B.Pharmacy 8th Semester Pharmacovigilance Important Question Answer

B.Pharm 8th Semester Pharmacovigilance Important Question Answer  

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Pharmacovigilance Important Question Answer  

Why to Study Pharmacovigilance?

Pharmacovigilance involves the identification and evaluation of drug safety data to minimize risk and maximize the benefits of medicines. It is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• To improve patient care and safety in relation to the use of medicines.

• To detect new adverse reactions or changes in the frequency/severity of known ADRs.

• To promote safe and effective use of medicines through education and guidance.

• To support regulatory decision-making for drug approvals, labeling, and withdrawal.

✅ Unit-Wise Key Topics in Pharmacovigilance 

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📘 Unit I: Introduction to Pharmacovigilance

Key Topics to Learn:

• Definition and objectives of Pharmacovigilance

• History and development of Pharmacovigilance

• Importance of drug safety and adverse drug reactions (ADRs)

• Scope of Pharmacovigilance in India and globally

• National Pharmacovigilance Program of India (PvPI)

• WHO Programme for International Drug Monitoring (PIDM)

• Key terminologies: ADRs, ADEs, Medication Errors, Pharmacovigilance System

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📘 Unit II: Adverse Drug Reactions (ADRs)

Key Topics to Learn:

• Definition and classification of ADRs

• Types of ADRs: Type A (Augmented), Type B (Bizarre), etc.

• Mechanisms of ADRs (e.g., Immunological, Genetic, Idiosyncratic)

• Risk factors associated with ADRs

• Detection and prevention of ADRs

• Management and reporting of ADRs

• Case studies on serious ADRs

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📘 Unit III: Pharmacovigilance Methods

Key Topics to Learn:

• Passive surveillance:

  • Spontaneous reporting systems (SRS)

  • Voluntary and mandatory reporting

  • CIOMS forms

• Active surveillance:

  • Cohort Event Monitoring (CEM)

  • Targeted Spontaneous Reporting (TSR)

• Data mining and signal detection

• Case-control and cohort studies in PV

• Role of pharmacovigilance in clinical trials (Phase IV)

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📘 Unit IV: Data Management & Regulatory Aspects

Key Topics to Learn:

• Structure and content of Individual Case Safety Reports (ICSRs)

• Database management systems in PV (e.g., Vigibase, EudraVigilance)

• MedDRA (Medical Dictionary for Regulatory Activities)

• WHO Drug Dictionary

• PV regulations in India (CDSCO, Schedule Y)

• International regulatory agencies (FDA, EMA, MHRA, PMDA)

• Role of ICH and CIOMS in PV

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📘 Unit V: Pharmacovigilance in Special Populations and Future Aspects

Key Topics to Learn:

• PV in special populations:

  • Pediatrics

  • Geriatrics

  • Pregnancy and lactation

• Vaccine safety surveillance

• Pharmacogenomics and adverse drug reactions

• PV in herbal/traditional medicines

• Role of hospital and community pharmacists in PV

• Future of Pharmacovigilance (AI, e-Reporting, Global harmonization)

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Pharmacovigilance Very Short Question Answer {2-Marks}  

Q1. What is drug event monitoring? 
Ans: Drug Event Monitoring (DEM) is a pharmacovigilance method used to identify adverse events related to new medicines by actively monitoring patient outcomes during treatment. It involves collecting data from healthcare professionals or patients in real-world settings after a drug is prescribed. 

 

Q2. List four drugs contraindicated in pregnant and lactating women. 
Ans: 

1. Isotretinoin 

2. Thalidomide 

3. Warfarin 

4. Tetracycline 

 

Q3. Suggest the structure for CIOMS form. 
Ans: The CIOMS (Council for International Organizations of Medical Sciences) form includes: 

• Patient details (age, sex) 

• Suspected drug(s) information 

• Adverse reaction description 

• Reporter and manufacturer details 

• Outcome and seriousness of the event 

 

Q4. What is Eudravigilance? 
Ans: Eudravigilance is a centralized European database maintained by the European Medicines Agency (EMA) for managing and analyzing information on suspected adverse reactions to medicines authorized in the European Economic Area. 

