Adverse-Events

Adverse Events Unreported: The Need for a Side Effect Monitoring System in Anticoagulation

Anticoagulant medications save lives every day. They prevent strokes, stop clots from forming, and reduce the risk of deadly complications. Yet these same drugs also carry serious risks: bleeding, drug interactions, and unpredictable side effects. In countries with strong pharmacovigilance systems, adverse events are tracked, reported, and analyzed to improve patient safety. In Pakistan, however, this critical safeguard is missing. 

Today, there is no robust nationwide mechanism for monitoring and reporting adverse drug reactions (ADRs), particularly for high-risk medicines like anticoagulants. Patients often experience complications that go unreported, uninvestigated, and unaddressed. Without systematic data, clinicians cannot accurately weigh benefits against risks, policymakers cannot set evidence-based guidelines, and the public remains vulnerable to preventable harm. 

The lack of pharmacovigilance in anticoagulation is especially concerning. Warfarin, direct oral anticoagulants (DOACs), and heparins are widely prescribed, but their safety profiles differ across populations. Genetic factors, dietary habits, and healthcare access all shape how patients in Pakistan respond to these drugs. International data cannot simply be imported; local evidence is essential. 

A national side effect monitoring system would fill this gap. It would: 

  • Collect real-time data on adverse events from hospitals, clinics, and pharmacies. 
  • Enable healthcare workers to report side effects quickly and easily. 
  • Generate population-specific insights that inform guidelines for safer prescribing. 
  • Alert regulators to unsafe practices or counterfeit drugs. 
  • Empower patients by ensuring their experiences contribute to safer healthcare. 

Establishing such a system requires investment, but the costs of inaction are higher: avoidable hospitalizations, higher treatment expenses, and lives lost to preventable complications. Pakistan has the opportunity to build a pharmacovigilance framework tailored to its needs, leveraging digital reporting tools and integrating with global safety networks. 

Anticoagulation therapy is a cornerstone of modern medicine. Without safety monitoring, it is also a gamble. Authorities must act now to protect patients by establishing a robust side effect reporting and monitoring system. Pharmacovigilance is not a luxury—it is a necessity for safe, responsible, and effective healthcare. 

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