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An Alternative Model for Clinical Trial Product Management: Exploring Distribution and Dispensing

Posted by Cheryl Robinson, RPh, MS on Oct 20, 2016 10:52:45 AM

pharmacy pic.pngManaging limited supplies of an investigational agent in a clinical trial can present challenges. The typical practice is to ship inventory to the research pharmacy or the principal investigator’s office at clinical a site in anticipation of enrollment. One challenge is that the amount needed at study sites can only be estimated, and inadequate inventory may delay the study while providing extra is expensive and wasteful. In the meantime, the agent(s) and clinical supplies sit in storage until enrollment proceeds and dispensing begins. This ties up inventory and can create additional challenges with expiration dates. However, there is an alternative model of clinical trial support for consideration.

The conventional practice of shipping inventory in bulk (e.g. each approved clinical site receives 50 bottles of an investigational agent) is deemed to be the business activity of pharmaceutical product distribution. The product is not intended for a specific patient at a site. For the business activity identified as dispensing, a specific patient has been named and a health care provider has written a prescription or order exclusively for that individual. You must understand the distinction between these two methods of supplying product as you contemplate the management of your clinical supplies.

Fisher BioServices’ Direct-to-Patient Pharmacy distributes investigational agents and clinical supplies to study sites on an as-needed basis, and also dispenses and ships agents directly to patients. This dual capability provides a number of advantages in managing clinical trials, especially in cases where supplies of the investigational agent are limited and/or of very high value.

Our Pharmacy can ship materials to clinical sites with a rapid turnaround time, so study sites can be sent a much smaller initial inventory, which saves space and allows better management of limited supplies. Once enrollment is in progress, sites can maintain a minimal inventory because patient’s medications are shipped to their residence rather than held at the study site.

Use of a Direct-to-Patient Pharmacy also improves patient participation. Patients may have difficulty getting to the clinical site to get the drugs they need. Under Fisher BioServices’ alternative model, the site sends us a notification and we ship the agents and supplies directly to the patient. This can significantly improve both participation in the study and compliance with the protocol.

By combining distribution and dispensing under one roof, our Direct-to-Patient Pharmacy can provide significantly tighter control and convenience in managing the investigational agents and related supplies needed for a clinical trial. Both distribution and dispensing occur on an as-needed basis, which reduces waste and allows full inventory accountability. We can confirm delivery of clinical supplies either at the shipment destination study site or patient residence. A registered pharmacist is the final check for every outgoing direct to patient order, and orders to clinical sites are not shipped without authorization from the sponsor or their delegate.

As with any clinical trial, clinical agents must be tracked and managed in a validated, 21 CFR part 11 compliant inventory management system and agent distribution must follow applicable FDA requirements. Fisher BioServices’ Direct-to-Patient Pharmacy operates in compliance with:

  • 21 CFR 211.142 for receiving and storage,
  • 21 CFR 211.150 for distribution,
  • 21 CFR 211.150(b) for recalls,
  • 21 CFR 211.204 for returns and destruction,
  • and is licensed in all 50 States.

We have Drug Enforcement Agency (DEA)–approved storage, and manage and ship investigational agents and supplies at any standard temperature, including controlled room temperature, refrigerated, frozen (-20°C), ultralow (-80°C) and cryogenic in liquid nitrogen-charged dry shippers.

We electronically segregate and physically separate all inventory by project. Incoming products are inspected according to a sampling plan based on ANSI/ASQ, and all discrepancies are documented. If a discrepancy is found, a 100 percent inspection is performed, and the client is notified.

The facility housing our Direct-to-Patient Pharmacy is equipped with extensive security and risk mitigation systems that operate 24/7, including but not limited to a dedicated HVAC system, temperature and humidity monitoring, dry chemical fire suppression, redundant back-up generators, and dedicated back-up cold storage units.

If you are planning a clinical trial, consider the advantages to your study—and the participants—of combining distribution and dispensing, in the form of a Direct-to-Patient Pharmacy for the management of investigational agents and supplies.

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