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Improving PharmacoVigilancein the European Union
Experiences from Stockholm, Sweden
Ulf Bergman
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Ulf Bergman, MD, PhD
Regional Adverse Drug Reaction UnitDepartment of Clinical Pharmacology
Karolinska Institutet, Karolinska University Hospital,
Stockholm, Sweden
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Ulf Bergman
Conflict of interest statementNo conflicts of interest of relevance
for this presentation
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Outline:
– historical background of ADR– to describe how we haveintegrated the regulatory task of pharmacovigilance for the Swedish Medical Products Agency
– with the public health focus on drugsafety for the Stockholm County council – the local health careprovider
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The European Union with 27 countries (+3 associates)with 490 million people
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Sweden
9 million inhabitants
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Southern RegionLund and Malmö
Northern Region Umeå
Uppsala RegionUppsala
Stockholm RegionStockholm
Western RegionGothenburg
South-east RegionLinköping
Six Health Care Regions - each with a medical school and with a Department of Clinical Pharmacology
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Stockholm county council
1.9 million inhabitants
7 Emergency hospitals
Karolinska UniversityHospital with two sites:Huddinge and Solna
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Functions of Clinical Pharmacology(WHO 1970)
”To improve patient care by promoting the safer and moreeffective use of drugs; to increase knowledge through research; to pass on knowledge through teaching; and to provide services, such as drug information, drug analysis, the monitoring of drugabuse, and advice on the experimental design of clinical drugstudies.
All these functions should in fact serve to enhance benefit-costratios of drugs.”
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Department of Clinical Pharmacology at Karolinska Institutet-Karolinska University Hospital
Right drug for the
Right patientin the
Right dosefor the
Right timeto the
Right costs
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Clinical Pharmacology– Therapeutic Drug Monitoring– Drug Information Centre– Drug & Therapeutics Committee– Regional Adverse Drug Reactions Unit– Pharmacoepidemiologyand much much more
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Pharmacovigilancefrom a regulatory
and from a public health
point of view
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Take Home messages:From a regulatory point of view:submit an ADR report
From a public healt point of view:Recognize Adverse Drug Reactions - a Differential diagnosis
An ADR diagnosis: (a minimum an ICD-10)
Y 57.9 Unintended effect of a medication in therapeutuic use
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History of Pharmacovigilance
Surveillance of Adverse Drug Reactions -ADRs
Thalidomide
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The Lancet December 16, 1961
THALIDOMIDE AND CONGENITAL ABNORMALITIES
Sir, - Congenital abnormalities are present in approximately 1.5% of babies. In recent months I have observed that the incidence of multiple severe abnormalities in babies delivered of women who were given the drug thalidomide (“Distaval”) during pregnancy, as an antiemetic or as a sedative, to be almost 20%.
These abnormalities are present in structures developed from mesenchyme – i.e., the bones and musculature of the gut. Bony development seems to be affected in a very striking manner, resulting in polydactyly, syndactyly, and failure of development of long bones (abnormally short femora and radii).
Have any of your readers seen similar abnormalities in babies delivered of women who have taken this drug during pregnancy?
Hurstville, New South Wales. W.G. McBride.
In our issue of Dec. 2 we included a statement from the Distillers Company (Biochemicals) Ltd. Referring to “reports from two overseas sources possibly associating thalidomide (“Distaval”) with harmful effects on the foetus in early pregnancy”. Pending further investigation, the company decided to withdraw from the market all its preparations containing thalidomide. – ED.L.
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Dear Doctor, may we introduce another form for you to fill in?
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Volountary reporting of suspected ADRs in Sweden since 1965
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The main purpose with the spontanous reporting system is to detect new ADRsunknown at the time of marketing.
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This serves as a signallingsystem generating hypothesisthat generally have to betested inpharmacoepidemiological studies.
