Post on 08-Mar-2018
Türkiye İlaç ve Tıbbi Cihaz Kurumu
w w w . t i t c k . g o v . t r
TURKISH MEDICINES AND MEDICAL DEVICES AGENCY Gulsen ONER, Pharm. M.Sc. Melda KECIK, Pharm. M.Sc.
2014 WHO Technical Briefing Seminar, November
Türkiye İlaç ve Tıbbi Cihaz Kurumu
I. About Turkey
II. About Turkish Medicines and Medical Devices Agency (TMMDA)
III. Rational Use of Medicines : Activities
OUTLINE
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ABOUT TURKEY
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DEMOGRAPHIC & ECONOMIC INDICATORS - 2013
*TurkStat, Turkey’s Statistical Yearbook, 2013 **http://data.worldbank.org/indicator/NY.GDP.PCAP.CD
Population* 76.7 million
Median Age* 30.4
GDP* 820 Billion $ (At current prices)
GDP Per Capita**
$10,946
Türkiye İlaç ve Tıbbi Cihaz Kurumu
HTP was introduced in response to a number of problems
At the turn of the millennium the performance of Turkey’s health sector:
• Health outcomes
• Financial protection
• Patient satisfaction
• Financial sustainability
HEALTH TRANSFORMATION PROGRAM (HTP) IN TURKEY, SINCE 2003
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• Efficiency
• Quality
• Access
HTP aimed to organize, fund and provide health care services in an effective, efficient and equitable manner.
HEALTH TRANSFORMATION PROGRAM (HTP)
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ACHIEVEMENTS (2000-2012)
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31.6
40
64
27.6
39.5
76.8
11.6 11
15.4 15.4
74.8
expectation of life atbirth (year)*
infant mortality rate(%)*
U5MR (per 1000 livebirths)**
maternal mortality (per100000 live births)**
OOP expenditure as ashare of total healthexpenditure (%)**
health servicessatisfaction rate
(satisfied)*
*Turkish Statistical Institute **Health Statistics Yearbook 2012/General Directorate of Health Research
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DRUG REGULATIONS
Turkish Medicines and Medical Devices Agency
(TMMDA)
Social Security Institution (SSI)
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ABOUT US
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
General Directorate of Pharmaceuticals & Pharmacy
(February 1946)
Turkish Medicines & Medical Devices Agency
(Affiliated to MoH since 2012)
TURKISH MEDICINES AND MEDICAL DEVICES AGENCY
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
• The Turkish Medicines and Medical Devices Agency (TMMDA) is the governmental regulatory authority on human medicinal products, medical devices and cosmetics in Turkey.
• TMMDA is responsible for;
o regulation
o evaluation and
o monitoring all these product groups
TURKISH MEDICINES AND MEDICAL DEVICES AGENCY
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
PRESIDENT
Department of Legal Consultancy Office of Executive Secretary
Vice Presidency of Support and Laboratory Services
Vice Presidency of Economic Assessments and Information
Management
Vice Presidency of Medicinal Products and Pharmacy
Vice Presidency of Medical Devices and Cosmetics
Department of Economic
Assessments
Department of Rational
Drug Use and Drug Supply
Management
Department of
Information Systems
Department of Medicine
Inspection
Department of Medical
Devices Inspection
Department of Cosmetics
Inspection
Administrative and Fiscal
Inspection
Department of Medicinal
Products Marketing
Authorization
Department of Clinical and
Technological Assessment
Department of Pharmacies
and Licencing of
Pharmaceutical Warehouses
Department of Clinical
Trials
Department of Risk
Management
Department of Medical
Devices Registration and
Coordination
Department of Medical
Devices Sectoral Services
Department of Medical
Devices Notified Body
and Clinical Trials
Department of Cosmetics
Scientific Advisory Committee Department of Strategy Development
Department of
Human Resources
Department of
Administrative and
Financial Affairs
Department of Analysis
and Control Laboratories
Department of
International Relations
Vice Presidency of Inspectorate
Quality Management 12
Türkiye İlaç ve Tıbbi Cihaz Kurumu
Marketing authorization of local/imported medicinal products
Marketing authorization application dossier;
A. new medicinal product
B. generic medicinal product
C. biological and biotechnological medicinal product
D. traditional herbal medicinal product
E. advance therapy medicinal product
The TMMDA’s MAIN ACTIVITIES – I
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Medical devices
Registration to Republic of Turkey Medical Devices and Drugs Databank (TITUBB)
Cosmetic products
Notification
The TMMDA’s MAIN ACTIVITIES - II
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Analysis and control process of medicines, medical devices, cosmetics, biotechnological products, enteral nutrition products, biological products
GxP inspections & Certification of manufacturing sites of human medicinal products
Market surveillance of medical devices & cosmetics
Pharmaceutical Track & Trace System (ITS)
The TMMDA’s MAIN ACTIVITIES - III
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Harmonization with EU Legislation - 2005
The Turkish MoH has implemented a number of regulations to bring its pharmaceutical laws in line with those in the European Union.
LEGISLATION
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ITS is a system that traces and checks all processes of medicines with datamatrix at every node from production/importation to the patient.
