Pharmacovigilance Committee

1. PREAMBLE

This Constitution is framed in accordance with the directions issued by the National Medical Commission (NMC), guidelines of the Pharmacovigilance Programme of India (PvPI) coordinated by the Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India, and the assessment and rating framework issued by NMC from time to time.

The institution is committed to ensuring patient safety through systematic monitoring, reporting, assessment, and prevention of adverse drug reactions (ADRs) and promoting the rational and safe use of medicines among all healthcare providers, students, and patients.

The Pharmacovigilance Committee shall function as the Adverse Drug Reaction (ADR) Monitoring Centre (AMC) enrolled with the Indian Pharmacopoeia Commission under the Pharmacovigilance Programme of India.

2. NOMENCLATURE

The Committee constituted under this Constitution shall be known as the "Pharmacovigilance Committee" (hereinafter referred to as "PvC" or "the Committee"), also referred to as the "Adverse Drug Reaction Monitoring Committee" or "ADR Monitoring Centre (AMC)" for the purpose of monitoring, collecting, analyzing, and reporting adverse drug reactions at the institution.

3. DEFINITIONS

For the purposes of this Constitution:

• Adverse Drug Reaction (ADR) means a response to a drug which is noxious and unintended and which occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

Serious ADR means any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Causality Assessment means the evaluation of the likelihood that a particular treatment is the cause of an observed adverse event.

Pharmacovigilance means the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.

Healthcare Provider includes all doctors, consultants, nurses, pharmacists, postgraduate and undergraduate students, resident doctors, interns, and all other persons involved in patient care at the institution.

PvPI means Pharmacovigilance Programme of India coordinated by the Indian Pharmacopoeia Commission, functioning as the National Coordination Centre (NCC-PvPI).

IPC means Indian Pharmacopoeia Commission, the autonomous institution under the Ministry of Health and Family Welfare, Government of India.

VigiFlow means the online web-based ADR reporting and documentation system provided by the Uppsala Monitoring Centre (UMC) for the Pharmacovigilance Programme of India.

4. COMPOSITION OF THE PHARMACOVIGILANCE COMMITTEE

4.1 The Pharmacovigilance Committee shall consist of the following members nominated by the Management of Netaji Subhas Medical College and Hospital:

Table 1: Composition of Pharmacovigilance Committee

4.2 Mandatory Requirements

• The Principal/Dean of the institution shall be the Chairman of the Committee.
• The Medical Superintendent shall be the Executive Member responsible for administrative coordination.
• The Coordinator shall preferably be from the Department of Pharmacology and shall oversee the overall functioning of the AMC.
• The Deputy Coordinator shall assist the Coordinator and take charge in the Coordinator's absence.
• The Committee shall have representation from major clinical departments including Medicine, Surgery, Obstetrics and Gynecology, Pediatrics, Dermatology, Psychiatry, and Anesthesiology.
• At least one senior nursing officer and the pharmacy in-charge shall be members to ensure comprehensive ADR monitoring.
• One junior resident doctor and one final year MBBS student shall be included to facilitate grassroots-level ADR reporting.
• All members should be trained in ADR reporting, causality assessment, and pharmacovigilance principles.

5. TENURE OF MEMBERS

• The Pharmacovigilance Committee shall function for a tenure of three years from the date of constitution.
• The Committee shall be reconstituted every three years with fresh nominations.
• The student member shall be nominated annually from the final year MBBS batch.
• Members may be re-nominated for subsequent terms.
• Any vacancy arising due to transfer, retirement, resignation, or otherwise shall be filled by fresh nomination within 30 days with intimation to IPC and NMC.

6. OBJECTIVES AND FUNCTIONS

The objectives and functions of the Pharmacovigilance Committee shall include:

• To generate awareness about adverse drug reactions (ADRs) among all sections of healthcare providers including doctors, consultants, nurses, pharmacists, postgraduate and undergraduate students, resident doctors, and interns
• To monitor and detect ADRs occurring in patients receiving treatment at the institution
• To collect, document, and report ADRs to the National Coordination Centre, Pharmacovigilance Programme of India (NCC-PvPI) through the VigiFlow system
• To perform causality assessment of reported ADRs using standardized assessment scales (WHO-UMC, Naranjo Algorithm)
• To analyze patterns and trends of ADRs within the institution
• To promote rational and safe use of medicines
• To educate healthcare professionals and patients about drug safety
• To conduct workshops, seminars, and training programs on pharmacovigilance and ADR reporting
• To maintain a comprehensive library and database of ADR-related information
• To undertake research activities related to drug safety and adverse drug reactions
• To coordinate with the Indian Pharmacopoeia Commission and comply with PvPI guidelines
• To submit periodic reports to the Management, NMC, and IPC
• To create and implement Standard Operating Procedures (SOPs) for ADR monitoring and reporting
• To investigate serious and unexpected ADRs and recommend appropriate action
• To participate in signal detection and risk management activities

