美国食品药物管理总局(FOOD AND DRUG ADMINISTRATION,简称 FDA)情况简介

FDA是美联邦政府卫生部(DEPARTMENT OF HEALTH AND HUMAN SERVICE简称DHHS直译应为卫生及人类服务部,实即卫生部及有关福利事宜)下的直属机构。是对食品及药物等方面制定规范及进行管理的权威性机关。FDA除主要对食品、药物外还包括有生物制品,化妆品及医疗设施等的管理,与农业部(负责肉类、疏菜、水果的管理)、环境保护局(E.P.A)(负责空气、饮水、废弃物、农药、毒品等的管理)分工统管环境中的化学物。它们都是以立法为根据的代表政府的执法机关。 FDA的前身为化学部(DEPARTMENT OF CHEMLSTRY)建于1906年。现有工作人员约8。

Evaluation of Mass Drug Administration Impact on Transmission of Lymphatic Filariasis in 13 Sanitary Districts in Burkina Faso

Introduction: Lymphatic filariasis (LF) is one of the neglected tropical diseases targeted for elimination as a public health issue in the world by 2020. To achieve this goal, one of the strategies is interruption of transmission using chemotherapy (mass drug administration). Burkina Faso in west Africa, an endemic country, has endorsed this resolution. In 2000, all Sanitary Districts (SD) in the country were endemic, and then a national elimination program has made it possible to stop mass treatment in 45 out of 70 SD over 12 years. Sixteen years later, 13 other SD were reeligible for Transmission Assessment Surveys (TAS). This study aimed to determine the current level of the Mass drugs Administration (MDA) impact indicators in these 13 targeted SD in order to decide whether we need to continue MDA. Method: It was a descriptive study that took place from June to September 2017 in 13 SD regrouped into 7 Evaluation Units (EU). The population of the study was 6 to 7 years old children. The community-based cluster survey method was used. The diagnostic test used to detect Wuchereria bancrofti’s circulating antigen (W. bancrofti) is the Filariasis Test Strip (FTS). The critical threshold of positivity was set at 18 positive subjects per EU. Results: We sampled a total of 12,060 children, 48.9% were female and 51.1% male. In the 7 EU, 13 children were positive to W. bancrofti test. The average antigenic prevalence was 0.11% (13/12,060). In all EU, the number of positive subjects was below the critical threshold. Conclusion: At the end of this evaluation of the transmission of lymphatic filariasis in 13 SD of Burkina Faso, we can tell the MDA could be stopped in these areas without risk of resurgence of the disease, according to the current recommendations of WHO. This can be possible by setting up post-TMM surveillance, considering migratory flows, and including villages where positive cases were found to search possible residual transmission zones.

Work Hard to Ensure Food,Drugs Safety for the People——An interview with Shao Mingli,director-general of the State Food and Drug Administration(SFDA)

Following is an interview given by Shao Mingli, director-general of China＇s State Food and Drug Administration to our reporter on what is being done to ensure food and drug safety in China. As everybody knows, food and drug safety is vital to people＇s lives.

Effectiveness of ivermectin mass drug administration in the control of soil-transmitted helminth infections in endemic populations: a systematic review and meta-analysis

Background Current soil-transmitted helminth(STH)control guidelines endorse the use of albendazole or meben-dazole for school-based targeted preventive chemotherapy(PC),yet their reduced efficacy against Strongyloides sterc-oralis and Trichuris trichiura presents significant limitations.Emerging evidence indicates that community-wide PC[or mass drug administration(MDA)]using ivermectin,commonly used in other neglected tropical disease(NTD)control programs,may play an important role in controlling these parasites.We conducted a systematic review and meta-analysis to evaluate the effectiveness of ivermectin PC in reducing STH prevalence in endemic populations.Methods We searched Pubmed,EMBASE,and Web of Science on February 14,2023,for studies that investigated the effectiveness of ivermectin PC,either alone or in combination with other anthelmintic drugs,on STH infec-tions,and provided a measure of STH prevalence before and after PC.We calculated pooled prevalence reductions for each STH using random-effects meta-analyses.Our protocol is available on PROSPERO(registration number CRD42023401219).Results A total of 21 were eligible for the systematic review,of which 15 were eligible for meta-analysis.All studies delivered ivermectin through MDA.The pooled prevalence reduction of S.stercoralis following MDA with ivermec-tin alone was 84.49%(95%CI:54.96-94.66)across five studies and 81.37%(95% CI:61.62-90.96)across seven studies with or without albendazole.The prevalence reduction of T.trichiura was 49.93%(95%CI:18.23-69.34)across five studies with ivermectin alone,and 89.40%(95%CI:73.66-95.73)across three studies with the addition of albendazole.There was high heterogeneity for all syntheses(I^(2)>65%).Conclusions This study underscores the key role of ivermectin-based MDA in addressing limitations in current global STH guidelines in terms of limited efficacy against S.stercoralis and T.trichiura.Based on these findings,revising inter-national STH guidelines to include ivermectin is a promising option to progress the control and eventual elimination ofSTHsandotherNTDs.

