Brazilian Health Surveillance Agency Brazilian Medicine Monitoring Centre/Pharmacovigilance Unit 1...

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

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

http://www.vasia.com/psecp



Pharmacovigilance Unit

Brazilian Medicine Monitoring Centre

Risk Assessment Team # 1

1 Doctor5 Pharmacists

ATC Group: C, G, H, M and R


1 Doctor4 Pharmacists

ATC Group: A, J, N and P


2 Doctors6 Pharmacists

ATC Group: B, D, L, S and V




Identify

Investigate

EvaluateAct

Inform Monitor

Process of handling a drug safety issue

Source: Pharmacovigilance. Mann, R. and Andrews E., 2002. p. 105




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




On-line form for UsersOn-line form for Users




On-line form for Health On-line form for Health ProfessionalsProfessionals




Medication Error formMedication Error form




Sentinel Hospital Project




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




158 SENTINEL HOSPITAL DISTRIBUTION

North Region -12 Hospitals

Center-west Region - 12 Hospitals

South Region - 25Hospitals

Northeast Region - 35 Hospitals

Southeast Region - 74 Hospitals




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




REPORTING PHARMACIES PROJECT




Pilot Project - Reporting PharmaciesSerious ADR X Non Serious ADR

N=81 ADR (46 Reports) 117 Reports in 6 months

71%

29% Serious

Non-Serious




65 pharmacies

143 pharmacies

Participated in the pilot project

Expansion forecast in 2005

149 Reporting Pharmacies – Pilot Project




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




Quality problems of medicines

StrangeParticle(screw)




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


CompoundCompound 66

20042004 132132 22

ActiveActive 103103


CompoundCompound 22

20052005 104104 11

ActiveActive 8383


CompoundCompound 11

TOTALTOTAL 433433 1212

International Recalling Project




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)




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




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




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




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




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




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




Internet Pharmacovigilance Communication (344)

0

10

20

30

40

50

60

2000 2001 2002 2003 2004 2005*

RecallSPCRegistryRDUTSDIWithdrawRestrictionCounterfit




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




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




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




Translations for Portuguease – WHO publications Translations for Portuguease – WHO publications by Pharmacovigilance Unit 2005by Pharmacovigilance Unit 2005




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




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 !!!


Brazilian Health Surveillance Agency Brazilian Medicine Monitoring Centre/Pharmacovigilance Unit 1...

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