ADR MONITORING IN HYPERTENSION OUT PATIENT DEPARTMENT OF HOSPITAL
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 2
Abstract
Adverse drug reactions (ADRs) to anti-hypertensive agents are common and can lead to noncompliance or even discontinuation of therapy. There is paucity of such data in the Indian context. We deemed it worthwhile to assess the suspected ADR profile of anti-hypertensive drugs in an ambulatory setting in a public teaching hospital. A longitudinal observational study was conducted in the outpatient department (OPD) of the concerned unit. Twenty consecutive patients per day, irrespective of their hypertensive diagnosis, were screened for suspected ADRs, 2 days in a week, over 6 months. Adverse event history, medication history and other relevant details were captured in a format as adopted. We screened 2000 patients (68.69% males, median age 38 years), of whose 429 were suspected of having at least one ADR; 84 cases had insufficient evidence about causality and were excluded from further analysis. Thus, 17.25% (95% confidence interval: 15.59-18.91%) of our study population reported ADRs with at least “possible” causality. Of 352 events recorded, 327 (92.90%) were “probable” and the rest “possible”. None was labeled “certain” as re-challenge was not performed. Patients received a median of 3.2 anti-hypertensive drugs each. Thirty-three different kinds of ADRs were noted, including tremor (19.60%), weight gain (15.34%) and constipation (14.49%). Among the incriminated drugs, anti-hypertensive represented the majority (57.10%) of the list. This study offers a representative profile of ADRs to be expected in anti-hypertensive out-patients in an Indian public hospital. Establishment of an anti-hypertensive drug ADR database can be a worthy longterm goal in the Indian context.
Authors and Affiliations
Sreenu Thalla, K. Venkatta Ramana, Sk. Sheherbanu, Sk. Ashya, A. Manikanteswara Reddy, B. Lakshmi
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