Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan

Background: Multidrug-resistant tuberculosis (MDR-TB) is a growing public health problem. Treatment regimens used against MDR-TB are costly, prolonged, and associated with more side effects as compared with the drug-susceptible tuberculosis. This study was framed to determine the incidence of advers...

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Main Authors: Farman Ullah Khan, Amjad Khan, Faiz Ullah Khan, Khezar Hayat, Asim ur. Rehman, Jie Chang, Waseem Khalid, Sidra Noor, Asad Khan, Yu Fang
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-05-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2022.876955/full
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author Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Amjad Khan
Faiz Ullah Khan
Faiz Ullah Khan
Faiz Ullah Khan
Faiz Ullah Khan
Khezar Hayat
Khezar Hayat
Khezar Hayat
Khezar Hayat
Khezar Hayat
Asim ur. Rehman
Jie Chang
Jie Chang
Jie Chang
Jie Chang
Waseem Khalid
Sidra Noor
Asad Khan
Yu Fang
Yu Fang
Yu Fang
Yu Fang
author_facet Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Amjad Khan
Faiz Ullah Khan
Faiz Ullah Khan
Faiz Ullah Khan
Faiz Ullah Khan
Khezar Hayat
Khezar Hayat
Khezar Hayat
Khezar Hayat
Khezar Hayat
Asim ur. Rehman
Jie Chang
Jie Chang
Jie Chang
Jie Chang
Waseem Khalid
Sidra Noor
Asad Khan
Yu Fang
Yu Fang
Yu Fang
Yu Fang
author_sort Farman Ullah Khan
collection DOAJ
description Background: Multidrug-resistant tuberculosis (MDR-TB) is a growing public health problem. Treatment regimens used against MDR-TB are costly, prolonged, and associated with more side effects as compared with the drug-susceptible tuberculosis. This study was framed to determine the incidence of adverse drug events, risk factors, and their management in MDR-TB patients.Methods: This prospective follow-up cohort study was conducted at the site of programmatic management of drug-resistant TB located at the Pakistan Institute of Medical Sciences, Islamabad. All patients, irrespective of their age, gender, and ethnicity, were included in the study. Adverse drug events were observed in patients at different time points during the study. Patients enrolled for the treatment from January 2018 were prospectively followed till December 2020 up to their end treatment outcomes.Results: Out of 126 MDR-TB patients enrolled for treatment, 116 met the inclusion criteria and were included in the final analysis. Most patients (50.9%) were between 18 and 45 years of age. A minimum of one adverse event was experienced by (50.9%) patients. Of all the adverse events, gastrointestinal disorders were more frequent (47.4%), followed by arthralgia (28.4%) and psychiatric disturbance (20.6%). Furthermore, multivariate analysis showed a significant association with the incidence of adverse events in patients with age group above 60 years (odds ratio (OR) 4.50; 95% CI 1.05-19.2), active smokers (OR 4.20; 95% CI 1.31-13.4), delayed reporting to the TB center (OR 4.03; 95% CI 1.34-12.1), and treatment without bedaquiline regime (OR 3.54; 95% CI 1.23-10.1). Most of the patients (94.6%), counseled by the pharmacist, were found to be satisfied with the information provided and looked for more pharmacist counseling opportunities in the management of MDR-TB.Conclusion: Current findings recommend that ADEs might be well managed by timely identification and reporting. Bedaquiline coupled with other active medications lowered the chance of ADEs in MDR-TB patients. Elderly patients, active smoking behavior, and those who have a delay in the treatment initiation are more prone to ADEs. Clinical pharmacist’s contribution to TB control programs may help caregivers and patients concerning the rational use of medication, early detection, and management of ADEs.
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spelling doaj.art-22f3f75b698a4b8b8083bf3b2dcaa2352022-12-22T02:09:40ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-05-011310.3389/fphar.2022.876955876955Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From PakistanFarman Ullah Khan0Farman Ullah Khan1Farman Ullah Khan2Farman Ullah Khan3Farman Ullah Khan4Amjad Khan5Faiz Ullah Khan6Faiz Ullah Khan7Faiz Ullah Khan8Faiz Ullah Khan9Khezar Hayat10Khezar Hayat11Khezar Hayat12Khezar Hayat13Khezar Hayat14Asim ur. Rehman15Jie Chang16Jie Chang17Jie Chang18Jie Chang19Waseem Khalid20Sidra Noor21Asad Khan22Yu Fang23Yu Fang24Yu Fang25Yu Fang26Department of Pharmacy Administration and Clinical Pharmacy, Xi’an Jiaotong University, Xi’an, ChinaCenter for Drug Safety and Policy Research, Xi’an Jiaotong University, Xi’an, ChinaShaanxi Center for Health Reform and Development Research, Xi’an Jiaotong University, Xi’an, ChinaResearch Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, China’s Western Technological Innovation Harbor, Xi’an, ChinaDepartment of Pharmacy, Quaid-i-Azam University, Islamabad, PakistanDepartment of Pharmacy, Quaid-i-Azam University, Islamabad, PakistanDepartment of Pharmacy Administration and Clinical Pharmacy, Xi’an Jiaotong University, Xi’an, ChinaCenter for Drug Safety and Policy Research, Xi’an Jiaotong University, Xi’an, ChinaShaanxi Center for Health Reform and Development Research, Xi’an Jiaotong University, Xi’an, ChinaResearch Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, China’s Western Technological Innovation Harbor, Xi’an, ChinaDepartment of Pharmacy Administration and Clinical Pharmacy, Xi’an Jiaotong