Investigational Drug Service Plays Vital Role in Hundreds of Clinical Trials
No one other than Cincinnati Children's three pharmacists and one pharmacy technician are allowed into the Investigational Drug Service’s (IDS) suite of storage and preparation rooms.
There’s a phone outside the main door where nurses and other clinicians can call to let the pharmacists know they’ve arrived and are ready to sign out a dose.
The medications inside are carefully monitored, not just because many are part of industry-sponsored pharmaceutical research, but also because tracking every tablet and milliliter of liquid medication is part of the facility’s mandate. There’s a great deal to track.
More than 200 active studies
Denise Lagory, RPh, has been with the IDS for 15 years, starting when the facility first shared space with the hospital’s regular pharmacy. Since then, it's moved to Location T and its number of active research studies has increased to more than 200.
The drug service has worked with investigators in Oncology, Human Genetics, Neurology, Pulmonology, Hematology, and many more.
“We support all the divisions in the Research Foundation,” she says.
As investigators prepare to seek protocol approvals from Cincinnati Children’s Institutional Review Board (IRB), they begin working with the IDS, as Lagory explains, “so that we can be aware of the studies coming and moving forward, so that once we gain approval, we can get to work.”
As soon as a study protocol is approved, Lagory and her staff go through training with the pharmaceutical company before medications can be shipped here. From there, every step is tightly regulated.
The facility tracks each dose as it comes in. Shelves of tracking logs and pharmaceutical manuals line the walls.
Constant flow of records
Once prescribed for a study, each dose gets logged as it goes out to inpatient nurses or outpatient care coordinators. Patients are required to return every untaken pill. Each leftover capsule gets counted, recorded and accounted for by the investigator and by the IDS. The service holds these pills until the pharmaceutical company gives permission for destruction.
While much of the work at the IDS is a constant flow of checks and records, the service also has two IV rooms—one with a hood specifically designed for preparing chemotherapy. Another compounding area is stocked with drawers of syringes and bags of empty capsules.
For blinded trials, the IDS can over-encapsulate drugs so that the test drug and the placebo appear identical. Liquid medications and placebos also can be modified to match taste and color.
Sometimes, Lagory hears about the FDA approving a drug they dispensed for a past study, but usually new studies come in so fast that she rarely learns how completed studies turn out. Even so, she’s excited to know that the work makes a real difference for children.
“The interesting thing is being able to see all of this different progress and all the work that’s being done,” Lagory says.
