Download pdf - Essential Medicines 2008 - Indonesia

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TION

AL LIST of ESSEN

TIAL M

EDIC

INES 2008

DEPARTEMEN KESEHATAN R.I.

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MINISTRY of HEALTH REPUBLIC of INDONESIA

N A T I O N A L

L I S T o f

E S S E N T I A L

M E D I C I N E S

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615.1 Ind n

Ministry of Health of The Republic of Indonesia. Cataloging in Publication Data.

615.1 Ind Indonesia. Ministry of Health Republic of Indonesia. n National list of essential medicines 2008.--

Jakarta : Ministry of Health of The Republic of Indonesia, 2008.

1. Judul 1. DRUGS

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CONTENT

Page

Foreword i

Content ii

The decree of The Ministry of Health regarding National List of Essential Medicines 2008

iii

Chapter I INTRODUCTION 1

Chapter II National List of Essential Medicines 2008 19

Chapter III Restricted Medicine List for Public Health Center 2008 63

APPENDICES

Appendix I Changes of National List of Essential Medicines 2005 88

Appendix II 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

100

Appendix III List of Participants of Technical Meetings and Plenary Session of National List of Essential Medicines 2008

105

Appendix IV Statement of Compliance 108

Appendix V Conflict of Interest Statement 109

Appendix VI Assessment Form 110

Index 112

National List of Essential Medicines 2008 ii

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;

b. 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;

c. Considering point (a) and (b), it is necessary to redetermine the National List of Essential Medicines by the Ministerial Decree;

Refers to : 1. Law No. 23 year 1992 regarding Health (States Paper Year 1992 No. 100. Additional to States Paper No. 3495);

2. 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);

3. 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);

4. Government Regulation No. 32 Year 1996 regarding Health Human Resource/ Health personnel (State Paper year 1996 No. 49, Additional to State paper No. 3637);

5. 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);

6. 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);

National List of Essential Medicines 2008 iii

7. Presidential Regulation No. 9 year 2005 regarding the authority, function, Organizational Structure and duty of States Ministries of the Republic of Indonesia;

8. Presidential Regulation No. 10 Year 2005 regarding Organization Unit and duty of the First Rank Officers of the States Ministries;

9. The Regulation of Ministry of Health No. 085/Menkes/Per/I/ 1989 regarding the Compulsory of Generic products prescribing at public health facilities;

10. 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;

11. The decree of the Minister of Health No. 189/Menkes/SK/III/ 2006 regarding the National Medicines Policy;

12. 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

To Stipulate :

The First : THE DECREE OF THE MINISTER OF HEALTH REGARDING NATIONAL LIST OF ESSENTIAL MEDICINES 2008.

The Second : The National List of Essential Medicines 2008 as mentioned in the first dictum is attached in the Appendix hereto.

The Third : 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 Fourth : 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 Fifth : The implementation of NLEM should be consistent and continuously in level of Health Service Units.

The Sixth : 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.

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The Seventh : 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)

National List of Essential Medicines 2008 v

FOREWORD

The 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 government’s 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 revision’s 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 i

CHAPTER I

INTRODUCTION The 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 Government’s 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 year’s (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. The selection of expert panel members has been tightly scrutinized, including valuation against conflict of interest.

2. 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.

3. Besides the opinion and experiences of expert panel members in this revision team, the utilization of evidence based medicine (EBM) data are important considerations.

4. The entire discussion process gives great attention to medicines for children, including its formulation. The WHO essential medicines list for children has been used as one of the guidelines. The siding with the individual rights of children is also shown by electing pediatricians into the expert panel that numbered to 4 (four) persons.

5. Revision of the medicines list has been holistic and total, meaning weighing all medicines listed in the NLEM 2005 including notes which may no longer be deemed fit. Earlier revisions were more in the evaluation of medicines which are suggested to be added on in the previous list.

National List of Essential Medicines 2008

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6. Transparency is also displayed with descriptions of arguments why a medicine must be deleted or be added from the NLEM 2005, or even be change of dosage form.

A. National Essential Medicines

Essential medicines are chosen medicines which are most needed to cater to the diagnoses, prophylaxis, therapy, and rehabilitation, which are made available to the health service units in accordance to its functions and tiers.

1. Criteria of National Essential Medicines

a. Selection Criteria

Selection of essential medicines is based on these criteria:

(1) Having got the most beneficial risk-benefit ratio.

(2) Guaranteed of quality, including stability and bio-availability.

(3) Practicality in storage and distribution.

(4) Practical in use and delivery, which are adjusted to man power and health services facilities.

(5) Advantageous in compliance and reception by patients.

(6) Having got the highest benefit-cost ratio based on direct and indirect expenses for the patient.

(7) If there is more than one choice which have the same therapeutic effects, then preference is made for:

- medicines with effects which are known to have scientific data; - medicines with pharmacokinetic data which are known to be most

beneficial; - medicines with better stability; - easily obtainable; - medicines that are most familiar.

(8) Fixed combination medicines have to follow the following criteria:

- the compounded medicine is useful in the form of that combination only;

- combination medicines have got to show higher efficacy and safety than each individual component;

- ratio of the components of patent combination medicines are ratios which are fixed for a large number of patients who need those combination medicines;

- combination medicines have got to increase the benefit-cost ratio; - combination antibiotics it must also prevent or lessen the

occurrences of resistance or other disadvantageous effects.


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b. Criteria of Additions and Deletions

1. When addition of new medicines are considered, the existing old medicines with the same indications which may be obsolete should be taken into account, unless there is a strong reason to keep both of them.

2. Medicines used in special program(s) are suggested by the program manager and will be assessed by general EM selection criteria.

3. In the revision process, the entire medicine list in the NLEM (2005) is evaluated by the National Revisions Committee. Deletion of medicines which are seen as no longer effective may here be decided upon or a substitution may be done when another better medicine has been available.

c. Guidance on Evidence and Recommendation

Proof of evidence and recommendations are adopted from the US Agency for Health Care Policy and Research. The type of study should rely on scientific data, such as depicted in the list below, but the recommendation should depend on the overall judgement of all available data. Testimonials are not considered for assessment.

STATEMENTS OF EVIDENCE

Ia Data are obtained from meta-analysis of randomized, controlled clinical

trials. Ib Data are obtained from at least one randomized, controlled clinical trial. IIa Data are obtained from at least one non-randomized and well designed

clinical trial. IIb Data are obtained from at least one quasi-experiment of another type of

study that is well designed. III Data are obtained from descriptive study that is well designed, like

comparative study, correlation study, and case study. IV Data are obtained from reports or opinion of expert panels.

2. Application of Concept of Essential Medicines

Essential medicines are the most basic medicines which are needed to cater for health services. If other than listed NLEM medicines are needed, a (Hospital) Formulary or another limited medicine list may be instituted.

The NLEM may also be expanded into other documents as the needs arise.


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a. National List of Essential Medicines (NLEM)

National List of Essential Medicines consists of selected, most needed medicines and made to be available at health services units in accordance with its functionality and its levels. NLEM are a national minimum standard to health services.

Implementation of NLEM is meant to increase the efficacy, safety, rational use, and medicine management which altogether increase efficiency of available cost, which in turn extends coverage and increase average quality of medicine prescriptions. Application of this National Essential Medicines Policy must be done consistently, and continuously at all levels of health services units.

Medicine dosage-form and strength, such as tablets, syrups, injections, and other forms, unit strength, dose, and size of package indicated in the NLEM are binding, in order to create standards. Sizes of packaging for each health service unit are based on logistics efficiency while distribution is related with common usage.

b. Therapeutic Guidelines

Medication Guidelines should be systematically structured to help physicians to make a correct diagnosis and optimal medication for a certain kind of disease. Guidelines of medication should be suited for every level of health services units, such as guidelines in basic medication at Public Health Center and guidelines in diagnosis and therapy at local hospitals.

Medication Guidelines consist of information about all kinds of diseases, especially sicknesses which are occurring frequently - with their respective complaints - and information about dosage form, unit strength, dose of medicines and length of time of medication.

c. Hospital Formulary

A hospital formulary is a list of medicines which have been agreed upon by key hospital physicians and their inherent (medicine) information which are used in the hospital concerned. A national hospital formulary is written by the Medicine and Therapeutic Committee based on NLEM and elaborated upon by taking into account other medicines proven effective which are needed by specialties in the concerned hospitals. The creation of a hospital formulary has to be based on therapeutic guidelines. The implementation of a hospital formulary must be monitored and its report be used to carry out evaluation and revision so as to keep up with advancements of scientific knowledge and medical science.

d. Specialists’ Formulary

Specialists’ formularies are books which are consist of comprehensive complete information on medicines needed by certain specialists of a hospital, to be used for patient care with special disease indications.

Specialists’ formularies are written to increase compliance of hospital specialists towards their hospital formulary, that has been ranked very low until today. Certain


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specializations may have many sub-specializations, for example the field of obstetrics and gynecology as a specialization that has got many sub-specializations, that special essential medicines list can be made for Obstetrics and Gynecology. The writings of a specialists’ formulary involve specialist professional association with its many sub-branches. With the involvement and active participation of specialists it is expected that they will feel that they are part of the association, so that rational medicine use can be positively applied.

e. National Indonesian Medicine Information

National medicine information consists of medicines which are on the market and are presented briefly, are relevant to physicians’ needs, pharmacists, and other health services workers. The National Indonesian Medicine Information is published by the Ministry of Health to guarantee objectivity, completeness, and unconfounding. Information on medicines that are covers indications, side-effects, dosages, how to use, and other important information which are most important for patients. The development of this book was based on more scientific data, related to benefits and actual medicine use.

3. Management and Medicine Use

To improve rational medicine use, the use of essential medicines at health service units should follow treatment guidelines and proper medicine management be instituted.

Effective medicine management is required to guarantee medicine availability in the right kinds and quantities while fulfilling quality standards. Important aspects of medicine management are as follows:

- Limitation of numbers and kinds of medicines based on an Essential Medicines List, using generic names, with a correct selection process;

- Bulk purchasing should be applied; - Competitive, transparent purchases; - Audit system and reporting from management report.

Application of Government Regulation Number 38 year 2007 on the coordination of the governance between the Central Government and the Provincial Government and other regional governments in order to synchronize its health management in the country. So, as with medicine management organizations, each state/city has got organizational structures and their own medicine management policies. This would open up basic differences in each state/city in carrying out medicine management.

The cycle of medicine distribution is started at the time a medicine is delivered from the factory or distributor, and it ends at the time medicine consumption reports are handed in to the logistics unit. Effective medicine distribution should have a system design and sound management such as: constant medicine supply, taking care of the quality of medicines at the time of distribution process, minimizing medicines which are unused because of spoilage or being expired, with correct planning in accordance with each province’s medicine needs, use of inventory records which are accurate, rationalization of medicine depots, and supply of information to estimate medicine needs.


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With decentralization in place it is hoped that state government or city or provinces can sufficiently supply respective individual medicine needs. The central government, in this matter, the Ministry of Health only lends back-up support when state/city or province cannot fully supply the medicine needs. The NLEM is a base for planning and supply or logistics of medicines in local (district/province/city) and central government.

Management and use of specialists’ medicines for certain situations, the government c.q. Directorate General of Pharmaceutical Services and Medical Devices, Ministry of Health can provide these through special channels (special access scheme) in accordance with The Decree of Minister of Health Number: 1379.A/Menkes/SK/XI/2002.

4. Communication, Information, and Education(CIE)

CIE on essential medicines are a pre-requisite to improve the use of medicines and rational prescribing by health providers. CIE for health providers and the public in general to increase rational use of medicines and be maintained continuously should use the following links:

a. Governmental organizations/private institutions. b. Related professional organization. c. Curriculum of education for health providers. d. Other possible channels.

Every listed medicine in NLEM must be accompanied by accurate information that is objective and understandable by health providers. This information covers indication, contraindication, dose, how to use, caution remarks, side-effects, medicine interaction, and dosage forms of preparations.

5. Research and Development

Research and development should be done to support the selection process and improvement of the NLEM. Research and development are done in line with medical science and technology in the subjects of medicine, pharmacy, epidemiology, and education. The outcome or result of research and development are utilized as inputs in the revision process and improvement of NLEM periodically.

6. Monitoring and Evaluation

Monitoring and evaluation are done to support the success of the application of the NLEM through mechanism and output evaluation of potential underlying problems and its effective solutions. This can be achieved through co-ordination, supervision, monitoring and evaluation of application of the NLEM by the Ministry of Health. Monitoring and evaluation are done gradually fitting to functions and levels.

7. NLEM Revisions

NLEM has to be revised and perfected periodically. Revisions are not only for keeping up with the advancement of knowledge, but also for practical reasons in the use and dispensing which fits health providers and the health service facilities.


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Perfection of NLEM is done continuously with input of suggestions from health service units and health research, whether governmental or private, conveyed to the Directorate General of Pharmaceutical Services and Medical Devices, Ministry of Health, Republic of Indonesia. NLEM revisions are done periodically every 3 (three) years.

8. Quality Control

Total medicine quality control covers the phases of product development, good manufacturing practices, monitoring of medicine quality in the distribution chain and their use, are important elements in applying the essential medicines concept.

9. Antibiotics Resistance

Antibiotic resistance will increase, especially with first-line essential antibiotics, which are relatively inexpensive. This condition is dangerous, because ultimately the public will lose sensitive antibiotics that are potential in fighting infectious diseases which are newly occurring or recurring. The reason is because of irrational use of antibiotics by both of health providers or patients.

In overcoming the problem of antibiotic resistance it takes the following efforts:

a. Conducting surveillance of microbe resistance so that antibiotics resistance patterns are obtained.

b. Surveillance of antibiotic use

Surveillance of antibiotic use is done by research institutions, hospitals, and public health centers, province or district health offices and other health, education and research institutions.

c. Containing antibiotic use by health providers by applying antibiotic prescription policy gradually, fitting to the conditions of patients and disease patterns, using first-choice antibiotics from the start, and reserving other antibiotics of subsequent choice for limited use.

d. To provide communication, information and education towards all parties using antibiotics whether they be health workers, patients or the public in general about how to use antibiotics rationally and the danger, caused by irrational use of medicines.

10. Donated Medicines

Donations in the form of money or medicines from another country, private organizations, or other international bodies can support the public health services in a country that needs it. In its operation, medicines donation must fulfill the requirements as described in WHO Guidelines for Medicines Donations 1999. Health services being used must fulfill a certain existing applicable guidelines/standards. This guideline covers general principles about selection of medicines, quality of medicines, shelf life, packaging and labeling, information and management.


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Four main principles of donated medicines are:

• Donated medicines must provide maximum usefulness to recipient country. • Understand the needs and respecting the authority of recipient country. • Does not use double standards for the quality of donated medicines. • Effective communication between donor country and recipient country.

Donated medicines are best received when they are in accordance with NLEM. In order for medicines supply and health logistics can help the operations of health workers, the types of medicines and health logistics must coincide with the disease patterns in Indonesia.

For medicines which are not marketed in Indonesia acceptance must follow a special channel (special access scheme), in accordance with the existing applicable rule.

B. Terminologies

1. Contents and Format of NLEM

a. The National Essential Medicine list is used as the basis for all units of (governmental) health services.

b. One type if medicines can be used in several forms of preparations and one form of preparation can consist of a few dosage forms.

c. In the NLEM, medicines are categorized according to class, subclass and sometimes sub-subclass therapy, which are in alphabetical order.

2. Nomenclature

a. Medicine names are written according to the last edition of Indonesian Pharmacopoeia. If it does not appear in the Indonesian Pharmacopoeia then generic names are used.

b. Medicines which are commonly used and do not have an INN (International Non-proprietary Name) are written with common names, for example ‘oral rehydration salt’.

c. Combination medicines which do not have a generic name are given agreed names which are generic names for combinations and each is written with the effective ingredients, followed with dosage of each component.

d. For some items which need a synonym are written within brackets.


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3. Explanatory Notes

a. Keywords

(1) Dosage Forms

Dosage forms or preparations are forms of medicines according to the production process in the form of usage, for example: capsule, enteric coated tablet, intravenous injection etc.

(2) Dosage strength

Strength of preparation is the content or percentage of effective components in ready made preparations. For dosage strength in the form of salt or its esther, salt or esther are written down within brackets, for example ethambutol tablet 250 mg (hydrochloride). As for dosages of effective components, the names of salts or esther (which are written within brackets) would be priored by the word ‘as’, for example: chloroquine tablet 150 mg (as phosphate).

(3) Packaging

Packaging is the smallest container that contains the medicine.

(4) Package Size

Package Size is the total number of preparation units or the smallest container in one standard packaging, for example 100 vials.

b. Other Notes

(1) Information in restricted columns are meant for medicines with certain restrictive notes:

(a) Monitoring of side-effects. (b) Limitation of indications. (c) Only for certain cases. (d) Tight screening is required or medical expert considerations needed. (e) Nature or medicine mechanism of action requires attention. (f) Special treatment required. (g) Special facilities needed. (h) Combination with other medicine needed. (i) Required for certain areas, like endemic areas. (j) Uses in accordance with existing health program.

(2) Writing of technical terms or foreign language words are written in italics.

(3) National Medicines Lists are medicine lists that are used by hospitals.

(4) NLEM for Public Health Center (primary health service units) in red colored paper.


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c. Abbreviations

i.a. injection : intraartherial injections i.c. injection : intracutaneous injection infiltr inj : infiltrated injection infusion sol : infusion solution inj : injection i.m. injection : intramuscular injection IU : international unit i.v. injection : intravenous injection liq : liquid p.v. injection : paravertebral injection rectal sol : rectal solution s.c. injection : subcutaneous injection sacch : sacchets/bags/pouches sol : solution supp : suppository

C. Renewal of Revision Process

Discussions were not conducted only limited to incoming requests, but revaluating the whole NLEM of 2005. This was done because the list was only updated during previous years and some old medicines have become obsolete or new and better medicines have become available. Also some uses of older medicines have been renewed and some have made other restrictions.

Expert teams and consultants work together in the discussion that is divided into several groups based on therapeutic class. Consultants are responsible for EBM data in accordance with his/her competence. Besides information from consultants and expert team, the secretariat supported fully with among others, information from Cochrane review and WHO Library. From this process, although EBM information is not always totally accepted, but discussions are no longer based on level-4 evidence or expert team opinion only.

