.v. injection/inj : paravertebral injectionctal sol : rectal solution.c. injection/inj : subcutaneous injectionacch : sacchets/bags/pouchesol : solutionupp : suppositoryb : tabletFI : water for injectionevision Processwere not conducted only limited to incoming requests, but revaluating the whole NLEM <strong>of</strong>as done because the list was only updated during previous years and some old medicinesobsolete or new and better medicines have become available. Also some uses <strong>of</strong> olderve been renewed and some have made other restrictions.and consultants work together in the discussion that is divided into several groups basedtic class. Consultants are responsible for EBM data in accordance with his/herBesides information from consultants and expert team, the secretariat supported fullythers, information from Cochrane review and WHO Library. From this process, althoughtion is not always totally accepted, but discussions are no longer based on level-4xpert team opinion only.g the concept <strong>of</strong> essential medicines has to be re-socialized. Seemingly, theg <strong>of</strong> the essential medicines is withering and explanation about this concept is'Essential Medicine is a floor not a ceiling' (WHO TRS 946), it is a minimum for health care.essential when you can't do without it. The difference <strong>of</strong> essential medicines and programll result in the availability <strong>of</strong> a specific medicine. This problem is overcome by socializationolicies by the Ministry <strong>of</strong> Health relating to essential medicines and program medicines.n process, from the start it has been planned to give attention to medicines for children.not only meant for harmony with the global policy, but Indonesia is consistently aiming atortality <strong>of</strong> babies and children, so that it needs this emphasis. The involvement <strong>of</strong> four, give sufficient contributions for this problem. Also the involvement <strong>of</strong> the Directorate <strong>of</strong>and other directorates are very intensive. The addition <strong>of</strong> medicines for children withespecially for children, like carbamazepine, is provided in the form <strong>of</strong> syrup.scussion <strong>of</strong> the Plenary Meeting it has been agreed that 78 medicines has been deleted2005 and 48 were added to the new list <strong>of</strong> <strong>2008</strong>. Changes in formulations (forms <strong>of</strong>, dosages, packaging) was agreed for 21 medicines. It was found that 33 medicines wereotes as important to be provided or supplied by the government through ways fitting withpplicable policies. The total number <strong>of</strong> medicines in the NLEM <strong>2008</strong> is 323 medicine items.on Processn processes started by sending letters to government health services institutions (hospital, B, C, public health center) as well as several chosen private parties, special programs inistry <strong>of</strong> Health and pr<strong>of</strong>essional organizations. Three months later, from 114 installationsm letters were sent to, 25 had responded. From those responses three had ”notion”, 22 were responding with “request for additions to the list”, and there was no oneding to delete medicines from the old list. Although in the letter sent, it has been informedgestion has got to come together with supporting data and functions, only 10 installationsending supporting data. Besides suggestions from the installations, the expert team andants, may give suggestions with supportive data.This process is a yardstick in carrying out the assessprocess and accountability in the future. The process co<strong>of</strong> recruitment <strong>of</strong> expert team members, tasks and obligprocesses, holding discussion meetings and socializati2. Committee Membersa. Organization(1) Organizational structure is a National Comm(a) Expert team(b) Consultants(c) Program manager and(d) Operational Secretariat(2) Membership <strong>of</strong> National Committee lasts unNLEM revision meeting. The Committee isDecree wherein its duties are stated.(3) Names <strong>of</strong> expert team members and selectonly differentiated into MDs, general practiti(4) Not all therapeutic classes need to be repreCommittee.(5) If an expert in a special field is needed, he/person to give an expert opinion in the revis<strong>of</strong> the expert team and also do not take part(6) Duties <strong>of</strong> expert team members and consult(a) Expert Team members are evaluatingevaluate suggested medicines whichnew list.(b) Consultants are joining the discussiinputs which may be needed to be usexpert team members.(c) Expert team members and consujustification to Ministry <strong>of</strong> HealthServices and Medical Devices to accassisting the Directorate <strong>of</strong> Rational M(7) Program manager is a representative <strong>of</strong> aowns special therapeutic programs and ma(8) The Operational Secretariat are DirectoratGeneral <strong>of</strong> Pharmaceutical Services and Mespecialization, clinical pharmphysicians/health service units (publicmust not represent pr<strong>of</strong>essional assjobs which are potential in creating cob. The selection process <strong>of</strong> Expert Team and Consul(1) Pre-requisites <strong>of</strong> Expert Team and Consulta(a) Have integrity and a high pr<strong>of</strong>essional(b) Expert team members and consulta(c) In order to get pr<strong>of</strong>essional expert teatial Medicines <strong>2008</strong>910
