Investigational Drug Service Research Articles

Economic outcomes associated with an investigational drug service within a Veterans Affairs health care system.

BackgroundAn investigational drug service (IDS) has a foundational role in ensuring the safe and efficient management of investigational drugs. The objective of this assessment is to determine economic value of an IDS within a Veterans Affairs health care system.MethodsThis assessment was a single-center retrospective record review. Study protocols managed by the IDS over a 2-year period were evaluated for cost avoidance, revenue, and waived revenue. Cost avoidance was defined as the cost savings generated when a research subject received sponsor-provided treatment in place of a therapy that would have been otherwise funded by the institution. Revenue from fees charged to investigators and waived revenue based on the standardized IDS fee schedule were also totaled. The total economic value to the institution accounted for the personnel costs of the IDS.ResultsTwenty-three investigational study protocols managed by the IDS resulted in economic outcomes. The total cost avoidance during the two-year period was $482,627.33. The total revenue and waived revenue associated with the IDS was $16,822 and $54,200, respectively. Oncology protocols had the highest contribution to the outcomes of cost avoidance and revenue and mental health protocols had the highest contribution for waived revenue. The overall economic value of the IDS to the institution was $393,649.33.ConclusionsOver a two-year period, the IDS demonstrated a substantial economic value that was largely driven by cost avoidance. Revenue generation from fees charged to investigators and cost savings to the investigator through waived revenue also contributed economic benefits to the institution.

Effects of pharmacist interventions on reducing prescribing errors of investigational drugs in oncology clinical trials.

This study aimed to investigate the effectiveness of pharmacist intervention in reducing and preventing prescribing errors of investigational drugs for cancer patients. A retrospective study was conducted during two periods: a baseline period from December 2015 to June 2016 and an intervention period from July 2016 to February 2017. The investigational drug service (IDS) pharmacists performed active interventions during the intervention period. Among 12,387 investigational drug orders, 395 (6.1%) prescribing errors were detected in 6477 orders at the baseline period, and 278 errors (4.7%) were detected in 5,910 orders at the intervention period. To identify factors that affect prescribing errors, three models were constructed for the multivariate analysis. Among factors affecting prescribing errors, sponsor initiated trial (SIT) was the strongest factor (AOR: 4.16, 95% CI: 3.31-5.23). Pharmacist intervention reduced prescribing errors by at least 25% in all constructed models after adjusting for confounding variables. Prescribing errors were 1.3 times higher when dealing with intravenous medications than when dealing with oral medications. There were 60% fewer prescribing errors in the blinded study than in the open study. SIT and multi-center/multi-nation studies had 4.2 and 2.4 times more frequent prescribing errors than in investigator-initiated trials (IIT) and single-center/single-nation studies, respectively. Fewer errors occurred in phase 2 and trials covering both phase 1 and phase 2 (phase 1/2) than in phase 3 trials. The IDS pharmacist intervention in cancer clinical trials was associated with significant reductions in prescribing errors and may lead to increased medication safety.

Internship to Increase Knowledge and Understanding of Clinical Research and Regulatory Issues in a Blood and Marrow Transplant Setting

Topic Significance & Study Purpose/Background/Rationale Evidence based care drives patient care. Research providing the ‘evidence’ to help advance patient outcomes and survival may not be as familiar to nurses. This poster presents findings from an internship completed at a large mid-western cancer teaching hospital. The purpose is to identify methods to help bedside nurses understand the significance of research conducted on their patients. Education and communication is essential between research staff and clinical nurses. Some large cancer hospitals have nurses who are directly involved with both clinical trial coordination and direct patient care for patients enrolled into a clinical trial. This change would allow the FDA to make a more informed decision on approving new therapies that could benefit millions of people. Methods, Intervention, & Analysis The internship included a practicum that was 120 hours. Majority of the 120 hours was spent with the Clinical Research Manager of the Blood and Marrow Transplant in the Clinical Trial Office. Remaining hours were spent with departmental interviews including, Data and Clinical Informatics, Regulatory and Compliance, Investigational Drug Services, Contracts and Budgets, and the institutions Institutional Review Board. Findings & Interpretation During the internship it was discovered that 1) research blood samples were missed during patients follow-up visits post-transplant in the hematology clinic. Missed blood samples can signal a red flag not only to the sponsor, who has money and time invested into the clinical trial, but also to the Federal Drug Administration (FDA), who ultimately decides if the therapy will be available to the general population. 2) Documenting clinical trial blood samples that have been drawn in the EMR was quoted as being ‘cumbersome'. 3) Clinic nurses communicate best in a face to face setting rather than email, as nurses do not have the ability to sit at a computer all day 4) Clinic nurses are not utilizing the research active tab in patients charts which is kept up to date by the clinical research coordinator Discussion & Implications 1) Educating clinic nurses about clinical trial compliance 2) Educating clinical trial staff about nursing workflow in the hematology clinic 3) Hiring a clinic nurse who oversees all research patients that are being seen in the hematology clinic each day.

Design of a relative value unit-based tool for the measurement and reimbursement of pharmacy services for clinical trials

ObjectiveTo develop a relative value unit (RVU)-based tool for the measurement and reimbursement of pharmacy services for clinical trials.MethodsA portfolio of activities was agreed by consensus in four tertiary hospitals....

