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PHIDISA Pharmacy Operational Team Report. Richards Bay Conference July 2004. Pharmaceutical Care Operational Team. Outline. Accomplishments, Challenges, and Future Plans/Proposals: Drug Procurement & Storage ARV Use Projection/Budget (Aug 2004-July 2005) Site Development & Personnel Needs
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PHIDISA Pharmacy Operational Team Report Richards Bay Conference July 2004
Outline • Accomplishments, Challenges, and Future Plans/Proposals: • Drug Procurement & Storage • ARV Use Projection/Budget (Aug 2004-July 2005) • Site Development & Personnel Needs • Pharmacist Accomplishments • Staff Training • Other Accomplishments & Future Plans • Non-ARV Budget
Drug ProcurementMajor Challenges • Forecast of drug usage& stock levels – • Need to project rate of patient enrollment • Assure uninterrupted supply of ARV • Awaited access to MHBD for ARV stock level • Challenge will increase as all sites become operational • Anticipate manufacturer backorders and delivery delays – estimate time from order to delivery • Treatment of ARV-experienced adults and pediatric patients (PEPFAR) – acquisition of paediatric formulations & new accountability system
Drug ProcurementFuture Plans/Challenges • Establish new mechanism for ARV procurement – via NIH contract instead of HJF • Establish new demand projection & budget for: • Opening of 2 Mil Hosp. & Umtata sickbay • Initiation of PHIDISA III protocol • Use of PEPFAR funds for paediatric patients & adult patients excluded from PHIDISA II • Separation of PHIDISA vs. PEPFAR accounts & stocks • Delivery of ARVs to the 2 new sites (at least 1-2 weeks prior to launching of PHIDISA II) • Potential for opening of 3 Mil & Phlaborwa
Pharmacy Personnel Accomplishments • Development of PHIDISA Pharmacy SOP • Key adherence counselors for all patients • Development of documentation tools: • Patient medication profiles • Patient 1st visit medication history (w/ info on herbal meds) & assessment • Patient progress note at all patient encounters • Abstract submitted to American Society of Health-System Pharmacists’ Annual Meeting – pending approval (Dec ’04, Orlando, FL)
Pharmacy Personnel & Site Development Challenges • 1 Mil - PHIDISA Pharmacy can only dispense ARVs, pts need to fill other supportive meds in C-block pharmacy • Drug Information Specialist hired for PHIDISA has not been able to receive training to perform this task due to more urgent administrative functions • Awaiting installation of computer & printer in Mtubatuba – for prescription entry & labelling printing – currently writing Rx labels manually • Pharmacy registration at Pharmacy Council • Training of pharmacist assistants • Projected workload increase with increasing enrolment into multiple protocols & additional sites
Pharmacy Personnel & Site Development Preparation of New Sites/Proposals Identify, hire, and train 2 new pharmacists ASAP (at least one month before launching of PHIDISA II at each site – ie. mid-August for 2 Mil & mid Sep for Umtata) • Preparation of 2 Mil and Umtata Pharmacies ASAP • Section head to visit both sites to assess readiness • 1-week training for new pharmacists at 1 Mil prior to beginning of PHIDISA II • US Pharmacists to assist in on-site clinical training • Register Umtata pharmacy with Pharmacy Council
Pharmacy Personnel TrainingFuture Plans/Proposals • US pharmacists on site periodically to provide intensive trainings • MicroMedex software – training by visiting US pharmacists and physicians at the different sites • At least one local, national, or regional HIV conference per pharmacist per year (leave coverage to be provided by 1 Mil pharmacists) • Attendance and presentations at PHIDISA clinic meetings • Continue or initiate self-training via medical journals or websites • Potential for training in the US for selected pharmacist(s)
Pharmacy Personnel NeedsFuture Plans/Proposals • Section head willassess the needs for additional pharmacy staff (pharmacist and/or pharmacist assistants) as enrolment increases • Liase with SAMHS pharmacy administration – for cross training of SAMHS pharmacists for PHIDISA project with potential for providing leave coverages • Potential for hiring and training part-time pharmacist(s) for leave coverage
Other Pharmacy Section Accomplishments • Conducted 1st PHIDISA substudy – led by Edmund Capparelli, Pharm.D., UCSD entitled: “Stability of Lopinavir/ritonavir (co-formulated as Kaletra®) at Elevated Temperatures – Relevance to HIV Therapy in Sub-Saharan Africa” To be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Oct 2004 (Washington DC); manuscript in preparation
Goals from July 2003 Not Yet Accomplished – Plan for the Future • Development of a Drug Information Center for PHIDISA • Pharmacovigilance substudy • Adherence substudy • Medication Usage Evaluation
Other Issues to Address • Initiate request for addition of rifabutin into the SAMHS pharmacy formulary for use in HIV/TB co-infected patients • Potential for acquisition, storage, and dispensing of nutritional supplement for PHIDISA III protocol • Budget for PHIDISA III nutrition supplement