scholarly journals Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital

2021 ◽  
Vol 12 ◽  
Author(s):  
Zakir Khan ◽  
Yusuf Karataş ◽  
Olcay Kıroğlu
Keyword(s):  
Retrospective Study ◽  
Adverse Drug Reactions ◽  
National Level ◽  
Small Sample ◽  
World Health ◽  
Health Concern ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions ◽  
Paediatric Patients

Drug safety in paediatric patients is a serious public health concern around the world. The paediatric patients are more prone to adverse drug reactions (ADRs) than adults. Moreover, there is a scarcity of information about ADRs in paediatric patients. This study was conducted to determine the frequency, causality, severity, preventability of paediatric patients’ ADRs reported in a tertiary care hospital in Adana, Turkey. A retrospective study was conducted on all spontaneously reported ADRs between January 01, 2020, to July 30, 2021, in paediatric patients. The ADRs reports were evaluated in terms of gender, age, ADR characteristics, suspected drugs and reporting source. All included ADRs reports were characterized according to the Naranjo Algorithm/World Health Organization (WHO) causality scales, Hartwig/Siegel and Common Terminology Criteria for Adverse Events (CTCAE) severity scales, the modified Schoumock and Thornton preventability scale and hospital pharmacovigilance center criteria for seriousness. Therapeutic groups were also coded using the WHO-Anatomical Therapeutic and Chemical (ATC) classification. During the study period, 8,912 paediatric patients who were admitted had 16 ADRs with 1.7 ADRs/1,000 admissions. The majority of ADRs were found in infants (31.2%) and children (56.2%) as compared to adolescents (12.5%). ADRs were observed more in females (81.2%) than males. Skin (62.5%) was the most affected organ due to the ADRs, and maculopapular rash and erythema multiforme were the most commonly reported symptoms. Most ADRs were probable/likely (93.7%), severe (50%), preventable or probably preventable (43.7%) and serious (37.5%). Antibiotics (93.7%) were found to be the most common cause of ADRs in paediatric patients. The majority of ADRs were associated with vancomycin (68.7%). Most of the ADRs were reported by a medical doctor in this study. This small sample size study highlights significant problems of ADRs in paediatric patients, mainly caused by antibiotics and with a majority of ADRs manifest as skin reactions. Furthermore, a high proportion of the identified ADRs were found to be preventable. More focused efforts are needed at the national level to avoid preventable ADRs in hospitals. Monitoring and management of ADRs and future studies would be beneficial for better patient care and safety.

scholarly journals A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS DUE TO PLATINUM ANALOGS - CHEMOTHERAPY IN A TERTIARY CARE HOSPITAL

2018 ◽  
Vol 11 (6) ◽  
pp. 215
Author(s):  
Sumit Kumar ◽  
Badruddeen Badruddeen ◽  
Singh S P ◽  
Mohammad Irfan Khan
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical College ◽  
Health Organization ◽  
A Prospective Study ◽  
Platinum Analogs

Objective: The objective of this study was to analyze the types of adverse drug reactions (ADRs) associated with platinum analogs (cisplatin, carboplatin and oxaliplatin) used for cancer chemotherapy in a tertiary care hospital and determine their causal relationship with the offending drug.Methods: This prospective, observational, non-interventional study was conducted in a tertiary care hospital at GSVM Medical College Kanpur, India, for 4 months. Patients of all age and either sex were included in the study. ADRs were reported by the physicians of oncology department of the hospital and ADRs were assessed for different parameters -causality, outcome, and seriousness of ADR as per the World Health Organization (WHO), type of ADRs as per expanded Rawlins and Thompson’s classification, predictability using council for international organization of medical sciences guidelines and severity using modified Hartwig’s scale. Descriptive statistics were used for data analysis.Results: A total of 140 ADRs were reported from platinum analogs following treatment of different types of cancer in hospital. The burden of ADRs in each patient was 2.41. Most of the ADRs were observed in the age group of 40–60 years. Vomiting (27 ADRs) was commonly reported reaction. Among platinum analogs, cisplatin leads to 82 ADRs (58.57%) followed by carboplatin with 53 ADRs (37.86%) and least with oxaliplatin 5 ADRs (3.57%). Most of the ADRs on causality assessment were possible (104, 74.29%) and probable (36, 25.71%) in nature. Type -A ADRs account for 4/5th of the total reported ADRs, followed by Type-B and C. Severity of 90.71% ADRs was found to be mild followed by moderate, with no case of severe and serious nature. Nearly, most of the ADRs were of predictable type (97.14%).Conclusion: The potential of platinum analogs to cause ADRs is high; thus, the need of effective ADRs monitoring is highly emphasized.

scholarly journals Antibiotic-Related Adverse Drug Reactions at a Tertiary Care Hospital in South Korea

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
In Young Jung ◽  
Jung Ju Kim ◽  
Se Ju Lee ◽  
Jinnam Kim ◽  
Hye Seong ◽  
...  
Keyword(s):  
South Korea ◽  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Clinical Information ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Manifestations