PHARMACEUTICAL TRACK AND TRACE SYSTEM (ITS)
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ACTIVITIES FOR RATIONAL USE OF MEDICINES (RUM)
IN TURKEY
Türkiye İlaç ve Tıbbi Cihaz Kurumu
October 2010 Rational Drug Use (RDU) Branch
March 2012 - Rational Drug Use and Drug Supply Management Departmant – TMMDA
RUM Activities
20 years
Represantatives İn all cities
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
7 pharmacist
5 doctor
1 biologist
1 dietician
1 health officer
2 IT expert (engineer)
RATIONAL DRUG USE UNIT
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Aim
Cooperation and coordination for all the stakeholders for activities for rational drug use,
Change the behaviors of all stakeholders in drug use
Objective
Complete and strenghten restructuring in order to conduct activities and raise awareness about RUM
RDU NATIONAL ACTION PLAN 2014-2017
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RDU NATIONAL ACTION PLAN 2014-2017 STAKEHOLDERS
PHSYICIANS PHARMACIST
HEALTH PROFESSIONALS PUBLIC DRUG INDUSTRY
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RDU NATIONAL ACTION PLAN 2014-2017 ( 6 TITLES / 20 STRATEGIC OBJECTIVES / 99 ACTIONS )
A. RDU STRUCTURING D. ALLIED HEALTH PERSONNEL
o 5 actions were planned under 1 Strategic Target Title o 12 actions were planned under 3 Strategic Objective Title..
Strenghtening RDU structuring: 5 actions Promotion: 4 action
Education: 7 actions
Monitoring-Evaluation: 1 actions
Administrative Arrangement and Planning: 0 action
B. PHYSICIANS E. PUBLIC
o 29 actions were planned under 4 Strategic Objective Title. o 23 actions were planned under 4 Strategic Objective Title..
Promotion: 6 actions Promotion: 12 actions
Education: 11 actions Education: 9 actions
Monitoring-Evaluation: 10 actions Monitoring-Evaluation: 1 action
Administrative Arrangement and Planning: 2 actions Administrative Arrangement and Planning: 1 action
C. PHARMACISTS F. PHARMACEUTICAL INDUSTRY
o 17 actions were planned under 4 Strategic Target Title. o 13 actions were planned under 4 Strategic Objective Titles.
Promotion: 4 actions Tanıtım: 4 faaliyet
Education: 9 actions Promotion: 4 actions
Monitoring-Evaluation: 1 actions Monitoring-Evaluation: 3 actions
Administrative Arrangement and Planning: 3 actions Administrative Arrangement and Planning: 5 actions
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Education for representatives in all cities
What is Rational Use of Medicines?
The Action Plan
Aims and responsibilities for representatives
National Meeting for RUM Representatives
ACTIVITIES FOR RUM IN TURKEY-1
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Drug utilization data with ATC/DDD
Assessment and Education Meetings on different cities
ACTIVITIES FOR RUM IN TURKEY -2
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Drug Industry Represantatives education
Cooperation with international organisations
RDU bulletin
Prescription Information System (PIS)
ACTIVITIES FOR RUM IN TURKEY -3
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Started in 2009
Financily supported by World Bank
Collects data from family physicians’ and specialist physicians’ prescriptions
Integrated with the e-prescription system
PIS aims to;
Monitor and evaluate physicians prescription behaviour.
Maintains data feedback to physicians (individual data).
PRESCRIPTION INFORMATION SYSTEM (PIS)
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PIS maintains 4 basic data support;
Statistics of individual physicians
Statistics for individual health care facilities
Trend analysis of provinces
Statistics of provinces or whole country
STATISTICS PROVIDED BY PIS
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
According to the PIS data;
Percentage of prescriptions that includes antibiotic in Turkey was %34.94 in 2011, %33.99 in 2012
But Gaziantep was the top city prescribing antibiotics with %57.58 in 2011 , %55.49 in 2012
Gaziantep was choosen as a pilot area to search the reason for irrational drug use especially antibiotics
AN EXPERIENCE - GAZIANTEP
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
July 5, 2013 - Meeting with 25 family physicians and directors of Health Institutions of Gaziantep
September 23-25, 2013 - Meeting with family physicians, pharmacists and the member of hospital infection committies
February 21-22, 2014 - Meeting with pharmacists, subject «Rational Use of Antibiotics »
August 2014 – Meeting with family physicians and specialist physicians « Rational Use of Antibiotics»
WHAT DID WE DO IN GAZIANTEP ?
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RESULT
Months 2012 2013 Differences % Differences
October %57.32 %49.61 - 7,71 - 13,45
November %59.15 %49.71 - 9,44 - 15,95
December %62.06 %55.94 - 6,12 - 9,86
2012 2013
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
NO ACTION TODAY NO CURE TOMORROW!!!
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Türkiye İlaç ve Tıbbi Cihaz Kurumu
Adress : Söğütözü Mahallesi 2176. Sokak No:5
06520 Çankaya/ANKARA - TURKEY
Phone : +90 312 218 30 00
Web site : www.titck.gov.tr
www.akilciilac.gov.tr
E-mail : melda.ciba@titck.gov.tr
gulsen.oner@titck.gov.tr
CONTACT US
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THANK YOU 35
Türkiye İlaç ve Tıbbi Cihaz Kurumu
BON APPETIT
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