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Dear Colleagues, For Your information my charge-free e-book " Assessment of adverse reactions" You can buy "Basic course of Pharmacovigilance" and "Pharmacovigilance Quality System" Follow for updates. Sincerely Yours, Galyna Cordero [email protected] Incorporating established frameworks like those provided by the World Health Organization (WHO) and the Naranjo algorithm into clinical practice enhances our ability to evaluate causality effectively. By systematically analyzing cases where adverse reactions occur—such as gastrointestinal disturbances following non-steroidal anti-inflammatory drug (NSAID) use or neurological symptoms after initiating antidepressant therapy—healthcare providers can make informed decisions regarding medication adjustments or alternative therapies.  Moreover, understanding adverse reactions contributes significantly to pharmacovigilance efforts to improve drug safety profiles over time. Continuous monitoring allows for identifying patterns that may not be evident in initial clinical trials due to limited sample sizes or controlled environments. This ongoing assessment is vital for updating treatment guidelines and ensuring that healthcare providers are equipped with current information on potential risks associated with specific medications. 1 Introduction to Adverse Reactions 1.1 Definition and Importance  Adverse reactions, often called adverse drug reactions (ADRs), are unintended and harmful responses to medications or treatments that can significantly impact patient health. These reactions can arise from various sources, including pharmacological properties of the drugs, individual patient characteristics such as genetics and preexisting conditions, and environmental factors. Understanding the definition of adverse reactions is crucial for healthcare professionals as it lays the foundation for effective monitoring, reporting, and management strategies to enhance patient safety.  The importance of recognizing and assessing adverse reactions cannot be overstated. They pose a substantial risk to patients, potentially leading to severe health complications or even fatalities. For instance, a seemingly benign medication may cause an unexpected allergic reaction in a susceptible individual, highlighting the need for vigilance in clinical practice. Furthermore, adverse reactions can lead to increased healthcare costs due to additional treatments required for managing these effects or prolonged hospital stays.  Incorporating established frameworks like those provided by the World Health Organization (WHO) and the Naranjo algorithm into clinical practice enhances our ability to evaluate causality effectively. #ebook #pharmacovigilance #drugsafety #patientsafety #education

🌍 World Pharmacists Day Reflections: Bridging the Knowledge Gap in Pharmacovigilance 💊 Yesterday, we celebrated #WorldPharmacistsDay with the theme: "Pharmacists: Meeting Global Health Needs." As a pharmacy student passionate about drug safety and pharmacovigilance, I’ve noticed a critical gap in public awareness regarding adverse drug reactions (ADRs), particularly in Nigeria. Many patients remain unaware of the importance of reporting side effects or complications from medications, leading to underreporting and preventable harm. Pharmacists are key in educating patients on the safe use of medications, encouraging them to report ADRs, and fostering a culture of pharmacovigilance. However, it’s concerning that many Nigerians may experience negative effects from medications and dismiss them without seeking professional advice. This compromises not only patient safety but also hinders efforts to track and manage risks associated with medications. In today's rapidly evolving healthcare landscape, monitoring and safeguarding against adverse drug reactions has never been more important. Pharmacovigilance is not just about reacting to problems, but also proactively preventing harm and ensuring the efficacy and safety of medications globally. We need to do more to raise awareness and build trust in the reporting systems by: * Educating patients on the significance of ADR reporting. * Enhancing pharmacist-patient communication. * Collaborating with global and local regulatory bodies to promote drug safety. As future pharmacists and healthcare professionals, it’s our responsibility to lead the charge in closing this knowledge gap and promoting safer medication practices in Nigeria and beyond. I'm passionate about contributing to this field and advancing the conversation around drug safety. Let’s connect and work together to enhance the future of pharmacovigilance, both locally and globally, ensuring better health outcomes for all. #PharmacistsMeetingGlobalHealthNeeds #Pharmacovigilance #AdverseDrugReactions #DrugSafety #PatientEducation #GlobalHealth #WorldPharmacistsDay #Nigeria #WHO #HealthcareInnovation #FuturePharmacist #PublicHealth #PatientSafety

I came across this amazing post💥. And I found it to be interesting and helpful as it's explained in a simple way and easy to learn and remember ✅. #pharmacovigilance #medical_terminologies

Pharmacovigilance Session 📝 Admission Helpline 📞: +91-9560102589 #BPharm #MPharm #PharmD #Pharma #Pharmacovigilance #PharmacyEducation #DrugSafety #ClinicalPharmacy #MedicationManagement #PharmaIndustry #Pharmacists #Pharmacology #HealthcareProfessionals #PharmacyLife #MedicineResearch #DrugDevelopment #PatientSafety #HealthcareInnovation #PharmacySchool

