The RASP project optimizing potential inappropriate prescribing in elderly inpatients

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1 The RASP project optimizing potential inappropriate prescribing in elderly inpatients Lorenz Van der Linden University Hospitals Leuven, Dpt of Pharmacy, Dpt of Geriatrics Background University Hospitals Leuven Leuven, Belgium ~2000 beds Three on-site acute geriatric wards = 3x28 beds 1 off-site geriatric ward Postgraduate course of Clinical Pharmacy (+2y) Pharmacy degree (5y), hospital pharmacy (+1y) = the past The postgraduate course will be absorbed as a major in the new hospital pharmacy program (~Dutch system) 1

2 RASP = Reduction of drugs on Admission by an adjusted STOPP-list in the elderly Population STOPP/START criteria List of drugs, which are potential inappropriate when prescribed in certain indications in people >65y Subdivided according to the different organ systems Most likely the best explicit set of criteria in Europe to this day RASP STOPP criteria adapted to our own customs/opinions + patient population + prescribing patterns Revised according to updated guidelines (= new literature search) RASP list 2

3 1. CARDIOVASCULAIR STELSEL Stelling 1.1: Antiaritmica (klasse I, III) bij chronische (permanente) voorkamerfibrillatie / voorkamerflutter Verklaring: Antiaritmica verbeteren noch de morbiditeit, noch de mortaliteit bij een oudere patiëntenpopulatie. Voornamelijk vanwege de AFFIRM studie in 2002 heeft rate control (= vertragen van het ventriculair antwoord) terrein gewonnen ten opzichte van rhythm control (= behouden van het sinusritme): er werd een trend tot lagere mortaliteit en minder hospitalisatie gezien (niet significant). Momenteel heeft dronedarone als eerste antiaritmicum in ATHENA aangetoond dat het een eerste hospitalisatie door cardiovasculair lijden of mortaliteit kan verlagen, bij niet-permanente VKF zonder ernstig hartfalen NYHA IV. Referenties: 1. A comparison of rate control and rhythm control in patients with atrial fibrillation. The AFFIRM investigators. N Eng J Med 2002;347: A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. Van Gelder et al. N Eng J Med 2002;347: ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation executive summary. European Heart Journal 2006;27: Effect of dronedarone on cardiovascular events in atrial fibrillation (ATHENA). Hohnloser et al. N Engl J Med 2009;360: Stelling 1.2: Digoxine zonder optimalisatie van β-blokker therapie (indien niet gecontraïndiceerd) bij chronisch systolisch hartfalen Verklaring: Digoxine heeft volgens de DIG studie (1) geen effect op de mortaliteit bij chronisch hartfalen in tegenstelling tot enkele bètablokkers (nebivolol, metoprolol succinaat, carvedilol, bisoprolol), ondanks de optimistische withdrawal studies (2, 3). In PROVED en RADIANCE kon men aantonen dat de toestand van de patiënt achteruitging bij stoppen van digoxine. Referenties: 1. The effect of digoxin on mortality and morbidity in patients with heart failure. The Digitalis Investigation Group. N Eng J Med 1997;336: Randomized study assessing the effect of digoxin withdrawal in patients to moderate chronic congestive heart failure: results of the PROVED trial. Proved Investigative Group. JACC 1993;22(4): Withdrawal of digoxin from patients with chronic heart failure treated with angiotensin-convertingenzyme inhibitors. Radiance study. Packer et al. N Engl J Med 1993;329(1):1-7. Go with the flow Elderly patient gets admitted Medication reconciliation RASP Geriatrician Follow-up? Discharge Follow-up 3

4 Why not just use the STOPP criteria? Initial goal was to include only those items that would be systematically missed by the geriatricians (~consensus based) 1. Shorter list (initially ) = bundling, deleting several items Disagreement on some items (even more deleting, changing content + adding) 1. Combination of BB + CCB = risk of symptomatic heart block Our own set of criteria together with our geriatricians to increase the chance of implementation afterwards! Why not use the START criteria? More easily outdated than a stop-list Dabigatran in atrial fibrillation (RE-LY) New aht guidelines are coming now (ACC/AHA) More difficult for a pharmacist to (advise to) start than to stop a drug = we need a diagnosis Disagreement BPP in pts taking steroids (not reimbursed in Belgian males) Ca/Vit D (recent evidence concerning higher MI risk) Ace-I in chronic heart failure (only evidence for systolic heart failure: important because in the elderly ~50% have HFPEF) BBrs aren t mentioned in the management of systolisch CHF 4

