1. Community Pharmacists Provision of Pharmaceutical Care to the Older Adult R. Grymonpre L. Vercaigne C. Metge P. Montgomery University of Manitoba

2. Community Pharmacists Expanded Role There is strong evidence that clinical pharmacy services add value to patient care and reduce health care utilization costs….clinical services are not widely provided in community pharmacy settings The Clinical Role of the Community Pharmacist. Office of the Inspector General, USA. January 1990 The judicious use of the professional qualifications of pharmacists [is encouraged] The Rational Use of Drugs by the Elderly: A Strategy for Action. Government of Quebec. 1995 National action to ensure appropriate use of all medication will require the active participation of …[seniors, physicians, pharmacists, nurses, governments, industry, family members and caregivers] Federal/Provincial/Territorial Strategy for Action. Health Canada. June 1996

3. Community Pharmacists Expanded Role The pharmacist is in an excellent position to monitor seniors medication use at the point of dispersal Optimizing Medication Use in Seniors Receiving Home Care. Canadian Association Community Care. August 1997 Pharmacists are perhaps both the most important – and least utilized – source of information and education about medications Seniors, Diversity & Access: Medication Use & Hard to Reach Seniors. National Pensioners and Senior Citizens Federation. May 1997 Pharmacists can play an increasingly important role as part of the primary health care team……this expanded role would allow pharmacists to consult with physicians and patients, monitor patients use of drugs, and provide better information and communication on prescription drugs. Building on Values: The Future of Health Care in Canada Final Report. Romanow RJ. (Commissioner) November 2002

4. Community Pharmacists Expanded Role Cochrane Review: increased scheduled health services but no decrease in hospital and ER admissions (1 of 7 studies); decreased hospital/ER admissions, number of specialty physician visits, numbers or costs of drugs, improved appropriateness of drugs (6 of 7 studies); improvements in targeted condition but no change in quality of life or incidence of ADR (10 of 13 studies); improvements in patient adherence (3 of 6 studies) favorable changes in physician prescribing (9 of 10 studies) Beney J, Bero L, Bond C. Expanding the roles of outpatient pharmacists: effects on health services utilisation, costs, and patient outcomes (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd.

5. Geriatric Pharmaceutical Care 2001:12.5% Canadians 65+ years old 2026:20% of Canadians 65+ years old In Manitoba (1996): 13.6% of population 65+ years old 34% of prescriptions dispensed average of 5 different drugs

6. Geriatric Pharmaceutical Care Life expectancy, at birth (1997): 75.8 years for men 81.4 years for women In one study of older persons, drugs contributed to 20% of hospitalizations Grymonpre et al J Am Geriatr Soc. 1988

7. Community-Based Geriatric Pharmacy Care 6 studies: Positive results: Improved adherence (1) Excellent physician & patient acceptance (81% & 91%) (1); DRIs identified and resolved (2) More appropriate drug use (1); more drug changes (1); fewer repeat prescriptions (1); reduced drug costs (1) Reduced outpatient visits (1); reduced hospitalizations and hospital stays; reduced health care costs (1) Negative results: No difference in SF-36 (1); no difference in health decline, falls (1) Poor physician acceptance (28%); DRIs identified but not resolved (1) No difference in numbers/costs of drug, medication adherence (1) no change in health services use (2)

8. Community-Pharmacists: Geriatric Pharmaceutical Care Bernsten C et al. Drugs & Aging 2001;18(1):63-77 Design: randomized (by pharmacy), controlled Participants: 190 sites, 2,454 patients, 65 years, 4 prescribed meds, oriented x 3, noninstitutionalized Intervention: pharmaceutical care for 18 months; community pharmacy Process measures: number of medications & changes; contacts with GP, GP acceptance & satisfaction; cost analysis; medication knowledge & adherence Outcome measures: SF-36, hospitalizations, symptoms (self- reported), patient satisfaction Results: improved satisfaction & symptom control, no difference in other measures

9. Community-Pharmacists: Geriatric Pharmaceutical Care Sellors J. SMART. Final report. Sept. 2000 Design: randomized, controlled Participants: 889 patients, 65 years, 5 prescribed meds, MMSE25, noninstitutionalized Intervention: pharmaceutical care; 24 community pharmacists Process measures: number and types of drug-related issues, resolution rate of issues, physician response, number of daily medications, medication units, & costs, inappropriate drugs, medication adherence Outcome measures: medication problems (self-reported), health care utilization and costs; SF-36 Results: DRIs identified in 88% of subjects (mean 3.2); 84% physician acceptance; 57% MD implementation; no difference in other measures.

10. Community-Based Geriatric Pharmacy Care Grymonpre RE et al Int J Pharm Pract 2001;9:235-41 Design: randomized, controlled Participants: 135 patients, 65 years, noninstitutionalized, 2 medications Intervention: pharmaceutical care for 1 year; wellness clinic Process measures: number and types of drug-related issues, resolution rate of issues, physician response, number & costs of medications, medication knowledge & adherence Outcome measures: symptoms (self-reported) Results: 952 issues identified, 29% resolution rate; positive MD response but 28% acceptance rate (by survey); no difference in other measures

11. Hypothesis Community pharmacists have the necessary skills and knowledge to improve drug taking behaviour of older adults and the prescribing habits of physicians, thereby optimizing disease control and reducing the amount of drug-related illness in this segment of the population.

