scholarly journals Adverse Drug Reactions to First-line Anti-tubercular Drugs Based on Individual Case Safety Report in a Single Tertiary Hospital

2021 ◽  
Vol 96 (5) ◽  
pp. 421-431
Author(s):  
Hyun Hwa Kim ◽  
Mira Moon ◽  
Nigh Choi ◽  
Dong Yoon Kang ◽  
Kyung Ok Chae ◽  
...  
Keyword(s):  
Treatment Period ◽  
Adverse Drug Reactions ◽  
Individual Case ◽  
Tertiary Hospital ◽  
System Organ Class ◽  
Drug Reactions ◽  
First Line ◽  
Antitubercular Drugs ◽  
Incidence And Mortality ◽  
Total Treatment

Background/Aims: Tuberculosis has incidence and mortality rates that are among the highest for all communicable diseases. Adverse drug reactions (ADRs) to anti-tubercular drugs are common, and have a major impact on treatment maintenance and prognosis. It is important to understand the characteristics of ADRs and establish a suitable management plan. Methods: We retrospectively reviewed patients with ADRs during treatment with first-line antitubercular drugs such as isoniazid, rifampicin, ethambutol, and pyrazinamide from 2009 to 2018. Age, sex, and total treatment period, and the onset, severity, seriousness, and system organ class of ADRs, were analyzed to understand the characteristics of first-line anti-tubercular drug-related ADRs. Results: A total of 1,606 of 5,482 patients (29.3%) experienced ADRs after administration of first-line anti-tubercular drugs. The incidence of ADRs related to isoniazid, rifampicin, ethambutol, and pyrazinamide was 22.2%, 21.3%, 24.5%, and 29.6%, respectively. A total of 2,098 ADR reports were made (mean of 1.3 ± 0.6 per patient). The rates of mild, moderate, and severe ADRs were 32.4%, 61.1%, and 6.5%, respectively. There were 127 reports (6.1%) of serious ADRs. Skin and appendage disorders were most frequently reported (27.5%), followed by gastrointestinal disorders (17.5%), and liver and biliary system disorders (13.1%). The total treatment period was longer in patients who experienced ADRs (224.0 ± 3.1 days vs. 247.0 ± 4.7 days, p = 0.009). Conclusions: The incidence of ADRs to first-line anti-tuberculosis drugs was 29.3%, and 6.5% were severe ADRS. ADRs prolonged the overall treatment duration, indicating the importance of their detection and management.

Effect of concomitant HIV infection on adverse drug reactions by first line antitubercular drugs - a case series analysis

2020 ◽  
Vol 3 (3) ◽  
pp. 222-225
Author(s):  
Alka Bansal ◽  
Lokendra Sharma
Keyword(s):  
Hiv Infection ◽  
Adverse Drug Reactions ◽  
Case Series ◽  
Individual Case ◽  
Drug Reactions ◽  
First Line ◽  
Drug Induced ◽  
Antitubercular Drugs ◽  
Cutaneous Reactions ◽  
Recovery Status

The pattern and severity of adverse drug reactions (ADRs) due to first-line anti-tubercular drugs in solely tubercular and TB-HIV co-infected patients could be different due to drug-disease and drug-drug interactions in TB-HIV co-infected patients. Nevertheless, the studies regarding this aspect are very meager. Hence a retrospective appraisal of individual case safety reports (ICSR) due to first-line antitubercular drugs spontaneously submitted to the ADR monitoring center was done for solely tubercular and TB-HIV coinfected patients. Out of eight ICSRs, four had concomitant HIV infection, and two of them were on antiretroviral (ARV) drugs. Co-infected patients showed rare and severe ADRs like optic neuritis, acute renal failure, and drug-induced liver injury (DILI). In contrast, four non-HIV co-infected tubercular patients suffered from comparatively less severe cutaneous reactions and vertigo. A high negative (-0.774) correlation coefficient between HIV co-infection and recovery status found that HIV co-infected patients had low chances of fully recovering. In conclusion, HIV co-infection and ARV drugs can affect the pattern, severity, and recovery status of adverse drug reactions due to first-line antitubercular drugs.

scholarly journals Relationship between adverse drug reactions to antibacterial agents and the Klebsiella pneumoniae carbapenemase-producing (KPC) Klebsiella pneumoniae outbreak: insight from a pharmacovigilance study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Milo Gatti ◽  
Emanuel Raschi ◽  
Fabrizio De Ponti
Keyword(s):  
Klebsiella Pneumoniae ◽  
Adverse Drug Reactions ◽  
Resistance Rate ◽  
System Organ Class ◽  
Drug Reactions ◽  
Safety Issues ◽  
Klebsiella Pneumoniae Carbapenemase ◽  
Outbreak Period ◽  
Close Relationship ◽  
Safety Signals

