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Research in Social & Administrative... Jun 2024The efficacy of medicines depends on their accessibility and availability. Dedicated medicine shortage reporting systems (MSRS) have been set up in different countries,... (Review)
Review
BACKGROUND
The efficacy of medicines depends on their accessibility and availability. Dedicated medicine shortage reporting systems (MSRS) have been set up in different countries, either mandatory or voluntary, following the recommendations of the World Health Organisation to ensure these.
OBJECTIVES
To explore how the Medicine Shortages Reporting System (MSRS) can tackle medicine shortages through improved access and sustainability.
METHODS
Personnel directly involved in the reporting mechanisms for medicine shortages in eight (8) countries participated in semi-structured interviews. An interview protocol based on the Dynamic Capabilities View and Organisational Information Processing Theory (OIPT) was developed. It contained questions related to participant's views on the process involved in MSRS and how it was used to tackle shortages. Data were thematically analysed.
RESULTS
Three core elements were identified to influence MSRS's ability to tackle shortages and ensure sustainability; (1) the ability to identify what information requirements the reporting system needs, (2) identify information processing capabilities, and (3) the ability to match requirements and information processing capabilities through a dynamic capability decision-making process. The dynamic decision-making process involves reiteratively sensing shortages by understanding and validating information received.
CONCLUSION
Building MSRS to tackle shortages for accessibility and sustainability is a systemic process that entails understanding the various elements and processes of MSRS. It includes defining medicine shortages, reconfiguring resources, defining accessibility and ensuring the system's sustainability. Our study provides insights into MSRS developed for mitigating medicine shortages and provides a framework for a sustainable MSRS. The findings extend the literature on medicine shortage management by identifying the various elements required to set up an MSRS. It also provides practical implications for countries that seek to establish MSRS to mitigate medicine shortages. Further studies could extend the number of participating countries to provide a clearer picture of the MSRS and how it can reduce medicine shortages.
Topics: Humans; Pharmaceutical Preparations; Health Services Accessibility
PubMed: 38458895
DOI: 10.1016/j.sapharm.2024.02.010 -
BMC Health Services Research Mar 2024Case managers play a vital role in integrating the necessary services to optimise health-related goals and outcomes. Studies suggest that in home care, case managers...
BACKGROUND
Case managers play a vital role in integrating the necessary services to optimise health-related goals and outcomes. Studies suggest that in home care, case managers encounter tensions in their day-to-day work, that is, disjuncture between what they should do, in theory, and what they actually do, in practice. However, direct exploration of these tensions is lacking. As such, this study aimed to describe the tensions encountered by case managers in public home care for older adults in Quebec and their influence on day-to-day work.
METHODS
An institutional ethnography was conducted through observations of work, interviews and a survey with case managers working in home care in Quebec. Data were analysed using institutional ethnography first-level analysis procedures. This included mapping the work sequences as well as identifying the tensions experienced by case managers through the words they used.
RESULTS
Three main tensions were identified. First, case managers perceive that, despite working to return hospitalised older adults at home safely, their work also aims to help free up hospital beds. Thus, they often find themselves needing to respond quickly to hospital-related inquiries or expedite requests for home care services. Second, they are supposed to delegate the care to "partners" (e.g., private organisations). However, they feel that they are in effect managing the quality of the services provided by the "partners." Consequently, they go to great lengths to ensure that good care will be provided. Finally, they must choose between meeting organisational requirements (e.g., reporting statistics about the work, documenting information in the older adults' file, doing mandatory assessments) and spending time providing direct care. This often leads to prioritising direct care provision over administrative tasks, resulting in minimal reporting of essential information.
CONCLUSION
The results are discussed using the three lenses of professional practice context analyses (i.e., accountability, ethics, and professional-as-worker) to formulate recommendations for practice and research. They suggest that, despite their important role, case managers have limited power in home care (e.g., with partners, with the hospital).
Topics: Humans; Aged; Case Managers; Quebec; Health Facilities; Anthropology, Cultural; Home Care Services
PubMed: 38448879
DOI: 10.1186/s12913-024-10709-6 -
JAMIA Open Apr 2024The goal of this study is to propose and test a scalable framework for machine learning (ML) algorithms to predict near-term severe acute respiratory syndrome...