Sulfuryl Group-Involved Drugs Approved by the Food and Drug Administration(FDA)from 2021 to 2023

Organic sulfone compounds,exhibiting interesting bioactivities,were widely applied in the field of pharmaceutical and medicine.And numerous of sulfuryl group-involved drugs were approved by the Food and Drug Administration(FDA).Odevixibat,maralixibat chloride and belzutifan approved in 2021 could be applied in the treatment of progressive familial intrahepatic cholestasis(PFIC),cholestatic pruritus and clear cell renal cell carcinoma(ccRCC),respectively.In 2022,abrocitinib,pyrukynd and voquezna were approved for the treatment of atopic dermatitis,pyruvate kinase deficiency(PKD)and acid-related disorders,respectively.Defencath for preventing bloodstream infections,sparsentan for treatment of proteinuria related to IgA nephropathy,and xacduro for treatment of hospital-acquired bacterial pneumonia(HABP)were approved in 2023.In this review,the synthesis and therapies of these sulfuryl group-involved drugs approved from 2021 to 2023 are discussed in details.

Awareness of and participation in mass drug administration programs used for onchocerciasis control in the Atwima Nwabiagya North District,Ghana

Background Studies on Mass drug administration(MDA)in Ghana targeting various diseases,have mostly focused on factors that affect coverage and compliance to MDA with limited focus on evidence regarding awareness and community perception of the program.Therefore,this study sought to provide empirical evidence on the knowledge of onchocerciasis,and awareness of and participation in the MDA among community members.Methods A community-based cross-sectional survey was conducted from August to October 2019 in communities within the Atwima Nwabiagya North District,Ghana.Data was collected from 2,008 respondents.Bivariate and multivariate logistic regression analyses were performed to measure the associations between socio-demographics,having heard of onchocerciasis and its prevention,and levels of awareness of the MDA program.Results A total of 1268 respondents(63.2%)were aware of the MDA program.The majority ofMost respondents(74.4%)were of the view that the information given about the program was not enough and 45.4%of the respondents had no idea about the relevance of the MDA program.Respondents who had ever heard about onchocerciasis prevention and persons who had previously participated in the MDA program were more likely to be aware of the MDA program during implementation(AOR=2.32;95%CI 1.79-3.01 and AOR=9.31;95%CI 7.06-12.26,respectively).Conclusions We observed a significant association between being aware of MDA campaigns and knowledge of onchocerciasis and its preventive methods,and participation in previous MDA campaigns.We recommend intensification and improvement of prevention campaigns regarding the onchocerciasis MDA program as key to ensuring increased MDA program participation.

Prevalence of epilepsy in the onchocerciasis endemic middle belt of Ghana after 27 years of mass drug administration with ivermectin

