Order Set Preparation for Product Awaiting Approval
Industry
Pharmaceutical Manufacturer
Problem
A 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.
PHSL Solutions
PHSL 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.
Results
PHSL 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.