PREVAIL Partnership for Research on Ebola Virus in Liberia - PDF document

1/27/2019 PREVAIL Partnership for Research on Ebola Virus in Liberia DEPLOYMENT EXPERIENCE LIBERIA, AFRICA 2018 Holly Van Lew, Pharm.D., BCPS Advance Practice Pharmacist Indian Health Service Phoenix Indian Medical Center DISCLOSURE The author, Holly Van Lew, has: • Nothing to disclose • No relevant financial relationships 1

1/27/2019 OBJECTIVES • Outline how the practice of pharmacy in Liberia, Africa differs from U.S pharmacy practice. • Discuss common medical conditions in Ebola survivors, and the role of the pharmacy in their care. • Review the pharmacists role in the Ebola vaccine clinical trials. • Describe the challenges of procuring, storing, and dispensing medications in Liberia, Africa. • Identify cultural practices and factors that contributed to the spread of Ebola in West Africa. PRE-ASSESSMENT QUESTIONS What are issues facing Liberia as it recovers from it’s semi - 1. recent Civil War, that directly impact medications and pharmacy practice? A. Poor sanitation/Limited access to running water Access to reliable power B. C. Transportation and poor roadways D. Concerns with shipping & effects of corruption All of the above E. 2

1/27/2019 PRE-ASSESSMENT QUESTIONS 2. What are the medical conditions in Ebola survivors for which the clinical trial pharmacists dispense medication? A. Uveitis – prednisone & difluprednate S/P Cataract surgery – ophthalmologic meds B. C. Back pain – analgesics and narcotic pain meds D. Positive Ebola in semen samples – ZMAPP investigational drug PRE-ASSESSMENT QUESTIONS 3. The PREVAC clinical trial: A. Included healthy adults and children Was blinded from everyone except the pharmacists B. C. Had to overcome issues of reliable power supply, storage at very low temperatures and difficulties with importation D. Was the “Natural History” trial that monitored Ebola Survivors 3

1/27/2019 ABOUT LIBERIA • Established as a homeland for freed African-American and Caribbean slaves in the 19th century • Mostly (>95%) indigenous African people • In civil war from 1989-2003 • Struggling to rebuild infrastructure: roads, electricity, water, sanitation, housing, jobs, medical care, education • Climate and Landscape • Humid, tropical climate • 2 seasons: Dry and Rainy • Beautiful ocean front property, rainforest • Ebola outbreak 2014-2015 • 10,678 cases  4810 deaths SANITATION 6 5 4 3 2 1 0 Category 1 Category 2 Category 3 Category 4 Series 1 Series 2 Series 3 4

1/27/2019 STREET CONDITIONS CITY VS RURAL LIFE 5

1/27/2019 CITY LIVING & WATER PHARMACY PRACTICE IN LIBERIA Only 200 pharmacists in the country • Most work in managerial/business/regulatory role • Pharmacists do not typically staff pharmacies Pharmacy school in Monrovia • Classes of 15-30 graduate per year • School loans paid once students graduate • Training is more like pharmacy technician level • Striving to change pharmacy practice 6

1/27/2019 PHARMACIES AND REGULATION PREVAIL/PREVAC Partnership for Research on Ebola Virus in Liberia (PREVAIL) • PREVAIL I – Phase 2 trial 1500 participants • PREVAIL II – ZMAPP infusion for active Ebola cases • PREVAIL III – Natural History trial – 8000 participants • PREVAIL IV – Viral Persistence in Semen- Drug GS-5734 • PREVAIL V – (PREVAC) 4500 participants 3 vaccines vs placebo • PREVAIL VI – Genomics of Ebola fatal cases – 500 cases • PREVAIL VII – Cataract Trial – 38 participants Partnership for Research on Ebola Vaccine (PREVAC) • As above, also known as PREVAIL V 7

1/27/2019 JFK HOSPITAL JFK HOSPITAL 8

1/27/2019 RANDOMIZATION - PREVAC • The trial may enroll approximately 5,500 participants, and started with a two-arm design under v2.0 before moving to a five-arm design under v3.0. Then under v4.0 the study used an undiluted version of rVSV • Two-Arm Design: • • 2 x Ad26 / MVA • • 1 x 0.5mL Placebo / 0.5mL Placebo (to match Ad26 /MVA) • Five-Arm Design: • • 2 x Ad26 / MVA • • 1 x 0.5mL Placebo / 0.5mL Placebo (to match Ad26 /MVA) • • 2 x rVSV / Placebo • • 1 x rVSV / rVSV • • 1 x 1mL Placebo / 1mL Placebo (to match rVSV) STUDY DRUG 9

