brazilian health surveillance agency brazilian medicine monitoring centre/pharmacovigilance unit 1...
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11Brazilian Health Surveillance Agency
www.anvisa.gov.brBrazilian Medicine Monitoring Centre/Pharmacovigilance Unit
NAIR R. DE SOUZA; MURILO F. DIAS; PATRÍCIA MANDALI DE F;
SILVIO C. F. ARANTES; LEANDRO A. M. SILVA; ELANE A. FARIA
BRAZILIAN PHARMACOVIGILANCE SYSTEM AND REGULATORY MATTERS
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22Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Quality Problems Rational Use
EffectivenessSafety
Guidelines
ADR Profile Risk Factors Inefectiviness Risk/Benefit Evaluation
Toxic effects Therapeutic Failure
Medication erros
TherapeuticUpdate
PHARMACOVIGILANCE IN BRAZILPHARMACOVIGILANCE IN BRAZIL
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33Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Pharmacovigilance Unit
Brazilian Medicine Monitoring Centre
Risk Assessment Team # 1
1 Doctor5 Pharmacists
ATC Group: C, G, H, M and R
Risk Assessment Team # 2
1 Doctor4 Pharmacists
ATC Group: A, J, N and P
Risk Assessment Team # 3
2 Doctors6 Pharmacists
ATC Group: B, D, L, S and V
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44Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Identify
Investigate
EvaluateAct
Inform Monitor
Process of handling a drug safety issue
Source: Pharmacovigilance. Mann, R. and Andrews E., 2002. p. 105
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55Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Identifya) Spontaneous adverse reaction reporting
- Health professionals- Users
b) Sentinel Networking- Sentinel Hospitals- Reponting Pharmacies
c) National in-Patient Record of drug exposure - Screening from DATASUS information
d) International Recall Monitoring Project
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66Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
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77Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
On-line form for UsersOn-line form for Users
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88Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
On-line form for Health On-line form for Health ProfessionalsProfessionals
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99Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Medication Error formMedication Error form
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1010Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Sentinel Hospital Project
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1111Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Sentinel Hospital Components
Vigilance
Pharmacovigilance
Technovigilance
Hemovigilance
Target-Medicines and blood derivates:
- ADR- Medication Errors- Rationality- Quality problems
-Health care material, diagnose kits and equipment:
- Adverse Events - Quality problems- Training
-Blood and blood components:- Adverse Events- Rationality
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1212Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
158 SENTINEL HOSPITAL DISTRIBUTION
North Region -12 Hospitals
Center-west Region - 12 Hospitals
South Region - 25Hospitals
Northeast Region - 35 Hospitals
Southeast Region - 74 Hospitals
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1313Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Distribution of adverse events reports collected by Pharmacovigilance Unit – UFARM/GGMED 2004 *
Quality Problems TOTAL %
Description Serious Non-Serious Serious Non-
Serious All
Sentinel Hospital 160 800 40 21 276 1297 61%
Pharmaceutical Industry 43 111 0 5 8 167 8%
Health Professionals 66 231 32 16 154 499 23%
Medicine Users 33 37 25 42 29 166 8%
Sub-Total 302 1179 97 84 2129 100%Total
% 20% 80% 54% 46% 100%
ADR Seriousness Lack of Efficacy
1481 181467
* Data obtained untill October 2004
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1414Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
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1515Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
REPORTING PHARMACIES PROJECT
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1616Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
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1717Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Pilot Project - Reporting PharmaciesSerious ADR X Non Serious ADR
N=81 ADR (46 Reports) 117 Reports in 6 months
71%
29% Serious
Non-Serious
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1818Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
65 pharmacies
143 pharmacies
Participated in the pilot project
Expansion forecast in 2005
149 Reporting Pharmacies – Pilot Project
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1919Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
EXAMPLE – Local Signal (ADR & Quality Problem)
Date: May 2003
Product: CELOBAR (barium sulfate, 150g)
Use: X-Ray exams in esophagus & stomach
Route of administration: Oral
Cases: 200
Deaths: 22
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2020Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Quality problems of medicines
StrangeParticle(screw)
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2121Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
YearYearNumber of recalled Number of recalled
Medicines in foreing Medicines in foreing countriescountries
Number of recalled Number of recalled medicines in medicines in
BrasilBrasilReceiving TypeReceiving Type
2002 2002 9696 99
ActiveActive 6060
ReactiveReactive 3232
CompoundCompound 44
20032003 101101 00
ActiveActive 6464
ReactiveReactive 3131
CompoundCompound 66
20042004 132132 22
ActiveActive 103103
ReactiveReactive 2121
CompoundCompound 22
20052005 104104 11
ActiveActive 8383
ReactiveReactive 2020
CompoundCompound 11
TOTALTOTAL 433433 1212
International Recalling Project
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2222Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Investigate
Initial Assessment (Signal detection)
- Causality (WHO)- Documentation (Case quality; PSUR; Papers)- Frequency (Database)- Implication (Risk evaluation)- Mechanism (Clinical, pharmaco-toxicological)- Class effect (Investigation)- Other evidence (Pré-clinical studies; Epi studies)
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2323Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Evaluate
Additional Assessment (Signal strengthing)
- Case Follow-up approach - Restrict consultation (Active searching - Sentinel Networking)- International consultation (Vigimed, WHO)- Periodic Evaluation (Internal Risk Assessment Team)- Inter-Institutional Evaluation (Crises meeting / Evaluation meeting) - Desproportionality Approach (Proportional Reported Ratio – PRR)- Local evaluation- Mandatory Phase IV studies
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2424Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Act
Risk Minimization Plan
- Provision of information- Marketing Intervention- Legal Status of a Medicine (Decrees)
- Status of Marketing- Summary of Product Characteristics
- Health Professionals- Patients
- Control at Hospital and Pharmacy level
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2525Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Inform
Risk Communication
- Provision of information - Alerts- Informs- Educational Materials and treeing- Dear Dr. Letters- Mass media approach- Report Document for Law Ministry and Legislative Board
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2626Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
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2727Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
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2828Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Distribution of the communications emited by Distribution of the communications emited by UFARM from 1999 to August 2005* (756 Total).UFARM from 1999 to August 2005* (756 Total).