Background. Adverse drug reactions (ADRs) are any unwanted/uncomfortable effects from medication resulting in physical, mental, and functional injuries. Antibiotics account for up to 40.9% of ADRs and are associated with several serious outcomes. However, few reports on ADRs have evaluated only antimicrobial agents. In this study, we investigated antibiotic-related ADRs at a tertiary care hospital in South Korea.Methods. This is a retrospective cohort study that evaluated ADRs to antibiotics that were reported at a 2400-bed tertiary care hospital in 2015. ADRs reported by physicians, pharmacists, and nurses were reviewed. Clinical information reported ADRs, type of antibiotic, causality assessment, and complications were evaluated.Results. 1,277 (62.8%) patients were considered antibiotic-related ADRs based on the World Health Organization-Uppsala Monitoring Center criteria (certain, 2.2%; probable, 35.7%; and possible, 62.1%). Totally, 44 (3.4%) patients experienced serious ADRs. Penicillin and quinolones were the most common drugs reported to induce ADRs (both 16.0%), followed by third-generation cephalosporins (14.9%). The most frequently experienced side effects were skin manifestations (45.1%) followed by gastrointestinal disorders (32.6%).Conclusion. Penicillin and quinolones are the most common causative antibiotics for ADRs and skin manifestations were the most frequently experienced symptom.

scholarly journals Determinants of Adverse Drug Reactions Due to Tuberculosis Therapy in African Countries: a Systematic Scoping Review Protocol

2021 ◽  
Author(s):  
Tasmiya Raúfo Irá ◽  
Neusa Torres Tovela ◽  
Elisa López Varela ◽  
Pravina Devi Laljeeth ◽  
Richard Beharilal ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Scoping Review ◽  
Clinical Management ◽  
World Health ◽  
Health Concern ◽  
Cochrane Library ◽  
Drug Reactions ◽  
African Countries ◽  
Tuberculosis Therapy ◽  
Research Studies

Abstract Background: Adverse drug reactions (ADRs) remain a significant public health concern worldwide mainly in developing countries. Adverse drug reactions due to multi-drugs regimen for the treatment of tuberculosis (TB) have negative implications such as toxicity, leading to poor compliance and interruption of medication before completion. Understanding the profile of ADRs is critical to establishing specific strategies for early detection, prevention and clinical management. The present study aims to map the existing literature on the determinants of adverse drug reactions due tuberculosis therapy in African countries. Methods and analysis: The scoping review will be guided by Arksey and O’Malley framework as well as recommendations by Levac et al., and Colquhoun et al. The search strategy will include searching electronic databases such as Cochrane library, PubMed, EBSCOhost (including Medline), ProQuest, Google scholar; CINAHL with Full Text and other sources such as World Health Organization (WHO) and governmental websites. Peer-reviewed literature and grey literature of primary and secondary studies with different study designs which addresses the main question will be included. Studies published within the period of 2000 to 2020 are eligible. The selection process will involve screening titles, abstracts, full texts. A standardized data charting form will be created in google forms to extract relevant information from the included studies. The NVIVO software version 12 will be used for thematic analysis of the studies to summarize the review findings. The quality of the included studies will be assessed using Mixed Method Appraisal Tool (MMAT) version 2018 and Authority Accuracy Coverage Objectivity Date Significance (AACODS) checklist (for grey literatures).Discussion: The study anticipates finding and mapping relevant research studies in African context on determinants of adverse drug reactions due to tuberculosis therapy. The synthesis of this evidence base will help to identify research gaps and will serve as guidance for future research studies on strengthening of the pharmacovigilance system of ADRs and its clinical management in Africa. The study findings will be disseminated through the traditional academic platforms, such as peer-reviewed publications and presentations at relevant local and international conferences, symposiums, and seminars.Systematic review registration: Prospero Registration Number: CRD42020203617.

scholarly journals Assessment of adverse drug reactions to antituberculosis regimen in a tertiary care hospital

2019 ◽  
Vol 8 (10) ◽  
pp. 2202
Author(s):  
Sanitha Kuriachan ◽  
Prakash Krishnan ◽  
Bharti Chogtu ◽  
Manu Mathew George
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Drug Reactions ◽  
Causality Assessment ◽  
Patient Adherence ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Skin Reactions ◽  
Antitubercular Treatment ◽  
Improve Patient

Background: Adverse drug reactions are common with multidrug therapy in tuberculosis, if detected early can improve patient compliance and prevent emergence of resistance.Methods: A prospective observational study as a part of Pharmacovigilance Program under Central Drugs Standard Control Organisation was conducted in Kasturba hospital, Manipal to collect adverse drug reactions (ADR). Data of patients reported with antitubercular treatment (ATT) related ADRs from September 2012 to August 2013 was evaluated for patient demography, type of tuberculosis, ATT regimen, organ/ system affected and time of onset of ADR. ADRs were then subjected to causality assessment as per WHO scale.Results: A total of 65 ADRs were reported in 60 patients during the study period, of which 46.7% were in males and 53.3% in females. 85% of ADRs were reported in patients with pulmonary tuberculosis. 77% of ADRs were observed with daily regimen. Common ADRs were hepatitis (40%), gastritis (15%), skin reactions (15%), peripheral neuropathy (14%), gout (6%) and nephritis (3%). Median duration for the onset of ADR was 31 days each for hepatitis, gout, nephritis and 20, 11, 9 days for gastritis, peripheral neuropathy and skin reactions respectively. As per causality assessment, 80% of ADRs were assigned “possible”, 11% “probable” and 9% “certain”. As per severity scale 27.7% of ADR were severe, 36.9% were moderate.Conclusions: Early detection and management of ADRs is vital for the success of ATT and patient adherence.