University, Xi’an, ChinaCenter for Drug Safety and Policy Research, Xi’an Jiaotong University, Xi’an, ChinaShaanxi Center for Health Reform and Development Research, Xi’an Jiaotong University, Xi’an, ChinaResearch Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, China’s Western Technological Innovation Harbor, Xi’an, ChinaInstitute of Pharmaceutical Sciences, University of Veterinary and Animal Sciences, Lahore, PakistanDepartment of Pharmacy, Quaid-i-Azam University, Islamabad, PakistanDepartment of Pharmacy Administration and Clinical Pharmacy, Xi’an Jiaotong University, Xi’an, ChinaCenter for Drug Safety and Policy Research, Xi’an Jiaotong University, Xi’an, ChinaShaanxi Center for Health Reform and Development Research, Xi’an Jiaotong University, Xi’an, ChinaResearch Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, China’s Western Technological Innovation Harbor, Xi’an, ChinaProgrammatic Management of Drug-Resistant TB Site Pakistan Institute of Medical Sciences, Islamabad, PakistanProgrammatic Management of Drug-Resistant TB Site Pakistan Institute of Medical Sciences, Islamabad, PakistanPharmaceutical Sciences, Universiti Sains, Malaysia, MalaysiaDepartment of Pharmacy Administration and Clinical Pharmacy, Xi’an Jiaotong University, Xi’an, ChinaCenter for Drug Safety and Policy Research, Xi’an Jiaotong University, Xi’an, ChinaShaanxi Center for Health Reform and Development Research, Xi’an Jiaotong University, Xi’an, ChinaResearch Institute for Drug Safety and Monitoring, Institute of Pharmaceutical Science and Technology, China’s Western Technological Innovation Harbor, Xi’an, ChinaBackground: Multidrug-resistant tuberculosis (MDR-TB) is a growing public health problem. Treatment regimens used against MDR-TB are costly, prolonged, and associated with more side effects as compared with the drug-susceptible tuberculosis. This study was framed to determine the incidence of adverse drug events, risk factors, and their management in MDR-TB patients.Methods: This prospective follow-up cohort study was conducted at the site of programmatic management of drug-resistant TB located at the Pakistan Institute of Medical Sciences, Islamabad. All patients, irrespective of their age, gender, and ethnicity, were included in the study. Adverse drug events were observed in patients at different time points during the study. Patients enrolled for the treatment from January 2018 were prospectively followed till December 2020 up to their end treatment outcomes.Results: Out of 126 MDR-TB patients enrolled for treatment, 116 met the inclusion criteria and were included in the final analysis. Most patients (50.9%) were between 18 and 45 years of age. A minimum of one adverse event was experienced by (50.9%) patients. Of all the adverse events, gastrointestinal disorders were more frequent (47.4%), followed by arthralgia (28.4%) and psychiatric disturbance (20.6%). Furthermore, multivariate analysis showed a significant association with the incidence of adverse events in patients with age group above 60 years (odds ratio (OR) 4.50; 95% CI 1.05-19.2), active smokers (OR 4.20; 95% CI 1.31-13.4), delayed reporting to the TB center (OR 4.03; 95% CI 1.34-12.1), and treatment without bedaquiline regime (OR 3.54; 95% CI 1.23-10.1). Most of the patients (94.6%), counseled by the pharmacist, were found to be satisfied with the information provided and looked for more pharmacist counseling opportunities in the management of MDR-TB.Conclusion: Current findings recommend that ADEs might be well managed by timely identification and reporting. Bedaquiline coupled with other active medications lowered the chance of ADEs in MDR-TB patients. Elderly patients, active smoking behavior, and those who have a delay in the treatment initiation are more prone to ADEs. Clinical pharmacist’s contribution to TB control programs may help caregivers and patients concerning the rational use of medication, early detection, and management of ADEs.https://www.frontiersin.org/articles/10.3389/fphar.2022.876955/fullmultidrug-resistant tuberculosisadverse drug eventmanagementpharmacistpatient satisfaction
spellingShingle Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Farman Ullah Khan
Amjad Khan
Faiz Ullah Khan
Faiz Ullah Khan
Faiz Ullah Khan
Faiz Ullah Khan
Khezar Hayat
Khezar Hayat
Khezar Hayat
Khezar Hayat
Khezar Hayat
Asim ur. Rehman
Jie Chang
Jie Chang
Jie Chang
Jie Chang
Waseem Khalid
Sidra Noor
Asad Khan
Yu Fang
Yu Fang
Yu Fang
Yu Fang
Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan
Frontiers in Pharmacology
multidrug-resistant tuberculosis
adverse drug event
management
pharmacist
patient satisfaction
title Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan
title_full Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan
title_fullStr Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan
title_full_unstemmed Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan
title_short Assessment of Adverse Drug Events, Their Risk Factors, and Management Among Patients Treated for Multidrug-Resistant TB: A Prospective Cohort Study From Pakistan
title_sort assessment of adverse drug events their risk factors and management among patients treated for multidrug resistant tb a prospective cohort study from pakistan
topic multidrug-resistant tuberculosis
adverse drug event
management
pharmacist
patient satisfaction
url https://www.frontiersin.org/articles/10.3389/fphar.2022.876955/full
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