 

Q5. What is teratogenicity? Give examples. 
Ans: Teratogenicity refers to the ability of a substance to cause birth defects in a developing fetus. Examples include thalidomide, isotretinoin, and valproic acid. 

 

Q6. What is post marketing safety? 
Ans: Post-marketing safety refers to the monitoring of a drug’s safety profile after it has been approved and released to the market to detect any previously unrecognized adverse drug reactions. 

 

Q7. Narrate the minimum criteria required for a valid report. 
Ans: A valid adverse drug reaction (ADR) report must include: 

1. An identifiable patient 

2. An identifiable reporter 

3. A suspect drug 

4. A suspected adverse reaction 

 

Q8. What is phase IV of clinical trials? 
Ans: Phase IV trials are post-marketing studies conducted after a drug’s approval to monitor its long-term effectiveness, rare side effects, and use in specific populations. 

 

Q9. What are the basic objectives of pharmacovigilance planning? 
Ans: The basic objectives include: 

1. Early detection of unknown ADRs 

2. Monitoring the frequency and severity of known ADRs 

3. Assessing risk-benefit ratio 

4. Improving patient safety 

 

Q10. Mention few examples of predictable adverse drug reactions. 
Ans: 

1. Hypoglycemia with insulin 

2. Bleeding with warfarin 

3. Dry mouth with anticholinergics 

4. Gastric irritation with NSAIDs 

 

Q11. Define the adverse drug reaction. 
Ans: An Adverse Drug Reaction (ADR) is a harmful or unintended response to a medication that occurs at normal therapeutic doses used in humans for prophylaxis, diagnosis, or therapy. 

 

Q12. Compute the limitations of detecting ADRs in clinical trials. 
Ans: Limitations include: 

1. Small sample size 

2. Short study duration 

3. Controlled settings not reflecting real-world use 

4. Exclusion of vulnerable populations (e.g., elderly, children) 

 

Q13. Discuss the PSUR. 
Ans: The Periodic Safety Update Report (PSUR) is a pharmacovigilance document submitted at defined intervals to regulatory authorities to provide an update on the worldwide safety experience of a drug. 

 

Q14. Classify ADRs according to severity. 
Ans: 

• Mild: No intervention needed (e.g., mild rash) 

• Moderate: Requires intervention (e.g., drowsiness) 

• Severe: Life-threatening or leads to hospitalization (e.g., anaphylaxis) 

 

Q15. List out factors affecting adverse effects of the vaccine. 
Ans: 

1. Age and immune status of recipient 

2. Vaccine strain and quality 

3. Dose and route of administration 

4. Presence of preservatives or adjuvants 

 

Q16. What are CIOMS working groups? 
Ans: CIOMS Working Groups are expert panels formed to develop guidelines and harmonize international pharmacovigilance practices to improve drug safety and reporting standards globally. 

 

Q17. Discuss the cohort study with example. 
Ans: A cohort study is an observational study where a group exposed to a drug is followed over time and compared to a non-exposed group. Example: Observing birth defects in infants born to mothers who took valproic acid vs. those who didn’t. 

 

Q18. Discuss the Defined Daily Doses. 
Ans: Defined Daily Dose (DDD) is the assumed average maintenance dose per day for a drug used for its main indication in adults. It helps in standardizing drug usage comparison across regions and time. 

 

Q19. Illustrate the importance of Pharmacogenomics. 
Ans: Pharmacogenomics studies how genetic variations affect drug response. It helps in personalized medicine, reducing ADRs, and optimizing drug efficacy based on an individual’s genetic makeup. 