1/27/2019 EBOLA SURVIVORS-MEDICAL CONDITIONS Ophthalmology complications • Cataracts – often bilateral causing blindness in young adults • Uveitis – onset during acute illness or later • Durezol (difluprednate) • Sunglasses • Reader glasses • Other ophthalmologic agents – latanprost, brimonidine, etc Neurological complications • Symptoms improved with time after Ebola infection • Slower mentation, memory loss, headache, tremors, etc • Some medications prescribed, but not many • Persistent virus shedding in semen • ZMAPP infusions – approximately 1-4 every 3 months PHARMACY CHALLENGES Medication Storage • Problematic due to numerous factors • Unreliable power access and surges • Non-working IV hood • Ruined equiment • Humid, warm temperatures – air conditioning not common • Difficult to obtain cold storage and other equipment • Shipping from other countries • Customs/taxing unreliable and often corrupt • Particularly difficult storage conditions for investigational vaccine • Storage at -80° C, -40° C and -20°C 10

1/27/2019 COLD STORAGE PHARMACY CHALLENGES Medication Procurement • Lack of standards – unreliable local drug sources • Most medications imported, especially for the clinical trials • Incredibly complex process of paperwork, justifications, and approvals Medication Dispensing • Everything documented & inventoried by hand • No labelling • No process for refills • Counselling • Many not literate • Lay beliefs about medications 11

1/27/2019 PHARMACY WORK AREA AT JFK 12

1/27/2019 TASKS AND DUTIES • Launch of version 4 (use of undiluted VSV) protocol for PREVAC in Liberia • Trained 3 pharmacists via video conference for version 4 launch of protocol in Mali • Revision of Pharmacy Manual for storage of investigational drug and shelf life • Wrote 4 SOPs (ADR, donation of meds, destruction of meds, Cold storage for Mali) TASKS AND DUTIES • Worked with Liberian pharmacists to complete first Journal Club • Managed temperature excursion with 25 doses of investigational drug • Instituted action logging process and completed preventative maintenance on -20C and -80C Freezers • Completed training and education regarding appropriate use of Durezol in post-op cataract patients to Liberian pharmacy team • Assessed needs for space, equipment needs and logistics for relocation of pharmacy at JFK hospital • Reviewed and edited all pharmacy entries in Finale Inventory system to ensure accuracy and consistency with data entry 13

1/27/2019 IHS PHARMACISTS THE SPREAD OF EBOLA • Poor Sanitation/No running water • Very physical cultural practices – elaborate handshakes, hugging • Burial practices • Washing/dressing the deceased by eldest child • Funerals were very social events, deceased highly revered • Cremation not an accepted practice • Led to fear and body knapping • Yellow cab • Fear of diagnosis or alerting health authorities of illness • Eating/sharing meals at markets 14

1/27/2019 CITY VIEWS ACCOMODATIONS 15

1/27/2019 COASTAL VIEWS AFRICAN WEDDING 16

1/27/2019 COLLEAGUES POST-ASSESSMENT QUESTIONS What are issues facing Liberia as it recovers from it’s semi - 1. recent Civil War, that directly impact medications and pharmacy practice? Poor sanitation/Limited access to running water A. Access to reliable power B. Transportation and poor roadways C. Concerns with shipping & effects of corruption D. All of the above E. 17

1/27/2019 POST-ASSESSMENT QUESTIONS 2. What are the medical conditions in Ebola survivors for which the clinical trial pharmacists dispense medication? A. Uveitis – prednisone & difluprednate S/P Cataract surgery – ophthalmologic meds B. C. Back pain – analgesics and narcotic pain meds D. Positive Ebola in semen samples – ZMAPP investigational drug POST-ASSESSMENT QUESTIONS 3. The PREVAC clinical trial: A. Included healthy adults and children Was blinded from everyone except the pharmacists B. C. Had to overcome issues of reliable power supply, storage at very low temperatures and difficulties with importation D. Was the “Natural History” trial that monitored Ebola Survivors 18

1/27/2019 QUESTIONS? • Contact information: • Email holly.vanlew@ihs.gov 19