administration & subsequent patient compliance in a Teaching Hospital ... Support the CDSCO for formulating safety r
PHARMACOVIGILANCE COMMITTEE PARUL INSTITUTE OF MEDICAL SCIENCES & RESERACH 1st October, 2016 PREAMBLE As per the Guidelines of Medical Council of India, it is essential to constitute Pharmacovigilance Committee to oversee various Pharmacological aspects of Drug administration & subsequent patient compliance in a Teaching Hospital wherein Medical College is proposed to be established. Therefore, all below referred members have been nominated in the Pharmacovigilance Committee of the Hospital against the post mentioned against their names. GOAL The broad goal of the committee will be to generate awareness about the need of identifying & reporting of Adverse Drug Reactions (ADR), amongst all sections of health care providers (Doctors, Consultants, Nurses, Pharmacists, Post Graduate & Under Graduate Students, service providers etc.) of Parul Institute of Medical Sciences & Research & Parul Sevashram Hospital and to identify ADR occurring in patients admitted to Parul Sevashram Hospital & report the same to the appropriate authorities. OBJECTIVES •
To monitor Adverse Drug Reactions (ADR)
•
To create awareness amongst health care professionals about the importance of ADR reporting
•
To monitor benefit-risk profile of medicines
•
Generate independent, evidence based recommendations on the safety of medicines
•
Support the CDSCO for formulating safety related regulatory decisions for medicines
•
Communicate findings with all key stakeholders
•
Create a national centre of excellence at par with global drug safety monitoring standards
CONSTITUTION
Sr. No.
Name
Designation
Post at PVC
1
Dr. V. P. Hathila
Dean
Chairman
2
Dr. Indira Parmar
Superintendent
3
Dr. B. D. Parmar
HOD, Medicine
Member Member
4
Dr. Dilip Ravalia
HOD, Surgery
Member
5
Dr. C. R. Kakani
HOD, OBGY
Member
6
Dr. Anita Patel
HOD, Anaesthesia
Member
7
Dr. Ashruti Kacha
HOD, Paediatrics
Member
8
Dr. H. L. Kubavat
HOD, Orthopaedics
Member
9
Dr. Devanshu Patel
Assistant Professor, Pharmacology
Member
10
Dr. Geetika Madan
Assistant Professor, PSM
Member
11
Dr. Ankit Bharti
Assistant Professor, Skin & VD
Member
12
Ms. Smrutibala Patel
Nursing Superintendent
Member
13
Ms. Hetal Mehta
Pharmacy Incharge
Member
14
Dr. D. C. Sharma
HOD, Pharmacology
Member Secretary
TENURE OF THE COMMITTEE October 2015 to October, 2018 The committee shall be reconstituted every three years. SCOPE OF THE COMMITTTEE The committee shall meet once in 03 months. The committee shall be responsible for planning, implementation and monitoring of various activities of the Pharmacovigilance Committee. They will work as mentors & facilitators. ROLES 1. Chairman: The Chairman will chair & conduct all meetings & will function as administrative head of the committee. 2. Member Secretary: The Member Secretary will play the pivotal role & shall undertake various activities of the Committee. 3. Members: Members will work as subject experts & will also do the mentoring of young faculty/ resident doctors/ students in the area of ADR.
GENERAL GUIDELINES Following General guidelines have been framed for committee functioning: • • • • • • •
• • •
Committees shall meet regularly in every quarter of the year and shall determine the next date of meeting at every meeting Agenda of the meeting (as per their scope) shall be determined beforehand and shall be communicated to all members of the committee Committees shall discuss, analyze, take a unanimous decision and communicate the decision for implementation to appropriate department /personnel Chairperson and convener of the committee shall bear the responsibility of committee functioning The Committee shall determine the protocols of functioning and all committee members shall abide by it. If a detailed analysis of specific agenda under consideration is carried out a record of same shall be maintained separately and filed in committee file It is advisable that a specific member of the committee shall be given the responsibility of maintaining all the records of committee functioning and communicate it to concerned personnel in the organization Committee shall monitor the implementation of decision taken through physical monitoring/ assessments/ review etc. Hospital and staff are obliged to follow the instructions Committee shall review their functioning at appropriate intervals, as decided by Chairman, to assess their functioning MINUTES OF MEETING
During the first meeting of the Committee scheduled on 1st October, 2015, all the committee members were educated about the objectives of the Pharmacovigilance Committee & following terminologies & importance of their observation was explained to all the members by Dr. D. C. Sharma. •
Adverse Drug Reaction
•
Adverse event (AE) Benefits: proven therapeutic good of a product but should also include the patient’s subjective assessment of its effects. Causal relationship . De-challenge and Re-challenge: a drug being stopped and restarted in a patient, respectively. Effectiveness
• • • •
• • • • • •
•
•
•
Efficacy Individual Case Study Report (ICSR) Life-threatening adverse event Temporal relationship Triage: process of placing a potential adverse event report into one of three categories: 1) non-serious case; 2) serious case; or 3) no case All the members were appraised about ADVERSE EVENT (AE) REPORTING which involves the receipt, triage, data entering, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports from healthcare professionals or patients (or other intermediaries); solicited reports from patient support programs; reports from clinical or post-marketing studies; reports from literature sources; reports from the media (including social media and websites); and reports reported to drug regulatory authorities themselves. CODING OF ADVERSE EVENTS was also explained to all the committee members which is the process by which information from an AE reporter, called the "verbatim", is coded using standardized terminology from a medical coding dictionary, such as MedDRA (the most commonly used medical coding dictionary). The purpose of medical coding is to convert adverse event information into terminology that can be readily identified and analyzed The concept of RISK MANAGEMENT was also explained to the committee that is Responsible for signal detection and the monitoring of the risk-benefit profile of drugs. For DR Reporting following material is proposed to procured & kept in Clinical Areas for DR Reporting & its Facilitation: • • •
•
Adverse Drugs Reaction Reporting Form Suspected Adverse Drug Event Notification Form (Yellow Form) Adverse Drug Event Alert Card
Finally, all the members were requested to monitor and analyze sentinel events, accidents, and formulate an adverse drugs policy to prevent, report, and analyze the adverse events within the hospital through a robust ADR reporting system, deal with external bodies and individuals for complaints on patient management and risk management policies to reduce actual/potential patient risk. Identify trends amongst incidents and initiate action for • • • • •
Prolonged Stays DAMA Transfers Adverse Drug Reactions Sentinel Events
The meeting cnncluded w'ith vote of thanks to the Chair.
Sr.
Name
Designation
Post at PVC
Dr. \/. I'. Flathila
Dcau
Chairman
Dr. lnilira Parrttztt
Supcrintcnclent
Member
Dr. B. D. Parmat'
HOD. Medicine
Member
lOD. Sr,rrgeri'
Mernber
Signature
No. 1
l
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Dr. Dilip Rar trlia
f
t)r. C. 1".. Kakani
I]OD.OBG\.
Member
6
I)r" . inita Patel
HOD. Anaesthesia
Merrber
7
Dr. A:,hrLrti Kacha
FIOD. Paedialrics
N,lernber
I
Dr
9
Dr'.
.1
+
i0
I
l. I-. Kubzrvat
[)evattshu
f
lOD.
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Assistant I'rof'essor"
Patel
Pharrnacolog-v
Dr. Clcetil
