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      Cutaneous adverse drug reactions in a tertiary care teaching hospital: A North Indian perspective

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          Abstract

          Background:

          Cutaneous manifestations of adverse drug reactions are a common occurrence and need to be differentiated from other causes of similar manifestations. Active search is essential for identification of these as patients may tend to downplay the causal association between drug use and the subsequent cutaneous manifestation.

          Purpose:

          To study the incidence of Cutaneous Adverse Drug Reactions (CADRs) in a tertiary care teaching hospital in North India.

          Methods:

          A prospective, observational study was conducted over a period of 6 months; using self-reporting method for selection of cases. The CADRs were graded as definite, possible and probable.

          Results:

          During the study period, 91 cases of CADRs were observed. Maximum incidence of CADRs was seen with antimicrobials (48.30%), followed by nonsteroidal anti-inflammatory drugs (21.90%). Maculopapular rash was the most common cutaneous manifestation of ADRs (42.85%).

          Conclusion:

          CADRs are a common occurrence and awareness about the same is essential for diagnosis and prevention.

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          Most cited references19

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          Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.

          J Lazarou, B H Pomeranz, P N Corey (1998)
          To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients. Four electronic databases were searched from 1966 to 1996. Of 153, we selected 39 prospective studies from US hospitals. Data extracted independently by 2 investigators were analyzed by a random-effects model. To obtain the overall incidence of ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the hospital plus the incidence of ADRs causing admission to hospital. We excluded errors in drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death. The overall incidence of serious ADRs was 6.7% (95% confidence interval [CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death. The incidence of serious and fatal ADRs in US hospitals was found to be extremely high. While our results must be viewed with circumspection because of heterogeneity among studies and small biases in the samples, these data nevertheless suggest that ADRs represent an important clinical issue.
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            Adverse drug reactions in a south Indian hospital--their severity and cost involved.

            Jayesh Pandit, Banadakoppa M Ramesh, G Parthasarathi (2003)
            The study was aimed to assess the pattern of occurrence of adverse drug reactions (ADRs) in the local population, severity of reported ADRs and additional financial resource utilisation associated with ADRs. This was a prospective, spontaneous reporting study conducted over a period of 7 months by clinical pharmacists. The WHO definition of an ADR was adopted. Each ADR was assessed for its causality by using the WHO Probability Scale. The severity of each reported ADR was assessed using the criterion developed by Hartwig et al. The average cost incurred in treating the ADRs was calculated. A total of 270 suspected ADRs were reported and evaluated from 164 patients. A total of 3.7% of the hospitalised patients experienced an ADR, 0.7% of the admissions were due to ADRs and 1.8% had a fatal ADR. The gastrointestinal system (36.3%) was most commonly involved with an ADR. The drug class most commonly implicated with ADRs was cardiovascular (18.3%). Majority (47%) of the reactions were 'moderate' in severity. The total cost incurred in managing all the reported ADRs was Rs 76,564 (US$ 1595) with an average cost of Rs 690 (US$ 15) per ADR. Detection and prevention of ADRs at the earliest is very important as they can cause not only morbidity and mortality but also involve high health care cost in their management. Well-trained pharmacists in the area of ADR detection, reporting and monitoring could prove as an asset in providing better patient care.
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              Drugs causing fixed eruptions: a study of 450 cases.

              A A Mahboob, Abu Haroon (1998)
              Drug eruptions are among the most common cutaneous disorders encountered by the dermatologist. Some drug eruptions, although trivial, may cause cosmetic embarrassment and fixed drug eruption (FDE) is one of them. The diagnostic hallmark is its recurrence at previously affected sites. We evaluated 450 FDE patients to determine the causative drugs. The ratio of men to women was 1:1.1. The main presentation of FDE was circular hyperpigmented lesion. Less commonly FDE presented as: nonpigmenting erythema, urticaria, dermatitis, periorbital or generalized hypermelanosis. Occasionally FDE mimicked lichen planus, erythema multiforme, Stevens-Johnson syndrome, paronychia, cheilitis, psoriasis, housewife's dermatitis, melasma, lichen planus actinicus, discoid lupus erythematosus, erythema annulare centrifugum, pemphigus vulgaris, chilblains, pityriasis rosea and vulval or perianal hypermelanosis. Cotrimoxazole was the most common cause of FDE. Other drugs incriminated were tetracycline, metamizole, phenylbutazone, paracetamol, acetylsalicylic acid, mefenamic acid, metronidazole, tinidazole, chlormezanone, amoxycillin, ampicillin, erythromycin, belladonna, griseofulvin, phenobarbitone, diclofenac sodium, indomethacin, ibuprofen, diflunisal, pyrantel pamoate, clindamycin, allopurinol, orphenadrine, and albendazole. Cotrimoxazole was the most common cause of FDE, whereas FDE with diclofenac sodium, pyrantel pamoate, clindamycin, and albendazole were reported for the first time. FDE may have multiform presentations.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Int J Appl Basic Med Res
                Journal ID (iso-abbrev): Int J Appl Basic Med Res
                Journal ID (publisher-id): IJABMR
                Title: International Journal of Applied and Basic Medical Research
                Publisher: Medknow Publications & Media Pvt Ltd (India )
                ISSN (Print): 2229-516X
                ISSN (Electronic): 2248-9606
                Publication date (Print): Jan-Jun 2011
                Volume: 1
                Issue: 1
                Pages: 50-53
                Affiliations
                [1]Department of Pharmacology, Dr HSJ Institute of Dental Sciences, Chandigarh, India
                [1 ]Department of Pharmacology, Government Medical College, Patiala, Punjab, India
                Author notes
                Address for correspondence: Dr. Ruchika Nandha, Department of Pharmacology, Dr HSJ Institute of Dental Sciences, PU, Sector 25, Chandigarh, Punjab, India. E-mail: rnandha23@ 123456yahoo.co.in
                Article
                Publisher ID: IJABMR-1-50
                DOI: 10.4103/2229-516X.81982
                PMC ID: 3657944
                PubMed ID: 23776774
                SO-VID: a7e3313d-f422-44bc-8de7-2fe27f08a8ef
                Copyright © Copyright: © International Journal of Applied and Basic Medical Research
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Categories
                Subject: Brief Communication

                Keywords: cutaneous adverse drug reactions,drug rash,drug reaction,pharmacovigilance
                Data availability:
                Keywords: cutaneous adverse drug reactions, drug rash, drug reaction, pharmacovigilance

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