Regulatory flexibilities and access to COVID-19 vaccines during the pandemic in Bhutan

Summary Coronavirus disease 2019 (COVID-19) is rapidly evolving with millions of cases and death reported globally. The first-ever case of COVID-19 in Bhutan was confirmed on 5 March 2020 in a 76-year-old American tourist. The national regulatory authorities have implemented varying degrees of regulatory flexibilities to prevent unnecessary death by ensuring timely access to medical products and technologies during the pandemic. The Drug Regulatory Authority of Bhutan, as a national medicines regulatory agency responsible for ensuring the quality of medical products has implemented several regulatory mechanisms to ensure access to medical products including COVID-19 vaccines during the pandemic. In this commentary, we discuss the regulatory flexibilities that ensured access to medical products and COVID-19 vaccines during the pandemic

Dementia care for people from culturally and linguistically diverse backgrounds: Qualitative secondary analysis of the aged care Australian royal commission data

Objective: Understanding the concerns and experiences of people living with dementia from culturally and linguistically diverse backgrounds is critical to ensure culturally appropriate care is delivered. This study aimed to describe the current experiences and concerns of older people from culturally and linguistically diverse backgrounds using the publicly available evidence from the Australian Royal Commission into Aged Care Quality and Safety. Methods: This was a qualitative secondary analysis of the Australian Royal Commission into Aged Care Quality and Safety data to explore new and nuanced insights about care for culturally and linguistically diverse people living with dementia. Using the keywords to search the data corpus, we extracted a topic-specific data set focused on dementia care and cultural diversity. Thematic analysis was used to identify and describe the present practices and challenges. Results: Our findings showed that the need for cultural connection for older people from culturally and linguistically diverse backgrounds increases as dementia progresses. Access to culture-specific food and music facilitated connection with their culture of origin. Many older people from culturally and linguistically diverse backgrounds with dementia reverted to their language of origin; however, the inability to communicate due to a lack of language support impacted their health and well-being, and care provision. Conclusions: Further work is needed to provide the necessary cultural experiences and language support to ensure comfort and equity in the provision of dementia care for Australians from migrant backgrounds

Experiences of older immigrants living with dementia and their carers: A systematic review and meta-synthesis

Objective To systematically review and synthesise evidence on the experiences of older immigrants living with dementia and their carers. Design A systematic review and meta-synthesis of qualitative studies. Methods Studies exploring the experiences of older immigrants living with dementia and their carers were eligible. Databases were searched including CINAHL, MEDLINE, PsycINFO, PubMed, Embase, Web of Science and Cochrane Library from January 2000 to April 2021. Quality assessment was undertaken using the Critical Appraisal Skills Programme checklist for qualitative studies. Data were then synthesised using the thematic synthesis approach. Results The results of this meta-synthesis were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and Enhancing transparency in reporting the synthesis of qualitative research statement. A total of 3857 studies were returned from the database search. Eighteen studies were included for meta-synthesis. Five synthesised findings were identified: living with dementia and caregiving; family relationships; barriers to dementia care services; stigma and discrimination; and legal and financial issues. The experiences of living with dementia and caregiving presented multiple challenges for older immigrants living with dementia and their families. However, there seems to be very little difference between the experiences of those who have migrated to a new country and those who were born and aged in the same country, but the ability to access and use the available services is different. Conclusion A lack of culturally appropriate dementia services, language barriers and dementia stigma can impede access to dementia care for older immigrants. Strategies to mitigate these barriers are urgently needed to ensure people from culturally and linguistically diverse backgrounds with dementia and their families have the information, education and support to access dementia services, in addition to research that explores the experiences of culturally and linguistically diverse populations. PROSPERO registration number CRD42021277913

Experiences of older immigrants living with dementia and their carers: a systematic review and meta-synthesis