19991999 20002000 20012001 20022002 20032003 20042004 2005*2005* TOTALTOTAL
Federal Alerts Federal Alerts - - 33 1212 1212 1010 77 22 4646International AlertInternational Alert 2525 2727 3232 3535 2626 4242 2626 213213Restrict ConsultRestrict Consult - - - - - - 99 88 1616 55 3838InformsInforms -- -- 77 66 33 66 55 2727Circular LettersCircular Letters -- -- -- 2020 8181 1414 1515 130130Available LettersAvailable Letters (Indústry)(Indústry) -- 11 33 55 55 77 77 2828
Massive Spreading (TV, Radio)Massive Spreading (TV, Radio) -- -- 1515 1010 2222 3030 1717 9595Regulamentations (RE, RDC, CP)Regulamentations (RE, RDC, CP) -- 22 1818 2020 3636 1212 44 9292Cientific SpreadingCientific Spreading 33 2626 1818 1717 99 77 77 8787
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2929Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Distribution of technical bulletins emited by Distribution of technical bulletins emited by UFARM from 1999 to August 2005*UFARM from 1999 to August 2005*
19991999 20002000 20012001 20022002 20032003 20042004 2005*2005* TOTALTOTAL
InternalInternal -- 1313 4040 3232 - - 3535 1717 137137ExecutiveExecutive -- -- -- 11 -- 1616 -- 1717
Legislative and Public Legislative and Public MinistryMinistry 11 11 1010 1111 1313 88 44 4848
JudiciaryJudiciary -- -- 77 99 -- -- -- 1616VISAsVISAs -- -- 99 55 -- 2121 -- 3535
Government ProgramsGovernment Programs -- -- 11 -- -- 2020 -- 2121
IDEC and PROCONIDEC and PROCON -- -- 55 77 -- 33 -- 1515
OthersOthers 22 33 88 1010 -- -- - - 232333 1717 8080 7575 2424 103103 2121 323323
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3030Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
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3131Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
General Brazilian Pharmacovigilance Communication Process (441)
0
10
20
30
40
50
60
70
80
90
1999 2000 2001 2002 2003 2004 2005
Consulta Restrita
Cartas Circulares
Divulgação em Massa (TV, Rádio)
Regulamentações (RE, RDC, CP)
Divulgação Científica
Restrict ConsultationInternal LettersMass Media (TV, radio) DecreesPosters/Papers
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3232Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Internet Pharmacovigilance Communication (344)
0
10
20
30
40
50
60
2000 2001 2002 2003 2004 2005*
RecallSPCRegistryRDUTSDIWithdrawRestrictionCounterfit
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3333Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
020406080
100120140160180
Months
Comunication from Pharmacovigilance Corporative E-mail for Medicine Users [Anual Mean - 39 % (# 343)] July 2004 - July 2005.
SI de usuários 13 16 16 12 68 29 26 6 18 17 11 16 8Total de SI 43 53 45 32 104 42 76 39 60 44 54 44 31
jul/04 ago/04 set/04 out/04 nov/04 dez/04 jan/05 fev/05 mar/05 abr/05 mai/05 jun/05 jul/05
Pharmacovigilance E-mails
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3434Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Category Questions form Medicine Users by Pharmacovigilance E-mail (343 = 1 year)
36%
2%3%8%3%
3%
6%2%10%
8%17%2%
RAM ação do medicamento análise de medicamentoscomposição de medicamentos contra-indicação indicações de usoinefetividade informações gerais interação medicamentosalegislação precauções outros
Pharmacovigilance E-mails
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3535Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Number of Trained people by Pharmacovigilance Unit since 1999 to Agost 2005 (Total 13.124)
21
869
1709
2240
36353321
1329
0
500
1000
1500
2000
2500
3000
3500
4000
1999 2000 2001 2002 2003 2004 2005
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3636Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Translations for Portuguease – WHO publications Translations for Portuguease – WHO publications by Pharmacovigilance Unit 2005by Pharmacovigilance Unit 2005
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3737Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Next steps . . .Next steps . . . Creation of States Pharmacovigilance Creation of States Pharmacovigilance
CentresCentres Increasing in number of the serious Increasing in number of the serious
reactions reports by the health reactions reports by the health professionals.professionals.
Drug monitoring in public health Drug monitoring in public health programs.programs.
Increase use of Risk Management Increase use of Risk Management approachapproach
Implement Crises ManagementImplement Crises Management
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3838Agência Nacionalde Vigilância Sanitária
www.anvisa.gov.brUnidade de Farmacovigilância
Pharmacovigilance UnitPharmacovigilance Unit
Centro Nacional de Monitorização de MedicamentosCentro Nacional de Monitorização de MedicamentosAgência Nacional de Vigilância SanitáriaAgência Nacional de Vigilância Sanitária
SEPN 515 BL.B 2º ANDAR, sala 2 SEPN 515 BL.B 2º ANDAR, sala 2 ED. ÔMEGA BRASÍLIA - DF CEP - 70770 - 502ED. ÔMEGA BRASÍLIA - DF CEP - 70770 - 502
[email protected]@anvisa.gov.br
THANKS FOR YOUR ATTENTION !!!