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Pharmacovigilance Short Question Answer {5-Marks} 

Q1. Explain the establishing pharmacovigilance program in hospital. 
Ans: 
Establishing a hospital-based pharmacovigilance (PV) program is essential to detect, assess, and prevent adverse drug reactions (ADRs). The process includes: 

1. Formation of PV Committee: Consisting of clinical pharmacologists, physicians, pharmacists, and nurses. 

2. Appointment of PV Officer: Responsible for coordinating ADR monitoring. 

3. Infrastructure Setup: Establish a reporting desk, access to ADR forms, and software tools. 

4. Training and Awareness: Educate healthcare professionals on ADR detection and reporting methods. 

5. Data Collection: Use standardized forms (like CDSCO or CIOMS) to collect ADR data. 

6. Reporting: Submit reports to the nearest Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India (PvPI). 

7. Analysis and Feedback: Assess causality, severity, and frequency, and provide feedback to departments. 
   This improves patient safety and strengthens drug use policies. 

 

Q2. What is vaccine safety surveillance? Explain in detail different types of pharmacovigilance methods used for passive and active surveillance. 
Ans: 
Vaccine safety surveillance involves the detection, reporting, and analysis of adverse events following immunization (AEFI). 

• Passive Surveillance: Relies on spontaneous reports from healthcare professionals or patients. 

• Example: WHO's VigiBase or India’s AEFI reporting. 

• Limitation: Underreporting and incomplete data. 

• Active Surveillance: Involves proactive methods like follow-up with vaccinated individuals. 

• Examples include cohort event monitoring, sentinel sites, and electronic health records analysis. 
  This dual approach ensures timely detection of rare or serious AEFIs, boosts public confidence in immunization programs, and helps modify vaccine strategies. 

 

Q3. Discuss in detail establishment and operation of drug safety department in pharmaceutical industry. 
Ans: 
A Drug Safety Department (DSD) ensures ongoing safety monitoring throughout a drug’s life cycle. 
Establishment Steps: 

1. Staffing: Trained pharmacovigilance professionals and medical reviewers. 

2. Infrastructure: Set up safety databases and compliance systems. 

3. SOP Development: Standard operating procedures for case processing, signal detection, and regulatory compliance. 
   Operation Includes: 

• Case Processing: Collecting and evaluating individual case safety reports (ICSRs). 

• Signal Detection: Using statistical methods to identify potential safety concerns. 

• Regulatory Reporting: Submitting PSURs, DSURs, and expedited reports to regulatory authorities like CDSCO, EMA, or USFDA. 

• Risk Management: Implementing Risk Evaluation and Mitigation Strategies (REMS) as needed. 
  Effective DSDs ensure compliance, safeguard patient health, and maintain product integrity. 

 

Q4. Mention the important aspects of ICH guidelines for expedited reporting. 
Ans: 
ICH guidelines (E2A) provide a harmonized approach for reporting serious and unexpected adverse drug reactions: 

1. Expedited Reporting Timeframe: 

1. Fatal or life-threatening ADRs: within 7 days 

2. Other serious unexpected ADRs: within 15 days 

2. Criteria for Reporting: 

1. Unexpected 

2. Serious (life-threatening, hospitalization, disability) 

3. Possibly related to the drug 

3. Format: CIOMS I form or electronic equivalent 

4. Follow-up Information: Must be submitted as soon as available. 

5. Reporting Entities: Sponsor is responsible during clinical trials. 
   This ensures timely communication of serious safety concerns to regulatory authorities globally. 

 

Q5. Write short note on pharmacogenomics and adverse drug reaction. 
Ans: 
Pharmacogenomics studies how an individual's genetic makeup affects drug response. Variations in genes can influence drug metabolism, efficacy, and risk of ADRs. 
Examples: 

• CYP2D6 polymorphism affects codeine metabolism. 

• HLA-B*1502 increases risk of Stevens-Johnson Syndrome with carbamazepine in Asians. 
  Pharmacogenomics helps in: 

• Predicting ADRs 

• Optimizing dosage 

• Avoiding ineffective drugs 

• Enabling personalized medicine 
  This minimizes ADR risks and improves therapeutic outcomes. 

 

Q6. How will you carry out drug safety evaluation in geriatric and pediatric populations? 
Ans: 
Drug safety evaluation in geriatrics and pediatrics requires special consideration due to physiological differences. 
In Geriatrics: 

• Altered pharmacokinetics due to reduced renal/hepatic function 

• Polypharmacy increases ADR risk 

• Close monitoring for cognitive or bleeding events 
  In Pediatrics: 

• Immature organ function affects metabolism 

• Dosage adjustments based on body weight/surface area 

• Ethical considerations in trials 
  Methods include active surveillance, population-specific clinical trials, and real-world data analysis. Proper labeling and age-appropriate formulations are crucial. 