BackgroundIn onchocerciasis-endemic areas with high ongoing Onchocerca volvulus transmission,a high prevalence of epilepsy has been reported.This study aimed to determine the prevalence and clinical characteristics of epilepsy in the Bono Region of Ghana following 27 years of implementation of ivermectin mass drug administration(MDA).MethodsBetween October 2020 and August 2021,cross-sectional surveys were conducted in nine communities in the Tain District and Wenchi Municipality of the Bono Region of Ghana.In the first stage,a random door-to-door approach was used to screen the population for epilepsy using a pre-tested questionnaire.Persons suspected of having epilepsy were invited for a second-stage neurological examination for case verification.Community O.volvulus microfilarial infection status and Ov16 seropositivity were also determined.Ninety-five confidence intervals(95%CI)for prevalence values were calculated using the Wilson Score Interval.ResultsOf the 971 participants,500(51.5%)were females,and the median age(interquartile range)was 26(15‒43)years.Fourteen participants(1.4%,95%CI:1.0‒2.0)were diagnosed as having epilepsy with generalized seizures being the most frequent seizure type(85.7%,12/14).The overall microfilarial prevalence of O.volvulus was 10.3%(November 2020)and 9.9%(August 2021);the Ov16 seroprevalence was 22.2%(June 2021).Only 63.2%took ivermectin in the last round of MDA distribution in March 2021.ConclusionsThe 1.4%prevalence of epilepsy in the Bono region is similar to the median epilepsy prevalence in sub-Saharan Africa.However,the persistent microfilarial prevalence and low ivermectin study coverage call for the Ghana Onchocerciasis Elimination Programme to step up its efforts to ensure that the gains achieved are consolidated and improved to achieve the elimination of onchocerciasis by 2030.

The impact of drug administration in USA, Europe and Japan on the reform plan in China

It is critical to ensure the safety and efficacy of human drugs through drug administration. Drug administration has a long history in developed countries, such as USA, European Union and Japan, and has achieved great success. In this study, we summarized the important changes in the practice of drug administration in USA, European Union and Japan since 1990s. We also discussed how these changes and experience could be applied in the reform plan in drug administration in China Food and Drug Administration （CFDA）. Our suggestions on future development of CFDA include improving post-market surveillance, advancing regulatory science, strengthening service-oriented regulation, and international cooperation.

Repurposing Loperamide as an Anti-Infection Drug for the Treatment of Intracellular Bacterial Pathogens

Infections caused by intracellular bacterial pathogens are difficult to treat since most antibiotics have low cell permeability and undergo rapid degradation within cells.The rapid development and dissemination of antimicrobial–resistant strains have exacerbated this dilemma.With the increasing knowledge of host–pathogen interactions,especially bacterial strategies for survival and proliferation within host cells,host-directed therapy(HDT)has attracted increased interest and has emerged as a promising antiinfection method for treating intracellular infection.Herein,we applied a cell-based screening approach to a US Food and Drug Administration(FDA)-approved drug library to identify compounds that can inhibit the intracellular replication of Salmonella Typhimurium(S.Typhimurium).This screening allowed us to identify the antidiarrheal agent loperamide(LPD)as a potent inhibitor of S.Typhimurium intracellular proliferation.LPD treatment of infected cells markedly promoted the host autophagic response and lysosomal activity.A mechanistic study revealed that the increase in host autophagy and elimination of intracellular bacteria were dependent on the high expression of glycoprotein nonmetastatic melanoma protein B(GPNMB)induced by LPD.In addition,LPD treatment effectively protected against S.Typhimurium infection in Galleria mellonella and mouse models.Thus,our study suggested that LPD may be useful for the treatment of diseases caused by intracellular bacterial pathogens.Moreover,LPD may serve as a promising lead compound for the development of anti-infection drugs based on the HDT strategy.

A Comparative Analysis of the Administration of Oral Hypoglycemic Drugs in Second Affiliated Hospital of Guiyang Medical College during 2012-2014

[Objective] This study aimed to analyze the application and administration of oral hypoglycemic drugs in Second Affiliated Hospital of Guiyang Medical College,aiming at providing guidance and reference for clinical medication for treatment of diabetes.[Method] The main types,dosages and prices of oral hypoglycemic drugs in Second Affiliated Hospital of Guiyang Medical College during 2012-2014 were compared and analyzed using the computer network system.[Result] During 2012-2014,sales quantity and sales amount of oral hypoglycemic drugs in Second Affiliated Hospital of Guiyang Medical College demonstrated an upward trend.[Conclusion] Integrative medicine can significantly improve symptoms of diabetes complications.Certain achievements have been made in diabetes treatment by Second Affiliated Hospital of Guiyang Medical College.

Exploratory study on performance evaluation of drug administration at provincial level in China

To construct a reliable indicator system to evaluate drug administration performance at provincial level in China, we referred to theories on government performance evaluation and practice of health performance evaluation, conducted field investigation, key person interview, fuzzy comprehensive evaluation and multi-round Delphi to build a three-dimensional evaluation indicator system of ＂input-process-outcome＂. Weight of indicators was determined by the analytic hierarchy process （AHP）. The related data were from Food and Drug Administration Statistical Yearbook for 2010 and China Statistical Yearbook for 2010. Thirty provinces were included in the rankings except Tibet for the unavailability of data. The ranking was highly accepted by officials from central and provincial drug administration agencies, which indicated the three-dimensional evaluation indicator system is feasible to assess drug administration performance at provincial level in China.