7. ROLES AND RESPONSIBILITIES OF COMMITTEE MEMBERS

7.1 Chairman (Principal/Dean)

• Provide overall leadership and guidance to the Committee
• Ensure adequate resources and infrastructure for Committee functioning
• Approve major decisions and policy matters related to pharmacovigilance
• Review annual performance and recommend improvements
• Facilitate coordination with NMC, IPC, and other regulatory authorities

7.2 Executive Member (Medical Superintendent)

• Provide administrative support for Committee activities
• Coordinate with hospital departments for ADR data collection
• Ensure implementation of recommendations across the hospital
• Facilitate availability of necessary resources and manpower
• Monitor compliance with pharmacovigilance protocols in clinical settings

7.3 Coordinator (Department of Pharmacology)

• Oversee the overall functioning of the ADR Monitoring Centre
• Collect, verify, and ensure completeness of ADR reports
• Perform causality assessment of reported ADRs
• Upload ADR reports to the VigiFlow system and maintain database
• Prepare agenda for meetings and coordinate meeting activities
• Organize awareness programs, workshops, and training sessions
• Coordinate research activities related to pharmacovigilance
• Maintain ADR library and documentation
• Prepare and submit periodic reports to Chairman, Management, IPC, and NMC
• Maintain Standard Operating Procedures (SOPs) for ADR monitoring
• Liaise with NCC-PvPI and Regional Training Centers

7.4 Deputy Coordinator

• Assist the Coordinator in all activities of the Committee
• Take charge of AMC operations in the absence of the Coordinator
• Assist in ADR data collection and causality assessment
• Help organize training programs and awareness activities
• Maintain backup documentation and records

7.5 Clinical Department Members

• Act as subject experts for ADRs in their respective specialties
• Encourage and facilitate ADR reporting from their departments
• Mentor junior faculty, resident doctors, and students in ADR identification and reporting
• Participate in causality assessment and evaluation of ADRs
• Provide clinical insights during Committee meetings
• Implement pharmacovigilance awareness in their departments

7.6 Nursing Representative

• Facilitate ADR reporting by nursing staff
• Monitor patients for potential ADRs during care delivery
• Coordinate with ward staff for timely ADR detection and documentation
• Participate in training programs for nursing personnel
• Assist in patient education regarding drug safety

7.7 Pharmacy Representative

• Monitor drug dispensing and identify potential ADRs
• Maintain records of drugs associated with ADRs
• Facilitate communication between pharmacy and clinical departments
• Provide pharmaceutical expertise in causality assessment
• Assist in medication error reporting and analysis

7.8 Resident Doctor and Student Members

• Act as frontline reporters of ADRs from wards and OPDs
• Participate in training programs and disseminate information among peers
• Assist in ADR data collection and documentation
• Provide feedback on awareness activities and training needs

8. MEETING PROCEDURES

• The Pharmacovigilance Committee shall meet at least once every three months (minimum four meetings per year).
• Additional emergency meetings may be convened by the Chairman or Coordinator as and when required, especially for serious or unexpected ADRs.
• The Coordinator shall prepare the agenda and circulate it to all members at least seven days before the meeting.
• Quorum for the meeting shall be seven members including either the Chairman or Executive Member.
• Minutes of meetings shall be recorded by the Coordinator and circulated within seven days of the meeting.
• Decisions shall be taken by consensus or, if required, by majority vote.
• Guest experts may be invited to meetings for specialized inputs when necessary.

9. ADR IDENTIFICATION AND REPORTING SYSTEM

9.1 Sources of ADR Reports

ADR reports may be received from:

• Inpatient departments and wards

Outpatient departments

Intensive care units and emergency departments

Operation theaters and post-operative wards

Nursing staff and paramedical personnel

Patients and their relatives

Hospital pharmacy

Laboratory and diagnostic departments

9.2 Reporting Mechanism

• All healthcare providers are encouraged to report any suspected ADR through the designated ADR reporting form (as per PvPI format).
• ADR reporting forms shall be available in all clinical departments, wards, OPDs, pharmacy, and on the hospital website.
• Reporters may submit ADR forms to the Coordinator/Deputy Coordinator directly or through designated collection boxes placed in strategic locations.
• Online/email reporting shall also be facilitated through the institutional email system.
• A 24/7 helpline number may be established for immediate reporting of serious ADRs.
• Reporters shall maintain patient confidentiality and use coded identifiers in ADR forms.