(d)(e)Signing a letter <strong>of</strong> consent, acceptance and availability.Willing to sign a conflict <strong>of</strong> interest statement. But somebody who has a conflict<strong>of</strong> interest can still be considered to become a member <strong>of</strong> the expert team, ifintegrity can be maintained. He/she may then not participate in a votingprocess.) Recruitment processes <strong>of</strong> Expert Team and Consultants:(a) The Secretariat sends a form <strong>of</strong> written availability and willingness,accompanied by his/her superior permission, 1 (one) month prior to thecommencement <strong>of</strong> the Meeting.(b) He or she must submit the filled-in form 1 (one) week after receiving, togetherwith a conflict <strong>of</strong> interest statement.(c) An acceptance and statement <strong>of</strong> willingness letter consists <strong>of</strong>:Explanation <strong>of</strong> job description <strong>of</strong> expert team.Schedule <strong>of</strong> material <strong>of</strong> discussion which have to be attended.on Methodsubmission <strong>of</strong> medicinesevision processes is started by sending submission forms to several health service unitsUniversity Hospitals, Special Hospitals, chosen State Hospitals, Provincial Hospitals,ilitary/Police Hospitals, chosen Private Hospitals, Regional Hospitals, Public Healthenter with beds). Provincial Health Units representative, public health center, androgram managers (in the directorate <strong>of</strong> Ministry <strong>of</strong> Health). Submission Request Formsre sent 3 (three) months before the first Meeting.ompilation <strong>of</strong> Submissionsompiled submissions are categorized or grouped in therapeutic classes.aterial <strong>of</strong> Revisionsaterial <strong>of</strong> Revisions are put in a matrix, which is put side by side with the WHO List 2007nd the latest NLEM 2005 edition. It is followed with the submitted medicines. Revisedaterials will be handed to expert team members 1 (one) week before technical discussioneeting.iscussion Criteriaubmissions to be discussed are suggestions which come with arguments andccompanied with scientific evidence.ethods <strong>of</strong> Revision Materials1) Revision can be the whole assessment or one <strong>of</strong> the following processes:(a) Only assessment <strong>of</strong> submission requests. Deleting or accepting submissions.(b) Taking into account the whole NLEM and incoming requests. Deleting andadding essential medicines whether from requests or from expert teammember's and consultants' opinion.2) Types <strong>of</strong> discussions meeting:(a) Preliminary Meeting consists <strong>of</strong>• Information about the understanding <strong>of</strong> essential medicines (definitions,criteria, (approximate) number <strong>of</strong> essential medicines in NLEM etc).(b)(c)• Implementation <strong>of</strong> NLEM (in refor procurement <strong>of</strong> PKD Medicin• NLEM Revision Procedure.• Procedure in technical discussand plenary meetings.• Attendance: expert team, conssecretariat.Technical discussion meetings• Discussion meetings <strong>of</strong> the prosubmission.• Discussion on benefit-risk <strong>of</strong> addwhich are on the old list.• Putting in focus those medicinincluded in the WHO list. These• Suggestion to put food supplem• If the Expert Team fails to makeperson outside the expert team m• Attendance for the meeting are:o Expert teamo Consultantso Related program manageo Related resource persons• Result <strong>of</strong> technical discussion mPlenary Meeting• Aims at making agreements, fothe NLEM.• Meeting Chairman is the head o• Formalization <strong>of</strong> NLEM draftDirectorate <strong>of</strong> Pharmaceuticalsomeone who is appointed by th• When the result <strong>of</strong> plenary mealtered, except editorial revision• Plenary meeting members shoumaking process and are alsodeploy the new NLEM.• Plenary meeting attendees are:o Those who attended thdiscussions;o Medical Committees oHospitals, chosen Privateschools who submitted suo Attendees from Faculty <strong>of</strong>o Attendees from Faculty <strong>of</strong>o Attendees from School <strong>of</strong>o Provincial Health Office suo Pr<strong>of</strong>essional organizatioassociations);o Pharmaceutical IndusWholesalers Association)tial Medicines <strong>2008</strong>1112
- 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 and 8: CHAPTER IINTRODUCTION
- Page 9 and 10: TATEMENTS OF EVIDENCEc. Hospital Fo
- Page 11: d Medicinesns in the form of money
- 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 21 and 22: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 23 and 24: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 25 and 26: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 27 and 28: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 29 and 30: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 31 and 32: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 33 and 34: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 35 and 36: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 37 and 38: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 39 and 40: CHAPTER IIIRESTRICTED MEDICINE LIST
- Page 41 and 42: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 43 and 44: EUTICNERICINN)idesc UseDOSAGE FORMt
- Page 45 and 46: UTICNERICINN)DOSAGE FORMRESTRICTION
- Page 47 and 48: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 49 and 50: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- Page 51 and 52: EUTICNERICINN)DOSAGE FORMRESTRICTIO
- 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 (
- Page 59 and 60: APPENDIX IIDECREE OF THE MINISTER O
- Page 61 and 62: THE MINISTER OF HEALTHOF THE REPUBL
- Page 63 and 64:
APPENDIX IIIPARTICIPANTS OF TECHNIC
- Page 65 and 66:
iaAkhmaduliati, Apt.i, S.Si, Apt, M
- Page 67 and 68:
::STATEMENT OF COMPLIANCEHAIRMAN/VI
- Page 69 and 70:
CONFLICT OF INTEREST STATEMENTndone
- Page 71 and 72:
yASSESSMENT FORM APPLICATIONFOR ADD
- Page 73 and 74:
DRUG INDEX1, 74, see acetosal64, 43
- Page 75:
X-Y-Z, 59, 84zidovudine, 30zinc oxi