scholarly journals A study of adverse cutaneous drug reactions in the department of dermatology of a teaching hospital in Jamnagar, India

2017 ◽  
Vol 6 (9) ◽  
pp. 2259
Author(s):  
Jagruti G. Dhanani ◽  
Anupama Sukhlecha
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Hospital Admissions ◽  
Causality Assessment ◽  
Adverse Drug Reaction Reporting ◽  
Drug Reactions ◽  
Dermatology Department ◽  
Female Ratio ◽  
Drug Eruptions ◽  
Cutaneous Drug Reactions

Background: Adverse drug reactions cause significant morbidity and mortality in health care set up. They are responsible for a significant number of hospital admissions. The data for adverse cutaneous drug reactions (ACDRs) is limited our country. Thus, the present study emphasises on the need of an effective adverse drug reaction reporting programme.Methods: A prospective study to assess the ACDRs in Dermatology department was conducted in a teaching hospital of India. Male to female ratio, most common class of drug, individual drugs causing ACDRs, common types of ACDRs were studied. Other parameters like causality assessment, preventability and seriousness of ACDRs were also studied.Results: A majority of the patients (38%) with ACDR were in the age group of 25-44 years followed by 45-64 years (31%). The rate of ACDRs was more in males (54%). The most frequent ACDR reported was maculopapular rash (38%), followed by urticaria (19%) and fixed drug eruptions (12%). Most of the reactions (93%) were bizarre/ unpredictable in nature. Amongst drug groups, antimicrobials (48%) were most frequently associated with ACDRs followed by NSAIDs (30%) and antiepileptics (12%).  Most of the reactions (94%) were mild-moderate in nature. Only 9% of ACDRs reported in this study were preventable. Paracetamol was the most common offending drug followed by cotrimoxazole, ibuprofen, amoxicillin, phenytoin in decreasing order. Causality assessment found ACDRs in probable category (68%) using WHO-UMC criteria.Conclusions: It is important to monitor and report adverse drug reactions in order to promote safe and rational use of medicines.

scholarly journals A study of cutaneous adverse drug reactions in the outpatient department of Dermatology at a tertiary care center in Gujarat, India

2017 ◽  
Vol 6 (5) ◽  
pp. 1115
Author(s):  
Dinesh A. Chavda ◽  
Satish D. Suthar ◽  
Shradhanand Singh ◽  
Jayesh D. Balat ◽  
Sailesh P. Parmar ◽  
...  
Keyword(s):  
Hospital Admissions ◽  
Care Center ◽  
Tertiary Care ◽  
Maculopapular Rash ◽  
Drug Reactions ◽  
Female Ratio ◽  
Drug Eruptions ◽  
Male Preponderance ◽  
Cutaneous Drug Reactions ◽  
A Prospective Study

Background: The data for adverse cutaneous drug reactions (ACDRs) is limited in Gujarat. The ACDRs are one of the frequent ADRs and cause of significant morbidity and mortality in patients of all areas of healthcare today. They are responsible for significant number of hospital admissions. Thus, the present study emphasises on the need and importance of an effective pharmacovigilance programme.Methods: A prospective study was undertaken in a 183 cases tertiary care teaching hospital of India. Male to female ratio, most common class of drug, individual drug causing ACDR, common types of ACDRs Parameters were studied. Other Parameters like Causality, preventability and severe or non-severe reactions were analyzed.Results: Majority of the patients (48%) with CADR belonged to the age group 25-44 followed by 45-64 (28%). Most frequent adverse cutaneous drug reactions reported were Urticaria (40%), Maculopapular rash (25%) & Fixed drug eruptions (21%) in decreasing order of frequency. Majority of reactions (96%) were Bizarre/Unpredictable in nature. As a group, antimicrobials (46%) were most frequently associated with CADR followed by NSAIDs (31%) and antiepileptics (11%).  Most of the reactions (93%) were mild-moderate and probable (77%) in nature. Approximately 60% of ACDRs reported in this study were preventable.Conclusions: There was slight male preponderance except acneiform eruptions. Cotrimoxazole being the most common offending drug then after Ibuprofen, Phenytoin among the anti-inflammatory, analgesics, antiepileptics class. Causality assessment resulted in high score 77% of probable category.

scholarly journals Pattern of adverse drug reactions reported to the regional Pharmacovigilance center at Nepal Medical College and Teaching Hospital, Kathmandu

