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 ◽  
...  

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.

Author(s):  
Sumit Kumar ◽  
Badruddeen Badruddeen ◽  
Singh S P ◽  
Mohammad Irfan Khan

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.


2021 ◽  
Vol 12 (2) ◽  
pp. 1611-1619
Author(s):  
Sadhana N Holla

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.


Author(s):  
Hemavathy G. ◽  
Jeyalalitha Rathinam ◽  
Preethi A. ◽  
Divakar R.

Background: Adverse drug reactions (ADRs) have a major impact on public health. Pharmacovigilance has become an integral part of pharmacotherapy. This study has been undertaken to retrospectively analyze the various adverse drug reactions and to promote the reporting of ADRs among the healthcare providers.Methods: A retrospective analysis of the reported ADRs over a period of 3 years at a tertiary care hospital, in Chennai was done. Data related to the number of adverse drug reactions, the demographic particulars, details on the drugs administered, type of ADRs, serious events and prevention strategies undertaken was analyzed. ADRs were assessed for their causality, severity, and preventability as per the standard criteria.Results: A total of 128 suspected ADRs were found to be reported over a period of 3 years. 81.25% ADRs were found to be of mild severity using the Hartwigs scale of assessment, 71.09% were classified as possible using the Naranjo’s causality assessment, the outcome of 63.28% were found to be recovering from the ADR and 41.40 % were under the probably preventable category. The most common ADRs were the skin reactions. The antimicrobial agents were found to have caused the highest number (58.59%) of ADRs followed by NSAIDs (14.84%) and the antihypertensive drugs (14.06%).Conclusions: The antimicrobial agents were associated with ADRs in majority of the patients. The commonly reported ADR s were the skin reactions.


Author(s):  
Manodeep Sen ◽  
Arpita Singh ◽  
Mukul Misra

Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in hospitals and pose great economic burden on the health care system. This study was conducted with the aim of creating awareness and developing a culture for proper communication and reporting of ADRs among health care professionals.Methods: This study is a retrospective analysis of total 60 reported ADRs from AMC at a tertiary care hospital during a period of 14 months from March 2015 to April 2016. These ADRs were analysed for the pattern and type of reactions, body systems involved, causative drugs, and severity of reaction, their outcome, management and causality assessment.Results: Patients in the age groups of 41-50 years were most commonly involved with slight male preponderance. Skin reactions like rashes and itching were the most commonly observed ADR. The most common causative drugs for ADR were antimicrobial agents; IV route was the most common route responsible. Majority of ADRs belonged to type B, were non serious and moderate in severity. Most of the patients recovered. On causality assessment scale, most of the ADRs were found to be probable with the causative drugs.Conclusions: Most of the ADRs were treatable by early and appropriate management. The major limitation was under-reporting of ADRs which can be overcome by creating awareness and enhancing the culture of ADR monitoring and reporting among health care professionals for safe use of drugs.


Author(s):  
S. G. S. Rajeshreddy V. ◽  
Lokesh V. Patil

Background: Adverse drug reactions (ADRs) constitute a major clinical problem in terms of human suffering and increased health care costs. To study the adverse drug reactions reported in a tertiary care hospital and study of causality assessment and severity of adverse drug reaction (ADR) cases reported.Methods: A prospective observational study was conducted as part of pharmacovigilance program over 12months between September 2015 and August 2016. Adverse drug reactions reported from hospital were filled into Suspected ADR - CDSCO forms and submitted to pharmacovigilance unit. Causal relationship was assessed and categorized by Naranjo’s algorithm and WHO - UMC causality scale. The severity of each ADR was assessed using Modified Hartwig and Siegel scale.Results: Total 120 cases were reported over 12 months. Among them, 66% were in males and 55% were in females. The majority of ADRs were due to antimicrobial agents (40.78%) followed by haematinics (12%) and anti-epileptics (10%). Maximum number of patients (30.25%) reported with dermatological manifestations. Highest number of ADRs was reported from the department of medicine (45%). As per Naranjo’s scale, 54% reports were assessed as probable and 46% classified as possible. Majority of cases were mild to moderate in severity.Conclusions: The pattern of ADRs reported in our hospital is similar with the pattern of studies conducted in other hospitals elsewhere. This study provides a database of ADRs due to commonly used drugs in our hospital, which will help clinicians for their optimum and safe use. Hence effective pharmacovigilance is required for the use of these drugs and their safety assessment.


Author(s):  
Payal P. Naik ◽  
Arvind S. Pandey ◽  
Swati S. Patel

Background: Drug resistant tuberculosis is an important public health issue in India. The treatment regimen followed is Programmatic Management of Drug resistant Tuberculosis (PMDT) approach. Adverse drug reactions (ADRs) are a serious issue which increases the risk of defaulter rate if poorly managed. Thus study was undertaken to assess the ADRs caused by PMDT therapy in indoor patients of Department of Respiratory Medicine in a tertiary care hospital at Surat.Methods: The prospective and observational study was carried out for one year period. The causality was determined by World Health Organization (WHO) Uppasala Monitoring Centre (UMC) scale and severity was determined by Modified Hartwig and Siegel scale. Fisher exact test was applied for statistical analysis.Results: Among 24 drug resistant tuberculosis patients, 12 (50%) patients developed ADRs due to second line antitubercular drugs. Occurrence of ADRs was more among Category V (100%) as compared to Category IV (36.8%). Occurrence of ADRs was more among females (60%). The commonly involved systems are auditory system (33.3%). Majority of ADRs developed within 61-90 days (66.7%) of initiation of drug therapy. Highest percentage of ADRs causing drugs was pyrazinamide (27.8%). On evaluation of the causality of ADRs, majority were found to be possible (53.3%). The severity assessment showed that most of the patients ADRs were of moderate level (73.3%).Conclusions: PMDT therapy is complicated but early management and reporting of ADRs decreases default rate.


2013 ◽  
Vol 7 (5) ◽  
pp. 384-388
Author(s):  
Harmeet S. Rehan ◽  
Deepti Chopra ◽  
Ravinder K. Sah ◽  
Ritu Mishra

Author(s):  
Gajanan P. Kulkarni ◽  
Lokesh V. Patil

Objective: To assess ADRs with reference to causative drugs, organ systems involved and seriousness of reactions.Methods: A prospective study conducted over a period of 1 y. The spontaneous adverse drug reactions reported between July 2016 and July 2017 at AMC centre BRIMS, Bidar were analyzed using Naranjo’s scale. Causality assessment of suspected drugs involved, system affected, and seriousness of reactions was assessed.Results: GIT system was most commonly involved, followed by generalized features, skin and appendages, CNS i. e, extrapyramidal system and dizziness, hearing and vestibular systems.Conclusion: Majority of the ADRs reported were mild to moderate severity and 20% can be categorized as severe reactions, which needed to treat under hospitalization


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