Overview The research pharmacists are responsible for receipt, storage formulating and dispensing medications for subjects on DF/HCC investigational protocols. DFCI coordinates the DF/HCC efforts to have common systems to manage investigational activities. There are three full-time research pharmacists at DFCI, a pediatric clinical pharmacy specialist and an adult clinical pharmacy specialist that review the treatment protocols. The research pharmacists are responsible for: ? Protocol review and for representing pharmacy at the various committees - CLINPOC, Operations and Audit Subcommittees, including SRC and IRB. ? Creation, approval and activation of on-line standing order templates to facilitate the actual process of ordering medication. ? Obtaining, storing, formulating and dispensing drugs for patients on investigational protocols. ? Maintaining the records in accordance with FDA and NCI guidelines. As part of the DF/HCC, the DFCI research pharmacy also coordinates drug distribution to affiliate institutions and monitors their usage. The coordination of drug distribution includes completion of drug accountability records, generation of site-specific paperwork and receipts, as well as online confirmation that a site is eligible to receive the drug. A new automated Chemo Order Entry (COE) system links specific pharmacy orders for all experimental protocols with protocol templates and with the QACT registration system and thus provides an additional measure in assuring patient safety in our clinical trials. Monthly meetings, standardization of policies and procedures, training of affiliate staff members, quality assurance indicators and coordination of drug inventory for the DF/HCC sites are also coordinated by the DFCI Research Pharmacy. The Research Pharmacists at each site are as follows: ? BIDMC - Keith Belken ? CHB -James Bennett ? DFCI - Caroline Harvey, Mark Sudol, Peter Ng ? MGH - Lalit Joshe ? BWH- Jon Silverman The pharmacy performed 377 full protocol reviews for the SRC and IRB in the calendar year 2003. Our protocol review process requires a detailed pharmacy review of the entire protocol document and supporting literature, with the primary focus on the pharmaceutical information, treatment, adverse events and consent sections. The pharmacist's review ensures that the sections are complete, understandable, accurate and consistent throughout the protocol document. Prior to protocol activation, the Research Pharmacy conducts a final review to assure all concerns have been addressed and the protocol, as written, can be conducted in a safe manner. During 2004 there were approximately 300 protocol order templates online and at least 300 chemotherapy (non-protocol) regimen templates online.
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