scholarly journals An observational study of cutaneous adverse drug reactions in tertiary hospital

Author(s):  
Tejashwani . ◽  
Dipti Patel ◽  
Neela Bhuptani

<p class="abstract"><strong>Background:</strong> Adverse cutaneous drug reactions include reactions due to overdose, side effects and idiosyncratic reactions. They pose a diagnostic challenge due to wide variety of causative agents and varied clinical manifestations. Our study aims to record various clinical patterns of adverse drug reactions, their offending drugs and to study the pattern of morbidity and mortality in patients with severe cutaneous adverse drug reactions especially in the HIV era.</p><p class="abstract"><strong>Methods:</strong> 90 patients with adverse cutaneous drug reactions were included who came to Dept. of Dermatology, Venereology and Leprosy at P.D.U. Govt. Medical College and Hospital, Rajkot, Gujarat from October 2011 to November 2017. Thorough history with all routine haematological and biochemical investigations and septic screening was done. The morphology of skin lesions was noted. The offending drug was withdrawn in the patients and appropriate treatment was given.<strong></strong></p><p class="abstract"><strong>Results:</strong> The most common age group observed was 31-40 years (24.44%) with male to female ratio being 1.2:1. Maculopapular rash was the most common clinical type (16.66%). NSAIDS were the most common offending drugs (16.66%). Among the individual drugs, carbamazepine was the most common offending drug(14.44%). Drug was prescribed by a medical practitioner in 86 cases (95.55%), while self administered in 4 cases (4.44%). History of some cutaneous drug reaction in the past was present in 17 patients (18.88%). Lesions were generalised in 76 cases (84.44%) and localised in 14 cases (15.55%).</p><p class="abstract"><strong>Conclusions:</strong> Knowledge of the pattern and the offending drug helps in better management and reduced complications in these patients and also helps in preventing recurrences.</p>

Author(s):  
Riddhi Shah ◽  
Sakshi Agrawal ◽  
Neela Bhuptani

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.


Author(s):  
B. Janardhan ◽  
D. Shailendra

<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>


2000 ◽  
Vol 16 (2) ◽  
pp. 47-49 ◽  
Author(s):  
Matitiahu Lifshitz ◽  
Perez Kornmehl ◽  
Haim Reuveni

Objective: To determine the incidence of adverse drug reactions in patients with acetaminophen overdose following administration of intravenous acetylcysteine, and to evaluate the cost-benefit ratio of intravenous compared with oral acetylcysteine therapy. Methods: The incidence of adverse drug reactions to intravenous acetylcysteine therapy was studied retrospectively in all patients with acetaminophen overdose who were admitted to Soroka University Medical Center, Beer-Sheva, Israel, from 1994 to 1998. Data were obtained from hospital records. All patients were treated with a 20-hour intravenous regimen according to the Prescott protocol. Special attention was paid to the clinical manifestations of adverse reactions, time of onset, and history of patient allergy and asthma. Cost of therapy (drug prices, hospital per diems) for intravenous versus oral acetylcysteine administration was evaluated in accordance with average rates prevailing in Israel in December 1998. Results: Ninety-two patients, 32 adolescents aged 12–18 years (mean ± SD 14.2 ± 1.9) and 60 adults aged 18–52 years (28.2 ± 3.2), were treated with intravenous acetylcysteine for acetaminophen overdose during the study period. Three patients (3.2%) developed adverse reactions: one adult presented with a maculopapular rash and pruritus, and two adolescents developed mild urticaria; no other adverse reactions were reported. All adverse reactions occurred during administration of the loading dose, 15–20 minutes after initiation of therapy. The reactions subsided a few hours after the acetylcysteine infusion was stopped and did not require antiallergy therapy. None of the three patients had a history of allergy. The 20-hour intravenous acetylcysteine protocol is approximately three times less expensive than the recommended oral regimen in terms of drug cost and length of hospitalization. Conclusions: Intravenous acetylcysteine is a relatively safe antidote for acetaminophen poisoning. The incidence rate of adverse reactions is low, and they are mild and easily controlled by termination of the infusion. We recommend intravenous acetylcysteine therapy, particularly for patients with vomiting caused by the acetaminophen overdose or by oral acetylcysteine therapy. The 20-hour intravenous acetylcysteine therapy has a cost-benefit advantage over oral therapy; however, the oral formulation is not approved by the FDA.


Author(s):  
Dinesh A. Chavda ◽  
Satish D. Suthar ◽  
Shradhanand Singh ◽  
Jayesh D. Balat ◽  
Sailesh P. Parmar ◽  
...  

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.


JMS SKIMS ◽  
2017 ◽  
Vol 20 (2) ◽  
pp. 73-76 ◽  
Author(s):  
Surjeet Singh ◽  
Zahoor A Wafai ◽  
Ajaz Koul

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  


Author(s):  
Priya Prathap ◽  
Elsy M.I ◽  
Ajitha K. N ◽  
Ajith Kumar ◽  
Sandhya George

<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>


Author(s):  
Jagruti G. Dhanani ◽  
Anupama Sukhlecha

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.


2019 ◽  
Vol 26 (6) ◽  
pp. 1306-1317
Author(s):  
Zen Yang Ang ◽  
Kit Yee Cheah ◽  
Nadiah B Abdullah ◽  
Safawati B Samsuri ◽  
Siao Hui Lee ◽  
...  

Purpose To identify the cost and reasons of returned parenteral chemotherapy regimens at a tertiary hospital in Kuala Lumpur, Malaysia. Methods Data were retrospectively extracted from all the Chemotherapy Return Forms in 2016, which is a compulsory documentation accompanying each return of parenteral chemotherapy regimen. The following data were extracted: patient’s diagnosis, gender, location of treatment (i.e. ward/daycare clinic), start date of chemotherapy regimen, type of cytotoxic drug returned, dose of cytotoxic drug returned, number of cytotoxic drug preparations returned and reason for return as well as whether the returned cytotoxic drug preparations could be re-dispensed. The cost of wastage was calculated based on the cost per mg (or per unit) of the particular returned cytotoxic drug. Results One hundred and fifty-nine cases of returned chemotherapy regimen comprising of 231 parenteral cytotoxic drug preparations were analysed. The total cost of returned chemotherapy regimen for 2016 was €3632, with €756 (20.8%) worth of chemotherapy regimens returned due to preventable reasons and €2876 (79.2%) worth of chemotherapy regimens returned due to non-preventable reasons. Approximately 50% of cases returned chemotherapy regimen were due to deterioration of patient’s clinical condition and another 24.5% of cases of returned chemotherapy regimen were attributed to adverse drug reactions. Conclusion Wastage associated to non-preventable reasons such as adverse drug reactions and preventable causes like refusal of patients can be further reduced by using newer healthcare innovations and establishment of written institutional protocols or standard operating procedures as references for in-charge healthcare personnel when cytotoxic drug-related issues occur. Adoption of cost-saving strategies that have been proven by studies could further improve current cost containment strategies.


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