1. Presented by: Peggy Odegard, PharmD, BCPS, CDE, FASCP Associate Professor, University of Washington The Medication Adherence Program: Promoting diabetes self-management through community pharmacies

2. The American Association of Diabetes Educators Foundation, for their grant support of the study Thank you

3. Thank you! MAP Study Team Gina Carpinito, PharmD Dale Christensen, PhD David Williams, RPh Don Downing, RPh David Blough, PhD 3

4. Describe the specific aims of the Medication Adherence Program (MAP) Study in Washington State Explain the MAP protocol for DM medication self-management support List the primary study findings –effect of the MAP intervention on DM medication adherence –key interventions to facilitate resolution of self-management challenges Discuss study conclusions and next steps Goals for learning…

5. Adherence to prescribed DM therapy is not ideal: –Retrospective studies: 31-87% adherence –Prospective studies: 53-98% adherence –General literature: 36-85% with better adherence to insulin 80% adherence would mean missing a refill by 6 or more days for a 30 day supply Missed refills may flag an adherence difficulty * Diabetes Educator.2007;33(6) Taking Medications is a Challenge!

6. 1.Regimen complexity 2.Dosing frequency greater than twice daily 3.Remembering doses and refills 4.Depression 5.Adverse effects or fearing them 6.Understanding the regimen 7.Belief and confidence in therapy 8.Cost 9.Ability to read the prescription label Diabetes Educator.2007;33(6) The challenges

8. Specific aims –To identify medication self-care challenges for people with diabetes –To improve medication self-care for patients with diabetes Study Hypothesis –A personal, diabetes-care focused call by the pharmacist in follow-up to a missed diabetes prescription refill will improve adherence MAP Study

9.  Study Design: Randomized, controlled trial, N=265 ◦ 4 participating Safeway pharmacies  120 MAP intervention patients  145 control (no-intervention, usual pharmacy care) patients  Intervention: ◦ Personal telephone call from pharmacist to patient who missed an oral DM Rx refill by 6 or more days. ◦ Call used to address medication self-management challenges and to promote optimal diabetes care Map Study

10. “Hello. This is (name), your Safeway pharmacist. I am calling to check in and see how you are doing with your diabetes management (discussion Q&A) I noticed that you did not refill your (drug name) this month. Would you like me to refill it now? Was there a reason that you didn’t refill it?” –Subsequent discussion allows for initiation of intervention actions MAP Call Script

11. Judy is a 67 year old, overweight female with type 2 DM, HTN, painful neuropathy, and high cholesterol who is late to refill her glyburide and metformin by 6 days Meds: –Glyburide 10 mg po BID –Metformin 1 gm po BID –Enalapril 40 mg po daily –Hydrochlorothiazide 25 mg po daily –Atorvastatin 40 mg po BID –Gabapentin 800 mg TID A call to Judy reveals –“yes, I take my pills every day but I don’t have any refills left on the prescriptions. I thought I needed new prescriptions from my doctor but I haven’t been able to make an appointment yet” Pharmacy note: –blood pressure last month 146/92 mmHg –blood glucose last month 218 mg/dL fasting –log book: fasting glucose last two weeks all above 200 mg/dL Case example…

12.  The pharmacist offered to call Judy’s physician for refill authorization and encouraged her to come in the same day to minimize gap in therapy  Judy was instructed to call the pharmacy for future refill needs and they will contact the doctor for authorization  Encouragement of her continued use of the medicine was provided  Referral to provider for diabetes check up recommended due to recent bp and glucose results The intervention

13.  Question 1: What services did pharmacists perform, and what were their views about this added service?  Question 2: Did the intervention improve DM medication adherence?  Adherence to specific medications  “medication possession ratio” or “MPR” ==============================  Question 3: What were the predictors of poor adherence prior to the intervention?  Question 4: What factors contributed most to the change in MPR in the 12 month follow-up period? MAP Study: Analysis

