PIT - Hisfarsi Bali, 11 July 2019

“It’s All About Medication Safety”

Collaboration of Hospital & Pharmaceutical

Industries to enhance awareness of
Pharmacovigilance & Patient Safety

Evi Dwi Nofiarny, Ssi, Apt, MSc.

Head of Corporate Quality Audit, Pharmacovigilance and QRM - Dexa Group
VP of International Society of Pharmacovigilance – Indonesia Chapter
Curriculum Vitae

Evi - Dwi Nofiarny Zulkarnain, Ssi, Apt, MSc

Professional experiences:
 Head of Corp Quality Audit, Pharmacovigilance & QRM, Dexa
Group – Jan 2019 - now
 Manager of Medical Affairs, Dexa Group, Jan’07 – now
 Manager of Clinical Research, Dexa Group, Jan’00 – Dec’06
 Research & Development, Dexa Medica, June’94 – May’96

Scientific Involvement:
• Vice President – International Society of Pharmacovigilance, Indonesia Chapter, 2017
– now

Formal education:
 Magister Pharmacology – Bio Medic FKUI Jakarta, 1996 – ‘99
 Apothecary program – ITB Bandung, 1993 – ‘94
 Pharmacy – ITB Bandung ,1988 – ‘93
 Agenda
“It’s All About Medication Safety”
A. Our Common goal: Medication & Patient Safety

B. Current Regulation & Challenges

C. Signal Management: from detecting signals to actions

D. Reporting Culture & System

E. Collaboration to foster Pharmacovigilance

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Comparison number of reports & number of reports per population in nine
ASEAN countries.
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A. Our Common goal: Medication & Patient Safety

Ethics in PV:
To know of something that is harmful to another person
who does not know, and not telling, is unethical.

PV Major Aims:
 Early detection of unknown safety problems
 Detection of increases in frequency
 Identification of risk factors
 Quantifying risks
 Preventing patients from being affected unnecessarily
Ref. Sten Olsson, Chief WHO programme Officer, The Uppsala Monitoring Centre

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Extended scope of Pharmacovigilance
• Adverse effects (properties of ingredients or patient)
• Patient effects of inadequate product quality (failing
GMP, distribution, storage, counterfeiting, etc.)
• Patient effects of inadequate use
– Medication errors
– Dependence and abuse
– Poisoning
• Safety challenges of mass treatment campaigns
– Immunization programs
– Other public health programs

Ref. Sten Olsson, Chief WHO programme Officer, The Uppsala Monitoring Centre

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B. PV Current Regulation & Challenges

Pharmaceutical Industry Health Care Provider

Regulation PerMenKes RI 1799 – 2010: PerMenKes - Standar Pelayanan

Industri Farmasi Kefarmasian:
- Di RS: No. 72-2016
PerKaBPOM 2011 – - Di Apotek: No. 73 – 2016
Penerapan PV bagi Industri - Di Puskesmas: No. 74 - 2016
Farmasi, Pedoman Teknis
Penerapan PV

Reporting to Mandatory Mandatory

Authority

PIT HISFARSI Bali – Evi Dwi Nofiarny 7

Importance of PV for Pharmaceutical Industries

• Ethic conduct:
– Promoting rational use of medicines
– Ensuring public confidence.
• Business Continuity:
– Company Image & Trust
– Impact to marketing promotion & sales
– Production & distribution, etc.
• Business Readiness: partners of choices
• Compliance to Regulation
• Needed in case of Legal issues / Lawsuits

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C. Signal Management: from detecting signals to
recommending actions

• Signal: information that arises from one or multiple sources

which suggests a new potentially causal association, or a new
aspect of a known association, between an intervention and an
event or set of related events, either adverse or beneficial, that
is judged to be of sufficient likelihood to justify verificatory
action.

Ref.: EMA GVP Module IX – Signal Management, 2012

Module VI – Management and reporting of adverse reactions to medicinal products, 2014

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 Sources of data and information
 Spontaneous adverse drug reaction (ADR) reporting systems, may be detected
from:
 monitoring of individual case safety reports (ICSRs)
 ADR databases
 articles from the scientific literature
 Review of information provided by marketing authorisation holders (e.g.
variations, renewals, post-authorisation commitments, periodic safety update
reports (PSURs), Risk Management Plan (RMP).
 active surveillance systems
 non-interventional studies & clinical trials,
 scientific literature and other sources of information.

