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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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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? serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

Monitoring and analysis of spontaneous adverse drug reactions

WHO-CC: Uppsala Monitoring Centre, Sweden


Who cc
WHO-CC serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

Uppsala Monitoring Centre

Collects volountary reports of

Adveres Drug Reactions

from all over the world


Who drug monitoring programme
WHO Drug Monitoring Programme serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.


WHO serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

WHO Collaborating Centre for International Drug Monitoring -

The Uppsala Monitoring Centre

> 4 million reports


Swedis
SWEDIS serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

Known reaction

Time-relasionship

Cannot be explained by the underlying diseases or medications


I stopped taking the medicine serious, unexpected adverse drug, mainly type B, reactions over 40 years ago. because I prefer the original disease to the side effects !


Causality assessment1
Causality Assessment serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

Known reaction

Time-relasionship

Cannot be explained by the underlying diseases or medications

Dissapperar at dechallenge

Reappear at Rechallenge


Adr reports in sweden
ADR reports in Sweden serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.


Pharmacovigilance from a public health point of view serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.


Bergman U, Wiholm B-E. serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

Drug-related problems causing admission to a medical clinic.

Eur J Clin Pharmacol 1981;20:193 200.


Bergman U, Wiholm B-E. serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 % serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

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 serious, unexpected adverse drug, mainly type B, reactions over 40 years ago.

% more ADR hospitalizations

More elderly patients

More drugs per patient

Pharmacologcal reactions

(type A) dominats completely


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 prospective analysis of 18 820 patients.

  • 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 prospective analysis of 18 820 patients.

    • 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? prospective analysis of 18 820 patients.

    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 prospective analysis of 18 820 patients.

    Health care provider Industry and Regulatory

    Agency

    Type A Type B

    Adverse Drug Reactions


    Keep in mind the origin
    Keep in mind the origin prospective analysis of 18 820 patients.

    • Advancement in safety heavily relies on reporting of safety events by health care professionals


    Take Home messages: prospective analysis of 18 820 patients.

    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


    Take Home messages: prospective analysis of 18 820 patients.

    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


    Thank you for staying till the end! prospective analysis of 18 820 patients.


    Time for prospective analysis of 18 820 patients.

    Questions & Answeres

    If you don’t ask stupid question

    You remain stupid

    Alvan Feinstein


    Pharmacovigilance1
    Pharmacovigilance prospective analysis of 18 820 patients.

    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 prospective analysis of 18 820 patients.

    Certain

    Probable

    Possible

    Unlikely

    Unclassifiable


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