PRAC updates clozapine monitoring guidelines for agranulocytosis risk

🚨 Last time, we explored Antimicrobial Resistance (AMR). Today, let’s shift focus to Antimicrobial Stewardship (AMS) in hospital settings, a critical strategy to protect patients and preserve antibiotic effectiveness. 🔹 What is AMS? Coordinated interventions to ensure the right drug, dose, route, and duration. 🎯 Goals: • Improve patient outcomes • Reduce resistance, toxicity & C. difficile infections • Optimize resources & lower costs ⚠️ Why it matters: ~20% of patients experience adverse effects from antimicrobials, including resistance, drug toxicity, and long-term microbiome disruption. 💡 Core Principles: • Start empiric therapy promptly, then tailor • Reassess at 48–72h (“antibiotic time-out”) • Early IV-to-oral switch • Shortest effective duration • PK monitoring for high-risk drugs 🏥 Building a Stewardship Program (CDC Core Elements): Leadership • Accountability • Pharmacy expertise • Action • Tracking • Reporting • Education 👉 Bottom line: AMS isn’t about restricting antibiotics—it’s about using them wisely to save lives today and preserve their power for tomorrow. #AntimicrobialStewardship #AMR #PatientSafety #ClinicalPharmacy #HealthcareExcellence

Revolutionising rare disease pharmacovigilance! Discover how curated real-world data, advanced analytics, and AI are transforming safety monitoring for small, diverse patient populations. It's about quality, not just quantity, to make better safety decisions. https://lnkd.in/e28V2qQi #RareDisease #Pharmacovigilance #RealWorldData #RWD #SafetyMonitoring #AIinHealthcare #HealthcareInnovation

⚠️ While metformin is a cornerstone in diabetes management, its use in patients with renal impairment requires careful consideration! Metformin is primarily cleared by the kidneys, and an accumulation of the drug can lead to a serious and potentially fatal condition known as lactic acidosis. 🩺 Understanding the link between metformin and kidney function is crucial for minimizing risks and optimizing patient outcomes. Here's what you need to know: 📍 eGFR is the key: Before initiating metformin, you must assess the patient's estimated glomerular filtration rate (eGFR). Metformin is contraindicated in patients with an eGFR below 30 mL/min/1.73 m2. * A "gray area": Exercise caution when prescribing to patients with an eGFR between 30 and 45 mL/min/1.73 m2. Initiation of metformin isn't recommended in this group. 📍 Regular monitoring is a must: Monitor eGFR at least annually in all patients taking metformin. For those at higher risk of developing renal dysfunction, like older adults, more frequent monitoring is essential. 📍 Re-evaluating therapy: If a patient's eGFR drops below 45 mL/min/1.73 m2, it's time to re-evaluate the risks and benefits of continuing metformin. ✅️ By proactively managing and monitoring eGFR, you can confidently and safely use metformin, ensuring the best possible care for your patients. ❓️Question for Discussion: What protocols or tools do you use in your clinical practice to monitor kidney function in your patients on metformin? Share your experience in the comments! 👇 #PVigilant_Health #be_vigilant_be_safe #ADRs #Drugsafety #Patientssafety #Pharmacovigilance

A new report finds there are fewer antibacterial medicines in clinical pipelines than just two years ago and relatively few qualify as innovative. https://trib.al/Dc2PU2o

This highlights the importance of balancing therapeutic benefits with emerging safety data. While GLP-1 receptor agonists like Ozempic have transformed diabetes and weight management, vigilance around rare but serious adverse events is critical. Continuous pharmacovigilance, timely updates to clinical guidelines, and transparent patient education can help ensure safe and informed use.

The Silent Threat in Healthcare: Adverse Drug Reactions—and How DNA Can Stop Them In the complex world of healthcare, one hidden threat continues to challenge providers and patients alike: Adverse Drug Reactions (ADRs). Often overlooked, ADRs are a leading cause of preventable harm, taking an immense toll—both human and financial—on our healthcare systems. The Scope of the Problem Did you know ADRs account for over 1.3 million emergency department visits and 350,000 hospitalizations each year in the U.S.? According to the FDA, ADRs represent up to 7% of all hospital admissions and cost the U.S. healthcare system more than $30 billion annually. Beyond finances, the emotional and psychological impact on patients and families is immeasurable. A Smarter Approach: Pharmacogenomics The future of drug safety isn’t luck or trial-and-error—it’s DNA-guided prescribing. Pharmacogenomic testing analyzes each patient’s genetic profile to predict drug responses, minimize ADR risk, and enable truly personalized care. Our precision health platform empowers nutrition experts, wellness professionals, and clinical prescribers to make evidence-based decisions—resulting in fewer medication-related complications, reduced liability, and a lower burden on overstretched healthcare systems. For payers and providers, it’s not just safer—it’s smarter: improved patient outcomes, significant ROI, and full HIPAA compliance. The Future Is Precision Forward-thinking care teams are embracing pharmacogenomics as an essential tool in modern practice. As precision health becomes standard, the era of “one-size-fits-all” prescribing is ending, and safer, more effective healthcare is within reach. How is your organization addressing ADR risks? Let’s start a conversation about moving from reactive care to proactive, precision-driven solutions. #PatientSafety #Pharmacogenomics #PrecisionMedicine #HealthcareInnovation #Genomics #WellnessProviders #PatientOutcomes #FutureofHealthcare #ScylexLab Sources: FDA, CDC, National Institutes of Health