Understanding the concept of essential medicines has to be re-socialized. Seemingly, the understanding of the essential medicines is withering and explanation about this concept is appreciated. ‘Essential Medicine is a floor not a ceiling’ (WHO TRS 946), it is a minimum for health care. A medicine is essential when you can’t do without it. The difference of essential medicines and program medicines will result in the availability of a specific medicine. This problem is overcome by socialization and special policies by the Ministry of Health relating to essential medicines and program medicines.

In the revision process, from the start it has been planned to give attention to medicines for children. This policy is not only meant for harmony with the global policy, but Indonesia is consistently aiming at decreasing mortality of babies and children, so that it needs this emphasis. The involvement of four pediatricians, give sufficient contributions for this problem. Also the involvement of the Directorate of Child Health and other directorates are very intensive. The addition of medicines for children with dosage forms especially for children, like carbamazepine, is provided in the form of syrup.

In the final discussion of the Plenary Meeting it has been agreed that 78 medicines has been deleted from NLEM 2005 and 48 were added to the new list of 2008. Changes in formulations


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(forms of preparations, dosages, packaging) was agreed for 21 medicines. It was found that 33 medicines were given short notes as important to be provided or supplied by the government through ways fitting with the existing applicable policies. The total number of medicines in the NLEM 2008 is 323 medicine items.

1. Revision Process

Revision processes started by sending letters to government health services institutions (hospital types A, B, C, public health center) as well as several chosen private parties, special programs in the Ministry of Health and professional organizations. Three months later, from 114 installations to whom letters were sent to, 25 had responded. From those responses three had ”no suggestion”, 22 were responding with “request for additions to the list”, and there was no one responding to delete medicines from the old list. Although in the letter sent, it has been informed that suggestion has got to come together with supporting data and functions, only 10 installations were sending supporting data. Besides suggestions from the installations, the expert team and consultants, may give suggestions with supportive data.

This process is a yardstick in carrying out the assessment, it is needed to build transparency process and accountability in the future. The process consists of creation of a committee, criteria of recruitment of expert team members, tasks and obligations of expert team members, revision processes, holding discussion meetings and socialization of NLEM.

2. Committee Members

a. Organization

(1) Organizational structure is a National Committee consisting of: (a) Expert team (b) Consultants (c) Program manager and (d) Operational Secretariat

(2) Membership of National Committee lasts until a next committee is formed for the next NLEM revision meeting. The Committee is legalized by the Minister of Health by a Decree wherein its duties are stated.

(3) Names of expert team members and selected consultants are indexed without titles, only differentiated into MDs, general practitioner, specialists, or pharmacists.

(4) Not all therapeutic classes need to be represented as a member or consultant in the Committee.

(5) If an expert in a special field is needed, he/she can be invited to become a resource person to give an expert opinion in the revision process. They will not become a part of the expert team and also do not take part in decision making.

(6) Duties of expert team members and consultants listed in the Ministerial Decree are:


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(a) Expert Team members are evaluating medicines listed in NLEM 2005 and also evaluate suggested medicines which are applied for deletion or inclusion in the new list.

(b) Consultants are joining the discussions and may give scientific or practical inputs which may be needed to be useful to be taken into consideration by the expert team members.

(c) Expert team members and consultants together give technical/scientific justification to Ministry of Health through Directorate of Pharmaceutical Services and Medical Devices to accept the new NLEM 2008 nationally, while assisting the Directorate of Rational Medicine Use in practicing its concept.

(7) Program manager is a representative of a directorate in the Ministry of Health who owns special therapeutic programs and manages the logistics of medicines.

(8) The Operational Secretariat are Directorate of Rational Medicines Use, Directorate General of Pharmaceutical Services and Medical Devices.

b. The selection process of Expert Team and Consultants

(1) Pre-requisites of Expert Team and Consultants

(a) Have integrity and a high professional standard.

(b) Expert team members and consultants are clinicians from several fields of specialization, Clinical Pharmacology, Dentistry, Pharmacists, physicians/health service units (public health center).

(c) In order to get professional expert team members who are impartial, he or she must not represent professional associations, hospital departments, or other jobs which are potential in creating conflicts.

(d) Signing a letter of consent, acceptance and availability.

(e) Willing to sign a conflict of interest statement. But somebody who has a conflict of interest can still be considered to become a member of the expert team, if integrity can be maintained. He/she may then not participate in a voting process.

(2) Recruitment processes of Expert Team and Consultants:

(a) The Secretariat sends a form of written availability and willingness, accompanied by his/her superior permission, 1 (one) month prior to the commencement of the Meeting.

(b) He or she must submit the filled-in form 1 (one) week after receiving, together with a conflict of interest statement.

(c) An acceptance and statement of willingness letter consists of: - Explanation of job description of expert team. - Schedule of material of discussion which have to be attended.


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3. Revision Methods

a. Submission of medicines

Revision processes is started by sending submission forms to several health service units (University Hospitals, Special Hospitals, chosen State Hospitals, Provincial Hospitals, Military/Police Hospitals, chosen Private Hospitals, Regional Hospitals, Public Health Center with beds). Provincial Health Units representative, public health center, and program managers (in the directorate of Ministry of Health). Submission Request Forms are sent 3 (three) months before the first Meeting.

b. Compilation of Submissions Compiled submissions are categorized or grouped in therapeutic classes.

c. Material of Revisions Material of Revisions are put in a matrix, which is put side by side with the WHO List 2007 and the latest NLEM 2005 edition. It is followed with the submitted medicines. Revised Materials will be handed to expert team members 1 (one) week before technical discussion meeting.

d. Discussion Criteria Submissions to be discussed are suggestions which come with arguments and accompanied with scientific evidence.

e. Methods of Revision Materials

(1) Revision can be the whole assessment or one of the following processes: (a) Only assessment of submission requests. Deleting or accepting

submissions. (b) Taking into account the whole NLEM and incoming requests.

Deleting and adding essential medicines whether from requests or from expert team member’s and consultants’ opinion.

(2) Types of discussions meeting:

(a) Preliminary Meeting consists of

• Information about the understanding of essential medicines (definitions, criteria, (approximate) number of essential medicines in NLEM etc).

• Implementation of NLEM (in relation with program medicines, guideline for procurement of PKD Medicines, DPHO- AsKes and others).

• NLEM Revision Procedure.

• Procedure in technical discussion (preparation of NLEM revision draft) and plenary meetings.

• Attendance: expert team, consultants, program managers, operational secretariat.


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(b) Technical discussion meetings

• Discussion meetings of the pro and contra whether to accept or refute a submission.

• Discussion on benefit-risk of additions or deletions of essential medicines which are on the old list.

• Putting in focus those medicines which are submitted, but were not included in the WHO list. These were specially scrutinized.

• Suggestion to put food supplements into NLEM will not be considered.

• If the Expert Team fails to make a decision on some choices, a resource person outside the expert team members will be invited.

• Attendance for the meeting are: o Expert team o Consultants o Related program managers of Ministry of Health o Related resource persons.

• Result of technical discussion meetings is NLEM revision draft.

(c) Plenary Meeting

• Aims at making agreements, formalizing, and socializing revised draft of the NLEM.

• Meeting Chairman is the head of the expert team. • Formalization of NLEM draft to become the new revision is the

Directorate of Pharmaceutical Services and Medical Devices task or someone who is appointed by the institute.

• When the result of plenary meeting has been legalized it may not be altered, except editorial revisions.

• Plenary meeting members should be responsible as part of the decision making process and are also expected in the active participation to deploy the new NLEM.

• Plenary meeting attendees are: o Those who attended the preliminary meeting and

technical discussions; o Medical Committees of University Hospitals,

Military/Police Hospitals, chosen Private Hospitals and other hospitals and medal schools who submitted suggestions for revision;

o Attendees from Faculty of Medicine o Attendees from Faculty of Pharmacy; o Attendees from School of Nursery; o Provincial Health Office submitting revision suggestion(s);


14

o Professional organizations (IBI, IDI, PPNI, ISFI, specialists’ associations);

o Pharmaceutical Industries (BUMN and Pharmaceutical Wholesalers Association)

4. Explanation of changes made

Medicine changes made in NLEM 2008 whether generic names or their formulations, based on therapeutic classes are as follows:

1. Analgesics, Antipyretics, Non-steroidal Anti-inflammatory Medicines, Medicines used to treat gout

1.1 Opioid Analgesics

Sufentanyl in the form of citrate 50 mcg/ml, was taken out from the list, because of poor availability in the market.

1.2 Non-opioid Analgesics

Methampyron i.m. inj. 250 mg/ml was taken out from the list for safety reason, where in the form of injection may cause anaphylactic shock. Suggestion to add ketoprofen supp. 100 mg and paracetamol supp. 120 mg and 240 mg were accepted, recalling that ketoprofen supp. is used for post-surgical patients who cannot yet receive oral medicine forms, while it is non-irritant to the stomach. While paracetamol supp. is needed to prevent febrile convulsion cases, post-surgery in children, in line with pediatric procedures. Availability and procurement of paracetamol supp., are limited to district level hospitals.

1.3 Anti-gout

Colchicine tablets 500 mcg has been listed in NLEMs from the start. But with the availability of many NSAIDs, its efficacy is valued not much different from other NSAID medicines, while their safety is lower than colchicine. Thus colchicine was taken out from the list. The WHO Model List 2007 did not contain colchicines either.

2. Anesthetics

2.1 Local Anesthetics

Lidocaine inj 5% + glucose 7.5% 2 ml amp was suggested to be added, especially for spinal anesthesia, in areas where bupivacaine are difficult to get. Besides, toxic effects against the heart is smaller. Lidocaine inj. 1% (HCl) + epinefrin 1 : 200,000 in packaging of 20 and 30 ml were deleted from the list, because the packaging is seen to be too large, so it would cause spoilage if not finished.


15

2.2 General Anesthetics and Oxygen

Suggested liquid isoflurane liq. 3 – 3.5 % 250 ml are accepted, because of advantages to the heart and are used for patients with specific certain conditions. Midazolam inj. i.v. 1 mcg/ml and i.v. inj. 5 mg/ml are choice medicine for patients with fragile vital signs, as sedative, hypnotic, and pre-anaesthetics. While liquid enflurane ih., btl 250 ml was taken out of the list with the reason being less advantageous if compared with isoflurane and halothane. While Thiopental powder. inj. i.v. 1,000 mg/ml was taken out from the list because of safety consideration.

5. Antiepileptic-Anticonvulsants

Suggestion of addition in the dosage form of syrup and chewable tablet for pediatric patients are accepted. So, in this class were listed: fenitoin syrup 50 mcg/5 ml, carbamazepin 100 mg/ml bottle 120 ml, chewable tablets 100 mg. Phenobarbital tab 50 mg was added, because it was still effective and cheap.

6. Anti-infective

In several previous revisions of NLEMs, cephalosporines were always suggested to be added, but only this time the National Committee, gave way to cephazolin with limitation to special use of surgery prophylaxis inj. 1 g/vial. Cephazolin is a chosen medicine for surgery prophylaxis to prevent surgical wounds infection. The same thing happens to Ceftriaxone inj. 1 g/vial, that is a chosen medicine for meningitis and is used for resistant cases of typhoid fever with chloramphenicol and cyprofloxacin. The delay of entry of cephalosporine antiinfectives is caused by the fast growing anti-infective resistance in hospitals, especially.

Expert team agreed to accept the inclusion of vancomycine inj. 500 mg to overcome MRSA (methicillin resistant S. aureus) infection, a serious nasocomial infection. Amphotericine*) inj. i.v. vial 50 mg was requested and accepted for inclusion, because it is the only systemic antifungal, mainly for pulmonary fungal infection. In the list it was marked *) that means “needing special expertise in its use”.

For anti-amoebic diloxanide furoate tab 500 mg was included, recalling the importance of treatment of cysts that does not show physical symptoms. In the anti-malarial case arthesunate inj. i.v. 60 mg/ml was added, that was valued to be having better efficacy compared to artemether inj., although from the side of usage artemether is more practical for public health center (primary health service units).

In the antiviral protease inhibitor group lopinavir were added because they were needed for HIV/AIDS, although their prices are higher. In anti-tuberculosis medicines, besides a few single medicines are provided, listed were some combination medicines for use by program needs. But in the case of dosage forms, it was left to program needs, whether they be in the form of FDC (fixed dose combination), or combipack. Single preparations are maintained for use in health services which are not yet able to carry out direct observed treatment shortcourse (DOTS) program.


16

8. Antineoplastic, Immunosuppressive and Medicines used in Palliative Care

Chlormetin and levamisol were taken out of the list, because they were no longer in use as anticancer medicines, because of their efficacy and safety. Addition of daunorubicin HCl powder inj. was suggested and accepted by expert team, as well as chlorambucil tablet 2 mg and melfalan tablet 2 mg. Daunorubicin is a main medication in Acute Lymphocyte Leukemia that is often found in children. Chlorambucil is low priced, registered in Indonesia and is in accordance with the WHO Model List. Melfalan is a cheap medicine and is needed in the treatment of multiple myeloma.

14. Dental Medication and Oral Health

From this therapeutic class many are evaluated as obsolete, even their uses are no longer being taught by Dental Schools, for example sulpha cones preparation and iodoform paste. There are some which are causing environmental damage, like the use of amalgam, because of that it is agreed upon that composite be used.

17. Cardiovascular Medicines

In this therapeutic category a few changes in subclass or deletions of medicines were applied because they are no longer in production and are no longer available in the market like procainamide, reserpine, quinidine. In the subclass of antiarrythmic added were amiodarone and digoxin. In the antihypertension class sodium nitroprusid inj. was added to be used for its specific efficacy in surgery needing hypotension technique and septic shock.

18. Dermatological Medicines

Many medicines were deleted because of obsolescence, for example gentian violet, liver oil ointment. These liquids like lotio kummerfeldi, if needed, can be entered into a hospital formulary.

New additions which are accepted are permethrine as an antiscabicide that is less toxic to children, in place of Gamexan. Other addition is Liquor Veilli (diluted salicylic acid), a simple effective medicine for wet dermatitis.

20. Electrolytes and Nutrients

Oral rehydration salt in 1000 ml sacchets are deleted from the list, because the packaging is too large, inefficient to store and it does not maintain freshness for long time. Only 200 ml sachets are available.

In the case of parenteral nutrition liquid namely liquid nutrients i.v. all of them were deleted from the list. The National Committee, especially expert team and consultants, are well aware of the importance of this preparation, but compositions which are available in the market vary and were too many, with uses which may be different.


17

For children use and neonates in this therapeutic class liquid nutrients were added: glucose 4% + NaCl 0.18% infusion, and sodium bicarbonate inj. 1.4% isotonic.

23. Psychotherapeutic Medicines

Alprazolam was deleted because valued to be non-essential and tend to cause overuse and dependence. In subclass therapy antidepression and antimania it was suggested addition of fluoxetine, sertraline and paroxetine. Fluoxetine cap/tab10 mg and cap/tab 20 mg were accepted as choice medicines for category SSRI.

In the antipsychotic subclass racemic methylphenidat addition was suggested in the form of regular release and extended release to be used for Attention Deficit Hyperactive Disorder (ADHD). Although evidence has not fully supported, but all these times it has been a choice medicine for ADHD. Addition of chlozapine was accepted because it is a selected medicine for other resistant antipsychotic medicines. This medicine is effective but it is necessary to watch for agranulocytosis side effect. Periodic leucocytes counts must be taken.

28. Ear treatment, Nose, and Throat

Important changes took place in looking at ear treatment, nose, and throat. Experts considered that treatment of ear infection does not need to use antibiotics or corticosteroids. Other than that antibiotic preparations in the form of nose or ear drops are not listed in the WHO Model List.

D. Socialization of NLEM 2008

In applying essential medicines concept, NLEM 2008 must be spread to health service facilities in the entire Indonesia. Socialization can be in the form of printed books which are delivered to all health service units and publicized in electronic form.


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CHAPTER II NATIONAL LIST OF ESSENTIAL MEDICINES

2008

THERAPEUTIC CLASS, GENERIC

NAME (INN) DOSAGE FORM RESTRICTION

1. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES, MEDICINES USED TO TREAT GOUT

1.1 OPIOID ANALGESICS codeine tablet 10 mg,

bottle 250 tablets

fentanyl

injection i.m./i.v. 0.05 mg/ml (citrate), box 5 ampoules @ 2 ml

Authority required : Anesthetist

morphine

injection i.m./s.c./i.v. 10 mg/ml (HCl/sulfate), box 10 ampoules @ 1 ml

tablet 10 mg (HCl/sulfate), bottle 30 tablets

pethidine

injection i.m./s.c./slow released i.v 50 mg/ml (HCl), box 10 ampoules @ 2 ml

sufentanyl injection 5 mcg/ml (citrate), box 5 vials @ 10 ml

1.2 NON-OPIOID ANALGESICS acetylsalicylic acid (acetosal)

tablet 100 mg, box 10 blisters @10 tablets

tablet 500 mg, box 10 blisters @10 tablets

ibuprofen tablet 200 mg, bottle 100 tablets

tablet 400 mg, bottle 100 tablets

ketoprofen suppositoria 100 mg Restricted use : Post operative patients

19 National List of Essential Medicines 2008

THERAPEUTIC

20

CLASS, GENERIC DOSAGE FORM NAME (INN)

RESTRICTION

methampyrone tablet 500 mg, bottle 1000 tablets

Restricted use : To reduce agranulocytosis

paracetamol tablet 100 mg, bottle 1000 tablets


syrup 120 mg/5 ml,bottle 60 ml suppositoria 120 mg suppositoria 240 mg

phenylbutazone coated tablet 200 mg, bottle 100/1000 tablets

Restricted use : Only for acute arthritis, to be taken after meals, for one week and to be followed by other safer NSAID as needed.