OBJECTIVES
The goal of this study is to propose and test a scalable framework for machine learning (ML) algorithms to predict near-term severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cases by incorporating and evaluating the impact of real-time dynamic public health data.
MATERIALS AND METHODS
Data used in this study include patient-level results, procurement, and location information of all SARS-CoV-2 tests reported in West Virginia as part of their mandatory reporting system from January 2021 to March 2022. We propose a method for incorporating and comparing widely available public health metrics inside of a ML framework, specifically a long-short-term memory network, to forecast SARS-CoV-2 cases across various feature sets.
RESULTS
Our approach provides better prediction of localized case counts and indicates the impact of the dynamic elements of the pandemic on predictions, such as the influence of the mixture of viral variants in the population and variable testing and vaccination rates during various eras of the pandemic.
DISCUSSION
Utilizing real-time public health metrics, including estimated from multiple SARS-CoV-2 variants, vaccination rates, and testing information, provided a significant increase in the accuracy of the model during the Omicron and Delta period, thus providing more precise forecasting of daily case counts at the county level. This work provides insights on the influence of various features on predictive performance in rural and non-rural areas.
CONCLUSION
Our proposed framework incorporates available public health metrics with operational data on the impact of testing, vaccination, and current viral variant mixtures in the population to provide a foundation for combining dynamic public health metrics and ML models to deliver forecasting and insights in healthcare domains. It also shows the importance of developing and deploying ML frameworks in rural settings.
PubMed: 38444986
DOI: 10.1093/jamiaopen/ooae014 -
MMWR. Morbidity and Mortality Weekly... Feb 2024Surveillance data can provide rapid, within-season influenza vaccine effectiveness (VE) estimates to guide public health recommendations. Mandatory reporting of...
Surveillance data can provide rapid, within-season influenza vaccine effectiveness (VE) estimates to guide public health recommendations. Mandatory reporting of influenza vaccine administration to California's immunization information registry began January 1, 2023, and mandatory reporting of all influenza laboratory test results, including negative results, was instituted in California on June 15, 2023. These data, collected by the California Department of Public Health during October 1, 2023-January 31, 2024, were used to calculate interim influenza VE against laboratory-confirmed influenza by comparing the odds of vaccination among case-patients (persons who received a positive influenza laboratory test result) and control patients (those who received a negative influenza laboratory test result). VE was calculated as 1 - adjusted odds ratio using mixed-effects logistic regression, with age, race, and ethnicity as fixed effects and specimen collection week and county as random effects. Overall, during October 1, 2023-January 31, 2024, estimated VE was 45% among persons aged ≥6 months, 56% among children and adolescents aged 6 months-17 years, 48% among adults aged 18-49 years, 36% among those aged 50-64 years, and 30% among those aged ≥65 years. Consistent with some previous influenza seasons, influenza vaccination provided moderate protection against laboratory-confirmed influenza among infants, children, adolescents, and adults. All persons aged ≥6 months without a contraindication to vaccination should receive annual influenza vaccination to reduce influenza illness, severe influenza, and strain on health care resources. Influenza vaccination remains the best way to prevent influenza.
Topics: Adolescent; Adult; Child; Infant; Humans; Influenza Vaccines; Influenza, Human; Vaccine Efficacy; Vaccination; California
PubMed: 38421946
DOI: 10.15585/mmwr.mm7308a4 -
Cytotherapy Jul 2024Cell and gene therapy poses evolving challenges. The current article summarizes the discussions held by European Regional Committee of the International Society for Cell... (Review)
Review
Current challenges in cell and gene therapy: a joint view from the European Committee of the International Society for Cell & Gene Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT).
