INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

Background: When more than one drug is manufactured at a shared facility or equipment in pharmaceutical manufacturing, the potential carry-over of the retained residue of existing drug product on product contact parts of the equipment to the next product can be a source of cross contamination. Permitted daily exposure (PDE) is derived based on the complete nonclinical and clinical data available and is a dose that is unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime.

Objective: The objective was to present a comprehensive review of available scientific knowledge for derivation of PDE.

Methods: PubMed and ScienceDirect databases were searched using keywords "PDE" and "pharmaceuticals" and all the relevant literature up to March 2021 was reviewed. We have also calculated PDEs for Tobramycin (CAS No. 32986-56-4) and Acetyl Salicylic Acid (ASA, CAS No. 50-78-2).

Results: This research will be useful for scientists working in the PDE domain. The given examples emphasize the importance of use of human data in calculating PDE.

Conclusion: The duty of the risk assessor entrusted with setting PDEs is to derive a data driven, scientifically justified value that is safe for patients, while avoiding unjustified conservativeness that puts unnecessary burden on manufacturing.

Background: Reducing interpersonal contact has been one of the least expensive and most widely used COVID-19 control strategies.

Objective: This systematic review has been conducted with the aim of identifying social distancing strategies and policies and their impact on the COVID-19 pandemic.

Methods: In order to compile this systematic review, Google Scholar, PubMed, Scopus, Web of Science, Science Direct, Magiran, SID, and Irandoc databases were searched from the COVID-19 outbreak until March 2021. Keywords included "social", "physical", "distance", "outbreak", "incidence", "prevalence", "spread", "new case", "death*", "mortality*", "morbidity*" , "covid-19", "coronavirus", "sars-cov-2" and "time series*". The articles were qualitatively evaluated by two researchers using the STROBE tool. Finally, the study data were divided into three conceptual categories by three researchers, who then agreed on one category. The practical suggestions were also categorized in the same way.

Results: The policies and strategies adopted to implement social distancing were included in five categories of restrictions, prohibitions, closures, incentives, and punishments. Transportation and travel restrictions, crowded places and schools closure, use of telecommunications and virtual communications, and financial and psychological support to society members were the main policies in this area.

Conclusion: Rapid and complete vaccination of all people around the world is out of reach, therefore social distancing and the implementation of physical restraints, especially in crowded and densely populated environments, should be done extensively until COVID-19 is eradicated.

Background: Healthwatch England estimated emergency readmissions have risen by 22.8% between 2012-13 and 2016-17. Some emergency readmissions could be avoided by providing patients with urgent out of hospital medical care or support. Sovereign Health Network (SHN) comprises of three GP practices, with a combined population of 38,000.

Objective: We will decrease the number of SHN patients readmitted within 30 days of discharge from Portsmouth Hospitals Trust following a non-elective admission (excluding Emergency Department attendance) by 40-60% by July 2020.

Methods: Four Plan, Do, Study, Act (PDSA) cycles were used to test the administrative and clinical processes. Our Advanced Nurse Practitioner reviewed all discharge summaries, added alerts to records, and proactively contacted patients either by text, telephone or home visit.

Results: 92 patients aged 23 days to 97 years were admitted onto the recent discharge scheme. Half of discharge summaries were received on the day of discharge, whilst 29% of discharge summaries were received more than 24 hours post-discharge, and one was received 11 days post-discharge. Following our interventions, there were 55% less than expected readmissions during the same time period.

Conclusion: To allow proactive interventions to be instigated in a timely manner, discharge summaries need to be received promptly. The average readmission length of stay following a non-elective admission is seven days. Our proactive interventions saved approximately 102.9 bed days, with potential savings of 1,775 bed days over a year. We feel the results from our model are promising and could be replicated by other Primary Care Networks to result in larger savings in bed days.

Background: This project was undertaken to improve the documentation of Just in Case (JiC) medication in a general practice. The outcome of a Strengths, Weaknesses, Opportunities, Threats (SWOT) analysis highlighted this as an area where awareness within the practice could be improved.

Objective: A Plan-Do-Study-Act (PDSA) approach was taken to the project and involved collaborative working and data collection from the general practice and relevant care homes.

Method: JiC medications are used to promptly manage symptoms experienced at the end of a patient's life and are part of the Gold Standard Framework (2006).

Results: Of the patients registered at the practice with JiC medication, 37.5% were incorrectly documented. This included errors/ inaccuracy with the clinical coding, or the medication. Three patients on practice generated searches had no JiC medication in the care homes, and 4 patients had JiC boxes in the care home that was not identified by the search.

Conclusion: This evaluation has identified documentation errors and discrepancies between practice and community records of JiC medication. A newly generated practice specific flowchart was created, with an aim of reducing the discrepancies. A guide of how to carry out a QI project like this was created for the RCGP and can be found on their website. A seminar at Bristol, North Somerset, and South Gloucestershire (BNSSG) CCG to present this project took place in 2021.

Background: The British Thoracic Society (BTS) Acute Non-Invasive Ventilation (NIV) standards state all patients who require acute NIV should be initiated on NIV within two hours of hospital admission. The delivery of acute NIV is a time critical intervention as prompt application of acute NIV substantially reduces mortality for patients with acute hypercapnic respiratory failure.

Objective: This audit aimed to assess the number of patients for whom there is a delay in the initiation of acute NIV. We also assessed the outcome of admission for patients started on acute NIV.

Methods: Data was collected on patients admitted to Kings Mill Hospital for acute NIV between 1/2/2019 and 31/3/2019. Awareness and knowledge of acute NIV was highlighted as an area for improvement. E-learning packages on 'Acute NIV' were designed and sent to medical-staff. The audit was repeated for patients admitted for acute NIV between 1/2/2020 and 31/3/2020 and analysed using chi-square tests.