 

Q7. What is the role of CDSCO in pharmacovigilance? Write a note on ATC classification of drugs. 
Ans: 
CDSCO Role: 

• Acts as the national regulatory authority for pharmacovigilance in India 

• Implements PvPI through IPC, Ghaziabad 

• Evaluates safety data, mandates labeling changes 

• Monitors ADRs via AMCs 
  ATC Classification: 
  The Anatomical Therapeutic Chemical (ATC) system classifies drugs based on: 

1. Anatomical main group 

2. Therapeutic subgroup 

3. Pharmacological subgroup 

4. Chemical subgroup 

5. Chemical substance 
   Example: Paracetamol – N02BE01 
   This system is used for drug utilization studies globally. 

 

Q8. Characterize the different methods of causality and severity assessment of ADRs and explain Naranjo’s scale. 
Ans: 
Causality Assessment Methods: 

1. WHO-UMC scale 

2. Naranjo’s Algorithm 

3. Karch & Lasagna scale 
   Severity Assessment: 

• Mild: No intervention needed 

• Moderate: Requires change in therapy 

• Severe: Life-threatening/hospitalization 
  Naranjo’s Scale: 

• Questionnaire with 10 questions 

• Each answer is scored 

• Total Score: 

• ≥9: Definite 

• 5–8: Probable 

• 1–4: Possible 

• 0: Doubtful 
  This helps determine if the ADR is truly due to the drug or other factors. 

 

Q9. Demonstrate the prerequisite for setting up a pharmacovigilance center in a CRO and hospital. 
Ans: 
In a Hospital: 

• Trained staff and designated ADR monitoring team 

• Access to patient medical records 

• Standard ADR reporting forms 

• Collaboration with PvPI 
  In a CRO (Contract Research Organization): 

• SOPs for safety data handling 

• Pharmacovigilance database system 

• Qualified Person for Pharmacovigilance (QPPV) 

• Audit and compliance systems 
  Both settings must ensure confidentiality, proper data handling, and adherence to regulatory standards. 

 

Q10. Define vaccine. Explain reasons for vaccination failure. 
Ans: 
Vaccine: A biological preparation that stimulates an immune response to prevent specific infectious diseases. 
Vaccination Failure Reasons: 

• Improper storage (cold chain failure) 

• Incomplete immunization schedule 

• Host factors (e.g., immunodeficiency) 

• Wrong route or dose 

• Vaccine quality or manufacturing defects 
  Effective surveillance and training are needed to minimize failure. 

 

Q11. Summarize the ATC classification of drugs with example. 
Ans: 
The ATC classification, developed by WHO, categorizes drugs based on the organ/system they act on and their chemical, pharmacological, and therapeutic properties. 
Structure: 

1. Anatomical Group (1 letter) 

2. Therapeutic Group (2 digits) 

3. Pharmacological Group (1 letter) 

4. Chemical Group (1 letter) 

5. Specific Drug (2 digits) 
   Example: Omeprazole – A02BC01 

• A: Alimentary tract 

• 02: Drugs for acid disorders 

• B: Antiulcer agents 

• C: Proton pump inhibitors 

• 01: Omeprazole 
  It supports global pharmacovigilance and drug usage studies. 

 

Q12. Explore the Pre-marketing and Post-marketing clinical trials. 
Ans: 
Pre-marketing Trials: 

• Phase I: Safety and dosage in healthy volunteers 

• Phase II: Efficacy in patient population 

• Phase III: Large-scale efficacy and safety studies 
  Post-marketing Trials (Phase IV): 

• Real-world monitoring 

• Detecting rare or long-term ADRs 

• Additional indications and populations 
  They together ensure a complete safety profile of a drug throughout its life cycle. 