Impact of five annual rounds of mass drug administration with ivermectin on onchocerciasis in Sierra Leone

Background:Onchocerciasis is endemic in 12 of the 14 health districts of Sierra Leone.Good treatment coverage of community-directed treatment with ivermectin was achieved between 2005 and 2009 after the 11-year civil conflict.Sentinel site surveys were conducted in 2010 to evaluate the impact of five annual rounds of ivermectin distribution.Methods:In total,39 sentinel villages from hyper-and meso-endemic areas across the 12 endemic districts were surveyed using skin snips in 2010.Results were analyzed and compared with the baseline data from the same 39 villages.Results:The average microfilaridermia(MF)prevalence across 39 sentinel villages was 53.10%at baseline.The MF prevalence was higher in older age groups,with the lowest in the age group of 1-9 years(11.00%)and the highest in the age group of 40-49 years(82.31%).Overall mean MF density among the positives was 28.87 microfilariae(mf)/snip,increasing with age with the lowest in the age group of 1-9 years and the highest in the age group of 40-49 years.Males had higher MF prevalence and density than females.In 2010 after five rounds of mass drug administration,the overall MF prevalence decreased by 60.26%from 53.10%to 21.10%;the overall mean MF density among the positives decreased by 71.29%from 28.87 mf/snip to 8.29 mf/snip;and the overall mean MF density among all persons examined decreased by 88.58%from 15.33 mf/snip to 1.75 mf/snip.Ten of 12 endemic districts had>50%reduction in MF prevalence.Eleven of 12 districts had≥50%reduction in mean MF density among the positives.Conclusions:A significant reduction of onchocerciasis MF prevalence and mean density was recorded in all 12 districts of Sierra Leone after five annual MDAs with effective treatment coverage.The results suggested that the onchocerciasis elimination programme in Sierra Leone was on course to reach the objective of eliminating onchocerciasis in the country by the year 2025.Annual MDA with ivermectin should continue in all 12 districts and further evaluations are needed across the country to assist the NTDP with programme decision making.

Uses of mathematical modeling to estimate the impact of mass drug administration of antibiotics on antimicrobial resistance within and between communities

Background: Antibiotics are a key part of modern healthcare,but their use has downsides,including selecting for antibiotic resistance,both in the individuals treated with antibiotics and in the community at large.When evaluating the benefits and costs of mass administration of azithromycin to reduce childhood mortality,effects of antibiotic use on antibiotic resistance are important but difficult to measure,especially when evaluating resistance that“spills over”from antibiotic-treated individuals to other members of their community.The aim of this scoping review was to identify how the existing literature on antibiotic resistance modeling could be better leveraged to understand the effect of mass drug administration(MDA)on antibiotic resistance.Main text: Mathematical models of antibiotic use and resistance may be useful for estimating the expected effects of different MDA implementations on different populations,as well as aiding interpretation of existing data and guiding future experimental design.Here,strengths and limitations of models of antibiotic resistance are reviewed,and possible applications of those models in the context of mass drug administration with azithromycin are discussed.Conclusions: Statistical models of antibiotic use and resistance may provide robust and relevant estimates of the possible effects of MDA on resistance.Mechanistic models of resistance,while able to more precisely estimate the effects of different implementations of MDA on resistance,may require more data from MDA trials to be accurately parameterized.

Status quo of resource allocation of Chinese grass-roots food and drug administrations: from 2011 to 2016

County grass-root food and drug administrations （CGFDA） undertake the front-line supervision of food and drug safety, whose resource allocation is vital to the regulation efficiency and performance. In this article, we aimed to analyze the status quo of resource allocation of CGFDA from the aspects of regulatory organization, staff, funding and equipment using official panel data from 2011 to 2016. The results illustrated that the total amount of regulatory resources of CGFDA was increased annuall y, reaching a rather large scale. However, many problems still existed in its allocation. Therefore, a series of measures should be taken to optimize the resource allocation of CGFDA, such as improving the network of institutional CGFDA, increasing the recruitment requirements on educational level and major, reallocating the structure of resources and guaranteeing the resource demand in less-developed areas.

