Role of risk management units at medical organizations in pharmcovigilance

Ophir Lavon, Clinical Pharmacology And Toxicology Unit, Carmel Medical Center, Haifa, Israel (

Risk management units commonly exist in hospitals and other medical organizations. They are responsible for collecting and analyzing data of adverse events and their root causes, planning and promoting interventions for safety and quality improvement, and coordinating activities dealing with professional liability and medical malpractice.
Due to regulatory, legal and financial importance of their work, risk management units are given wide jurisdiction and access to medical data. In addition, these units often set the priority of the organization's attention and resources.
Traditionally, risk management units focus on medical sectors and specialties that are regarded high risk, such as obstetrics and surgery. This is governed by viewing mainly the narrow direct effects and costs. An updated approach should be implemented, looking broadly and more comprehensively at all aspects and consequences of impaired medical treatment. Here medications take the lion's share. As medication treatment is far more prevalent and diverse than other therapeutic interventions, medication errors and adverse reactions are the number one real patient safety and risk management issue, contrary to common beliefs. Guaranteeing medication safety should be prioritized.
Risk management units are advised to integrate clinical pharmacologists or pharmacists into their staff, and meticulously use their permissions and resources to collect data regarding medication use. This information should be analyzed using risk management tools and methods (e.g., Root Cause Analysis, Factor Mode and Effect Analysis, Trigger Tool). Risk management units should plan and promote interventions for improving medication safety, both in coordination with the pharmacy and pharmacology professionals and independently. Risk management units should lead the efforts to identify and improve gaps in medication safety.

Abstract Reference & Short Personal Biography of Presenting Author

Head of Patient Safety and Risk Management Unit, and Clinical Pharmacology and Toxicology Unit, Carmel Medical Center, Haifa, Israel.
Clinical lecturer, Rappaport Faculty of Medicine, Technion, Haifa, Israel.
Board member, Israel Society for Clinical Pharmacology.
Tresurer and board member, Israel Society of Toxicoloy.
Member of the scientific board and steering committee, ISOP Israel.
Consultant and member of the advisory committee, pharmacy and pharmacovigilance departments, Israel Ministry of Health.

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