 

Q13. Illustrate the organization and objectives of ICH. 
Ans: 
ICH (International Council for Harmonisation) brings together regulatory authorities and pharmaceutical industry to ensure drug safety and efficacy through harmonized guidelines. 
Organization: 

• Members: EU, USA, Japan, etc. 

• Working groups (e.g., E2, Q1) 
  Objectives: 

• Standardize technical guidelines 

• Promote public health 

• Reduce duplication of clinical trials 

• Ensure global drug safety 
  Guidelines like E2E (pharmacovigilance) have global impact on ADR reporting. 

 

Q14. Explain the Schedule Y of Drugs and Cosmetics Act in brief. 
Ans: 
Schedule Y outlines the regulatory requirements for clinical trials in India. 
Key Features: 

• Phases I–IV of clinical trials 

• Ethics committee approval 

• Informed consent process 

• SAE (Serious Adverse Event) reporting timelines 

• Investigator responsibilities 
  Revised Schedule Y (2005) enhanced focus on safety, ethics, and GCP (Good Clinical Practice) in Indian clinical trials. 

 

 

Pharmacovigilance Long Question Answer {10-Marks} 

Q1. Classify adverse drug reaction. How will you detect and report ADR along with causality assessment scales? 
Ans: 
Adverse Drug Reactions (ADRs) are unintended and harmful reactions that occur at normal therapeutic doses. The classification of ADRs helps in identifying their nature, risk factors, and management. 

Classification of ADRs: 

1. Type A (Augmented): 

1. Dose-dependent and predictable. 

2. Example: Hypoglycemia with insulin. 

2. Type B (Bizarre): 

1. Not dose-dependent, unpredictable, and often due to immunological or genetic factors. 

2. Example: Anaphylaxis with penicillin. 

3. Type C (Chronic): 

1. Occurs with long-term use. 

2. Example: Adrenal suppression with corticosteroids. 

4. Type D (Delayed): 

1. Appears after a long time. 

2. Example: Teratogenic effects or carcinogenesis. 

5. Type E (End of use): 

1. Occurs on drug withdrawal. 

2. Example: Withdrawal seizures after stopping benzodiazepines. 

6. Type F (Failure): 

1. Unexpected failure of therapy. 

2. Example: Antimicrobial resistance. 

Detection of ADRs: 
ADRs can be detected by: 

• Monitoring patient complaints, clinical signs, and abnormal lab values. 

• Spontaneous reporting by healthcare professionals. 

• Reviewing prescriptions and discharge summaries. 

• Interviewing patients during follow-ups. 

ADR Reporting Process: 

1. Use standard forms like CDSCO ADR Form or CIOMS I form. 

2. Fill in details: patient info, suspect drug, reaction description, seriousness, and outcome. 

3. Submit to the nearest Adverse Drug Reaction Monitoring Centre (AMC) or online via PvPI. 

4. The AMC forwards data to NCC-PvPI (Ghaziabad). 

Causality Assessment Scales: 

• WHO-UMC Scale: Categorizes causality into certain, probable, possible, unlikely, etc. 

• Naranjo’s Algorithm: A 10-question scoring system classifying ADR as definite (≥9), probable (5–8), possible (1–4), or doubtful (0). 
  These scales help in determining the relationship between drug and reaction, which is critical for patient safety and regulatory actions. 

 

Q2. Discuss in detail basic and detailed drug information resources in pharmacovigilance. 
Ans: 
In pharmacovigilance, drug information resources are essential for identifying, evaluating, and reporting adverse drug reactions (ADRs). These resources are divided into basic (general) and detailed (specialized) types. 

Basic Drug Information Resources: 
These are commonly used by healthcare professionals for general knowledge and drug use guidance: 

1. National Formularies: 

1. Indian Pharmacopoeia (IP), British National Formulary (BNF) – provide dosage, indications, and side effects. 

2. Package Inserts: 

1. Manufacturer-provided documents describing drug use, warnings, contraindications, and ADRs. 

3. Standard Textbooks: 

1. Goodman & Gilman, Katzung's Pharmacology – offer pharmacokinetics, ADRs, and clinical use. 

4. Online Databases: 

1. Medline, PubMed, Drugs.com – offer peer-reviewed drug information. 

Detailed Drug Information Resources: 
These are specialized resources used for in-depth pharmacovigilance activities such as causality assessment, regulatory reporting, and signal detection. 

