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

-)

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.

(

)rtl-ropaeclics

Assistant I'rof'essor"

Patel

Pharrnacolog-v

Dr. Clcetil
Assistltttt [)l'otcsstrt-

Mer"nber

N{ember

Member'

PSM 11

Dr. ,\nl
12

Ms.

Sr-nrutibala

Assistant Prof-essorSkin & VD

N4ember

Nr-rrsin{.1

N{ember

Sr-rpet'intendent

Iratel

Mehta

13

N,{s. }{e1al

14

Dr. I). C. Shan-na

Pharmacy,'In charge

Member

rIOD.

N4embcr Secretarl'

Pharmacologl'

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Parul

University Estab isheC & ncorporated Under Gujarat Private Universlties (SeconC Ai'renomeni) Act, 2015 (Guj. Act No. 7 of 2015)

PHARMACOVIGILANCE COMMITTEE 21.'t

o$o wTNUTES

Januaryr2016

oF MEETING

Research, Limda, Chairman, Dr. V.P. Hathila, Dean of Parul Institute of Medical Sciences & members Waghodia, Vadodara welcome all the committee members. Then all the committee sellintroduced themselves. The committee is as under:

Sr. No.

Name

Designation

Post at PVC

8

Dr. V. P. Hathila Dr. Indira Parmar Dr. B. D. Parmar Dr. Dilip Ravalia Dr. C. R. Kakani Dr. Anita Patel Dr. Ashruti Kacha Dr. H. L. Kubavat

Chairman Member Member Member Member Member Member Member

9

Dr. Devanshu Patel

10

13

Dr. Geetika Madan Dr. Ankit Bharti Ms. Smrutibala Patel Ms. Hetal Mehta

Dean Superintendent HOD, Medicine HOD, Surgery HOD, OBGY HOD, Anaesthesia HOD, Paediatrics HOD, Orthopaedics Assistant Professor, Pharmacology Assistant Professor, PSM Assistant Professor, Skin & VD Nursing Superintendent Pharmacy Incharge

t4

Dr. D. C. Sharma

HOD, PharmacologY

Member Secretary

1

2 J 4 5

6 7

11

l2

Member Member Member Member Member

o

n .*ttit"tion of Committee

o

Only one ADR forms was received from OBGY department'

o

discussed' The reasons for non receipt of ADR forms from other departments were

a

The ADR form designed by PvPI was explained point wise'

a

And the directions were given about the feeling of the form

was approved unanimously'

& its essential

components.

about the The committee members were directed to communicate the discussion filling of the forms to faculties of their department & allied department' system was For sending the ADR forms from the clinical departments following decided.

P.O.Limda,Tal.Waghodia,Dist.Vadodara-39'l760,GujaratState'lndia'

web : www.paruluniversity ac'in Tel.: + g1-2668-260300/307, Tel. Fax: +g1-2668-260201, E-mail :[email protected],

/

o

Head

of the departments will

department

o

&

iurange

to collect the filled ADR forms from the

send to Medical Superintendent.

The blank ADR forms along with the minutes of the meeting

will be sending to each

clinical department from the dean's office. The meeting concluded with vote of thanks to the Chair. Sr.

Name

Designation

Post at PVC

I

Dr. V. P. Hathila

Dean

Chairman

2

Dr. Indira Parmar

Superintendent

Member

J

a

Dr. B. D. Parmar

HOD, Medicine

Member

4

Dr. Dilip Ravalia

HOD, Surgery

Member

Signature

w/:

M

'yyQro,4^,+-,

fto6t*

-__<

4,,

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 Bharli

Assistant Professor, Skin & VD

Member

I2

Ms. Smrutibala Patel

Nursing Superintendent

Member

}sJ

13

Ms. Hetal Mehta

Pharmacy In charge

Member

\}.YZ

I4

Dr. D. C. Sharma

HOD, Pharmacology

Member Secretary

C

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Parul

University Estab

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(Secor:

& incorporated Under Gujarat Private Universities Act, 2015 (Gui. Act No. 7 of 20'15)

i::rJment)

PHARMAC VIGILAN 28th

1oD pttNtlrgs or

April,2016

ttrsrtNe

Chairman, Dr. V.P. Hathila, Dean of Parul Institute of Medical Sciences

&

Research, Limda,

is as under: Waghodia, Vadodara welcome all the committee members. The committee -t Sr. No.

Name

Designation

Post at PVC

8

Dr. V. P. Hathila Dr. Indira Parmar Dr. B. D. Parmar Dr. Dilip Ravalia Dr. C. R. Kakani Dr. Anita Patel Dr. Ashruti Kacha Dr. H. L. Kubavat

Chairman Member Member Member Member Member Member Member

9

Dr. Devanshu Patel

10

13

Dr. Geetika Madan Dr. Ankit Bharti Ms. Smrutibala Patel Ms. Hetal Mehta

Dean Superintendent HOD, Medicine HOD, Surgery HOD, OBGY HOD, Anaesthesia HOD, Paediatrics HOD, Orthopaedics Assistant Professor, Pharmacology Assistant Professor, PSM Assistant Professor, Skin & VD Nursing Superintendent Pharmacy In-charge

t4

Dr. D. C. Sharma

HOD, Pharmacology

Member Secretary

1

2 J

4 5

6 1

11

t2

Member Member Member Member Member

a

Minutes of the last meeting were approved.

o

Four ADR forms filled by Skin & VD Department were received.

o

It was decided to motivate the other departments for filling of the Adverse Reaction forms. There was discussion about the reporting of trivial or mild known reactions & serious reactions.