Abstract Background The management of Klebsiella pneumoniae carbapenemase producing (KPC) infections represents a major challenge. Several safety and efficacy concerns are shared by available antibiotics used in KPC infections, leading to the occurrence of serious adverse drug reactions (ADRs), with ceftazidime-avibactam possibly showing a more favourable risk-benefit profile. We investigated the potential impact of resistance on ADR reports in countries with different prevalence of KPC isolates (Italy vs. United Kingdom [UK]), and described safety profile of newer and older antibiotics used in KPC infections. Methods Three spontaneous reporting systems (SRSs) with different features (Italy, UK and worldwide FAERS) were used to describe safety profiles of colistin, meropenem, tigecycline, gentamicin and ceftazidime-avibactam in terms of System Organ Class and Preferred Term level. ADRs were plotted with prevalence of KPC isolates in Italy and UK. A comparison between before-after the KPC outbreak period (1999–2008 vs. 2009–2018) of overall and serious ADRs for selected antibiotics in each SRS was performed. Relationship between total and serious number of ADR reports per year and KPC isolates per year after KPC outbreak (2009–2017) was investigated for both Italy and UK. Results A total of 16,329 ADR reports were collected in the three SRSs, with meropenem (42.6%) and gentamicin (36.9%) having the highest number of reports. Significant increase in total and serious ADR reports after the KPC outbreak compared to previous 10 years was found for colistin, meropenem and gentamicin (p < 0.01). No significant increase in tigecycline ADRs was reported in FAERS and UK database. Unexpected safety signals involving selected antibiotics were not detected. Significant positive relationship between overall and serious ADR reports and KPC isolates per year for both Italy (p < 0.01; p = 0.005) and UK (p = 0.032; p = 0.013) was found. Conclusion KPC outbreak led to significant increase in ADRs to selected antibiotics, and a close relationship with antimicrobial resistance was found, both in countries with high and low resistance rate. New safety signals were not detected for selected agents. Active surveillance should be maintained to promptly identify unexpected safety issues.

Parenteral cytotoxic drug wastage at a tertiary hospital in Kuala Lumpur: How much and why?

2019 ◽  
Vol 26 (6) ◽  
pp. 1306-1317
Author(s):  
Zen Yang Ang ◽  
Kit Yee Cheah ◽  
Nadiah B Abdullah ◽  
Safawati B Samsuri ◽  
Siao Hui Lee ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Chemotherapy Regimen ◽  
Tertiary Hospital ◽  
Cytotoxic Drug ◽  
Healthcare Personnel ◽  
Kuala Lumpur ◽  
Drug Reactions ◽  
Start Date ◽  
Standard Operating ◽  
The Cost

Purpose To identify the cost and reasons of returned parenteral chemotherapy regimens at a tertiary hospital in Kuala Lumpur, Malaysia. Methods Data were retrospectively extracted from all the Chemotherapy Return Forms in 2016, which is a compulsory documentation accompanying each return of parenteral chemotherapy regimen. The following data were extracted: patient’s diagnosis, gender, location of treatment (i.e. ward/daycare clinic), start date of chemotherapy regimen, type of cytotoxic drug returned, dose of cytotoxic drug returned, number of cytotoxic drug preparations returned and reason for return as well as whether the returned cytotoxic drug preparations could be re-dispensed. The cost of wastage was calculated based on the cost per mg (or per unit) of the particular returned cytotoxic drug. Results One hundred and fifty-nine cases of returned chemotherapy regimen comprising of 231 parenteral cytotoxic drug preparations were analysed. The total cost of returned chemotherapy regimen for 2016 was €3632, with €756 (20.8%) worth of chemotherapy regimens returned due to preventable reasons and €2876 (79.2%) worth of chemotherapy regimens returned due to non-preventable reasons. Approximately 50% of cases returned chemotherapy regimen were due to deterioration of patient’s clinical condition and another 24.5% of cases of returned chemotherapy regimen were attributed to adverse drug reactions. Conclusion Wastage associated to non-preventable reasons such as adverse drug reactions and preventable causes like refusal of patients can be further reduced by using newer healthcare innovations and establishment of written institutional protocols or standard operating procedures as references for in-charge healthcare personnel when cytotoxic drug-related issues occur. Adoption of cost-saving strategies that have been proven by studies could further improve current cost containment strategies.

