Framework for Patient Safety

Mohiuddin, AK

doi:10.24926/iip.v10i1.1637

Cited by 3 publications

(2 citation statements)

References 36 publications

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“…The intersection of drugs, devices, and biologics in combination products creates a complex regulatory environment. Understanding and navigating this landscape is crucial for manufacturers, regulators, and healthcare professionals to ensure that these products meet rigorous safety and efficacy standards ( 59 ).…”

Section: Significant Importance In the Field Of Pharmaceuticals And N...mentioning

confidence: 99%

Ensuring safety and efficacy in combination products: regulatory challenges and best practices

Gupta,

Tiwari,

Yadav

et al. 2024

Front. Med. Technol.

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Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.

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Section: Significant Importance In the Field Of Pharmaceuticals And N...mentioning

confidence: 99%

Ensuring safety and efficacy in combination products: regulatory challenges and best practices

Gupta,

Tiwari,

Yadav

et al. 2024

Front. Med. Technol.

View full text Add to dashboard Cite

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“…11 One of the important tasks of nurses is to provide correct medication while maintaining the patients' safety, which requires proper knowledge and performance as any defect in the medication knowledge of the nurses can lead to irreversible damage or death of the patient. 12,13 In this regard, no specific study has been conducted on nurses' knowledge resources. However, it has been shown that nurses use the results and the suggestion of researches and studies in their practice and tend to increase patients' quality of life.…”

Section: Introductionmentioning

confidence: 99%

Comparing the pharmacology knowledge and performance of nurses and nursing students in the use of information resources in pediatrics wards: An observational study

et al. 2022

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Objectives: One of the major duties of nurses is proper medication administration while maintaining patient safety, which requires sufficient knowledge and practice. Any gaps in knowledge used by nurses can lead to irreversible injury or death of the patient. This study is aimed to determine and compare the pharmacology knowledge and performance of nurses and nursing students in using the information resources in pediatrics wards. Method: This descriptive observational study was performed on 300 nurses and nursing students. Sources of knowledge and performance of nurses and nursing students were analyzed with researcher-made tools to determine their pharmaceutical knowledge, sources of knowledge, and attitudes by independent t-test, chi-square, one-way analysis of variance, Pearson, and Spearman tests. Result: Three hundred questionnaires were examined. The clinical experience of nurses and students was their most important source of information in drug challenges for 33.7% of the participants. About 24.6% of nurses obtained the required information from specialized books on pediatric medicine. About 17.1% of the participants attained their knowledge from multiple sources (e.g. various available sources such as the Internet, pharmacy books, software, and their experiences and colleagues), while electronic sources and the Internet were the sources of knowledge for 15.5% and 7.7% of the nurses, respectively. Concerning nursing students, 6.3% used books, 41.7% considered colleagues (clinical experiences), 20.8% employed electronic resources, 22.8% used the Internet, and 9.1% relied on multiple sources. There were significant differences in the knowledge and performance of the nurses based on their source of pharmacological knowledge (P < 0.05). Conclusion: Most of the resources used in the hospital are not up-to-date and evidence-base, and the majority of nurses tend to rely on their clinical experience or their collegues information for medication administration rather than reading books or searching for up-to-date approaches and information. Nursing students also trust nurses’ clinical experiences more than other sources provided for them including books and Internet. Some action should be taken by the managers for boosting the nurses’ tendency for using up-to-date information resources.

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Patient safety culture in African health facilities: a systematic review and meta-analysis

Muhammed,

Fenta

2024

IJQHC Communications

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Background The risk of a patient being harmed in a hospital is high in low- and middle-income countries (LMICs), with the risk of health care-associated infection being up to 20 times higher than in developed countries. The purpose of this review was to assess the current patient safety culture and provide insight into areas of strength and areas for improvement in terms of patient safety culture. Method Data sources: English language articles were selected by consulting PubMed databases, African journals online, and Google scholar data sources from 2012-2022, . Medcalc software was used for all calculations. The random effects model was used. The presence of heterogeneity and Publication bias were assessed. Result The systematic review and meta-analysis result showed that the overall pooled result of patient safety culture status was 51.6% with 95% CI (43.364 to 59.773). The results of Cochran’s Q test and I2 statistics showed substantial heterogeneity among the included studies (Q=119.1617, df = 16, P < 0.0001 and I2=86.57%), and thus random effects model was used for meta-analysis. Non-punitive response to errors and staffing were the dimensions with the lowest positive response rate. Whereas, Team-work within units and supervisor expectation were the areas with good positive response rate. Conclusion The studies indicated a predominance of hospital organizational cultures that were immature or weak in terms of patient safety. For them to be effective, safety culture evaluation should be linked to hospital-wide safety culture development strategies.

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Framework for Patient Safety

Cited by 3 publications

References 36 publications

Ensuring safety and efficacy in combination products: regulatory challenges and best practices

Ensuring safety and efficacy in combination products: regulatory challenges and best practices

Comparing the pharmacology knowledge and performance of nurses and nursing students in the use of information resources in pediatrics wards: An observational study

Patient safety culture in African health facilities: a systematic review and meta-analysis

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