tion <strong>of</strong> Government Regulation Number 38 year 2007 on the coordination <strong>of</strong> theance between the Central Government and the Provincial Government and other regionalments in order to synchronize its health management in the country. So, as with medicineement organizations, each city has got organizational structures and their own medicineement policies. This would open up basic differences in each city in carrying out medicineement.cle <strong>of</strong> medicine distribution is started at the time a medicine is delivered from the factory ortor, and it ends at the time medicine consumption reports are handed in to the logisticsfective medicine distribution should have a system design and sound management suchstant medicine supply, taking care <strong>of</strong> the quality <strong>of</strong> medicines at the time <strong>of</strong> distributions, minimizing medicines which are unused because <strong>of</strong> spoilage or being expired, withplanning in accordance with each province's medicine needs, use <strong>of</strong> inventory recordsare accurate, rationalization <strong>of</strong> medicine depots, and supply <strong>of</strong> information to estimatee needs.ecentralization in place it is hoped that state government or city or provinces canntly supply respective individual medicine needs. The central government, in this matter,istry <strong>of</strong> Health only lends back-up support when city or province cannot fully supply thee needs. The NLEM is a base for planning and supply or logistics <strong>of</strong> medicines in locality/province) and central government.ement and use <strong>of</strong> specialists' medicines for certain situations, the government c.q.rate General <strong>of</strong> Pharmaceutical Services and Medical Devices, Ministry <strong>of</strong> Health canthese through special channels (special access scheme) in accordance with The Decreeter <strong>of</strong> Health Number: 1379.A/Menkes/SK/XI/2002.unication, Information and Education (CIE)essential medicines are a pre-requisite to improve the use <strong>of</strong> medicines and rationalbing by health providers. CIE for health providers and the public in general to increasel use <strong>of</strong> medicines and be maintained continuously should use the following links:overnmental organizations/private institutions.elated pr<strong>of</strong>essional organization.urriculum <strong>of</strong> education for health providers.ther possible channels.isted medicine in NLEM must be accompanied by accurate information that is objectivederstandable by health providers. This information covers indication, contraindication,ow to use, caution remarks, side-effects, medicine interaction, and dosage forms <strong>of</strong>tions.rch and Developmentch and development should be done to support the selection process and improvement <strong>of</strong>EM. Research and development are done in line with medical science and technology injects <strong>of</strong> medicine, pharmacy, epidemiology, and education. The outcome or result <strong>of</strong>h and development are utilized as inputs in the revision process and improvement <strong>of</strong>periodically.6. Monitoring and EvaluationMonitoring and evaluation are done to support the sthrough mechanism and output evaluation <strong>of</strong> potentisolutions. This can be achieved through co-ordination,application <strong>of</strong> the NLEM by the Ministry <strong>of</strong> Health. Monfitting to functions and levels.7. NLEM RevisionsNLEM has to be revised and perfected periodically. Revadvancement <strong>of</strong> knowledge, but also for practical reashealth providers and the health service facilities.Perfection <strong>of</strong> NLEM is done continuously with input <strong>of</strong> shealth research, whether governmental or private, cPharmaceutical Services and Medical Devices, Ministrrevisions are done periodically every 3 (three) years.8. Quality ControlTotal medicine quality control covers the phases <strong>of</strong> prpractices, monitoring <strong>of</strong> medicine quality in the distribelements in applying the essential medicines concept.9. Antibiotics ResistanceAntibiotic resistance will increase, especially with frelatively inexpensive. This condition is dangerous,sensitive antibiotics that are potential in fighting infectiorecurring. The reason is because <strong>of</strong> irrational use <strong>of</strong> apatients.In overcoming the problem <strong>of</strong> antibiotic resistance it takea. Conducting surveillance <strong>of</strong> microbe resistance sobtained.b. Surveillance <strong>of</strong> antibiotic useSurveillance <strong>of</strong> antibiotic use is done by researchcenters, province or district health <strong>of</strong>fices andinstitutions.c. Containing antibiotic use by health providers bgradually, fitting to the conditions <strong>of</strong> patients aantibiotics from the start, and reserving other anuse.d. To provide communication, information and educwhether they be health workers, patients or tantibiotics rationally and the danger, caused by irrtial Medicines <strong>2008</strong>56