2012 ◽  
Vol 26 (1) ◽  
pp. 54-61 ◽  
Author(s):  
Durga Bista ◽  
Bal Ram Shrestha ◽  
Prakash Rai ◽  
Akhilesh Chandra Jauhari ◽  
Vishnu Kant Kulshrestha
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Causality Assessment ◽  
Age Group ◽  
Drug Reactions ◽  
Preliminary Stage ◽  
Medical College ◽  
Probable Relationship ◽  
Pharmacovigilance Center ◽  
Inflammatory Drugs

The Pharmacovigilance program in Nepal is at very preliminary stage. Present study analyzed the pattern, causality, severity and preventability of the reported adverse drug reactions (ADRs) to the Pharmacovigilance center at Nepal Medical College and Teaching Hospital (NMCTH), from June 2007 to July 2011. A total of 40 ADR cases were reported, among which 23 (57.5%) were in males and 17 (42.5%) in females. Nineteen (47.5%) ADRs were reported in the age group between 21-40 years. Department of Medicine reported 12(30%) ADRs. Among the total ADRs, antibiotics [n=17, (42.5%)] were responsible for most of the reactions followed by non steroidal anti-inflammatory drugs [n=5, (12.5%)]. Most of the drugs were found to affect dermatological system [n=14, (35%)]. Carbamazepine accounted for 5 (12.5%) ADRs. The causality assessment showed 34 (85%) of the ADRs to have a ‘probable’ relationship with the suspected reaction.DOI: http://dx.doi.org/10.3126/jnpa.v26i1.6633JNPA. XXVI(1) 2012 54-61

NEONATAL ADVERSE DRUG REACTIONS: ANALYSIS OF PHARMACOVIGILANCE REPORTS AFTER DIRECT DRUG EXPOSURE IN FRANCE

2015 ◽  
Vol 101 (1) ◽  
pp. e1.22-e1
Author(s):  
Florentia Kaguelidou ◽  
Frédérique Beau-Salinas ◽  
Pascal Auriche ◽  
Evelyne Jacqz-Aigrain
Keyword(s):  
Nervous System ◽  
Adverse Drug Reactions ◽  
Drug Exposure ◽  
Causality Assessment ◽  
Preterm Neonates ◽  
Drug Reactions ◽  
Female Ratio ◽  
Spontaneous Reports ◽  
Causality Score ◽  
Active Substances

BackgroundTerm and preterm neonates are at higher risk for serious adverse drug reactions than older children and adults. To date, no study has investigated spontaneous reports of adverse drug reactions (ADRs) following direct drug exposure of neonates.MethodsThis is a retrospective study of all spontaneous reports of ADRs registered in the French Pharmacovigilance Database from 1986 to 2012. All reports concerning individuals from birth to ≤30 days, 1 month or 4 weeks were retrieved. ADRs classified as related to ‘pregnancy’ or ‘breastfeeding’ were discarded. Reports were described with regards to characteristics of the infant, the reported ADR(s) (registered according to the Medical Dictionary for Regulatory Activities [MedDRA]) and the reported suspected medicine(s) (registered according to the Anatomical Therapeutic Chemical [ATC] Classification) Causality assessment was performed using the French Causality assessment method.ResultsA total of 1688 unique reports were analysed. More than half of these reports included at least on serious ADR (n=995; 59%). Median age at ADR occurrence was 9 days and a slight predominance of male neonates was observed (male/female ratio of 1.3). Fourteen percent of neonates presented a medical history of preterm birth, infection or genetic and/or congenital abnormality. Overall, 3127 ADRs were described in these reports. The most commonly reported system organ classes (SOCs) were injury, poisoning and procedural complications (16%), general disorders and administration site conditions (12.5%), blood and lymphatic system disorders (12%), gastrointestinal disorders (8%), investigations (8%) and nervous system disorders (8%). In the majority of ADRs reported (n=2279, 73%), infants fully recovered without sequelae but 4% of neonates deceased as a consequence of the reported ADR. Approximately 1/3 of the reported ADRs fell under 10 categories of ADRs the MedDRA classification and 1 out of 5 ADRs was coded as drug maladministration, medication error, overdose or drug maladministration without clinical consequences. A total of 2238 medicinal products out of the 2797 reported were described as suspect or interacting. Therapeutics classes must commonly incriminated were antiinfectives for systemic use and nervous system drugs. Active substances most frequently related to serious adverse reactions were zidovudine, ibuprofen and nevirapine. A total of 4103 drug-ADR pairs were described in the database; the global intrinsic causality score was ‘doubtful/unlikely’ for 35% of them and the extrinsic causality score was ‘never described before’ for only 6% of these pairs. Among the 10 most frequently encountered drug-ADR pairs, 2 active substances were mainly implicated: zidovudine and phytomedione (Vitamin K).ConclusionsWe have provided a unique overview of ADR notifications after direct drug exposure in the neonates. Reporting of ADRs in neonates is scarce. The majority of ADRs are classified as serious and a subsequent proportion is associated to drug administration errors. The number of commonly incriminated drugs is limited and causality assessment is particularly challenging. There is still a need to increase awareness and education of health professionals on neonatal drug safety and to promote detailed ADR reporting in this paediatric population.

