SALMAH BAHRI, PhD., RPh. Director of Pharmacy Practice and - - PowerPoint PPT Presentation
SALMAH BAHRI, PhD., RPh. Director of Pharmacy Practice and Development Pharmaceutical Services Division Ministry of Health Malaysia NATION ONAL REGULATO TORY Y CONFEREN ENCE E 2013 7-9 May 2013 Ista tana
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SALMAH BAHRI, PhD., RPh.
Director of Pharmacy Practice and Development Pharmaceutical Services Division Ministry of Health Malaysia
NATION ONAL REGULATO TORY Y CONFEREN ENCE E 2013 7-9 May 2013 Ista tana Hotel l Kuala la Lumpur
Pharmacy Transformation
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A clear and official government statement that defines and prioritises the medium to long term-goals set by the government for the pharmaceutical sector A formal record of aspirations, aims, decisions and commitments of the government and all stakeholders in both public and private sectors to a common goal for the pharmaceutical sector Identifies strategies and provides a transparent framework for the coordinated implementation of these strategies by stakeholders in the public and private sectors Existing legislation can provide the executive power and legal framework to implement the DUNas Ministry of Health (MOH) to oversee, monitor and administer the legislation
5 2000: Initiation of formulation DUNas 2001-2003:
stakeholders & policy makers 14 June 2006: DUNas Approved by MOH 12 April 2013: DUNas II Approved by MOH 11 October 2006: DUNas I Approved by Cabinet 15-17 Oct. 2012 DUNas Full-term Review 2009: DUNas Mid-term Review
To reflect achievements and outcomes attained from strategies implemented Serves as platform to obtain input and consensus from all stakeholders on new propositions and strategies The intitial objectives of DUNAS were maintained Introductions of new strategies and revision of current strategies to fulfill the current needs of the country.
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Quality, Safety and Efficacy of Drugs Drug Availability Drug Affordability Quality Use of Drugs Human Resource Development Research and Development Technical Co-operation Management of the National Medicines Policy Quality, Safety and Efficacy of Medicines Access to Medicines Quality Use of Medicines Partnership and Collaboration for the Healthcare Industry Governance in Medicines
Supporitng Components Core Components
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To improve health outcomes of Malaysians through: Promoting equitable access to essential medicines Ensuring availability of safe, effective and affordable medicines of good quality Promoting quality use of medicines by healthcare providers and consumers
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Legislation & Regulations
Strengthened to ensure appropriate practices in development, production, importation, supply, marketing, sale and management (including prescribing, dispensing, administration and disposal) of medicines Level of regulation shall be consistent with potential benefits and risks to the community
Pharmaceutical Quality Assurance
about Medicines
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Resp esponsible for
Pharmaceuti tical l Regu egula latory Con
n Mala laysia
importers and wholesalers
Activities
clinical trials
framework & community engagement
communication and effective use of medicines by the consumers.
facilitating regional and international harmonisation of technical requirements of registration of medicines
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Regul egulatin ing Premises s that Sup upply Medi edicines
shall handle registered medicines
carried out at premises regulated according to the appropriate legislations.
medicines comply with legislations, regulations, guidelines and directives
ensure compliance to existing regulatory requirements.
Effect ctive Enf nforcement
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Med edicines Advertisement and and Pr Prom
All relevant stakeholders shall comply with existing legislations, guidelines and relevant codes of ethics for advertising and promotion
enforcement of laws and regulations by MOH together with other relevant authorities for market surveillance shall be enhanced to manage and control the problem of counterfeit medicines
counterfeit medicines and public education shall be implemented and enhanced.
Cou
edicines
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Post Marketing Surveillance
ensure products conform to standards and requirements
conforming products
All complaints pertaining to medicines shall be investigated and appropriate action shall be taken in a timely manner
Management of Complaints about Medicines
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management and supply network shall be maintained
and regulated to create incentives and foster competition in medicine prices
developed to ensure essential medicines needed for quality healthcare are affordable
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efficacy, clinical effectiveness & cost effectiveness of treatment
Chain Network -TQM,GDP & ICT
Malaysia
Information
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Selection
Medicines National Medicines Formulary National Drug & Therapeutic Committee Traditional & Complementary Medicines Formulary Life-saving & Orphan Medicines Formulary Halal Medicines National Essential Drug List
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National Medicines Formulary
National Drug & Therapeutic Committee National Essential Drug List Traditional & Complementary Medicines Formulary
Therapeutic Committee
Malaysia
SELECTION OF MEDICINES
relevant stakeholders
Committee shall be established and function based on the guidelines developed by MOH
medicines industry for:
distribution & utilisation
committee under MOH
by health providers
Life-saving Medicines and Orphan Medicines Halal Medicines
Strategic partnerships with the relevant authorities to make certified halal medicines available in Malaysia
accessibility of live-saving and orphan medicines without jeopardising elements of safety, quality & efficacy
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Procurement
Disposal of Medicines Distribution & Storage of Medicines Medicines Supply in Emergency & Medicines Donations
and transparent procurement system to ensure adequate & timely availability of medicines Supply of Medicines
economical distribution network
and quality assurance to comply to GDP
network for logistic, inventory and financial transaction in all health facilities
all organisations to manage national emergency situation
drug supplies in emergency situations and receiving donations
accordance with prevailing laws and regulations
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▪ National Pricing
Reference
information
billing
data
(exempted)
Implemented to foster healthy competition in medicines pricing
generic International Non-proprietary Name (INN) In selection of procurement, priority to domestically manufactured medicines.
