This newsletter from the Egyptian Pharmaceutical Vigilance Center (EPVC) focuses on a rare but serious adverse drug reaction, updates on national pharmacovigilance training initiatives, and results from the ongoing VigiTest competition.
1. Local Case Report: Colistimethate Sodium-Induced Bartter-like Syndrome
- Incident: A case was reported of an elderly female patient who developed Bartter-like syndrome after receiving intravenous Colistimethate sodium for sepsis.
- Symptoms: The syndrome presented with polyuria (excessive urination) and hypocalcemia (low calcium levels), serious enough to require hospitalization.
- Outcome: The reaction resolved after the antibiotic was stopped.
- Background: Colistin is a last-resort antibiotic for multidrug-resistant infections. Bartter-like syndrome is a rare side effect involving severe electrolyte imbalances.
- Recommendation for Healthcare Professionals:
- Monitor serum electrolytes in patients receiving colistimethate sodium.
- Be aware that discontinuation of the drug may be necessary to correct the imbalance.
2. EPVC News & Initiatives
- “Together for Safe Medicine” Initiative (Wave 7): The EPVC announced the launch of the seventh wave of its national initiative. Pharmacovigilance activities are scheduled to begin in May 2025, aiming to empower pharmacists across Egypt with knowledge on adverse drug reaction (ADR) reporting.
- Training for TB & Chest Centers: The EDA conducted a specialized training program for 85 pharmacists and nurses from chest units in several governorates. The focus was on monitoring adverse events related to TB medications and integrating healthcare providers into the national VigiFlow reporting database to support the National Tuberculosis Control Program.
- Participation in Al Salam University Job Fair: The EPVC participated in a career fair, delivering a lecture on pharmacovigilance principles to approximately 950 pharmacy students. The event aimed to raise awareness about ADR reporting and the risks of substandard medicines among future pharmacists.
3. VigiTest Competition
- The results of the latest VigiTest competition were announced, with 18 participants achieving a perfect score.
- The newsletter published the questions and answers, which tested knowledge on topics like:
- Types of adverse drug reactions (e.g., Type A – dose-dependent).
- The meaning of a “black box warning” (serious/life-threatening risks).
- The importance of post-marketing surveillance.
- A list of the top 10 winners, primarily PV specialists and hospital pharmacists, was published.
4. EPVC Tips: Medical Device Vigilance
This month’s tips focused on reporting issues with medical devices, advising professionals to report:
- Device malfunctions, even if no harm occurred.
- Full device details (model, serial number).
- Incidents related to user error or confusing instructions.