9.3 ADR Report Contents

Each ADR report shall contain:

• Patient demographics (age, gender, coded identifier - no personal identifiers)
• Details of suspected drug(s) including name, dose, route, frequency, and duration
• Description of adverse reaction including onset, duration, severity, and outcome
• Concomitant medications and medical history
• Laboratory investigations and diagnostic findings
• Action taken (drug withdrawal, dose reduction, treatment given)
• Reporter details (name, designation, contact information)
• Date of reporting

10. CAUSALITY ASSESSMENT

10.1 Assessment Process

• All reported ADRs shall undergo causality assessment by the Coordinator and Deputy Coordinator with inputs from clinical experts.
• Causality assessment shall be performed using standardized scales such as:
• WHO-UMC Causality Assessment Scale (Certain, Probable, Possible, Unlikely, Conditional, Unassessable)
• Naranjo Algorithm (Definite, Probable, Possible, Doubtful)
• Severity of ADRs shall be classified as Mild, Moderate, or Severe.
• Serious ADRs (life-threatening, causing hospitalization, disability, or death) shall be identified and prioritized.
• Assessment reports shall be documented and maintained in the ADR database.

10.2 Management of Serious ADRs

• Serious ADRs shall be reported to NCC-PvPI within 24 to 48 hours of detection.
• Immediate clinical intervention shall be coordinated with the treating department.
• Root cause analysis may be conducted for serious or unusual ADRs.
• Recommendations for preventing recurrence shall be formulated and communicated.
• Serious ADRs shall be reviewed in the next Committee meeting.

11. REPORTING TO INDIAN PHARMACOPOEIA COMMISSION

• All ADRs after causality assessment shall be reported to the National Coordination Centre, Pharmacovigilance Programme of India (NCC-PvPI) through the VigiFlow online system.
• Reports shall be uploaded within 7 to 14 days of receipt and assessment.
• The Coordinator shall maintain login credentials for VigiFlow and ensure timely data entry.
• Serious ADRs shall be reported on priority within 24 to 48 hours.
• Periodic reports (quarterly and annual) shall be submitted to IPC as per PvPI guidelines.
• The institution shall comply with all data quality and reporting standards prescribed by IPC.

12. AWARENESS GENERATION AND TRAINING PROGRAMS

12.1 Target Audience

Training and awareness programs shall be conducted for:

• Faculty members and medical officers
• Postgraduate students and resident doctors
• Undergraduate medical students (all phases)
• Nursing staff and paramedical personnel
• Pharmacy staff
• Interns and house surgeons
• Patients and caregivers

12.2 Training Activities

• Conduct at least two major workshops or conferences per year for all healthcare providers including students (as per NMC assessment criteria for Level-1 scoring).
• Organize orientation programs for new faculty, residents, and students during induction.
• Conduct Continuing Medical Education (CME) programs on drug safety and rational drug use.
• Prepare and disseminate educational materials including posters, brochures, newsletters, and online resources.
• Organize pharmacovigilance week/day celebrations with awareness activities.
• Conduct case discussions and journal club presentations on ADRs.
• Provide hands-on training for ADR reporting and causality assessment.
• Utilize digital platforms (webinars, e-learning modules) for wider reach.

12.3 Documentation

• Maintain records of all training programs including attendance sheets, photographs, and feedback forms.
• Prepare reports on training activities for submission to Management, IPC, and NMC.
• Document evidence of conducting workshops for healthcare providers and students (required for NMC assessment).

13. RESEARCH ACTIVITIES

• The Committee shall encourage and coordinate research activities related to pharmacovigilance and drug safety.
• Research proposals may be developed on topics such as ADR patterns, drug utilization studies, medication errors, and signal detection.
• Faculty and postgraduate students shall be encouraged to publish research papers on ADRs and pharmacovigilance.
• The institution shall aim to publish a minimum of two research papers related to ADRs per year (as per NMC assessment criteria for Level-3 scoring).
• Collaboration with other institutions and participation in multi-centric pharmacovigilance studies shall be promoted.
• The Committee shall maintain a library of ADR-related literature and research publications.