12. Manitoba Pharmaceutical Care Project Research Questions: Can a workable model of community-based pharmaceutical care be provided to physicians and elderly patients? What is the impact of community pharmacists practicing pharmaceutical care on: Physician and patient acceptance and implementation of recommendations? Use of medications by older persons?

13. Objectives: To document measures of the patient-focussed pharmacy care provided: numbers and types of drug-related issues identified; numbers and types of recommendations made; physician and patient acceptance of recommendations; endpoints of plans of action; interview and work-up times; level of remuneration To measure the impact of comprehensive patient-focussed pharmacy on: medication adherence (primary measure); numbers and costs of medications

14. Methods: Pharmacy & Pharmacist Selection Invitation for participation and application Selection based on criteria & signed contract: demonstrate an understanding of pharmaceutical care removed from dispensing activities for 6 hours/week recruit 1 client/week x 74 weeks provide pharmaceutical care to patients agree to training & group sessions complete and submit required documentation access to confidential area space & equipment for maintaining files access to library of references

15. Methods: Process of Care Intervention Eligible clients perceived to be at risk recruited Intervention: Comprehensive patient-focussed pharmacy care medication history develop, implement and document patient care plans: o identification of drug-related issues o intervention (MD &/or client) o follow-up Remuneration provided

16. Methods: Process of Care Action Plan Characterized by a single or multiple drug-related issue(s) and disease state(s) Requiring a single or multiple recommendation(s) Resulting in one desired endpoint Issues : undertreated diabetes, lack of knowledge, condition requiring monitoring Recommendations : add drug, educate client, refer to dietician, monitor blood sugars Acceptance: client and MD accepted recommendations Endpoint : blood sugars normalized

17. Methods: Process of Care Endpoint Dependent on issue(s) identified in plan of action health outcome - clinical issue symptom/measure of disease or side effect: BP, BS, pain, constipation process endpoint – drug issue no indication, wrong drug, overdose when not feasible to look at clinical endpoint (immunization, osteoporosis, stroke prophylaxis) education & nonadherence Status of issue at follow-up partially resolved - positive trend but desired target not reached

18. Methods: Research design Design: prospective, nonrandomized, controlled, before- after trial, survey and population based Setting: community pharmacies Study Subjects: convenience sample; 65+ years old; noninstitutionalized; willing to provide signed informed consent; taking at least 1 medication Control Subjects: randomly selected from Manitoba Health database; 3:1 match by age, gender, and Adjusted Clinical Group

19. Methods: Process Measures Population based measures: medication adherence (primary measure); numbers and costs of medications Survey based measures (test only): interview and work-up times; remuneration; numbers and types of drug-related issues identified; numbers and types of recommendations made; physician and patient acceptance of recommendations; endpoints of plans of action

20. Methods: Data analysis Population based data: Required sample size (total) = 220 10% change in medication adherence = 0.10 = 0.05 std deviation 25% (Annals 1998) Mixed modeling procedure (SAS)

21. Medication Adherence: Cumulative Medication Acquisition (CMA) CMA* = days supply in interval actual number of days in interval *CMA values are only calculated on medications with 3 or more fills and a prescribed rate (quantity dispensed days supply) of 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5. Using these criteria, DPIN was determined to be a valid measure of medication adherence compared to pill count with 77% concordance & McNemars p=0.6837 Grymonpre RE et al [ABSTRACT] Can J Clin Pharm (in press) 2004

22. Remuneration: Pharmacy Consultation Grymonpre et al J Res Pharm Econ 2001:11(1):51-61

23. Results: Pharmacy recruitment Total number of pharmacies: 11 (selected from 15 applicants) Total number of test pharmacists: 15 Orientation session: May 1 & 2, 1998 (9 hours) Ongoing one-on-one support with resource pharmacist and groups sessions.

24. Results: Client recruitment Study duration: May 1, 1998 - Jan 31, 2000 Total number of clients evaluated: 337 Total number of eligible clients: 213 (63%) 124 Exclusions: no consent 78 insufficient documentation 46

25. Results: Demographic Data

26. Results: Drug Benefit Plans No 3 rd party coverage70/126 (56%) Blue Cross42/126 (33%) Dept. Veterans Affairs9/126 (7%) Other*5/126 (4%) *Great West Life, Indian Affairs, Assure

27. Results: Time required

28. Results: Action Plans 211 of 213 clients had 1 Action Plan 732 Action Plans were developed mean of 3.5 1.7 per person characterized by 945 drug-related issues involving 1005 recommendations

29. 945 Drug-Related Issues

30. Recommendations to physician Of 1005 recommendations made: 499 (50%) recommendations involved the MD 114 (23%) of 499 recommendations to MD not made/documented

