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.

Clinical pattern and causative agents of adverse cutaneous drug reactions in a tertiary care hospital SKIMS Soura Srinagar.

JMS SKIMS ◽  
2017 ◽  
Vol 20 (2) ◽  
pp. 73-76 ◽  
Author(s):  
Surjeet Singh ◽  
Zahoor A Wafai ◽  
Ajaz Koul
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
Pharmacovigilance Center ◽  
Causative Agents ◽  
Cutaneous Drug Reactions

Background: Adverse drug reactions are the most frequent side effects of drugs. Most of them being benign but can prove fatal sometimes. Aim: To study the different clinical spectrum of cutaneous adverse drug reactions and to determine causative drugs. Methods: It was a prospective hospital based study carried out for a period of 3 years. It was part of continuous adverse drug reaction monitoring carried out by our pharmacovigilance center at SKIMS. Results: Out of 1225 total adverse drug reactions 685 were enrolled as cutaneous ADR’s. Most common types observed were maculopapular rash (43.9%), fixed drug eruptions (36.2%) and urticaria (15.1%). The drugs most incriminated for various cutaneous ADR’s were antimicrobials (48.7%), anticonvulsants (22%), and NSAIDS (17.9%). Antimicrobials were also responsible for maximum of (58.3%) of severe cutaneous ADR’s like TEN and SJS. Conclusion: Pattern of cutaneous ADR’s and their causative drugs are similar to those observed in other regions with small variations, as reported by similar studies. However, due to emergence of newer drugs and differing trends in use of drugs, both pattern of cutaneous ADR’s as well as drugs causing them are changing every year. Further studies of similar nature with more expertise are required for safe use of drugs in future. JMS 2017;20(2):73-76  

scholarly journals Cutaneous adverse drug reactions in a tertiary care hospital: An observational study

2020 ◽  
Vol 1 (1) ◽  
pp. 6-9 ◽  
Author(s):  
Baijayanti Rath ◽  
Manas Ranjan Naik ◽  
Bhabagrahi Rath ◽  
Renuka Bhoi ◽  
Jai Prakash
Keyword(s):  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Developed Countries ◽  
Care Hospital ◽  
Severity Assessment ◽  
Drug Reactions ◽  
Fixed Drug Eruption ◽  
Antitubercular Drugs ◽  
Drug Eruptions ◽  
Fixed Drug

Introduction: Cutaneous adverse drug reactions (CADRs) are one of the most common ADRs caused by drugs causing a lot of morbidity and mortality. The overall incidence of CADRs in developed countries is 1-3 %, while that in the developing countries is reported to be higher between 2 % and 5 %. Changes in drug metabolism drug interactions, oxidative stress, and various cytokines are the various factors that cause cutaneous adverse drug reactions. Aim and objective: This study aims to evaluate the patterns of CADRs, the causative drugs along with causality and severity assessment. Methods: A total of 50 Patients with cutaneous adverse drug reactions who were included in our last study attended skin OPD, VIMSAR Burla, from June 2018 to September 2018 and were analyzed for causality assessment using the WHO-UMC scale and severity assessment using  Hartwig and Siegel's scale. Results: Out of 50 patients, 48 % belong to the age group 21-40 years. Around 44 % of CADRs were fixed drug eruptions. NSAID was found to be the most offending drug and it contributed to a maximum of 32 % of ADRs. 16 % of ADRs were found to be caused by antitubercular drugs. Paracetamol was the key NSAID, contributing 87.5 % of ADRs. Causality was certain, probable, and possible for 8 %, 24 %, and 60 % of ADRs respectively. Severity was mild for 64 % and moderate for 34 % of ADRs. Conclusions: NSAID and antitubercular drugs are the commonest drugs causing CADRs. Fixed drug eruption is the most common CADRs and the commonest drug was paracetamol. Causality grade was possible and the severity grade was mild.

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 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 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 PATTERN OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: A CROSS-SECTIONAL STUDY

2017 ◽  
Vol 10 (3) ◽  
pp. 170 ◽  
Author(s):  
Sangeetha Raja ◽  
Jamuna Rani R ◽  
Kala P
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching

ABSTRACTObjective: The aim of this study was to carry out adverse drug reactions (ADRs) monitoring in various departments of a tertiary care teaching hospital.Methods: A cross-sectional study was conducted on ADRs reported in the hospital from December 2012 to May 2013 after obtaining InstitutionalEthics Committee approval.Results: A total of 40 ADRs were reported, 47.50% were males and 52.50% were females. The female adult population was 45%. The majority of ADRswere due to antimicrobial agents especially beta-lactam antibiotics (42.5%) followed by NSAIDs (7.50%). A maximum number of patients (75%)were reported with dermatological manifestations. The department of medicine reported the highest number of ADRs (37.5%). As per Naranjo’sprobability scale, 62.5% reports were assessed as probable. 62.5% reports were documented as mild according to Modified Hartwig’s criteria forseverity assessment.Conclusion: This study was done to sensitize the practicing physicians on the importance of adverse drug monitoring and reporting.Keywords: Pharmacovigilance, Adverse drug reactions, Tertiary care teaching hospital, Antimicrobial agents.

