1. Management of drug-related problems in patients with chronic renal insufficiency: a cluster randomised controlled trial Lyne Lalonde, Ph.D. Karolane Paquin, B. Pharm. Anne Lord, M.Sc. Diane Lamarre, M. Sc. Michelle Normandeau, B. Pharm Djamal Berbiche, Ph.D. Marie-Claude Laliberté, B.Sc. Louise Corneille, M.D., F.R.C.P. (C) Louis Prud’homme, M.D., F.R.C.P. (C) Unrestricted research grants from Pfizer Canada and Bourse du Cercle du Doyen (Faculty of pharmacy, University of Montreal) and unrestricted educational grants from Merck Frosst, Amgen, BMS-Sanofi, ProDoc, Léo Pharma, Sabex, Roche, Shire Biochem, Pharmaceutical Partners of Canada

2. ProFiL program Training and communication-network program Facilitate the management of drug-related problems (DRPs) by community pharmacists for CRI patients followed in a pre-dialysis clinic ProFiL pharmacists intervene more frequently to manage DRPs

3. Objectives Prevalence of DRPs Rate of DRPs resolution

4. Methodology

5. Study design Pilot cluster randomized controlled trial Community pharmacies were randomly assigned to the ProFiL program or the Usual Care Consecutive CRI patients attending a predialysis clinic were recruited and followed- up for six months

6. Study population Community pharmacists: Agree to participate to the ProFiL program In the area of Laval (Québec) Patients: Attend the Laval predialysis clinic Report being a patient of one of the participating pharmacies

7. ProFiL program Workshop Pharmacotherapy Familiarise pharmacists with the ProFiL tools Clinical ProFiL tools Clinical summary (lab results, diagnoses) List of medications as documented in predialysis chart Pharmaceutical consultation service Hospital pharmacist with expertise in nephrology was available to answer questions Usual care pharmacists did not have access to the program

8. Drug-related problems Baseline and at six months Based on: Community pharmacy chart Clinical ProFiL tools  Clinical summary  List of medications as documented in the predialysis chart List of OTC and NP as documented during a telephone interview

9. Prevalence of Drug-related problems Baseline Six-monthConsensus Consensus

10. Rate of DRPs resolution Maintained Resolved with change Pharmacotherapy Laboratory result Use of OTC / NP Not evaluable Drug-related problems BASELINESIX-MONTH

11. Results

12. 66 pharmacies et 118 pharmacists sollicited ProFil program Usual care 21 pharmacies et 50 pharmacists 20 pharmacies et 51 pharmacists 41 pharmacies et 101 pharmacists 48 patients 36 pharmacists 14 pharmacies 42 patients 45 pharmacists 15 pharmacies 119 eligible patients

13. Community pharmacies ProFiL 14 Usual care 15 Pharmacist workload: n (%)  25 prescriptions per hour  25 prescriptions per hour 5 (35.7) 9 (64.3) 8 (53.5) 7 (46.7) Surface area (feet 2 ) : n (%) < 1000 1000 - 2500 2501 - 5000 > 5000 2 (14.3) 3 (21.4) 0 (0) 9 (64.3) 1 (6.7) 4 (26.7) 3 (20.0) 7 (46.7)

14. Community pharmacists ProFiL 36 Usual care 45 Gender : n (%) Women Men 14 (38.9) 22 (61.1) 29 (64.4) 16 (35.6) Year of graduation: n (%) 2001 or after 1991 – 2000 1981 – 1990 1980 or before 4 (11.1) 12 (33.3) 4 (11.1) 16 (44.4) 17 (37.8) 15 (33.3) 10 (22.2) 3 (6.7)

15. Patients ProFiL (n=48) Usual care (n=42) Age (year) : mean (SD) 72.0 (10.4)72.3 (10.3) Genre : n (%) Men Women 30 (62.5) 18 (37.5) 26 (61.9) 16 (38.1) Chronic renal insufficiency severity : n (%) Moderate (Creatinine clearance : 30-59 mL/min) Severe (Creatinine clearance : < 30 mL/min) 16 (33.3) 32 (66.7) 18 (42.9) 24 (57.1) Number of comorbid conditions : mean (SD) 5.5 (1.7)5.3 (2.0) Prescribed medications : mean (SD) 12.0 (4.2)11.2 (4.9) Prescribers in past 6 months : mean (SD) 3.6 (1.9)3.3 (2.0) One pharmacy in past 6 months: n (%) 47 (97.9)40 (95.2)

16. Prevalence of DRPs at baseline ProFiL 169 DRPs in 48 patients 3.5 DRPs per patient Usual Care 144 DRPs in 42 patients 3.4 DRPs per patient

17. Type of DRPs at baseline Dose too small (17.9%) Dose too high (4.2%) Adverse reaction (4.2%) Drug interaction (1.9%) Inadequate medication use (15.7%) 23.1% 18.3% 5.9% 49.7% 30.6% 19.4% 8.3% 37.0% 0% 10% 20% 30% 40% 50% 60% Potentiel riskAdd a medication Stop a medication Optimize pharmacotherapy ProFiLUsual care Medications or OTC/NP to be used with caution in CRI Concomittant use of medications in same pharmacologic class

18. Sources of information to identify DRPs 11.8% 13.6% 7.1% 9.5% 48.6% 9.7% 26.4% 6.3% 9.0% 58.0% 0% 10% 20% 30% 40% 50% 60% Laboratory test results Medication renewal OTC / NP use Allergies and intolerances Unspecified ProFiLUsual Care

19. Type of products involved 85.2% 6.5% 8.3% 72.9% 17.4% 9.7% 0 20 40 60 80 100 Prescribed medications OTCs Natural products ProFiLUsual Care

20. Rate of DRPs resolution 12.4% 8.3% 44.4% 9.5% 19.4% 20.1% 16.2% 41.7% 11.1% 25.4% 0 5 10 15 20 25 30 35 40 45 50 Change in pharmacotherapy Change in OTC/NPNormalization of lab results MaintainedNot evaluable ProFiLUsual Care DRPs resolved: ProFiL: 46.2% Usual Care: 47.2%

21. Discussion

22. Prevalence of DRPs In moderate and severe CRI patients followed- up in a predialysis clinic by a multidisciplinary team of health professionnels: 3.5 DRPs per patient Similar to dialysis patients Non optimal use of medications ProFiL: 50% and Usual Care: 37%

23. Rate of DRPs resolution DRPs resolved: ProFiL: 46.2% and Usual Care: 47.2% DRPs maintained: ProFiL: 44.4% and Usual Care: 41.7% In a six-month period, ProFiL program did not improve the rate of DRPs resolution

24. How to explain?? Small sample size and short follow-up Important differences between ProFiL and UC pharmacies and pharmacists Implementation and evaluation at the same time Change in clinical practices: Use of laboratory test results Documentation of OTC and NP