Types of Pharmacovigilance: A Comprehensive Overview

Types of Pharmacovigilance encompass various approaches to monitoring the safety and efficacy of medicinal products throughout their lifecycle. These methods ensure that potential risks associated with drugs are identified, assessed, and mitigated effectively, safeguarding public health. From clinical trial monitoring to post-marketing surveillance, each type plays a crucial role in maintaining drug safety and regulatory compliance【1】.

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1. Clinical Trial Pharmacovigilance

Clinical trial pharmacovigilance is one the types of pharmacovigilance. It focuses on ensuring the safety of investigational drugs during their development stages (Phase I-IV trials). Activities in this category include:

• Adverse Event Reporting: Identifying and documenting adverse events (AEs) during trials.
• Risk Assessment: Regularly analyzing safety data to determine risk-benefit ratios.
• Regulatory Compliance: Meeting the safety reporting requirements set by agencies like the FDA and EMA.

Studies show that effective pharmacovigilance during clinical trials significantly reduces post-marketing safety issues【2】.

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2. Post-Marketing Pharmacovigilance

Once a drug is approved and enters the market, pharmacovigilance efforts shift to post-marketing surveillance. This phase involves:

• Spontaneous Reporting Systems (SRS): Healthcare providers and consumers report adverse drug reactions (ADRs) voluntarily. Notable systems include the FDA’s FAERS and the EMA’s EudraVigilance【3】【4】.
• Periodic Safety Update Reports (PSURs): Manufacturers periodically submit safety updates to regulatory authorities.
• Real-World Data Analysis: Using data from electronic health records and insurance claims to detect safety signals.

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3. Passive Pharmacovigilance

Passive pharmacovigilance relies on voluntary reporting of ADRs by healthcare professionals and patients. This system is cost-effective and widely used but is limited by underreporting, which can skew safety data【5】.

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4. Active Pharmacovigilance

Active pharmacovigilance involves proactive measures to gather safety data, often through studies like:

• Cohort Event Monitoring (CEM): Monitoring specific groups of patients over time for ADRs.
• Prescription Event Monitoring (PEM): Linking prescription data with reported ADRs to detect patterns.

This approach provides more robust data compared to passive systems【6】.

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5. Targeted Pharmacovigilance

Targeted pharmacovigilance focuses on specific populations or drugs identified as high risk. For example, it may monitor populations such as pregnant women or elderly patients taking new medications【7】.

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6. Comparative Pharmacovigilance

Comparative pharmacovigilance examines the safety profiles of similar drugs (e.g., generics vs. brand-name drugs) to identify any disparities in ADR frequency or severity.

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7. Regional and National Pharmacovigilance

Pharmacovigilance can also be classified based on geographic scope:

• National Programs: Such as India’s Pharmacovigilance Programme of India (PvPI)【8】.
• Regional Collaborations: Initiatives like the African Union’s Pharmacovigilance Network emphasize building capacity in under-resourced areas【9】.

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8. Herbal and Traditional Medicine Pharmacovigilance

With increasing global use of herbal medicines, monitoring their safety is essential. WHO has advocated for integrating herbal pharmacovigilance into national programs【10】.

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9. Vaccine Pharmacovigilance

This type focuses on monitoring the safety of vaccines, particularly in light of large-scale immunization programs. It gained prominence during the COVID-19 pandemic, emphasizing signal detection for rare adverse events【11】.

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Types of Pharmacovigilance: Conclusion

Pharmacovigilance is a multifaceted discipline, with types tailored to different stages of drug development and use. A robust pharmacovigilance framework, combining active and passive approaches, is essential for ensuring patient safety and maintaining public trust in healthcare systems.

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References

1. World Health Organization. “Pharmacovigilance: Ensuring the Safe Use of Medicines.” WHO, 2022.
2. Arora, A., & Sharma, S. (2013). “Clinical trial pharmacovigilance: Challenges and opportunities.” International Journal of Clinical Trials, 2(4), 78-85.
3. FDA Adverse Event Reporting System (FAERS). Accessed 2023.
4. European Medicines Agency. “EudraVigilance.” EMA, 2022.
5. Hazell, L., & Shakir, S. A. W. (2006). “Under-reporting of adverse drug reactions.” Drug Safety, 29(5), 385–396.
6. Edwards, I. R., & Aronson, J. K. (2000). “Adverse drug reactions: definitions, diagnosis, and management.” The Lancet, 356(9237), 1255-1259.
7. Harpaz, R., et al. (2012). “Performance of pharmacovigilance signal-detection algorithms for the FDA Adverse Event Reporting System.” Clinical Pharmacology & Therapeutics, 93(6), 539-546.
8. “Pharmacovigilance Programme of India (PvPI).” Indian Pharmacopoeia Commission, 2022.
9. Olsson, S. (2008). “The role of the WHO Programme for International Drug Monitoring in coordinating worldwide drug safety efforts.” Drug Safety, 31(6), 511–515.
10. World Health Organization. “Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems.” WHO, 2004.
11. CDC. “Vaccine Adverse Event Reporting System (VAERS).” Accessed 2023.