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Since 1968
WHOcollects volountary reports of
Adverse Drug Reactionsfrom 10 countries
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WHO drug monitoring programmeParticipating countries 1968
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What is an adverse drug reaction?What is an adverse drug reaction?ADRADR
A response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of
physiological functionWHO, 1972
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Pharmacovigilance:monitoring and analysis of
spontaneous adverse drug reactions- ADRs
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Since 1978WHO-CC the UMC
Uppsala Monitoring Centre
collects volountary reports of Adveres Drug Reactionsfrom all over the world
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Member countries 1968-2008
0
10
20
30
40
50
60
70
80
90
100
196819
7019
7219
7419
7619
7819
8019
8219
8419
8619
8819
9019
9219
9419
9619
9820
0020
0220
0420
0620
08
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WHO Drug Monitoring Programme 2008
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WHO Collaborating Centre for International Drug Monitoring - The Uppsala Monitoring Centre > 4 million reportsCumulative number of active reports processed per year
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WHO
WHO Collaborating Centre for International Drug Monitoring
40th Anniversary
The Uppsala Monitoring Centre
30th Anniversary in October 2008
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David Finney (92) & Barbro Westerholm (75)at the Anniversary of the WHO UMC in Uppsala in October 2008
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David FinneyThe scientific group on monitoring adverse drug reactionsreported to the Director General, WHO 1964
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Pharmacovigilancefrom a regulatory
point of view
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Medical Products Agency, Uppsala
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SWEDISSwedish Drug Information System
From 1965-2007
105.000 causality assessed ADR reports
National spontaneous ADRs from all Health Care in SwedenNumber of reports - 13 yrs
20065130
0
500
1000
1500
2000
2500
3000
3500
4000
4500
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
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Southern RegionLund och Malmö1996
North Region Umeå1992
Uppsala RegionUppsala1996
Stockholm RegionStockholm 1995
Western RegionGöteborg1997
Southwestern RegionLinköping2000
Decentralised ADR reporting
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ADR reporting in France– 31 regional centers receive
spontaneous reports from the health care
– Common database since 1984 – Coordinated by Afssaps,
(‘Agence Française de SécuritéSanitaire des Produits de Santé’)
Assignments for centres:– collect, evaluate and stimulate
ADR reporting– inform and co-operate with the
health care profession – expert, consultant questionnaires
epidemiological studies – support scientific development
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ADR reporting in UK
5 regional centres "Yellow Card Centres"
1. Yellow Card Centre Northern and Yorkshire
2. Yellow Card Centre West Midlands 3. Yellow Card Centre Mersey 4. Yellow Card Centre Wales 5. Yellow Card Centre Scotland
Common database "Yellow Card database"
These centres ska focus on : follow-up, education and communication
to stimulate ADR reporting
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Medication Safety in the European Union
Regional Adverse Drug Reaction Unitin Stockholm in the
Department of Clinical PharmacologyKarolinska Institutet,
Karolinska University Hospital
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Regional ADR Unit in Stockholm
1000 ADR reports/year
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Causality Assessment
Known reactionTime-relationship
Disappear at DechallengeRe-appear at Rechallenge
Cannot be explained by other medicationsCannot be explained by the underlying
diseases
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Weekly meeting with the Regional ADR Unit
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TOTALEN AB+I LÄN
0
200
400
600
800
1 000
1 200
2 000 2001 2 002 2 003 2004 2005 2006 2007
AN
TAL
RA
PPO
RTE
R
I-län totalt
AB-län totalt
Number of ADR reports per year in Stockholm
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Causality Assessment
1000 ADR reports/yearcorresponds to 529 ADR reports per million
inhabitants
a figure well above the highest in Europe (450 ADRsper million, Frauenhofer ISI 2005).
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Medical Products Agency, Uppsala
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TOTALEN AB+I LÄN
0
200
400
600
800
1 000
1 200
2 000 2001 2 002 2 003 2004 2005 2006 2007
AN
TAL
RA
PPO
RTE
R
I-län totalt
AB-län totalt
Number of ADR reports per year in Stockholm
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The Adverse Drug Reactions head for Uppsala
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The European Union with 27 countries (+3 associates)with 490 million people
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ADR reports in Sweden 2000-2007TOTALEN RIKET
0
1 000
2 000
3 000
4 000
5 000
6 000
2 000 2001 2 002 2 003 2004 2005 2006 2007
ANTA
L RA
PPO
RTE
R
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SWEDIS
Reports of serious adverse drug reactions
are transferred to the EudraVigilance database
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Medication Safety in the European Union
Reports are sent electronically.
All regulatory authorities haveaccess to the system designed to perform signal detection and analyses
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Medication Safety in the European Union
Serious suspected adverse drugreactions are collected centrally in the European pharmacovigilancedatabase EudraVigilance -created in 2001.
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The EudraVigilancesystem
2008 > 1 million reports
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Medication Safety in the European Union
Pharmacovigilance within Europe is co-ordinated by the EMEA in London.