scholarly journals STUDY TO EVALUATE USE OF IRRATIONAL FIXED DRUG COMBINATIONS

2017 ◽  
pp. 64-66
Author(s):  
Sudhakar K. ◽  
C. Deepa Latha ◽  
Deepika Baloju ◽  
A. R. Malahat ◽  
G. Vijayalakshmi
Keyword(s):  
Adverse Drug Reactions ◽  
Health Care Workers ◽  
Prospective Observational Study ◽  
Adverse Drug Reaction Reporting ◽  
Tertiary Care ◽  
Drug Combinations ◽  
Drug Reactions ◽  
Care Workers ◽  
Fixed Drug ◽  
Awareness Programs

Objective: To identify fixed drug combinations causing the adverse drug reactions both rational and irrational.Methods: A prospective observational study was carried out over a period of 6 mo (between June 2016 to December 2016) to evaluate adverse drug reactions related to fixed drug combinations in a tertiary care teaching hospital using suspected adverse drug reaction reporting form.Results: A total number of 64 adverse drug reactions were reported during this period. Of the total adverse drug reactions reported, 27 (42%) were due to fixed drug combinations. 6 (28.5%) were serious and 21(71.5%) were non-serious. Causality was certain in 4 (14.8%) cases and probably in remaining 23 (85.2%) cases. 19(70%) irrational fixed drug combinations were reported.Conclusion: The above results show that irrational fixed drug combinations contribute major extent to adverse drug reactions. Hence, awareness programs should be conducted for all the health care workers to improve the rationality of prescription and to decrease adverse drug reactions.

Cutaneous reactions to drugs

2020 ◽  
pp. 5752-5760
Author(s):  
Sarah Walsh ◽  
Daniel Creamer ◽  
Haur Yueh Lee
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Normal Function ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Drug Induced ◽  
Drug Eruptions ◽  
Fixed Drug ◽  
Iatrogenic Illness ◽  
Systemic Symptoms

Adverse reactions to medications are common and important cause of iatrogenic illness. Severe cutaneous adverse drug reactions include toxic epidermal necrolysis, Stevens–Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis, which together constitute 2% of all adverse drug reactions and may be life-threatening. Less severe drug-induced skin reactions such as exanthems, urticaria, lichenoid drug rashes, and fixed drug eruptions are more common, sometimes termed benign cutaneous adverse reactions, and generally resolve without sequelae. Drugs may also cause adverse events due to alteration of the normal function of the skin or its appendages. This may take the form of photosensitivity, abnormal pigmentation, or disrupted growth of hair or nails.

scholarly journals An observational study of adverse drug reactions reported in a rural tertiary care hospital

2019 ◽  
Vol 8 (11) ◽  
pp. 2367
Author(s):  
Ravi D. Mala ◽  
D. M. Ravichand ◽  
B. V. Patil ◽  
B. S. Payghan ◽  
Anurag Yadav
Keyword(s):  
Adverse Drug Reactions ◽  
Antimicrobial Agents ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Unintended Effects ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Physician Visits ◽  
Medical College

Background: Adverse drug reactions (ADRs) are noxious and unintended effects of a drug that occurs at doses normally used in humans. ADRs may also result in diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of this study are to analyze and assess the causality and severity of reported ADRs.Methods: A cross sectional study of ADRs reported to Pharmacovigilance cell of MNR Medical College and Hospital Sangareddy in a year. The details of the various ADRs were statistically analyzed to find out pattern of ADRs. The WHO-UMC causality category and Hartwig-Seigel Scale were used to assess causality and severity of ADRs respectively.Results: The study shows, out of 60 suspected ADRs, the majority of ADRs were adults (68.3%) and out of whom 56% were females. According to the WHO-UMC Causality categories, 43.3% of the ADRs were categorized under Probable/likely, followed by possible (35%). The Hartwig-Siegel severity assessment scale shows that the majority (90%) of suspected ADRs were of mild category.Conclusions: The pattern of ADRs reported in our study is comparable to other studies. The commonest organ system affected was gastrointestinal tract, nervous and cutaneous system. Antimicrobial agents were causing maximum ADRs and medicine and allied departments have more number of ADRs. This study provides a valuable database for ADRs due to all commonly used drugs at hospitals and also helps in creating awareness regarding safe & judicious use of drugs to prevent ADRs.

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.

Sign in / Sign up

Export Citation Format

Share Document