scholarly journals Pattern of Adverse Drug Reactions Due to Cancer Chemotherapy in Tertiary Care Teaching Hospital in Bangladesh

1970 ◽  
Vol 8 (1) ◽  
pp. 11-16 ◽  
Author(s):  
Sneegdha Poddar ◽  
Razia Sultana ◽  
Rebeka Sultana ◽  
Maruf Mohammad Akbor ◽  
Mohammad Abul Kalam Azad ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Cancer Chemotherapy ◽  
Economic Status ◽  
Alkylating Agents ◽  
Descriptive Analysis ◽  
Tertiary Care ◽  
Tertiary Hospital ◽  
Drug Reactions ◽  
College Hospital ◽  
Medical College

The objective of the present study was to evaluate the pattern of adverse drug reactions (ADRs)occurring in cancer patients treated with chemotherapy in tertiary care hospitals in Bangladesh. A prospectivehospital based study over a period of six month was carried out in the Department of oncology, Bangabandhu SheikhMujib Medical University and Dhaka Medical College Hospital. The data were subjected to descriptive analysis. Atotal of 50 patients having ADRs due to cancer chemotherapy were randomly selected. Adverse drug reactions weremostly occurred in the age group between 41-50 years (26%). Considering socio-economic status of cancer patientsmarried persons (82%) have significantly higher risk than unmarried (18%). Prevalence of breast cancer (20%),cervical cancer (14%) and leukemia (16%) were higher and they were treated mostly by adjuvant chemotherapy(46%) and secondly by chemotherapy (38%) alone. In most cases ADRs were developed in patients receivingalkylating agents (40%) and antimetabolites (40%) as anticancer therapy. The five certain ADRs observed in thecurrent study were nausea, stomatitis, alopecia, myelosuppression and increased ESR level in both male and femalepatients. Moreover, hematological system was affected severely by alkylating agents and antimetabolites. Similarstudies covering more patients from different regions are needed to validate our findings.Key words: ADRs; Cancer; Chemotherapy; Tertiary hospital; Bangladesh.DOI: 10.3329/dujps.v8i1.5330Dhaka Univ. J. Pharm. Sci. 8(1): 11-16, 2009 (June)

scholarly journals Clinical profiles and trends in CD4+ counts to first-line antiretroviral therapy among HIV/AIDS patients in western part of Odisha state of India

2018 ◽  
Vol 6 (5) ◽  
pp. 1559
Author(s):  
Pradhan B. ◽  
Majhi C. ◽  
Murmu B.
Keyword(s):  
Body Weight ◽  
Antiretroviral Therapy ◽  
Adverse Drug Reactions ◽  
Cd4 Count ◽  
Drug Reactions ◽  
First Line ◽  
Cd4 Counts ◽  
Clinical Stages ◽  
Clinical Profiles ◽  
Hiv Aids

Background: HIV infection is globally pandemic and about 36.7 million people living with HIV/ AIDS (PLHA) in 2016. At present CD4+ count is the gold standard of immunological marker of disease severity. Highly active antiretroviral therapy (HAART) is the first line of treatment to improve CD4 count. AIMS AND OBJECTIVES of study was to observe the clinical profiles and response in CD4+ counts to first-line HAART in PLHA and their adverse reactions.Methods: Total 153 PLHA with CD4+ counts <250/µl was consecutively taken in the study and detail clinical examinations, baseline CD4+ counts and body weights were noted. HAART was started in 26 (16.99%), 37 (24.18%), 78 (50.98%) and 12 (7.84%) cases in WHO clinical stages of I, II, III, and V respectively and CD4+ counts, body weight and any adverse drug reactions were noted at 15 days, 3, 6, 18 and 24 months intervals and data were collected and analyzed.Results: Out of 153 cases 89 were male and 64 were female. Mean age was 35.4±9.08 years for male and 30.2±5.75 years for female. Mean baseline CD4+ count was 202±75/µl and mean body weight was 47.44kg. Mean CD4+ count was increased to 314.22±166.53, 343±194.02, 378±221.30 and 299.6±146.55/µl at 6, 12, 18 and 24 months respectively. Commonest adverse drug reaction was headache and GIT side effects.Conclusions: HAART improves clinical and immunological parameter CD4+ count in PLHA, irrespective of their clinical stages. Headache and GIT manifestations are commonest adverse drug reactions.

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