14. CharacteristicControl (N=145)Intervention (N=120)p value Age (years (SD))61 (13)65 (13)0.015 % female50.353.8NS # different Rxs/12 months 56.4 (42)59.7 (37)NS % insulin use23 NS Medication complexity Score* 23.423.9NS MPR DM meds, 12 months pre 0.840.86NS Refill gap (max)22.722.3NS % MPR >0.865.274.40.029 MAP Study: Baseline * Complexity score=# unique meds x mean #doses per day

15. Problem reported by patients (N=119) Frequency (% of sample) Difficulty with taking DM medication32 (27) - remembering dose29 (24) - reading Rx label6 (5) - side effects6 (5) - hypoglycemia5 (4) - gastrointestinal upset5 (4) Forget to order refills31 (26) Forget to pick up refills9 (8) Baseline Medication Self-Management Problems

16. Question 1: What services did pharmacists perform, and what were their views about this added service?

17. Actions Intervention CharacteristicsMean (SD) # visits per subject3.4 (2.4) Time on calls with subject (minutes)12.6 (10.7) Actions # subjects (%) DM Education42 (35) Adherence Support48 (40) Optimize regimen through consultation with prescriber 7 (6) Economic adjustment (e.g. changed to generic) 3 (3)

18. Pharmacists Impressions (N=7) QuestionYesNoMaybe Was a report on missed refills helpful? 700 Was call focused on DM needs?7 (reported as DM med ed or DM care) 00 Did you feel prepared to answer questions about DM ? 610 Would a CDE have been helpful to your patients? 41 – not practical in retail setting 2 – patients not at readiness level Was the $10 reimbursement per call sufficient? 601 If a report were made available after the study, would you use it? 42, not enough time to call 1

19. Question 2: Did the intervention improve DM medication adherence?

20. Medication Possession Ratio (MPR) independent t-test Improved for intervention over 12 months (p=0.012). Control change was not significant.

21. independent t-test difference between differences Yes – the change in MPR for intervention was significant as compared to control between baseline and 12 months, P=0.004 P=0.004 Is this change in MPR meaningful? MPR Change

22. Intervention subjects were 4.77 times more likely than control subjects to achieve an oral DM medication adherence rate greater than 80% during the 12 month intervention follow-up period Likelihood of oral DM medication adherence rate above 80%? EffectOdds Ratio95% Confidence Limits Intervention versus Control 4.771.996-11.403 * Logistic regression model included demographic, medication, and baseline adherence variables

23. The regression model which included demographic variables, regimen complexity, and prior oral DM 12 month adherence measures, explained 70% of the change in MPR scores during the post period. Statistically significant predictors of MPR change: –Low MPR during the prior period (p<0.0001) –Less resistance to taking meds (p=0.04) –Less time needed with the pharmacist (p=0.001) Predictors of MPR improvement during the 12 month post period among STUDY patients

24. Pharmacies performing the most interventions were those who integrated late refill messages into the daily dispensing workflow Days late for refills is an easy but imprecise indicator of adherence problems, as it generates false + signals if drugs were obtained from other sources Key reasons patients give for sub-optimal adherence: –forgot to refill prescriptions –forgot to take doses of medications. Challenges in optimizing pharmacy-based DM interventions: Patients who do not pick up their own medication refills Patients using both community and mail order pharmacies Patients using multiple physicians for diabetes care MAP Study: Lessons Learned

25. Because adults with DM visit pharmacies more often than they visit any other health professional, it is believed that there is an untapped opportunity for pharmacists to provide self-management education and support for medications. A community pharmacy-based medication adherence service for DM patients based on late refill alerts is feasible with adequate training and incentives.  This study shows that  a brief telephone follow-up by pharmacists in response to missed refills improves DM medication adherence  individuals with low prior adherence and those who are not resistant to using medications will have the greatest impact on adherence from the intervention  Individuals who require more time may not be as responsive to the intervention  Effective interventions involved: ◦ Patient education ◦ Adherence support – integrating dosing with ADLs ◦ Advice regarding prevention of side effects Conclusions

26. Questions?