Essential Medicines 2008 - Indonesia

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615.1 Ind n

NATIONAL LIST of ESSENTIAL MEDICINES 2008

NATIONAL LIST of ESSENTIAL MEDICINES 2008

DEPARTEMEN KESEHATAN R.I.

MINISTRY of HEALTH REPUBLIC of INDONESIA1

Ministry of Health of The Republic of Indonesia. Cataloging in Publication Data. 615.1 Ind n Indonesia. Ministry of Health Republic of Indonesia. National list of essential medicines 2008.-Jakarta : Ministry of Health of The Republic of Indonesia, 2008. 1. Judul 1. DRUGS

2

CONTENT Page Foreword Content The decree of The Ministry of Health regarding National List of Essential Medicines 2008 Chapter I Chapter II Chapter III APPENDICES Appendix I Appendix II Changes of National List of Essential Medicines 2005 The Decree of Ministry of Health Number 239/MENKES/ SK/III/2008, 5 March 2008, regarding The Establishment of National Committee on Revision of The NLEM 2008 List of Participants of Technical Meetings and Plenary Session of National List of Essential Medicines 2008 Statement of Compliance Conflict of Interest Statement Assessment Form 88 100 INTRODUCTION National List of Essential Medicines 2008 Restricted Medicine List for Public Health Center 2008 i ii iii 1 19 63

Appendix III Appendix IV Appendix V Appendix VI Index

105 108 109 110 112

National List of Essential Medicines 2008

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THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA THE DECREE OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA NUMBER : 791/MENKES/SK/VIII/2008 REGARDING THE NATIONAL LIST OF ESSENTIAL MEDICINES 2008 THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA Considers : a. in order to increase the quality of health services and to ensure the availability, equity, affordability of the essential medicines to the community at all levels, it is therefore, the National List of Essential Medicines should be revised; the National List of Essential Medicines which mentioned in the Decree of the Minister of Health No. 497/Menkes/SK/VII/2006 has to be revised according to progress of medical sciences, health technology, disease pattern and the health program respectively; Considering point (a) and (b), it is necessary to redetermine the National List of Essential Medicines by the Ministerial Decree; Law No. 23 year 1992 regarding Health (States Paper Year 1992 No. 100. Additional to States Paper No. 3495); Law No. 29 year 2004 regarding Medical Practice (State Paper year 2004 No. 116, Additional to State Papers of the Republic of Indonesia No. 4431); Law No. 32 year 2004 regarding the Regional Government Administration (State Paper year 2004 No. 125, Additional to State Paper No. 4437) as lastly changed by Regulation No. 12 year 2008 regarding the second changing on the Regulation No. 32 year 2004 regarding Regional Government (State Paper year 2008 No. 59, Additional State Paper No. 4844); Government Regulation No. 32 Year 1996 regarding Health Human Resource/ Health personnel (State Paper year 1996 No. 49, Additional to State paper No. 3637); Government Regulation No. 72 Year 1998 regarding the Security of the pharmaceutical product and Medical Devices (State Paper year 1998 No. 138, Additional to State Paper No. 3781); Government regulation No. 38 year 2007 regarding Division of governing administration of central government, Provincial Government, and local government in Municipality/District (State paper Year 2007 No. 82, Additional State Paper NO. 4737);

b.

c. Refers to : 1. 2.

3.

4.

5.

6.

National List of Essential Medicines 2008

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7.

Presidential Regulation No. 9 year 2005 regarding the authority, function, Organizational Structure and duty of States Ministries of the Republic of Indonesia; Presidential Regulation No. 10 Year 2005 regarding Organization Unit and duty of the First Rank Officers of the States Ministries; The Regulation of Ministry of Health No. 085/Menkes/Per/I/ 1989 regarding the Compulsory of Generic products prescribing at public health facilities; The decree of the Minister of Health of the Republic of Indonesia no. 1575/Menkes/Per/XI/2005 regarding Organization and Management of the Ministry of Health as has been changed by the Regulation of the Minister of Health No. 1295/Menkes/Per/XII/2007; The decree of the Minister of Health No. 189/Menkes/SK/III/ 2006 regarding the National Medicines Policy; The decree of the Minister of Health No. 239/Menkes/SK/III/ 2008 regarding The Establishment of The National Committee on Revision of The National List of The Essential Medicines 2008. Has decided

8. 9.