sodium diclofenac tablet 25 mg, box 10 stripes @ 10 tablets

tablet 50 mg, box 10 stripes @ 10 tablets

1.3. MEDICINES USED TO TREAT GOUT

allopurinol tablet 100 mg, bottle 100/1000 tablets

Note : - Blocks uric acid production

(in 35% of cases) - Not for acute attack

probenecid tablet 500 mg, bottle 100/1000 tablets

Note : - Increases uric acid renal

excretion (in 65% of cases) - Dosage 2 X ½ tablet,

increase water intake - Not for acute attack

2. ANESTHETICS

2.1 LOCAL ANESTHETICS bupivacaine p.v. injection 0.50% (HCl),

box 5 vials @ 20 ml injection 0.5% (HCl) +

glukosa 7.5%, box 5 ampoules @ 4 ml

Restricted use : Only for spinal anesthesia


THERAPEUTIC

21


RESTRICTION

ethyl chloride spray, bottle 100 ml Note : Air tight package

lidocaine

infiltr injection 1% (HCl), box 100 amps @ 2 ml

p.v. injection 2% (HCl), box 100 ampoules @ 2ml

gel 2%, tube 10 g spray 4%, bottle 50 ml injection 5% + glukosa 7,5 %,

ampoule 2 ml

Restricted use : Only for spinal anesthesia

2.2 GENERAL ANESTHETICS and OXYGEN halothane inhalation liquid,

bottle 50/250 ml

isoflurane inhalation liquid, bottle 250 ml

ketamine i.v. injection 10 mg/ml (as HCl), box 10 vial @ 20 ml

i.v. injection 50 mg/ml (as HCl), box 10 vial @ 20 ml

midazolam i.v. injection 1 mg/ml i.v .injection 5 mg/ml

Restricted use : Only for special conditions

nitrous oxide inhalation, gas in tube

oxygen inhalation, gas in tube

propofol injection 10%, box 5 ampoules @ 20 ml

thiopental i.v. powder for injection 500 mg/ampoule (as sodium salt) (for dissolved in 20 ml WFI), box 25 ampoules

2.3 MEDICINES USED FOR PREOPERATIVE MEDICATION PROCEDURES atropine injection 1 mg/ml (sulfate),

box 50 ampoules @ 1 ml


THERAPEUTIC

22


RESTRICTION

diazepam tablet 5 mg, bottle 1000 tablet

injection 5 mg/ml, box 100 ampoules @ 2 ml

morphine i.m./s.k./i.v. injection 10 mg/ml (HCl/sulfate), box 10 ampoules @ 1 ml

3 ANTIALLERGICS and MEDICINES USED IN ANAPHYLAXIS chlorpheniramine tablet 4 mg ( maleate),

bottle1000 tablets injection 5 mg/ml (maleate),


dexamethasone injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml

diphenhydramine i.m. injection 10 mg/ml (HCl), box 100 ampoules @ 1 ml

epinephrine (adrenaline) s.c./i.m. injection 0,1% (HCl/bitartrate), box 100 ampoules @ 1 ml

Note : - Drug of choice for

anaphylactic reaction - Dosage 0,3 mg – 0,5 mg

i.m., may be repeated

4. ANTIDOTES and OTHER SUBSTANCES USED IN POISONING 4.1 SPECIFIC

atropine i.m./i.v./s.c injection 1 mg/ml (sulfate), box 10 ampoules @ 2 ml

Restricted use : Caution on package: “only for antidotes (large dose)”.

calcium folinic (leucovorin, Ca) tablet 1 mg, bottle 100 tablets tablet 15 mg, bottle 10 tablets injection 3 mg/ml,


calcium gluconate injection 100 mg/ml, box 24 ampoules @ 10 ml


THERAPEUTIC

23


RESTRICTION

deferoxamine powder for injection 500 mg/ml (mesilate), box 10 vials @ 10 ml

methylthioninium chloride (methylene blue)

injection i.v. 10 mg/ml (as dihydrate), box 10 ampoules @ 10 ml

naloxone

injection 0.02 mg/ml (HCl), box 10 ampoules @ 2 ml


protamine sulfate i.m. injection 10 mg/ml, box 10 vials @ 5 ml

sodium bicarbonate tablet 500 mg, bottle 1000 tablets

sodium thiosulfate i.v. injection 25%, box 10 ampoules @10 ml

4.2 NON-SPESIFIC

active carbon activated powder, sacch 0.5 kg

apomorphine s.c. injection 5 mg/ml (HCl), box 10 ampoules @ 1 ml

magnesium sulfate powder, sacch 30 g

5. ANTIEPILEPTICS – ANTICONVULSANTS

carbamazepine tablet 200 mg, bottle 100/1000 tablets

chewable tablet 100 mg syrup 100 mg/5 ml,

bottle 120 ml

diazepam i.m./i.v. injection 5 mg/ml, box 100 ampoule @ 2 ml

rectal sol 4 mg/ml, tube 2.5 ml

magnesium sulfate i.v. injection 20%, ampoule 25 ml

i.v. injection 40%, ampoule 25 ml


THERAPEUTIC

24


RESTRICTION

phenobarbital tablet 30 mg, bottle 1000 tablets



i.m injection 50 mg/ml, box 100 ampoules @ 2 ml

i.v.injection 50 mg/ml (as sodium salt), box 100 ampoules @ 2 ml

phenytoin capsule 30 mg (as sodium salt), bottle 250 capsules

capsule 100 mg (as sodium salt), bottle 250 capsules

injection 50 mg/ml (as sodium salt), box 10 ampoules @ 2 ml

syrup 50 mg/5 ml,bottle 120 ml

valproate tablet 250 mg (as sodium salt), bottle 50 tablets

tablet 500 mg (as sodium salt), bottle 50 tablets

syrup 250 mg/5 ml (as sodium salt), bottle 120 ml

6. ANTI-INFECTIVE MEDICINES

6.1 ANTHELMINTHICS

6.1.1 Intestinal Anthelminthics

albendazole tablet 400 mg, box 5 stripes @ 6 tablets

Note : - For strongiloides. - Pediatric dose : 20

mg/kgBW

mebendazole tablet 100 mg, bottle 100 tablets

syrup 100 mg/5 ml,bottle 30 ml


THERAPEUTIC

25


RESTRICTION

praziquantel scored tablet 300 mg, bottle 100/1000 tablets

pyrantel

scored tablet 250 mg (pamoate), bottle 250 tablets

suspension 125 mg/5 ml (pamoate), bottle 30 ml

6.1.2 Antifilarials

diethylcarbamazine scored tablet 100 mg (citrate), bottle 1000 tablets

Note : For endemic area

6.1.3 Antischistosomals

praziquantel tablet 600 mg, bottle 100 tablets

Restricted use :- Only for Central Sulawesi - Only for South Kalimantan,

for Fasciolopsis buski treatment

6.2 ANTIBACTERIALS

6.2.1 Beta Lactam medicines

amoxicillin trihydrate scored tablet 500 mg, box 10 stripes @ 10 tablets

dry syrup 125 mg/5 ml, bottle 60 ml

ampicillin i.m./i.v. powder for injection 250 mg/vial (as sodium salt), box 10 vials

i.m./i.v. powder for injection 500 mg/vial (as sodium salt), box 10 vials

benzathine benzylpenicillin

i.m. injection 1.2 millions IU/ml, box 25 vials @ 4 ml


benzylpenicillin crystal i.m./i.v. injection 10 millions IU/vial, box 25 vials


THERAPEUTIC

26


RESTRICTION

cefazolin powder for injection 1 g / vial, box 2 vials

Note : Prophylactics, to prevent operation wound infection

ceftriaxone powder injection 1 g / vial, box 2 vials

dicloxacillin capsule 250 mg (as sodium salt), box 25 stripes @ 4 capsules

scored tablet 500 mg (as sodium salt)

syrup 62.5 mg/5 ml (as sodium salt), bottle 60 ml

i.m./i.v. powder for injection 500 mg/vial (as sodium salt) (soluble in 5 ml WFI), box 20 vials

phenoxymethylpenicillin (penicillin V)

tablet 500 mg (as potassium salt), bottle 1000 tablets

tablet 250 mg (as potassium salt), box 10 stripes @ 10 tablets

dry syrup 250 mg/5 ml (as potassium salt), bottle 60 ml

procaine benzylpenicillin

powder for injection i.m. 3 millions IU/vial, box 100 vials

powder for injection i.m. 1 million IU/vial, box 100 vials

6.2.2 Other antibacterials

6.2.2.1 Tetracycline doxycycline capsule 100 mg(hyclate/HCl),

box 10 stripes @ 10 capsules

Note : May be used for renal patients


THERAPEUTIC

27


RESTRICTION

oxytetracycline i.v. injection 250 mg/3 ml (HCl), box 10 ampoules @ 3 ml

i.v. injection 50 mg/ml (HCl), box 10 vials @ 10 ml

tetracycline

capsule 250 mg (HCl), bottle 1000 capsules

capsule 500 mg (HCl), box 10 stripes @ 10 capsules

6.2.2.2 Chloramphenicol chloramphenicol capsule 250 mg,

bottle 1000 capsules suspension 125 mg/5 ml (as

palmitate), bottle 60 ml i.v. powder for injection 100

mg/ml (as succinate sodium), box 10 vials @ 10 ml

6.2.2.3 Sulfa-Trimethoprim

NLEM co-trimoxazole I (adult) combination of : sulfamethoxazole 400 mg trimethoprim 80 mg

tablet, box 10 stripes @ 10 tablets

NLEM co-trimoxazole II (paediatric) combination of: sulfamethoxazole 100 mg trimethoprim 20 mg

tablet, bottle 100 tablets

NLEM co-trimoxazole III combination of : sulfamethoxazole 80 mg/ml trimethoprim 16 mg/ml

i.v. injection, box 5 ampoules @ 5 ml, box 5 vials @ 10 ml

Note : Minimized use

sulfadiazine tablet 500 mg, bottle100 tablets

trimethoprim scored tablet 200 mg, bottle 100 tablets


THERAPEUTIC

28


RESTRICTION

6.2.2.4 Macrolides

clindamycin injection 150 mg/ml (as phosphate), box 100 ampoules @ 2 ml

Note : Benefit for bone infections

erythromycin

capsule 250 mg (as stearate), bottle 100 capsules

syrup 200 mg/5 ml (as ethyl succinate), bottle 60 ml

6.2.2.5 Aminoglycosides

gentamicin injection 10 mg/ml (as sulfate) @ 2 ml

injection 40 mg/ml (as sulfate), box 10 ampoules @ 2 ml

6.2.2.6 Quinolones

ciprofloxacin scored tablet 500 mg (as HCl), box 10 blister @ 10 tablets

Caution : Not for fist line treatment on gram possitive bacteria infection

vancomycin powder injection 500 mg/vial, box 1 vial

Restricted use : Benefit for MRSA infection

6.2.2.7 Specific Use

metronidazole

tablet 250 mg, bottle 100/1000 tabs


suppositoria 500 mg, box 6 suppositoria

infusion solution 5 mg/ml, bottle 100 ml

sulfasalazine tablet 500 mg, bottle 500 tablets

Restricted use : Specific for ulcerative colitis


THERAPEUTIC

29


RESTRICTION

6.3 SPECIFIC ANTI-INFECTIVE MEDICINES

6.3.1 Antileprosy medicines

clofazimine, micronized

oily capsule 100 mg, bottle 100 capsules

dapsone scored tablet 100 mg, bottle 1000 tablets

rifampicin capsule 300 mg, box 10 stripes @ 10 capsules

Restricted use : Only for tuberculosis and leprosy

6.3.2 Antituberculosis medicines

ethambutol tablet 250 mg (HCl), bottle 100 tablets

tablet 500 mg (HCl), bottle 100 tablets

isoniazid tablet 100 mg, bottle 1000 tablets


pyrazinamide tablet 500 mg, bottle 100 tablets

rifampicin scored tablet 300 mg, box 10 stripes @10 tablets

tablet 450 mg, box 10 stripes @10 tablets



streptomycin powder for injection 1000 mg/vial (as sulfate), box 100 vials

combination of : rifampicin isoniazid

caplet 150 mg; 75 mg tablet 150 mg; 50 mg

Note : Dosage form and usage according to National Tuberculosis Program


THERAPEUTIC

30


RESTRICTION

combination of : rifampicin isoniazid ethambutol

capl 150 mg tablet 150 mg tablet 400 mg

Note : Dosage form and usage according to National tuberculosis program.

combination of : rifampicin isoniazid pyrazinamide

capl 150 mg; 75 mg;450 mg tablet 75 mg; 50 mg; 300 mg tablet 400 mg; 150 mg;

500mg


combination of : rifampicin isoniazid pyrazinamide ethambutol

capl 150 mg; 450 mg tablet 75 mg; 300 mg tablet 400 mg; 500 mg tablet 275 mg; 250 mg;

500mg

Note : Dosage form and usage according to National tuberculosis program

6.3.3 Urinary Antiseptics NLEM co-trimoxazole I (adult)

combination : sulfamethoxazole 400 mg trimethoprim 80 mg


methenamine mandelate (hexamine mandelat)

enteric coated tablet 500 mg, bottle 100/1000 tablets

nitrofurantoine scored tablet 100 mg, bottle 100 tablets


6.4 ANTIFUNGAL MEDICINES

6.4.1 Systemic amphotericin ∗) i.v injection vial 50 mg/10 ml,

vials @ 10 ml

griseofulvin, micronized scored tablet 250 mg, bottle 100 tablets

∗ Complementary list


THERAPEUTIC

31


RESTRICTION

ketoconazole tablet 200 mg, bottle 100 tablet

Restricted use : Only for cronic mucocuta-neous candidiasis, which are not responsive to nystatin and other fungicides, systemic mycosis infection (candidiasis, parakoksidioido-mikosis etc)

nystatin coated tablet 500,000 IU/tablet, bottle 100/1000 tablets

suspension 100,000 IU/ml, bottle 12 ml

6.4.2. Topical NLEM antifungal medicines

combination of: benzoic acid 6% salicylic acid 3%

ointment, pot 30 g

miconazole

powder,2% (nitrate),sacch 20 g cream, 2% (nitrate), tube 10g

nystatin vaginal tablet 100,000 IU/tablet, box 10 stripes @10 tablets

sodium thiosulfate liquid 25%, bottle 30 ml

6.5 ANTIPROTOZOAL MEDICINES

6.5.1 Antiamoebic and antigiardiasis medicines

diloxanide tablet 500 mg (furoate)

metronidazole tablet 250 mg, bottle 100 tablets



THERAPEUTIC

32


RESTRICTION

6.5.2 Antimalarial medicines 6.5.2.1 For prophylaxis chloroquine tablet 150 mg (as phosphate),

bottle 1000 tablets

6.5.2.2 For curative treatment

NLEM antimalarial medicines combination of :

pyrimethamine 25 mg sulfadoxine 500 mg


Restricted use : For specific area which already resistent to chloroquin (decided by District Health Offices)

artemether injection 80 mg/ml, box 6 ampoules @ 1 ml

artesunate injection i.v./i.m. 60 mg/ml, box 8 vials @ 1 ml

combination of : artesunate 50 mg amodiaquin 200 mg

tablet, box 2 blisters @ 12

tablets (combipack) box 3 blisters @ 8 tablets

chloroquine

tablet 150 mg(as phosphate), bottle 1000 tablets

syrup 50 mg/5ml, bottle 60 ml

primaquine tablet 15 mg (as phosphate), bottle 1000 tablets

quinine tablet 222 mg (bisulfate), bottle 1000 tablets

i.v. injection 25% (as HCl), box 100 ampoules @ 2 ml

Restricted use : Only for severe malaria

6.6 ANTIVIRAL MEDICINES

6.6.1 Antiherpes medicines

aciclovir scored tablet 200 mg scored tablet 400 mg


THERAPEUTIC

33


RESTRICTION

6.6.2. Antiretrovirals 6.6.2.1. Nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (3TC) tablet 150 mg

stavudine tablet 30 mg, bottle 60 tablets tablet 40 mg, bottle 60 tablets

zidovudine tablet 300 mg, bottle 60 tablets


syrup 50 mg/5 ml, bottle 10ml i.v. infusion solution 200

mg/10 ml

6.6.2.2 Non-nucleoside reverse transcriptase inhibitors (NNRTI) efavirenz tablet 200 mg,

bottle 90 tablets tablet 600 mg,

bottle 30 tablets

nevirapine tablet 200 mg, box 6 blisters @ 10 tablets

6.6.2.3 Protease inhibitors

lopinavir tablet

7. ANTIMIGRAINE MEDICINES

7.1 FOR PROPHYLAXIS

dihydroergotamine

tablet 2.5 mg (as mesilate), box 10 stripes @ 10 tablets

propranolol

scored tablet 40 mg (HCl) bottle 100 tablets

7.2 FOR TREATMENT OF ACUTE ATTACK

ergotamine tablet 1 mg (tartrate), bottle 100 tablets


THERAPEUTIC

34


RESTRICTION

combination of : ergotamine 1 mg caffeine 50 mg

tablet, box 30/100 tablets

8. ANTINEOPLASTIC, IMMUNOSUPPRESSIVES and MEDICINES USED IN PALLIATIVE CARE 8.1 HORMONES AND ANTIHORMONES medroxyprogesterone

acetate tablet 250 mg,

bottle 50 tablets injection 200 mg/ml,

box 1 vial 2.5 ml

tamoxifen tablet 20 mg (citrate), bottle 30 tablets

testosterone soft capsule 40 mg (undecanoate), box 5 stripes @ 4 capsules

8.2. IMMUNOSUPPRESSIVE MEDICINES

azathioprine tablet 50 mg, bottle 100 tablets

ciclosporin soft capsule 25 mg, bottle 50 capsules


8.3 CYTOTOXIC MEDICINES asparaginase powder for injection

10,000IU/vial, box 1 vial

bleomycin powder for injection 15 mg/ampoule (as HCl), box 1 ampoule

busulfan coated tablet 2 mg, bottle 100 tablets

calcium folinate (leucovorin, Ca)

tablet 15 mg, bottle 10 tablets injection 3 mg/ml,

box 5 ampoules @ 1/10 ml


THERAPEUTIC

35


RESTRICTION

chlorambucyl tablet 2 mg

cyclophosphamide coated tablet 50 mg, bottle 28 tablets

i.v. powder injection 200 mg/vial, box 1 vial

i.v. powder for injection 500 mg/vial, box 1 vial

i.v. powder injection 1000 mg/vial, box 1 vial

cysplatin powder for injection 10 mg/vial, box 10 vial

powder for injection 50 mg/vial, box 100 vial

cytarabine

i.m./i.v./s.c powder injection 100 mg/vial, box 5 vials

dacarbazine powder for injection 100 mg/vial, box 1 vial

dactinomycin i.v. injection 0.5 mg/vial, box 1 vial 0.5 mg

daunorubicin

powder injection 20 mg/vial (HCl), box 1 vial @ 4 ml

doxorubicin i.v. powder for injection 10 mg/vial (HCl), box 1 vial @ 5 ml

i.v. powder for injection 50 mg/vial (HCl), box 1 vial @ 25 ml

etoposide injection 20 mg/ml, box 10 ampoules @ 5 ml

capsule 100 mg, bottle 10 capsules

fluorouracyl i.v. injection 50 mg/ml, box 10 ampoules @ 5 ml


THERAPEUTIC

36


RESTRICTION

melphalan

tablet 2 mg Note : Storage at 2-8oC

mercaptopurine tablet 50 mg, bottle 25 tablets

methotrexate tablet 2.5 mg (as sodium salt), bottle 100 tablets

powder for injection 50 mg/vial (as sodium salt), box 1 vial

i.v./i.m./i.t. powder for injection 5 mg/vial (as sodium salt), box 1 vial

procarbazine capsule 50 mg (as HCl), bottle 100 capsules

vinblastine

powder for injection 10 mg/vial (sulfate), box 1 vial

vincristine i.v. powder for injection 1 mg/vial (sulfate), box 1 vial

Caution :- Not for intrathecal use - Storage at 2-8oC

8.4 MEDICINES FOR PALLIATIVE TREATMENT morphine tablet 10 mg (sulfate),

bottle 30 tablets

Restricted use : Palliative Care Hospital

9. ANTIPARKINSONISM MEDICINES NLEM antiparkinsonism

medicines combination of :

