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STAY AWAY FROM A DOCTOR
Should we expect a rise in adverse effects in the elderly?
7OCT
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Jan L. Brozek, MD, PhDDepartment of Clinical Epidemiology & Biostatistics
Informal meeting of the Pharmacovigilance Working PartyWarsaw • October 6–7, 2011
Financial• none
Non-Financial/personal/academic• GRADE working group• Cochrane Collaboration
Pote
ntia
l CO
I
stay away from
a doctor
stay away from
a good doctor
Should we expect a rise
in adverse effects in the
elderly?
yesnoit
depends...
79 year old lady Patie
nt
imagine a 79-year-old whom you know well
• hypertension• diabetes mellitus type 2• osteoporosis• arthritis• COPD
Patie
nt
if she was correctly managed
according to the most recent
guidelines...
Time Medication Other activities
7:00 AM Ipratropium MDIAlendronate 70 mg/wk
Check feet + blood sugarSit upright 30’ when alendronate
8:00 AM Calcium 500 mg + vit D 200 IUHydrochlorothiazide 12.5 mg Lisinopril 40 mg Glyburide 10 mg Aspirin 81 mg Metformin 850 mg Naproxen 250 mg Omeprazole 20 mg
Eat breakfast*
* Make sure you eat:Na 2.4 g/d + K 90 mmol/dEnough Mg + CaLittle saturated fat and cholesterolDASH diet
12:00 PM Eat lunch*
1:00 PM Ipratropium MDICalcium 500 mg + vit D 200 IU
7:00 PM Ipratropium MDICalcium 500 mg + vit D 200 IULovastatin 40 mgMetformin 850 mg Naproxen 250 mg
Eat dinner*
11:00 PM Ipratropium MDI
as needed Salbutamol MDI
why is that?
yes, AE will
increase
• medicalization• clinical guidelines• pay-for-performance• ‘good’ doctors• studies in elderly• pragmatic trials • independent
studies• better journal
editors
• ?• better guidelines• sensible quality measures• really good doctors• studies still exclude aged• trials still explanatory• studies still run by industry• editorial quality = constant
no, AE will not
increase
is an increase in
AE actually
bad ?
yes, AE will
increase
• medicalization• similar guidelines• pay-for-
performance• ‘good’ doctors• studies in elderly• pragmatic trials • independent
studies• better journal
editors
• ?• better guidelines• sensible quality
measures• really good doctors• studies still exclude
aged• trials still explanatory• studies still run by
industry• editorial quality =
constant
no, AE will not
increase
implementation
utilization in decisions
reporting
generation
