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Arshiya Fatima1, Md Mohsin1*, Shayma Khan1, Asna Yasmeen1, Mohd Avez Ali1, Musa Khan2.
1Department of Pharmacy Practice (Pharm.D), MESCO College of Pharmacy, ( Osmania University ), Hyderabad, T.S., INDIA.
2Depertment of General Medicine, Osmania General Hospital (OGH), AfzalGunj, Hyderabad, T.S, INDIA.

ORIGINAL RESEARCH ARTICLE
Volume 6, Issue 2, Page 72-79.

*Author for correspondence
E-mail: shams4mohsin2018@gmail.com

ABSTRACT
Aims and Objectives: The aim of the study is to estimate the prevalence of adverse drug reactions (ADRs) in patients on cardiovascular drugs and to assess their occurrence, severity, quantification by clinical and laboratory means, management and possible prevention.
Materials and Methods: The present study was conducted over a period of 6 months. Naranjo probability assessment scale was applied to report the causality. Severity assessment was done based on Hartwig and Siegal Severity Scale and preventability assessment based on Schumock and Thornton preventability scale.
Results: The most ADRs occurred in the age group 51-60 years. ADRs in patients after hospital admission were 69.3% & patients who presented to the hospital with ADRs 30.6%. All ADRs reported were type-A ADRs i.e. dose-dependent. The cardiovascular system was mostly affected by 29.3%. Anti-hypertensives showed maximum ADRs. Based on Naranjo’s scale ADRs reported were, definite 10.6%, probably 85.3%, possibly 4% and doubtful 0%. Hartwig’s and Siegal severity assessment scale showed ADRs were mild 37.3%, moderate 56% and severe 6.6%. Schumock & Thornton preventability Scale showed 17.3% of ADRs were definitely preventable. The most potent management in our study was found to be drug discontinuation 61.3% followed by dose reduction and supportive treatment 38.6%.
Conclusion: Inter-individual variability is the underlying cause of the ADRs in the majority of the patients. Other causes include factors such as age, polypharmacy, concomitant diseases, availability of newer drugs, underreporting by healthcare professionals and lack of a formal system for monitoring of adverse drug reactions play an important role. Additionally, the association can be made with the use of medication history, medication reconciliation and drug exposure timeline. After identification the offending agent should be discontinued, treatment recommendations should be made and patient education should be provided to prevent future adverse reactions.
Keywords: ADRs, Cardiovascular, Hartwig and Siegal Severity Scale, Schumock and Thornton preventability scale.