Objective To systematically review and synthesise evidence on the experiences of older immigrants living with dementia and their carers. Design A systematic review and meta-synthesis of qualitative studies. Methods Studies exploring the experiences of older immigrants living with dementia and their carers were eligible. Databases were searched including CINAHL, MEDLINE, PsycINFO, PubMed, Embase, Web of Science and Cochrane Library from January 2000 to April 2021. Quality assessment was undertaken using the Critical Appraisal Skills Programme checklist for qualitative studies. Data were then synthesised using the thematic synthesis approach. Results The results of this meta-synthesis were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and Enhancing transparency in reporting the synthesis of qualitative research statement. A total of 3857 studies were returned from the database search. Eighteen studies were included for meta-synthesis. Five synthesised findings were identified: living with dementia and caregiving; family relationships; barriers to dementia care services; stigma and discrimination; and legal and financial issues. The experiences of living with dementia and caregiving presented multiple challenges for older immigrants living with dementia and their families. However, there seems to be very little difference between the experiences of those who have migrated to a new country and those who were born and aged in the same country, but the ability to access and use the available services is different. Conclusion A lack of culturally appropriate dementia services, language barriers and dementia stigma can impede access to dementia care for older immigrants. Strategies to mitigate these barriers are urgently needed to ensure people from culturally and linguistically diverse backgrounds with dementia and their families have the information, education and support to access dementia services, in addition to research that explores the experiences of culturally and linguistically diverse populations

Aversive reaction between disulfiram and betel quid among inpatients with alcohol use disorder in Bhutan: A preliminary study

Betel Quid (BQ) is commonly used in the Asia-Pacific region. Disulfiram is prescribed for people with alcohol use disorders (PwAUDs) after the completion of detoxification as an alternative to rehabilitation. This prospective observational study reports the aversive reactions and common symptoms of Disulfiram and BQ in PwAUDs. Participants included PwAUDs admitted to the psychiatric ward at the Jigme Dorji Wangchuck National Referral Hospital for detoxification, who were on Disulfiram and using BQ at the same time. Aversive reactions between Disulfiram and BQ were observed for 100 patients over a year. Twenty participants showed aversive reactions between BQ and Disulfiram. Common symptoms included sweating, diarrhea, dizziness, tremors, palpitations, shortness of breath, nausea and vomiting, and headache. Since PwAUDs in Bhutan are inducted on Disulfiram after detoxification, and most use BQ simultaneously, this study will help inform health care providers to educate people about the aversive reactions of Disulfiram and BQ

Evolution of Medicines Regulatory System in Bhutan: History, Status and Challenges

Bhutan is a small landlocked Kingdom in the eastern Himalayas, situated between China and India. Health care in Bhutan is provided free by the government, as guaranteed under the Constitution. No proper system for regulation of medicines existed before 2003. The Essential Drugs Program, instituted in 1986, played the role of regulatory authority and issued technical clearances for sale and distribution of medicines. Notable improvements were seen in the procurement, quantification and store management of medicines under the umbrella of the Essential Drugs Program. The path to medicines regulation in Bhutan started with the enactment of The Medicines Act of the Kingdom of Bhutan in 2003. The Drug Regulatory Authority, established under the Ministry of Health in 2004, began to register medicines before they were imported into Bhutan. Premises licensed for manufacture, sale, distribution, storage and dispensing medicines are monitored for regulatory compliance. Systems for pre-marketing and post-marketing control of medicines were initiated. Bhutan's medicines regulatory system has gradually evolved over the last decade. As a new regulatory system, it faces a number of challenges as the scope of regulatory activities continues to expand. However, there is a need to further strengthen the capacity of drug testing laboratories, and the availability and capacity of regulatory human resources should be enhanced and infrastructure improved for effective regulation of medicinal products in the country. As systems evolve and people change over time, institutional memory is lost. It is important to document the steps adopted by Bhutan, so that other small nations can learn from Bhutan's experiences. This article documents the path Bhutan has taken towards strengthening the regulatory system for medicines. The article also addresses the challenges invovled and recommends measures to address them.https://doi.org/10.21423/jrs-v06n02p035 (DOI assigned 3/11/2019

Chemical restraint as behavioural euthanasia: case studies from the Royal Commission into Aged Care Quality and Safety

Abstract Background The prescription of psychotropic medication to older people living with dementia in residential aged care has become an increasing concern. The use of prescription medication is often prefaced as a way of preventing harm to self and others. However, the use of such medications has been considered a way of managing some of the behavioural and psychological symptoms of dementia. Using a large secondary data set, this study aimed to identify the precursors and mediating factors that influence the use of chemical restraint of older people in residential aged care. Methods Publicly available documents from the Australian Royal Commission into Aged Care Quality and Safety were used as the data corpus for this study. Keywords were used to search over 7000 documents to extract a set of topic-related content. We identified the cases of seven people in respite or permanent residential aged care who had been prescribed or administered psychotropic medication under circumstances that appeared to demonstrate chemical restraint. All documents relating to the cases were collated for our data set. A descriptive case study approach to analysis was taken. Results Four key descriptive patterns were identified: labelling and limits to tolerance, pushing prescription as a solution, coverups and avoiding consent, and family’s fight for liberty. Triangulation across the data and academic literature supports the findings. Conclusion Our findings provide some insight into how chemical restrain happens. Featuring throughout the cases were reports of a lack of workforce capacity to care for and support residents exhibiting dementia behaviours. Prescription of psychotropic medications featured as a “first resort” care solution. Family and friends found such approaches to care unacceptable and frequently challenged the practice. Where consent for prescription was explicitly denied, more covert approaches are demonstrated. Family awareness, presence, and advocacy were key to challenging the practice of chemical restraint. Shortfalls in the capacity of the current workforce come into play here. However, workforce shortcomings can no longer mask this ubiquitous practice. Just as importantly the spotlight needs to be turned on the prescribers and the providers