14. DOCUMENTATION AND RECORD KEEPING

The Committee shall maintain the following records:

• ADR reporting forms (original and copies)

Causality assessment reports

Database of all reported ADRs (VigiFlow system and institutional database)

Meeting minutes and attendance records

Training program records (attendance, materials, feedback)

Correspondence with IPC, NMC, and other authorities

Standard Operating Procedures (SOPs)

Annual reports and periodic submissions

Research publications and presentations

Patient information materials and educational resources

All records shall be maintained for a minimum of five years and shall be made available for inspection by NMC, IPC, or other regulatory authorities.

15. COORDINATION WITH OTHER COMMITTEES

The Pharmacovigilance Committee shall coordinate with:

• Hospital Infection Control Committee (HICC): For ADRs related to antimicrobials and infection control measures
• Institutional Ethics Committee (IEC): For ethical considerations in pharmacovigilance research

Drug and Therapeutics Committee: For formulary decisions based on ADR data

Patient Safety Committee: For overall patient safety initiatives

Medical Education Unit (MEU): For training programs on pharmacovigilance

Hospital Administration: For resource allocation and policy implementation

16. DUTIES OF THE INSTITUTION

The Management of Netaji Subhas Medical College and Hospital shall:

• Ensure enrollment of the institution as an ADR Monitoring Centre (AMC) with the Indian Pharmacopoeia Commission under PvPI

Provide adequate infrastructure including dedicated space, computers, internet connectivity, and phone lines for AMC functioning

Allocate budget for Committee activities including training programs, awareness materials, and travel for coordination meetings

Ensure availability of VigiFlow system access and necessary software

Facilitate attendance of Coordinator and members in pharmacovigilance training programs organized by Regional Training Centers

Display information about the Pharmacovigilance Committee and ADR reporting mechanism at prominent locations in the hospital

Support research activities and publication of ADR-related studies

Provide protected time for Coordinator and members to conduct Committee activities

Ensure compliance with all IPC and NMC guidelines regarding pharmacovigilance

Monitor and evaluate Committee performance as per NMC assessment and rating criteria

17. PERFORMANCE EVALUATION (AS PER NMC ASSESSMENT CRITERIA)

The institution's pharmacovigilance activities shall be evaluated based on NMC's Assessment and Rating Framework with the following performance levels:

Table 3: NMC Performance Levels for Pharmacovigilance Committee

The institution shall strive to achieve and maintain Level-3 performance through systematic planning and execution of pharmacovigilance activities.

18. ANNUAL REPORT

• The Pharmacovigilance Committee shall prepare an annual report containing:
• Total number of ADRs reported during the year
• Categorization of ADRs by type, severity, causality, and drug class
• Number of serious ADRs and actions taken
• Number of ADRs reported to IPC through VigiFlow
• Details of workshops and training programs conducted with attendance records
• Research activities and publications related to ADRs
• Challenges faced and recommendations for improvement
• Comparative analysis with previous years
• Action plan for next year
• The annual report shall be submitted to:
• Management of the institution
• National Medical Commission
• Indian Pharmacopoeia Commission (as part of PvPI compliance)

19. CONFIDENTIALITY AND ETHICAL CONSIDERATIONS

• All ADR reports and patient information shall be treated as confidential.
• Patient identity shall not be disclosed in any reports or publications.
• ADR data shall be used solely for pharmacovigilance purposes and improving patient safety.
• Reporters of ADRs shall be protected from any adverse consequences (no-blame culture).
• Ethical principles shall be followed in all pharmacovigilance research activities.
• The Committee shall ensure compliance with applicable data protection and privacy regulations.

20. DISPLAY AND DISSEMINATION

• This Constitution and details of the Pharmacovigilance Committee shall be displayed on the institution's notice boards and website.
• Information about Committee composition, Coordinator contact details, ADR reporting forms, and reporting mechanisms shall be made easily accessible.
• Copies of this Constitution shall be made available to all departments, faculty members, and students.
• Regular updates on pharmacovigilance activities shall be communicated through circulars, emails, and newsletters.
• Information materials on drug safety and ADR reporting shall be displayed in clinical areas, OPDs, and pharmacy.

21. AMENDMENTS

This Constitution may be amended from time to time in accordance with changes in the guidelines issued by the National Medical Commission, Indian Pharmacopoeia Commission, Pharmacovigilance Programme of India, or the Government of India.

Any amendments shall require approval from the Management and intimation to IPC and NMC.

22. EFFECTIVE DATE

This Constitution shall come into effect from the date of approval by the Management of Netaji Subhas Medical College and Hospital and notification to the National Medical Commission and Indian Pharmacopoeia Commission.