Brazilian Sanitary Surveillance Agency @anvisa.gov.br SNGPC National System of Management of...

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 -


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


LEGAL AND OPERATIONAL ASPECTS OF INTERNATIONAL

AND NATIONAL TRADE

LEGAL AND OPERATIONAL ASPECTS OF INTERNATIONAL

AND NATIONAL TRADE


INTERNATIONALSYSTEM

INTERNATIONALSYSTEM


INTER-AMERICANINTER-AMERICANSYSTEMSYSTEM

INTER-AMERICANINTER-AMERICANSYSTEMSYSTEM


SOUTH SOUTH AMERICAN AMERICAN

SYSTEMSYSTEM

SOUTH SOUTH AMERICAN AMERICAN

SYSTEMSYSTEM


BRAZILIANBRAZILIANSYSTEMSYSTEM

BRAZILIANBRAZILIANSYSTEMSYSTEM


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


“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


LIST “A1”LIST “A1”


NARCOTIC SUBSTANCES

NARCOTIC SUBSTANCES


LIST “B1”LIST “B1”

PSYCHOTHROPIC PSYCHOTHROPIC SUBSTANCESSUBSTANCES

PSYCHOTHROPIC PSYCHOTHROPIC SUBSTANCESSUBSTANCES

LIST “C1”LIST “C1”

(Others under Special (Others under Special Control)Control)


(Others under Special (Others under Special Control)Control)


(Retinoids)(Retinoids)


(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


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)


(Anti-retrovirals(Anti-retrovirals


(Anti-retrovirals(Anti-retrovirals


(Anabolic steroids)(Anabolic steroids)


(Anabolic steroids)(Anabolic steroids)

PLANTSPLANTS

NARCOT/PSYCHOT.NARCOT/PSYCHOT.

PROSCRIBEDPROSCRIBED


LIST “F1”LIST “F1”



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


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


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.


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


PROPOSAL FOR NEW CONTROL OF NATIONAL TRADE

PROPOSAL FOR NEW CONTROL OF NATIONAL TRADE


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


Substance and Drug ChainSubstance and Drug Chain

PHARMACEUTICALINDUSTRY DISTRIBUTOR

DISPENSING POINT

PHARMO-CHEMICAL INDUSTRY

USERS

EXPORT SUBSTANCES /

DRUGS

IMPORTSUBSTANCES /

DRUGS


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


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


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


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


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


Sub-Project CDMCSub-Project CDMC

Control of Dispensing of Control of Dispensing of

Controlled DrugsControlled Drugs


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.


• 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)


• 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)


Target Clients of Sub-Project CDMCTarget Clients of Sub-Project CDMC

• Pharmacies

• Drugstores

• Prescribers


Partners in Sub-Project CDMCPartners in Sub-Project CDMC

• Professional Councils

• State and Federal District Sanitary

Surveillance Offices

• Municipal Sanitary Surveillance Offices


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


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


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


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]


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


CDMC – Control of PrescriptionCDMC – Control of Prescription

CONSUMIDOR

AUTORIZAPRESCREVERConselho

MedicinaMedicina Veterinária

Odontologia

DISPENSAÇÃO

FARMACÊUTICOFarmacias /Drogarias

PRESCRIÇÃO

PRESCRITOR

MÓDULOFEDERAL

MÓDULOFEDERAL

TRANSMISSÃOELETRÔNICAESCRITURAÇÃO

datavisaFarmácia/Drogaria


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


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


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


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


CDMC – Main ScreenCDMC – Main Screen


CDMC – Registers PrescriptionCDMC – Registers Prescription


CDMC – Registers Prescription (2)CDMC – Registers Prescription (2)


CDMC – Registers ItemsCDMC – Registers Items


CDMC – Prescription ObservationsCDMC – Prescription Observations


CDMC – Tax BillsCDMC – Tax Bills


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.


Open to Questions !Open to Questions !


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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