Brazilian SanitarySurveillance Agency [email protected]
SNGPC
National System of Management of National System of Management of Controlled ProductsControlled Products
Coordination of Controlled DrugsCoordination of Controlled Drugs
Administrative Rule Administrative Rule 158/2002
- Pilot Project -- Pilot Project -
Brazilian SanitarySurveillance Agency [email protected]
AgendaAgenda
• International and National International and National
Grounds for adoption of ControlGrounds for adoption of Control
• Current Control Guidelines Current Control Guidelines
Established by the Brazilian Established by the Brazilian
GovernmentGovernment
• SNGPC ProposalsSNGPC Proposals
• QuestionsQuestions
• ClosingClosing
Brazilian SanitarySurveillance Agency [email protected]
LEGAL AND OPERATIONAL ASPECTS OF INTERNATIONAL
AND NATIONAL TRADE
LEGAL AND OPERATIONAL ASPECTS OF INTERNATIONAL
AND NATIONAL TRADE
Brazilian SanitarySurveillance Agency [email protected]
INTER-AMERICANINTER-AMERICANSYSTEMSYSTEM
INTER-AMERICANINTER-AMERICANSYSTEMSYSTEM
Brazilian SanitarySurveillance Agency [email protected]
SOUTH SOUTH AMERICAN AMERICAN
SYSTEMSYSTEM
SOUTH SOUTH AMERICAN AMERICAN
SYSTEMSYSTEM
Brazilian SanitarySurveillance Agency [email protected]
BRAZILIANBRAZILIANSYSTEMSYSTEM
BRAZILIANBRAZILIANSYSTEMSYSTEM
Brazilian SanitarySurveillance Agency [email protected]
Justice Department
s
Justice Department
s
International OrganizationsInternational Organizations
MinistriesMinistries
State and Municipal Health Councils
State and Municipal Health Councils
CONASSCONASSCONASEMSCONASEMS
ANVISAANVISAINCQSINCQS
LACENLACEN
VISAVISA
SNVSSNVSSNVSSNVS
SINMETROSINMETRO
SNVE
NATIONAL SANITARY SURVEILLANCE NATIONAL SANITARY SURVEILLANCE SYSTEMSYSTEM
NATIONAL SANITARY SURVEILLANCE NATIONAL SANITARY SURVEILLANCE SYSTEMSYSTEM
Brazilian SanitarySurveillance Agency [email protected]
Brazilian SanitarySurveillance Agency [email protected]
“To approve Technical Regulation about
substances and drugs subject to special control”
“To approve Technical Regulation about
substances and drugs subject to special control”
GROUNDGROUND
Brazilian SanitarySurveillance Agency [email protected]
LIST “A1”LIST “A1”
LIST “A2”LIST “A2”
NARCOTIC SUBSTANCES
NARCOTIC SUBSTANCES
LIST “A3”LIST “A3”
LIST “B1”LIST “B1”
PSYCHOTHROPIC PSYCHOTHROPIC SUBSTANCESSUBSTANCES
PSYCHOTHROPIC PSYCHOTHROPIC SUBSTANCESSUBSTANCES
LIST “C1”LIST “C1”
(Others under Special (Others under Special Control)Control)
LIST “C1”LIST “C1”
(Others under Special (Others under Special Control)Control)
LIST “C2”LIST “C2”
(Retinoids)(Retinoids)
LIST “C2”LIST “C2”
(Retinoids)(Retinoids)
OTHER OTHER SUBSTANCESSUBSTANCES
OTHER OTHER SUBSTANCESSUBSTANCES
LIST “D1”LIST “D1”
(Precursors)(Precursors)
LIST “D1”LIST “D1”
(Precursors)(Precursors)
LIST “D2”LIST “D2”(Chemical Inputs)(Chemical Inputs)
LIST “D2”LIST “D2”(Chemical Inputs)(Chemical Inputs)
SUBSTANCESSUBSTANCES
PRECURSORS/ PRECURSORS/ CHEMICAL INPUTSCHEMICAL INPUTS
SUBSTANCESSUBSTANCES
PRECURSORS/ PRECURSORS/ CHEMICAL INPUTSCHEMICAL INPUTS
LIST “B2”LIST “B2”
LIST “C3”LIST “C3”(Immune-supressors)(Immune-supressors)
LIST “C3”LIST “C3”(Immune-supressors)(Immune-supressors)
LIST “C4”LIST “C4”
(Anti-retrovirals(Anti-retrovirals
LIST “C4”LIST “C4”
(Anti-retrovirals(Anti-retrovirals
LIST “C5”LIST “C5”
(Anabolic steroids)(Anabolic steroids)
LIST “C5”LIST “C5”
(Anabolic steroids)(Anabolic steroids)
PLANTSPLANTS
NARCOT/PSYCHOT.NARCOT/PSYCHOT.
