What Comes First to Your Mind: Drug Efficacy or Drug Safety?

Abstract

Disease-treatment guidelines are most often implemented clinically as part of comprehensive medication management to ensure patients receive the most effective and evidence-based care.  Post-marketing pharmacovigilance programs are the main source of medication safety monitoring. However, pharmacovigilance programs have multiple problems including underreporting of adverse drug events (ADEs), inconsistent reporting standards, and difficulties in data analysis and interpretation making it difficult to examine safety information.  Patients with multiple chronic diseases leading to polypharmacy are at an increased risk of ADEs.  There are various elements that constitute a successful approach while balancing efficacy and safety including: 1) Medication-related problems and ADE risk identification, prevention, and management; 2) Interdisciplinary collaboration; 3) Beneficiary-centered personalized care; 4) Technology integration; 5) Outcome evaluation and quality improvement; and 6) Pre-emptive pharmacovigilance studies by the virtual addition of drugs to patients’ drug regimen. In conclusion, medications generally enter the market with proven efficacy but often lack short- and long-term safety information.  A personalized transformative approach leveraging innovative clinical science-based technology and medication safety experience can create a more effective, patient-centered approach to managing complex medication regimens, ultimately improving patient safety and outcomes.