Every once in a while, someone performs an act so consequential that it alters the course of a whole industry, nation, or indeed the entire world. Abraham Lincoln’s Emancipation Proclamation re-wrote American history. Physicist J. Robert Oppenheimer and the scientists in the Manhattan Project forever altered the conduct of global warfare. And American pharmacologist and Food and Drug Administration (FDA) drug reviewer Frances Kelsey, in rejecting to approve the marketing of the infamous Thalidomide to Americans, eternally altered the conduct of drug safety reviews.
Every day, we are called to make a positive difference. We may not ourselves become legends of history, but as in the words of Robert F. Kennedy, “Few will have the greatness to bend history itself, but each of us can work to change a small portion of events. It is from numberless diverse acts of courage and belief that human history is shaped.”
Louis Kibathi is a Patient Safety Expert and Global Qualified Person for Pharmacovigilance (QPPV). With a Bachelor of Pharmacy (BPharm) and a Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance (MPharm-Epivigil) from the University of Nairobi, Louis is passionate about patient and drug safety, with the sole aim of ensuring global access to safe, quality and high-quality drugs. In addition to being a pharmacovigilance consultant, he has held various positions in both the national and county governments. When not thinking about drug safety, Louis is a voracious reader, with the works of Leo Tolstoy, Pablo Neruda and F. Scott Fitzgerald among his favorite.
Project Summary
QUALITY OF ADVERSE EVENT REPORTS IN KENYA AND SAFETY SIGNALS FOR ANTIRETROVIRAL THERAPY RELATED ARRHYTHMIAS
One of the potential areas for signal detection is the relationship between antiretroviral therapy and cardiovascular diseases (CVDs). Cardiovascular diseases are some of the major causes of death and morbidity among Human Immunodeficiency Virus (HIV) patients. Disproportionality analysis is one of the methods for detecting potential new signals using spontaneous reports databases. The study sought to identify the trend of quality of Kenyan individual case safety reports (ICSRs) as well as identify safety signals for cardiac arrhythmias associated with the use of antiretroviral drugs in HIV patients. Interrupted time series analysis of the report quality revealed a major change point in the fourth quarter of 2012. In the period following this event, the average quarterly completeness scores increased by 0.055 ± 0.017 (p = 0.003). A strong association was found between some ARV drugs and cardiac arrhythmia. The strongest signals identified were for foetal and neonatal arrhythmias, tachyarrhythmia and ventricular arrhythmias. With regard to bradycardia and bradyarrhythmia in HIV patients on ARVs, the signals were only significant for zalcitabine, lopinavir/ritonavir and nelfinavir. The strongest signal for tachyarrhythmias was recorded in delavirdine (>4). Protease inhibitors produced relatively strong signals for torsade de pointes with indinavir, saquinavir, nelfinavir and fosemprenavir all having signals of more than two. Efavirenz, nelfinavir and raltegravir also exhibited a strong signal for ventricular arrhythmia. For all the ARVs in which sinus node dysfunction was reported, the signal was more than 2. These potential signals require further investigation using more rigorous research methods such as cohort event monitoring.