Its Committee for Human MedicinalProducts –CHMP - gives scientific opinions about pre- and marketed products.
Much is also delegated to the Pharmacovigilance working party.
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Pharmacovigilancefrom a public health
point of view
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Epidemiology of ADRs
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ADRs:Type A
augmented pharmacological effects
Type B bizzare effects
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Types of ADRsType A
Predictable from pharmacology of the drug, dose-dependent and preventable
Type BBizzare, unpredictable from known
pharmacology, and no dose-dependency
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Swedish ADR hospitalization studies
1. Beermann B, Biörck G, Groshinsky-Grind M. Läkemedelsbiverkningar och intoxikationer som orsak till intagning på invärtesmedicinsk klinik.
Läkartidningen 1978;75:959-60.2. Bergman U, Wiholm B-E. Drug-related problems causing admission to a medical clinic. Eur J Clin Pharmacol 1981;20:193 200.3. Sarlöv C, Andersén-Karlsson E, von Bahr C. Läkemedelsbiverkningar leder till sjukhusvård för hjärtpatienter. Läkartidningen 2001;47:5349-53.4. Mjörndal T, Boman MD, Hägg S, Bäckström M, Wiholm B-E, Wahlin A et al. Adverse drug reaction as a cause for admissions to a department of internal medicine. Pharmacoepidemol Drug Safe 2002;11:65-72.5. Von Euler M, Eliasson E, Öhlén G, Bergman U. Adverse drug reactions causing hospitalisation can be monitored from computerized medical records and thereby indicate the quality of drug utilisation. PharmacoepidemiolDrug Safe 2006;15:178-184
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ADR hospitalizations in %
1.Beermann B, Biörck G, Groshinsky-Grind M. Läkemedelsbiverkningar
och intoxikationer som orsak till intagning på invärtesmedicinsk klinik. 9 %Läkartidningen 1978;75:959-60.
2.Bergman U, Wiholm B-E. Drug-related problems causing admission 6 % to a medical clinic. Eur J Clin Pharmacol 1981;20:193 200.
3.Sarlöv C, Andersén-Karlsson E, von Bahr C. Läkemedelsbiverkningar 14 %leder till sjukhusvård för hjärtpatienter. Läkartidningen 2001;47:5349-53.4.Mjörndal T, Boman MD, Hägg S, Bäckström M, Wiholm B-E, Wahlin A.
Adverse drug reaction as a cause for admissions to a department of internal 12 %medicine. Pharmacoepidemol Drug Safe 2002;11:65-72.5.Von Euler M, Eliasson E, Öhlén G, Bergman U. Adverse drug reactions
causing hospitalisation can be monitored from computerized medical records 11 %and thereby indicate the quality of drug utilisation. PharmacoepidemiolDrug Safe 2006;15:178-184
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Mean AGE in ADR hospitalizations1.Beermann B, Biörck G, Groshinsky-Grind M. Läkemedelsbiverkningar
och intoxikationer som orsak till intagning på invärtesmedicinsk klinik. 71 yearLäkartidningen 1978;75:959-60.
2.Bergman U, Wiholm B-E. Drug-related problems causing admission 66 year
to a medical clinic. Eur J Clin Pharmacol 1981;20:193 200.
3.Sarlöv C, Andersén-Karlsson E, von Bahr C. Läkemedelsbiverkningar 77 yearleder till sjukhusvård för hjärtpatienter. Läkartidningen 2001;47:5349-53.4.Mjörndal T, Boman MD, Hägg S, Bäckström M, Wiholm B-E, Wahlin A.
Adverse drug reaction as a cause for admissions to a department of internal 74 yearmedicine. Pharmacoepidemol Drug Safe 2002;11:65-72.5.Von Euler M, Eliasson E, Öhlén G, Bergman U. Adverse drug reactions
causing hospitalisation can be monitored from computerized medical records 72 yearand thereby indicate the quality of drug utilisation. PharmacoepidemiolDrug Safe 2006;15:178-184
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Number of drugs/patient with ADR hospitalizations
1.Beermann B, Biörck G, Groshinsky-Grind M. Läkemedelsbiverkningar
och intoxikationer som orsak till intagning på invärtesmedicinsk klinik. 3,7Läkartidningen 1978;75:959-60.
