Abstract

PROSPECTIVE PHARMACOVIGILANCE ASSESSMENT OF ANTI-HYPERTENSIVE AGENTS: A SURVEY BASED ANALYSIS

Pranay Enanath Suryawanshi*, Aakash B. Makwana, Jainam Dilip Solanki, Aditi Sambhaji Shinde, Pallavi Madhav Shriwad, Tejas Govind Shitole

ABSTRACT

Hypertension, one of the major chronic non-communicable diseases which has affected more than a billion people globally, was studied, using a prospective, survey-based pharmacovigilance methodology, to evaluating adverse drug reactions from antihypertensive drugs in the community. Data were collected for six months through a 25-item multilingual questionnaire, which was based on the standards from Indian and US regulatory bodies, community pharmacies administered the questionnaire through digital and verbal methods. Medical Dictionary for Regulatory Activities, International Classification of Diseases 9/10 codes and US Prescribing Information were used to classify the Adverse Drug Reactions into expected (labelled) and unexpected (unlabelled) reactions. Calcium Channel Blockers caused the highest number of Adverse Drug Reactions (32.84%), among monotherapies, followed by Angiotensin Receptor Blockers (17.51%). Combination therapy with Angiotensin II Receptor Blockersand Calcium Channel Blockers represented 10.94% of cases. Analysis of system organ class revealed that general disorders (35.03%) and nervous system disorders (30.58%) were the most common adverse drug reaction categories. Serious effects comprised hospitalization (25%), disability (9.37%), life-threatening events (9.37%), and deaths (6.25%), they represented 71. 88% of cases. The demographic was almost gender balanced and predominantly aged 46-60 years (47.65%), while the use of concomitant antidiabetic drugs was quite high (45.76%). These results underline the importance of strengthening pharmacovigilance, encouraging rational use of antihypertensive drugs and establishing adverse drug reaction reporting systems at the community level.

Keywords: Pharmacovigilance, Adverse Drug Reactions (ADRs), Drug Safety Monitoring, Antihypertensive Agents, Hypertension.