Jul-Sep, 2012 - Indian Journal of Pharmacy Practice

Indian Journal of Pharmacy PracticeAssociation of Pharmaceutical Teachers of IndiaProspective Monitoring and Reporting of Adverse Drug Reactions associated with Antiplateletand Antiepileptic Drugs in a South Indian Tertiary Care Teaching Hospital1 1 2 3 4 4Varun T , Sebastian J , Ramesh A* , Narahari MG , Keshava Bs and Harsha S1Department of Pharmacy Practice, Talla Padmavathi College of Pharmacy, Warangal2Department of Pharmacy Practice, JSS College of Pharmacy, Mysore.3 4,5Department of Medicine, Department of Nuerology, JSS Medical College Hospital, Mysore.A B S T R A C TSubmitted: 17/03/2012Accepted: 25/06/2012A prospective monitoring of adverse drug reactions associated with antiplatelet and antiepileptic drugs was carried out in a tertiary care teachinghospital. Patients diagnosed with Acute Coronary Syndrome (ACS) or ischemic stroke receiving antiplatelet drugs (Aspirin and Clopidogrel) andepileptic patients receiving antiepileptic drugs were followed for a period of six months prospectively at a tertiary care teaching hospital. WHOprobability scale and Naranjo's algorithm, Modified Hartwig and Seigel scale, and Modified Shumock and Thornton scales were applied to assessthe causality, severity and preventability of the reported ADRs. At the end of the study period, 15 ADRs were observed with Aspirin and 14 ADRswere observed with Clopidogrel in antiplatelet agents' class and 24 ADRs with Phenytoin and 12 ADRs with Valproic acid in antiepileptic agents'class. Among the antiplatelet agents, 82.75% of ADR's were found probable and 37.93% ADRs were possible. In antiepileptic drug class, 73.33%ADRs were found probable. In assessment of severity level, 6 ADRs were found in severity level 1 and 20 ADRs were in level 3 in severity inantiplatelet agents class and in antiepileptic drugs class 9 ADRs were found in level 1 and 23 ADRs were found level 2 severity, and 15 ADRs werefound preventable in anti epileptic agents. Medications were discontinued in 14 cases and the dose was adjusted in 10 cases. Phenytoin andSodium Valproate were found responsible for majority ADRs in Anti epileptic drugs class and Aspirin accounted for more number of ADRs inantiplatelet agents' class.Keywords: Adverse Drug Reactions, Antiplatelets, Antiepileptic drugs.INTRODUCTIONWorld Health Organization defines ADR as a response to adrug that is noxious and unintended and occurs at dosesnormally used in man for the prophylaxis, diagnosis, andtherapy of disease, or for modification of physiological1function. Adverse drug reactions (ADRs) occur frequently inmodern medical practice due to various pre disposing factors,resulting in increasing the morbidity, mortality and cost ofcare. Worldwide clinically significant ADRs occurapproximately in 20% of hospitalized patients and found to be2the fourth leading cause of mortality.Patients with cardiovascular diseases and epilepsy areparticularly vulnerable to ADRs due to their advanced age,polypharmacy, pathophysiology of the disease, age relatedchanges in liver and kidney function and the influence of heartdisease on drug metabolism. The ADR potential for aparticular drug varies with the individual, the disease beingAddress for Correspondence:Dr. Ramesh Adepu, Professor, Department of Pharmacy Practice, JSS Collegeof Pharmacy, SS Nagar, Mysore – 570 015E-mail: adepu63@gmail.comtreated, and the extent of exposure to other drugs. Majority ofsignificant ADRs involving cardiovascular drugs are2, 3predictable and therefore preventable.Across the world, after the stroke and the dementia, epilepsyconstitutes the common neurological condition seen by4neurologists in elderly. In India approximately 5.5 millionpeople are suffering from Epilepsy, among them 4.1 millionpatients resides in rural area and every year half million new5patients are added to the existing list. The ultimate goal of theepilepsy treatment is to make the patient free from seizureswithout adverse effects of medication and improved qualityof life. Over 80% of patients may achieve seizurefree statewith one suitable antiepileptic medication. But the remaining20% of patients may require poly therapy for seizure control.Majority antiepileptic agents suppress the pathologicalneuronal hyper excitability that constitutes the finalsubstrates in many seizure disorders was considered to beresponsible for adverse drug reactions. The other drug relatedproblems such as drug interactions also contribute to Adverse6Drug Reactions that may add to the economic burden.Assessing and resolving the potential drug related problemssuch as ADRs will improve the therapeutic outcomes and alsohelps in improving patients' quality of life.Indian Journal of Pharmacy Practice Volume 5 Issue 3 Jul - Sep, 2012 20