Revisiting the clinical trial history and regulatory mechanisms in Nepal in the context of COVID-19 pandemic.

Presence of Nepal in global clinical trials has been visibly negligible despite the history of conducting large scaled randomized controlled trial on Hepatitis E vaccine decades ago. Majority of the problem is attributed to the lack of collaborative work, financial and human resource constrains. COVID-19 pandemics seems to have triggered urgency among the authorities of Nepal leading to a substantial increase in the number of clinical trials in collaboration with national and international organizations/institutions. Immediately after detection of the first COVID-19 case on 13 January 2020, the Ethical Review Board (ERB) of NHRC received several research proposals, subsequently leading to the approval of the first clinical trial for COVID-19 on 01 July 2020 to investigate potential of traditional Ayurveda based medicine for COVID treatment. Soon, number of other clinical trial proposals received approval and implemented in the country, however budgetary allocation from the Government of Nepal (GON) was prioritized for COVID-19 outrage management and vaccination coverage only. Collaborations with various international institutions played a significant role in the successful implementation of large-scale clinical trials in the country and further laid the path for future. In this review paper we present the recent developments in clinical trials in Nepal, budgetary allocation from the government and the mechanisms in place for regulation of clinical research in the country along with challenges and way forward.

Knowledge of community pharmacists in the Kathmandu Valley, Nepal about the risks associated with medication use during pregnancy.

BACKGROUND: Community pharmacists are among the most accessible health care providers. OBJECTIVE: This study evaluates the knowledge of community pharmacists about the risks associated with medication use during pregnancy. METHODS: A cross-sectional study was carried out in March 2021 among the 344 community pharmacies in the Kathmandu Valley, Nepal. Convenience sampling was used for data collection using a structured and validated questionnaire. RESULTS: The majority of participants were male: 264 (76.7%), 94.2% were between the age of 21 to 30 years, and 53.1% had work experience of less than one year. Over half had completed diploma in pharmacy. Less than 10 medicines were dispensed to pregnant women daily in 61.6% of the pharmacies. Only 28.8% of the community pharmacists always inquired about pregnancy status from women in the reproductive age group. The median knowledge score was significantly different among individuals with different work experience and qualifications (p < 0.001). There was also difference in median scores according to average number of medicines dispensed daily (p = 0.006). The knowledge score also differed according to average number of medicines dispensed to pregnant woman and inquiry by the pharmacist about pregnancy status (p < 0.001). CONCLUSION: Our study revealed that the median knowledge scores need improvement.

Critical Evaluation of Drug Advertisements in a Medical College in Lalitpur, Nepal.

PURPOSE: The information provided in drug advertisements (DAs) often do not follow the recommended criteria and may promote irrational prescribing behaviors. Recently Health Action International (HAI) formulated detailed criteria to evaluate DAs which further develop and expand on the World Health Organization (WHO) criteria. This study was done to evaluate DAs using both criteria. METHODS: The study was carried out from October 2019 to January 2020 in the Department of Pharmacology of KIST Medical College, Lalitpur, Nepal. A structured proforma was used to collect data. RESULTS: Altogether 100 DAs were analyzed. Maximum (85%) were having pictorial presentations. Majority (89%) were found to have authentic information and 3% were found to have exaggerated information. All DAs mentioned generic name, brand name, active drug per dosage form and approved therapeutic uses. Only 4% of DAs mentioned about the adverse effects that can be caused by the use of these medicines. The DAs evaluated as per the HAI criteria for pictures and images showed that people portrayed did not seem to be Nepalese. Females and males were portrayed differently with females being laypersons and males being healthcare professionals. Nineteen DAs contained 33 references to scientific literature. Thirty references contained adequate citation information to be identified and were retrievable. Retrieved references were of high methodological quality and from peer-reviewed journals. There was only one graph in the DAs and it contained the number needed to treat (NNT) information. The graph was not having statistical calculations and was not obscured by other visual material. CONCLUSION: Using both HAI and WHO criteria for assessing the DAs was the strength of this study. None of the DAs fulfilled all the criteria. Additionally, lack of any information on harm in the large majority of DAs, and very limited backing of claims with references was also seen.