Development of complexity categories for an investigational drug services complexity scoring tool to assess pharmacy effort in clinical trial initiation and maintenance.

Purpose: Research pharmacy effort required to safely and compliantly manage investigational products (IP) varies between studies. No validated tool exists in the United States to evaluate these differences in effort. The Vizient Pharmacy Research Committee Investigational Drug Services (IDS) Subcommittee previously developed a systematic complexity scoring tool (CST) through expert consensus to assign a complexity score for pharmacy effort.

Single-patient expanded access: A primer for pharmacists.

Purpose: The process of providing treatment with investigational drugs through expanded access is explained. Roles and informational resources for pharmacists are discussed.

Summary: Expanded access is a regulatory pathway for the treatment of serious or life-threatening diseases or conditions with investigational agents outside of clinical trials.

Surface contamination of counting tools after mock dispensing of cyclophosphamide in a simulated outpatient pharmacy.

Purpose: The primary aim was to determine if dispensing of cyclophosphamide tablets resulted in accumulated residue on pharmacy counting tools during a simulated outpatient dispensing process. Secondary objectives included determining if cyclophosphamide contamination exceeded a defined threshold level of 1 ng/cm and if a larger number of prescriptions dispensed resulted in increased contamination.

Methods: Mock prescriptions of 40 cyclophosphamide 50 mg tablets were counted on clean trays in three scenarios using a simulated outpatient pharmacy after assaying five cleaned trays as controls.

Potential role of a pharmacist to enhance medication-related aspects of clinical trials conducted in a dedicated clinical research unit.

Purpose: Pharmacist involvement in medication reconciliation has been shown to have a positive impact on patient care in a number of settings [1-6], but there have been no evaluations of the effect of this pharmacist role on patient care during the conduct of clinical trials. Pharmacist involvement in the medication reconciliation process for clinical trials may provide improved protocol compliance.

Methods: This was a retrospective pilot study conducted in a dedicated research unit that assessed completeness of the medication reconciliation process by clinical trial teams for patients participating in a clinical trial involving investigational medication(s).

Surface contamination of hazardous drug pharmacy storage bins and pharmacy distributor shipping containers.

Purpose This study was conducted to determine whether there is contamination on exterior drug packaging using shipping totes from the distributor and carousel storage bins as surrogate markers of external packaging contamination. Methods A two-part study was conducted to measure the presence of 5-fluorouracil, ifosfamide, cyclophosphamide, docetaxel and paclitaxel using surrogate markers for external drug packaging. In Part I, 10 drug distributor shipping totes designated for transport of hazardous drugs provided a snapshot view of contamination from regular use and transit in and out of the pharmacy.

Clinical developments in the treatment of relapsed or relapsed and refractory multiple myeloma: impact of panobinostat, the first-in-class histone deacetylase inhibitor.

Background: Panobinostat is a new agent for the treatment of relapsed and refractory multiple myeloma (rrMM) as part of a combination regimen. This article presents an overview of the mechanism of action, pharmacokinetics, safety, efficacy, patient care strategies, and role of the agent in treating rrMM patients.

Results: Panobinostat belongs to the class of drugs known as histone deacetylase inhibitors, and has high activity against Class I, II, and IV nonhistone deacetylases and histone deacetylases.

Multiple myeloma: Updates for pharmacists in the treatment of relapsed and refractory disease.

There have been a number of recent advances in the treatment of patients with relapsed and refractory multiple myeloma. However, despite additional FDA-approved therapies including carfilzomib and pomalidomide as well as clinical trials investigating new combinations of existing treatments, multiple myeloma remains an incurable disease. New therapies currently in the drug development pipeline for relapsed and refractory disease include additional proteasome inhibitors (oprozomib, marizomib, ixazomib), histone deacetylase inhibitors (panobinostat, ricolinostat, quisinostat), monoclonal antibodies (daratumumab, elotuzumab, SAR650984), Bruton's tyrosine kinase inhibitors (ibrutinib), a selective inhibitor of nuclear export, and others.

Survey to assess the role of pharmacy technicians and nonpharmacist staff in the operation of research pharmacies.

Purpose: Results of a survey assessing trends and innovations in the use of pharmacy technicians and other nonpharmacist staff in the research pharmacy setting are reported.

Methods: A Web-based survey was distributed to Internet communities of members of the American Society of Health-System Pharmacists and the University Health-System Consortium involved in investigational drug research and related practice areas. The survey collected data on the characteristics of institutions with pharmacy department staff dedicated to such research activities and the participation of pharmacists, technicians, and other staff in key areas of research pharmacy operations.

Carfilzomib: a novel agent for multiple myeloma.

Objectives: Carfilzomib is a new agent for the treatment of relapsed and refractory multiple myeloma (MM). This article presents a comprehensive overview of the pharmacokinetics, pharmacodynamics, dosing schedule, safety, efficacy, preparation and administration of carfilzomib, and its role in treating MM patients.

Key Findings: Carfilzomib is a selective proteasome inhibitor that differs structurally and mechanistically from bortezomib.