Using focused pharmacovigilance for ensuring patient safety against antileishmanial drugs in Bangladesh’s National Kala-azar Elimination Programme  

作　　者：Md.Sakhawat Hossain Amresh Kumar A.F.M Akhtar Hossain Md.Mahshin Abhijit Sharma Md.Akter Hossain Varun Sharma Rashidul Haque A.K.M Shamsuzzaman Shomik Maruf Prakash Ghosh Vivek Ahuja Dinesh Mondal 

机构地区：[1]Shaheed Taj Uddin Ahmed Sarani,Parasitology Laboratory,International Centre for Diarrhoeal Disease Research(icddr,b),Mohakhali,Dhaka 1212,Bangladesh [2]Program for Appropriate Technology in Health(PATH),15th Floor,Dr.Gopal Das Bhawan 28 Barakhamba Road,New Delhi 110001,India [3]Communicable Disease Control Unit,Directorate General of Health Services,Government of Bangladesh,Mohakhali,Dhaka 1212,Bangladesh [4]Adverse Drug Reaction Monitoring Cell,Directorate General of Drug Administration(DGDA),Government of Bangladesh,Mohakhali,Dhaka 1212,Bangladesh [5]Nutrition Infection Interaction Research Group,Nutrition and Clinical Services Division(icddr,b),Dhaka 1212,Bangladesh [6]Infectious Disease Research Institute(IDRI),Seattle,USA

出　　处：《Infectious Diseases of Poverty》2018年第1期787-799,共13页贫困所致传染病（英文）

基　　金：This activity was supported by funds from PATH,USA.The funders had no role in the study’s design,data collection and analysis,decision to publish,or preparation of the paper.

摘　　要：Background:Adverse effects of antileishmanial drugs can affect patients’quality of life and adherence to therapy for visceral leishmaniasis(VL)and post-kala-azar dermal leishmaniasis(PKDL).In Bangladesh,there are 26 treatment centers that manage leishmaniasis cases coming from 100 endemic upazilas(subdistricts)of 26 districts(these include VL,PKDL,treatment failure,and relapse VL and cutaneous leishmaniasis cases).This study aimed to investigate the feasibility of using focused pharmacovigilance for VL(VLPV)in Bangladesh’s National Kala-azar Elimination Programme for the early detection and prevention of expected and unexpected adverse drug reactions(ADRs).Methods:This activity has been going on since December 2014.Activity area includes secondary public hospital or Upazila health complex(UHC)in hundred sub districts and Surya Kanta Kala-azar Research Center(SKKRC)in Mymensingh District,a specialized center for management of complicated VL and PKDL cases.Communicable Disease Control(CDC)of the Directorate General of Health Services(DGHS)assigned twenty five of hundred UHCs and SKKRC(total 26)as treatment centers depending on their suitable geographical location.This was implemented for better management of VL cases with Liposomal Amphotericin B(AmBisome®)to ensure patient convenience and proper utilization of this expensive donated drug.A VLPV expert committee and a UHC VLPV team were established,an operational manual and pharmacovigilance report forms were developed,training and refresher training of health personnel took place at UHCs and at the central level,collected information such as patient data including demographics,treatment history and response,adverse events were analyzed.This report includes information for the period from December 2014 to December 2016.Results:From December 2014 to December 2016,1327 leishmaniasis patients were treated and 1066(80%)were available for VLPV.Out of these,57,33,9,and 1%were new VL,PKDL,VL relapse,and other cases,respectively.Liposomal amphotericin B was mostly use

关 键 词：Visceral leishmaniasis PHARMACOVIGILANCE Antileishmanial drugs Health system BANGLADESH 

分 类 号：R53[医药卫生—内科学]