benserazide 25 mg levodopa 100 mg


trihexyphenidyl tablet 2 mg (HCl), bottle 250 tablets

10. MEDICINES AFFECTING THE BLOOD

10.1 ANTIANAEMIA MEDICINES

cyanocobalamine injection 500 mcg/ml, box 100 ampoules @ 1 ml


THERAPEUTIC

37


RESTRICTION

fe (II) sulfate 7 H20 coated tablet 300 mg, bottle 1000 tablets

syrup, bottle 60 ml drops, bottle

folic acid tablet 1 mg, bottle 1000 tablets


10.2 MEDICINES AFFECTING COAGULATION heparin sodium

i.v./s.c. injection 5000 IU/ml, box 1 vial 5 ml

phytomenadione (vitamin K1) coated tablet 10 mg, bottle 1000 tablets


i.m injection 2 mg/ml, ampoule 1 ml

Dose : - New born baby dose 1 mg - Premature baby dose 0,5

mg

protamine sulfate injection 10 mg/ml, box 10 vial @ 5 ml

Authority required

warfarin tablet 2 mg (as sodium/ potassium salt), bottle 100 tablets

11. BLOOD PRODUCTS and PLASMA SUBSTITUTES

11.1 BLOOD PRODUCTS factor VIII (consentrate)

powder for injection 250 IU/vial + solvent 10 ml, box 1 vial

Authority required : Used for the treatment of haemophilia A

factor IX complex powder for injection 1000 IU/vial + solvent 25 ml, box 1 vial

powder for injection 500 IU/vial + solvent 10 ml, box 1 vial

Authority required : Used for the treatment of haemophilia B


THERAPEUTIC

38


RESTRICTION

protein plasma fraction

Authority required : Right procedures needed

11.2 PLASMA SUBSTITUTES and PLASMA EXPANDERS

hydroxy ethyl starch infusion solution 6%, bottle 500 ml

infusion solution 10%, bottle 500 ml

NLEM plasma substitutes combination of: polygeline (equivalent 0.63

g nitrogen) 17.5 g sodium chloride 4.25 g potassium chloride 0.19 g calcium (bound at

polypeptide) 0.125 g pyrogen free sterile water

to 500 ml

infusion solution, bottle 500 ml

Restricted use :- Only for special cases - Need special facility and

skill - Various combination in

market could be used

12. DIAGNOSTIC AGENTS

12.1 RADIOCONTRAST MEDIA

12.1.1 Angiography meglumine amidotrizoate

injection 65%, box 1 vial @ 50 ml

12.1.2 Billigraphy

sodium iopodate capsule 500 mg, bottle 6 capsules

12.1.3 Histerosalpingography meglumine sodium

amidotrizoate

injection 76%, box 1 ampoule 20 ml

12.1.4 Myelography iohexole injection 240 mg I/ml,

box 1 vial 10 ml injection 300 mg I/ml,

box 1 vial 10 ml injection 350 mg I/ml,

box 1 vial 20 ml


THERAPEUTIC

39


RESTRICTION

iopamidol injection 0.408 g/ml, box 10 ampoule @ 10 ml

injection 0.612 g/ml, box 10 ampoule @ 20 ml

iophendilate injection consist of 30.5 % iodium, box 1 ampoule @ 3 ml

12.1.5 Metabolism

NLEM media contrast substance combination of : sodium bicarbonate 1.25 g simethicone 0.042 g

granule, sacch, with anhydric acetic acid 10%

barium sulfate powder, sacch 200 g suspension 2.2%,

bottle 250/450 ml suspension 55%, bottle 2 l suspension 65%,

bottle 500 ml

meglumine sodium amidotrizoate

sol 59.7 %, bottle 120 ml

12.1.6 Urograph iopamidole injection 0.612 g/ml,

box 10 ampoules @ 20 ml injection 0.755 g/ml,


meglumine sodium amidotrizoate

i.v. injection 76%, box 1 ampoule @ 20 ml

12.2 FUNCTION TEST

12.2.1 Renal sodium aminohypurate i.v. injection 200 mg/ml,

box 1 ampoule 10 ml


THERAPEUTIC

40


RESTRICTION

12.2.2 Liver sodium bromsulphtalein i.v. injection 5%,

box 1 ampoule 3 ml

12.2.3 Miscellaneous fluorescein eye drops 1% (sodium salt),

bottle 5 ml eye drops 2% (sodium salt),

bottle 5 ml injection 10%,

box 1 ampoule @ 5 ml injection 20%,

box 1 ampoule @ 5 ml

12.3 SKIN TEST tuberculin protein purified

derivative

i.c. injection 1:10, box 1 vial 2 ml

13. ANTISEPTICS dan DISINFECTANTS

13.1 ANTISEPTICS

chlorhexidine sol 5.0% (gluconate), bottle 2.5 l

For diluted

hydrogen peroxyde concentrate solution, bottle 1000 ml

Storage :- Storage in glass bottle with

glass cap, air tight, saved from light.

- For diluted until 3%. policresulen (metacresol

sulphonate and methanal condensate)

liquid, bottle 10 ml / 50 ml

povidone-iodine solution 10%, bottle 1000 ml

13.2 DISINFECTANTS

calcium hypochlorite powder, sacch 20 g ‘Samijaga’ program

chlorine base compound powder (for 0.1% sol), bottle 100 g

ethanol 70% sol, bottle 100 ml /1000 ml


THERAPEUTIC

41


RESTRICTION

paraformaldehyde tablet 1 g, bottle 100 tablets sol 5%, bottle 1000 ml

saponificated cresol 50% (lysol)

liquid, bottle 1000 ml

14. MEDICINES and DENTAL MATERIAL USED FOR ORAL HEALTH

14.1 MEDICINES USED FOR DENTAL and ORAL HEALTH, NLEM dental anesthetics

combination of: lidocaine HCl 2% epinephrine 1 : 80,000

injection, box 20/50/100 ampoules @ 2 ml

calcium hydroxide paste, box 2 tubes

chlorhexidine

liquid 0,2% (gluconate)

Note : For making dilutions

chlorphenol camphor menthol


ethyl chloride spray 0.05-0.2 ml, bottle 100 ml

eugenol liquid, bottle 10 ml

fluorine tablet 0.5 mg, bottle 100 tablets

lidocaine injection 2% (HCl), box 100 ampoules @ 2 ml

paste 5% (HCl), tube 10 g spray 15% (HCl), bottle 60 ml

nystatin suspension 100,000 UI/ml, bottle 12 ml

sodium hypochlorite concentrate liquid 5%, bottle 10 ml

Note : For making dilutions

14.2 DENTAL MATERIAL USED FOR ORAL HEALTH

gelatin sponge cubicles 1x1x1 cm, tin 50 pcs


THERAPEUTIC

42


RESTRICTION

glass ionomer ART (Atraumatic Restorative Treatment)

powder bottle10 g sol, bottle 6 g (4.8 ml) cocoa butter 5 g

gutta percha points box 120 sticks

resin composite set

root canal filling paste, bottle

surgical ginggival pack set

temporary filling

sol and powder, bottle 100 g

15. DIURETICS

furosemide tablet 40 mg, bottle 250 tablets

i.v./i.m. injection 10 mg/ml, box 25 ampoules @ 2 ml

hydrochlorothiazide tablet 25 mg, bottle 1000 tablets

mannitol infusion liquid 20%, bottle 500 ml

spironolactone



16. HORMONES, OTHER ENDOCRINE MEDICINES and CONTRACEPTIVES

16.1 ANTIDIURETIC HORMONES desmopressin spray

vasopressin i.m./s.c. injection 20 IU/ml, box 10 ampoules @ 1 ml


THERAPEUTIC

43


RESTRICTION

16.2 ANTIDIABETIC

16.2.1 Oral Antidiabetic

glibenclamide tablet 2.5 mg, bottle 100 tablets


glipizide tablet 5 mg, box 5 blisters @ 20 tablets

metformin tablet 500 mg, bottle 100 tablets

16.2.2 Injectable Antidiabetic

intermediate insulin injection 100 IU/ml, box 1 vial @ 10 ml

regular insulin injection 100 IU/ml, box 1 vial @ 10 ml

regular insulin : intermediate insulin (30 : 70)

injection 100 IU/ml, box 1 vial @ 10 ml

16.3 SEX HORMONE and FERTILITY RELATED MEDICINES

16.3.1 Androgens testosterone oil injection 200 mg/ml

(enantate), box 1 vial @1 ml

16.3.2 Estrogens conjugated estrogens tablet 0.625 mg,

box stripes 28 tablets

ethinylestradiol tablet 0.05 mg, bottle 100 tablets

tablet 0.5 mg, bottle 100 tablets

16.3.3 Progestogens

hydroxy progesterones i.m. injection 125 mg/ml, box 1 ampoule 2 ml


THERAPEUTIC

44


RESTRICTION

norethisterone tablet 5 mg, bottle 30 tablets

16.3.4 Contraceptives

16.3.4.1 Oral Hormonal Contraceptives combination :

levonorgestrel 150 mcg ethinylestradiol 30 mcg

pill

Note : According to National Family Planning Program coordinated by National Family Planning Coordination Board (BKKBN)

16.3.4.2 Injectable Hormonal Contraceptives

medroxyprogesterone acetate

depot injection 150 mg

16.3.4.3 Intra-uterine Devices copper - containing device

set / pcs

16.3.4.4 Implantable Contraceptives

levonorgestrel implant 2 rods (3-4 years)

16.4 THYROID and ANTITHYROID HORMONES lugol solution bottle 30 ml

Note : Dilute before use

propylthiouracyl scored tablet 100 mg, bottle 1000 tablets

thyroxine sodium


16.5 CORTICOSTEROID HORMONES dexamethasone tablet 0.5 mg,

bottle 1000 tablets injection 5 mg/ml (as sodium

phosphate), box 100 ampoule @ 1 ml

hydrocortisone tablet 10 mg powder for injection 100

mg/vial (sodium succinate), box 100 vial @ 2 ml

prednisone tablet 5 mg, bottle 1000 tablets


THERAPEUTIC

45


RESTRICTION

17. CARDIOVASCULAR MEDICINES

17.1 ANTI-ANGINAL MEDICINES

atenolol tablet 50 mg, box 10 stripes @ 10 tablets

diltiazem HCl tablet 30 mg, box 10 stripes @ 10 tablets

isosorbide dinitrate sublingual tablet 5 mg, bottle 60 tablets

nitroglycerine sublingual tablet 0.5 mg, bottle100/1000 tablets

17.2 ANTIARRHYTHMIC MEDICINES

amiodarone tablet 200 mg, box 30 tablets injection 150 mg/3 ml,


digoxin tablet 0.0625 mg, bottle 100 tablets


injection 0.25 mg/ml, box 1 ampoule @ 2 ml

Pediatric dose : Tablet 0,0625 mg for pediatrics

disopyramide capsule 100 mg (phosphate), bottle 100 capsules

epinephrine (adrenaline) injection 0.1% (as bitartrate), box 100 ampoules @ 1 ml

Note : For intracardial or resusitation

lidocaine i.v. injection 2% (HCl), box 100 ampoules @ 2 ml

propranolol tablet 10 mg (HCl), bottle 100 tablets

i.v. injection 1 mg/ml (HCl), box 10 ampoules @ 1ml


THERAPEUTIC

46


RESTRICTION

verapamil tablet 40 mg (HCl), bottle 30 tablets


Special use : For supraventricular arrhythmia.

17.3 ANTIHYPERTENSIVE MEDICINES

atenolol tablet 50 mg, bottle 50 tablets

captopril scored tablet 12.5 mg, box 10 stripes @ 6 tablets

scored tablet 25 mg, box 10 stripes @ 6 or 10 tablets

Caution :- Not for pregnant women - Having cough side effect

clonidine ∗) i.m. injection 0.15 mg/ml (HCl), box 1 ampoule 1 ml

Note : For severe hypertension


lisinopril tablet 5 mg, box 3 stripes @ 10 tablets


tablet 20 mg, CD box 3 stripes @ 10 tablets

methyldopa coated tablet 250 mg, bottle 100 or 1000 tablets

nifedipine tablet 10 mg

sodium nitroprusside *) injection, vial

17.4 PLATELET ANTIAGGREGATION

acetylsalicylic acid (acetosal) tablet 80 mg, box 10 blisters @ 10 tablets



THERAPEUTIC

47


RESTRICTION

17.5 ANTI THROMBOTIC MEDICINES

streptokinase injection 750,000 IU/vial injection 1,500,000 IU/vial

Restricted use : - Authority required - Need special facility and

skill

17.6 MEDICINES USED IN HEART FAILURE captopril scored tablet 12.5 mg,

box 10 stripes @10 scored tablets

scored tablet 25 mg, box 10 stripes @ 10 scored tablets



tablet 0.25 mg, bottle 100 or 1000 tablets



furosemide tablet 40 mg, box 20 stripes@ 10 tablets

injection i.v./i.m. 10 mg/ml, box 25 ampoules @ 2 ml

17.7 MEDICINES USED for SHOCK ATTACK

17.7.1 Medicines used for Cardiogenic Shock

dobutamine

injection 50 mg/ml; vial 5 ml injection 25 mg/ml;

ampoule 10 ml

dopamine injection 40 mg/ml (HCl), box 5 ampoules @ 5 ml

epinephrine (adrenaline) injection i.v. 0.1 % (as HCl/ bitartrate), box 100 ampoules @ 1 ml


THERAPEUTIC

48


RESTRICTION

17.7.2 Medicines used for Anaesthetic Shock ephedrine injection 50 mg/ml (HCl),

box 100 ampoules @ 1 ml Note : Used as long acting vasopressor

norepinephrine injection 4 mg/ml, ampoule 2 ml

17.8 LIPID-LOWERING AGENTS

simvastatin scored tablet 10 mg, box 30 tablets

18. DERMATOLOGICAL MEDICINES

18.1 ANTIACNE MEDICINES

retinoic acid cream 0.05%, tube 20 g

18.2 ANTI-INFECTIVE MEDICINES

silver sulfadiazine cream 1%, pot 500 g Special use : Large area burn wounds

NLEM anti-infective medicines combination of : bacitracin 500 IU/g polymixin B 10,000 IU/g

ointment, tube 5 g


NLEM antifungal medicines combination of : benzoic acid 6% salicylic acid 3%

ointment, pot 30 g Note : General antifungal ointment

miconazole

powder 2% (nitrate), sacch 20 g

cream 2% (nitrate), tube 10 g


18.4 ANTI-INFLAMMATORY and ANTIPRURITIC MEDICINES betamethasone ointment 0.1% (as valerate),

tube 5 g cream 0.1% (as valerate),

tube 5 g


THERAPEUTIC

49


RESTRICTION

hydrocortisone cream 2.5% (acetate), tube 5 g

liquor veilli (salicylic acid solution 0,1 %) combination of : salicylic acid 0.1 % boric acid 0.5 % glycerine 10 %

solution

Note : - Fresh prepared (r.p.=

recentus paratus) - For wet dermatitis

18.5 SCABICIDES and PEDICULICIDES permethrin cream 5 %, tube

2-4 ointment, combination of : salicylic acid 2 % sulfur precipitate 4 %

ointment, pot 30 g

18.6 CAUSTIC MEDICINES silver nitrate sol 20%, bottle 10 ml

Note : For hypergranulation

18.7 MEDICINES AFFECTING SKIN DIFFERENTIATION and PROLIFERATION coal tar sol 5 %, bottle 100 ml

podophyllum resin alcoholic sol 25 %, bottle 30 ml

Authority required : - Should be applicated by

practitioners - Should be cleaned 1-4

hours after used, make sure that no residues

- Only for severe thickening, causing danger of absorptions

- Not for pregnant women because of terratogenic effect

- Not for use by patients - Not for take away home

salicylic acid

ointment 2%, pot 30 g ointment 5%, pot 30 g ointment 10%, pot 30 g


THERAPEUTIC

50


RESTRICTION

urea cream 10 %, tube 40 g

18.8 MISCELLANEOUS liquor carbonis detergents suspension 2%, bottle 30 ml

suspension 5%, bottle 30 ml

liquor faberi liquid

salicyl powder powder 2%, box 100 g

19. PERITONEAL DIALYSIS SOLUTIONS NLEM haemodialysis solution sol, bottle 1 gallon

NLEM peritoneal dialysis solution

infusion sol, 24 bottle @ 1000 ml

20. ELECTROLYTE, NUTRITION SOLUTIONS, and OTHERS

20.1 ORAL

oral rehydration salts combination of : sodium chloride 0.52 g potassium chloride 0.30 g trisodium citrate

dihydrate 0.58 g anhydric glucose 2.70 g

powder, 100 sacch each sacch for 200 ml water

- Drink slowly to prevent vomiting

- 1 sacchet to be dissolved in 200 ml water

potassium chloride ready-to-dissolve tablet 300 mg, air tight tube 10 tablets

- Dissolve before use - Storage in air tight

container

sodium bicarbonate

tablet 500 mg, ottle 1000 tablets

20.2 PARENTERAL calcium gluconate i.v. injection 10%,


darrow glucose ana (DG ana)

infusion sol, bottle 500 ml

dextrose infusion sol 5 %, bottle 500 ml


THERAPEUTIC

51


RESTRICTION

glucose infusion sol 5%, bottle 500 ml infusion sol 10%,

bottle 500 ml infusion sol 40%, bottle 25 ml

half strength darrow glucose

infusion sol, bottle

intralipid liquid infusion sol 10%, bottle 100/500 ml

infusion sol 20%, bottle 100/500 ml

Restricted use : - Only for special cases - Need special facility and

skill

mannitol infusion sol 20 %, bottle 500 ml

NLEM nutritious solution combination of : glucose 5 % sodium chloride 0.225 %

infusion sol, bottle 500 ml Note : For pediatric use

nutritious solution combination of : glucose 4 % sodium chloride 0.18 %


potassium chloride i.v. injection 1 meq/ml, box 1 ampoule 10 ml

ringer lactate infusion sol, bottle 500 ml

sodium bicarbonate

i.v. injection 8.4%, bottle 25 ml

injection 1.4% isotonik, bottle

Note : Need to check blood gas level

sodium chloride infusion sol 0,9%, bottle 500 ml

infusion sol 3%, bottle 500 ml injection 15%, vial 50 ml

Note : Need to check sodium level.