scholarly journals A clinical study of cutaneous adverse drug reactions

2017 ◽  
Vol 6 (4) ◽  
pp. 919
Author(s):  
Riddhi Shah ◽  
Sakshi Agrawal ◽  
Neela Bhuptani
Keyword(s):  
Adverse Drug Reactions ◽  
Clinical Manifestations ◽  
Specific Treatment ◽  
Drug Reactions ◽  
Diagnostic Challenge ◽  
Female Ratio ◽  
Medical College ◽  
Causative Agents ◽  
Cutaneous Drug Reactions ◽  
Morbilliform Rash

Background: Adverse cutaneous drug reactions pose a diagnostic challenge due to a myriad of clinical manifestations and wide variety of causative agents. Present study aims to record various clinical patterns of adverse drug reactions, their causative agents and to study the pattern of morbidity and mortality in patients with severe cutaneous adverse drug reactions.Methods: 150 patients with adverse cutaneous drug reactions were included who came to Department of Dermatology, Venereology and Leprosy at PDU Govt. Medical College and Hospital, Rajkot, Gujarat from September 2009 to September 2011. Thorough history with all routine haematological and biochemical investigations, septic screening were done. HIV testing was done in severe reactions. Appropriate specific treatment was given with counselling regarding the offending drug.Results: The most common age group was 21-30 years (26.67%) with male to female ratio being 0.92:1. Morbilliform rash was the most common clinical type (42.67%) in both HIV reactive and non-reactive patients. Antimicrobials were the most common group (29.33%) and nevirapine was the most common offending drug (27.33%). Mortality rate was 2% (3 out of 150 cases) and all the patients were of toxic epidermal necrolysis.Conclusions: The pattern of cutaneous adverse drug reactions and the causative drugs are remarkably different in our study. Knowledge of the pattern and the causative agent helps in better management and reduced consequences in these patients particularly in severe adverse cutaneous drug reactions.

scholarly journals Prevalence and pattern of adverse cutaneous drug reactions presenting to a tertiary care hospital

2017 ◽  
Vol 3 (1) ◽  
pp. 74
Author(s):  
B. Janardhan ◽  
D. Shailendra
Keyword(s):  
Drug Reaction ◽  
Adverse Drug Reactions ◽  
Tertiary Care ◽  
Clinical Manifestations ◽  
Care Hospital ◽  
Drug Reactions ◽  
Medical Sciences ◽  
Female Ratio ◽  
The Mean ◽  
Cutaneous Drug Reactions

<p class="abstract"><strong>Background:</strong> An adverse cutaneous drug reaction (ACDR) is defined as an undesirable clinical manifestation resulting from administration of a particular drug. With an ever increasing number of drugs and varied formulations being continuously made available it is important that a close watch on the risks of adverse drug reactions is looked for, to ensure safe use of medicines in the interest of the patient. In the present study our aim is to study the prevalence &amp; pattern of cutaneous adverse drug reactions reported to department of dermatology at MediCiti Institute of Medical Sciences, Hyderabad, India<span lang="EN-IN">.</span></p><p class="abstract"><strong>Methods:</strong> All suspected cutaneous adverse drug reactions reported to the department of dermatology at MediCiti Institute of Medical Sciences during the two year period from January 2013 to December 2014 were included in this study. A thorough clinical examination of all these cases &amp; details related to the drug use and clinical manifestations of the cutaneous adverse drug reaction were documented using a structured proforma. Naranjo scale was used to assess causality in all the causes of cutaneous adverse drug reactions.<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age of the patients was 42 years (age range: 1-64 years). Most of them were in the age group of 30-39 years. The male to female ratio was 1.78:1. The most common type of skin eruptions observed were maculopapular rash (35.55%), urticaria (26.19%) and fixed drug eruption (17.87%). The mean duration between drug intake and appearance of rash was 4 days (range: 1-120 days)<span lang="EN-IN">. </span></p><p class="abstract"><strong>Conclusions:</strong> The pattern of ACDRs and the drugs causing them in this study were similar to that reported in other studies both in terms of disease burden and clinical pattern. Knowledge of adverse cutaneous drug reactions will help to identify common medications contributing to dermatological reactions, so as to anticipate, prevent and limit their undue consequences<span lang="EN-IN">.</span></p>