Effectiveness of azithromycin mass drug administration on trachoma:a systematic review

Backgrounds:Azithromycin mass drug administration(MDA)is a key part of the strategy for controlling trachoma.This systematic review aimed to comprehensively summarize the present studies of azithromycin MDA on trachoma;provide an overview of the impact of azithromycin MDA on trachoma in different districts;and explore the possible methods to enhance the effectiveness of azithromycin MDA in hyperendemic districts.Methods:PubMed,Embase,the Cochrane Central Register of Controlled Trials,Web of Science,and ClinicalTrials.gov were searched up to February 2021 with no language restriction.Studies reporting the effect of azithromycin MDA on trachoma were included.Mathematical modeling studies,animal studies,case reports,and reviews were excluded.The trachomatous inflammation-follicular(TF)<5.0%was used to judge the effect of azithromycin MDA on eliminating trachoma as a public health problem.Two researchers independently conducted the selection process and risk of bias assessment.Results:A total of 1543 studies were screened,of which 67 studies including 13 cluster-randomized controlled trials and 54 non-randomized studies were included.The effect of azithromycin MDA on trachoma was closely related to the baseline prevalence in districts.For the districts with baseline prevalence between 5.0%and 9.9%,a single round of MDA achieved a TF<5.0%.For the districts with baseline between 10.0%and 29.9%,annual MDA for 3 to 5 years reduced TF<5.0%.However,for the districts with high level of baseline prevalence(TF>30.0%),especially with baseline TF>50.0%,annual MDA was unable to achieve the TF<5.0%even after 5 to 7 years of treatment.Quarterly MDA is more effective in controlling trachoma in these hyperendemic districts.Conclusions:Azithromycin MDA for controlling trachoma depends on the baseline prevalence.The recommendation by the World Health Organization that annual MDA for 3 to 5 years in the districts with TF baseline>10.0%is not appropriate for all eligible districts.

Lymphatic filariasis, infection status in Culex quinquefasciatus and Anopheles species after six rounds of mass drug administration in Masasi District, Tanzania

Background:Lymphatic filariasis(LF)elimination program in Tanzania started in 2000 in response to the Global program for the elimination of LF by 2020.Evidence shows a persistent LF transmission despite more than a decade of mass drug administration(MDA).It is advocated that,regular monitoring should be conducted in endemic areas to evaluate the progress towards elimination and detect resurgence of the disease timely.This study was therefore designed to assess the status of Wuchererio bancrofti infection in Culex quinqefasciatus and Anopheles species after six rounds of MDA in Masasi District,South Eastern Tanzania.

Mass drug administration for lymphatic filariasis elimination in a coastal state of India: a study on barriers to coverage and compliance

Background:Lymphatic filariasis is targeted for elimination in India through mass drug administration(MDA)with diethylcarbamazine(DEC)combined with albendazole(ABZ).For the strategy to be effective,>65%of those living in endemic areas must be covered by and compliant to MDA.Post the MDA 2011 campaign in the endemic district of Odisha,we conducted a survey to assess:(i)the filariasis knowledge in the community,(ii)the coverage and compliance of MDA from the community perspective,and(iii)factors affecting compliance,as well as the operational issues involved in carrying out MDA activities from the drug distributor’s perspective.Methods:A sample of 691 participants-both male and female,aged two years or above-were selected through multistage stratified sampling and interviewed using a semi-structured questionnaire.Additionally,drug distributors and the medical officers in charge of the MDA were also interviewed to understand some of the operational issues encountered during MDA.Results:Ninety-nine percent of the study participants received DEC and ABZ tablets during MDA,of which only just above a quarter actually consumed the drugs.The cause of non-compliance was mostly due to fear of side effects,lack of awareness of the benefits of MDA,and non-attendance of health staff in the villages.Lack of adequate training of drug distributors and poor health communication activities before the MDA campaign commenced and the absence of follow-up by health workers following MDA were a few of the operational difficulties encountered during the MDA campaign.Conclusion:Currently MDA is restricted to the distribution of drugs only and the key issues of implementation in compliance,health education,managing side effects,and logistics are not given enough attention.It is therefore essential to address the issues linked to low compliance to make the program more efficient and achieve the goal of filariasis elimination.