Cell and gene therapy poses evolving challenges. The current article summarizes the discussions held by European Regional Committee of the International Society for Cell & Gene Therapy and the European Society for Blood and Marrow Transplantation (EBMT) on the current challenges in this field, focusing on the European setting. This article emphasizes the imperative assessment of real-world cell and gene therapy activity, advocating for expanded registries beyond hematopoietic transplantation and chimeric antigen receptor-T-cell therapy. Accreditation's role in ensuring standardized procedures, as exemplified by JACIE (The Joint Accreditation Committee of ISCT-Europe and EBMT), is crucial for safety. Access to commercial products and reimbursement variations among countries underscore the need for uniform access to advanced therapy medical products (ATMPs). Academic product development and point-of-care manufacturing face barriers to patient access. Hospital Exemption's potential, demonstrated by some initial experiences, may increase patient accessibility in individual situations. Regulatory challenges, including the ongoing European ATMPs legislation review, necessitate standardized criteria for Hospital Exemption and mandatory reporting within registries. Efforts to combat unproven therapies and fraud involve collaboration between scientific societies, regulatory bodies and patient groups. Finally, is important to highlight the vital role of education and workforce development in meeting the escalating demand for specialized professionals in the ATMP field. Collaboration among scientific societies, academic institutions, industry, regulatory bodies and patient groups is crucial for overcoming all these challenges to increase gene and cell therapy activity in Europe.
Topics: Humans; Genetic Therapy; Europe; Cell- and Tissue-Based Therapy; Registries; Societies, Medical; Accreditation
PubMed: 38416085
DOI: 10.1016/j.jcyt.2024.02.007 -
Vaccines Feb 2024Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing... (Review)
Review
Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about SSNHL cases following administration of various COVID-19 vaccines. Post-marketing studies have been conducted in different countries using either pharmacovigilance or medico-administrative databases to investigate SSNHL as a potential adverse effect of COVID-19 vaccines. Here, we examine the advantages and limitations of each type of post-marketing study available. While pharmacoepidemiological studies highlight the potential association between drug exposure and the event, pharmacovigilance approaches enable causality assessment. The latter objective can only be achieved if an expert evaluation is provided using internationally validated diagnostic criteria. For a rare adverse event such as SSNHL, case information and quantification of hearing loss are mandatory for assessing seriousness, severity, delay onset, differential diagnoses, corrective treatment, recovery, as well as functional sequelae. Appropriate methodology should be adopted depending on whether the target objective is to assess a global or individual risk.
PubMed: 38400164
DOI: 10.3390/vaccines12020181 -
RESEARCH ARTICLE: Adolescent abortions in the Covid-19 landscape: Exposing the legal Achilles' heel.Indian Journal of Medical Ethics 2024The law ought to ensure that reproductive health services are accessible to all persons - married or unmarried - without subjecting them to heightened scrutiny or...
The law ought to ensure that reproductive health services are accessible to all persons - married or unmarried - without subjecting them to heightened scrutiny or procedural requirements. However, the intersection of various laws and their impact on the willingness of medical professionals to offer abortion and reproductive health services to adolescents makes timely, safe, and affordable abortions difficult for adolescents to obtain. This challenge is exacerbated by a lack of public healthcare facilities, particularly in rural areas, and the overall restricted access to healthcare services during the Covid-19 pandemic. We delve into how legal uncertainties and gaps in multiple legislations pose obstacles for adolescents seeking abortion services, particularly in consensual sexual relationships. We specifically examine the unintended barriers stemming from the Protection of Children from Sexual Offences Act, 2012 (POCSO), which categorises consensual sexual relationships among adolescents as sexual offences without recognising their evolving sexual autonomy. Notably, POCSO includes a mandatory reporting provision, compelling the reporting of all sexual offences involving a "child" to law enforcement. This complexity is further compounded by the requirement for third-party authorisation for abortion by medical boards. The Indian courts, in rendering inconsistent, moralistic, and biased judgments on adolescent access to abortion services during the Covid-19 pandemic, contributed to the complexities.
Topics: Pregnancy; Female; Adolescent; Humans; Pandemics; COVID-19; Abortion, Induced; Sexual Behavior; Sex Offenses; Abortion, Legal
PubMed: 38375642
DOI: 10.20529/IJME.2024.002 -
Indian Journal of Medical Ethics 2024To address the under reporting of sexual offences against children, the Protection of Children from Sexual Offences (POCSO) Act, 2012, makes reporting of such offences...
