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Coordination of Controlled Drugs
SNGPC
National System of Management of
Controlled Products
- Pilot Project -
Administrative Rule 158/2002
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Agenda
• International and National
Grounds for adoption of Control
• Current Control Guidelines
Established by the Brazilian
Government
• SNGPC Proposals
• Questions
• Closing
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
LEGAL AND OPERATIONAL
ASPECTS OF INTERNATIONAL
AND NATIONAL TRADE
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
INTERNATIONALS
YSTEM
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
INTER-AMERICAN
SYSTEM
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
SOUTH AMERICAN
SYSTEM
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
BRAZILIAN
SYSTEM
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
NATIONAL SANITARY SURVEILLANCE SYSTEM
Justice
Department
s
Ministries
SNVS
State and Municipal
Health Councils
International
Organizations
CONASS
CONASEM
S
ANVISA
INCQ
S
SNVE
LACEN
VISA
SINMETR
O
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br

GROUND
“To approve Technical
Regulation about substances
and drugs subject to special
control”
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
STRUCTURE OF LISTS - ANNEX I
SUBSTANCES
NARCOTIC
SUBSTANCES
PSYCHOTHROPIC
SUBSTANCES
OTHER
SUBSTANCES
LIST “A1”
LIST “A3”
LIST “C1”
LIST “D1”
LIST “B1”
(Others under Special
Control)
(Precursors)
LIST “B2”
LIST “C2”
LIST “D2”
(Retinoids)
(Chemical Inputs)
LIST “A2”
PLANTS
NARCOT/PSYCHOT.
LIST “E”
PROSCRIBED
LIST “C3”
SUBSTANCES
(Immune-supressors)
LIST “F1”
LIST “F2”
LIST “F3”
Brazilian Sanitary
Surveillance Agency
LIST “C4”
(Anti-retrovirals
LIST “C5”
(Anabolic steroids)
[email protected]
PRECURSORS/
CHEMICAL INPUTS
NOTE:
Inspection
coverage: over
600
substances.
www.anvisa.gov.br
PRESCRIPTION (Type)
TYPE
LIST
ANNEX
DISTRIBUTION
VALIDITY
(VISA/PROFESSIONAL)
Notification of
Prescription “A”
(YELLOW)
Notification of
Prescription “B”
(BLUE)
A1-A2
(Narcotics)
A3
(Psychotropics)
B1-B2
(Psychotropics)
IX
X
Notification of
Prescription Retinoids
(WHITE)
C2
(Systemic Use)
XI
Notification of
Prescription Thalidomide
(WHITE)
Special Control
Prescription in 2
copies
C3
(Immunesup.)
XIII
C1-C2-C4-C5
(others)
XVII
Brazilian Sanitary
Surveillance Agency
VISA: distributed for
free- (official)
Professional:
accreditation.
VISA: distributes
number.
Professional:
accreditation and
manufacturing.
VISA: distributes
number.
Professional:
accreditation and
manufacturing.
VISA: distributed for
free- (official)
Professional:
accreditation.
Professional:
manufacturing.
[email protected]
National
Federate
Unit
Federate
Unit
Federate
Unit
National
www.anvisa.gov.br
PRESCRITION (PERIOD OF TREATMENT)
TYPE OF PRESCRIPTION
Notification of Prescription
“A”
LIST
Notification of Prescription
“B”
A1-A2
(Narcotics)
A3
(Psychotropics)
B1-B2
(Psychotropics)
Notification of Prescription
- Retinoids
C2
(Systemic Use)
Notification of Prescription
- Thalidomide
C3 (Immunes.)
Special Control Prescription
in 2 copies
C1-C2-C4-C5
(others)
TREATMENT
N.º OF DE
AMPULES
OTHER
PHARMACEUTICAL
FORMS
05
30 DAYS
05
60 DAYS
05
60 DAYS
-
30 DAYS
05
60 DAYS
Prescriptions above allowed quantities must be accompanied
by medical justification.
