Improving PharmacoVigilance in the European Union Experiences from Stockholm, Sweden
Ulf Bergman
Ulf Bergman, MD, PhD Regional Adverse Drug Reaction Unit Department of Clinical Pharmacology Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden
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Ulf Bergman
[email protected]
Conflict of interest statement
No conflicts of interest of relevance for this presentation
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Outline: – historical background of ADR – to describe how we have integrated the regulatory task of pharmacovigilance for the Swedish Medical Products Agency – with the public health focus on drug safety for the Stockholm County council – the local health care provider Improving PV in EU, Krakow 2008
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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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Six Health Care Regions - each with a medical school and with a Department of Clinical Pharmacology
Northern Region Umeå
Uppsala Region Uppsala
Western Region Gothenburg
Stockholm Region Stockholm
Southern Region Lund and Malmö
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South-east Region Linköping
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Stockholm county council 1.9 million inhabitants 7 Emergency hospitals Karolinska University Hospital 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 more effective 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 drug abuse, and advice on the experimental design of clinical drug studies. All these functions should in fact serve to enhance benefit-cost ratios of drugs.”
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Department of Clinical Pharmacology at Karolinska InstitutetKarolinska University Hospital
Right drug for the
Right patient in the
Right dose for the
Right time to the
Right costs
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Clinical Pharmacology – Therapeutic Drug Monitoring – Drug Information Centre – Drug & Therapeutics Committee – Regional Adverse Drug Reactions Unit – Pharmacoepidemiology and much much more
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Pharmacovigilance from a regulatory and from a public health point of view Improving PV in EU, Krakow 2008
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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. Improving PV in EU, Krakow 2008
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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 ADRs unknown at the time of marketing.
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This serves as a signalling system generating hypothesis that generally have to be tested in pharmacoepidemiological studies.
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Since 1968
WHO collects volountary reports of Adverse Drug Reactions from 10 countries
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WHO drug monitoring programme Participating countries 1968
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What is an adverse drug reaction? ADR
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 function WHO, 1972 Improving PV in EU, Krakow 2008
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Pharmacovigilance:
monitoring and analysis of spontaneous adverse drug reactions- ADRs
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Since 1978 WHO-CC the UMC
Uppsala Monitoring Centre collects volountary reports of Adveres Drug Reactions from all over the world
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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 reports Cumulative 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 Finney The scientific group on monitoring adverse drug reactions reported to the Director General, WHO 1964
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Pharmacovigilance from a regulatory point of view
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Medical Products Agency, Uppsala
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SWEDIS Swedish Drug Information System From 1965-2007
105.000 causality assessed ADR reports
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National spontaneous ADRs from all Health Care in Sweden Number of reports - 13 yrs
2006 5130 4500 4000 3500 3000 2500 2000 1500 1000 500 0
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Decentralised ADR reporting North Region Umeå 1992
Uppsala Region Uppsala 1996
Western Region Göteborg 1997
Stockholm Region Stockholm 1995
Southern Region Lund och Malmö 1996
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Southwestern Region Linköping 2000
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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 Sécurité Sanitaire 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. 2. 3. 4. 5.
Yellow Card Centre Northern and Yorkshire Yellow Card Centre West Midlands Yellow Card Centre Mersey Yellow Card Centre Wales 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 Unit in Stockholm in the
Department of Clinical Pharmacology Karolinska Institutet, Karolinska University Hospital
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Regional ADR Unit in Stockholm 1000 ADR reports/year
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Causality Assessment Known reaction Time-relationship Disappear at Dechallenge Re-appear at Rechallenge Cannot be explained by other medications Cannot be explained by the underlying diseases
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Weekly meeting with the Regional ADR Unit
Number of ADR reports per year in Stockholm TOTALEN AB+I LÄN
1 200
1 000
ANTAL RAPPORTER
800
I-län totalt
600
AB-län totalt
400
200
0 2 000
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2 002
2 003
2004
46
2005
2006
2007
Causality Assessment 1000 ADR reports/year corresponds to 529 ADR reports per million inhabitants a figure well above the highest in Europe (450 ADRs per million, Frauenhofer ISI 2005).
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Medical Products Agency, Uppsala
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Number of ADR reports per year in Stockholm TOTALEN AB+I LÄN
1 200
1 000
ANTAL RAPPORTER
800
I-län totalt
600
AB-län totalt
400
200
0 2 000
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2 002
2 003
2004
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2005
2006
2007
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 2000-2007 TOTALEN RIKET
6 000
5 000
ANTAL RAPPORTER
4 000
3 000
2 000
1 000
0 2 000
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2 002
2 003
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2004
2005
2006
2007
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 have access to the system designed to perform signal detection and analyses
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Medication Safety in the European Union
Serious suspected adverse drug reactions are collected centrally in the European pharmacovigilance database EudraVigilance created in 2001.
