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DY Patil (deemed to be) University School of Medicine, Nerul, Navi Mumbai [Constituent College of DY Patil (deemed to be) University, established under Sec 3 of UGC Act 1956] Pharmacovigilance Unit (Established in 2010) 2020 DY Patil (deemed to be) University School of Medicine, Sector 7, Nerul, Navi Mumbai 400706 Tel: 91-22-27702218 Email id: [email protected]; [email protected] www.dypatil.edu

[Constituent College of DY Patil (deemed to be) …...Books and journals Books and journals are purchased and kept in central library. These are available to teaching staff Hospital

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DY Patil (deemed to be) University School of Medicine,

Nerul, Navi Mumbai [Constituent College of DY Patil (deemed to be) University, established under Sec 3 of UGC

Act 1956]

Pharmacovigilance Unit (Established in 2010)

2020 DY Patil (deemed to be) University School of Medicine, Sector 7, Nerul, Navi Mumbai 400706

Tel: 91-22-27702218 Email id: [email protected]; [email protected]

www.dypatil.edu

Dr DY Patil

Founder President

Dr. Vijay Patil Mrs. Shivani Patil

President Trustee

Contents

Sr. No. Chapter 1 Vision

2 Mission

3 Objectives 4 Members

5 Supporting staff 6 Facility

7 Other resources 8 Activities

9 Research projects and publications related to pharmacovigilance

10 Advisory role of the unit

11 Future activities

Vision

To be recognized as medical institute which provides world-class information related to drug safety and ensures safe use of medicines by a;; healthcare professionals in the institute

Mission

To provide quality information and world-class health care to the society by being compassionate, caring and committed to the service.

Objectives

1. To monitor Adverse Drug Reactions (ADRs) at D Y Patil Hospital and attached healthcare institutions

2. To optimize safe and effective use of medicines at D Y Patil Hospital and attached healthcare institutions

3. To provide the safety related information to all stakeholders

4. To create awareness amongst health care professionals about the importance of ADR reporting

5. To monitor benefit-risk profile of medicines

Members (2019-2020)

Chairman: Dr. Deepak Langade Professor and Head, Department Of Pharmacology Dr. D Y Patil School of Medicine Nerul, Navi Mumbai

993055000

[email protected] [email protected]

Secretary: Dr. Vaishali Thakare Associate Professor Department Of Pharmacology

9869366927

[email protected] [email protected]

Members: Dr. Surekha Patil Dean Dr. D Y Patil School of Medicine, Nerul, Navi Mumbai

9930923108

[email protected]

Dr. Vijaya Badhwar Ex-Dean & Prof., Dept. of Obst. & Gynecology

9820362011 [email protected]

Dr. Rahul Peddawad CEO, Dr. D.Y.Patil Hospital

9892144650 [email protected]

Dr. Anant Patil Asst. Professor Department of Pharmacology

9920449433 [email protected] [email protected]

Dr. Archana Bhate Professor and Head, Department Of General Medicine

9821366812

[email protected]

Dr. N.J.Nadkarni Professor, Department of Dermatology & VD

9820285490

[email protected]

Dr. Meena Kumari Professor, Department of General Surgery

9820319129

[email protected]

Dr. Meena Satia Professor, Department of Obstetrics & Gynecology

9869084018 [email protected]

Dr. Fiona Mahapatro Professor, Department of Psychiatry

9820642258

[email protected] [email protected]

Dr. Rajesh Rai Professor and Head, Department of Pediatrics

9920403863

[email protected] [email protected]

Dr. Prakash Samant Professor and Head, Department of Orthopedics

9821212222

[email protected]

Dr. Shubha Mohite Professor, Department of Anesthesia

9820409985

[email protected]

Dr. Deepali Rajpal Professor, Department of Emergency Medicine

9819180937

[email protected]

Dr. Somnath Mallakmir Professor, Dept. in cardiology

9322282302 [email protected]

Dr. Girija Nair Prof.& Head, Department of Pulmonary medicine

9324294457 [email protected]

Dr. Nita Shanbhag Prof.& Head, Department of Ophthalmology

9322402424 [email protected]

Sheila Ramandiea Head of Nursing services

976946736 [email protected]

Sister Surekha Sister In-charge

8850945321 [email protected]

Supporting staff

Attendant-One

Clerk-One

Facility

The office of “Pharmacovigilance Unit” is located in the Department of

Pharmacology on the fifth floor of the college building.

Other resources

For the effective functioning of the “Pharmacovigilance Unit” following

resources are always available:

Computer: 1

Cupboard: 1

Round the clock internet connection

Books and journals

Books and journals are purchased and kept in central library. These are

available to teaching staff

Hospital is recognised as Adverse Drug Reaction

Monitoring Centre under Pharmacovigilance Program

of India (PvPI).

