scholarly journals Clinical Profile of Cutaneous Adverse Drug Reactions in a Tertiary Care Centre

2016 ◽  
Vol 3 (3) ◽  
Author(s):  
Priya Prathap ◽  
Elsy M.I ◽  
Ajitha K. N ◽  
Ajith Kumar ◽  
Sandhya George
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Clinical Profile ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Tertiary Care Centre ◽  
Dermatology Department ◽  
Female Ratio ◽  
The Common

<div><p><strong><em>Context</em></strong><em>: C</em><em>utaneous adverse drug reactions  (cADR) constitute 2-3% of all hospitalized patients. However there is paucity of data regarding occurrence of cADR among out patients. Hence we decided to do a study on clinical profile of cADR and to find out the common drugs resulting in cADR  . </em></p><p><strong><em>Objective: </em></strong><em>To observe the clinical spectrum and the causative drugs of cADR  among patients attending  Dermatology Department in our hospital. </em></p><p><strong><em>Methods: </em></strong><em>Patients with cADR who attended Dermatology Out Patient Department (OPD) in our institution  were studied for a period of one year.</em></p><p><strong><em>Results:</em></strong><em>71 patients were diagnosed to have cADR. Male to female ratio was 1.15 :1. Maculopapular rash (22/71 ; 31%) was the commonest presentation followed by generalised pruritus (16/71; 22.5%) , fixed drug eruption( FDE) ( 8/71 ;11.3%) and urticaria (5/71 ;7%). Antimicrobials (40.8%), NSAIDS (22.5%) and  Antiepileptics (22.5 %) were the common drugs responsible for these eruptions.</em>  </p></div>

scholarly journals Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

2018 ◽  
Vol 8 (1) ◽  
pp. 27
Author(s):  
Vijaya Chandra Reddy Konda ◽  
Sree Surya Durga Devi Pilla ◽  
A. Surekha ◽  
K. R. Subash ◽  
K. Umamaheswara Rao
Keyword(s):  
Adverse Drug Reactions ◽  
Continuous Monitoring ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Drug Reactions ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
The Common ◽  
Clinical Patterns

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

scholarly journals An observational study to monitor cutaneous adverse drug reaction profile in Dermatology Department of tertiary care teaching hospital

2019 ◽  
Vol 8 (3) ◽  
pp. 442
Author(s):  
Janaki R. Torvi ◽  
S. G. S. Rajesh Reddy V.
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Drug Reactions ◽  
Dermatology Department ◽  
Care Teaching ◽  
Cutaneous Adverse Drug Reaction ◽  
Reaction Profile

Background: Incidence of cutaneous adverse drug reactions (CADRs) in developed countries is 1 to 3% and in developing countries, it is much higher i.e. 2 to 6%. 1 in 1000 hospitalized patients will develop severe cutaneous adverse reaction. Maculopapular rash represents majority of cutaneous drug reaction followed by urticaria. Most frequently elicited CADRs are associated with antimicrobials and NSAIDs. This study was designed to monitor Cutaneous adverse drug reaction profile of tertiary care teaching hospital.Methods: This is a prospective observational study of 6 months’ duration to monitor cutaneous adverse drug reactions in dermatology department of tertiary care teaching hospital. CADRs were analysed with respect to demographic details, suspected drugs and type of reaction. Causality assessment is by Naranjo algorithm. Data is represented in tables and graphs. Data is analyzed in Microsoft excel 2007.Results: Total 57 cases of cutaneous adverse drug reactions were reported. Among them, 57.9% were in males and 42.1% were in females. Majority of CADRs were due to antiretroviral drugs (38.5%) followed by antibacterial (28%) and antiepileptics (14%). Maculopapular rash is most common CADR (35%). Causality of 74% CADRs were probable according to Naranjo algorithm.Conclusions: CADRs are more commonly associated with antiretroviral therapy (ART), antibacterial drugs and antiepileptic drugs. In case of ART, antiepileptic drug and drugs used in chronic illness compliance plays a major role in the success of therapy. Adverse drug reactions lead to problem of non compliance and failure of therapy. Cutaneous adverse reactions like FDE heal with hyper pigmentation leads to cosmetic problem. Stevens Johnson syndrome (SJS) is life threatening that requires prompt withdrawal of drug and intensive medical management. Many drugs are available without prescription in India leading to problem of misdiagnosis of CADRs. So, data obtained from this study helps in proper diagnosis and treatment of CADRs.

