1. Potential Barriers for HIV Medication Adherence Programs Wayne A. Duffus, MD, PhD June 21 st, 2010

2. Why Focus on Medication Adherence? Intensified focus in HIV prevention and at CDC on: –HIV testing –PWP (“prevention with positives”) including linkage to and retention in care, prevention services, and improving adherence Promoting HIV medication adherence to –Maximize benefits of treatment for HIV-positive persons –Likely reduce viral load at the population level

3. Flexibility Policy as it Relates to Access, Adherence and Monitoring Services HAB Policy Notice 07-03 No more than 5% of a states ADAP funding; 10% under extraordinary circumstances –Enable access to medications –Supporting adherence to the medication regimen –Services to monitor progress in taking medications Current, comprehensive coverage of HAART and OI medications No current limitations to access ADAP in the state –No client waiting list or limits on enrollment –No restrictions or limitation on HIV medications –Administrative support is maintained

4. Source of Information South Carolina Washington, DC* Kentucky* Mississippi Arizona Texas Colorado* Virginia* Nevada NASTAD *ADAPs with central office level adherence programs

5. State ADAP Operation South Carolina –Contract pharmacy after years of having an in-house central pharmacy –Adherence monitoring not formally part of pharmacy contract –Individual facilities can use Ryan White funding as part of core services for adherence monitoring –Barriers to adherence are assessed at the provider level using the standardized Ryan White Part B intake/assessment tool –Quality Management Steering Committee selected 10 priority measures. Treatment adherence was not one of them for state level monitoring. Requires a Quality Manager to visit sites and thus enable completeness of reporting.

6. Selected State ADAP Operation Mississippi –Medications are picked up by the patient from the nearest County Health Department –Central Office gets a report of who does/doesn’t collect meds –Information on med pick-up frequency is stored but not actively relayed to provider –New program: District Social Worker to be notified –Contact patient and provider

7. State of Kentucky* Mail order pharmacy: contract with the University of Kentucky Pharmacy Has 6 regional Ryan white subcontractor; every region has an adherence counselor Individual facilities does own adherence counseling Statewide Quality Management Program: implemented in 2009 with report to central office –Training on adherence for case managers –New intake form has assessment tool of barriers to treatment and medication adherence –Variables collected include: # refills in one year; time lapse between diagnosis date and first prescription

8. ADAP Operation Washington, DC* –Primarily a pharmacy network where medications are picked-up. In some cases medications are sent directly to the provider office –Central office developed minimal guidelines for medical case management that includes adherence monitoring –Have contract with the Center for Minority Studies: monthly 2 hour treatment adherence roundtable including funded providers, pharmaceutical reps, clients, case managers, etc –Overwhelming numbers of new cases and linkage to care with adequate provider availability an issue

9. State ADAP Operation Texas –Network of 480 local pharmacies and one mail order pharmacy –Central office sends medications to each pharmacy after receiving faxed prescription from pharmacies –Clinic sites have case managers who assess adherence –Geographic distance from central office to individual providers makes on-site monitoring prohibitive

10. State ADAP Operation Colorado* –Co-located clinic and pharmacy –Actively track utilization –Contact patient and provider Nevada –Two pharmacies (North and South): one pick-up only, other pick-up/mail order –Had formal adherence program in the past but with decreased funding availability had to end program –Current database does not store previous medication history for long periods

11. State of Virginia* Medications are dispensed from central pharmacy and collected from any of 135 local health departments (LHD) LHDs provide ADAP services in-kind (eligibility and medication coordination) ADAP Adherence Pilot Project –Six local health departments (LHD) funded for 18-months –Two different approaches: Client-based vs Process-based –Challenges at all level: LHD, administrative, service delivery Adherence services provided by a wide variety of staff which results in variability across sites HIPAA regulations limit access to health records for staff from other agencies Follow up between providers and case management is sporadic

12. Barriers to Adherence Programs State policy –No legislative regulation that specifically prohibits implementation –No Board of Pharmacy rule that prohibits implementation, however, may specify licensed individual to perform duties related to medication monitoring –Treatment adherence services vary widely across state and Ryan White programs Structural and Medical –Transportation, housing instability, substance use, mental health

13. Barriers to Adherence Programs Financial –Resource availability (Part B only vs Part A and Part B) –Wait list and other cost containment measures –Contract pharmacy cost to include adherence as part of service delivery –Choice between providing medications or providing services

14. Barriers to Adherence Programs Providers –Perceived intrusion into physician-patient relationship –Difficult to access or to be involved at the state level Personnel –Special skills not possessed by existing staff eg. data analysis, in-house pharmacist, research –Staff with multiple responsibilities and limited availability at the local level

15. Barriers to Adherence Programs Administrative –Understaffed, inertia to create another program –Unclear on content of an adherence program at the state level –Insecurity on how to administer an adherence program when the interaction is provider-patient –Formal evaluations not yet conducted at existing adherence programs

16. Path Forward Funding to allow implementation and sustainability of programs Create adherence models at the state level, provider level or case management level (dissemination of best practices) Distinguish adherence monitoring at the patient- provider vs central office-population level Clear advice/discussion on what to do with the data collected and how relevant to the mission at all levels of care

17. Path Forward Improved communication needed between state, provider and case management Define agency responsible for promoting change at the facility, provider, or patient level Promote ADAP integration with HIV surveillance to provide lab data eg. CD4/VL, genotypes Consider adoption of other measures of adherence: mortality, community viral load, community resistance