Pharmacovigilance

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a critical role in ensuring that medicines are safe and effective for use by the public.

Key Objectives of Pharmacovigilance:

1. Identify adverse drug reactions (ADRs) early.

2. Improve patient care and safety in relation to the use of medicines.

3. Promote the safe and effective use of drugs, especially through risk-benefit analysis.

4. Inform and support public health policies and decision-making regarding drug use.

Importance of Pharmacovigilance:

• New drugs may have unknown side effects that only become apparent after widespread use.

• It helps to monitor the effectiveness of medications in the real-world setting.

• Ensures compliance with regulatory requirements, helping manufacturers and healthcare providers maintain drug safety.

• Allows for early detection of medication errors, misuse, and abuse.

Main Activities in Pharmacovigilance:

• Spontaneous reporting systems: Collect reports from healthcare professionals and patients on suspected adverse effects.

• Data analysis: Detect patterns or signals of possible risks.

• Risk management: Develop strategies to reduce identified risks.

• Post-marketing surveillance: Ongoing monitoring after a drug is released to the market.

• Regulatory action: Includes changes to product labeling, restrictions on use, or drug withdrawal if necessary.

Organizations Involved:

• World Health Organization (WHO): Coordinates global pharmacovigilance activities.

• Regulatory authorities like:

  • U.S. FDA (Food and Drug Administration)

  • EMA (European Medicines Agency)

  • CDSCO (Central Drugs Standard Control Organization in India)

• Pharmaceutical companies: Required to monitor and report safety data on their products.

Conclusion:

Pharmacovigilance is a vital component of healthcare systems, ensuring ongoing evaluation of medicine safety and protecting public health. Its importance continues to grow with the increasing complexity of therapies and global access to medications.