d Medicinesns in the form <strong>of</strong> money or medicines from another country, private organizations, or othertional bodies can support the public health services in a country that needs it. In itson, medicines donation must fulfill the requirements as described in WHO Guidelines fores Donations 1999. Health services being used must fulfill a certain existing applicablees/standards. This guideline covers general principles about selection <strong>of</strong> medicines,<strong>of</strong> medicines, shelf life, packaging and labeling, information and management.ain principles <strong>of</strong> donated medicines are:onated medicines must provide maximum usefulness to recipient country.nderstand the needs and respecting the authority <strong>of</strong> recipient country.oes not use double standards for the quality <strong>of</strong> donated medicines.ffective communication between donor country and recipient country.d medicines are best received when they are in accordance with NLEM. In order fores supply and health logistics can help the operations <strong>of</strong> health workers, the types <strong>of</strong>es and health logistics must coincide with the disease patterns in Indonesia.dicines which are not marketed in Indonesia acceptance must follow a special channell access scheme), in accordance with the existing applicable rule.sts and Format <strong>of</strong> NLEMhe National Essential Medicine list is used as the basis for all units <strong>of</strong> (governmental)ealth services.ne type if medicines can be used in several forms <strong>of</strong> preparations and one form <strong>of</strong>reparation can consist <strong>of</strong> a few dosage forms.the NLEM, medicines are categorized according to class, subclass and sometimes sububclasstherapy, which are in alphabetical order.clatureedicine names are written according to the last edition <strong>of</strong> Indonesian Pharmacopoeia. If itoes not appear in the Indonesian Pharmacopoeia then generic names are used.edicines which are commonly used and do not have an INN (International NonroprietaryName) are written with common names, for example 'oral rehydration salt'.ombination medicines which do not have a generic name are given agreed names whichre generic names for combinations and each is written with the effective ingredients,llowed with dosage <strong>of</strong> each component.or some items which need a synonym are written within brackets.atory Noteseywords) Dosage FormsDosage forms or preparations are forms <strong>of</strong> medicines according to the productionprocess in the form <strong>of</strong> usage, for example: capsule, enteric coated tablet, intravenousinjection etc.7tial Medicines <strong>2008</strong>8(2) Dosage strengthStrength <strong>of</strong> preparation is the content or permade preparations. For dosage strength inare written down within brackets, for(hydrochloride). As for dosages <strong>of</strong> effective(which are written within brackets) would bchloroquine tablet 150 mg (as phosphate).(3) PackagingPackaging is the smallest container that con(4) Package Sizeb. Other NotesPackage Size is the total number <strong>of</strong> preparastandard packaging, for example 100 vials.(1) Information in restricted columns are meanotes:(a) Monitoring <strong>of</strong> side-effects.(b) Limitation <strong>of</strong> indications.(c) Only for certain cases.(d) Tight screening is required or medical(e) Nature or medicine mechanism <strong>of</strong> acti(f) Special treatment required.(g) Special facilities needed.(h) Combination with other medicine need(i) Required for certain areas, like endem(j) Uses in accordance with existing heal(2) Writing <strong>of</strong> technical terms or foreign languag(3) National Medicines Lists are medicine lists t(4) NLEM for Public Health Center (primary heac. Abbreviationscap : capsulecapl : capletg : grami.a. injection/inj : intraartherial injectionsi.c. injection/inj : intracutaneous injectioninfiltr injection/inj : infiltrated injectioninfusion sol : infusion solutioninj : injectioni.m. injection/inj : intramuscular injectioni.t. injection/inj : intrathecal injectionIU : international uniti.v. injection/inj : intravenous injectionliq : liquidmcg : microgrammg : miligram
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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