scholarly journals CUTANEOUS ADVERSE DRUG REACTIONS IN GENERAL PRACTICE - AN ANALYSIS

2016 ◽  
Author(s):  
*G. Rajaram ◽  
P. Sugirda ◽  
R. Lenin
Keyword(s):  
Urban Area ◽  
General Practitioners ◽  
Adverse Drug Reactions ◽  
Maculopapular Rash ◽  
New Drugs ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Fixed Drug ◽  
The Common ◽  
Reported Data

Aim: To study the pattern of cutaneous adverse drug reactions presenting to general practitioners in a semi urban area.  Methodology and Results: This study was conducted among general practitioners of Villupuram, a semi urban area in Tamilnadu State. During the study, a total of 60 CADRs were reported. Data were collected using standard CDSCO ADR form. The majority of CADRs were observed in the age group of 20-40 years. According to WHO causality assessment, 48 were probable and 12 were possible. The severity assessment using modified hartwig and seigel revealed 18 mild, 41 moderate and one severe CADRs. The common drug groups implicated are antibiotics followed by NSAIDS and anticonvulsants. Maculopapular rash was the most common presentation of CADRs.Conclusion: Among the various types of CADRs seen in this study, Maculopapular rash was the most common followed by fixed drug eruption. studies antimicrobials were the most common causative agent followed by NSAIDs and anti- convulsants. This study on CADRs gains importance as the pattern of drug use is changing periodically and everyday many new drugs enter the market.

scholarly journals Analysis of cutaneous adverse drug reactions in a tertiary care teaching hospital

2019 ◽  
Vol 8 (5) ◽  
pp. 843
Author(s):  
Anusha S. ◽  
Nandhini Priya M. ◽  
Shanthi N.
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tamil Nadu ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Drug Reactions ◽  
Female Ratio ◽  
Adr Reporting ◽  
The Common

Background: Cutaneous Adverse Drug Reaction (CADR) is considered as one of the reasons for discontinuation of drug as well as medication non-adherence. This study analyses the common drugs causing CADR, clinical spectrum of different types of CADR, causality and drugs causing severe CADR.Methods: This was a retrospective cross-sectional observational study conducted by the Department of Pharmacology, Coimbatore Medical College, Coimbatore, Tamil Nadu, India. The study was conducted using data collected in CDSCO’s ADR reporting forms with CADR from June 2015 to July 2017. Patient’s information, details related to adverse drug reaction, suspected medication details, concomitant medication history, causality and seriousness were recorded.Results: A total of 102 CADR were evaluated in this study. The mean age of sample was 37.21±20.33 years. Maximum number of cases was in the age group of 40-49 years. Male to female ratio was 0.96:1. The commonly incriminated drugs causing CADR were antimicrobial agents. Ciprofloxacin (21.57%), phenytoin (9.8%), diclofenac sodium (6.86%), anti-snake venom (6.86%) and vancomycin (3.92%) were the common drugs implicated in CADR. Maculopapular rash and itching were the most common CADR. Anticonvulsants especially phenytoin was commonly associated with severe CADR.Conclusions: The present study has made an impact on all departments of this institution and awareness has been created about spontaneous reporting of all adverse drug reactions in CDSCO ADR reporting forms to the pharmacovigilance centres. Thus, sound knowledge about the adverse drug reactions may decrease the occurrence of drug induced morbidity and mortality. 

scholarly journals Descriptive study of clinical profile and outcome in patients of acute on chronic liver failure, at a tertiary care center in Northern India

2020 ◽  
Vol 7 (11) ◽  
pp. 1687
Author(s):  
Rakesh Kumar ◽  
Vandana Rana ◽  
Varghese Koshy ◽  
Vandana Gangadharan ◽  
George Koshy
Keyword(s):  
Liver Failure ◽  
Care Center ◽  
Tertiary Care ◽  
Descriptive Study ◽  
Chronic Liver ◽  
Clinical Profile ◽  
Chronic Liver Failure ◽  
Tertiary Care Centre ◽  
Female Ratio ◽  
Common Cause

