HOPA Introduces First Investigational Drug Service Best Practice Standards For Institutions And Infusion Clinics

CHICAGO, Sept. 29, 2014 /PRNewswire-USNewswire/ -- Pharmacists have an important role in ensuring that clinical trials are conducted according to good clinical trials practices. The Hematology/Oncology Pharmacy Association has released the HOPA Investigational Drug Service Best Practice Standards, the first of its kind that provides the best practice standards and guidance for pharmacists and institutions that conduct clinical trials. The HOPA Investigational Drug Service Best Practice Standards emphasizes the critical role of the pharmacist in the investigational drug service from protocol concept to close-out. This document provides a foundation for pharmacy to be involved very early in protocol development and review, to ensure that the trial meets institutional medication guidelines, is executed efficiently, and adheres to all regulations and standards.

Investigational agents often are considered high-risk or hazardous medications and therefore require consideration for additional safe practices for the patient and staff. "The oncology pharmacist is uniquely qualified to provide this level of expertise which includes understanding the basic characteristics of drugs, knowledge of supplier issues, mixing, methodology of administrations, informed consent, and helping with supportive care related to the study," says Editor Barry Goldspiel, PharmD BCOP BCPS.

Pharmacy is usually involved in the education of patients and helping with the supportive care aspects of the trials. "Pharmacists have assumed various roles from education to direct patient care. These standards help illuminate various roles that a pharmacist can directly play in the conduct of clinical trials. As experts in drug therapy and operational dispensing, the pharmacist provides a unique perspective on the handling of the clinical trial medications - from education to the operational/dispensing trial conduct for the life of the clinical trial," states Lead Author Sapna Amin, PharmD BCOP. "Pharmacists play a vital role in clinical trials. In addition to managing the safe use of investigational drugs, pharmacists also play an integral role in developing medication order sets using research protocol specifications. Pharmacists also serve as a resource for principle investigators and clinical research staff on questions related to investigational drugs," says Lead Author Joyce Lee, PharmD BCOP BCPS.

In addition, the guidelines provide an outline for the role of the pharmacy technician which is unique to this document. "The pharmacy technician can assume some responsibilities for clinical trials implementation and execution which can then allow the (investigational) pharmacist to be more involved with clinical aspects of the trials," states Dr. Goldspiel. These guidelines address various best practices for pharmacy operations and provide ancillary information about the different mechanisms for obtaining investigational drugs for a single patient, and provide a concise summary of and reference source for the procedures for obtaining investigational drugs on a "compassionate" basis. This best practice guideline should be used in conjunction with other applicable state and federal guidelines.

Read HOPA Investigational Drug Service Best Practice Standards

HOPA is a nonprofit professional organization formed in 2004 to help oncology and hematology pharmacy practitioners and their associates provide the best possible cancer care. HOPA supports research, conducts educational conferences to advance knowledge, encourages professional development and advocates for health policy issues that improve patient care. HOPA has nearly 2,100 members and includes oncology pharmacists, as well as pharmacy interns, residents, technicians, researchers, and administrators specializing in hematology/oncology practice. For more information, visit www.hoparx.org.

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SOURCE Hematology/Oncology Pharmacy Association (HOPA)