A Prospective Study on Adverse Drug Reactions in Inpatients of General Medicine Department in a Tertiary Care Hospital- A clinical Pharmacist-led Study
Shereen Hassan
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Nitte Deemed to be University), Mangaluru- 575018, Karnataka, India.
U. Ujwal Kumar
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Nitte Deemed to be University), Mangaluru- 575018, Karnataka, India.
Venessa Mascarenhas
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Nitte Deemed to be University), Mangaluru- 575018, Karnataka, India.
G. Suresh
Department of General Medicine, Justice K.S. Hegde Charitable Hospital, NITTE (Nitte Deemed to be University), Mangaluru-575018, Karnataka, India.
K. C. Bharath Raj
*
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, NITTE (Nitte Deemed to be University), Mangaluru- 575018, Karnataka, India.
Prashant Nayak
Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, NITTE (Nitte Deemed to be University), Mangaluru-575018, Karnataka, India.
*Author to whom correspondence should be addressed.
Abstract
The present study was carried out to determine the incidence of Adverse Drug Reactions (ADRs) in general medicine department and to assess and analyze the causality, severity, and preventability of ADRs. A prospective observational study was conducted in the general medicine department for six months. All patients receiving drug therapy are considered and are selected based on the inclusion criteria. Patient demographic details like age, gender, diagnosis, past medical history, concomitant medications, etc., are recorded from the patient data gathering form. The causality assessment is accomplished using Naranjo and WHO scales. The severity is carried out using the Modified Hartwig and Siegel scale. The preventability evaluation is accomplished using the Modified Schmock and Thornton scale. The study included 385 patients were between the age group of 18 years and, out of which 34 patients developed adverse drug effects including female and male. Patients between the age group of 40-50 years (18.1%) developed a high incidence of ADRs. The causality was assessed using Naranjo’s causality assessment scale, 44.1% reactions were probable; 29.4% reactions were certain, 23.5% reactions were possible and 2.9 % reactions were conditional. When the reactions were assessed most of them were assessed 55.1% were moderate and 61.8% were probably preventable. Appropriate observation of the drug effect is essential to ensure the safety of the patient. This also will have the advantage of reducing the incidence of the ADRs, thus deplete the complications and helps to improve the quality of life of the patients.
Keywords: Adverse drug reaction, causality, severity, preventability, naranjo scale