Background: Acute-on-chronic liver failure (ACLF) is a recently described syndrome that is characterized by abrupt deterioration in patients with chronic liver disease (CLD) and has high short-term mortality. The aim of this study was to describe the clinical profile, causes and outcomes of ACLF at a tertiary care centre in Northern India.Methods: In this descriptive study of 50 consecutive patients, were included, between August 2015 to January 2018, who were admitted and diagnosed as ACLF as defined by APASL. Causes of acute precipitating event and CLD and outcomes were assessed.Occurrence and severity of organ failure was also assessed.Results: 48 (96 %) were males and 2 (4%) were females with male to female ratio was 24:1. The mean age of male and female subjects was similar, 40.7±9.9 years and 39.2±9.4 years respectively. The most common cause of CLD was alcohol in 50% cases and next most common cause was hepato-tropic viruses HBV infection in 20%, HCV in 6% cases and there was unknown cause in 12 % cases. The most common precipitating factor of acute decompensation was alcohol in 50% cases, hepatotropic viruses in 30% cases. Excluded sepsis and GI bleed as precipitating events. The combined mortality at the end of 1-month and 3-months, in our study was 60%. CLIF-SOFA score was found to be the most reliable scoring system to discriminate between survivors and non survivors. Conclusions: Alcohol was the commonest precipitating cause of ACLF. Organ failures (OFs) are independently predictive of mortality.

scholarly journals Collection and analysis of adverse drug reactions of antiretroviral therapy in a tertiary care hospital in central India

2018 ◽  
Vol 7 (7) ◽  
pp. 1326
Author(s):  
Sandeep Kumar Adwal ◽  
B. L. Bamboria ◽  
Ashutosh Chourishi ◽  
Aditya Bamboria
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Professionals ◽  
Prospective Observational Study ◽  
Causality Assessment ◽  
Tertiary Care ◽  
Central India ◽  
Treatment Interruption ◽  
Care Hospital ◽  
Drug Reactions ◽  
The Common

Background: The main objective of study is to monitor and analyze the adverse drug reactions (ADRs) of ART and to assess causality and severity of the ADRs detected.Methods: It is a prospective observational study conducted in the ART centre of a tertiary care teaching hospital in central India. The data collected were recorded on standard ADR reporting forms. Causality was assessed by Naranjo’s algorithm. Severity of ADR’s was assessed by modified Hartwig and Seigel scale. Modified Shumock and Thorton criteria used for preventability assessment.Results: In twelve months duration 351 patients on ART were observed for ADRs. Total 166 ADRs detected in 96 patients. Incidence of ADRs was slightly more in female. The common systems involved were gastrointestinal 42.77% followed by nervous system 18.07%, musculoskeletal 15.06% skin/mucous membrane 07.83%, metabolic and nutritional 04.82%, red blood cell disorders 01.20 %, endocrinal 00.60 % and others 09.64%. The causality assessment as per Naranjo’s scale showed that out of 166 ADRs, 28.92% were probable and 71.08% were possible. Severity assessment by modified Hartwig and Siegel scale showed that 83.34% ADRs were mild and 15.66% were moderate. 46.39 % ADRs were probably preventable.Conclusions: Considering the magnitude of ADR related problems, there is a need for greater awareness among health care professionals, to detect and report them. These ADRs if recognized in time and managed properly can prevent treatment interruption.

scholarly journals Adverse drug reactions or events in children with assessment of causality and severity: a retrospective analysis from Bhavnagar

2020 ◽  
Vol 9 (12) ◽  
pp. 1883
Author(s):  
Jayendra R. Gohil ◽  
Aniket B. Sarwade ◽  
Hardik R. Chauhan ◽  
Jay R. Jasani ◽  
Hinal R. Gujrati
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Drug Events ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Pediatric Age Group ◽  
Skin Redness ◽  
The Common ◽  
Probable Category