20.3 MISCELLANEOUS

water for injections box, ampoule/vial @ 10 ml/20 ml


THERAPEUTIC

52


RESTRICTION

21. OPHTHALMOLOGICAL PREPARATION 21.1. LOCAL ANESTHETICS bupivacaine injection 0.5% (HCl),


tetracaine eye drops 0.5% (HCl), bottle 5 ml

21.2 ANTI-INFECTIVE AGENTS

amphotericin eye ointment 3%, tube 3.5 g

gentamicin eye ointment 0,3%, tube 3.5 g eye drops 0.3%, bottle 5 ml

idoxuridine eye drops 0.1%, bottle 5 ml eye ointment 0.5%, tube 4 g

oxytetracycline eye ointment 1% (HCl), tube 3.5 g

sulfacetamide eye drops 15% (sodium), bottle 5 ml

21.3 ANTI-INFLAMMATORY AGENTS betamethasone eye drops 1 mg/ml (sodium),

bottle 5 ml

21.4 MYDRIATICS atropine eye drops 0.5% (sulfate),

bottle 5 ml eye drops 1% (sulfate),

bottle 5 ml

homatropine eye drops 2% (as hydro bromide), bottle 15 ml

21.5 MIOTICS and ANTIGLAUCOMA MEDICINES

acetazolamide tablet 250 mg, bottle 100 tablets

i.m/i.v. powder for injection 500 mg/vial (as sodium salt), box 10 vials + 10 ampoules WFI @ 5 ml


THERAPEUTIC

53


RESTRICTION

pilocarpine eye drops 2% (HCl/nitrate), bottle 5 ml

eye drops 4% (HCl/nitrate), bottle 5 ml

timolol eye drops 0.25% (maleate), bottle 5 ml

eye drops 0.5% (maleate), bottle 5 ml

21.6 MISCELLANEOUS combination of :

hydroxypropyl methylcellulose 5 mg

dextran (70) 1 mg glycerine 2 mg benzalkonium

chloride 0.01% w/v

sol 2%, bottle 5 ml

Note : For dry eyes syndrome

sodium chromoglycate eye drops 2%, bottle 15 ml

22. OXYTOCICS and UTERIC RELAXANTS

22.1 OXYTOCICS

methyl ergometrine coated tablet 0.125 mg (maleate), bottle 100 tablets

injection 0.200 mg/ml, box 100 ampoules @ 1 ml

oxytocin injection 10 IU/ml, box 100 ampoules @ 1 ml

22.2 UTERIC RELAXANTS magnesium sulfate injection 20%,

box 10 vials @ 20 ml injection 40%,

box 10 vials @ 20 ml


THERAPEUTIC

54


RESTRICTION

23. PSYCHOTHERAPEUTIC MEDICINES

23.1 MEDICINES USED in GENERALIZED ANXIETY and SLEEP DISORDERS diazepam tablet 2 mg,


bottle 1000 tablets i.m. injection 5 mg/ml,


23.2 MEDICINES USED in DEPRESSIVE DISORDERS amitriptyline coated tablet 25 mg (HCl),

box 10 blisters @ 10 tablets

fluoxetine capsule/tablet 10 mg, box 30 tablets

capsule/tablet 20 mg, box 30 tablets

lithium carbonate tablet 200 mg, box 10 stripes @ 10 tablets

Caution : - If possible, need to check

blood concentration level - Safety windows is 0,8-1,2

mmol eq/l

23.3 MEDICINES USED for OBSESSIVE COMPULSIVE DISORDERS clomipramine tablet 25 mg (HCl),

bottle 1000 tablets

23.4 MEDICINES USED in PSYCHOTIC DISORDERS chlorpromazine coated tablet 25 mg (HCl),

bottle 1000 tablets coated tablet 100 mg (HCl),

bottle 1000 tablets i.m. injection 25 mg/ml (HCl),



THERAPEUTIC

55


RESTRICTION

clozapine ∗) tablet 25 mg, box 50 tablets tablet 50 mg, box 50 tablets

Caution :- Need to check blood

leucocyte regularly (agranulocytosis)

- Drug of choice in psychotic disorder treatment which already resistent to other antipsychotics.

fluphenazine tablet 2.5 mg (HCl), bottle 100 tablets

i.m. injection 25 mg/ml (decanoate), box 10 vials @ 1 ml

haloperidol tablet 0.5 mg, bottle 100/1000 tablets

tablet 1.5 mg, bottle 100/1000 tablets

tablet 2 mg, box 100 tablets tablet 5 mg,

bottle 100/1000 tablets drops 2 mg/ml,

bottle 15 ml/100 ml i.m. injection 2 mg/ml (HCl)

box 5 ampoules @ 1 ml i.m. injection 5 mg/ml (HCl)

box 5 ampoules @ 1 ml injection 50 mg/ml (as

decanoate) box 5 ampoules @ 1 ml (long acting)

Note : Second generation antipsychotic

risperidone



23.5. MEDICINES USED for ADHD (dl) methylphenidate*) regular release tablet 10 mg,

box 30 tablets extended release tablet 20 mg,

box 30 tablets

Authority required : Need special skill





24. MUSCLE RELAXANTS (PERIPHERALLY-ACTING) and CHOLINESTERASE INHIBITORS

24.1 NEUROMUSCULAR INHIBITORS atracurium

injection 25 mg/2,5 ml, ampoule 2.5 ml

rocuronium i.v injection 10 mg/ml; vial 5 ml

succinylcholine powder i.v./i.m. injection 100 mg/ vial (chloride), box 10 vials

Authority required : - Restricted use (only for

special cases) - Need special facillities and

skill

24.2 MEDICINES USED for MIASTENIA GRAVIS neostigmine ∗) injection 0.5 mg/ml (methyl

sulfate), box 50 ampoules @ 1 ml

pyridostigmine tablet 60 mg (bromide), box 10 stripes/blisters @ 10 tablets

25. GASTROINTESTINAL MEDICINES

25.1 ANTACIDS and OTHER ANTIULCER MEDICINES NLEM antacid I combination of: aluminium hydroxide 200 mg magnesium hydroxide 200 mg

chewable tablet, bottle 1000 tablets

NLEM antacid II combination of : aluminium

hydroxide 200 mg/5 ml magnesium

hydroxide 200 mg/5 ml

suspension, bottle 60 ml





ranitidine tablet 150 mg, box 3 stripes @10 tablets

25.2 ANTIEMETIC MEDICINES

chlorpromazine coated tablet 25 mg (HCl), bottle 1000 tablets

i.m. injection 25 mg/ml (HCl), box 100 ampoules @ 1 ml

i.m injection 5 mg/ml (HCl), box 100 ampoules @ 2 ml

dimenhydrinate tablet 50 mg, bottle 1000 tablets

Note : - Adult dose : ½ - 1 tablet - Use ½ - 1 hour before

meals to get better efficacy metoclopramide tablet 10 mg (as HCl),

bottle 100 tablets injection 5 mg/ml (as HCl),

box 10 ampoules @ 2 ml syrup 5 mg/5 ml, bottle 50 ml drops 0.1 mg/drop,

bottle 10 ml

25.3 ANTIHAEMORRHOID MEDICINES NLEM antihaemorrhoid

combination of : bismuth subgallate 150 mg hexachlorophene 2.5 mg lidocaine 10 mg zinc oxide 120 mg supp to 2 g

suppositoria, box 100 supps

25.4 ANTISPASMODIC MEDICINES atropine tablet 1 mg (sulfate),

tin 100 tablets i.m./i.v./s.c. injection 0.25

mg/ml (sulfate), box 100 ampoules @ 1 ml

i.m./i.v./s.c. injection 1 mg/ml (sulfate), box 50 ampoules @ 1 ml




belladonna extract tablet 10 mg, bottle 100/1000 tablets

25.5 MEDICINES USED IN DIARRHOEA oral rehydration salts

combination of : sodium chloride 0.52 g potassium chloride 0.30 g trisodium citrate


powder, 100 sacchs, each sacch for 200 ml of water

- Drink slowly to prevent vomitting

- 1 sachet to be dissolved in 200 ml of water

25.6 CATARTIC MEDICINES

bisacodyl



glycerine liquid, bottle 100 ml

25.7 ANTI-INFLAMMATORY MEDICINES sulfasalazine tablet 500 mg, box 10 stripes

@ 10 tablets

26. MEDICINES ACTING ON RESPIRATORY TRACT

26.1 ANTIASTHMATIC

aminophylline scored tablet 200 mg, bottle 1000 tablets

injection 24 mg/ml, box 100 ampoules @10 ml

budesonide aerosol 100 mcg/puff, canister 15 ml

aerosol 200 mcg/puff, canister 15 ml

dexamethasone tablet 0.5 mg, bottle 1000 tablets

i.v. injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml




ephedrine tablet 25 mg (HCl), bottle 1000 tablets

epinephrine (adrenaline) injection 0.1 % (as HCl/bitartrate), box 100 ampoules @ 1 ml

salbutamol tablet 2 mg (as sulfate), bottle 100/1000 tablets

tablet 4 mg (as sulfate), bottle 100/1000 tablets

ih liquid 0.5 % , bottle 10 ml ih/aerosol 100 mcg/dose (as

sulfate), tube 200/400 doses

injection 50 mcg/ml (as sulfate), box 100 ampoules @ 1 ml

respirator liquid for nebulizer 2.5 mg/2.5 ml NaCl, box 4x5 nebules

Note : For intermittent inhalation and first accute attack.

26.2 ANTITUSSIVES

codeine tablet 10 ml (HCl/phosphate), bottle 250 tablets

dextromethorphan tablet 15 mg (HBr), bottle 1000 tablets

syrup 10 mg/5 ml (HBr), bottle 60 ml

26.3 EXPECTORANT glyceryl guaiacolate syrup 25 mg/5 ml,bottle 60 ml


obat batuk hitam (OBH) liquid, bottle 200 ml concentrate liquid,

bottle 1000 ml




27. IMMUNOLOGICALS

27.1 SERA and IMMUNOGLOBULINS antitetanus immunoglobulin

(human)

i.m. injection 500 IU, vial

Note :- Storage at 2-8º C

antidiphtheria sera (A.D.S) i.m. injection 10,000 IU/vial, box 10 vials @ 5 ml

i.m. injection 20,000 IU/vial, box 10 vials @ 10 ml


antirabies sera i.m. injection 100 IU/ml, box 10 vial @ 20 ml

Indication :- For post-exposure treatment

in rabies area - Storage at 2-8º C

antitetanus sera (A.T.S) for prophylaxis : i.m. injection 1500 IU/ampoule,

box 10 ampoules @ 1 ml for curative treatment : i.m./i.v. injection 10,000

IU/ampoule, box 10 ampoules @ 2 ml

i.m./i.v injection 20,000 IU/vial, box 10 vials@ 4 ml


immunoglobulin sera injection i.m., box 10 vial @ 10 ml


snake antivenom sera snake antivenom special

for snake from outside papua

snake antivenom special for papua snake

i.m./i.v. injection, box 10 vial @ 5 ml

Note :- Only for specific area - Storage at 2-8º C.

27.2 VACCINES

BCG vaccine i.c. injection, box 5 ampoules @ 2 ml

i.c. injection, box 5 ampoules @ 4 ml

Note :- Storage below 5º C




diphtheria, pertusis and tetanus adsorbed vaccine (DPT)

i.m injection, box 10 vial @ 5 ml


hepatitis B vaccine (recombinant)

injection 20 mcg/ml, box 1 vial 0.5; 1 ml


measles vaccine s.c injection, box 10 vials (10 doses) @ 5 ml


poliomyelitis vaccine drops, box vial 10/20 doses


rabies vaccine (human) s.k./i.c. powder for injection, box 7 vial @ 1 dose + 7 ampoules solvent @ 2 ml

booster : box 5 ampoules @ 1 dose + 5 ampoules solvent @ 4 ml

Indication :- Storage at 2-8º C - Used for pre-exposure and

post-exposure treatment in rabies area

tetanus adsorbed vaccine (tetanus adsorbed toxoid)

i.m.injection, box 1 vial 5 ml


tetanus and diphteria adsorbed vaccine (TD)

i.m. injection, box 10 vial @ 5 ml


28. MEDICINES USED FOR EAR, NOSE and THROAT carboglycerine ear drops 10 %, bottle 5 ml

hydrogen peroxide concentrate liquid, bottle 1000 ml

Note :- Storage in glass bottle with

glass cap, air tight, save from light

- For making dilution until 3%

lidocaine spray liquid 4% (HCl),

bottle 50 ml

oxymetazoline nasal drops 0.025% (HCl), bottle 15 ml

nasal drops 0.050 % (HCl), bottle 10 ml




29. VITAMINS and MINERALS ascorbic acid tablet 50 mg,

bottle 1000 tablets

calcium gluconate injection 100 mg/ml, box 24 ampoules @ 10 ml

calcium lactate tablet 500 mg, bottle 1000 tablets

ergocalciferol capsule 50,000 IU, bottle 100 capsules

suspension 10.000 IU/ml, bottle 60 ml

Note :Therapeutic use for hypocalcemia (seldom needed in tropical countries)

iodine

soft capsule 200 mg, bottle 1500 capsules

nicotinamide tablet 100 mg

pyridoxine tablet 10 mg (HCl), bottle1000 tablets


retinol tablet 5000 IU, bottle 1000 tablets

soft capsule 50,000 IU, bottle 50 capsules


soft capsule 200,000 IU (as palmitate), bottle 50 capsules

thiamine tablet 50 mg (HCl), bottle 1000 tablets

vitamin B complex tablet, bottle 1000 tablets


CHAPTER III RESTRICTED MEDICINE LIST

FOR PUBLIC HEALTH CENTER 2008

THERAPEUTIC

CLASS, GENERIC NAME (INN)

DOSAGE FORM RESTRICTION

1. ANALGESICS, ANTIPYRETICS, NON-STEROIDAL ANTI-INFLAMMATORY MEDICINES, MEDICINES USED TO TREAT GOUT

1.1 OPIOID ANALGESICS pethidine

injection i.m./s.c./slow released i.v 50 mg/ml (HCl), box 10 ampoules @ 2 ml

Authority required : Used only for nursing Public Health Center (PHC)

1.2 NON-OPIOID ANALGESICS acetylsalicylic acid (acetosal)

tablet 100 mg, box 10 blisters@10 tablets

tablet 500 mg, box 10 blisters@10 tablets

ibuprofen tablet 200 mg, bottle 100 tablets


methampyrone tablet 500 mg, bottle 1000 tablets

Restricted use : To reduce agranulocytosis

paracetamol tablet 100 mg, bottle 1000 tablets


syrup 120 mg/5 ml,bottle 60 ml suppositoria 120 mg suppositoria 240 mg

sodium diclofenac tablet 25 mg, box 10 stripes @ 10 tablets



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RESTRICTION

1.3. MEDICINES USED TO TREAT GOUT

allopurinol tablet 100 mg, bottle 100/1000 tablets

Note : - Blocks uric acid production

(in 35% of cases) - Not for acute attack

probenecid tablet 500 mg, bottle 100/1000 tablets

Note : - Increases uric acid renal

excretion (in 35% patients) - Dosage 2 X ½ tablet,

increase water intake - Not for acute attack

2. ANESTHETICS

2.1 LOCAL ANESTHETICS ethyl chloride spray, bottle 100 ml Note :

Air tight package

lidocaine

infiltr injection 1% (HCl), box 100 amps @ 2 ml

p.v. injection 2% (HCl), box 100 ampoules @ 2ml

gel 2%, tube 10 g spray 4%, bottle 50 ml

2.2 GENERAL ANESTHETICS and OXYGEN ketamine i.v. injection 10 mg/ml (as

HCl), box 10 vial @ 20 ml i.v. injection 50 mg/ml (as

HCl), box 10 vial @ 20 ml

Authority required : Used only for nursing PHC

oxygen inhalation, gas in tube

thiopental i.v. powder for injection 500 mg/ampoule (as sodium salt) (for dissolved in 20 ml WFI), box 25 ampoules

Authority required : Used only for nursing PHC

2.3 MEDICINES USED FOR PREOPERATIVE MEDICATION PROCEDURES atropine injection 1 mg/ml (sulfate),



THERAPEUTIC

65


RESTRICTION

diazepam tablet 5 mg, bottle 1000 tablet


morphine i.m./s.k./i.v. injection 10 mg/ml (HCl/sulfate), box 10 ampoules @ 1 ml

3. ANTIALLERGICS and MEDICINES USED IN ANAPHYLAXIS chlorpheniramine tablet 4 mg ( maleate),

bottle1000 tablets injection 5 mg/ml (maleate),


dexamethasone injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml

diphenhydramine i.m. injection 10 mg/ml (HCl), box 100 ampoules @ 1 ml

epinephrine (adrenaline) s.c./i.m. injection 0,1% (HCl/bitartrate), box 100 ampoules @ 1 ml

Note : - Drug of choice for

anaphylactic reaction - Dosage 0,3 mg – 0,5 mg

i.m. may be repeated

4. ANTIDOTES and OTHER SUBSTANCES USED IN POISONING 4.1 SPECIFIC

atropine i.m./i.v./s.c injection 1 mg/ml (sulfate), box 10 ampoules @ 2 ml

Restricted use : - Caution on package: “only

for antidotes (large dose)” - Used only for nursing PHC

calcium folinic (leucovorin, Ca) tablet 1 mg, bottle 100 tablets

sodium bicarbonate tablet 500 mg, bottle 1000 tablets

sodium thiosulfate i.v. injection 25%, box 10 ampoules @ 10 ml


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RESTRICTION

4.2 NON-SPESIFIC active carbon activated powder, sacch 0,5 kg

magnesium sulfate powder, sacch 30 g

5. ANTIEPILEPTICS – ANTICONVULSANTS diazepam i.m./i.v. injection 5 mg/ml,

box 100 ampoules @ 2 ml rectal sol 4 mg/ml, tube 2,5 ml

phenobarbital tablet 30 mg, bottle 1000 tablets



i.m injection 50 mg/ml, box 100 ampoules @ 2 ml

i.v.injection 50 mg/ml (as sodium salt), box 100 ampoules @ 2 ml

phenytoin capsule 30 mg (as sodium salt), bottle 250 capsules

capsule 100 mg (as sodium salt), bottle 250 capsules

injection 50 mg/ml (as sodium salt), box 10 ampoules @ 2 ml

Restricted used : Specific for continued treatment for patient who referred back to PHC

