1. Resources for ADAP Programs AIDS Education and Training Centers (AETCs) National HIV Telephone Consultation Service (Warmline) Clinical Pharmacist Roles in ADAP Programs NASTAD ADAP Conference, July 15, 2009 Ronald H. Goldschmidt, MD Cristina Gruta, Pharm D San Francisco General Hospital University of California San Francisco

2. 11 Regional AETCs 130 Local Perfomance Sites www.aidsetc.org

3. Target Populations – Physicians – Advanced practice nurses – Nurses – Physician assistants – Pharmacists – Oral health professionals – Other healthcare professionals, including medical case managers – Ryan White Program-funded providers serving hard-to-reach and underserved populations

4. Trainings – Didactic Presentations – Interactive Skills Building – Intensive Hands-On Clinical Training with Patients – Patient Specific Clinical Consultations – Technical Assistance and Capacity Building

5. Profession of AETC Training Attendees July 1, 2006 - June 30, 2007 19,597 training events 46,896 hours of training 126,528 healthcare providers trained (73,157 trainees) 44% minority 66% minority-serving *Includes nurses, nurse practitioners, and advanced practice nurses Source: HRSA/HAB, 2008

6. Most Frequent Topics Discussed Antiretroviral Therapy Diagnostic Tests & Disease Progression Adherence Clinical Manifestations of HIV Co-Morbidities Substance Use Opportunistic Infections Drug-Drug Interaction Adverse Drug Reactions Prevention Racial/Ethnic Minorities Risk Assessment Women with HIV Basic Science/ Epidemiology/Global

7. National Centers – National Resource Center – National Evaluation Center – National Minority AETC – National HIV Telephone Consultation Center

8. National Resource Center – Training Materials – Curricula – Charts and Tables – Online Training – Pocket Guides – Self-Study Materials – Slide Sets – Training Materials – Web Links

9. Slide sets Adolescents African Americans Antiretroviral Therapy Case Finding Corrections Cultural Competence Drug Interactions Epidemiology General Testing HIV Testing Hepatitis Co-infection Latinos (U.S.) Managing Side Effects Mental Illness & Health Food Safety & Nutrition Older Adults Opportunistic Infections Oral Health Palliative Care Pediatrics Post-exposure Prophylaxis Preventing Mother-to-Child Transmission Prevention with Positives Primary Care Resistance Testing Sexually Transmitted Infections Starting Treatment Substance Use/Abuse

10. Clinical Manual for Management of the HIV-Infected Adult, 7/10/07 Each chapter can be accessed on line – Testing and Assessment – Health Maintenance and Disease Prevention – Antiretroviral Therapy – Complications of Antiretroviral Therapy – Complaint-Specific Workups – Disease-Specific Treatment – Pain and Palliative Care – Neuropsychiatric Disorders – Populations – Resources for Clinicians and Patients

11. National HIV/AIDS Clinicians’ Consultation Center UCSF – San Francisco General Hospital Warmline Warmline ( 800) 933 - 3413 National HIV Telephone Consultation Service Consultation on all aspects of HIV testing and clinical care PEPline PEPline ( 888) 448 - 4911 National Clinicians’ Post-Exposure Prophylaxis Hotline Recommendations on managing occupational exposures to HIV and hepatitis B & C Perinatal HIV Hotline Perinatal HIV Hotline ( 888) 448 - 8765 National Perinatal HIV Consultation & Referral Service Advice on testing and care of HIV-infected pregnant women and their infants Referral to HIV specialists and regional resources HRSA AIDS ETC Program & Community Based Programs, HIV/AIDS Bureau & Centers for Disease Control and Prevention (CDC) www.ucsf.edu/hivcntr

13. Physicians Internal Medicine Infectious Diseases Family Medicine Ob-Gyn Clinical Pharmacists ------------------------------------------------ Expert consultation, free of charge National Clinicians’ Consultation Center (NCCC) Warmline, PEPline and Perinatal Hotline

