Profile of adverse drug reactions in patients on anti-tubercular drugs in a sub Himalayan rural tertiary care teaching hospital

Sood, Anuradha; Bansal, Rekha; Sharma, Añil; Himani, Himani; Bhagra, Suruchi; Kansal, Dinesh

doi:10.18203/2320-6012.ijrms20163312

Cited by 9 publications

(6 citation statements)

References 4 publications

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“…15 Similarly Athira et al, found that the majority of the ADRs were related to was gastro-intestinal tract, followed by skin reactions. 23 Similar results have been reported by Sood et al, Hassan et al, and Sribaddana et al 18,26,27 However study done by Aamir et al, had reported joint pain as the most common ADR while as a study done by Kurniawati et al, found skin reactions as the most common ADRs. 17,19 Another study done by Kheirollah et al, found that the most common ADR was hepatitis.…”

Section: Figure 2: Causality Assessment (Who-umc)supporting

confidence: 63%

Adverse drug reactions associated with first line anti-tubercular drugs, their prevalence and causality assessment in patients on Directly Observed Treatment Short-course (DOTS) in a tertiary care hospital

Nazir¹,

Farhat²,

Adil³

et al. 2018

Int J Basic Clin Pharmacol

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Background: Treatment of tuberculosis involves giving multiple drugs to the patient which is done to prevent development of resistance besides targeting all bacterial sub-populations. The objective of the present study was to find out the adverse drug reactions (ADRs) of the first line anti-tubercular drugs and to calculate prevalence and causality of these drugs.Methods: The study was conducted by the Department of Pharmacology, Government Medical College, Srinagar in association with the department of Chest medicine. All patients of tuberculosis on directly observed treatment-short course (DOTS) of either sex or age group were enrolled. An assessment of the causality and allocation of ADRs was done using Naranjo’s monitoring scale and WHO-UMC scale.Results: A total of 57 ADRs with 13 different types were observed in 164 patients, with an overall prevalence of about 34.7%. Thirty seven (64.9%) ADRs were categorized as having a ‘probable’ causal relationship while 17 (29.8%) was categorized as ‘possible’ as per the Naranjo’s scale. As per the WHO-UMC monitoring scale fifty two (91.2%) were categorized as ‘possible’ while three (5.3%) were categorized as ‘certain’.Conclusions: Occurrence of ADRs generally results in non-adherance. Timely detection of ADRs through an effective pharmacovigilance programme is the need of hour. The establishment of an active pharmacovigilance centre which was set up in our institution has paved the way to improve the quality of patient care by ensuring safer use of drugs and has helped us to identify and report the various ADR’s encountered.

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Section: Figure 2: Causality Assessment (Who-umc)supporting

confidence: 63%

Adverse drug reactions associated with first line anti-tubercular drugs, their prevalence and causality assessment in patients on Directly Observed Treatment Short-course (DOTS) in a tertiary care hospital

Nazir¹,

Farhat²,

Adil³

et al. 2018

Int J Basic Clin Pharmacol

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“…This distribution of AEs by organ systems is in agreement with the results of Falzon et al; in that study, the rate of gastrointestinal AEs, including hepatic AEs, was 75%, while in other systems, the rate was much lower 22 . In contrast, Sood et al, stated that the most common ADRs in patients were in the CNS (27.5%), followed by the gastrointestinal system (19%); psychiatric (12.5%), audio‐vestibular (8%) and ophthalmic (0.6%) AEs were also reported 23 …”

Section: Discussionmentioning

confidence: 73%

“…22 In contrast, Sood et al, stated that the most common ADRs in patients were in the CNS (27.5%), followed by the gastrointestinal system (19%); psychiatric (12.5%), audio-vestibular (8%) and ophthalmic (0.6%) AEs were also reported. 23 In our study, we examined 12 types of AEs in different organ systems in male and female TB inpatients and outpatients. The frequency of AEs in our study was higher in females than in males (150 vs 120 registered AEs, respectively).…”

Section: Discussionmentioning

confidence: 99%

Tuberculosis drug safety and pharmacovigilance in health system of Kosova: A cross‐sectional analysis

