NATIONAL LIST of ESSENTIAL MEDICINES 2008

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CHAPTER IINTRODUCTIONential Medicine in Indonesia was first introduced with the publication of The National Listines (NLEM) in 1980, followed by the National Medicines Policy document in 1983. Thesential Medicines, named DOEN (NLEM) is revised periodically every 3-4 years. DOENdition. The Government's commitment to do periodic revisions is a reputation of its own.e World Health Organization (WHO) has carried out the first phase of Good GovernanceM) program in Indonesia by conducting a survey on transparency of five pharmaceuticalthem is the selection process of essential medicines, which from the aspect ofthess is valued to be insufficient. From the meeting of the 30 WHO Essential Medicine List), it was reiterated that the importance of transparency of the selection process both byers who do revisions, revision process, and revision methods which have got to be moresed medicine (EBM), and the importance of the conflict of interest statement from expertf the above mentioned issues, this year's (2008) revision has been geared into itsse of it, the revision process this time is rather different from the earlier revision process,ovements are as follows:lection of expert panel members has been tightly scrutinized, including valuation againstt of interest.he beginning of discussion, program managers who use medicines in the environment ofistry of Health have been included, not only during the plenary meeting. This endeavor isto be a re-learning process to the internal of the Ministry of Health to fully understand thet of essential medicines.s the opinion and experiences of expert panel members in this revision team, theion of evidence based medicine (EBM) data are important considerations.tire discussion process gives great attention to medicines for children, including itsation. The WHO essential medicines list for children has been used as one of thenes. The siding with the individual rights of children is also shown by electing pediatriciansexpert panel that numbered to 4 (four) persons.n of the medicines list has been holistic and total, meaning weighing all medicines listedLEM 2005 including notes which may no longer be deemed fit. Earlier revisions werethe evaluation of medicines which are suggested to be added in the previous list.arency is also displayed with descriptions of arguments why a medicine must be deleteddded, or even be change of dosage form.ential Medicinesedicines are chosen medicines which are most needed to cater to the diagnoses,therapy, and rehabilitation, which are made available to the health service units ino its functions and tiers.1. Criteria of National Essential Medicinesa. Selection CriteriaSelection of essential medicines is based on these(1) Having got the most beneficial risk-benefit ra(2) Guaranteed of quality, including stability and(3) Practicality in storage and distribution.(4) Practical in use and delivery, which are adfacilities.(5) Advantageous in compliance and reception(6) Having got the highest benefit-cost ratio baspatient.(7) If there is more than one choice which hpreference is made for:- medicines with effects which are know- medicines with pharmacokinetic data- medicines with better stability;- easily obtainable;- medicines that are most familiar.(8) Fixed combination medicines have to follow- the compounded medicine is useful in- combination medicines have got to sindividual component;- ratio of the components of patent comfixed for a large number of patients wh- combination medicines have got to inc- combination antibiotics it must alsoresistance or other disadvantageous eb. Criteria of Additions and Deletions1. When addition of new medicines are considsame indications which may be obsolete sha strong reason to keep both of them.2. Medicines used in special program(s) arewill be assessed by general EM selection cr3. In the revision process, the entire medicineNational Revisions Committee. Deletion oeffective may here be decided upon or abetter medicine has been available.c. Guidance on Evidence and RecommendationProof of evidence and recommendations are adoPolicy and Research. The type of study should rethe list below, but the recommendation shouldavailable data. Testimonials are not considered fotial Medicines 200812