PROSCRIBEDPROSCRIBED
SUBSTANCESSUBSTANCES
LIST “F1”LIST “F1”
LIST “F2”LIST “F2”
LIST “F3”LIST “F3”
LIST “E”LIST “E”
NOTE: Inspection
coverage: over 600
substances.
NOTE: Inspection
coverage: over 600
substances.
STRUCTURE OF LISTS - ANNEX I STRUCTURE OF LISTS - ANNEX I
Brazilian SanitarySurveillance Agency [email protected]
PRESCRIPTION (Type)TYPE LI ST ANNEX DI STRI BUTI ON
(VISA/ PROFESSIONAL) VALI DI TY
Notification of Prescription “A”
(YELLOW)
A1-A2 (Narcotics)
A3 (Psychotropics)
IX
VISA: distributed for free- (official) Professional: accreditation.
National
Notification of Prescription “B”
(BLUE)
B1-B2 (Psychotropics)
X VISA: distributes number.
Professional: accreditation and manufacturing.
Federate
Unit
Notification of Prescription - Retinoids
(WHITE)
C2 (Systemic Use)
XI VISA: distributes number.
Professional: accreditation and manufacturing.
Federate
Unit
Notification of Prescription - Thalidomide
(WHITE)
C3 (Immunesup.)
XI I I VISA: distributed for free- (official) Professional: accreditation.
Federate
Unit
Special Control Prescription in 2 copies
C1-C2-C4-C5 (others)
XVI I Professional: manufacturing.
National
Brazilian SanitarySurveillance Agency [email protected]
PRESCRITION (PERIOD OF TREATMENT)
TREATMENT
TYPE OF PRESCRI PTI ON LI ST
N.º OF DE AMPULES
OTHER PHARMACEUTICAL
FORMS Notification of Prescription “A”
A1-A2 (Narcotics)
A3 (Psychotropics)
05
30 DAYS
Notification of Prescription “B”
B1-B2 (Psychotropics)
05
60 DAYS
Notification of Prescription - Retinoids
C2 (Systemic Use)
05
60 DAYS
Notification of Prescription - Thalidomide
C3 (Immunes.) -
30 DAYS
Special Control Prescription in 2 copies
C1-C2-C4-C5 (others)
05
60 DAYS
Prescriptions above allowed quantities must be accompanied by medical justification.
Prescriptions above allowed quantities must be accompanied by medical justification.
Brazilian SanitarySurveillance Agency [email protected]
BOOKKEEPING
TYPE COVERAGE ANNEX FREQUENCY (UPDATI NG)
FI LE
SPECIFIC REGISTRATION
BOOK (maximum of 5)
Industry Distributor Drugstore Pharmacy
XVI I I
Weekly
2 years 5 years
GENERAL REGISTRATION
BOOK
Pharmacy
- Weekly 2 years
BSPO (3 copies)
All Establishments
XX Quarterly and Annual
2 years
BMPO (2 copies)
Pharmacy Drugstore
XXI Quarterly and Annual
2 years
MCPM (3 copies)
Authorized Official Bodies
XXI I Quarterly 5 years
RMV (2 copies)
Industry Distributor
XXI I I Monthly 2 years
RMNRA (2 copies)
Pharmacy Drugstore
XXIV Monthly 2 years
Brazilian SanitarySurveillance Agency [email protected]
PROPOSAL FOR NEW CONTROL OF NATIONAL TRADE
PROPOSAL FOR NEW CONTROL OF NATIONAL TRADE
Brazilian SanitarySurveillance Agency [email protected]
Overall ObjectivesOverall Objectives
Rationalization of Control
Automation Of Control
Dynamization of Sanitary Actions
Help Access To Drug
Implant the Principle Of Shared
Responsibility
SNGPCSNGPC
Help Prescription
Help Bookkeeping
Brazilian SanitarySurveillance Agency [email protected]
Substance and Drug ChainSubstance and Drug Chain
PHARMACEUTICALINDUSTRY DISTRIBUTOR
DISPENSING POINT
PHARMO-CHEMICAL INDUSTRY
USERS
EXPORT SUBSTANCES /
DRUGS
IMPORTSUBSTANCES /
DRUGS
Brazilian SanitarySurveillance Agency [email protected]
Basic Structure of SNGPCBasic Structure of SNGPC
INDÚSTRIASQuímica
FarmacêuticaVeterinária
Farmoquímica
XML
MóduloRemoto
XML
MóduloRemoto
ALIMENTADORES eCONSULTORES ON-LINE
CENTROS DEPlantioCultivo
Colheita
XML
MóduloRemoto
DISPENSADORFarmáciasDrogarias
XML
MóduloRemoto
CONSULTAS
MÓDULOESTADUAL
MERCOSUL
OEACICAD
SENADOBID
JIFE / INCBNDS
MÓDULOMUNICIPAL
MÓDULOPAF
MÓDULOCONSELHOS
ENSINO E PESQUISAUniversidadesLaboratóriosFaculdades
XML
MóduloRemoto
DISTRIBUIDORDistribuidorasImportadorasExportadoras
Estabelecimentos Regulados
SISTEMAda
EMPRESA
MÓDULOFEDERAL
ANVISA
Brazilian SanitarySurveillance Agency [email protected]
The Partners of the Master ProjectThe Partners of the Master Project
