The off-label administration of antidotes and the pharmacovigilance
Medical Review (Med. pregled), 2023, 59(2), 13-24.
L. Neykova-Vasileva1, V. Vasilev2, K. Paskalev2
1 Clinic of Emergency Toxicology, Department of Toxicology, Military Medical Academy – Sofia
2 Department of Disaster Medicine, MHAT – Sofia, Military Medical Academy
Abstract. The antidotes are life-saving medicinal products that could alter the course of intoxication. Their administration is frequently outside the approved indications, i.e., off-label. The aim of this paper is to analyze the off-label antidote therapy in the light of pharmacovigilance and to present our perspective on this. Documentary and logical analyses of the international experience from the literature are utilized and compared with the Bulgarian experience. During intoxications in the emergency toxicology, the best possible action should be taken as early as possible, including administering antidotes. Frequently, the off-label administration is required for off-label aged patients, different dosing, or administration. The clinical toxicologist can assess which action is in the “best interest” of the patient based on the available scientific evidence and their own clinical experience, and to recommend using unlicensed medicinal products when there is no licensed alternative in the country. The same is applicable when the administration of an antidote is required in disasters, including natural hazards triggering technological disasters. The off-label antidote therapy is implemented on a benefit–risk basis in accordance with the pharmacovigilance rules and is subject to strict monitoring throughout the period of their clinical use. The off-label administration of antidotes in emergency toxicology is based on the physician’s clinical experience and scientific communications related to the off-label administration of antidotes to do what is clinically best for the patient, namely, preserving the patient’s life and working capacity, including during disaster settings
Key words: off-label, antidotes, benefit, risk, pharmacovigilance
Address for correspondence: Lyudmila Neykova-Vasileva, MD, e-mail: lussi66@abv.bg