scholarly journals Glucocorticoids: Boon or Bane-An assessment of safety proϐiling of steroids in a tertiary care hospital

2021 ◽  
Vol 12 (2) ◽  
pp. 1611-1619
Author(s):  
Sadhana N Holla
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care Hospital ◽  
Adverse Drug Reaction Reporting ◽  
Tertiary Care ◽  
Careful Consideration ◽  
World Health ◽  
Care Hospital ◽  
Drug Reactions ◽  
Relative Risks ◽  
Health Organization

Glucocorticoids are used in therapy empirically, but undesirable effects occur with large doses or prolonged administration. The aim of the study is to assess the pattern of adverse drug reactions of glucocorticoids in a tertiary care hospital. A retrospective analysis of adverse drug reactions (ADRs) following administration of glucocorticoids was conducted in the ADR monitoring center, Department of Pharmacology, Kasturba Medical College, Manipal. Clinical and treatment data were collected from the patient case records in the suspected adverse drug reaction reporting form as per the World Health Organization guidelines.  ADRs were assessed for Causality, Preventability and Severity using WHO causality assessment scale, Modified Schumock and Thornton’s scale and Hartwig’s severity scale, respectively. 100 ADRs were observed in 85 patients, with 51% males and 49% females. Prednisolone (53%) was the most common drug responsible for ADRs, followed by betamethasone (9%) and dexamethasone (8%). Hyperglycemia (34%) was the most common ADR, followed by cutaneous adverse reactions (32%). Acne (20%) was common among them. Over 86% reactions were categorized "possible". Among ADRs (91%) treated, only 16 % recovered. About 39% of cases were "probably preventable". The majority of ADRs (72%) were moderate in “severity”. Given the number and severity of side effects, the institution of glucocorticoids requires careful consideration of the relative risks and benefits in each patient.

scholarly journals A PROSPECTIVE STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL IN SOUTH INDIA

2019 ◽  
pp. 89-92
Author(s):  
JERIN JAMES ◽  
JAMUNA RANI
Keyword(s):  
Adverse Drug Reactions ◽  
South India ◽  
Causality Assessment ◽  
Tertiary Care Hospital ◽  
Negative Impact ◽  
Tertiary Care ◽  
Laboratory Data ◽  
Health Concern ◽  
Care Hospital ◽  
Drug Reactions

Objective: The objective of this study was to determine the prevalence of adverse drug reactions (ADRs) in a tertiary care teaching hospital in South India and to analyze the causality according to the Naranjo scale. Methods: This study was carried out at the SRM Medical College, Chennai, a tertiary care hospital, which is an ADR monitoring center under Pharmacovigilance Programme of India, over a period of 1 year, from September 2017 to August 2018, after approval by the Institutional Ethics Committee. These ADRs were reported by the clinical pharmacy team of our hospital to the department of pharmacology. The relevant data were collected from the patient case notes, treatment charts, laboratory data reports, ADR notification forms, patient interview, and reporter interviews after written informed consent was obtained from each patient. Patients of either sex of all ages who developed ADR within the hospital were included in the study. Patients who developed ADR outside the hospital were excluded from the study. The collected ADRs were subjected to the Naranjo causality assessment scale. Hartwig’s scale was used to assess the severity of the reaction. The causalities and other aspects of the ADRs were analyzed in detail. Results: A total of 80 ADRs were reported during this study period. The ADRs were most frequently reported in the adult age group (75%) with slight female preponderance (60%). Antibiotics contributed to the maximum number of ADRs which accounted for 52.5% of the total, of which beta-lactams were the highest (37.5%) followed by analgesics. Causality assessment of ADRs by the Naranjo scale showed that the maximum reactions could be categorized as probable (85%) followed by the possible category (15%). The most common presentation of ADR was itching (45%) followed by rashes (30%). Three cases of severe adverse reactions were reported, one case each of anaphylaxis to pantoprazole and diclofenac and one case of Steven–Johnson syndrome to cotrimoxazole. Conclusion: ADRs are a common occurrence but are often not recognized. Even if recognized, they are underreported as many physicians are unaware that all ADRs should be reported to ADR monitoring centers. ADRs are an important cause of morbidity and mortality all over the world and are an important public health concern. It inflicts a negative impact on the treatment and exerts a greater economic burden on the patient if it results in prolongation of the duration of hospitalization or other comorbidities. Therefore, the practicing physicians, as well as the nursing staff, should be sensitized of the importance of ADR reporting to their respective pharmacovigilance centers.

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