2.Bergman U, Wiholm B-E. Drug-related problems causing admission 3,5 to a medical clinic. Eur J Clin Pharmacol 1981;20:193 200.
3.Sarlöv C, Andersén-Karlsson E, von Bahr C. Läkemedelsbiverkningar 6,2leder till sjukhusvård för hjärtpatienter. Läkartidningen 2001;47:5349-53.4.Mjörndal T, Boman MD, Hägg S, Bäckström M, Wiholm B-E, Wahlin A.
Adverse drug reaction as a cause for admissions to a department of internal 7medicine. Pharmacoepidemol Drug Safe 2002;11:65-72.5.Von Euler M, Eliasson E, Öhlén G, Bergman U. Adverse drug reactions
causing hospitalisation can be monitored from computerized medical records 8,3and thereby indicate the quality of drug utilisation. PharmacoepidemiolDrug Safe 2006;15:178-184
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% phararmacological (typ A) ADRs
1.Beermann B, Biörck G, Groshinsky-Grind M. Läkemedelsbiverkningar
och intoxikationer som orsak till intagning på invärtesmedicinsk klinik. >75 %Läkartidningen 1978;75:959-60.
2.Bergman U, Wiholm B-E. Drug-related problems causing admission >75 % to a medical clinic. Eur J Clin Pharmacol 1981;20:193 200.
3.Sarlöv C, Andersén-Karlsson E, von Bahr C. Läkemedelsbiverkningar 100 %leder till sjukhusvård för hjärtpatienter. Läkartidningen 2001;47:5349-53.4.Mjörndal T, Boman MD, Hägg S, Bäckström M, Wiholm B-E, Wahlin A.
Adverse drug reaction as a cause for admissions to a department of internal 91 %medicine. Pharmacoepidemol Drug Safe 2002;11:65-72.5.Von Euler M, Eliasson E, Öhlén G, Bergman U. Adverse drug reactions
causing hospitalisation can be monitored from computerized medical records 89 %and thereby indicate the quality of drug utilisation. PharmacoepidemiolDrug Safe 2006;15:178-184
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Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients.
British Medical Journal 2004;329;15-9
Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Kevin Park B and Breckenridge AM.
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Types of ADRs
Type APredictable from pharmacology of the drug, dose-dependent
and preventable
95%Type B
Bizzare, unpredictable from known pharmacology, and no dose-dependency
5%Pirmohamed M. et al. Br Med J 329:15-19 (2004)
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How Many ADRs Were Avoidable?
Definitely avoidable 8.6%Possibly avoidable 63.1%Not avoidable 28.1%
72 % of ADRs were definitely or possibly avoidable
Pirmohamed M. et al. Br Med J 329:15-19 (2004)
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Importance forHealth care provider Industry and Regulatory
Agency
Type A Type BAdverse Drug Reactions
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The Swedish Medical Quality Council 1999
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Swedish Medical Quality Council
Focus on type A reactions from a public health point of view
Reporting of clinically important ADRs should be stimulated by providing feedback to each clinic
Reporting of Type-A reactions should be considered as a quality indicator to be commented upon in a “quality report”.
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Feedback of ADR reporting
We tested this in field study in 4 clinics: 2 Internal Medicine, Cardiology, Psychiatry
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Internal Medicine, Halmstad
Year 2000 2001 2002 2003 2004 2005 2006
Number of reports 11 8 17 23 28 100 271
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Acceptance of this Quality Indicator
with ADR feed-backwas tested by a VAS (10 best)
(Visual Analog Scale)
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Do you think presenting the reported side effects w ill help improve the quailty of drug usage?n=52 Mean=79
0
10
20
30
40
50
60
70
80
90
100
HS1HS3HS5HS7HS9
HS11HS13HS15 U1 U3 U5 U7 U9
VB 1VB 3VB 5VB 7VB 9HA2HA4HA6HA8
HA10HA12HA14HA16
Doctors
%
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Do you regard the reported side effects of type A to be a valuable indicator of quailty in the reporting of side effects? n=52 Mean=70
0
10
20
30
40
50
60
70
80
90
100
HS1HS3HS5HS7HS9HS11HS13HS15 U1 U3 U5 U7 U9
VB1VB3VB5VB7VB9HA2HA4HA6HA8HA10HA12HA14HA16
Doctors
%
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Will the presentation of number of reported side effects from your clinic, affect your reporting of side effects in the future?/ affect your motivation to report side effects in the future?
n=52 Mean=74
0
10
20
30
40
50
60
70
80
90
100
HS1HS3HS5HS7HS9
HS11HS13HS15 U1 U3 U5 U7 U9
VB 1VB 3VB 5VB 7HA1HA3HA5HA7HA9
HA11HA13HA15HA17
Doctors
%
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Primary Health Care centres (PHC) in Stockholm
were offered contracts where the PHCs received extra payment depending on the adherence to the proposed guidelines.