Krasniqi

Neziri

Jakupi³

et al. 2020

Pharmacoepidemiology and Drug

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Background Tuberculosis (TB) remains a significant worldwide social and life‐threatening epidemiological problem. Because this disease requires multiple drug treatment and prolonged therapy for several months, followed by a high probability of adverse effects (AEs), we assessed AE monitoring for anti‐TB drugs in the Health Care System of Kosova. Methods This survey was a cross‐sectional analysis performed at the primary, secondary and tertiary health care levels in Kosova. We included 930 registered tuberculosis patients within three levels of this health system in our study. Furthermore, we interviewed 62 physicians and 71 nurses at TB health facilities. Data were collected from official TB registers and personal contact with patients for 12 months. Results The representative age group was 19 to 29 years (30.49%), followed by a group of patients aged >60 years (23.23%). Among 930 patients treated with TB drugs, the total incidence of adverse AEs was 29.03%. Female TB patients had a higher rate of AEs than did male patients (33.56% vs 28.84%, respectively). The highest incidence of registered AEs was recorded in the gastrointestinal system (270, 80.83%), followed by the central nervous system (CNS, 7.50%) and was lower in other organ systems. The reporting of anti‐TB drug effects by medical staff (TB medical doctor and TB medical nurse) at different levels of TB medical settings occurred among 62.90% of medical doctors and 81.69% of nurses. Only 53.23% of medical doctors and 46.48% of nurses completed pharmacovigilance training. Conclusion The pharmacovigilance approach in Health System of Kosova is not comprehensible and not systematic. The relatively low incidence of AEs among TB patients is due under reporting of these by medical staff. The knowledge, attitudes, and adherence of medical staff reveal low awareness for pharmacovigilance activities, and this concern should be addressed to reinforce this important issue for the safe treatment of TB patients.

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“…Tuberculosis has been a public health problem affecting our nation for long, inviting attention of physicians, public health specialists, researchers and policy makers in new, efficient, cost effective, pragmatic and different ways to tackle with this burden. One out of every 3 persons in the world are infested by mycobacterium tuberculosis [8] . In our study we found 70 members developed 80 ADRs among the 184 patients who are on the ATT drugs according to RNTCP guidelines.…”

Section: Discussionmentioning

confidence: 99%

“…These results are similar to Shinde et al, Reena Verma et al [21,3] . Arthralgia seen in (3) patients, Vomiting (3) patients, Erythroderma in (4) patients [8] . The only ADR supposed to be encouraged by Ethambutol is irregularity like Blurred vision / Optic neuritis observed in (2) members [17,8] .…”

Section: Discussionmentioning

confidence: 99%

Analysis of anti-tuberculosis drugs and its effects on TB ward patients in tertiary care hospital

Subbarao¹,

Prasad²,

Naidu³

2020

ATMPH

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Here Tuberculosis (TB) is the airborne transferable ailment brought about by Mycobacterium tuberculi. Which has been one of the basic maladies influencing human networks? Other than infection related intricacies there are not kidding ADRs to the ATT. Targets are the principle goals of study were to assess the ADRs instigated by ATT drugs and furthermore survey causality and seriousness and educating to PvPI for signal age and the board was given. Materials and strategies of the investigation were directed for 7months at a tertiary consideration showing emergency clinic (Mar-Sep) 2019 at SVRRGH emergency clinic Tirupati. Patients who created at any rate 1ADR were taken as study subjects. Discovery and checking of these ADRs was finished by meeting the patients. ADRs were then checked for causality and seriousness by utilizing Naranjo and Hart hairpiece polls separately. Results During the investigation time frame 184 patients were conceded in pulmonology ward out of them 70 patients developed 80 ADRs. More number of ADRs was observed in males (57) than females (13). Most common ADR was found to be Gastritis (30) followed by hepatitis (13) then they are classified according to system wise. Causality assessment by Naranjo scale has definite 35%, probable 62.5%, possible 2.5%.Hartwig showed Mild were 31.25%, moderate 40%, severe were 28.75% reported. p value found to be <0.05(0.03). Present paper is emphasized by the position of emerging policies to decrease the occurrence ADRs. Early detection of ADRs can be achieved by vigilance programmed and proper counseling. As a clinical pharmacist we have the liability to support the patient during the period of ATT therapy. Furthermore, strategies are in need of development to improve the patient compliance and therapeutic outcome

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Profile of adverse drug reactions in patients on anti-tubercular drugs in a sub Himalayan rural tertiary care teaching hospital

Cited by 9 publications

References 4 publications

Adverse drug reactions associated with first line anti-tubercular drugs, their prevalence and causality assessment in patients on Directly Observed Treatment Short-course (DOTS) in a tertiary care hospital

Adverse drug reactions associated with first line anti-tubercular drugs, their prevalence and causality assessment in patients on Directly Observed Treatment Short-course (DOTS) in a tertiary care hospital

Tuberculosis drug safety and pharmacovigilance in health system of Kosova: A cross‐sectional analysis

Analysis of anti-tuberculosis drugs and its effects on TB ward patients in tertiary care hospital

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