Results: 25 patients were included in the initial audit and 30 patients in the re-audit. Prior to intervention 31% of patients had a delay in the initiation of acute NIV, which increased to 77% post-intervention (p < 0.0001). Prior to intervention there was a mortality rate of 17% and a mortality rate of 13% post-intervention (p > 0.05).

Conclusion: Further work is required to ensure the sustained delivery of acute NIV to BTS standards, however variable achievements in the targets does not seem to have a significant adverse effect on patient outcomes.

Background: Health care workers face a wide range of chemical, physical, and biological occupational hazards in their jobs.

Objective: The present study aimed to investigate research trends on post-exposure prophylaxis (PEP) against blood-borne viral infections among health care workers.

Method: Keywords related to health care workers, PEP, and blood-borne viruses were entered in the Scopus database for the period from 1950 to 27 January 2022.

Results: The search query returned 271 papers. The earliest publication was in 1984. The Pan African Medical Journal ranked first (n = 8, 3.0%), followed by the Infection Control and Hospital Epidemiology and Journal of Hospital Infection with 6 (2.2%) papers for each. One hundred ninety-one journals took part in publishing the retrieved papers. Authors from 63 different countries took part in publishing the retrieved papers. The United States (US) ranked first (n = 53, 19.6%) followed by India (n = 26, 9.6%). The United States Centers for Disease Control and Prevention contributed the most (n = 9, 3.3%) and ranked first in the top active institutions. The mean number of authors per paper was 4.4 and the mean number of citations per paper was 17.0. The most frequent author keywords focused on PEP, health care workers, occupational exposure, HIV, hepatitis B, anti-retroviral and needle-stick injuries. Research themes in the retrieved papers focused on knowledge/attitude/practice and management and epidemiology of occupational exposure and PEP. There was a limited number of research publications in this field.

Conclusion: Research activity in this field needs to be strengthened in low- and middle-income countries through reporting and training of HCWs.

Background: The health emergency provoked by the worldwide pandemic requires immediate action to achieve the immunization of the population and to stop further contagion. The systems of public procurement needed to adapt in a very short time to reach agreements with the pharmaceutical industry.

Objective: Proposing options between the waiving of patent protections and innovative public procurement, principally the European Advance Purchase Agreements (APA).

Methods: A description of the actual situation and the necessary regulatory reforms. The sources are scientific articles, legislative compendiums and opinion pieces and the current press.

Results: The debate over the waiving of patent protections at this time is both misleading and ineffective due to the economic and legal problems involved. The path of the APA has proven to be very effective, although some deficits should be corrected, principally regarding questions of transparency and confidentiality.

Conclusions: Among the possible options for the acquisition of the COVID-19 vaccine and its universal access, agreements and cooperation between States and innovative industry are desirable. One successful path is that of the advance purchase agreements utilized by the European Union, another could be that of voluntary licensing. We propose following these routes as opposed to the waiving of patent protections.

Background: The patients' guide by the Batz Patient Safety Foundation promotes patients' active participation in healthcare and a safe hospital experience.

Objective: The aim was to adapt the Spanish version of the guide to the local context and evaluate its acceptability from healthcare professionals' and patients' perspectives in two hospitals in Buenos Aires, Argentina.

Methods: This implementation study had a formative research phase to adapt the guide with input from individual interviews and focus group discussions. The intervention comprised training sessions for professionals on patient-centered care and use of the guide, the appointment of coordinators, and distribution of the guide. The adapted guide (section During Admission) was distributed in two hospitals. Before and after intervention, we administered surveys to explore acceptability, utility, and patient satisfaction.

Results: Findings from formative research showed that the Batz guide needed to be shortened and adapted to the local healthcare context Although professionals had agreed on the importance of clinical guidelines; after using the Batz guide, they found it complex and difficult to implement. Patients' satisfaction with healthcare before and after implementing the guide did not differ significantly. Best scores were found in items related to availability of nurses, staff competence and staff kindness. A 78% of patients found the Batz guide useful.

Conclusion: It is of critical importance to adapt the guide to the local culture, pilot it, and provide training to promote its implementation, improving acceptability and utility.

Background: Hepatitis B virus (HBV) infection is a serious global public health problem, with significant morbidity and mortality from acute and chronic complications. Increasing awareness and improving knowledge of HBV helps reduce the risk of the disease. Although many studies have been conducted on HBV in Ghana, few have focused on examining knowledge, attitude and preventive practices among adolescents towards the disease.

Objective: The objective of this study was to assess HBV knowledge, attitude and practice (KAP) among adolescents in high schools in the Asante Mampong Municipality in the Ashanti Region of Ghana.

Methods: A descriptive cross-sectional study was conducted among 398 adolescents from six senior high schools within the Asante Mampong Municipality. Data was collected using a 30-item structured questionnaire. Each item had two response options: "Yes" and "No". A scoring system was generated and respondents were given a score on each item answered. A positive response to an item was scored 1 point and a negative response was scored 0. Scores were then summed up and averaged to give the mean knowledge, attitude and practice scores.

Results: The majority of the respondents were male (60%), between 15 and 17 years (45%), Christian (93%) and in their first year of study. The adolescents had basic knowledge, positive attitude, and poor practices towards HBV. There was no significant relationship between the demographic variables of the respondents and KAP mean scores.

Conclusion: There is the need to introduce health education and awareness programs in schools within the Asante Mampong Municipality to improve students' level of knowledge of HBV. Countrywide studies examining KAP towards HBV infection among adolescents are also warranted.