31. 385 recommendations made to MD: start drug 80 (21%) stop drug 61 (16%) switch drug 61 (16%) monitor therapy 54 (14%) decrease dose 29 ( 8%) increase dose 28 ( 7%) dispensing task 12 (3%) change dosing time 11 (3%) refer other hcp 9 (2%) change dose form 8 (2%) encourage adherence 5 (1%) other 27 (7%)

32. Physician response Of 385 recommendations made to MD : physician response to 87 (23%) unknown Of 298 known responses: 82% accepted and 4% partially accepted

33. Recommendations to patient Of 1005 recommendations made: 1003 (99.8%) recommendations involved patients 89 (9%) required recommendations to patients not made/documented

34. 914 recommendations to patient educate 153 (17%) start drug 127 (14%) monitor 122 (13%) change drug 92 (10%) stop drug 76 (8%) disp.related task 48 (5%) increase dose 43 (5%) compliance aid 43 (5%) decrease dose 41 (4%) nonpharm. advice 38 (4%) change time 34 (4%) enc. adherence 34 (4%) refer to hcp 25 (3%) other 38 (4%)

35. Patient response Of 914 recommendations made to patient: patient response to 142 (16%) unknown Of 772 known responses: 90% accepted and 3% partially accepted

36. Endpoints of 732 Plans of Action Of 732 Plans of Action: Endpoint unknown for 278 (38%) Of 454 documented endpoints, 344 (76%) were resolved or partially resolved.

37. Medication Adherence: Pre- versus Post- Intervention 199 Test vs 506 Control Subjects P=0.0064

38. Number of Different Drugs: Pre- versus Post- Intervention 199 Test vs 506 Control Subjects P=0.0044

39. Annual drug costs: Pre- versus Post- Intervention 199 Test vs 506 Control Subjects P=0.0716

40. Summary Some difficulties with process: target recruitment rate of 1 client/week could not be met 23% recomm. involving MD not made/documented 9% recomm. involving patient not made/documented 23% of MD responses not determined/documented 16% of patient responses not determined/ documented 38% of endpoints not determined/documented

41. Summary When process successfully implemented & documented: 99% of clients experienced 945 drug-related issues requiring 1005 recommendations 86% physician acceptance rate 93% patient acceptance rate positive endpoints achieved for 76% action plans

42. Benefits: Health & Health Costs Compared to control subjects, test subjects had: a lower rate of increase in numbers of drugs (p=0.004) a lower rate of increase in costs of drugs (p=0.07) greater improvements in medication adherence (p=0.006)

43. Conclusions The delivery & documentation of pharmaceutical care was challenging & required one-on-one support by a resource pharmacist Older adults experienced several drug related issues Community pharmacists had the necessary skills and knowledge to identify & resolve these issues which resulted in desired process endpoints and health outcomes Community pharmacists providing patient focussed care reduced numbers and costs of medications and improved medication adherence

44. Acknowledgements JApotex Inc. JCIHR (formerly NHRDP) JCentre on Aging JManitoba Health JManitoba Pharmacists JManitoba Pharmaceutical Association JManitoba Society for Pharmacists JJenny Kleine Golden (1972-2002)

45. Acknowledgements JMs. Marie Berry (Vimy Park Pharmacy) JMrs. Carol Boscow (The Pas Super Thrifty) JMrs. Barbara Bromilow (Pharmasave Beasejour) JMrs. Donna Campbell (Pharmasave) JMr. Bill Cechvala (Vimy Park Pharmacy) JMr. Terry Chan (Shoppers Drug Mart) JMrs. Wendy Clark (Carman Pharmacy) JMrs. Morna Cook (Dixons Pharmacy) JMs. Shelley Cowie (Shoppers Drug Mart) JMs. Camella Crook (C&C PC and Consulting) JMr. Quy Doan (Shoppers Drug Mart) JMr. Brian Dusik (St. James Pharmacy) JMrs. Michele Fontaine (Shoppers Drug Mart) JMr. Myles Haverluck (Dauphin Clinic Pharmacy) JMr. Warren Hicks (The Pas Super Thrifty Drug Mart) JMr. Rob Jaska (Medical Centre Pharmacy) JMrs. Nadine Karpinski (Shoppers Drug Mart) JMr. Darryl Lancaster (Pharmasave) JMrs. Tracy Lelong-Young (Prescription Plus Pharmacy) JMrs. Donna McLeod (Pharmasave) JMrs. Nancy Metcalfe (Pfahls Drugs Ltd.) JMr. Real Mulaire (St. Pierre Pharmacy) JMrs. Lisa Olench (Pharmasave) JMrs. Julie Penelton (St. James Pharmacy) JMr. Sigfried Pfahl (Pfahls Drugs Ltd.) JMr. Don Radley (Pharmasave) JMrs. Nancy Remillard (Pharmasave) JMr. Jay Rich (Shoppers Drug Mart) JMr. Mark Scott (Shoppers Drug Mart) JMr. Trevor Shewfelt (Dauphin Clinic Pharmacy) JMr. Rolland Villar (Shoppers Drug Mart) JMrs. Sonia Wriedt (Pharmasave)