Collaboration of Hospital & Pharmaceutical Industries to ...hisfarsibali.org/Materi Simposium 1 Evi...
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Evi Dwi Nofiarny, Ssi, Apt, MSc. Head of Corporate Quality Audit, Pharmacovigilance and QRM - Dexa Group VP of International Society of Pharmacovigilance – Indonesia Chapter Collaboration of Hospital & Pharmaceutical Industries to enhance awareness of Pharmacovigilance & Patient Safety PIT - Hisfarsi Bali, 11 July 2019 “It’s All About Medication Safety”
Transcript of Collaboration of Hospital & Pharmaceutical Industries to ...hisfarsibali.org/Materi Simposium 1 Evi...
Evi Dwi Nofiarny, Ssi, Apt, MSc.
Head of Corporate Quality Audit, Pharmacovigilance and QRM - Dexa Group
VP of International Society of Pharmacovigilance – Indonesia Chapter
Collaboration of Hospital & Pharmaceutical
Industries to enhance awareness of
Pharmacovigilance & Patient Safety
PIT - Hisfarsi Bali, 11 July 2019
“It’s All About Medication Safety”
Formal education:
Magister Pharmacology – Bio Medic FKUI Jakarta, 1996 – ‘99
Apothecary program – ITB Bandung, 1993 – ‘94
Pharmacy – ITB Bandung ,1988 – ‘93
Evi - Dwi Nofiarny Zulkarnain, Ssi, Apt, MSc
Curriculum Vitae
Scientific Involvement:
• Vice President – International Society of Pharmacovigilance, Indonesia Chapter, 2017
– now
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
Agenda
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
“It’s All About Medication Safety”
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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: Industri Farmasi PerKaBPOM 2011 – Penerapan PV bagi Industri Farmasi, Pedoman Teknis Penerapan PV
PerMenKes - Standar Pelayanan Kefarmasian: - Di RS: No. 72-2016 - Di Apotek: No. 73 – 2016 - Di Puskesmas: No. 74 - 2016
Reporting to Authority
Mandatory Mandatory
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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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Signal management process:
Signal detection
Signal validation
Signal analysis &
prioritisation
Signal assessment
Recommendation for
action
Exchange of information
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.
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How to create a patient reporting culture?
Reporting culture conditions
• Vigilance : attention for side effects
• Openness : willingness to share experience
• Involvement : improve patient safety
Ref. Dr. Agnes Kant, Netherlands Pharmacovigilance centrelareb
Need to develop a positive ADR reporting culture
D. Reporting Culture & System
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Information is like a fish: it’s better when it’s fresh
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Bit.ly/pvfarmasirs
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
*DexaGroup: Dexa Medica, Ferron Par Pharmaceuticals, Fonko Indonesia, Betapharmacon, Anugerah Argon Medica
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 13
Output of AE / PTC Reports
Product Technical Complaints: • CAPA: process improvement • Change in Products information,
product labelling, packaging, etc. • Change in Manufacturing or
Distribution process.
Adverse Events: • Add warning and precaution • Adjusted / Limitation on
indication or patient’s population target
Recall Stop Production
Common Goal: RISK MANAGEMENT
- Detection: to anticipate repeat Events
- Mitigation: to minimize or mitigate impact of Adverse Events
Laporan AE / PTC dari rekan-rekan di Rumah Sakit berperan penting
menghidupkan aktivitas Pharmacovigilance di Industri Farmasi
Penting untuk Signal Detection & Risk Benefit Assessment
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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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Pharmacovigilance Curriculum Training, Seminar, Annual Meeting Special Interest Group (SIG) Publication Etc.
E. Collaboration to foster Pharmacovigilance
ISoP aims to foster science, learning and research in pharmacovigilance in all countries.
https://isoponline.org/ 19
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/ 21
https://isoponline.org/chapters/indonesia/ PIT HISFARSI Bali – Evi Dwi Nofiarny 22
PIT HISFARSI Bali – Evi Dwi Nofiarny
https://isoponline.org/chapters/indonesia/
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https://isoponline.org/wp-content/uploads/2019/02/155537_ISOP_2019_Web.pdf
How to join ISoP: www.isoponline.org (under “Members”)
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