6. ANTI-INFECTIVE MEDICINES

6.1 ANTHELMINTHICS

6.1.1 Intestinal Anthelminthics mebendazole tablet 100 mg,

bottle 100 tablets syrup 100 mg/5 ml,

bottle 30 ml

pyrantel

scored tablet 250 mg (pamoate), bottle 250 tablets

suspension 125 mg/5 ml (pamoate), bottle 30 ml


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RESTRICTION

6.1.2 Antifilarials diethylcarbamazine scored tablet 100 mg (citrate),

bottle 1000 tablets

Note : For endemic area

6.2 ANTIBACTERIALS

6.2.1 Beta lactam medicines

amoxicillin trihydrate scored tablet 500 mg, box 10 stripes @ 10 tablets

dry syrup 125 mg/5 ml, bottle 60 ml

ampicillin i.m./i.v. powder for injection 250 mg/vial (as sodium salt), box 10 vials

i.m./i.v. powder for injection 500 mg/vial (as sodium salt), box 10 vials

benzathine benzylpenicillin

i.m. injection 1,2 millions IU/ml, box 25 vials @ 4 ml


benzylpenicillin crystal i.m./i.v. injection 10 millions IU/vial, box 25 vials

phenoxymethylpenicillin (penicillin V)

tablet 500 mg (as potassium salt), bottle 1000 tablets

tablet 250 mg (as potassium salt), box 10 stripes @ 10 tablets

dry syrup 250 mg/5 ml (as potassium salt), bottle 60 ml

Restricted used : Not used for severe infection

procaine benzylpenicillin

powder for injection i.m. 3 millions IU/vial, box 100 vials

powder for injection i.m. 1 million IU/vial, box 100 vials


THERAPEUTIC

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RESTRICTION

6.2.2 Other antibacterials

6.2.2.1 Tetracycline oxytetracycline i.v. injection 250 mg/3 ml

(HCl), box 10 ampoules @ 3 ml

i.v. injection 50 mg/ml (HCl), box 10 vials @ 10 ml

tetracycline

capsule 250 mg (HCl), bottle 1000 capsules

capsule 500 mg (HCl), box 10 stripes @ 10 capsules

6.2.2.2 Chloramphenicol chloramphenicol capsule 250 mg,

bottle 1000 capsules suspension 125 mg/5 ml (as

palmitate), bottle 60 ml

6.2.2.3 Sulfa-Trimethoprim

NLEM co-trimoxazole I (adult) combination of : sulfamethoxazole 400 mg trimethoprim 80 mg


NLEM co-trimoxazole II (paediatric) combination of: sulfamethoxazole 100 mg trimethoprim 20 mg


sulfadiazine tablet 500 mg, bottle100 tablets


6.2.2.4 Macrolides

erythromycin

capsule 250 mg (as stearate), bottle 100 capsules

syrup 200 mg/5 ml (as ethyl succinate), bottle 60 ml


THERAPEUTIC

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RESTRICTION

6.2.2.7 Specific Use

metronidazole



6.3 SPECIFIC ANTI-INFECTIVE MEDICINES

6.3.1 Antileprosy medicines

clofazimine, micronized

oily capsule 100 mg, bottle 100 capsules

dapsone scored tablet 100 mg, bottle 1000 tablets

6.3.2 Antituberculosis medicines

ethambutol tablet 250 mg (HCl), bottle 100 tablets


isoniazid tablet 100 mg, bottle 1000 tablets


pyrazinamide tablet 500 mg, bottle 100 tablets

rifampicin scored tablet 300 mg, box 10 stripes @10 tablets




streptomycin powder for injection 1000 mg/vial (as sulfate), box 100 vials

Note : Special packaging


THERAPEUTIC

70


RESTRICTION

combination of : rifampicin isoniazid

caplet 150 mg; 75 mg tablet 150 mg; 50 mg

Note : Dosage form and usage according to National Tuberculosis Program

combination of : rifampicin isoniazid ethambutol

capl 150 mg tablet 150 mg tablet 400 mg


combination of : rifampicin isoniazid pyrazinamide

capl 150 mg; 75 mg;450 mg tablet 75 mg; 50 mg; 300 mg tablet 400 mg; 150 mg;

500mg


combination of : rifampicin isoniazid pyrazinamide ethambutol

capl 150 mg; 450 mg tablet 75 mg; 300 mg tablet 400 mg; 500 mg tablet 275 mg; 250 mg;

500mg


6.3.3 Urinary Antiseptics NLEM co-trimoxazole I (adult)

combination : sulfamethoxazole 400 mg trimethoprim 80 mg


nitrofurantoine scored tablet 100 mg, bottle 100 tablets



6.4.1 Systemic griseofulvin, micronized scored tablet 250 mg,

bottle 100 scored tablets

nystatin coated tablet 500,000 IU/tablet, bottle 100/1000 tablets

suspension 100,000 IU/ml, bottle 12 ml


THERAPEUTIC

71


RESTRICTION

6.4.2. Topical NLEM antifungal medicines

combination of: benzoic acid 6% salicylic acid 3%

ointment, pot 30 g

nystatin vaginal tablet 100,000 IU/tablet, box 10 stripes @ 10 tablets

6.5 ANTIPROTOZOAL MEDICINES

6.5.1 Antiamoebic and antigiardiasis medicines

metronidazole tablet 250 mg, bottle 100 tablets


6.5.2 Antimalarial medicines 6.5.2.1 For prophylaxis chloroquine tablet 150 mg(as phosphate),

bottle 1000 tablets

6.5.2.2 For curative treatment

NLEM antimalarial medicines combination of :

pyrimethamine 25 mg sulfadoxine 500 mg


Restricted use : For specific area which already resistent to chloroquine (decided by District/Municipality Health Offices)

artemether injection 80 mg/ml, box 6 ampoules @ 1 ml

artesunate injection i.v./i.m. 60 mg/ml, box 8 vials @ 1 ml


THERAPEUTIC

72


RESTRICTION

combination of : artesunate 50 mg amodiaquin 200 mg

tablet, box 2 blisters @ 12

tablets (combipack) box 3 blisters @ 8 tablets

chloroquine

tablet 150 mg(as phosphate), bottle 1000 tablets

syrup 50 mg/5ml, bottle 60 ml

primaquine tablet 15 mg (as phosphate), bottle 1000 tablets

quinine tablet 222 mg (bisulfate), bottle 1000 tablets

i.v. injection 25% (as HCl), box 100 ampoules @ 2 ml

Restricted use : - Only for severe malaria - Used only for nursing PHC

7. ANTIMIGRAINE MEDICINES

7.1 FOR PROPHYLAXIS

dihydroergotamine

tablet 2.5 mg (as mesilate), box 10 stripes@ 10 tablets

7.2 FOR TREATMENT OF ACUTE ATTACK

ergotamine tablet 1 mg (tartrate), bottle 100 tablets

combination of : ergotamine 1 mg caffeine 50 mg

tablet, box 30/100 tablets

9. ANTIPARKINSONISM MEDICINES NLEM antiparkinsonism

medicines combination of :

benserazide 25 mg levodopa 100 mg

tablet, bottle 100 tablets Authority required : Parkinsonism diagnostic has to be ensured

trihexyphenidyl tablet 2 mg (HCl), bottle 250 tablets

Authority required : Parkinsonism diagnostic has to be ensured


THERAPEUTIC

73


RESTRICTION

10. MEDICINES AFFECTING THE BLOOD

10.1 ANTIANAEMIA MEDICINES

cyanocobalamine (vitamin B12)

injection 500 mcg/ml, box 100 ampoules @ 1 ml

fe (II) sulfate 7 H20 coated tablet 300 mg, bottle 1000 tablets

syrup, bottle 60 ml drops, bottle

folic acid tablet 1 mg, bottle 1000 tablets


10.2 MEDICINES AFFECTING COAGULATION phytomenadione (vitamin K1) coated tablet 10 mg,

bottle 1000 tablets injection 10 mg/ml,

box 100 ampoules @ 1 ml i.m injection 2 mg/ml,

ampoule 1 ml

Dose : - New born baby dose 1 mg - Premature baby dose 0,5 mg

12. DIAGNOSTIC AGENTS

12.2 FUNCTION TEST

12.2.3 Miscellaneous fluorescein eye drops 1% (sodium salt),

bottle 5 ml eye drops 2% (sodium salt),

bottle 5 ml injection 10%,

box 1 ampoule @ 5 ml injection 20%,


12.3 SKIN TEST tuberculin protein (purified

derivative)



THERAPEUTIC

74


RESTRICTION

13. ANTISEPTICS dan DISINFECTANTS

13.1 ANTISEPTICS

hydrogen peroxyde concentrate solution, bottle 1000 ml

Storage :- Storage in glass bottle with

glass cap, air tight, saved from light

- For diluted until 3%

povidone-iodine sol 10%, bottle 1000 ml

13.2 DISINFECTANTS

calcium hypochlorite powder, sacch 20 g ‘Samijaga’ program

ethanol 70% sol, bottle 100 ml /1000 ml

paraformaldehyde tablet 1 g, bottle 100 tablets sol 5%, bottle 1000 ml

saponificated cresol 50% (lysol)


14. MEDICINES and DENTAL MATERIAL USED FOR ORAL HEALTH

14.1 MEDICINES USED FOR DENTAL and ORAL HEALTH, NLEM dental anesthetics

combination of: lidocaine HCl 2% epinephrine 1 : 80,000

injection, box 20/50/100 ampoules @ 2 ml

calcium hydroxide paste, box 2 tubes

chlorphenol camphor menthol


ethyl chloride spray 0,05-0,2 ml, bottle 100 ml

Note : Air tight package

eugenol liquid, bottle 10 ml

fluorine tablet 0,5 mg, bottle 100 tablets

Authority required : For PHC in specific area


THERAPEUTIC

75


RESTRICTION

lidocaine injection 2% (HCl), box 100 ampoules @ 2 ml

paste 5% (HCl), tube 10 g spray 15% (HCl), bottle 60 ml

nystatin suspension 100.000 UI/ml, bottle 12 ml

14.2 DENTAL MATERIAL USED FOR ORAL HEALTH

gelatin sponge cubicles 1x1x1 cm, tin 50 pcs

glass ionomer ART (Atraumatic Restorative Treatment)

powder bottle10 g sol, bottle 6 g (4,8 ml) cocoa butter 5 g

gutta percha points box 120 sticks

resin composite set

root canal filling paste, bottle

temporary filling

sol and powder, bottle 100 g

15. DIURETICS

furosemide tablet 40 mg, bottle 250 tablets

i.v./i.m. injection 10 mg/ml, box 25 ampoules @ 2 ml

16. HORMONES, OTHER ENDOCRINE MEDICINES and CONTRACEPTIVES

16.2 ANTIDIABETIC

16.2.1 Oral Antidiabetic

glibenclamide tablet 2,5 mg, bottle 100 tablets


metformin tablet 500 mg, bottle 100 tablets


THERAPEUTIC

76


RESTRICTION

16.3 SEX HORMONE and FERTILITY RELATED MEDICINES

16.3.4 Contraceptives

16.3.4.1 Oral Hormonal Contraceptives

Note : According to National Family Planning Program coordinated by BKKBN

combination : levonorgestrel 150 mcg ethinylestradiol 30 mcg

pill

16.3.4.2 Injectable Hormonal Contraceptives

medroxyprogesterone acetate

depot injection 150 mg

16.3.4.3 Intra-uterine Devices Copper - containing device

set / pcs

16.4 THYROID and ANTITHYROID HORMONES lugol solution bottle 30 ml

Note : Dilute before use

propylthiouracyl scored tablet 100 mg, bottle 1000 tablets

16.5 CORTICOSTEROID HORMONES

dexamethasone tablet 0,5 mg, bottle 1000 tablets

injection 5 mg/ml (as sodium phosphate), box 100 ampoule @ 1 ml

hydrocortisone tablet 10 mg powder for injection 100

mg/vial (sodium succinate), box 100 vial @ 2 ml

prednisone tablet 5 mg, bottle 1000 tablets

Note : Second line used after dexamethasone


THERAPEUTIC

77


RESTRICTION

17. CARDIOVASCULAR MEDICINES

17.1 ANTI-ANGINAL MEDICINES

atenolol tablet 50 mg, box 10 stripes @ 10 tablets

isosorbide dinitrate sublingual tablet 5 mg, bottle 60 tablets

17.2 ANTIARRHYTHMIC MEDICINES

propranolol tablet 10 mg (HCl), bottle 100 tablets

i.v. injection 1 mg/ml (HCl), box 10 ampoules @ 1ml

17.3 ANTIHYPERTENSIVE MEDICINES

captopril scored tablet 12.5 mg, box 10 stripes @ 6 tablets

scored tablet 25 mg, box 10 stripes @ 6 or 10 tablets



17.4 PLATELET ANTIAGGREGATION

acetylsalicylic acid (acetosal) tablet 80 mg, box 10 blisters @ 10 tablets

17.6 MEDICINES USED IN HEART FAILURE captopril scored tablet 12.5 mg, box 10

stripes @ 10 scored tablets scored tablet 25 mg, box 10

stripes @ 10 scored tablets



tablet 0.25 mg, bottle 100 or 1000 tablets




THERAPEUTIC

78


RESTRICTION

furosemide tablet 40 mg, box 20 stripes @ 10 tablets

injection i.v./i.m. 10 mg/ml, box 25 ampoules @ 2 ml

17.7 MEDICINES USED for SHOCK ATTACK,

17.7.1 Medicines used for cardiogenic shock

epinephrine (adrenaline) injection i.v. 0,1 % (as HCl/ bitartrate), box 100 ampoules @ 1 ml

17.8 LIPID-LOWERING AGENTS

simvastatin scored tablet 10 mg, box 30 scored tablets

18. DERMATOLOGICAL MEDICINES

18.2 ANTI-INFECTIVE MEDICINES

NLEM anti-infective medicines combination of : bacitracin 500 IU/g polymixin B 10,000 IU/g

ointment, tube 5 g


NLEM antifungal medicines combination of : benzoic acid 6% salicylic acid 3%

ointment, pot 30 g Note : General antifungal ointment


18.4 ANTI-INFLAMMATORY and ANTIPRURITIC MEDICINES betamethasone ointment 0.1% (as valerate),

tube 5 g cream 0.1% (as valerate),

tube 5 g

hydrocortisone cream 2.5% (acetate), tube 5 g


THERAPEUTIC

79


RESTRICTION

18.5 SCABICIDES and PEDICULICIDES 2-4 ointment,

combination of : salicylic acid 2 % sulfur precipitate 4 %

ointment, pot 30 g

18.6 CAUSTIC MEDICINES silver nitrate sol 20%, bottle 10 ml

Note : For hypergranulation

18.7 MEDICINES AFFECTING SKIN DIFFERENTIATION and PROLIFERATION coal tar sol 5 %, bottle 100 ml

podophyllum resin alcoholic sol 25 %, bottle 30 ml

Authority required : - Should be applicated by

practitioners - Should be cleaned 1-4

hours after used, make sure that no residues

- Only for severe thickening, causing danger of absorptions

- Not for pregnant women because of terratogenic effect

- Not for use by patients - Not for take away home

salicylic acid

ointment 2%, pot 30 g ointment 5%, pot 30 g ointment 10%, pot 30 g

18.8 MISCELLANEOUS liquor carbonis detergents suspension 2%, bottle 30 ml

suspension 5%, bottle 30 ml

liquor faberi liquid

salicyl powder powder 2%, box 100 g


THERAPEUTIC

80


RESTRICTION

20. ELECTROLYTE, NUTRITION SOLUTIONS, and OTHERS

20.1 ORAL oral rehydration salts



powder, 100 sacch each sacch for 200 ml water


- 1 sacchet to be dissolved in 200 ml water

sodium bicarbonate


20.2 PARENTERAL glucose infusion sol 5%, bottle 500 ml

infusion sol 10%, bottle 500 ml

infusion sol 40%, bottle 25 ml

ringer lactate infusion sol, bottle 500 ml

sodium chloride infusion sol 0.9%, bottle 500 ml

infusion sol 3%, bottle 500 ml injection 15%, vial 50 ml

Note : - Need to check sodium

level - Used only for nursing PHC

20.3 MISCELLANEOUS

water for injections box, ampoule/vial @ 10 ml/20 ml

21. OPHTHALMOLOGICAL PREPARATION 21.1. LOCAL ANESTHETICS tetracaine eye drops 0.5% (HCl),

bottle 5 ml

21.2 ANTI-INFECTIVE AGENTS

oxytetracycline eye ointment 1% (HCl), tube 3.5 g

sulfacetamide eye drops 15% (sodium), bottle 5 ml


THERAPEUTIC

81


RESTRICTION

21.4 MYDRIATICS atropine eye drops 0.5% (sulfate),

bottle 5 ml eye drops 1% (sulfate),

bottle 5 ml

21.5 MIOTICS and ANTIGLAUCOMA MEDICINES

pilocarpine eye drops 2% (HCl/nitrate), bottle 5 ml

eye drops 4% (HCl/nitrate), bottle 5 ml

22. OXYTOCICS and UTERIC RELAXANTS

22.1 OXYTOCICS

methyl ergometrine coated tablet 0.125 mg (maleate), bottle 100 tablets

injection 0.200 mg/ml, box 100 ampoules @ 1 ml

oxytocin injection 10 IU/ml, box 100 ampoules @ 1 ml

23. PSYCHOTHERAPEUTIC MEDICINES

23.1 MEDICINES USED in GENERALIZED ANXIETY and SLEEP DISORDERS diazepam tablet 2 mg,


bottle 1000 tablets i.m. injection 5 mg/ml,


23.2 MEDICINES USED in DEPRESSIVE DISORDERS amitriptyline coated tablet 25 mg (HCl),

box 10 blisters@10 tablets

23.3 MEDICINES USED for OBSESSIVE COMPULSIVE DISORDERS clomipramine tablet 25 mg (HCl),

bottle 1000 tablets


THERAPEUTIC

82


RESTRICTION

23.4 MEDICINES USED in PSYCHOTIC DISORDERS chlorpromazine coated tablet 25 mg (HCl),

bottle 1000 tablets coated tablet 100 mg (HCl),

bottle 1000 tablets i.m. injection 25 mg/ml (HCl),


haloperidol tablet 0.5 mg, bottle 100/1000 tablets

tablet 1.5 mg, bottle 100/1000 tablets

tablet 2 mg, box 100 tablets tablet 5 mg,

bottle 100/1000 tablets drops 2 mg/ml,

bottle 15 ml/100 ml i.m. injection 2 mg/ml (HCl),

box 5 ampoules @ 1 ml i.m. injection 5 mg/ml (HCl),

box 5 ampoules @ 1 ml injection 50 mg/ml (as

decanoate), box 5 ampoules @ 1 ml (long acting)

