An analysis of serious adverse drug reactions at a tertiary care teaching hospital

Prajapati, Kinjal; Desai, Mira; Shah, Samidh; Panchal, Jigar; Kapadia, Jigar D; Dikshit, R K

doi:10.4103/2229-3485.192044

Cited by 15 publications

(4 citation statements)

References 16 publications

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“…Although majority of the ADRs were nonserious in nature, the common criteria for serious ADRs were initiation or prolongation of hospitalization and required intervention to prevent damage in geriatric and pediatric group, respectively. Similiar observation has been reported by Prajapati et al [ 19 ]…”

Section: Discussionsupporting

confidence: 85%

An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital

et al. 2018

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Objectives:To analyze clinical spectrum, seriousness, outcome, causality, severity and preventability of ADRs in geriatrics and pediatric patients.Materials and Methods:All ADRs reported in geriatrics (≥ 65 years) and pediatrics (≤ 12 years) indoor as well outdoor patients from January, 2010 to April, 2016 at ADR monitoring centre, Department of Pharmacology, B. J. Medical College and Civil Hospital were identified. A retrospective analysis was carried out for clinical presentation, causality (as per WHO-UMC scale and Naranjo's algorithm), severity (Hatwig and Seigel scale) and preventability (Schaumock and Thornton criteria).Results:Out of 3690 ADRs, 160 were in geriatric patients (4.33%) while 231 in pediatric patients (6.26%). The most commonly affected body system was gastrointestinal (53, 33.13%) followed by neurological disorders (26, 16.25%) in geriatric patients. While in pediatric patients, the most commonly affected body system was skin and appendages (73, 31.60 %) followed by gastrointestinal disorders (58, 25.11%). The most common causal drugs in geriatric patients was cardiovascular (38, 23.75%) followed by antimicrobials (28, 13.25%). While in pediatric patients, the most common causal drug group was antimicrobials (85, 33.46%) followed by blood products (36, 14.12%). Total 17 ADRs reported following vaccination, 7 (41.17%) were injection site abscess and 11 (64.70%) were due to pentavalent vaccine. Polypharmacy was common in geriatrics (31, 19.37%). Causality assessment for majority of ADRs in geriatrics (83, 52.5%) and pediatrics (171, 67.32%) were probable.Conclusion:ADRs are common in geriatric and pediatric patients usually within four weeks of oral therapy. Active surveillance of drug safety monitoring in these vulnerable population is recommended.

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Section: Discussionsupporting

confidence: 85%

An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital

et al. 2018

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“…[ 14 ] A study in Ahmedabad, India, reported that an average of 5 drugs per prescription was recommended to patients suffering from serious adverse effects. [ 15 ] From the present study, it was also evident that level of polypharmacy increased with age of the patients. The maximum level of polypharmacy was 5.82 (±0.36) in the age group of 61–70 years.…”

Section: Discussionsupporting

confidence: 65%

Polypharmacy and comorbidity status in the treatment of type 2 diabetic patients attending a tertiary care hospital: An observational and questionnaire-based study

et al. 2018

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Purpose/Aim:Diabetes mellitus is associated with several comorbid conditions. Thus, often, diabetic patients are prescribed multiple drugs. Although multiple drugs help to combat various diseases, they also increase the propensity of drug interactions and adverse drug reactions. The present study thus tried to evaluate the comorbid conditions and concurrent medications associated with type 2 diabetic patients. It also aimed to address patient compliance for the medications provided to them.Materials and Methods:This was a cross-sectional observational study conducted for 2 months – January–February 2017. Data were collected from prescriptions of the patients and also by interviewing the willing patients, attending the Diabetic Clinic of R. G. Kar Medical College, Kolkata, India.Results:During the study period, 150 patients were interviewed and their prescriptions were studied. Out of 150 patients, 69 (46%) were males and 81 (54%) were females. The mean age of the study population was 51.5 (±0.78) years. The present study evaluated that 83.3% (125) of the study population suffered from at least one comorbid conditions, the most common being hyperlipidemia (70.7%) and hypertension (47.3%). The average number of drugs prescribed is 4.72 (±0.11) per prescription. Metformin was prescribed to 96% of the patients. The concurrent medications recommended included hypolipidemics (72%), antihypertensives (68%), drugs for peptic ulcer (34.7%), and antiplatelets (10.7%).Conclusion:The present study thus concluded that diabetic patients suffer from a number of comorbid conditions, most commonly, cardiovascular problems. The comorbidity increased with the age. The level of polypharmacy was also high, thereby increasing the pill burden for the patients.

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“…9,10 Moreover, the drug side effects extend the hospital stay of TB patients and increase the total cost of hospitalization. [11][12][13] The DOTS strategy emphasizes the clinical importance of monitoring AEs during the treatment course in TB patients.…”

Section: Introductionmentioning

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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An analysis of serious adverse drug reactions at a tertiary care teaching hospital

Cited by 15 publications

References 16 publications

An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital

An analysis of adverse drug reactions in extremes of age group at tertiary care teaching hospital

Polypharmacy and comorbidity status in the treatment of type 2 diabetic patients attending a tertiary care hospital: An observational and questionnaire-based study

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

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