1 2 Why should I lose time to send a report of adverse drug reactions?

1

2

Why should I lose time to send a report of adverse

drug reactions?

3

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

4

5

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?

6

Pharmacovigilance

Monitoring and analysis of spontaneous adverse drug

reactions

WHO-CC: Uppsala Monitoring Centre, Sweden

7

WHO-CC

Uppsala Monitoring Centre

Collects volountary reports of Adveres Drug Reactionsfrom all over the world

8

WHO Drug Monitoring Programme

Associate member Official member

9

WHO

–  

  WHO Collaborating Centre for International Drug Monitoring -

The Uppsala Monitoring Centre

> 4 million reports

10

SWEDIS

Swedish Drug Information System 1965-2007

105.000 ADR reports with causality assessment

11

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

12

13

Causality Assessment

Known reaction Time-relasionship

Cannot be explained by the underlying diseases

or medications

14

I stopped taking the medicine because I prefer the original disease

to the side effects !

15

Causality Assessment

Known reaction Time-relasionship

Cannot be explained by the underlying diseases

or medications

Dissapperar at dechallenge

Reappear at Rechallenge

16

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

17

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

18

19

Pharmacovigilance from a public

health point of view

20

Bergman U, Wiholm B-E.

Drug-related problems causing admission to a medical clinic.

Eur J Clin Pharmacol 1981;20:193 200.

21

22

23

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

24

25

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

26

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

27

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

28

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

29

% 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

30

31

In summary: ADRs in 2000 vs 1970s

% more ADR hospitalizations More elderly patients

More drugs per patient

Pharmacologcal reactions (type A) dominats completely

32

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.

33

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)

34

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)

35

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)

36

Importance forHealth care provider Industry and Regulatory

Agency

Type A Type B

Adverse Drug Reactions

37

Keep in mind the origin– Advancement in

safety heavily relies on reporting of safety events by health care professionals

38

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

39

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

40

Thank you for staying till the end!

41

Time for

Questions & Answeres

If you don’t ask stupid questionYou remain stupid

Alvan Feinstein

42

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

43

Causality Assessment

CertainProbablePossible

UnlikelyUnclassifiable