• State and Federal District Sanitary State and Federal District Sanitary
Surveillance OfficesSurveillance Offices
• Municipal Sanitary Surveillance OfficesMunicipal Sanitary Surveillance Offices
• Medicine CouncilsMedicine Councils
• Veterinary CouncilsVeterinary Councils
• Odontology Councils Odontology Councils
• Pharmacy CouncilsPharmacy Councils
Brazilian SanitarySurveillance Agency [email protected]
The Clients of the Master ProjectThe Clients of the Master Project
• Chemical IndustriesChemical Industries
• Pharmo-Chemical IndustriesPharmo-Chemical Industries
• Pharmaceutical IndustriesPharmaceutical Industries
• Veterinary IndustriesVeterinary Industries
• Distributors, Importers/ExportersDistributors, Importers/Exporters
• Drug DistributorsDrug Distributors
• PharmaciesPharmacies
• DrugstoresDrugstores
• Health ProfessionalsHealth Professionals
Brazilian SanitarySurveillance Agency [email protected]
Structure of the Master ProjectStructure of the Master Project
SNGPCMaster Project
Sub-Project: Drug Commercialization Survey
- LCMC
Sub-Project : Control of Dispensing - CDMC
Sub-Project Control of Production Chain and of
Drug Distribution - CCPDM
Sub-Project Control of Production Chain and of
Distribution of Substances - CCPDS
Sub-Project Integration of SNGPC with External Systems - ISE
Anvisa -> UNAnvisa -> OAS
Brazilian SanitarySurveillance Agency [email protected]
Sub-Project LCMCSub-Project LCMC
Survey of Commercialization of Survey of Commercialization of
Controlled Drugs in the Year of Controlled Drugs in the Year of
20012001
Brazilian SanitarySurveillance Agency [email protected]
Sub-Project CDMCSub-Project CDMC
Control of Dispensing of Control of Dispensing of
Controlled DrugsControlled Drugs
Brazilian SanitarySurveillance Agency [email protected]
Objectives of CDMCObjectives of CDMC
• Single Prescription Model.Single Prescription Model.
• Create a single identification for each prescription.Create a single identification for each prescription.
• Allow the same prescription to be filled/dispensed Allow the same prescription to be filled/dispensed
many times, if treatment is chronic (under the many times, if treatment is chronic (under the
principle of frequent patient).principle of frequent patient).
• Control the flow of prescription from prescription to Control the flow of prescription from prescription to
full dispensing.full dispensing.
• Computerize the bookkeeping process of Pharmacies Computerize the bookkeeping process of Pharmacies
and Drugstores.and Drugstores.
Brazilian SanitarySurveillance Agency [email protected]
• Create a relationship between the prescribers, the Create a relationship between the prescribers, the
prescribed drug, the patient receiving the drug, the prescribed drug, the patient receiving the drug, the
pharmacy or drugstore that dispensed the drug and pharmacy or drugstore that dispensed the drug and
the buyer, allowing crossing of all this information.the buyer, allowing crossing of all this information.
• Implant the System that will receive electronically Implant the System that will receive electronically
the information from the establishments. the information from the establishments.
Objectives of CDMC Objectives of CDMC (continued)(continued)
Brazilian SanitarySurveillance Agency [email protected]
• Link drug that has been dispensed to respective Link drug that has been dispensed to respective
manufacturing batch. This function will be used manufacturing batch. This function will be used
together with others, in the next projects, to allow together with others, in the next projects, to allow
tracking of a drug batch.tracking of a drug batch.
• Extract statistical data on drug consumption based Extract statistical data on drug consumption based
on patient profiles. on patient profiles.