Signal management process:

Signal Recommen
Signal Signal Signal Exchange of
analysis & dation for
detection validation assessment information
prioritisation action

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 D. Reporting Culture & System

How to create a patient reporting culture?

Reporting culture conditions

• Vigilance : attention for side effects
• Openness : willingness to share experience
• Involvement : improve patient safety

Need to develop a positive ADR reporting culture

Ref. Dr. Agnes Kant, Netherlands Pharmacovigilance centrelareb

PIT HISFARSI Bali – Evi Dwi Nofiarny 11

 Information is like a fish:
it’s better when it’s fresh

Bit.ly/pvfarmasirs

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PV & AE Reporting at Pharmaceutical Industries
• Pharmacovigilance Activities (ICH E2E):
– Passive Surveilance: spontaneous report, case series
– Active Surveillance: Registries, Drug Event Monitoring
• Follow-up of AE/PTC report:
– Further data collection / clarification & assessment
– Investigation
– Visit: Discussion & Sharing information
– Responses/ letter to Reporter: Medical Information
– Reporting to Regulatory Authorities

Reporting PV for Dexa Medica Group* products:

 Marketing & Sales team
 PV DXG Official E-mail: [email protected]
 Websites: www.dexa-medica.com ; www.ferron-pharma.com
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*DexaGroup: Dexa Medica, Ferron Par Pharmaceuticals, Fonko Indonesia, Betapharmacon, Anugerah Argon Medica
Output of AE / PTC Reports
Product Technical Complaints: Common Goal: RISK MANAGEMENT
• CAPA: process improvement - Detection: to anticipate repeat
• Change in Products information, Events
product labelling, packaging, etc.
• Change in Manufacturing or - Mitigation: to minimize or mitigate
Distribution process. impact of Adverse Events

Adverse Events:
• Add warning and precaution
• Adjusted / Limitation on
indication or patient’s population
target

 Recall
 Stop Production
Laporan AE / PTC dari rekan-rekan di Rumah Sakit berperan penting
menghidupkan aktivitas Pharmacovigilance di Industri Farmasi

Penting untuk Signal Detection & Risk Benefit Assessment

PIT HISFARSI Bali – Evi Dwi Nofiarny 14
 Pharmacovigilance Award

Presented by:
Head of Indonesia National Agency of Drug and Food Control
(NA-DFC), Bandung - 30 October 2018

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https://e-meso.pom.go.id

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E. Collaboration to foster Pharmacovigilance

ISoP aims to foster science, learning and research in pharmacovigilance in

all countries.

 Pharmacovigilance Curriculum
 Training, Seminar, Annual Meeting
 Special Interest Group (SIG)
 Publication
 Etc.

https://isoponline.org/
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ISoP is proud to be affiliated to the following organizations:

ISoP is an affiliated organisation to the

European Association for Clinical Pharmacology and
Therapeutics (EACPT)
www.eacpt.org

ISoP is also an International Member of the

Council For International Organizations of Medical Sciences
(CIOMS)
www.cioms.ch

Following elections at the 83rd CIOMS Executive Committee

and XXII General Assembly meeting on 29 November 2016,
ISoP is pleased to announce the election of Prof Herve Le Louet
– past president of ISoP- as new CIOMS President.

Drug Safety is the premier international journal covering the

disciplines of pharmacovigilance, pharmacoepidemiology,
benefit-risk assessment and risk management.
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https://isoponline.org/special-interest-groups/medication-errors/
https://isoponline.org/chapters/indonesia/
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https://isoponline.org/chapters/indonesia/

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How to join ISoP: www.isoponline.org (under “Members”)

https://isoponline.org/wp-content/uploads/2019/02/155537_ISOP_2019_Web.pdf 24
 Bit.ly/pvfarmasirs

Evi Dwi Nofiarny, Ssi, Apt, MSc.

[email protected] 25
[email protected]