Pharmacovigilance
What is Pharmacovigilance?
PV is the science and interventions to evaluate and prevent ADRs and other drug- and medication-related problems. It is an essential public health function to monitor the safe and effective use of medicines across their life-cycles, from clinical trials to post-marketing surveillance.
The main objectives of pharmacovigilance are:
- For the identification of unknown adverse reactions.
- The frequency and intensity of recognised side effects.
- To determine the risk-benefit of the medicine.
- To ensure that the drug safety information is reported and used properly by regulatory authorities and medical practitioners.
Significance of Pharmacovigilance in the Healthcare Industry
Patient Safety
The prime objective of pharmacovigilance is the protection of the wellbeing of the patient. Through the continuous monitoring of drug safety, PV helps minimize the damage of ADRs and therefore contributes to raise efficacy of treatment.
Regulatory Compliance
All pharmaceutical industry organizations must satisfy national and international pharmacovigilance rules, namely:
- The U.S. Food and Drug Administration (FDA)
- EMA Z drugs are approved by the European Medicines Agency (EMA)
- Central Drugs Standard Control Organisation (CDSCO, India)
- World Health Organization (WHO)
Enhancing Public Trust
Timely drug safety monitoring allows people to have confidence in the safety of the drugs they take, as well as confidence in the healthcare providers who prescribe these drugs, and in the regulatory agencies who monitor such drugs.
Pharmacovigilance: Past, Present, and Future
The original origins of current pharmacovigilance began with the thalidomide disaster in the 1960s that caused mass birth defects and served to establish more formal drug safety protocols around the world.
Key Milestones
- 1961: Thalidomide tragedy leads to worldwide recognition.
- 1968: Programme for International Drug Monitoring established by WHO.
- 1995: Founded EudraVigilance in Europe.
2000s: Integration of pharmacovigilance with e-health and real-world data as a result of technological progress.
Key aspects of pharmacovigilance
Adverse Drug Reactions (ADRs)
Undesirable or adverse reactions which occur after a drug has been used under approved conditions.
Signal Detection
identification and prioritization of safety evidence from diverse data sources to generate new information.
Benefit-Risk Assessment
Weighing the pros and cons of a drug to make a judgment whether the benefits of the drug clearly outweigh the drawbacks.
Risk Management Plan (RMP)
A detailed strategy to determine, assess, and mitigate a drug’s safety risks over time.
Rose V. Pharmacovigilance Activity Types
Spontaneous Reporting
ADRICH(*) Voluntary reporting of ADRs from healthcare professionals and patients to the national competent authority.
Active Surveillance
Routine acquisition of data in defined populations such as prescription event monitoring or patient registries.
Cohort Event Monitoring
Pharmacovigilance: the monitoring of test patients over time to collect ADRs and more information on drug action.
Selected Clinical Studies
Performing directed research to evaluate the safety of a drug in certain situations or populations.
Pharmacovigilance Database and System
Global Databases
- VigiBase (WHO)
- FAERS (Fuel and Drug Administration Adverse Event Reporting System)
- EudraVigilance (EV) (European Medicines Agency)
- Indian PvPI (Pharmacovigilance Programme OF India)
Software Tools
- Oracle Argus Safety
- ARISg
- MedDRA (Medical Dictionary for Regulatory Activities)
Such tools assist in the ease of reporting of adverse events, case processing and signal detection.
Pharmacovigilance in Pharmaceutical Companies
Role in Drug Development
Pharmacovigilance is important in all phases:
- Pre-Clinical and Clinical Studies: Monitoring safety in experimental or closed conditions.
- Post-Marketing Surveillance: Monitoring Use of medications in the general population after they have been released for sale (From Martindale, The Extra Pharmacopoeia, 30th ed, p226, p29) Concept of drug safety monitoring.
Regulatory Submissions
Pharmaceutical companies are required to report many kinds of safety information to regulators:
- Adverse Events / AdverseEventswithGrade3_4 ICSRs (Individual Case Safety Reports).