Objectives of CDMC Objectives of CDMC (continued)(continued)
Brazilian SanitarySurveillance Agency [email protected]
Target Clients of Sub-Project CDMCTarget Clients of Sub-Project CDMC
• Pharmacies
• Drugstores
• Prescribers
Brazilian SanitarySurveillance Agency [email protected]
Partners in Sub-Project CDMCPartners in Sub-Project CDMC
• Professional Councils
• State and Federal District Sanitary
Surveillance Offices
• Municipal Sanitary Surveillance Offices
Brazilian SanitarySurveillance Agency [email protected]
Strategies of Sub-Project CDMCStrategies of Sub-Project CDMC
• Single prescription Single prescription
• Validity of prescription at national levelValidity of prescription at national level
• Prescription for chronic treatmentPrescription for chronic treatment
• Tracking of drugTracking of drug
• Tracking of Prescriber X Patient X Drug X Tracking of Prescriber X Patient X Drug X
DispensaryDispensary
• More consistent statistical dataMore consistent statistical data
Brazilian SanitarySurveillance Agency [email protected]
Execution of Sub-Project CDMCExecution of Sub-Project CDMC
• Alterations in Prescription Control
• Structural Alteration of Prescription
• Partnership with Professional Councils
• Computerization of data capturing of
Drug Sales
Brazilian SanitarySurveillance Agency [email protected]
Sub-Project CDMC : Control of PrescriptionsSub-Project CDMC : Control of Prescriptions
Formato
Série(4 AlfaNum)
Seqüência(11 dígitos)
DígitoVerificador(2 dígitos)
(AAA1 23145498721-22)
ANVISA
VISA ESTADUAL/DFConselho RegionalMedicina
Medicina VeterináriaOdontologia
PRESCRITOR
SERVIÇO DE SAÚDE
Distribuição
TRANSMISSÃO ELETRÔNICA
MÓDULOFEDERAL
MÓDULOFEDERAL
Brazilian SanitarySurveillance Agency [email protected]
CDMC - Prescriptions - ManufacturingCDMC - Prescriptions - Manufacturing
Beginning
Supply of Safety Seals(ANVISA ???)
Who will Distribute ?
Professional CoucilDistributes
Municipal VisaDistributes
Printing on Common Paper :- By Prescriber- By Institution- By State
[professional council] [municipal visa]
Who will pay ?
[both]
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Role of PrescriberCDMC – Role of Prescriber
1
2
Professional Council
Management System of Seal Distribution (SGDS)
ClassifiesProfessional
RequestsSeals
Issuance ofAuthorization
Municipal Visa
AUTHORIZATION for DRUGPRESCRIPTION
Safety Seals
Professional
Professional
Registration
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Control of PrescriptionCDMC – Control of Prescription
CONSUMIDOR
AUTORIZAPRESCREVERConselho
MedicinaMedicina Veterinária
Odontologia
DISPENSAÇÃO
FARMACÊUTICOFarmacias /Drogarias
PRESCRIÇÃO
PRESCRITOR
MÓDULOFEDERAL
MÓDULOFEDERAL
TRANSMISSÃOELETRÔNICAESCRITURAÇÃO
datavisaFarmácia/Drogaria
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Control of BookkeepingCDMC – Control of Bookkeeping
Consumidor
VISA ESTADUAL/ MUNICIPAL
Indústrias
Distribuidoras
FILIAIS
COMPRAS eDEVOLUÇÕES
COMPRAS eDEVOLUÇÕES
TRANSFERÊNCIAS
DISPENSAÇÃO
DESCARTE
ESCRITURAÇÃOdatavisa
Farmácia e Drogaria
BANCOANVISA
MÓDULOFEDERAL
MÓDULOFEDERAL
?!?ROUBO
Farmacias /Drogarias
Brazilian SanitarySurveillance Agency [email protected]
CDMC - Prescriptions - FormatCDMC - Prescriptions - Format
RECEITA
____________________________________________________________________ASSINATURA
CARIMBO DO PRESCRITOR (CR e Nome)( ) 1ª Via - Retenção Drograria / Farmácia( ) 2ª Via - Orientação para o Paciente
RESPONSÁVEL: DR. NOME DO PRESCRITOR NONONONONONONO
BAIRRO: NONONONONONONONONO CIDADE: NONONONONONONONONO
UF: NO C.E.P.: XX.XXX-XXX TELEFONE: 0(XX)XX XXXX-XXXXX
ENDEREÇO: NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO
NOME DO PACIENTE
Gráfica NONONONONONONONONC.N.P.J.: XXX.XXX.XXX/XXXX-XX Fone: 0(XX)XXXX-XXXXX
NOME DA INSTITUIÇÃO NONONONONOLOGO
INSTITUIÇÃOOPCIONAL
C.P.F. ou Nº CARTÃO SUS DO PACIENTE/RESPONSÁVEL SEXO DO PACIENTE IDADE DATA DA EMISSÃO
ANOSFM
*PTC - PRESCRIÇÃO PARA TRATAMENTO CRÔNICO
30 dias, a partir da data de emissão, respeitando o período para tratamento crônicoATENÇÃO:
CONTATOS:
Visa Municipal: (XX) XXXX-XXXXXVisa Estadual: (XX) XXXX-XXXXX
www.visa_uf.gov.bremail: [email protected]
Anvisa: (XX) XXXX-XXXXXwww.anvisa.gov.bremail: [email protected]
Ministério da Saúde: [email protected]
ORIENTAÇÃO AO PACIENTE
Sr(a). Profissional de saúde: notifique a(s) reação(ões) adversa(s) de medicamentos.