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
BOOKKEEPING
TYPE
COVERAGE
ANNEX
FREQUENCY
(UPDATING)
FILE
SPECIFIC
REGISTRATION
BOOK
(maximum of 5)
GENERAL
REGISTRATION
BOOK
BSPO
(3 copies)
Industry
Distributor
Drugstore
Pharmacy
Pharmacy
XVIII
Weekly
2 years
5 years
-
Weekly
2 years
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
XXII
Quarterly
5 years
RMV
(2 copies)
Industry
Distributor
XXIII
Monthly
2 years
RMNRA
(2 copies)
Pharmacy
Drugstore
XXIV
Monthly
2 years
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
PROPOSAL FOR NEW CONTROL
OF NATIONAL TRADE
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Overall Objectives
Dynamization of
Sanitary Actions
Rationalization
of Control
Implant the Principle
Of Shared
Responsibility
Automation
Of Control
SNGPC
Help
Bookkeeping
Help Access
To Drug
Help Prescription
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Substance and Drug Chain
PHARMOCHEMICAL
INDUSTRY
PHARMACEUTICAL
INDUSTRY
DISTRIBUTOR
DISPENSING
POINT
IMPORT
SUBSTANCES /
DRUGS
Brazilian Sanitary
Surveillance Agency
USERS
EXPORT
SUBSTANCES /
DRUGS
[email protected]
www.anvisa.gov.br
Basic Structure of SNGPC
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
The Partners of the Master Project
• State and Federal District Sanitary
Surveillance Offices
• Municipal Sanitary Surveillance Offices
• Medicine Councils
• Veterinary Councils
• Odontology Councils
• Pharmacy Councils
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
The Clients of the Master Project
• Chemical Industries
• Pharmo-Chemical Industries
• Pharmaceutical Industries
• Veterinary Industries
• Distributors, Importers/Exporters
• Drug Distributors
• Pharmacies
• Drugstores
• Health Professionals
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Structure of the Master Project
Sub-Project:
Drug Commercialization Survey
- LCMC
Sub-Project :
Control of Dispensing - CDMC
SNGPC
Master Project
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 -> UN
Anvisa -> OAS
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Sub-Project LCMC
Survey of Commercialization of
Controlled Drugs in the Year of
2001
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Sub-Project CDMC
Control of Dispensing of
Controlled Drugs
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Objectives of CDMC
• Single Prescription Model.
• Create a single identification for each prescription.
• Allow the same prescription to be filled/dispensed
many times, if treatment is chronic (under the
principle of frequent patient).
• Control the flow of prescription from prescription to
full dispensing.
• Computerize the bookkeeping process of Pharmacies
and Drugstores.
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Objectives of CDMC (continued)
• Create a relationship between the prescribers, the
prescribed drug, the patient receiving the drug, the
pharmacy or drugstore that dispensed the drug and
the buyer, allowing crossing of all this information.
• Implant the System that will receive electronically the
information from the establishments.
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Objectives of CDMC (continued)
• Link drug that has been dispensed to respective
manufacturing batch. This function will be
used
together with others, in the next projects, to allow
tracking of a drug batch.
• Extract statistical data on drug consumption based on
patient profiles.
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Target Clients of Sub-Project CDMC
• Pharmacies
• Drugstores
• Prescribers
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Partners in Sub-Project CDMC
• Professional Councils
• State and Federal District
Sanitary Surveillance Offices
• Municipal Sanitary Surveillance
Offices
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Strategies of Sub-Project CDMC
• Single prescription
• Validity of prescription at national level
• Prescription for chronic treatment
• Tracking of drug
• Tracking of Prescriber X Patient X Drug X
Dispensary
• More consistent statistical data
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Execution of Sub-Project CDMC
• Alterations in Prescription Control
• Structural Alteration of Prescription
• Partnership with Professional Councils
• Computerization of data capturing of
Drug Sales
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Sub-Project CDMC : Control of Prescriptions
MÓDULO
MÓDULO
FEDERAL
FEDERAL
TRANSMISSÃO ELETRÔNICA
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC - Prescriptions - Manufacturing
Beginning
Supply of Safety Seals
(ANVISA ???)
Who will pay ?
Who will Distribute ?
