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Why should I lose time to send a report of adverse
drug reactions?
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The voluntary ADR reporting was developed to detect rare, serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.
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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
What is an adverse drug reaction?What is an adverse drug reaction?
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Pharmacovigilance
Monitoring and analysis of spontaneous adverse drug
reactions
WHO-CC: Uppsala Monitoring Centre, Sweden
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WHO-CC
Uppsala Monitoring Centre
Collects volountary reports of Adveres Drug Reactionsfrom all over the world
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WHO Drug Monitoring Programme
Associate member Official member
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WHO
–
WHO Collaborating Centre for International Drug Monitoring -
The Uppsala Monitoring Centre
> 4 million reports
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SWEDIS
Swedish Drug Information System 1965-2007
105.000 ADR reports with causality assessment
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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
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Causality Assessment
Known reaction Time-relasionship
Cannot be explained by the underlying diseases
or medications
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I stopped taking the medicine because I prefer the original disease
to the side effects !
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Causality Assessment
Known reaction Time-relasionship
Cannot be explained by the underlying diseases
or medications
Dissapperar at dechallenge
Reappear at Rechallenge
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ADR reports in Sweden
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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TOTALEN 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
AN
TA
L R
AP
PO
RT
ER
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Pharmacovigilance from a public
health point of view
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Bergman U, Wiholm B-E.
Drug-related problems causing admission to a medical clinic.
Eur J Clin Pharmacol 1981;20:193 200.
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Bergman U, Wiholm B-E. Drug-related problems causing admission to a medical
clinic. Eur J Clin Pharmacol 1981;20:193 200.
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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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. Pharmacoepidemiol Drug 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. Pharmacoepidemiol Drug 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 year
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 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. Pharmacoepidemiol Drug 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.
3,7 Läkartidningen 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. Pharmacoepidemiol Drug 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. Pharmacoepidemiol Drug Safe 2006;15:178-184
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In summary: ADRs in 2000 vs 1970s
% more ADR hospitalizations More elderly patients
More drugs per patient
Pharmacologcal reactions (type A) dominats completely
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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 A• Predictable 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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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 dose-dependency
— 5%____________________________________
– 76% of patients were 65 years or over
• 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 B
Adverse Drug Reactions
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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:Adverse Drug Reactions- ADRs
Spontaneous ADR monitoring is basis for Pharmacovigilance
Pharmacological ADRs is a matter for the local
health care provider – quality of care
An area for Clinical Pharmacology
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Take Home messages:
Adverse Drug Reaction- a Differential diagnosis
An ADR diagnosis: (a minimum an ICD-10 Y 57.9 Ogynnsam effekt av drog eller läkemedel i terapeutiskt bru
Submitt an ADR report
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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 questionYou remain stupid
Alvan Feinstein
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Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.
Source: The Importance of Pharmacovigilance, WHO 2002
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Causality Assessment
CertainProbablePossible
UnlikelyUnclassifiable