To address the under reporting of sexual offences against children, the Protection of Children from Sexual Offences (POCSO) Act, 2012, makes reporting of such offences mandatory. The duty to report such offences has been extended to healthcare professionals. The inclusion of healthcare professionals within mandatory reporting, however, strikes at the very foundation of the doctor- patient relationship based on trust and confidentiality and conflicts with the patient confidentiality safeguards of the Mental Healthcare Act, 2017. It also has unintended public health consequences, such as denial of medical termination of pregnancy due to fear of prosecution under POCSO. An urgent reassessment of these mandatory reporting norms for healthcare professionals, and a solution-based approach that harmonises societal interest in the reporting of sexual crimes with the child's right to health is essential.
Topics: Child; Pregnancy; Female; Humans; Mandatory Reporting; Sex Offenses; Confidentiality; Health Personnel; Physician-Patient Relations
PubMed: 38375641
DOI: 10.20529/IJME.2024.003 -
Frontiers in Psychiatry 2023Many jurisdictions implement mandatory substance use treatment for justice-involved persons. Germany is one such country; however, debates about the appropriateness and...
Many jurisdictions implement mandatory substance use treatment for justice-involved persons. Germany is one such country; however, debates about the appropriateness and effectiveness of this disposal abound. Very little attention has been paid in the international literature to patients receiving mandatory treatment in Germany. This systematic review synthesises research on patients receiving substance use treatment in forensic hospitals under §64 of the German Penal Code with regard to three primary outcomes: treatment completion, reoffending, and the recurrence of substance use. Forty-five publications reporting on 36 studies were reviewed; publication dates ranged from 1988 to 2023. On average, 47% of patients did not successfully complete treatment, compared to 45% who did. Average follow-up reconviction rates were higher than in mentally ill and general offender populations as reported elsewhere. Approximately half of all patients reused substances during treatment. Suggestions for future research, including a focus on strength- and recovery-based indicators, and harmonising routine outcomes measurements, are given.
PubMed: 38375516
DOI: 10.3389/fpsyt.2023.1217561 -
BMC Public Health Feb 2024Rapid antigen-detection tests for SARS-CoV-2 self-testing represent a useful tool for pandemic control and expanding access to community-level case screening. COVID-19... (Observational Study)
Observational Study
BACKGROUND
Rapid antigen-detection tests for SARS-CoV-2 self-testing represent a useful tool for pandemic control and expanding access to community-level case screening. COVID-19 self-tests have been extensively used in high-income countries since 2021; however, their introduction and programmatic implementation in low- and middle-income countries was delayed. We aimed to identify and continuously improve a weekly COVID-19 self-testing model among staff at healthcare facilities and schools.
METHODS
This mixed-methods, observational prospective study was conducted in 5 healthcare centres and 24 schools in Georgia, between June and December 2022. The study comprised the integration of COVID-19 self-testing into the national mandatory testing programme for high-risk groups, with primary distribution of self-tests among staff performed weekly, plus secondary distribution to their household members. These use cases were selected because NCDC was seeking to strengthen their already strong weekly testing programme, by investigating self-testing to ease the burden of testing in the healthcare system. Online surveys and semi-structured interviews were used for data collection.
RESULTS
In total, 2156 participants were enrolled (1963 female, 72%). At baseline and mid- and end-points, 88%, 97% and 99%, respectively, of participants agreed/strongly agreed they would self-test. Similarly, the majority were willing to report their self-testing results (88%, 98% and 96% at baseline and mid- and end-points, respectively). Weekly reporting of test results to the national COVID-19 database was high during all the implementation. There were 622 COVID-19 positive results reported, and linked to care, from 601 individuals (282 participants and 319 household members). Findings from qualitative interviews showed great satisfaction with self-testing for its convenience, ease of use, trust in the results, no need to travel for diagnostics, and increased perception of safety.
CONCLUSIONS
Our findings contribute to the evidence-base regarding self-testing strategies conducted via workplaces and secondary distribution to households. Willingness to perform a COVID-19 self-test increased after implementation. This pilot enhanced pandemic preparedness through expansion of the national self-testing reporting system, development of communications materials, changes in the national legal framework and coordination mechanisms, and improved perceptions around self-care in the community. The lessons learnt can inform operational aspects of the introduction and scale-up of self-care strategies.
Topics: Female; Humans; COVID-19; SARS-CoV-2; Pilot Projects; Self-Testing; Prospective Studies
PubMed: 38368339
DOI: 10.1186/s12889-024-17930-2