Where
Pharmacists
Think Out
Loud.
A digital roundtable where clinical pharmacists, compounding specialists, and regulatory analysts trade hard-won wisdom — before the official guidance catches up.
Dr. Kwame Osei, PharmD, BCPS, BCCCP
University of Chicago Medicine
"We had three patients with subtherapeutic vancomycin levels despite troughs in range. That's when I knew we needed to switch to AUC-guided dosing — and this community helped us build the protocol."
When Kwame Osei caught a pattern of vancomycin failures in his MICU, he brought the data to Formulary before he brought it to his P&T committee. The thread that followed — 94 replies over 72 hours — became the foundation for the dosing protocol now used across three ICUs. That is what this community is for: the gap between the evidence and the guidance, filled by the people living it.
Vancomycin AUC/MIC target: our switch from trough-only — full protocol attached
Sharing our institution's transition roadmap, Bayesian software comparison (DoseMe vs. DIAN vs. InsightRx), and 6-month AKI outcome data.
Propofol infusion syndrome: early biomarker triggers we now use in our MICU
Lipase trending, metabolic acidosis pattern, and the lactate threshold that changed our monitoring protocol.
Extended infusion β-lactams: who is actually doing this and what are your outcomes?
PK/PD rationale is clear. Operationalizing it on a busy unit is another matter. Let's compare notes.
Dr. Sunita Mehta, PharmD, FIACP
Cedars-Sinai Medical Center
"The USP 795 revision changed our beyond-use dating calculations for water-activity-sensitive formulations. We had two weeks to update 40 SOPs. I posted our framework here first."
Sunita Mehta has spent 18 years in sterile and non-sterile compounding, watching USP standards evolve faster than most institutions can adapt. Her Formulary contributions read like the margin notes in a well-worn reference — specific, practical, and ruthlessly honest about what works in a real cleanroom versus what looks good on paper. Her stability study on extemporaneous vancomycin oral solution became the most-bookmarked post in the Compounding Lab channel.
USP 795 beyond-use dating under the new water activity framework — our updated SOP matrix
Sharing our decision tree for Category 1 vs. Category 2 non-sterile preparations, with worked examples for aqueous vs. non-aqueous formulations.
Vancomycin oral solution stability: our 45-day refrigerated data (n=24 batches)
HPLC concentration data at days 0, 7, 14, 30, 45. Spoiler: the 30-day BUD in the literature may be conservative.
503B outsourcing: what we outsource and why — a frank cost-benefit analysis
After the 2023 inspection findings, we restructured our 503B relationships. Here's our risk-stratification framework.
Dr. Anders Johansson, PharmD, MBA
Northwell Health
"By the time the FDA guidance hits your inbox, the P&T decision should already be made. I use Formulary as my early-warning system — the community processes these approvals faster than any official channel."
Anders Johansson oversees formulary policy for a 23-hospital system and has sat on four P&T committees simultaneously. When the FDA approved the first interchangeable Humira biosimilar, he had already been tracking the community discussion for six weeks. His Formulary thread on biosimilar substitution frameworks drew contributions from 34 formulary directors across the country, producing a decision matrix that three health systems have since adopted formally.
Humira biosimilar interchangeability: our P&T substitution decision framework (34 institutions weighed in)
Covering automatic substitution policies, patient notification workflows, specialty pharmacy contracting, and the payer pushback we didn't expect.
New FDA guidance on 503B compounders and hospital pharmacies — what actually changes
Parsing the draft guidance line by line. The scope-of-practice implications are significant for integrated health systems.
GLP-1 shortage allocation: our ethics framework for prioritizing existing patients vs. new starts
We developed a tiered allocation protocol with our ethics committee. Sharing the full framework for adaptation.
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