scholarly journals Adverse drug reactions in hospitalized patients in a tertiary care teaching hospital: analysis of the reported cases

2018 ◽  
Vol 7 (7) ◽  
pp. 1377
Author(s):  
Althab Begum M. ◽  
Satyajit Mohapatra ◽  
R. Jamuna Rani
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Spontaneous Reporting ◽  
Causality Assessment ◽  
Tertiary Care ◽  
General Medicine ◽  
Drug Reactions ◽  
Tertiary Care Teaching Hospital ◽  
Care Teaching ◽  
Organ Systems

Background: Adverse Drug Reactions (ADR’s) contributes to the burden of drug-related morbidity and mortality. ADRs are seen frequently in hospitals due to a variety of factors like complexity of diseases, drug interactions, polypharmacy, and possible negligence. The purpose of the study was to identify and assess ADR in various departments of a tertiary care teaching hospital.Methods: A prospective spontaneous reporting was carried out in a tertiary care teaching hospital during a period of four months from November 2016 to February 2017. All suspected spontaneous ADRs were assessed and the information was collected and analyzed by the pharmacologists for causality assessment using the Naranjo’s causality assessment scale.Results: A total of 30 ADRs were reported with female preponderance (70%). Majority of ADRs were from General Medicine and Oncology departments. The most affected organ systems were skin (80%) followed by the gastrointestinal system (13.3%). The most frequent drugs causing ADRs were antibiotics (56.3%) in which type B reactions were more compared to type A and followed by anticancer drugs (10%). The severity assessment showed that most of them were mild reactions (76.6%). Causality assessment revealed that 90% of the reactions were probable, 10% were possible and no reactions were unlikely.Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to increased hospital stay. The reporting of the ADRs to regional Pharmacovigilance centers should be encouraged to ensure drug safety.

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 Causality Assessment Of Adverse Drug Reactions In Wards Of An Indian Public Teaching Hospital

2014 ◽  
Vol 17 (3) ◽  
pp. A156-A157
Author(s):  
A. Malik ◽  
P. Tiwari ◽  
S. D’cruz ◽  
A. Sachdev
Keyword(s):  
Adverse Drug Reactions ◽  
Teaching Hospital ◽  
Causality Assessment ◽  
Drug Reactions

scholarly journals A study and evaluation of cutaneous adverse drug reaction in the patients attending dermatology department of tertiary care teaching hospital in Eastern Uttar Pradesh

2021 ◽  
Vol 10 (6) ◽  
pp. 664
Author(s):  
Dharmender Gupta ◽  
Bikash Gairola ◽  
Bijay Kumar ◽  
Masuram Bharath ◽  
Mohd Shadab Ansari
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Health Care Professionals ◽  
Tertiary Care ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Dermatology Department ◽  
Drug Eruptions ◽  
Cutaneous Drug Reactions ◽  
Cutaneous Adverse Drug Reaction

Background: Cutaneous adverse drug reactions (CADRs) are most frequently reported type of ADRs and can be caused by variety of drugs. The clinical patterns of adverse cutaneous drug reactions and the drug responsible for them is changing every year due to the emergence of newer molecules and changing trends in the use of drugs.Methods: This was a prospective, cross-sectional and observational study done for a period of 6 months to evaluate the clinical pattern of CADRs and their causative drugs in the tertiary health care.Results: Over all 55 patients were detected with cutaneous adverse drug reaction. The majority of CADRs were in the age group of 18-35 years (63.46%). Fixed drug eruptions (FDE) being the most common adverse cutaneous drug reaction (34.68%) followed by maculopapular rash (23%), NSAIDs being the most common, followed by antimicrobial agents.Conclusions: Knowledge of these drug eruptions, the causative drugs are essential for the clinicians and implementing the ADRs reporting and monitoring system, one can promote drug safety and better patients care, among health care professionals.

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