Quantidade e FormaFarmacêutica
Dose por UnidadePosológica
Posologia TempoMeses
*PTCMedicamento ou Substância
MESES
Brazilian SanitarySurveillance Agency [email protected]
CDMC - Prescriptions – Dispensing StampCDMC - Prescriptions – Dispensing Stamp
Nº BATCH OF DISPENSED DRUG
Nº EAN CODE OF DRUGOR Nº OF MAIPULATION ORDER
CITY - FU
1ª Via - Retenção Drograria / Farmácia2º Via - Anexada na Receita do Paciente
ADDRESS OF BUYER
NANE OF BUYER
NAME OF ESTABLISHMENT NONONONONON
AREA: NONONONONONONONONO CITY: NONONONONONONONONO FU: NO ZIP.: XX.XXX-XXX
TELEPHONE: 0(XX)XX XXXX-XXXXXAADDRESS : NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO
Gráfica NONONONONONONONONC.N.P.J.: XXX.XXX.XXX/XXXX-XX Fone: 0(XX)XXXX-XXXXX
FORM FOR DISPENSING CONTROL
C.N.PJ.: XXX.XXX.XXX/XXXX-XX State Registration: XX.XXX.XXX/XXX-XX Nº Special Author.: X.XXX.XXXX
QUANTITYDISPENSED
C.P.F. OF BUYER
CONTACT TELEPHONES
_______________________Stamp/Signature of Pharmacist
Nº FISCAL DOCUMENTDATE OF DISPENSING
_______________________Signature/Fingerprint of Buyer
Brazilian SanitarySurveillance Agency [email protected]
Initial Suvey
Modeling
Prototyping
Validation of Prototype (by client)
Implementation
Validation Adjust Model
Implantation
Post-implantation Validation
[needs adjustments]
[needs adjustments]
[necessary corrections]
Preparation of Training Material
Training
Beginning
Fim do Project
Sub-Project CDMC – Current StatusSub-Project CDMC – Current Status
MODULE available for National Imlantation
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Main ScreenCDMC – Main Screen
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Registers PrescriptionCDMC – Registers Prescription
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Registers Prescription (2)CDMC – Registers Prescription (2)
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Registers ItemsCDMC – Registers Items
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Prescription ObservationsCDMC – Prescription Observations
Brazilian SanitarySurveillance Agency [email protected]
CDMC – Tax BillsCDMC – Tax Bills
Brazilian SanitarySurveillance Agency [email protected]
CDMC - Prescriptions - BenefitsCDMC - Prescriptions - Benefits
CDMCCDMC• Centralization of information and distribution of
control (Shared Responsibility);• Inhibit illegal sale of drugs;• Inhibit Prescription forgery;• Reduction of bureaucracy for Prescriber;• Help access to drug, especially for patients
undergoing chronic treatment;• Help prescription of opiates for patients who need
them;• Encourage Pharmaceutical Care;• Raise awareness as to importance of Notification of
Adverse Reactions;• Provide accurate and current statistical information;• Increase communication between ANVISA and its
partners.
Brazilian SanitarySurveillance Agency [email protected]
Open to Questions !Open to Questions !
Brazilian SanitarySurveillance Agency [email protected]
Coordination of Controlled DrugsCoordination of Controlled Drugs
ANVISA Office of the ANVISA Office of the OmbudsmanOmbudsman
SEPN 515, Bloco B, Edifício Ômega, 1° subsoloBrasília (DF) - CEP 70.770-502Telephone: ( 61) 448-1235 / 448-1464Fax: ( 61) 448-1144http://www.anvisa.gov.br/ouvidoria/fale_com.htm
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