Activities

The Pharmacovigilance Unit conducts meeting of its members every

quarter

Sensitization program for PG students is done annually

Regular sensitization programs are conducted for nursing professionals

The Pharmacovigilance Unit of the institute receives and submits

Adverse Drug Reactions (ADRs) reported by the healthcare professionals

in the institute

A total of 95 ADRs are reported by different departments in the institute

Distribution of ADRs reported in last 4 years

Other educational activities conducted by the pharmacovigilance unit

S.No Programmes Date Number of attendees

1 Sensitization programme for Post-Graduate students

27/11/2017 70

2 Sensitization of UG students Guest lecture by Dr Deepak Langade

26/11/2018 22,220

3 Sensitization programme for Nursing students

02/11/2018 42

4 Lecture during Medinspire- ADR Reporting: Challenges in Indian healthcare system- Dr. Nitya Gogtey, Additional Professor, Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai

110

5 Lecture during Medinspire- Pharmacovigilance: Reporting systems and mechanisms Dr. Moin Don

14/2/2019 110

6 Lecture during Medinspire- Pharmacovigilance: Global perspective Dr. Sudhir Bansod

14/2/2019 110

5 Sensitization programme for Post graduate students

18/7/2018 95

2

49

41

3

0

10

20

30

40

50

60

Year 2017 Year 2018 Year 2019 Year 2020

Nu

mb

er

of

AD

Rs

6 Sensitization programme for Nursing students

22/6/2019 97

7 Pharmacovigilance workshop Current Global trend in pharmacovigillance & Risk Management- Dr Sudhir Bansode, Senior Director, Pharmavigillance, Switzerland

10/10/2019 43

Invitation letter to Dr. Deepak Langade as Guest Speaker for

conducting Virtual Lecture on “Pharmacovigilance”

Pharmacovigilance sensitization program for nursing staff was conducted on

2/11/2018 at 2.00 PM in Demo room of Male surgical ward. Chairperson of

Pharmacovigilance committee, Dr Deepak Langade, provided introduction on

pharmacovigilance and its Importance to nursing staff of D Y Patil Hospital and

Research Centre, Nerul, Navi Mumbai. Member secretary of Pharmacovigilance

committee, Dr. Vaishali Thakare further elaborated information with power

point presentation. In this program, nurses were also briefed about the

reporting system and importance of accuracy in ADR reporting. Following

members of Pharmacovigilance Committee attended the program. Dr. Archna

Bhate – Prof & Head of General Medicine, Dr. Anant Patil – Assistant Professor

in Pharmacology and Mrs Sheela Remedious – Matron in D.Y. Patil Hospital and

Research Centre.

Conference participation outside institute:

Dr. Anant Patil presented oral paper “Age and gender wise analysis of patients

receiving thalidomide versus overall patient population treated

for Lepra reaction: Retrospective analysis from a tertiary care hospital” in 11th

Annual Conference of South Asian College of Clinical Pharmacology an Affiliate

of Clinical Pharmacology (SAC ACCP), “Clinical Pharmacology: Contributing to

Global Health Policies” (2018)

Dr. Vaishali Thakare and Dr. Kavitha V attended “Advanced

Pharmacovigilance Training Workshop” as a delegate on 5th May 2018

organized by Department of Pharmacology, Seth GS Medical College and

KEM Hospital, Mumbai

Medinspire 2019

Dr. Anant Patil participated as a speaker in 17th Pharmacovigilance 2018 (15th

November) organized by Virtue Insights in Mumbai

Panel discussion: Manual and medical devices reporting: Detecting and evaluating drug safety signals Moderator: S.R.SALUNKHE, Former Assistant commissioner, FDA Maharashtra Panellists: 1. Dr. ARUN BHATT, Consultant – Clinical Research & Development 2. Dr. SANJEEV MIGLANI, Founder and Director, AWINSA Life Sciences 3. JYOTSNA PATWARDHAN, Head Development QA, Novartis 4. Dr. PRADEEPA RAMAKRISHNA, Global Safety Physician/ Lead Surveillance Physician, AstraZeneca 5. Dr. ANANT PATIL, Asst Professor Department of Pharmacology, Dr DY Patil Medical College

Dr. Anant Patil participated as a speaker in 20th Pharmacovigilance 2020 (07th

November 2019) organized by Virtue Insights in Mumbai

Panel discussion: Ensure safe use of medicines and minimizing the risks related to the medicinal product Moderator: PRASHANT BODHE, Director, CliniSearch Panellists: 1. OMPRAKASH S. SADHWANI, Former Joint Commissioner and controlling Authority, Food and Drug Administration (Maharashtra state) 2. Dr. DEEPA ARORA, Director, CLINEXEL Life Sciences

3. Dr. ARUN BHATT, Consultant – Clinical Research & Development 4. Dr. PRADEEPA RAMAKRISHNA, Global Safety Physician/ Lead Surveillance Physician, AstraZeneca 5. Dr. ANANT PATIL, Asst Professor Department of Pharmacology, Dr. DY Patil Medical College 6. Dr. KAVYA KADAM, Consultant Global Clinical Trials

Dr. Anant Patil participated as speaker in 1st Global Pharma

Summit in Mumbai (9th November 2019)

Topic: Pharmacovigilance: How do we do it?

Dr. Vaishali Thakare attended 5 days Skill Development Program on

“Pharmacovigilance for Medical Products” from 23-27th September 2019

organized by National Coordination Centre (NCC), Pharmacovigilance

Program of India (PvPI)

Research projects and Publications

ADR Reporting from Pulmonary Medicine -2018-2019

Dr. Vaishali Thakare and Dr. Deepak Langade from the Department of

Pharmacology and PVPI -Committee, Dr.D.Y. Patil hospital & Research

centre presented paper in CME scheduled on “World TV Day 2019”

Advisory role of the unit

The pharmacovigilance unit provides regular updates on safety signals to

healthcare professionals in the institute which are received from the

PvPI

The pharmacovigilance unit also generates safety signals based on the

adverse drug reactions reported by the healthcare professionals in the

institute and helps in safe use of medicines

Future activities

The pharmacovigilance unit plans to continue efforts of sensitizing the

healthcare professionals and students on importance of adverse drug

reaction reporting and safe use of medicines.

Collaborative activities with other departments

Research projects on pharmacovigilance

Participation in national and international conferences