Note : - Second generation

antipsychotic - Specific for PHC which

integrated to mental health care

25. GASTROINTESTINAL MEDICINES

25.1 ANTACIDS and OTHER ANTIULCER MEDICINES NLEM antacid I combination of: aluminium hydroxide 200 mg magnesium hydroxide 200 mg

chewable tablet, bottle 1000 tablets

NLEM antacid II combination of : aluminium

hydroxide 200 mg/5 ml magnesium

hydroxide 200 mg/5 ml

suspension, bottle 60 ml


THERAPEUTIC

83


RESTRICTION

25.2 ANTIEMETIC MEDICINES

chlorpromazine coated tablet 25 mg (HCl), bottle 1000 tablets

i.m. injection 25 mg/ml (HCl), box 100 ampoules @ 1 ml

i.m injection 5 mg/ml (HCl), box 100 ampoules @ 2 ml

dimenhydrinate tablet 50 mg, bottle 1000 tablets

Note : - Adult dose : ½ - 1 tablet - Use ½ - 1 hour before

meals to get better efficacy 25.3 ANTIHAEMORRHOID MEDICINES NLEM antihaemorrhoid

combination of : bismuth subgallate 150 mg hexachlorophene 2.5mg lidocaine 10 mg zinc oxide 120 mg supp to 2 g

suppositoria, box 100 supp

25.4 ANTISPASMODIC MEDICINES atropine tablet 1 mg (sulfate),

tin 100 tablets i.m./i.v./s.c. injection 0.25

mg/ml (sulfate), box 100 ampoules @ 1 ml

i.m./i.v./s.c. injection 1 mg/ml (sulfate), box 50 ampoules @ 1 ml

belladonna extract tablet 10 mg, bottle 100/1000 tablets

25.5 MEDICINES USED IN DIARRHOEA oral rehydration salts



powder, 100 sacchs, each sacch for 200 ml of water


- 1 sachet to be dissolved in 200 ml of water


THERAPEUTIC

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RESTRICTION

25.6 CATARTIC MEDICINES

glycerine liquid, bottle 100 ml

26. MEDICINES ACTING ON RESPIRATORY TRACT

26.1 ANTIASTHMATIC

dexamethasone tablet 0.5 mg, bottle 1000 tablets

i.v. injection 5 mg/ml (as sodium phosphate), box 100 ampoules @ 1 ml

ephedrine tablet 25 mg (HCl), bottle 1000 tablets

epinephrine (adrenaline) injection 0.1 % (as HCl/bitartrate), box 100 ampoules @ 1 ml

salbutamol tablet 2 mg (as sulfate), bottle 100/1000 tablets

tablet 4 mg (as sulfate), bottle 100/1000 tablets

26.2 ANTITUSSIVES

codeine tablet 10 mg (HCl/phosphate), bottle 250 tablets

dextromethorphan tablet 15 mg (HBr), bottle 1000 tablets

syrup 10 mg/5 ml (HBr), bottle 60 ml

26.3 EXPECTORANT glyceryl guaiacolate syrup 25 mg/5 ml,bottle 60 ml


obat batuk hitam (OBH) liquid, bottle 200 ml concentrate liquid,

bottle 1000 ml


THERAPEUTIC

85


RESTRICTION

27. IMMUNOLOGICALS

27.1 SERA and IMMUNOGLOBULINS antidiphtheria sera (A.D.S) i.m. injection 10,000 IU/vial,

box 10 vials @ 5 ml i.m. injection 20.000 IU/vial,

box 10 vials @ 10 ml


antirabies sera i.m. injection 100 IU/ml, box 10 vial @ 20 ml

Indication :- For post-exposure treatment

in rabies area - Storage at 2-8º C

antitetanus sera (A.T.S) for prophylaxis : i.m. injection 1500

IU/ampoule box 10 ampoules @ 1 ml

for curative treatment : i.m./i.v. injection 10,000

IU/ampoule, box 10 ampoules @ 2 ml

i.m./i.v injection 20,000 IU/vial, box 10 vials@ 4 ml


snake antivenom sera snake antivenom special

for snake from outside papua

snake antivenom special for papua snake

i.m./i.v. injection, box 10 vial @ 5 ml

Note :- Only for specific area - Storage at 2-8º C.

27.2 VACCINES

BCG vaccine i.c. injection, box 5 ampoules @ 2 ml

i.c. injection, box 5 ampoules @ 4 ml

Note :- Storage below 5º C

diphtheria, pertusis and tetanus adsorbed vaccine (DPT)

i.m injection, box 10 vial @ 5 ml


hepatitis B vaccine (recombinant)

injection 20 mcg/ml, box 1 vial 0.5; 1 ml



THERAPEUTIC

86


RESTRICTION

measles vaccine s.c. injection, box 10 vials (10 doses) @ 5 ml


poliomyelitis vaccine drops, box vial 10/20 doses


rabies vaccine (human) s.c./i.c. powder for injection, box 7 vial @ 1 dose + 7 ampoules solvent @ 2 ml

booster : box 5 ampoules @ 1 dose + 5 ampoules solvent @ 4 ml

Indication :- Storage at 2-8º C - Use for pre-exposure and

post-exposure treatment in rabies area

tetanus adsorbed vaccine (tetanus adsorbed toxoid)

i.m. injection, box 1 vial 5 ml


tetanus and diphteria adsorbed vaccine (TD)

i.m. injection, box 10 vial @ 5 ml


28. MEDICINES USED FOR EAR, NOSE and THROAT carboglycerine ear drops 10 %, bottle 5 ml

29. VITAMINS and MINERALS ascorbic acid tablet 50 mg,

bottle 1000 tablets

calcium lactate tablet 500 mg, bottle 1000 tablets

pyridoxine tablet 10 mg (HCl), bottle1000 tablets


retinol tablet 5000 IU, bottle 1000 tablets



soft capsule 200,000 IU (as palmitate), bottle 50 capsules


THERAPEUTIC

87


RESTRICTION

thiamine tablet 50 mg (HCl), bottle 1000 tablets

vitamin B complex tablet, bottle 1000 tablets

Minister of Health

Dr. dr. SITI FADILAH SUPARI, SpJP (K)


CHANGES OF NLEM 2005

NO GENERIC NAME (INN) DOSAGE FORM

ADDITION (+), DELETION (-), CHANGE OF

DOSAGE FORM

1 acetazolamide tablet 250 mg, bottle 100 tablets

i.m/i.v. powder for injection, 500 mg/vial (as sodium salt), box 10 vials + 10 ampoules water for injection @ 5 ml

Moved to other therapeutic sub-class

2 active carbon activated powder, sacch 0.5 kg Change of generic name

3 alprazolam

tablet 0.25 mg, box 10 stripes @ 10 tablets

tablet 0.5 mg, box 10 stripes @ 10 tablets

−

4 amiloride


−

5 amiodarone

tablet 200 mg, box 30 tablets injection 150 mg/3 ml,


+

6 amphotericin *)

i.v injection vial 50 mg/10 ml, vials @ 10 ml

+

7 antitetanus immunoglobulin (human)

i.m. injection 500 UI, vial +

8 artesunate

i.v/i.m injection 60 mg/ml, box 8 vials @ 1 ml

+

9 atracurium

injection 25 mg/2,5 ml, ampoule 2,5 ml

+

10 benzoil peroxyde gel 2.5%, tube 5 g gel 5%, tube 5 g

−

National List of Essential Medicine 2008 88 88

NO GENERIC NAME (INN)

ADDITION (+), DELETION (-),

DOSAGE FORM CHANGE OF DOSAGE

FORM

11 benzylpenicilin

eye ointment 1.000 IU/g, tube 5 g

−

12 betamethasone

eye drop 1 mg/ml (sodium), bottle 5 ml

+

13 bupivacaine

infiltrate injection 0.25% (HCl), box 5 vial @ 20 ml

−

14 carbamazepine

chewable tablet 100 mg syrup 100 mg/5 ml, bottle 120 ml

+

15 cefazolin

powder for injection 1 g / vial, box 2 vials

+

16 ceftriaxone

powder injection 1 g / vial, box 2 vials

+

17 chlorambucyl

tablet 2 mg +

18 chloramphenicol

ear drop 3 %, bottle 5 ml −

19 chlorhexidine sol 1.5 % (gluconate), bottle 2.5 l sol 4.0 % (gluconate), bottle 2.5 l

−

20 chlorhexidine sol 5.0% (gluconate), bottle 2.5 l

+

21 chlormethine

powder injection 10 mg/vial (HCl), box 1 vial

−

22 clomiphen tablet 50 mg (citrate), bottle 10 tablets

−

23 clomipramine


−

24 clozapine ∗) tablet 25 mg, box 50 tablets tablet 50 mg, box 50 tablets

+






FORM

25 codeine tablet 10 mg (phosphate), bottle 250 tablet

Change of dosage strength and packaging

26 colchicine

tablet 500 mcg, box 3 stripes @ 10 tablets

−

27 combination of: ergotamine 1 mg caffeine 50 mg

tablet, box 30/100 tablets +

28 combination of: extr. apii herba 92 mg extr. ortosiphonis folium

28 mg

capsule −

29 compound thymi syrup

liquid, bottle 100 ml −

30 copper –containing device

set / pcs +

31 daunorubicin

powder injection 20 mg/vial (HCl), box 1 vial @ 4 ml

+

32 desmopressin spray Change of dosage form

33 devitalization paste (non arsen)

paste, bottle −

34 dextran 70

Infus sol 6%, bottle 500 ml −

35 dextrose

infusion solution 5 %, bottle 500 ml

+

36 diethylcarbamazine scored tablet 100 mg (citrate), bottle 1000 tablet

Change of dosage strength

37 digoxin



injection 0.25 mg/ml; box 1 ampoule 2 ml

+





FORM

38 diloxanide

tablet 500 mg (furoate) +

39 disodium edetate

eye drop 0.35%, bottle 5 ml −

40 dobutamine

injection 50 mg/ml, vial 5 ml injection 25 mg/ml, ampoule

10 ml

+

41 edrofonium

injection i.v. 10 mg/ml (chloride), box 10 vial @ 10 ml

−

42 efavirenz tablet 200 mg, bottle 90 tablets tablet 600 mg, bottle 30 tablets

Change of therapeutic sub-class and dosage form

43 enflurane inhalation liquid, bottle 250 ml −

44 etacridine (rivanol)

solutio 0.1 %, bottle 300 ml powder, bottle 100 g

−

45 ethosuccimide

capsule 250 mg, bottle 100/1000 capsules

syrup 250 mg/5 ml, bottle 60 ml

−

46 ethyl ester from oleum iodized papaveris (iodized oil)

i.a./i.v. injection 1 ml consist of 0,96 ml (equivalent with 0.48 g iodine), box 1 ampoule 10 ml

−

47 etonogestrel implant 1 rods (3 yrs)

−

48 fe (II) sulfate 7H2O

syrup, bottle 60 ml +

49 fentanyl i.m./i.v. injection 0.05 mg/ml (citrate), box 5 ampoules @ 2 ml

Change of packaging

50 fluoxetine capsule/tablet 10 mg, box 30 tablets

capsule/tablet 20 mg, box 30 tablets

+





FORM

51 framicetin

sterile kassa 1% (sulfate), box 10 pieces

−

52 gamexan

cream 1%, bottle 30 ml −

53 gelatin spons

layer 5 x 7 x 1 cm −

54 gentian violet

sol 1%, bottle 10 ml

−

55 haloperidol i.m. injection 2 mg/ml (HCl) box 5 ampoules @ 1 ml

i.m. injection 5 mg/ml (HCl) box 5 ampoules @ 1 ml

Change of salt form

56 hydrochlorothiazide tablet 25 mg, bottle 1000 tablets

+

57 hydrocortisone

tablet 10 mg +

58 hydrocortisone cream 1% (acetate), tube 5 g

−

59 hydrocortisone acetate

eye drop 1%, bottle 5 ml −

60 intermediate insulin

injection 40 IU/ml, box 1 vial 10 ml

−

61 iodine

injection 480 mg/ml, box 1 ampoule 10 ml

−

62 iodoform paste

paste −

63 isoflurane

inhalation liquid, bottle 250 ml +

64 isoprenaline

injection 1mg/ml (HCl), box 1 ampoule 2 ml

−

65 ketoprofen

suppositoria 100 mg

+

66 levamisole

tablet 50 mg (HCl), box 4 bls @ 9 tablets

−





FORM

67 levertrane

ointment 5% −

68 levonorgestrel pill 75 mcg, 150 mcg

−

69 levonorgestrel implant 6 rods (5 yrs)

−

70 lidocaine

injection 5% + glucose 7.5 %, ampoule 2 ml

+

71 lidocaine

injection 1% (HCl) + epinephrine 1 : 200,000, box 10 vials @ 30 ml

injection 2% (HCl) + epinephrine 1 : 200,000, box 10 vials @ 20 ml

−

72 liquor faberi

liquor with menthol 0,1% liquor with menthol 0,5%

−

73 liquor veilli (salicylic acid solution 0.1 %) combination of : salicylic acid 0.1 % boric acid 0.5 % glycerine 10 %

solution +

74 lisinopril




−

75 lithium carbonate tablet 200 mg, box 10 stripes @ 10 tablets


76 lopinavir

tablet +

77 lotio kummerfeldi liquid, packaging as needed −





FORM

78 mannitol infusion sol 20%, bottle 500 ml −

79 melphalan tablet 2 mg +

80 meningococcus polysaccharide A + C vaccine

powder injection, box 10 vials @ 10 dosage + 10 ampoules solvent @ 5 ml

−

81 methampyrone

i.m. injection 250 mg/ml, box 25 vials @ 10 ml box 100 ampoules @ 2 ml

−

82 methyl cellulose, changed to be

combination of hydroxypropyl methyl-cellulose 5 mg dextran (70) 1 mg glycerine 2 mg

benzalkonium chloride 0.01% w/v

sol 2 %, bottle 5 ml Change of therapeutic sub-class and the composition is written completely

83 (dl) methylphenidate ∗) regular release tablet 10 mg, box 30 tablets

extended release tablet 20 mg, box 30 tablets

+

84 methyl prednisolone tablet 4 mg, bottle 100 tablets

−

85 metoclopramide

syrup 5 mg/5 ml, bottle 50 ml drop 0.1 mg/drop, bottle 10 ml

+

86 midazolam

i.v. injection 1 mg/ml i.v. injection 5 mg/ml

+

87 NLEM nutritious solution I

infusion sol, bottle 500 ml −

88 NLEM nutritious solution II


−






FORM

89 NLEM nutritious solution III

infusion sel, bottle 500 ml −

90 NLEM nutritious solution IV


91 NLEM nutritious solution V


92 NLEM otic medicine combination of:

neomycin sulfate 500 mg polymixin B sulfate

1.000.000 IU/100 ml

ear drop, bottle 5 ml

−

93 neomycin

tablet 500 mg, bottle 100 tablets −

94 nicotinamide tablet 100 mg +

95 norepinephrine injection 4 mg/ml, ampoule 2 ml

+

96 nutritious solution combination of : glucose 4 % sodium chloride 0.18 %


+

97 oral rehydration salts powder, 100 sacch, each sacch for 1000 ml of water

−

98 pancuronium

i.v. injection 2 mg/ml (bromide), box 10 ampoules @ 2 ml

−

99 paracetamol

suppositoria 120 mg suppositoria 240 mg

+

100 patent blue V

s.c. injection 2.5%, box 1 ampoule 2 ml

−

101 permethrin

cream 5%, tube +

102 perphenazin

tablet 4 mg (HCl), bottle 100/1000 tablets

tablet 16 mg (HCl), bottle 100/1000 tablets

−





FORM

103 phenobarbital


+

104 phenol liquid

bottle 10 ml −

105 phenytoin

syrup 50 mg/5 ml, bottle120 ml +

106 phytomenadione

i.m injection 2mg/ml, ampoule 1 ml

+

107 piridostigmine

tablet 10 mg (bromide), box 10 stripes/bls @ 10 tablets

−

108 policresulen (metacresol sulphonate & methanal condensate)

liquid, bottle 10 ml / 50 ml Moved to other therapeutic class

109 prednisolon

eye drop 0,5%, bottle 5 ml eye ointment 1%, tube 3,5 g

−

110 procainamide

injection 100 mg/ml (HCl) −

111 propranolol

scored tablet 40 mg (HCl), bottle 100 tablets

+

112 propyliodone

injection in oil 500-600 mg/ml, box 1 ampoule 20 ml

−

113 propylthiouracyl tablet 100 mg, bottle 1000 tablets Change of dosage strength

114 propranolol

tablet 10 mg, box 100 tablets tablet 40 mg, box 100 tablets

−

115 protein plasma fraction (including fibrinogen)

Dosage form and strength are deleted

116 quinidine

tablet 200 mg (sulfate), bottle 100/1000 tablets

−

117 reserpin

tablet 0,10 mg, bottle 1000 tablets tablet 0,25 mg, bottle 1000 tablets

−





FORM

118 resin composite

set +

119 retinol

tablet 5000 UI, bottle 50 tablet soft capsule 100,000 UI,

bottle 50 soft capsules

+

120 retinol

injection 100,000 IU/ ampoule, box 100 ampoules @ 1 ml

oily injection 100,000 IU/ampoule (as palmitate), box 100 ampoules @ 2 ml

−

121 regular insulin


−

122 regular insulin : intermediate insulin (30 : 70)


