Potential Barriers for HIV Medication Adherence Programs

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