14. NCCC Call Volume Since 1992

15. Total Consultations Provided by the NCCC 2008 Warmline - 1992 41,833 calls to date PEPline - 1997 78,831 calls to date Perinatal Hotline - 2004 1,573 calls to date 122,287 calls to date Currently: 13,178 calls/yr (1,178 calls/month) Warmline321 PEPline747 Perinatal Hotline 31

16. Facility of Warmline Callers 2008 FacilityN% Hospital122031.7 Outpatient207653.9 Community Clinic 99825.9 Private Practice/HMO 55214.3 OH/EH 2466.4 Other 2075.4 Urgent Care 641.7 Dental 90.2 Other Medical2787.2 Other Non-medical601.6 Unknown2165.6 Hospital122031.7

17. Profession of Warmline Callers 2008 Profession N% MD/DO249064.7 NP/PA66717.3 RN/LVN2777.2 Pharmacist1122.9 Dental80.2 Other Medical1132.9 Other Non-medical431.1 Unknown1403.6

18. HIV+ Patient Load of Warmline Callers 2008

19. Warmline Call Topics 2008 TopicsN% Antiretroviral Therapy126558.0 Management of Clinical Problems60627.8 Health Care Maintenance61 2.8 HIV Diagnostic Testing/Prevention of HIV Transmission 118 5.4 References/Non-Clinical General Info 42 1.9 Referral14 0.6 Other73 3.4

20. Warmline Non-Occupational Exposures Call Topics 2008 Non-Occupational Exposure Call Topics N% Risk assessment and/or source patient testing155428.3 PEP decision137825.0 Drug selection and/or adverse drug reactions100818.3 Baseline and/or follow-up testing136424.8 Referral to care102 1.9 Other95 1.7

21. PEPline Callers 2008 Profession of PEPline CallersN% MD/DO 383742.8 NP/PA165118.4 RN/LVN222024.8 Pharmacist107 1.2 Dental165 1.8 Other Medical375 4.2 Other Non-medical118 1.3 Unknown488 5.5

22. PEPline Call Type 2008 PEPline Call TypeN% Calls Involving Potential Exposure 795488.3 Treating Clinician 571871.7 Exposed Caller 112314.1 Other Health Professional 790 9.9 Unknown 323 4.1 Calls Not Involving Potential Exposure 105511.7

23. Most common HIV Testing Qs Indeterminate tests Interpretation of Western Blot Rapid test v. Standard tests False positives and negatives Confirmatory testing After Rapid or Standard test Concurrent illnesses/problems – effects on tests Pregnancy, IDU, acute illness, autoimmune disease State laws Post-exposure (after occupational / non-occupational exposures) Confidentiality issues Consent

24. Special characteristics of NCCC consultations? Clinical faculty blend of… Expert knowledge Primary care foundation Multidisciplinary approach Non-judgmental approach to consultation Readily available

25. State HIV Testing Laws Compendium www.ucsf.edu/hivcntr Descriptions of each state’s HIV testing laws Definitions of commonly used terms Links to helpful resources Health Resources and Services Administration (HRSA) AIDS Education and Training Centers and Centers for Disease Control and Prevention (CDC Centers for Disease Control and Prevention (CDC ) National HIV/AIDS Clinicians’ Consultation Center Warmline, PEPline, Perinatal Hotline National HIV/AIDS Clinicians’ Consultation Center Warmline, PEPline, Perinatal Hotline UCSF – San Francisco General Hospital

26. State HIV Testing Laws Compendium - Topics www.ucsf.edu/hivcntr Requirements and restrictions on testing Anonymous or confidential testing Consent requirements Written, verbal, none Opt-in, opt-out Counseling requirements Pre-test, post-test; mandatory vs. recommended; etc. Special situations (pregnancy, criminal justice system) Disclosure Reporting requirements, including name-based reporting

27. Pharmacist Support of ADAP Cristina Gruta, PharmD cgruta@nccc.ucsf.edu HIV Pharmacist Specialist, NCCC Asst Clin Professor (WOS), UCSF School of Pharmacy

28. AETC Pharmacist Trainings San Francisco Area AETC Model

29. Why train pharmacists? Integral part of HIV healthcare team whether in ambulatory, inpatient, or community practice setting Pharmacists as both patient educators and clinicians fills good niche for HIV medication management – Adverse effect management – Drug-drug interactions – Adherence counseling