The fight against lymphatic filariasis:perceptions of community drug distributors during mass drug administration in coastal Kenya

Background:Lymphatic filariasis(LF)#a neglected tropical disease(NTD)and leading cause of global disability,is endemic in 32 countries in Africa with almost 350 million people requiring regular drug administration,and only 16 countries achieving target coverage.Community Drug Distributors(CDDs)are critical for the success of NTD programs,and the distribution of medicines during mass drug administration(MDA)in Africa;however they could also be a weak link.The primary aim of this study is to explore and describe perceptions of CDDs during MDA for LF in Mvita sub-county in Mombasa county and Kaloleni sub-county in Kilifi county,Kenya;and provide recommendations for the effective engagement of communities and CDDs in low-resource settings.Methods:In September 2018,we conducted six focus group discussions with community members in each sub-county,three with men aged 18-30,31-50,and 51 years and above and three with women stratified into the same age groups.In each sub-county,we also conducted semi-struaured interviews with nine community health extension workers(CHEWs),the national LF focal point,the county NTD focal points,and seven community leaders.Content analysis of the data was conducted,involving a process of reading,coding,and displaying data in order to develop a codebook.Results:We found that several barriers and facilitators impact the engagement between CDDs and community members during MDA.These barriers include poor communication and trust between CDDs and communities;community distrust of the federal government;low community knowledge and perceived risk of LF,poor timing of MDA,fragmented supervision of CDDs during MDA;and CDD bias when distributing medicines.We also found that CDD motivation was a critical factor in their ability to successfully meet MDA targets.It was acknowledged that directly observed treatment and adequate health education were often not executed by CDDs.The involvement of community leaders as informal supervisors of CDDs and community members improves MDA.Conclusions:In order to achieve global targets around the elimination of LF,CDDs and communities must be effectively engaged by improving planning and implementation of MDA.

Lymphatic filariasis elimination endgame in an urban Indian setting: the roles of surveillanee and residual microfilaremia after mass drug administration

Background:To secure the gains of lymphatic filariasis(LF)elimination programs,attention is needed to the Yesidual microfilaremia phase;in which high-risk populations may be crucial.The present study documents the impact of mass drug administration(MDA)in the urban Indian setting of Surat City,with high rates of in-migration.

Ethical challenges in mass drug administration for reducing childhood mortality:a qualitative study

Background:Mass drug administration(MDA)of medications to entire at-risk communities or populations has shown promise in the control and elimination of global infectious diseases.MDA of the broad-spectrum antibiotic azithromycin has demonstrated the potential to reduce childhood mortality in children at risk of premature death in some global settings.However,MDA of antibiotics raises complex ethical challenges,including weighing near-term benefts against longer-term risks—particularly the development of antimicrobial resistance that could diminish antibiotic efectiveness for current or future generations.The aim of this study was to understand how key actors involved in MDA perceive the ethical challenges of MDA.Methods:We conducted 35 semi-structured interviews from December 2020–February 2022 with investigators,funders,bioethicists,research ethics committee members,industry representatives,and others from both highincome countries(HICs)and low-and middle-income countries(LMICs).Interview participants were identifed via one of seven MDA studies purposively chosen to represent diversity in terms of use of the antibiotic azithromycin;use of a primary mortality endpoint;and whether the study occurred in a high child mortality country.Data were analyzed using constructivist grounded theory methodology.Results:The most frequently discussed ethical challenges related to meaningful community engagement,how to weigh risks and benefts,and the need to target MDA We developed a concept map of how participants considered ethical issues in MDA for child mortality;it emphasizes MDA’s place alongside other public health interventions,empowerment,and equity.Concerns over an ethical double standard in weighing risks and benefts emerged as a unifying theme,albeit one that participants interpreted in radically diferent ways.Some thought MDA for reducing child mortality was ethically obligatory;others suggested it was impermissible.Conclusions:Ethical challenges raised by MDA of antibiotics for childhood mortality-which span socio-cultural issues,the environment,and efects on future generations-require consideration beyond traditional clinical trial review.The appropriate role of MDA also requires attention to concerns over ethical double standards and power dynamics in global health that afect how we view antibiotic use in HICs versus LMICs.Our fndings suggest the need to develop additional,comprehensive guidance on managing ethical challenges in MDA.