THE SAFETY SPOTLIGHT: EXPLORING INTRIGUING PHARMACOVIGILANCE CASES A series where we delve into compelling real-world pharmacovigilance cases that highlight unexpected challenges in patient safety. CASE OVERVIEW: A 43-year-old previously healthy male developed Toxic Epidermal Necrolysis (TEN) after taking ibuprofen, a commonly used non-steroidal anti-inflammatory drug (NSAID). This severe adverse reaction presented several unique challenges: Extensive Skin Involvement: The patient exhibited widespread skin desquamation, affecting 70% of the total body surface area. Complications: The extensive skin loss led to secondary bacterial infections, including Acinetobacter baumannii, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Management: The patient required hospitalization in a burn center, administration of antibiotics (colistin and meropenem), and supportive care, including hydration and nutritional support. Why This Matters? While ibuprofen is widely considered safe and is available over-the-counter, this case underscores the importance of recognizing rare but life-threatening adverse reactions such as TEN. Early diagnosis, immediate discontinuation of the offending drug, and prompt supportive management are crucial to improving patient outcomes. This case also highlights the need for healthcare professionals to be vigilant for severe cutaneous adverse reactions, even with commonly used medications. I wanted to share this case as a reminder of the importance of monitoring for severe adverse drug reactions and the critical role of pharmacovigilance in ensuring patient safety. If you have encountered similar cases or have insights on adverse drug reactions associated with NSAIDs, I would appreciate your thoughts. Stay tuned for more intriguing pharmacovigilance cases in this series, and feel free to share your experiences and insights to enrich our collective learning. Reference: The First Documented Ibuprofen-Induced Toxic Epidermal Necrolysis in the Middle East and North Africa Region: A Case Report, Complications, and Management. https://lnkd.in/g4b5e38Z #Pharmacovigilance #DrugSafety #PatientSafety

🚀 Updates in Good Pharmacovigilance Practices (GVP)! 🚀 Recent publication of several EMA key guidance documents, effective from August 6th, 2024, including: *GVP Module XVI – Risk minimisation measures (Rev 3) *GVP Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures (New!) *GVP Annex I - Definitions (Rev. 5) *GVP Introductory cover note (updated) Eignapharma experts have made a thorough analysis and want to highlight the Module XVI Addendum II that was launched for public consultation in 2021. To assess RMM results and emphasizing the importance of mixed methods approaches, appropriate sampling strategies, and patient-reported outcomes, the final version provides a detailed guidance on #methods for evaluating the effectiveness of risk minimisation measures (RMM) by outlining various data sources (e.g., surveys, registries, medical records) and research methods (e.g., qualitative, pharmacoepidemiologic). #Eignapharma #EMA #GVP #pharmacovigilance #RMP #RMM

🚀 Updates in Good Pharmacovigilance Practices (GVP)! 🚀 Recent publication of several EMA key guidance documents, effective from August 6th, 2024, including: *GVP Module XVI – Risk minimisation measures (Rev 3) *GVP Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures (New!) *GVP Annex I - Definitions (Rev. 5) *GVP Introductory cover note (updated) Eignapharma experts have made a thorough analysis and want to highlight the Module XVI Addendum II that was launched for public consultation in 2021. To assess RMM results and emphasizing the importance of mixed methods approaches, appropriate sampling strategies, and patient-reported outcomes, the final version provides a detailed guidance on #methods for evaluating the effectiveness of risk minimisation measures (RMM) by outlining various data sources (e.g., surveys, registries, medical records) and research methods (e.g., qualitative, pharmacoepidemiologic). #Eignapharma #EMA #GVP #pharmacovigilance #RMP #RMM

Adverse Drug Reporting: A Critical Pillar of Public Health in Pakistan I recently completed a webinar on pharmacovigilance, a vital aspect of ensuring drug safety. In Pakistan, where healthcare infrastructure faces numerous challenges, adverse drug reporting (ADR) plays a crucial role in protecting public health. Despite being the fifth most populous country, with over 240 million people, Pakistan struggles with an underdeveloped pharmacovigilance system. According to the World Health Organization (WHO), only 2% of adverse drug reactions are reported in low- and middle-income countries, including Pakistan. This low reporting rate significantly hampers the ability to monitor and mitigate drug-related risks effectively. In 2023, Pakistan's Drug Regulatory Authority (DRAP) received approximately 12,000 ADR reports, a number that pales in comparison to the actual incidences, as estimated by public health experts. This discrepancy highlights the need for greater awareness and robust reporting mechanisms across the country. Effective ADR reporting is not just a regulatory requirement but a moral obligation for all healthcare professionals. Strengthening pharmacovigilance can lead to safer healthcare practices, better patient outcomes, and enhanced public trust in the healthcare system. Many thanks to Dr. Soha F. and RxConnect for providing us with invaluable opportunities for continued education and staying updated in our field. Your efforts are truly appreciated and make a significant impact on our professional growth.