Cutaneous adverse drug reactions to modern medicines and initial experiences from a Spontaneous adverse drug reaction reporting program in a tertiary care teaching hospital of Western Nepal
Keywords:
Contact dermatitis, cutaneous adverse drug reactions, Naranjo algorithm, maculopapular rash, pharmacovigilance.Abstract
Background Cutaneous adverse drug reactions (ADRs) affect 2-3% of hospitalized patients; most are usually mild and respond to topical drugs. These reactions can arise as a result of immunologic or non-immunologic mechanisms. Extremes of age, female sex, previous history of ADRs and environmental factors are the major risk factors. The Naranjo algorithm is widely used to determine the causality of an ADR. Objective To share the authors’ experience of spontaneous adverse drug reaction reporting program Nepal. Patients and methods During a period from September, 2004 to March, 2005, any patient who experienced a dermatological ADR were asked to report the Pharmacovigilance Cell of the Manipal Teaching Hospital, Pokhara, Nepal. Morphology of the eruption was recorded.Results A total of 45 cutaneous ADRs were reported during the study period. Maculopapular rash (15 reports) was the most common, followed by contact dermatitis (7 reports), fixed drug eruptions (6 reports) and erythema (4 reports). Conclusion Considering its effectiveness, the pharmacovigilance program in Manipal Teaching Hospital should be strengthened and transformed to a full-fledged active reporting program. The nationwide extension of this program would be beneficial.References
Forrester JW. Counterintuitive behavior of social systems. MIT Technology Rev 1971; 73: 52-68.
Roujeau JC, Stern RS. Severe adverse cutaneous reactions to drugs. N Engl J Med 1994; 331: 1272-85.
Bigby M, Jick S, Jick H, Amdt K. Drug-induced cutaneous reactions: a report from the Boston Collaborative Drug Surveillance Program on 15,438 consecutive inpatients, 1975 to 1982. JAMA 1986; 256: 3358-63.
Leape LL, Brennam TA, Laird N et al. The nature of adverse events in hospitalized patients study II. N Engl J Med 1991; 324: 377-84.
Bates DW, Spell N, Cullen DJ et al. The cost of adverse drug events in hospitalized patients. JAMA 1997; 227: 307-11.
Classen DC, Pestotnik SL, Evans RS et al. Adverse drug events in hospitalized patients. Excess length of stay, extra costs and attributable mortality. JAMA 1999; 277: 301-6.
Stern RS, Chosidow OM, Wintroub BU. Cutaneous drug reactions. In: Fauci AS, Braunwald E, Iseelbacker KJ et al., editors. Harrison’s Principles of Internal Medicine. 15th edn. New York: McGraw-Hill; 2001. p. 336-42.
Kramer MS, Leventhal JM, Hutchinson TA et al. An algorithm for the operational assessment of adverse drug reactions. Background, description and instructions for use. JAMA 1979; 242: 623-32.
Naranjo CA, Busto U, Sellers EM et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239-45.
David S, Coulson R. Community pharmacist reporting of suspected ADRs: (1) The first year of the yellow card demonstration scheme. Pharmacol J 1999; 263: 786-8.
Michel DJ, Knodel LC. Comparison of three algorithms used to evaluate adverse drug reactions. Am J Health System 1986; 7: 1709-14.
Berry LL, Segal R, Sherrin TP, Fudge KA. Sensitivity and specificity of three methods of detecting adverse drug reactions. Am J Hosp Pharm 1988; 45: 1534-9.
Blaiss MS, De Shazo RD. Drug Allergy Pediatr Clin N Am 1988; 35: 1131-47.
Rigby M. Rates of cutaneous reactions to drugs. Arch Dermatol 2001; 137: 765-70.
Naldi L, Conforti A, Venegoni M et al. Cutaneous reactions to drugs. An analysis of spontaneous reports in four Italian regions. Br J Clin Pharmacol 1999; 48: 839-46.
http//www.WHO. The safety of medicines.html. Accessed on 15.06.2005.
Bates DW, Evans RS, Murff H et al. Detecting adverse events using information technology. J Am Med Inform Assoc 2003: 10: 115-28.
Peachey J. From pharmacovigilance to pharmacoperformance. Drug Saf 2002; 25: 399-405.