1. Micromedex: 

1. Comprehensive database providing evidence-based drug monographs, interactions, and ADRs. 

2. Lexicomp: 

1. Provides detailed clinical drug information, toxicology, and drug ID tools. 

3. Martindale: The Complete Drug Reference: 

1. International reference offering exhaustive drug information, including investigational and herbal drugs. 

4. VigiBase: 

1. WHO global database for individual case safety reports (ICSRs). 

5. MedDRA (Medical Dictionary for Regulatory Activities): 

1. Standardized terminology for ADR coding in regulatory reporting. 

6. FDA and EMA Websites: 

1. Contain drug safety alerts, black box warnings, and risk evaluation documents. 

Importance in Pharmacovigilance: 

• Helps in assessing ADR seriousness and causality. 

• Aids in regulatory compliance and global signal detection. 

• Supports safe prescribing and patient counseling. 

Thus, both basic and detailed resources play a vital role in ensuring safe and effective pharmacotherapy. 

 

Q3. Discuss in detail Cohort and Case-Control study. Explain the applications of MedDRA and standard MedDRA queries. 
Ans: 
Cohort Study: 
A cohort study is a prospective or retrospective observational study where two groups (exposed vs. unexposed) are followed over time to assess the occurrence of specific outcomes, such as ADRs. 

• Advantages: Time-sequencing, risk estimation. 

• Example: Following a group of patients taking valproic acid to assess the risk of neural tube defects. 

Case-Control Study: 
In this retrospective study, individuals with a particular outcome (cases) are compared to those without it (controls) to identify exposure to suspected drugs. 

• Advantages: Quick, cost-effective, suitable for rare ADRs. 

• Example: Identifying drug exposure in patients who developed Stevens-Johnson Syndrome compared to controls. 

MedDRA (Medical Dictionary for Regulatory Activities): 
MedDRA is an internationally accepted terminology used for coding, reporting, and analyzing medical data related to ADRs. 

Structure: 

• Five levels: System Organ Class (SOC), High-Level Group Terms, High-Level Terms, Preferred Terms (PT), and Lowest Level Terms (LLT). 

• Ensures consistent global reporting. 

Standard MedDRA Queries (SMQs): 
SMQs are predefined sets of MedDRA terms grouped to identify safety signals and retrieve ADR data. 

• Example: SMQ for “liver injury” includes all relevant PTs and LLTs. 

• Uses: Signal detection, risk assessment, data mining, and expedited reporting. 

Together, cohort/case-control studies and MedDRA tools contribute to better safety profiling and ADR analysis in pharmacovigilance. 

 

Q4. Differentiate between adverse drug reactions and adverse events with suitable examples. Explain the mechanisms of Type-A and Type-B ADRs. 
Ans: 
Adverse Drug Reaction (ADR): 

• An unintended and harmful response to a drug at normal doses used for treatment or diagnosis. 

• Example: Bleeding with warfarin at therapeutic dose. 

Adverse Event (AE): 

• Any untoward medical occurrence in a patient during treatment but not necessarily causally related to the drug. 

• Example: Fever occurring during drug treatment, but unrelated to drug itself. 

Key Differences: 

Feature	ADR	AE
Relation to Drug	Causally related	Not necessarily related
Dose	Occurs at normal dose	Any dose
Reporting	Mandatory in PV	Broader scope

Type-A (Augmented) Reactions: 

• Mechanism: Due to exaggerated pharmacological effect. 

• Dose-dependent, predictable. 

• Example: Hypoglycemia with insulin, bleeding with heparin. 

• Management: Dose adjustment or monitoring. 

Type-B (Bizarre) Reactions: 

• Mechanism: Often immunologic or idiosyncratic. 

• Not dose-dependent, unpredictable. 

• Example: Anaphylaxis with penicillin, agranulocytosis with clozapine. 

