Potential Barriers for HIV Medication Adherence Programs Wayne

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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 patientprovider 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

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. CD 4/VL, genotypes • Consider adoption of other measures of adherence: mortality, community viral load, community resistance