Sterile Compounding Pharmacist
Basic Home Infusion
JCAHO-accredited compounding pharmacy providing preservative-free, sterile preparations for use in implantable intrathecal (IT)infusion devices, clinical pharmacy services, and in-home pump management to over 1000 patients and 100 specialist practices in 43 states.
Directly assisted and supervised weekly aseptic compounding of 150+ sterile, preservative-free IT preparations for use in chronic pain anspasticity management. Ensured efficient daily workflow, rigorous quality checks, prescription processing, and physician consultation.
Accomplishments and Contributions
Formulation and Compounding Procedure Improvement Initiative
Championed policy reforms to address formulation quality, compounding procedure, and efficiency issues impeding growth.
- Devised new protocols for isotonicity, packaging, pH adjustment/buffering, and nitrogen sparging to attenuate adsorptive, hydrolytic, and oxidative drug degradation in preservative-free infusion preparations.
- Reduced compounding time by 40% by retooling workflow bottlenecks and pooling tasks, e.g. magnetic stirrers ensured faster, more thorough dissolution vs. manual stirring while freeing compounders to prepare subsequent steps.
- Zero incidents of mixing issues or drug precipitation (vs. >20 in 2013); reduced incidents of early refills or efficacy issues.
- 300 + patients added to census from several prominent practices, possible due to expanded volume capacity.
Comprehensive Regulatory Overhaul Project
Coordinated with owners to audit pharmacy/cleanroom SOPs and tighten regulatory compliance record.
- Authored new cleaning and environmental control policies , and put in place more robust procedures for sterility and filter integrity testing, depyrogenation validation, and media fill testing.
- 21% increase in USP Gap Analysis score from Q3 2013 to Q2 2014 (77% to 98%), maintained through tenure.
- Passed 3 unannounced inspections by New Jersey, Virginia, and Tennessee/NABP. (joint inspection)
- Reinforced staff buy-in via direct involvement in USP 797- and OSHA-compliance planning/implementation.
Drew on strong communication skills and technical know-how to successfully mediate a dispute with Shimadzu Corp. over the capabilities of a $30,000+ HPLC system purchased by BHI in mid-2012.
- Guided parties to cooperative resolution (avoiding costly legal action) by de-escalating the rhetorical tone, educating BHI staff on HPLC technology and limitations, and securing additional field support to strengthen intercompany ties.
In-house Stability Analysis Project Reboot
Reoriented stalled stability testing project to a well-defined axis of objectives, having resolved the above dispute.
- Coordinated with Phenomenex to develop a binary gradient elution method to separate and quantitatively measure formulary drugs and degradation products using HPLC/UV-Vis Spectrometry.
- Readied project for self-sufficiency by drafting plans to validate method as stability-indicating per USP 1050, securing lab needs and personnel, and aggregating physicochemical/stability information on formulary drugs.
Third Party Rx Billing Procedures
Asked by CFO to devise a system for billing compounded prescriptions to replace the untenable, labyrinthine one in use.
- Dissected use of CPR+ pharmacy software over 2 weeks, and seamlessly integrated critical unused features into Rx workflow.
- Slashed lengthy ordeal to 1 minute per claim using auto-generated tickets to transmit pricing data for each Rx from Pharmacy to Billing, where billers could create ready-to-submit invoices with one click and zero detective work.
- Increased processing efficiency by 200%by allowing delegation of claims submission (25% of billing workload) to any biller.
- Cleared backlog of claims (>$500,000 in reimbursements)in 2 months, with all new claims sent within 1 week.
Streamlining Business-Ops & Record-Keeping
Slashed RPh and tech hours sunk into administrative tasks by 30-50% using electronic record keeping solutions.
- Built searchable, self-calculating Excel workbook for C-II perpetual inventory recording, replacing 20+ minute written record with 5-minute Patient/Quantity entry and automatic “balance” calculation.
- Cut regulatory record entry time from 1-2 hours to 0.5 hours/day by using customized Excel workbooks.
- Generated 100+ custom CPR+ templates for complex compounds and weekly orders, avoiding tedious manual entry.
- Championed adoption of NitroPDF, a powerful PDF editor that enhanced all aspects of data management and allowed for instant search and retrieval of needed files/patient charts.