Introduction
Pharmacovigilance (PV) is the science of monitoring, detecting, assessing, and preventing adverse effects or other drug-related problems. It ensures that medications remain safe and effective for public use. The importance of PV cannot be overstated, as adverse drug reactions (ADRs) contribute to a significant number of hospitalisations, fatalities, and economic burdens worldwide.
In the United States, ADRs cause approximately 128,000 deaths annually (JAMA Study, 1998). In the European Union, ADRs are responsible for an estimated 197,000 deaths per year (European Commission Report, 2008).
Agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organisation (WHO) have established robust pharmacovigilance systems to ensure drug safety.
With the rise of artificial intelligence, real-world evidence (RWE), and big data analytics, pharmacovigilance is evolving to detect safety concerns earlier and more efficiently.
The Need for Pharmacovigilance
A Public Health Concern
ADRs contribute significantly to hospital admissions and healthcare costs. Research shows that:
10% of all hospital admissions worldwide are due to ADRs, and 5% of hospitalised patients experience an ADR (BMJ Study, 2004).
In the United States, ADR-related costs exceed $136 billion annually, surpassing the costs of several chronic diseases such as diabetes (American Journal of Medicine, 2018).
Underreporting of ADRs
One of the biggest challenges in pharmacovigilance is underreporting. Studies suggest that only 5-10% of ADRs are ever reported, leaving significant gaps in safety monitoring (Hazell & Shakir, Drug Safety, 2006).
History and Evolution of Pharmacovigilance
The Thalidomide Disaster
The thalidomide tragedy of the 1950s-60s remains one of the most infamous medical disasters. Thalidomide, prescribed for morning sickness, led to over 10,000 infants worldwide being born with severe birth defects (The Lancet, 1961).
Regulatory Developments
WHO launched the International Drug Monitoring Programme (1968) to strengthen global pharmacovigilance (WHO Report).
The International Council for Harmonisation (ICH) was established to standardise pharmacovigilance regulations globally (ICH Official Website).
Key Concepts in Pharmacovigilance
Adverse Drug Reactions (ADRs): Any harmful reaction to a drug at normal doses. ADRs are responsible for 3-6% of all hospital deaths (JAMA Study, 1998).
Signal Detection: Identifying patterns in ADR data to detect potential safety concerns.
Risk-Benefit Analysis: Evaluating whether a drug's benefits outweigh its risks.
The Pharmacovigilance Process
Pre-Market Drug Safety
Before a drug is approved, it undergoes clinical trials (Phases 1-3) to assess its safety. However, these trials often lack long-term data and may not detect rare ADRs.
Post-Market Surveillance
Once a drug is in widespread use, real-world monitoring becomes crucial. Regulatory agencies require pharmaceutical companies to submit Periodic Safety Update Reports (PSURs) (EMA Guidelines).
Global Pharmacovigilance Systems
Major Regulatory Agencies
FDA’s FAERS (U.S.): Collects ADR reports for analysis (FAERS Database).
EudraVigilance (Europe): The EU’s central ADR monitoring database (EudraVigilance).
WHO’s VigiBase: The world’s largest ADR database (VigiBase).
Technologies in Pharmacovigilance
Real-World Evidence (RWE): Data from electronic health records and wearable devices help identify drug safety trends (FDA RWE Guidelines).
Mobile Health Apps: Patients can report ADRs directly, improving data collection. Example : OnTracka
Cloud-based patient management systems: Effective data-driven safety monitoring of patient and participant cohorts are made possible by Patient Management Systems, like Hybrid Healthcare Cloud by OnTracka
Case Studies in Pharmacovigilance
Rofecoxib (Vioxx): Withdrawn in 2004 due to cardiovascular risks (NEJM Study, 2005).
COVID-19 Vaccines: Monitored globally for safety (WHO COVID-19 Safety Report).
Diethylstilbestrol (DES): Linked to cancer risks, highlighting the importance of long-term drug safety studies (NIH Report).
Challenges in Pharmacovigilance
Underreporting of ADRs affects safety analysis.
Lack of global standardisation complicates data sharing.
Bias in ADR reporting impacts regulatory decisions.
Future of Pharmacovigilance
AI-driven predictive analytics will enhance ADR detection.
Pharmacogenomics will personalise medicine to reduce ADR risks.
Blockchain technology may improve transparency in drug safety monitoring (Blockchain in Healthcare, 2021).
Conclusion
Pharmacovigilance is essential for ensuring drug safety, preventing ADR-related hospitalisations and deaths, and maintaining public trust in medications. With advancements in AI, real-world evidence, and global collaboration, pharmacovigilance is becoming more efficient and predictive, ensuring safer medications for everyone.