knowledge on pharmacovigilance and a positive attitude towards ADR reporting however nurses were found to be less knowledgeable than physicians, dentists, and pharmacists. The main barrier for not reporting ADRs was difficulty to understand whether an adverse event occurred (n = 187). A total of 2581 ADR reports were reported in Malta. Among HCPs, physicians and dentists reported most ADRs (1060 reports), followed by pharmacists (307 reports) and nurses (257 reports).

Conclusion: Further ADR educational and promotional efforts are needed to increase awareness on the importance of quality ADR reporting and increase the number of ADR reports reported by local HCPs.