Background: Objective was to study the occurrence of adverse drug reactions in pediatric age group in a tertiary care hospital setting.Methods: A retrospective study was undertaken to analyze adverse drug events in pediatrics wards of a tertiary care hospital. Any event marked as ‘suspected adverse drug reaction’ was included in the study and ADR forms were analyzed for causality and severity. Other parameters like age and sex, class of drug, types of ADR, commonly involved systems and polypharmacy were studied.Results: Total 74 cases of admitted patients (13 deaths: 11 infants, 6 neonates) with severe ADR were studied of whom 39% were females. Antimicrobials were the commonest drug class (54%) with Skin most commonly involved. 77% cases were of probable category according to Naranjo’s scale of causality assessment. 11% cases were prescribed polypharmacy.Conclusions: Antibiotics were the class of drug causing maximum ADRs. The commonest system involved was skin. Redness, itching & rashes were the common symptoms. Antimicrobials should be used judiciously. Polypharmacy should be avoided. ADR reporting should be strengthened. Extra vigilance is required for infants and neonate’s prescriptions.

scholarly journals STUDY TO EVALUATE SEVERE ADRS IN A TERTIARY CARE TEACHING HOSPITAL

2017 ◽  
pp. 55-58
Author(s):  
A. R. Malahat ◽  
C. Deepa Latha ◽  
Sudhakar K. ◽  
Deepika Baloju ◽  
G. Vijayalakshmi
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Prospective Observational Study ◽  
Healthcare Professionals ◽  
Tertiary Care ◽  
Care Centre ◽  
Drug Reactions ◽  
Tertiary Care Centre ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching

Objective: This study attempts to analyze the severe ADRs in a tertiary care centre and assess their seriousness, outcome, causality and severity. We emphasize on the need for reporting of ADRs by all healthcare professionals as it will reduce the burden of morbidity due to drugs and ensure better and more efficient healthcare. To analyse and evaluate the severe ADVERSE DRUG REACTIONs reported from various departments in a Tertiary care Teaching hospital.Methods: It is a prospective observational study that was carried out over a period of 6 mo (from July 2016 to December 2016) to assess the percentage of severe adverse drug reactions reported to the Pharmacovigilance cell of a tertiary care teaching hospital. The data collected included patient’s demographic details, presenting complaints, clinical diagnosis and details of the drug(s) prescribed. The data was analysed for causality (as per the WHO-UMC scale) and severity (as per Hartwig and Siegel scale).Results: Out of 64 ADRs reported, 17 were serious. The majority of serious ADRs were categorized as probable (82.35%), whilst 1(5.8%) was categorized as possible and 2(11.76%) as certain in nature. The criteria for the majority of serious ADRs were hospitalization (%) followed by intervention to prevent permanent impairment or damage (%).Conclusion: The highest percentage of severe cases was reported with Antitubercular therapy (23.5%) followed by analgesics (23%) and anti epileptic agents (17.6%).

A CLINICAL STUDY OF CUTANEOUS ADVERSE DRUG REACTIONS IN TERTIARY CARE HOSPITAL

2021 ◽  
pp. 24-26
Author(s):  
Jaydip Tank ◽  
Radha Dhudshia ◽  
Mitesh Thakkar ◽  
Bela Shah
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Care Hospital ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Cutaneous Eruption ◽  
Johnson Syndrome ◽  
Culprit Drug ◽  
Fixed Drug ◽  
Steven Johnson Syndrome

The patterns of cutaneous eruption and the offending agent vary amongst the different population previously studied. This study aims to determine the different clinical patterns of cutaneous adverse drug reactions (CADRs) in our population and recognize the common drug implicated. A prospective observational study was conducted over a period of two years recording various CADRs. Out of the 630 patients, common reactions observed were Fixed drug eruption (25.71%), Urticaria / Angioedema (21.27%), Exanthematous rash(15.87%), Erythema multiforme(3.81%), Steven-Johnson Syndrome (4.13%) and Toxic epidermal necrolysis (2.07 %). The most common pharmacological group was Antimicrobials (37.01%), NSAIDS (16.64%), Anticonvulsants (7.61%) and Antiretroviral therapy (12.52%). Cotrimoxazole was the culprit in 11.11%, Nevirapine in 9.36%, Amoxycillin in 7.61% and Phenytoin in 5.23% of patients. 10 patients of TEN proved to be fatal. Among 15.56% HIV reactive patients, the most common pattern was exanthematous rash (45.91%) with Nevirapine(59.20%) as the most common culprit drug.

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