Order Set Preparation for Product Awaiting Approval

IndustryPharmaceutical Manufacturer
ProblemA manufacturer wanted assistance reviewing their draft Prescribing Information (PI) before the drug’s PDUFA date. They were seeking help drafting an order set, or a protocol on how to use the newly launched product, which could be provided to healthcare systems and hospital P&T Committees.
PHSI SolutionPHSL reviewed the supporting literature and labeling provided by the client and provided a draft order set for the manufacturer’s review and approval. Standard order set sections were drafted to include, but not limited to, the following: concomitant medications, take home medications, nursing orders, pre-medications, laboratory monitoring, drug instructions, and more. PHSL conducted a conference call to review the draft order set with the manufacturer to address question related the order set.
ResultsPHSL provided two draft revisions prior to the final submission. Having a standardized order set available enabled the manufacturer to quickly provide a protocol to hospitals and healthcare systems, helping to mitigate delays in P&T committee evaluation and review. This allowed for faster uptake of their product in hospital systems and helped to ensure the drug was used correctly.