The contract required each practice to analyse their prescribing and to write a “quality report”including questions about adverse events and reporting.
The project budget was €2 Mio and the savings was estimated to be 5 times more: 10 Mio
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In the annual “quality report”, among the 139 PHCsparticipating in the program:
80% stated that they discussed ADRs as part of their internal continuous professional education
50% stated that they had local routines for ADR reporting
An estimated 300 reports were submitted from these PHCs, cf 585 received from primary care the same year
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In agreement with these positive experiences, the Regional Drug Safety Centre is now providing feedback of ADRs to all seven emergency hospitals in Stockholm.
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Number of ADR reports per year in StockholmTOTALEN AB+I LÄN
0
200
400
600
800
1 000
1 200
2 000 2001 2 002 2 003 2004 2005 2006 2007
AN
TAL
RA
PPO
RTE
R
I-län totalt
AB-län totalt
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In agreement with these positive experiences, the Regional Drug Safety Centre is now providing feedback of ADRs to all seven emergency hospitals in Stockholm.
In 2006, 529 ADR reports per million inhabitants were received at the Centre, a figure well above the highest in Europe (450 ADRs per million, Frauenhofer ISI 2005).
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Assessment of the European Community System of Pharmacvigilance(Fraunhofer 2006.) Reports per million inhabitants
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An ADR diagnosis: (a minimum an ICD-10)
Y 57.9 Unintended effect of a medication
in therapeutuic use
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Number of hospitalizations with the ADR diagnosis in Stockholm
Individer och vårdtillfällen med orsaksdiagnos Y57.9 i SLL
0
100
200
300
400
500
600
700
2000 2001 2002 2003 2004 2005 2006 2007
Individervårdtillfällen
aldkl (Alla) KOEN (Alla) dia Y579 diagrupp (Alla) inrtxt (Alla)
year
Data
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Number of hospitalizations with the ADR diagnosis in Stockholm
Andelen vårdtillfällen i SLL med Y57.9 diagnos
0,00%
0,05%
0,10%
0,15%
0,20%
0,25%
2000 2001 2002 2003 2004 2005 2006 2007
År vårdtillfällen SLL vårdtillfällen Y57.9 % av vårdtillf med Y57.92000 276930 295 0,11%2001 278390 340 0,12%2002 286572 434 0,15%2003 291626 463 0,16%2004 294072 512 0,17%2005 298138 527 0,18%2006 303552 543 0,18%2007 307515 647 0,21%
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regulatory point of view:volountary reporting
public health point of view:diagnosis of ADRs
Pharmacovigilance from a
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Keep in mind the origin
– Advancement in safety heavily relies on reporting of safety events by health care professionals
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Take Home messages:From a regulatory point of view:submit an ADR report
From a public healt point of view:Recognize Adverse Drug Reactions - a Differential diagnosis
An ADR diagnosis: (a minimum an ICD-10)
Y 57.9 Unintended effect of a medication in therapeutuic use
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Thank you for staying till the end!
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Time forQuestions & Answeres?
If you don’t ask stupid questionYou remain stupid
Alvan Feinstein
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ICPE Conference
25th Anniversary 2009Mid-Year Meeting– April 25-27, 2009– Stockholm, Sweden
Annual Meeting- August 16-19, 2009 - Providence,Rhode Island, USA
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Welcome to Stockholm! 25th ICPEMid-Year Meeting April 25-27 2009
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ConclusionFeedback and economic incentives of ADR
reporting seem to be powerful tools in enhancing the awareness of ADRs and thus the quality of drug prescribing.
Integrating adverse events into a drug-prescribing program may result in better understanding of benefits and risks of drug treatment in individual patients.
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Medication Safety in the European Union
Pharmaceutical companies are also required to provide
regulators with annual safety reports from clinicaltrials and
periodic safety update reports at regular intervals post-
authorisation.