This newsletter from the Egyptian Pharmaceutical Vigilance Center (EPVC) highlights a critical medication error risk and a common adverse drug reaction, alongside updates on national pharmacovigilance activities.
1. Critical Safety Alert: Tranexamic Acid Injection (DHPC)
- Issue: A serious risk of medication errors where Tranexamic Acid injection is mistakenly administered intrathecally (into the spinal canal) instead of a local anesthetic like bupivacaine.
- Consequence: This error can cause severe, life-threatening injuries, including seizures, cardiac arrhythmias, permanent neurological damage (paraplegia), and death.
- Cause: Similar packaging and vial appearance between the products contribute to the mix-ups.
- Preventive Measures Recommended:
- Store separately from other drugs to avoid confusion.
- Use auxiliary warning labels on the vials.
- Double-check the label before administration.
- Utilize barcode scanning in medication cabinets.
2. Local Case Report: Statin-Induced Muscle Pain
- Incident: A case of a 45-year-old female who experienced persistent muscle aches (myalgia) after starting Atorvastatin for high cholesterol.
- Background: Muscle-related adverse effects are a well-known side effect of statins, ranging from mild pain to severe muscle breakdown (rhabdomyolysis).
- Management Recommendations for Healthcare Professionals:
- Consider reducing the dose or implementing a statin “holiday”.
- Switch to a different statin or a non-statin alternative (e.g., Ezetimibe, PCSK9 inhibitors).
- Assess for drug interactions and encourage lifestyle modifications.
3. EPVC News & Initiatives
- Vigiflow Expansion: The EPVC thanked the Egyptian Health Care Authority (EHA) and the Ministry of Health and Population (MoHP) for their high quantity and quality of adverse drug reaction reports submitted to the national database. Specific directorates and hospitals were acknowledged for their contributions.
- “Together for Safe Medicine” Initiative: Registration for the 7th wave of the initiative was announced, continuing the effort to promote pharmacovigilance among pharmacists across Egypt.
4. EPVC Tips: Medication Errors
The newsletter listed common types of medication errors (e.g., wrong dose, wrong drug, wrong route) to raise awareness and emphasize the need for accuracy in prescribing, dispensing, and administering medicines.
