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Why should I lose time to send a report of adverse drug reactions?

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Why should I lose time to send a report of adverse drug reactions?. The voluntary ADR reporting was developed to detect rare, serious, unexpected adverse drug, mainly type B, reactions over 40 years ago. . What is an adverse drug reaction?.

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slide3
The voluntary ADR reporting was developed to detect rare, serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.
slide5

What is an adverse drug reaction?

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

pharmacovigilance
Pharmacovigilance

Monitoring and analysis of spontaneous adverse drug reactions

WHO-CC: Uppsala Monitoring Centre, Sweden

who cc
WHO-CC

Uppsala Monitoring Centre

Collects volountary reports of

Adveres Drug Reactions

from all over the world

slide9
WHO

WHO Collaborating Centre for International Drug Monitoring -

The Uppsala Monitoring Centre

> 4 million reports

swedis
SWEDIS

Swedish Drug Information System

1965-2007

105.000 ADR reports with causality assessment

six health care regions each with a medical school
Six Health Care Regions - each with a medical school

Northern Region

Umeå

Uppsala Region

Uppsala

Western Region

Gothenburg

Stockholm Region

Stockholm

Southern Region

Lund and Malmö

South-east Region

Linköping

causality assessment
Causality Assessment

Known reaction

Time-relasionship

Cannot be explained by the underlying diseases or medications

causality assessment1
Causality Assessment

Known reaction

Time-relasionship

Cannot be explained by the underlying diseases or medications

Dissapperar at dechallenge

Reappear at Rechallenge

slide20
Bergman U, Wiholm B-E.

Drug-related problems causing admission to a medical clinic.

Eur J Clin Pharmacol 1981;20:193 200.

slide23
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

swedish adr hospitalization studies
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

adr hospitalizations in
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

mean age in adr hospitalizations
Mean AGE in ADR hospitalizations

1.Beermann B, Biörck G, Groshinsky-Grind M. Läkemedelsbiverkningar

och intoxikationer som orsak till intagning på invärtesmedicinsk klinik. 71 year

Läkartidningen 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 year

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 72 year

and thereby indicate the quality of drug utilisation. Pharmacoepidemiol

Drug Safe 2006;15:178-184

number of drugs patient with adr hospitalizations
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 6,2

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 7

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 8,3

and thereby indicate the quality of drug utilisation. Pharmacoepidemiol

Drug Safe 2006;15:178-184

phararmacological typ a adrs
% 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

in summary adrs in 2000 vs 1970s
In summary: ADRs in 2000 vs 1970s

% more ADR hospitalizations

More elderly patients

More drugs per patient

Pharmacologcal reactions

(type A) dominats completely

slide32
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.

types of adrs
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)
types of adrs1
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)
how many adrs were avoidable
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)
importance for
Importance for

Health care provider Industry and Regulatory

Agency

Type A Type B

Adverse Drug Reactions

keep in mind the origin
Keep in mind the origin
  • Advancement in safety heavily relies on reporting of safety events by health care professionals
slide38
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

slide39
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

slide41
Time for

Questions & Answeres

If you don’t ask stupid question

You remain stupid

Alvan Feinstein

pharmacovigilance1
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

causality assessment2
Causality Assessment

Certain

Probable

Possible

Unlikely

Unclassifiable

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