the generic INN name
interchangeable (NI) medicines
and legislated except for those in NI list
use of generic medicines
National Financing Mechanism
underprivileged are not denied access to essential medicines
Generic Policies Price of Drugs
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STRATEGIES
Development & Implementation of Models of Best Practice Education & Training
Provision of Timely & Accurate Information on Medicines
Strengthening Seamless Care Between Healthcare Providers Research & Development in Quality Use of Medicines Engagement of Payers involved in Reimbursements for Medicines Use
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Models of best practice
R&D in QUM Timely & Accurate Information
Education & Training
accordance to CPGs, STGs, Good Dispensing Practice, others (relevant)
activities (compliance to guidelines) Conducting studies to evaluate effectiveness of QUM programs
made available
responsible promotion, packaging & PILs, ethical advertising
reporting on medicines, timely response in misinformation cases
empowerment
QUM
Strengthen Seamless Care Between Healthcare Providers
Engagement of Payers – involves in Reimbursements for Medicines Use
Responsibility of payers: support & engage in QUM activities
Quality Use of Medicines
28 www.knowyourmedicines.gov.my On going QUM activities in Malaysia
Research in QUM Activities: National Study on Use of Medicines by Consumers in 2012 done by PSD, MOH in collaboration with USM :
(2008 - 44.4%)
medicines (2008 – 65.7%)
61%)
pharmacists were necessary in order to understand and
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STRATEGIES
To achieve aim by:
relevant stakeholders.
competent and effective human resource based on needs through:
professional career pathway
facilities.
maintaining a responsible medicines industry. Human Resource Development Research & Development Technical Collaboration & Partnership A Viable & Responsible Pharmaceutical Industry
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Human Resource Development
Viable & Responsible Pharmaceutical Industry Technical Collaboration & Partnership Research & Development
(comply with policies & standards)
& relevant stakeholders
standards
production in sufficient quantities, incentives, export local produced medicines
areas in regulatory practices, training and human resource, medicines accessibility, quality use, R&D.
exchange and sharing of information.
with relevant stakeholders
and the relevant Ministries
incentivised.
technology between foreign and local companies
Partnership & Collaboration
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STRATEGIES
Health professional bodies and relevant stakeholders shall have codes of conducts and be responsible to ensure compliance by its members with the code. Stakeholders shall perform in accordance with the standard of practice developed by appropriate authorities/relevant professional bodies. Compliance with the standards shall be supported by legislation where appropriate. Relevant legislations / regulations shall be developed and / or reviewed to ensure an efficient supply chain network and integrated medicines management to safeguard the public.
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Accountability, Transparency & Good Governance
WH WHO Go Good
Governance for
edicin ines (GG GGM)
mplementation (Pha hase se III) stage
ransparent data and nd inf nform rmation sharin ing on
medici cines in n the health sect ctor
Medici icine price ices, dru rug g re regi gistration status, all tra ransaction
nd deci cisions of
ittees on
medici cines
Acce ccess to to inf nformation
r crit riteri ria in n the select ction and nd appoin intment of
membe bers to
cision-making committees-
Committees, Procurement Technical Committee, Tender Board
y of
ransparency cy through decl claratio ion of
re relatio ions wi with drug com
Guid idelines on
ceivin ing Gi Gifts
Guid idelines on
Managi ging g wi with Sales Representative
Managing g Con
licts of Int nterest
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rotocols for
censing g and nd insp nspectio ion of
ishments, select ction, pro rocu curement, distri ribution, con
inic ical tria ials and nd con
icin ines pro romotio ions
ce of
ndustry and nd ot
r stakeholders rs to
regu gulatory ry/ethic ical standards
Efficie ient, transparent & & ac acco countable le proc
Malaysia ian Gu Guid ideline on
GGM
nd ince ncentives system for
GGM
rform rmance audit it of
ciliti ities, ind ndustry wi with re regard to
GGM M and nd effort rts to
acce cess to
cines
Standards s of Go Good
Go Governance
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New Pharmacy Bill Transparency & mechanism to regulate Medicines Price Halal Hub – explore OIC market Benchmarking & Accreditation Liberalization & Harmonization
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