• Management: Drug withdrawal, supportive care. 

Understanding these distinctions is vital for effective pharmacovigilance, ADR detection, and patient safety enhancement. 

 

Q5. Illustrate the vaccine safety surveillance along with the different types of pharmacovigilance methods used for passive and active surveillance. 
Ans: 
Vaccine Safety Surveillance refers to monitoring and evaluating the safety of vaccines after administration to detect adverse events following immunization (AEFIs). This ensures vaccines remain safe, builds public trust, and helps in timely risk mitigation. 

Types of Surveillance Methods: 

1. Passive Surveillance: 

1. Based on spontaneous, voluntary reporting by healthcare providers or patients. 

2. Example: India’s AEFI surveillance, WHO’s VigiBase. 

3. Advantages: Inexpensive, broad coverage. 

4. Limitations: Underreporting, lack of causality confirmation. 

2. Active Surveillance: 

1. Proactively seeks AEFIs using predefined methodologies. 

2. Types Include: 

1. Cohort Event Monitoring: Follows a group of vaccinated individuals. 

2. Electronic Health Records Monitoring: Automated detection from hospital records. 

3. Sentinel Surveillance: Select healthcare sites actively monitor for vaccine-related ADRs. 

Additional Tools: 

• Phase IV Trials: Post-marketing surveillance for new vaccines. 

• Lot Quality Assurance Sampling (LQAS): For identifying batch-related vaccine issues. 

• Case-Control Studies: To investigate vaccine-related rare events. 

Examples of Vaccine-Related ADRs: 

• Fever, injection-site reaction, anaphylaxis, Guillain-Barre syndrome. 

Importance: 

• Detect rare and delayed effects. 

• Maintain safety for all population groups. 

• Aid in policy decisions for immunization programs. 

Effective vaccine pharmacovigilance ensures public health safety and supports national immunization efforts. 

 

Q6. Explain the drug safety evaluation in pediatrics and geriatrics. 
Ans: 
Drug safety evaluation in pediatric and geriatric populations is critical due to physiological and metabolic differences affecting drug action. 

Pediatrics: 

• Challenges: Immature liver and kidney function, variable absorption, altered pharmacokinetics. 

• Considerations: 

• Age-appropriate formulations 

• Dosing based on body weight or surface area 

• Need for special ethics in clinical trials 

• Evaluation Methods: 

• Pediatric-specific clinical trials 

• Pediatric pharmacovigilance programs 

• Monitoring growth, development, and behavior for ADRs 

Geriatrics: 

• Challenges: Decreased organ function, polypharmacy, comorbidities. 

• Risks: Higher susceptibility to ADRs like confusion, falls, bleeding. 

• Considerations: 

• Renal/hepatic dose adjustments 

• Drug-drug interaction assessment 

• Monitoring for cognitive or metabolic changes 

• Evaluation Methods: 

• Geriatric pharmacovigilance networks 

• Regular medication review 

• Comprehensive Geriatric Assessment (CGA) 

General Measures for Both Groups: 

• Use of Risk Management Plans (RMPs) 

• Post-marketing surveillance (Phase IV) 

• Inclusion of pediatric/geriatric data in labeling 

Thus, tailoring pharmacovigilance for age-specific groups improves safety, minimizes ADRs, and enhances therapeutic outcomes. 

 

 

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📚 FAQs on B.Pharmacy Pharmacovigilance

Q. What is Pharmacovigilance?

Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects of medicines to ensure patient safety.

Q. Why is Pharmacovigilance important?

It ensures safe and effective drug use, helps identify adverse drug reactions (ADRs), and supports regulatory decisions for drug safety.

Q. What is the role of WHO in Pharmacovigilance?

WHO manages the global PIDM (Programme for International Drug Monitoring) to collect and analyze safety data across countries.

Q. What are common methods used in Pharmacovigilance?

Passive (Spontaneous Reporting) and Active Surveillance (CEM, TSR), clinical trials (Phase IV), and data mining for signal detection.

Q. What is an ADR?

An Adverse Drug Reaction (ADR) is a harmful or unintended response to a drug under normal use conditions.

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