Key #Pharmacovigilance Updates from #MARC (#New_Zealand) – June 2025 The Medicines Adverse Reactions Committee (MARC) met in June 2025 to review several important safety issues: 🔹 Panvax Risk Management Plan – Committee recommended additional subgroup analyses (including Māori and Pacific Peoples) in post-pandemic vaccine studies and preparation of guides for vaccinators as part of risk minimisation. 🔹 Arexvy (RSV vaccine) & Guillain-Barré Syndrome (GBS) – While causality remains unconfirmed, the Committee advised aligning the NZ data sheet with Australian information to reflect potential GBS risk. 🔹 Nintedanib & Renal Adverse Events – Recommended updates to NZ product information to include risks of renal failure (including fatal cases), proteinuria, and thrombotic microangiopathy, consistent with EU guidance. 🔹 Macrolide Antibiotics & Cardiovascular Death – Evidence supports a potential class effect (particularly arrhythmia risk with clarithromycin and erythromycin). Recommended harmonising warnings across macrolide data sheets with clarithromycin wording. These discussions highlight MARC’s role in ensuring up-to-date risk communication and patient safety in #New_Zealand. #Pharmacovigilance #DrugSafety #Medsafe #MARC #RSV #Nintedanib #Macrolides #PatientSafety

🔍 Azithromycin: Updated Benefit-Risk Review The German regulator BfArM has completed a re-evaluation of azithromycin to reassess its benefit-risk profile in light of newer safety data. Key risk concerns—including QT-interval prolongation, arrhythmias, and rare cardiovascular death—are under renewed scrutiny. Prescribers should weigh the antibiotic’s benefits against these risks, especially in patients with underlying cardiac conditions or when used with other QT-prolonging agents. 📖 Source: BfArM – “Azithromycin: re-evaluation of the benefits and risks” (Risk Assessment Procedure published 2025) https://lnkd.in/dRsJEiPP #Pharmacovigilance #DrugSafety #Azithromycin #BenefitRisk #RegulatoryUpdate #CardiovascularSafety #Antibiotics #PatientSafety

Europe’s Pharmacovigilance Risk Assessment Committee (PRAC) has issued a critical safety warning regarding caspofungin usage in critically ill patients undergoing renal dialysis. The PRAC alert highlights potential hazards associated with using polyacrylonitrile-based membranes during continuous renal replacement therapy (CRRT) for patients treated with caspofungin, an antifungal agent used for invasive candidiasis and aspergillosis. Research indicates that these membranes can bind to caspofungin, reducing its effectiveness and possibly leading to treatment failure. A multicenter in vitro study from France revealed significant caspofungin sequestration due to these membranes, which was not resolved by increasing the drug dose. Alternative treatments, such as fluconazole, or consideration of different hemofiltration membranes may be necessary to ensure effective fungal management. However, a recent in vivo study found no evidence of caspofungin depletion in ICU patients using these membranes, underscoring the need for further investigation on clinical outcomes. For a comprehensive examination of this safety warning and its implications for treatment regimens, please visit www.onehealthupdate.com. https://lnkd.in/gGumHBeb

“Doctor, is this a side effect or an adverse reaction?” This is one of the most common — and confusing — questions patients (and even some healthcare professionals) face. We often use these terms interchangeably, but in reality, they are not the same. Have you ever taken a medicine and felt drowsy, or Heard hair loss during chemotherapy, and wondered: “Is this just a side effect… or something more serious?” Let’s break it down 👇 🔹 Side Effects Definition: Any unintended effect of a drug at normal doses. Nature: Often predictable, related to how the drug works. Examples: • Antihistamines → drowsiness • Chemotherapy drugs → hair loss Note: Sometimes even beneficial (e.g., drowsiness helping in sleep). 🔹 Adverse Drug Reactions (ADR) Definition: A harmful or unpleasant reaction at normal doses. Nature: Always undesirable, can be severe or life-threatening. Examples: • Penicillin → anaphylaxis (serious allergic reaction) • Warfarin → severe bleeding Official Difference Side Effect: Broad term → includes all unintended effects (good, bad, or minor). ADR: Narrower, serious → only those unintended effects that are noxious, harmful, or unpleasant. ⚖️ Key Insight 👉 All ADRs are side effects, but not all side effects are ADRs. This clarity is vital for patient safety, clinical practice, and pharmacovigilance reporting. ✅ In practice: Regulatory bodies like WHO, US FDA, EMA, and CDSCO (India) use both terms, but ADR is the term used in pharmacovigilance reporting, while “side effects” is used more in patient communication (like in medication leaflets). 💡 Next time you hear someone use “side effect” and “ADR” interchangeably, will you pause and think about the difference? #MedicationSafety #ADR #PatientCare #Pharmacovigilance #Healthcare #LetsLiveAgain