DIRECTORATE GENERAL PHARMACEUTICAL DEVELOPMENT AND MEDICAL SERVICES
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1 DIRECTORATE GENERAL PHARMACEUTICAL DEVELOPMENT AND MEDICAL SERVICES
2 OUTLINE I. Introduction II. Regulation III.Strategies to Improve Medicines Accessibility IV. Conclusion
3 I. INTRODUCTION
4 NATIONAL HEALTH SYSTEM a. To achieve the availability, fair distribution and affordability of medicines b. To ensure the safety, efficacy and quality of medicines and public protection c. To improve pharmaceutical care services d. To improve Rational Use of Medicine e. Selft reliance on medicines Medicines, Medical Devices and Food Human Resources Health Services National Health System Community Empowerment Health Financing Human Resources OBJECTIVE : Helath Development Good
5 II. REGULATION
6 HEALTH DEVELOPMENT IMPROVEMENT THE HEALTH DEGREE AND WELFARE To improve people access to health services, including safe, effective and good quality of medicines NATIONAL MEDICINES POLICY (Government Regulation number 7 of 2005 ) 6
7 AVAILABILITY, FAIR DISTRIBUTION AND AFFORDABILITY SAFETY, EFFICACY AND QUALITY NATIONAL MEDICINES POLICY Decree of Ministry of Health-Republic of Indonesia number 189/MENKES/SK/III/2006 RATIONAL USE OF MEDICINES PULIC PROTECTION 7
8 AVAILABILITY, FAIR DISTRIBUTION AND AFFORDABILITY 1. Production capacit of essensial medicine 2. The chain of distribution available from the central, provincial to local, public and private 3. Pharmacies should meet the standard of pharmaceutical services 4. Continuity of Budget (insurance) 5. Rational use of medicines
9 SAFETY, EFFICACY AND QUALITY 1. Good quality of raw material and doses form 2. Good Manufacturing Practice 3. Good Distribution Practice 4. Registered medicines use only 5. Labeling and package insert 6. Preventing illegal medicines
10 RATIONAL USE OF MEDICINES Diagnose Patient condition Indication Affordable Information RIGHT Medicines Aware of Adverse Drug Reaction Patients Need Dose, administration & duration
11 III. STRATEGIES TO IMPROVE MEDICINES ACCESSIBILITY 11
12 ACCESS TO ESSENTIAL MEDICINE I. Rational Use of Drug II. Affordability III. Financial Sustainablility IV. Health Care System V. Drug Supply System
13 STRATEGIES IN IMPROVING ACCESS TO MEDICINES : 1. Social inssurance 2. JAMKESMAS Formulary 3. Revitalize Reposition Generic Medicines 4. SAS (Special Access Scheme) for medicines that have not been registered in Indonesian 5. Orphan Drug in future IMPROVING ACCESS AFFORDABILITY 13
14 STRATEGIES IN IMPROVING MEDICINES ACCESSIBILITY.. (1) CONDITION (2010) Antineoplastic in Indonesia FORWARD Encourage local pharmaceutical companies to: 69 items 351 dosage forms Produce Import GOAL GENERIC IMPORTED 68 item LOCAL 1 item IMPROVING ACCESS 14
15 JAMKESMAS FORMULARY. (2) JAMKESMAS FORMULARY *Decree of Ministry of Health RI number : 1455/Menkes/SK/X/2010, 4 Oct 2010 List of Essential Medicines and the Information The corridor to health care giver to improve the health services for the member of Jamkesmas based on standard and criteria In hospital and other health care services as the guideline to program JAMKESMAS implementation 15
16 A. Common Use medicine Antineoplastic, Imunosupresan and Paliative therapy 8.3 Sitotoxid Asparaginase Bleomisin Busulfan Dakarbazin Doksorubisin Etoposid Fluorourasil Ifosfamid Kalsium folinat (leukovorin, ca) Karboplatin Klorambusil Melfalan Merkaptopurin Metotreksat Paklitaksel Prokarbazin Siklofosfamid Sisplatin Sitarabin Vinblastin Vinkristin medicine with 10 influence blood 10.3 Intoksikasi Zat Besi FORMULARY.. HEMATOLOGY- ONCOLOGY MEDICAL in JAMKESMAS FORMULARY B. Restricted Use Medicine 4 Antidot dan Other Medicines for Toxicity Deferasiroks Deferipron Kalsium folinat (leukovorin, Ca) Antineoplastic, Imunosupresan and Paliative 8 therapy 8.3 Sitotoksik 9 Dinatrium Klodronat 10 Irinotecan 11 Uromiteksan
17 REVITALIZE GENERIC MEDICINES.. (3) 1. Generic Medicines Pricing 2. Fast-track registration 3. Competitive and Conducive business climate Upstream Sector Downstream Sector Social Dimension Economy dimension Science and Technology MUTIDIMENSION IN MEDICINES USE 1. Obligation on generic prescribing in public health care 2. Generic substitution 3. Generic medicines in JAMKESMAS 4. Advocacy to stake holder and community 17
18 REPOSITION GENERIC MEDICINES (4) Grand Strategy Generic Medicines : Low price Grand Strategy Generic Medicines = Good Quality Community interpretation : Generic medicines = Medicines with low quality REPOSITION Generic has a good price and quality Doctors and patient will not have any doubt in generic use 18
19 LIMITED NON REGISTERED MEDICINES SPECIAL ACCESS SCHEME / SAS (5) MEDICINES (incl. product biology) Medical Devices cytotoxic IMPORT DONATION SAS AKSES Disaster/epidemic/ outbreak Program needs Health care (hospital, primary health care, research center) PATIENT/COMMUNITY Processed Food (for therapy) Essential for health care NON DONATION Program needs Health care (hospital, primary health care, research center Institution/ Private procurement 19
20 IV. CONCLUSION Medicines accessibility has an important role in achieving goal of therapy. Government strategies in improving medicines accessibility : Social insurance Jamkesmas formulary Revitalize and Reposition of Generic Medicines Orphan drugs 20
21 Thank you
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