- Periodic Safety Update Reports (PSUR)
- DSURs (Development Safety Update Reports)
- Risk Management Plans (RMPs)
Jobs in the field of Pharmacovigilance
Key Roles
- Drug Safety Associate
- Pharmacovigilance Officer
- Medical Reviewer
- Signal Detection Analyst
- Aggregate Report Writer
- responsible person for pharmacovigilance (pharmacovigilance responsible person)
Required Skills
- Academic background is a pharmacy, medical or life sciences discipline.
- Familiarity with GVP, ICH and regulatory requirements.
- Experience with safety databases
- Skills of Data Analysis and Communication
Employers
- The Big Pharma (Pfizer, Roche, GSK, etc.)
- Psych Data Entry: That thing that happens when you get signed up for some sort of plasibo psych test at a major research center or pharmaceurical company (IQVIA, Parexel etc.)
- Regulatory bodies
- Health IT & consulting companies
Issues Related to Pharmacovigilance
Data Overload
The explosion of electronic health record, patient app, and real-world data presents headaches of data integration and analysis.
Global Regulatory Variations
Countries have varying reporting requirements, time frame for reports, and data templates.
The Trade-Off Between Immune Innovation and Safety
Striking the right balance between accelerating drug approval and maintaining a stringent approach for safety is a difficult one.
12 Future of Pharmacovigilance
AI and Robotics
So, what are AI and machine learning even for?
- Automated case processing
- Pattern recognition in the detection of signals
- Risk assessment using predictive analytics
Real-World Evidence (RWE)
Leveraging real-world, wearable, and registry data to improve drug safety signals.
Patient-Centric Approaches
Engaging patients directly through mobile apps and portals to report adverse events in real time.
Global Harmonization
Work is being done to standardize reporting and enhance cooperation across borders.
Frequently Asked Questions (FAQ) About Pharmacovigilance
Why do we need pharmacovigilance?
It provides the mechanism to protect public health through the surveillance of adverse drug reactions and minimize injury and risk associated with drugs.
Who can provide an ADR report?
ADRs may be reported by healthcare professionals, patients, caregivers, and pharmaceutical companies.
Pharmacovigilance How is data collected?
[1] Spontaneous reports, clinical trials, registries, patient surveys, and electronic health records.
What is needed to work in pharmacovigilance?
Normally qualification in pharmacy, medicine, nursing, life science, etc. Specialized education or certification is also an advantage.
What are the popular tools / softwares / technology in pharmacovigilance?
Top systems are Oracle Argus, ARISg, MedDRA and WHO’s VigiBase.
Is pharmacovigilance a good career?
Yes, it’s an emerging field that can lead to job opportunities all over the world, job security and the chance to make an impact in healthcare.
What do regulators do with pharmacovigilance data?
They review the data in order to update drug labels, issue safety warnings and occasionally pull drugs from the market.
Can Phramacovigilance be outsourced?
Many companies outsource PV but to Contract Research Organizations (CROs) and dedicated PV service vendors.
How frequently are safety reports sent in?
It varies depending on the nature of the report and how often you have to make it, quarterly on up to annually.”
How has coronavirus affected pharmacovigilance in drug safety space?
It sped up the use of digital tools and underscored the importance of real-time adverse event monitoring around vaccines and treatments.
Conclusion
Pharmacovigilance is fundamental to the practice of contemporary medicine, it is an ongoing exercise to ensure that the medications that are available remain safe and effective. From tragedy to AI-and real-world data-fueled present day, the field of pharmacovigilance has come a long way. For patients, it represents safer treatments; for professionals, it represents a fulfilling and impactful career.
Whatever your role – whether you are a student, healthcare professional or business – getting to grips with what pharmacovigilance is and how it works is simply crucial to health worldwide. Pharmacovigilance will continue to lead the way in drug safety and patient care as the world learns and develops.