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The EudraVigilance system 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 Medicinal Products –CHMP - gives scientific opinions about pre- and marketed products. Much is also delegated to the Pharmacovigilance working party.
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Pharmacovigilance from 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 ADRs Type A
Predictable from pharmacology of the drug, dose-dependent and preventable Type B
Bizzare, unpredictable from known pharmacology, and no dose-dependency
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Swedish ADR hospitalization studies 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. Pharmacoepidemiol Drug Safe 2006;15:178-184 1.
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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 and thereby indicate the quality of drug utilisation. Pharmacoepidemiol Drug Safe 2006;15:178-184
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11 %
Mean AGE in ADR hospitalizations 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
71 year 66 year
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. 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. Pharmacoepidemiol Drug Safe 2006;15:178-184
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77 year 74 year 72 year
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. 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. 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. Pharmacoepidemiol Drug Safe 2006;15:178-184
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3,7 3,5 6,2 7 8,3
% phararmacological (typ A) ADRs 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. 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. Pharmacoepidemiol
Drug Safe 2006;15:178-184
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>75 % >75 % 100 % 91 % 89 %
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 A Predictable from pharmacology of the drug, dose-dependent and preventable
95% Type B Bizzare, unpredictable from known pharmacology, and no dosedependency
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 for Health care provider
Industry and Regulatory Agency
Type A
Type B
Adverse 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
Number of reports 11
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8
2002
2003
17
23
79
2004
2005
2006
28
100
271
Acceptance of this
Quality Indicator
with ADR feed-back was tested by a VAS (10 best) (Visual Analog Scale)
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Do you think presenting the reported side effects will help improve the quailty of drug usage? n=52 Mean=79 100 90 80 70
50 40 30 20 10
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16
14
HA
12
HA
10
HA
HA
8
6
HA
4
HA
2
HA
HA
9
VB
7
5
VB
3
Doctors
VB
1
VB
VB
U9
U7
U5
U3
15 U1
HS
13
11
HS
9
HS
HS
7
HS
5
3
HS
HS
1
0 HS
%
60
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=70 100 90 80 70
50 40 30 20 10
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16
14
HA
12
HA
HA
10
8
HA
HA
6
4
HA
2
HA
9
HA
VB
7
VB
5
3
Doctors
VB
1
VB
VB
U9
U7
U5
U3
U1
15
13
HS
HS
11
9
HS
7
HS
5
HS
HS
3
HS
1
0
HS
%
60
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=74 100 90 80 70
50 40 30 20 10
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17
15
HA
13
HA
HA
HA
11
9
7
HA
HA
5
HA
3
HA
1
HA
7
5
VB
3
VB
VB
1
VB
U9
U7
U5
U3
15 U1
13
HS
HS
HS
11
9
7
HS
HS
5
3
HS
HS
1
0 HS
%
60
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 PHCs participating 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 Stockholm TOTALEN AB+I LÄN
1 200
1 000
ANTAL RAPPORTER
800
I-län totalt
600
AB-län totalt
400
200
0 2 000
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2 002
2 003
2004
87
2005
2006
2007
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 aldkl (Alla) KOEN (Alla) dia Y579 diagrupp (Alla) inrtxt (Alla)
Individer och vårdtillfällen med orsaksdiagnos Y57.9 i SLL 700
600
500
400
Data Individer vårdtillfällen
300
200
100
0 2000
2001
2002
2003
2004 year
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2005
2006
2007
Number of hospitalizations with the ADR diagnosis in Stockholm Andelen vårdtillfällen i SLL med Y57.9 diagnos 0,25% 0,20% 0,15% 0,10% 0,05% 0,00% 2000
År 2000 2001 2002 2003 2004 2005 2006 2007
2001
vårdtillfällen SLL 276930 278390 286572 291626 294072 298138 303552 307515
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2003
2004
vårdtillfällen Y57.9 295 340 434 463 512 527 543 647 92
2005
2006
2007
% av vårdtillf med Y57.9 0,11% 0,12% 0,15% 0,16% 0,17% 0,18% 0,18% 0,21%
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Pharmacovigilance from a regulatory point of view: volountary reporting
public health point of view: diagnosis of ADRs
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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 for
Questions & Answeres? If you don’t ask stupid question You remain stupid
Alvan Feinstein
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ICPE Conference
25th Anniversary 2009 Mid-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 ICPE Mid-Year Meeting
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April 25-27 2009
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Conclusion Feedback 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 clinical trials and periodic safety update reports at regular intervals postauthorisation.
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