Compliance to current national medicines law for proper storage and dispensing of medicines at community pharmacies in Bhutan

Introduction: Compliance of community pharmacies with the national medicines law for proper storage and dispensing of medicines is crucial for ensuring the quality and safety of medicines. Community pharmacies in Bhutan are of two types: retail pharmacies and wholesale pharmacies. Objective: This study was aimed to assess the compliance of community pharmacies with the Medicines Act of the Kingdom of Bhutan 2003 and Bhutan Medicines Rules and Regulation 2012. Methods: This is a retrospective cross-sectional study from the inspection reports of community pharmacies inspected from January 2015 to December 2017. Descriptive statistics in frequency and percentage was used to report the results. Results: The overall compliance level for the regulatory provisions under critical and minor categories was 90.4% followed by 86.74% for major category. Around 32.99% of community pharmacies were found without standard operating procedures for storing and dispensing of medicines while 100% of community pharmacies had technical authorization from the Drug Regulatory Authority. Conclusion: Although the compliance level of community pharmacies in Bhutan for storing and dispensing of medicines was found to be above 80%, there are several areas that need to be corrected to ensure full compliance. This study will serve as a baseline for policymakers, managers, and researchers in developing designs for future interventions

Comparing clinico-demographics and neuropsychiatric symptoms for immigrant and non-immigrant aged care residents living with dementia: a retrospective cross-sectional study from an Australian dementia-specific support service

Background Neuropsychiatric symptoms of dementia such as agitation and aggression are common in people living with dementia. The presentation of neuropsychiatric symptoms is influenced by the cultural background of people living with dementia. Further, identifying factors contributing to neuropsychiatric symptoms may be complicated if people living with dementia are immigrants or from non-English-speaking backgrounds. Most of what is known about differences in neuropsychiatric symptoms between racial and ethnic groups living with dementia come from community-based samples. This study investigated differences in clinico-demographics and neuropsychiatric symptoms between immigrants and non-immigrants living with dementia in residential aged care homes who were referred to two Dementia Support Australia programs. Methods This was a retrospective observational cross-sectional study from 2018 to 2022 using data extracted from the Dementia Support Australia database. Immigrant status was identified by documented country of birth. We conducted exploratory subgroup analyses for English-speaking or non-English-speaking immigrants in comparison to non-immigrants. Neuropsychiatric Inventory and PainChek® were used to assess neuropsychiatric symptoms of dementia and pain, respectively. Results Of the 23,889 referrals, 36% were immigrants living with dementia. Immigrants were 0.8 years older than non-immigrants on average. Immigrants had a slightly higher prevalence of mixed dementia (9.5%) than non-immigrants (8.2%). Overall, the groups had no difference in the severity of neuropsychiatric symptoms and associated caregiver distress. However, there was a significant difference in the total number of neuropsychiatric inventory domains (Cohen’s d = -0.06 [-0.09, - 0.02], p <.001) between non-English-speaking immigrants and non-immigrants. Immigrants were more likely to present with agitation/aggression, while non-immigrants were more likely to present with hallucinations. Factors contributing to neuropsychiatric symptoms were common between the groups, with language barriers and cultural considerations frequently endorsed for immigrants. Conclusion This study reveals a mixed picture of neuropsychiatric symptoms between immigrants and non-immigrants. However, due to the exploratory nature of the hypotheses, our findings need to be replicated in future studies to confirm any conclusions. There is a need for increased awareness on the impact of culture and language on neuropsychiatric symptoms for people receiving residential care. Future studies investigating neuropsychiatric symptoms in different immigrant groups will help increase our understanding of neuropsychiatric symptoms for all people