One of the objective of the PvPI programme is to prepare and Indian database for all the drugs, hence it was decided to report all type of reactions.

P.O. Limda, Tal. Waghodia, Dist. Vadodara - 391760, Gujarat State, lndia. g1-266g-260300i307, Tel. Fax: +91-2668-260201, E-mail :[email protected], web : www.paruluniversity.ac.in Tel.: +

o

To report the Adverse Drug Reaction to national centre it was decided that the forms

will

be send to Adverse Drug Reaction, Monitoring Centre, GMERS Medical College,

Gotri, Vadodara, Gujarat for analysis

&

Vigiflow uploading to national

centre.

GMERS Medical College, Gotri, Vadodara is a Adverse Drug Reaction Monitoring Centre (AMC) by PvPI.

The meeting concluded with vote of thanks to the Chair. Sr. Name Desisnation Post at PVC 1

Dr. V. P. Hathila

Dean

Chairman

2

Dr. Indira Parmar

Superintendent

Member

J

Dr. B. D. Parmar

HOD, Medicine

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

t2

Ms. Smrutibala Patel

Nursing Superintendent

Member

13

Ms. Hetal Mehta

Pharmacy In charge

Member

Signature

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Dr. D. C. Sharma

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HOD, Pharmacology

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Member Secretary

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Parul

University Established & lncorporated Under Gujarat Private Universities (Second Amendment) Act, 2015 (Guj. Act No. 7 of 20.15)

PHARMACOVIGILANCE COMMITTEE 24th August,2016

4th

Minutes of Meeting

Pharmacovigilance committee meeting was held on 24108116 committee room, Dean's office, Parul Sevashram Hospital.

at 3:00 pm at staff

1) Member secretary, Dr. D.C. Sharma, Head of the Department of Pharmacology welcomed all the members of the committee and invited Head of the Deparlment of all clinical disciplines.

2) Only 1 ADR form was received from Skin Depa(ment after the last meeting. 3) All the members and invitees were apprised of the importance of ADR reporling and about the Pharmacovigilance programme of India (PvPI).

4) A power point presentation for the above was given by Miss. Snehal S. Anturlikar, Tutor, Department of Pharmacology. History of pharmacovigilance activity starting from 1986 by WHO and its status in India starting from 2004 till date, aims and objects of the programme were discussed.

5) Guidance about filling of the ADR reports column-wise was given and discussed to avoid the errors in filling up the forms for the improvement and quality reporting. 6) Dr. V.P. Hathila, Dean, Parul Institute of Medical Sciences and Research informed that one of the members Dr. C.R. Kakani, Head of Department, Obstetrics and Gynecology has resigned. Now Dr. S.L. Pagi has joined as Professor and Head of Department, Obstetrics and gynecology. 56 replacement of the name of Dr. C.R. Kakani by Dr. S.L.Pagi was approved by the committee.

7) There was discussion about the fixed dose combinations and their rationality. It was suggested that the combinations included in the latest Essential Medicines List of WHO and National Essential Medicine List are considered rational.

8) The recent alert from Pharmacovigilance Programme of India about the use of tramadol was informed and discussed.

Parul lnstitute of Medical Sciences & Research Faculty of Medicine P.O. Limda, Tal. Waghodia, Dist. Vadodara - 391760, Gujarat State, lndia. + Tel.: 91-2668-260300, Tel. Fax: +91-2668-260201, E-mail : [email protected], Web:www.paruluniversity.ac.in

The meeting concluded with vote of thanks to the Chair.

Name

Designation

Post at PVC

I

Dr. \/. P. I lathila

Dean

('hairrran

2

Dr. Indira Parmar

Superintendent

Member

J

Dr. B. D. Parmar

HOD. Medicine

Member

4

Dr. Dilip Ravalia

HOD, Surgery

Member

5

Dr. C. R. Kzrkani

L{OD. OBC}Y

Member

Sr.

2\- & *zol( Signature

No.

6

Dr. Anita Patel

HOD. Anaesthesia

Member

7

Dr. Ashruti Kacha

HOD. Paediatlics

Member

8

Dr. H. L.

T(r-Lbar,'at

HOD. Orthopaedics

Menrber

L)

Dr.

Devanshu

Member

Patel

Assistant ProlcssorPharrracologl'

Dr. Geetika Madan

Assistirrrt Prolessor.

Menrbe r

10

\

'**S

/

PSM i1

Dr. Ankit Bhatti

Assistlnt Prtr['essrrr'Skin & VD

Member

12

Ms.

Nursing

Member

Srnrutibala

Patel

Superintendenl

13

Ms. Helarl Mehta

Pharmacy ln charge

N4ember

14

Dr'. D. C. Sharma

HOD.

Nlernbcr Secretarv

Pharmacology

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