Pelden Chejor

Bio: Pelden Chejor is an academic researcher. The author has contributed to research in topics: Pharmacovigilance. The author has an hindex of 1, co-authored 3 publications receiving 3 citations.

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

Abstract: 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...

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

Abstract: 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)

Compliance of good storage practices of pharmacies and medicine outlets: a scoping review

Abstract: Ensuring good storage practices (GSPs) of medicine outlets is important to maintain and ensure the safety, quality, and efficacy of dispensed medicines. The objective of this scoping review was to determine the most common GSP compliance issues within pharmacies and medicine outlets. PRISMA extension for scoping reviews guidelines were followed, and PubMed and Google Scholar were searched to identify the relevant primary literature from January 2016 and February 2022. All study designs in English were eligible for inclusion as long as they reported quantitative data for the fulfilment of individual GSP activities. Duplicate independent screening of the search results was undertaken. Quality assessment was performed on studies for final inclusion. Data extraction was performed by one reviewer, and the observed aggregate percentage compliance (% compliance), along with 95% confidence interval for the root GSP operation, was calculated. Of the 380 records identified, 15 articles were included. The studies were conducted in 10 countries and the majority were participatory research studies. Fire safety had the lowest aggregate % compliance (0.9%). Controlled substance, climate, light, ventilation and temperature and stock and bookkeeping operations all had overall aggregate % compliance levels below 50%. Despite evidence of basic controls and measures, we identified low compliance for many GSP operations. To ensure the integrity of medicines, it is important to increase the enforcement of security measures, invest resources in personnel training, account for informal vendor practices, and facilitate sharing global data publicly from external and governing body inspections and reviews of storage practices.

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

Abstract: 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.