5 Outcomes.? 1. Polypharmacy as a means to predict an ADR? (Arch Intern Med. 2010;170(13): ) 2. PIMs as a means to predict an ADR? (Ann Pharmacother. 2010;44;957-63) 3. Medication reviews in a certain population, e.g. heart failure? (Arch Intern Med. 2008;168(7): ) 4. Effect on falls? (Age and Ageing 2006; 35: ) 5. Effect on mortality or rehospitalisation? (Br J Clin Pharmacol.65:3; ) More research needed! (Should we strive for an effect on mortality, LOS or rehospitalisation?) No implementation without validation Baseline measurement of effect of our first attempt (2009) (results not shown) Validation of the content (CVI) (results not shown) (2010) Reliable? (2010) easy-to-use, reliable system with validated content and one that works! 5

6 Assessing the reliability of an instrument A lot of (good!) data comes out of nursing journals They are in some ways a way ahead of us pharmacists, especially for the inpatient population In Belgium the gap is being filled as we speak by specialist nurses (heart failure nurse, geriatric nurse, ) How? Test/retest + Cohen s Kappa Methods: test/retest Assessing the internal reliability: will the same rater get the same result for the exact same patient? 2 pharmacists (A.Q., L.D.) reviewed 6 randomly selected patient cases at time 0 (= 03/05/2010) and 4 weeks later (= 27/05/2010) Calculation of the Pearson coefficient to determine possible differences 6

7 Pearson coefficient of correlation, Pearson s R Measure of correlation between two variables -1 to 1 = -1 indicating a negative, 0 no and 1 a positive correlation The more towards -1 or 1 this coefficient, the stronger the association between the two variables and the more accurately you can predict one variable from knowledge of the other variable. What we want: high correlation! Calculated with SPSS 17.0 Methods: kappa test Inter-rater reliability: will different raters come to the same conclusion for a given patient case? 10 pharmacists and 10 geriatricians: 20 detailed patient cases. Results from each participant were compared with those of the investigators using the Cohen's kappa statistic (moderate , favorable , almost perfect ) and the proportion of positive (ppos) and negative (pneg) agreement. Possible differences between pharmacists and geriatricians were detected by the Mann-Whitney U-test (2-tailed, p 0.05). 7

8 What do you need? RASP list What do you need? 8

9 Cohen s kappa: calculations Possibilities Both raters select the RASP item = A Golden standard selects the item, the rater doesn t = B Golden standard doesn t select the item, but the rater does = C Both raters don t select the RASP criterion = D N = A+B+C+D P 0 = relative observed agreement between observers = (A+D/)N P e = hypothetical propability of chance agreement = (A+C)x(A+B)x(B+D)x(C+D)/N² Ppos = proportion of positive agreement = (A+A)/ ((A+A) + (A+C)) Pneg = proportion of negative agreement = (D+D)/ ((D+B) +(C+D)) Results Test/retest Test-retest results were optimal with a Pearson coefficient of r=0.979 (p<0.001). Kappa test Inter-rater reliability was favorable with a median Cohen's k of 0.70 among pharmacists (ppos = 0.71, pneg = 0.98) and 0.64 among geriatricians (ppos =0.70, pneg = 0.98). 9

10 Comparison between geriatricians and pharmacists Geriatricians Pharmacists 1,2 1, ,8 0,8 0,6 0,4 KAPPA PPOS PNEG P > ,6 0,4 KAPPA PPOS PNEG 0,2 0, Future perspective All the results have been written down in one article, which is pending acceptance as we speak RASP 2.0 is in the making Clinical trial will start in September

11 Thanks for your attention! Questions? 11