Data Dose June 2024 #1
Tackling Medication Errors with Pharmacovigilance
Medication errors present a major challenge in global healthcare systems. These errors can happen at any stage, from prescription to administration, and have serious consequences for patients. Errors can include giving medication to the wrong patient, prescribing incorrect dosages, missing necessary medications, or entering orders incorrectly. This article explores the types of medication errors, the role of pharmacovigilance in reducing these errors, and strategies to improve patient safety. Read more...
FDA Staff Raises Concerns About Ecstasy Drug’s Safety in Report
US Food and Drug Administration (FDA) staff have raised safety concerns about an experimental MDMA drug intended to treat post-traumatic stress disorder (PTSD). Developed by Lykos Therapeutics Inc., this psychedelic drug, commonly known as ecstasy or molly, could become the first new PTSD treatment in over two decades if approved. Additionally, its approval could open the door for other recreational drugs to be used in mainstream medical treatments. Despite its potential, the FDA remains cautious and unconvinced of the treatment's safety and effectiveness, indicating that further evidence is needed before it can be approved. Read more...
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Asia-Pacific Roundup: India revises pharmacovigilance guidance for vaccines
India’s Central Drugs Standard Control Organization (CDSCO) has recently issued updated guidance for the industry on pharmacovigilance requirements for human vaccines. This update aligns with the New Drugs and Clinical Trials Rules, 2019. The primary aim of this guideline is to identify risks, create a risk profile for a vaccine and its administration program, and design an appropriate pharmacovigilance plan to mitigate these risks. It also aims to uncover any critical information missing from premarket Phase 1/2/3 trials, where the safety profile was not fully established. Read more...
New International Regulations to Protect Against Pandemics Finally Approved
After two years of intense negotiations, including long nights this week, the World Health Assembly (WHA) has finally passed amendments to the International Health Regulations (IHR) and committed to finalizing pandemic agreement talks within a year. Failing to agree on the amendments before the WHA opened on Monday, member states have been racing to complete them in drafting committee meetings that often extended into the early hours. WHO Director-General Dr. Tedros Adhanom Ghebreyesus, who lost his voice during the late-night sessions, noted that the efforts have made the world safer. Read more...