TATEMENTS OF EVIDENCEc. Hospital FormularyabData are obtained from meta-analysis of randomized, controlled clinical trials.Data are obtained from at least one randomized, controlled clinical trial.Data are obtained from at least one non-randomized and well designed clinical trial.Data are obtained from at least one quasi-experiment of another type of study that iswell designed.A Hospital Formulary is a list of medicines whicphysicians and their inherent (medicine) inforconcerned. A National Hospital Formulary is wCommittee based on NLEM and elaborated upoproven effective which are needed by specialtiesof a Hospital Formulary has to be based on therapHospital Formulary must be monitored and its rerevision so as to keep up with advancements of scIData are obtained from descriptive study that is well designed, like comparative study,correlation study, and case study.Data are obtained from reports or opinion of expert panels.ation of Concept of Essential Medicinesial medicines are the most basic medicines which are needed to cater for health services.r than listed NLEM medicines are needed, a (Hospital) Formulary or another limitede list may be instituted.EM may also be expanded into other documents as the needs arise.ational List of Essential Medicines (NLEM)ational List of Essential Medicines consists of selected, most needed medicines andade to be available at health services units in accordance with its functionality and itsvels. NLEM are a national minimum standard to health services.plementation of NLEM is meant to increase the efficacy, safety, rational use, andedicine management which altogether increase efficiency of available cost, which in turnxtends coverage and increase average quality of medicine prescriptions. Application ofis National Essential Medicines Policy must be done consistently, and continuously at allvels of health services units.edicine dosage-form and strength, such as tablets, syrups, injections, and other forms,nit strength, dose, and size of package indicated in the NLEM are binding, in order toreate standards. Sizes of packaging for each health service unit are based on logisticsfficiency while distribution is related with common usage.herapeutic Guidelinesherapeutic Guidelines should be systematically structured to help physicians to make aorrect diagnosis and optimal medication for a certain kind of disease. Guidelines ofedication should be suited for every level of health services units, such as guidelines inasic medication at Public Health Center and guidelines in diagnosis and therapy at localospitals.herapeutic Guidelines consist of information about all kinds of diseases, especiallyicknesses which are occurring frequently - with their respective complaints - andformation about dosage form, unit strength, dose of medicines and length of time ofedication.d. Specialists' FormularySpecialists' Formularies are books which arinformation on medicines needed by certain speccare with special disease indications.Specialists' Formularies are written to increase ctheir hospital formulary, that has been ranked vemay have many sub-specializations, for examplea specialization that has got many sub-specializacan be made for Obstetrics and Gynecology. Tinvolve specialist professional association winvolvement and active participation of specialistare part of the association, so that rational medicine. Indonesian National Medicine InformationNational medicine information consists of medipresented briefly, are relevant to physicians' needworkers. The National Indonesian Medicine InfHealth to guarantee objectivity, completenesmedicines that are covers indications, side-efimportant information which are most important fwas based on more scientific data, related to bene3. Management and Medicine UseTo improve rational medicine use, the use of essentialfollow treatment guidelines and proper medicine managEffective medicine management is required to guarantand quantities while fulfilling quality standards. Importaas follows:- Limitation of numbers and kinds of medicines basgeneric names, with a correct selection process;- Bulk purchasing should be applied;- Competitive, transparent purchases;- Audit system and reporting from management reptial Medicines 200834
Page 1 and 2: 651.1IndPNATIONAL LIST of ESSENTIAL
Page 3 and 4: MINISTRY of HEALTHREPUBLIC of INDON
Page 5 and 6: THE MINISTER OF HEALTHOF THE REPUBL
Page 7: CHAPTER IINTRODUCTION
Page 11 and 12: d Medicinesns in the form of money
Page 13 and 14: (d)(e)Signing a letter of consent,
Page 15 and 16: tological Medicinesedicines were de
Page 17 and 18: CHAPTER IIAL LIST OF ESSENTIAL MEDI
Page 19 and 20: EUTICNERICINN)DOSAGE FORMRESTRICTIO
Page 39 and 40: CHAPTER IIIRESTRICTED MEDICINE LIST
Page 43 and 44: EUTICNERICINN)idesc UseDOSAGE FORMt
Page 45 and 46: UTICNERICINN)DOSAGE FORMRESTRICTION
Page 53 and 54: CHANGES OF NLEM 2005ERIC NAME(INN)D
Page 55 and 56: ERIC NAME(INN)DOSAGE FORMADDITION (
Page 57 and 58: ERIC NAME(INN)DOSAGE FORMADDITION (
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APPENDIX IIDECREE OF THE MINISTER O
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THE MINISTER OF HEALTHOF THE REPUBL
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APPENDIX IIIPARTICIPANTS OF TECHNIC
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iaAkhmaduliati, Apt.i, S.Si, Apt, M
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::STATEMENT OF COMPLIANCEHAIRMAN/VI
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CONFLICT OF INTEREST STATEMENTndone
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yASSESSMENT FORM APPLICATIONFOR ADD
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DRUG INDEX1, 74, see acetosal64, 43
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X-Y-Z, 59, 84zidovudine, 30zinc oxi
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