30. Pharmacist HIV Trainings: SFAETC Model Since 1999, SFAETC has been conducting HIV trainings directed to community pharmacists Trainings borne out of partnership with California ADAP Statewide needs assessment done to determine HIV training needs of pharmacists staffing stores with low-, moderate-, and high-volume HIV customers http://www.aidsetc.org/pdf/workgroups/pharmTE-Guidebook_FINAL.pdf

31. Pharmacist HIV Trainings: SFAETC Model Needs assessment established core competencies for pharmacist trainings – Make pharmacist trainees more aware of HIV resources – Review issues around HIV client confidentiality and cultural competency – Provide updates on the latest advances in HIV care – Heighten awareness surrounding intricacies of HIV-specific adherence counseling – Heighten awareness of integrating pharmacy services to system of care and local HIV community

32. Pharmacist HIV Trainings: SFAETC Model Designed a one-day training, “The Community Pharmacist: A Key Member of the HIV Care Team” Formats were didactic presentations and case- based workshops Workshop topics: – Drug-drug interactions – Adherence support – HIV resistance testing interpretation – Adverse effect management

33. Pharmacist HIV Trainings: SFAETC Model First course in May 2000 – ~ 12 courses – >600 pharmacists trained More recent iteration of course has focused on medication errors Beyond the one day training format – Group consultation led by SFAETC PharmD at community pharmacies – “HIV 101” trainings by SFAETC PharmD at low-volume pharmacies

34. Pharmacist HIV Trainings: Beyond the SFAETC Model http://www.aidsetc.org/pdf/workgroups/pharmTE-Guidebook_FINAL.pdf

35. Pharmacy Consultation Support for California ADAP DISCLAIMER! The following slides were NOT reviewed by California SOA/ADAP

36. CA SOA-PAETC Partnership Medical-Pharmacy Consultation support for CA SOA since 1999 PAETC consultation team consists of two MDs, one PharmD, and one RN all expert in HIV Provides medical and pharmacy-related perspective/advice to various SOA sections – ADAP – EIP/TMP – CBC – CSP Also provides direct global cross-sectional support, e.g. QM, clinic chart reviews

37. Pharmacist Consultation Support for California ADAP Specific projects – ADAP Medical Advisory Committee (MAC)-- provide technical assistance to ADAP officials about MAC clinical discussions – Develop process for systematic review of agents for ADAP formulary consideration – Cost-containment consultations-- give input on potential clinical impact of potential cost containment steps

38. Pharmacist Consultation Support for California ADAP Specific projects, cont’d – T-20 access program (2003-2005) Screened all ADAP clients for T-20 eligibility Approval criteria dependent on CD4+ count and resistance profile of virus – If CD4+ 50-200, need to have 2 other active agents – If CD4+ 50, can have </=1 active agent Time-intensive clinical screening of pt’s HIV treatment history including resistance test interptretation >300 clients screened

39. Pharmacist Consultation Support for California ADAP Ongoing projects – Provide clinical support/tools in developing/implementing ART prescribing criteria – Clinical opinions on pipeline ART agents and expected time of FDA-approval – Periodic formulary review

40. Pharmacist Consultation Support for California ADAP Ongoing projects – Clinical inquiries regarding appropriate ART use – Review and provide clinical input regarding prior authorization criteria (e.g. maraviroc PA and tropism assay requirement) – Provide clinical information regarding off-label use

41. Future Directions ADAP needs clinical “eyes” to ensure programs are on target – HIV pharmacists involvement in formulary discussions on national level – HIV expertise to inform formulary decisions and ADAP questions – Pharmacotherapy of hepatitis co-infection and primary care conditions Quality management projects – Optimizing of ADAP prescribing with goal of decreasing duplications, omissions, errors, etc. Caring for HIV in primary care settings – Educational support for new or experienced primary providers HIV trainings booklets of drugs/ interactions, etc. – HIV expert consultation perhaps key to care for HIV pts in primary care setting

42. rgoldschmidt@nccc.ucsf.edu cgruta@nccc.ucsf.edu