+

123 rocuronium

i.v. injection 10 mg/ml, vial 5 ml +

124 silver amalgam

powder 65 - 75%, bottle 1 oz −

125 silver nitrate sol 40%, bottle 10 ml

−

126 sodium bicarbonate

injection 1,4% isotonic

+

127 sodium fucidic

cream 20 mg/g, tube 5 g −

128 sodium nitroprusside *)

injection, vial +

129 stavudin tablet 30 mg, bottle 60 tablets tablet 40 mg, bottle 60 tablets

Change of therapeutic sub-class and dosage form

130 succinyl choline iv/i.m powder injection 500 mg/vial (chloride), box 10 vial

Change of generic name

131 sufentanyl

injection 50 mcg/ml (citrate), box 5 vial @ 5 ml

−





FORM

132 sulfonic preparation cones, bottle 100 butir

−

133 sulpirid

capsule 50 mg, box 10 stripes @ 10 capsules


−

134 suxamethonium

iv/i.m powder injection 500 mg/vial (chlorida), box 10 vial

−

135 thiamine

injection 100 mg/ml, box 100 ampoules 1 ml

−

136 thiopental

i.v. powder for injection 500 mg/ampoule (as sodium salt) (for dissolved in 20 ml WFI), box 25 ampoules

−

137 trichloracetic acid crystal, sacch

−

138 tropicamide

eye drop 1%, bottle 5 ml −

139 tuberkulin protein (purified derivative)


−

140 valproate tablet 250 mg (as sodium salt), bottle 50 tablets

tablet 500 mg (as sodium salt), bottle 50 tablets

syrup 250 mg/5 ml (as sodium salt), bottle 120 ml

Change of dosage form and strength

141 vancomycin powder injection 500 mg/vial, box 1 vial

+

142 vecuronium

powder injection 10 mg/vial (bromide), box 20 vials

−

143 warfarin tablet 2 mg (potassium salt), bottle 100 tablets






FORM

144 zidovudine tablet 100 mg, bottle 100 tablets Change of therapeutic sub-class and dosage form

145 zinc phosphate cement

Powder and liquid, set 30 g bottle 1 set

−


THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA THE DECREE OF THE MINISTER OF HEALTH

OF THE REPUBLIC OF INDONESIA NUMBER: 239/MENKES/SK/III/2008

REGARDING

THE ESTABLISHMENT OF NATIONAL COMMITTEE ON REVISION

OF THE NATIONAL LIST OF ESSENTIAL MEDICINES 2008

THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA

Considers : a. in order to enhance the quality of health services, the availability of a good quality, safe, effective and sufficient quantity of essential medicines is the responsibility of the government as authorized in the National Medicines Policy;

b. as according to the point (a) above, it is necessary to support the implementation of rational use of medicines;

c. as according to the progress of the medical sciences and health technology, disease pattern, health program and the improvement of public health status as a result of the currently health development, it is therefore, the National list of Essential Medicines should be revised;

d. in order to revise the National List of Essential Medicines (NLEM), it is necessary to establish The National Committee On Revision of the National List of Essential Medicines 2008 by Ministerial decree.

Refers to : 1. Law No. 23 year 1992 regarding Health (State Paper year 1992 No.

100, additional to State Paper No. 4431); 2. Government Regulation No. 27 year 1998 regarding Safety of

Pharmaceutical Products and Medical Devices (State Paper year 1998 No. 138, Additional to State Papers of the Republic of Indonesia No. 3781);

3. Government Regulation No. 38 year 2007 regarding Division of Municipality/District Administrative (State of the Republic of Indonesian Paper year 2007 No. 82);

4. The Regulation of the President of the Republic of Indonesia No. 9 year 2005 regarding the locality, duty, function, structure of the organization and the job description of the States Ministries of the Republic of Indonesia;

5. The Regulation of the President of the Republic of Indonesia No. 10 year 2005 regarding Organization Unit and duty of the First Rank Officers of the States Ministries of the Republic of Indonesia;

6. The Regulation of the Minister of Health of the Republic of Indonesia No. 1575/Menkes/Per/XI/2005 regarding the Organization and Ethical Task of the Health Department of the Republic of Indonesia;

7. The Decree of the Minister of Health of the Republic of Indonesia No. 189/MENKES/SK/III/2006 regarding The National Medicines Policy.

National List of Essential Medicines 2008 100

Has decided

To stipulate

: THE DECREE OF THE MINISTER OF HEALTH REGARDING THE ESTABLISMENT OF THE NATIONAL COMMITTEE ON REVISION OF THE NATIONAL LIST OF ESSENTIAL MECICINES 2008

The First : To establish The National Committee on Revision of National List of Essential Medicines 2008 with organization structure as set forth in the appendix hereto;

The Second : The responsibilities of National Committee of NLEM are as follows:

a. The Steering Committee The Steering Committee is responsible to provide advice and direction of the revision according to prevailing laws and regulations;

b. The Expert Team The Expert Team is responsible to evaluate the medicines in NLEM 2005 and to analyze the proposed medicines to be added to or deleted from the NLEM 2008.

c. The Consultant The consultant is responsible to provide the technical support or scientific findings needed by the expert team.

d. The Expert Team and The Consultant jointly provide the technical and the scientific support to the Ministry of Health vide Directorate General of Pharmaceutical Services and Medical Devices on implementing NLEM nationwide and to assist the Directorate of Rational Use of Medicine to execute its policy.

e. The Members The Members are responsible to provide input needed for evaluation of NLEM 2005 and to analyze the proposed medicines to be added to or deleted from NLEM 2008.

f. The Organizing Committee The Organizing Committee are responsible in recording, documentation and supplying the data, preparing the procedures and guidelines, and preparing the recommended draft of NLEM 2008, arranging the technical meetings and plenary session, preparing the draft documentations, and finalizing NLEM 2008 and its dissemination.

The Third : The Revision of NLEM should be conducted during 2008; The Fourth

: On implementing the duties of The National Committee of Revision of NLEM are responsible to the Ministry of Health vide Directorate General of Pharmaceutical Services and Medical Devices; and report the activities at least 1 (one) month after the termination of their task.


The Fifth

: The duty period of The National Committee of Revision of NLEM started since the stipulation date of this decree and terminated at the end of 2008.

The Sixth

: The budget of The National Committee of Revision of NLEM and activities is under Annual National Budget of Directorate of Rational Use of Medicine in the year of 2008;

The Seventh : This decree shall be effective as of the date of stipulation, and there will be reconsideration or amendment as required if there are shortcomings of mistakes in the stipulation.

Stipulated in : Jakarta On Date : March 5, 2008.

Minister of Health


Circulation to: 1. The Coordinator Minister of the Public Welfare 2. The Minister of Home Affair 3. The Head of National Planning and Development Board 4. The Head of National Agency of Drug and Food Control 5. The First Ranks officers in the Ministry of Health. 6. The Head of Province Health Office all over the Republic of Indonesia. 7. The Directors of all Teaching Hospitals and Vertical Hospitals within the Ministry of Health all

over the Republic of Indonesia. 8. The Head of Municipality or District Health Office all over the Republic of Indonesia. 9. Whom it may concern, to be implemented as required.


APPENDIX : THE DECREE OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA NUMBER : 239/MENKES/SK/III/2008 DATE : MARCH 5, 2008

THE ESTABLISHMENT OF NATIONAL COMMITTEE ON REVISION

OF THE NATIONAL LIST OF ESSENTIAL MEDICINES 2008

Steering Committee : 1. Director General of Pharmaceutical Services and Medical Devices 2. Head of National Agency of Food and Drug Control 3. Director General of Medical Services 4. Director General of Diseases Control and Sanitation 5. Deputy 1 of National Agency of Food and Drug Control

Head of Authority : Director General of Pharmaceutical Services and Medical devices Expert Team : Chairman : Iwan Darmansjah (General Practitioner) Vice Chairman : Rianto Setiabudy (General Practitioner) Members :

1. Abdul Muthalib (General Practitioner) 2. Asril Aminullah (General Practitioner) 3. Bambang Sudarmanto (Specialist) 4. Dede Gunawan (Specialist) 5. Djakaria (Specialist) 6. Gunawan (Specialist) 7. Hanafi Trisnohadi (Specialist) 8. Inge Sutanto (General Practitioner) 9. Nugroho Kampono (Specialist) 10. Omo Abdul Madjid (Specialist) 11. Robert Reverger (Specialist) 12. Sarwono Waspadji (specialist) 13. Silvia Desiree Fadiel (Dentist) 14. Sri Rezeki S. Hadinegoro (Specialist)

Counsultant :

1. Arini Setiawati ((Pharmacist) 2. Atie W. Soekandar (General Practitioner) 3. Engko Sosialine (Pharmacist) 4. Irawan Mangunatmaja (Specialist) 5. Iwan Dwiprahasto (General Practitioner) 6. Kartono Muhammad (General Practitioner) 7. Nani Sukasediati (Pharmacist) 8. Pinky F. Riawan (General Practitioner) 9. Sri Suryawati (Pharmacist)


Organizing Committee : Head : Director of Rational Use of Medicines Secretary : Zorni Fadia (General Practitioner) Seecretary I : Dita Novianti (Pharmacist) Members :

1. Secretary to Director General of Pharmaceutical Services and Medical devices

2. Director of Public Medicines and Medical Supply 3. Director of Maternal Health 4. Director of Child Health 5. Director of Direct Communicable Diseases Control 6. Director of Animal Sourced Diseases Elimination 7. Director of Non-Communicable Diseases 8. Director of Epidemiologic Surveillance, Immunization and

Dimension Health 9. Head of Sub Directorate of Standardization and Technical

Assistance, Rational Use Medicines Directorate 10. Head of Sub Directorate of Promotion, Rational Use Medicines

Directorate Secretariat :

1. Erie Gusnellyanti 2. Liza Fetrisiani 3. Prihadi Mulyono 4. Anwar Wahyudi 5. Nofiyanti 6. Mulyati

Stipulated in : Jakarta

On Date : March 5, 2008. Minister of Health



LIST OF PARTICIPANTS OF TECHNICAL MEETINGS AND PLENARY SESSION

NATIONAL LIST OF ESSENTIAL MEDICINES 2008

1 Director General of Pharmaceutical Services and Medical Devices 2 Head of National Agency of Food and Drug Control 3 Director General of Medical Services 4 Director General of Diseases Control and Sanitation 5 Deputy I of National Agency of Food and Drug Control 6 Secretary to Director General of Pharmaceutical Services and Medical Devices 7 Director of Rational Use of Medicine 8 Director of Public Medicines and Medical Supply 9 Director of Maternal Health 10 Director of Child Health 11 Director of Direct Communicable Diseases Control 12 Director of Non-Communicable Diseases Control 13 Director of Animal Sourced Diseases Elimination 14 Director of Epidemiologic Surveillance, Immunization and Dimension Health 15 Director of Public Nutrition 16 Director of Mental Health Services 17 Director of Primary Medical Services 18 Director of Specialist Medical Services 19 Director of Public Hospital Dr. M Yunus Bengkulu 20 Director of Public Hospital DR. M. Djamil Padang 21 Director of Public Hospital Ulin Banjarmasin 22 Director of National Public Hospital RS Cipto Mangunkusumo 23 Director of Central Public Hospital Hasan Sadikin Bandung 24 Director of Central Public Hospital Muh. Hussein Palembang 25 Director of Public Hospital dr. Moewardi, Solo 26 Director of Public Hospital dr. Sardjito, Yogyakarta 27 Director of Central Public Hospital Wahidin Sudirohusodo, Makasar 28 Director of Public Hospital Dr. Karyadi, Semarang 29 Director of Public Cardiovascular Hospital Harapan Kita 30 Director of Mental Hospital Cimahi 31 Director of Provincial Public Hospital Wahidin Sudirohusodo Mojokerto-East Java 32 Director of Provincial Public Hospital dr. Soetomo, Surabaya 33 Director of Public Hospital Kab. Tangerang 34 Director of Provincial Public Hospital Arifin Achmad, Pekanbaru 35 Director of Central Public Hospital Sanglah - Denpasar 36 Director of Siloam Karawaci Hospital, Banten 37 Director of Sumber Waras Hospital, Jakarta 38 Director of Husada Hospital, Jakarta 39 Director of Public Hospital Yos Sudarso, Padang 40 Director of PT. Indofarma 41 Director of PT. Kimia Farma 42 Director of PT. Phapros 43 Health Directorate of National Army - POLRI


105

44 Head of Provincial Health Office in Nangroe Aceh Darusalam 45 Head of Provincial Health Office in South Sulawesi 46 Head of Provincial Health Office in DKI Jakarta 47 Head of Provincial Health Office in West Java 48 Head of Provincial Health Office in Central Java 49 Head of Provincial Health Office in East Java 50 Head of Provincial Health Office in West Kalimantan 51 Head of Provincial Health Office in Central Kalimantan 52 Head of Provincial Health Office in Western Southeast Nusa Tenggara 53 Head of Provincial Health Office in Eastern Southeast Nusa Tenggara 54 Head of Provincial Health Office in Papua 55 Head of Provincial Health Office in Central Sulawesi 56 Head of Provincial Health Office in North Sulawesi 57 Head of Provincial Health Office in West Sumatera 58 Head of Provincial Health Office in North Sumatera 59 Head of District Health Office in Karang Anyar 60 Head of District Health Office in Sleman 61 Head of District Health Office in Surakarta 62 Head of Public Health Center of Pajang, Surakarta 63 Head of Public Health Center of Tebet, Jakarta 64 Chairman of Indonesian Medical Doctors Association 65 Chairman of Indonesian Midwives Association 66 Chairman of Indonesian Pharmacologist Association 67 Chairman of Indonesian Nursery Association 68 Chairman of Indonesian Pharmacist Association 69 Chairman of Indonesian Anesthesiologist and Reanimation Specialist Association 70 Prof. dr. Iwan Darmansjah, SpFK. 71 Prof. dr. Rianto Setiabudy, SpFK. 72 Prof. dr. Abdul Muthalib, SpPD (K). 73 Prof. dr. Djakaria, SpRad (K). 74 Prof. dr. Nugroho Kampono, SpOG. 75 Prof. Dr. dr. Hanafi Trisnohadi, SpKJ(K) 76 Prof. Dr. dr. Inge Sutanto 77 Prof. Dr. dr. Sarwono Waspadji, SpPD (K) 78 Prof. Dr. dr. Sri Rezeki S. Hadinegoro,SpA (K) 79 Prof. Dr. Arini Setiawati,PhD. 80 Prof. dr. Iwan Dwiprahasto, M.MedSc, PhD. 81 Prof. dr. Asril Aminullah, Sp.A (K) 82 dr. Omo Abdul Madjid, SpOG. 83 dr. Bambang Sudarmanto, Sp.A. 84 dr. Dede Gunawan, SpS (K) 85 dr. Robert Reverger, SpKJ (K) 86 dr. Gunawan Darmansjah, SpAn. 87 dr. Irawan Mangunatmadja , SpA.(K) 88 drg. Silvia Desiree, SpKGA 89 DR. Atie W. Soekandar, Sp.FK. 90 DR. Sri Suryawati 91 dr. Kartono Muhammad 92 dr. Pinky F. Riawan 93 Dra. Engko Sosialine, M. Biomed 94 dr. Zorni Fadia 95 dr. Abdullah Akhmad 96 Dra. Detty Yuliati, Apt.


106

97 Dita Novianti, S.Si, Apt, MM 98 Erie Gusnellyanti, S.Si, Apt. 99 dr. Djentot Fibihanindyo Putro 100 Dra. Dara Amelia, Apt. 101 Dra. Ema Viaza, Apt. 102 Rohayati Rahafat, S.Si, Apt. 103 Drs. Suhata 104 Awan Yurianto 105 Suprihandoyo 106 Prihadi Mulyono 107 Anwar Wahyudi 108 Nofiyanti 109 Mulyati -----------


107

STATEMENT OF COMPLIANCE CHAIRMAN/VICE CHAIRMAN/

EXPERT/CONSULTANT*) I, as undersigned below

Name : Address :

declare as follows:

1. Disposed to be the Chairman/Vice Chairman/Expert/Consultant*) of The National Committee of NLEM (National List of Essential Medicines) 2008.

2. Disposed to attend Technical Discussion Meeting of NLEM Revision. 3. Disposed to sign Conflict of Interest Statement.

Jakarta, ....................................... ( )

*) Strike out the unnecessary statement


108

CONFLICT OF INTEREST STATEMENT Indonesian National Essential Medicines Committee (2008)

For the evaluation of the Selection of Essential Medicines an evaluation committee is needed that would guarantee that its members are impartial and free from conflicts of interest that would biased the outcome of their choice(s) of medicines. Therefore all individuals chosen as National Committee Members are required to sign a statement as below, as consented:

1. No direct family members, including self, have important positions in or have stakes in the drug business so as to bias his/her selection.

2. Committee Members, including Chairman and Consultants, should not solicit or receive

money or gratuities that clearly indicate a form of bribery.

3. Committee Members should refrain from presenting faked data in the form of publications or statements of dubious nature.

4. In its deliberations members should use their intellectual judgment, instead of stating

mere opinions without support of scientific data.

5. When in the discussion of a subject, a member feels that he/she might have a conflict of judgment, he/she must acknowledge the chairman of the nature of its possible conflict. In the case of a serious conflict of interest, he/she will not be allowed to participate in a voting procedure.

6. Committee Members may not deliberately leak important confidential issues of decision

to a third party. I, the undersigned below: Name: ......................................... Function: Chairman / Vice Chairman / Member / Consultant Declares that he/she understood the above statement and will obey the written rules above. ---------------------------------------- ---------------------- Committee Member Date


109

ASSESSMENT FORM APPLICATION FOR ADDITION / DELETION OF NATIONAL LIST OF ESSENTIAL MEDICINES

2008

NO SUBJECT 1 Summary

2 Reason of deletion

3 Public relation

4 Comparation with similar medicine on the list

5 Pharmacological characteristic

6 Effectiveness evidence

7 Safety evidence

8 Benefit – cost ratio

9 Formulation

10 The using of the medicine by international guidance

11 Prevailing laws and regulatiuon which is supporting to delete the medicine

12 Recommendation

13 References


110

RECAPITULATION OF APPLICATION FOR NLEM REVISION

2008 Application from Name of Institution : Address : Phone No/Facs :

CHANGE

NO THERAPEUTIC CLASS

GENERIC NAME (INN)

DOSAGE FORM PACKAGING

ADDITION DELETION

SUPPORTING EBM *)

Explanation : ………………….200.. *) Based on trusted literature / reference Stamp / signature *) Enclose the related literature / reference

Name _____ NIP.


111