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

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.

Awareness and practice of medical waste management among healthcare providers in National Referral Hospital.

INTRODUCTION: The management and treatment of Medical Waste (MW) are of great concern owing to its potential hazard to human health and the environment, particularly in developing countries. In Bhutan, although guidelines exist on the prevention and management of wastes, the implementation is still hampered by technological, economic, social difficulties and inadequate training of staff responsible for handling these waste. The study aimed at assessing the awareness and practice of medical waste management among health care providers and support staff at the National Referral Hospital and its compliance with the existing National guidelines and policies. MATERIALS AND METHODS: An observational cross-sectional study was conducted from March to April 2019. Three research instruments were developed and used; (i) Demographic questionnaire, (ii) Awareness questions, and (iii) the Observational checklist. The data was coded and double entered into Epi data version 3.1 and SPSS version 18 was used for analysis. Descriptive statistics were used to present the findings of the study. RESULTS: The majority of the respondents were female (54.1%) with a mean age of 32.2 (±7.67) years, most of whom have not received any waste management related training/education (56.8%). About 74.4% are aware of medical waste management and 98.2% are aware on the importance of using proper personal protective equipment. Only 37.6% knew about the maximum time limit for medical waste to be kept in hospital premises is 48 hours. About 61.3% of the observed units/wards/departments correctly segregated the waste in accordance to the national guidelines. However, half of the Hospital wastes are not being correctly transported based on correct segregation process with 58% of waste not segregated into infectious and general wastes. CONCLUSION: The awareness and practice of medical waste management among healthcare workers is often limited with inadequate sensitization and lack of proper implementation of the existing National guidelines at the study site. Therefore, timely and effective monitoring is required with regular training for healthcare workers and support staff. Furthermore, strengthening the waste management system at National Referral Hospital would provide beneficial impact in enhancing safety measures of patients.

Evaluation of a rapid immunochromatographic test kit to the gold standard fluorescent antibody test for diagnosis of rabies in animals in Bhutan.

BACKGROUND: Rabies kills approximately 59,000 people each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance and diagnostic activities, especially in resource poor settings. In this study, a total of 179 brain tissue samples collected from different rabies suspect animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) were selected and tested using both rapid immunochromatographic kit and the reference standard fluorescent antibody test (FAT). We evaluated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of a rapid antigen detection test kit produced by BioNote, Inc. (Hwaseong-si, Korea) relative to a FAT for its fit-for-purpose for confirmation of clinical cases of rabies for early response and enhancing rabies surveillance. RESULTS: Among 179 samples examined in this study, there was a concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test results were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9-95.6) and specificity of 100% (95% CI: 93.4-100) using FAT as the reference standard. The positive and negative predictive values were found to be 100% (95% CI:96.7-100) and 84.4% (95% CI: 73.6-91.3), respectively. Overall, there was 94.4% (95% CI: 90-96.9) test agreement between rapid test and FAT (Kappa value = 0.874) with a positive percent agreement and negative percent agreement of 92 and 100%, respectively. CONCLUSIONS: Our finding demonstrated that the rapid test kit (BioNote) can be used for rabies surveillance and confirming clinical case of rabies in animals for making rapid decisions particularly controlling rabies outbreaks in resource poor settings.

Seroprevalence and risk factors of canine distemper virus in the pet and stray dogs in Haa, western Bhutan.

BACKGROUND: Canine Distemper Virus (CDV) is a highly contagious virus belonging to family Paramyxovirade, genus Morbillivirus and responsible for high morbidity and mortality in dogs worldwide. Infected domestic dogs can cause spillover infections to wild carnivores that are in contact. We conducted a seroprevalence survey of CDV in domestic dogs in two areas of western Bhutan (Haa district) located at the periphery of the Jigme Khesar Strict Nature Reserve, which is home to several endangered wildlife. A total of 238 serum samples, 119 each from the pet and stray dog, were collected during summer and winter seasons. Samples were tested for CDV antibodies using a sandwich enzyme-linked immune-sorbent assay (ELISA) test. RESULTS: The seroprevalence of CDV was found to be 11.3% (95% CI 6.7-14.2). Dogs sampled during winter were less likely to test seropositive against CDV antibodies than those sampled during summer (adjusted odds ratio: -2.6; 95% CI: - 1.2-6.1). Dogs in good body condition were found to be more likely to test seropositive against CDV than dogs in poor condition and obese dogs (adjusted odds ratio: 2.2; 95% CI: 0.1-5.9). There were no significant differences in the seroprevalence of CDV among different sexes, breeds and age classes, pet and stray dogs and between the two study sites. CONCLUSIONS: Our study indicates that CDV seroprevalence was equally distributed among pet and stray dogs. We suggest strengthening the management practices of dogs through responsible dog ownership, dog population management and waste management to minimize the transmission risk of infectious diseases to wildlife.