10.

11. 12.

To Stipulate The First The Second The Third

: : : : THE DECREE OF THE MINISTER OF HEALTH REGARDING NATIONAL LIST OF ESSENTIAL MEDICINES 2008. The National List of Essential Medicines 2008 as mentioned in the first dictum is attached in the Appendix hereto. The National List of Essential Medicines (NLEM) is the list of the selected medicines that satisfy the priority health care needs of the population and are intended to be available within the context of functioning health systems. The implementation of NLEM is to increase the appropriateness, safety, rationalization of the medicine use and management and also increase the effectiveness and efficiency of the available budget in order to expand, to distribute evenly and to increase the quality of health services for all community levels. The implementation of NLEM should be consistent and continuously in level of Health Service Units. With approval of this decree, therefore the Decree of Minister of Health No. 497/Menkes/SK/VII/2006 regarding the National List of Essential Medicines 2005, hereby cancelled and believed not to be applicable any more.

The Fourth

:

The Fifth The Sixth

: :

National List of Essential Medicines 2008

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The Seventh

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This decree shall be effective as of the date of stipulation. Stipulated in : Jakarta On Date : August 21, 2008. Minister of Health

Dr. dr. SITI FADILAH SUPARI, Sp.JP (K)

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FOREWORDThe National Medicines Policy (2006) mandates the enforcement to enhance the quality of health services; to ensure the availability of safe, efficacious and good quality medicines in sufficient amount and type, affordability and accessibility of medicine particularly essential medicine for the whole community, to be governments responsibility. Essential medicine is selected medicine that mostly needed for health service, including diagnosis, prevention, therapy and rehabilitation, which enforced to be provided in health care units, according to their function and level. This revisions renewal applied a new approach, whereas the process of addition and deletion preceded with re-evaluation of existing list of previous National List of Essential Medicines (NLEM) by The National Committee of NLEM, therefore there were deletion of obsolete medicines and addition of new medicines in consequence of science improvement. It needs the transparency of evaluating process which utilize scientific evidence and consider the pediatric formulation. NLEM revised regularly every three years; the last revision carried out in 2005. Current revision is conducted by The National Committee of NLEM, which legalized through The Decree of Minister of Health. Hopefully, by the prevailing of NLEM 2008, mandate of The National Medicines Policy could be applied better. A great thankfulness is given to all parties involved in the process of revision and formulation of NLEM 2008. Jakarta, August 2008 Director General Pharmaceutical Services and Medical Devices

Dra. Kustantinah, Apt. MAppSc. NIP. 140 100 965

National List of Essential Medicines 2008

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CHAPTER I

INTRODUCTIONThe concept of Essential Medicine in Indonesia was first introduced with the publication of The National List of Essential Medicines (NLEM) in 1978, followed by the National Medicines Policy document in 1983. The National List of Essential Medicines, named DOEN (NLEM) is revised periodically every 3-4 years. DOEN 2008 is a revised edition. The Governments commitment to do periodic revisions is a reputation of its own. In the year 2007, the World Health Organization (WHO) has carried out the first phase of Good Governance on Medicines (GGM) program in Indonesia by conducting a survey on transparency of five pharmaceutical functions. One of them is the selection process of essential medicines, which from the aspect of transparency process is valued to be insufficient. From the meeting of the 30th WHO Essential Medicine List in Sri Lanka (2007), it was reiterated that the importance of transparency of the selection process both by expert panel members who do revisions, revision process, and revision methods which have got to be more rely on evidence based medicine (EBM), and the importance of the conflict of interest statement from expert panel members. Recalling some of the above mentioned issues, this years (2008) revision has been geared into its betterment. Because of it, the revision process this time is rather different from the earlier revision process, some of these improvements are as follows: 1. 2. The selection of expert panel members has been tightly scrutinized, including valuation against conflict of interest. Since the beginning of discussion, program managers who use medicines in the environment of the Ministry of Health have been included, not only during the plenary meeting. This endeavor is hoped to be a re-learning process to the internal of the Ministry of Health to fully understand the concept of essential medicines. Besides the opinion and experiences of expert panel members in this revision team, the utilization of evidence based medicine (EBM) data are important considerations. The entire discussion process gives great atte