[professional council]
[municipal visa]
Professional Coucil
Distributes
Municipal Visa
Distributes
[both]
Printing on Common Paper :
- By Prescriber
- By Institution
- By State
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Role of Prescriber
1
Classifies
Professional
Registration
Professional
2
Professional Council
Requests
Seals
Issuance of
Authorization
Management System of
Seal Distribution (SGDS)
Professional
AUTHORIZATION for
DRUG
PRESCRIPTION
Municipal Visa
Safety
Seals
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Control of Prescription
PRESCRIÇÃO
CONSUMIDOR
ESCRITURAÇÃO
TRANSMISSÃO
ELETRÔNICA
datavisa
Farmácia/Drogaria
Brazilian Sanitary
Surveillance Agency
[email protected]
PRESCRITOR
MÓDULO
MÓDULO
FEDERAL
FEDERAL
www.anvisa.gov.br
CDMC – Control of Bookkeeping
COMPRAS e
DEVOLUÇÕES
COMPRAS e
DEVOLUÇÕES
ESCRITURAÇÃO
TRANSFERÊNCIAS
DISPENSAÇÃO
datavisa
Farmácia e Drogaria
MÓDULO
MÓDULO
FEDERAL
FEDERAL
DESCARTE
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC - Prescriptions - Format
NOME DA INSTITUIÇÃO NONONONONO
LOGO
INSTITUIÇÃO
OPCIONAL
RESPONSÁVEL: DR. NOME DO PRESCRITOR NONONONONONONO
ENDEREÇO: NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO
BAIRRO: NONONONONONONONONO
CIDADE: NONONONONONONONONO
UF: NO
TELEFONE: 0(XX)XX XXXX-XXXXX
C.E.P.: XX.XXX-XXX
RECEITA
NOME DO PACIENTE
C.P.F. ou Nº CARTÃO SUS DO PACIENTE/RESPONSÁVEL
SEXO DO PACIENTE
M
Medicamento ou Substância
MESES
F
Quantidade e Forma
Farmacêutica
DATA DA EMISSÃO
IDADE
ANOS
Dose por Unidade
Posológica
ORIENTAÇÃO AO PACIENTE
Posologia
*PTC
Tempo
Meses
*PTC - PRESCRIÇÃO PARA TRATAMENTO CRÔNICO
CONTATOS:
Sr(a). Profissional de saúde: notifique a(s) reação(ões) adversa(s) de medicamentos.
____________________________________________________________________
ASSINATURA
CARIMBO DO PRESCRITOR (CR e Nome)
ATENÇÃO:
30 dias, a partir da data de emissão, respeitando o período para tratamento crônico
Visa Municipal: (XX) XXXX-XXXXX
Visa Estadual: (XX) XXXX-XXXXX
www.visa_uf.gov.br
email: [email protected]
Anvisa:
(XX) XXXX-XXXXX
www.anvisa.gov.br
email: [email protected]
Ministério da Saúde: 0800-XXXXXXX
www.saude.gov.br
[email protected]
( ) 1ª Via - Retenção Drograria / Farmácia
( ) 2ª Via - Orientação para o Paciente
Gráfica NONONONONONONONON
C.N.P.J.: XXX.XXX.XXX/XXXX-XX Fone: 0(XX)XXXX-XXXXX
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC - Prescriptions – Dispensing Stamp
NAME OF ESTABLISHMENT NONONONONON
C.N.PJ.: XXX.XXX.XXX/XXXX-XX
State Registration:
XX.XXX.XXX/XXX-XX
Nº Special Author.: X.XXX.XXXX
AADDRESS: NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO TELEPHONE:
0(XX)XX XXXX-XXXXX
AREA: NONONONONONONONONO CITY:
ZIP.: XX.XXX-XXX
NONONONONONONONONO FU: NO
FORM FOR DISPENSING CONTROL
QUANTITY
DISPENSED
Nº EAN CODE OF DRUG
OR Nº OF MAIPULATION ORDER
NANE OF BUYER
Nº BATCH OF DISPENSED
DRUG
C.P.F. OF BUYER
ADDRESS OF BUYER
CITY - FU
_______________________
Signature/Fingerprint of Buyer
CONTACT TELEPHONES
DATE OF DISPENSING
Nº FISCAL DOCUMENT
_______________________
1ª Via - Retenção Drograria / Farmácia
2º Via - Anexada na Receita do Paciente
Gráfica NONONONONONONONON
C.N.P.J.: XXX.XXX.XXX/XXXX-XX Fone: 0(XX)XXXX-XXXXX
Brazilian Sanitary
Surveillance Agency
Stamp/Signature of Pharmacist
[email protected]
www.anvisa.gov.br
Sub-Project CDMC – Current Status
Beginning
Initial Suvey
Modeling
Prototyping
Validation of Prototype (by client)
[needs adjustments]
Implementation
Validation
Preparation of
Training Material
Adjust Model
[needs adjustments]
Implantation
Post-implantation Validation
Training
[necessary corrections]
MODULE
available for National Imlantation
Fim
do Project
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Main Screen
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Registers Prescription
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Registers Prescription (2)
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Registers Items
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Prescription Observations
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC – Tax Bills
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
CDMC - Prescriptions - Benefits
CDMC
• 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 Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Open to Questions !
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br
Coordination of Controlled Drugs
ANVISA Office of the
Ombudsman
SEPN 515, Bloco B, Edifício Ômega, 1° subsolo
Brasília (DF) - CEP 70.770-502
Telephone: ( 61) 448-1235 / 448-1464
Fax: ( 61) 448-1144
http://www.anvisa.gov.br/ouvidoria/fale_com.htm
Brazilian Sanitary
Surveillance Agency
[email protected]
www.anvisa.gov.br