Streamlining and Cycle Time Reduction of the Start-up Phase of Clinical Trials

Abstract Objective The start-up phase of a clinical trial (CT) plays a vital role in execution of novel drug development. Hence, this study aims to identify the factors responsible for delaying the CT start-up phase. Further, it focuses on streamlining and reducing the cycle time of the start-up phase of newly sponsored CTs. Methodology Thirteen sponsored CTs conducted (between 2016 and 2017) in clinical research department at King Fahad Medical City, Riyadh were analyzed to identify the data specific start-up metrics using Find an improvement area-Organize a team-Clarify current practices-Understand source of variation/problem-Select a Strategy-Plan-Do-Check-Act (FOCUS-PDCA) cycle. Five measures incorporated in the metrics were: date of initial contact with site to the signing of confidentiality agreement; date of receiving questionnaire from sponsor to date of its completion; time taken to review protocol and approve investigational drug service (IDS) form; time taken to review protocol and approve pharmacy and pathology and clinical laboratory medicine (PCLM) form and date of receipt of institutional review board (IRB) submission package to final IRB approval. Fishbone analysis was used to understand the potential causes of process variation. Mean time was calculated for each metrics prior to and post implementation of the intervention protocol to analyze and compare percentage reduction in the mean cycle time of CTs. Results Of the various potential factors of delay identified through Fishbone analysis, the two major ones were lack of well-defined timeline for approval and review of the study protocol; and inconsistent IRB meetings. Post introduction of the new intervention protocol, the entire CT lifecycle was reduced by 45.6% (24.8 weeks9 vs 13 weeks, before and after intervention, respectively). Conclusion Varied factors are responsible for delay of the start-up phase of CTs and understanding the impact of each factor allows for optimization and faster execution of the start-up phase of CTs.

The dual trigger study: Rationale and study design of a prospective double-blind randomized clinical trial comparing pregnancy rates after co-administration of low dose hCG at the time of GnRH agonist trigger or 35h later for the prevention of OHSS.

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian stimulation. The use of gonadotropin releasing hormone (GnRH) agonist for the trigger of oocyte maturation is effective in the prevention of OHSS although it may result in a lower pregnancy rate. The use of adjuvant low dose human chorionic gonadotropin (hCG) at the time of trigger or at the time of oocyte retrieval may improve pregnancy rates. The goal of this dual trigger study is to evaluate the safety and efficacy of the use of low dose hCG administered at the time of GnRH agonist trigger or 35 h later as well as the potential impact on pregnancy rates. The population will consist of 82 women undergoing IVF treatment who are at risk of developing OHSS. This study will be a single center prospective randomized double-blind placebo controlled trial. The randomization schedule will be administered by the Investigational Drug Services of the University. After controlled ovarian stimulation, induction of oocyte maturation will be achieved using a GnRH agonist and patients will be randomized to receive either low dose hCG 1000 IU at the time of trigger and placebo at oocyte retrieval (Study group) or placebo at the time of trigger and hCG 1500 IU at the time of oocyte retrieval (Control group). The main outcomes will be live birth rates and incidence of OHSS. Two ancillary studies will include a quality of life survey and serum assessment of independent corpus luteum function.

Participation of a coordinating center pharmacy in a multicenter international study.

The activities of a coordinating center pharmacy (CCP) supporting a multicenter, international clinical trial are described. Serving in a research support role comparable to that of a commercial clinical trial supply company, a CCP within the Johns Hopkins Hospital Investigational Drug Service (JHH IDS) uses its management expertise and infrastructure to support multicenter trials, such as the recently completed Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage, Phase III (CLEAR III) trial. The role of the CCP staff in supporting the CLEAR III trial was overall investigational product (IP) management through coordination of IP-related operations to ensure high-quality care for study participants at study sites in the United States and abroad. For the CLEAR III trial, the CCP coordinated IP supply activities; provided education to site pharmacists; developed study-specific documents, including pharmacy manuals; communicated with trial stakeholders, including third-party IP distributors; monitored treatment assignments; and performed quality assurance monitoring to ensure compliance with institutional, state, federal, and international regulations regarding IP procurement and storage. Acting as a CCP for a multicenter international study poses a number of operational challenges while providing opportunities for the CCP to contribute to research of global importance and enrich the skill sets of its personnel. The development and implementation of the CCP at JHH IDS for the CLEAR III trial included several responsibilities, such as IP supply management, communication, and database, regulatory, and finance management.

Safety risks with investigational drugs: Pharmacy practices and perceptions in the veterans affairs health system.

Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists' perceptions about safety risks posed by investigational drugs. An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies.

Regulations Guiding the Interstate Shipment of Investigational Product

Purpose: Investigational drug services (IDSs) are often responsible for delivery of investigational product, whether to a study participant pursuant to a prescription or in bulk to another investigational study site. These deliveries must often cross state borders. For situations in which the study is not conducted under an investigational new drug application, these shipments are subject to the legislation of the receiving state. Summary: Every state board of pharmacy in the United States was contacted in an effort to compile a single resource describing interstate investigational product shipping regulations for each state. The majority of the states require registration with their board of pharmacy for shipment of medication into the state. Some states will allow for exceptions and/or fee waiver in certain situations. Controlled substances also fall under the jurisdiction of the Drug Enforcement Administration, with additional constraints placed on their shipment by many states. Conclusion: Knowledge of state legislative requirements surrounding interstate shipment of investigational product is crucial for IDSs to maintain compliance with all regulations. This document provides an important framework for obtaining and interpreting this information. However, as legislation changes on a regular basis, current legislation should be reviewed prior to the commencement of interstate shipping.

Tomorrow’s drugs: Improving lives through clinical trials

HSE 2 PharmacyToday • APRIL 2013 For Sam Abdelghany, PharmD, BCOP, practicing pharmacy is an Indiana Jones–style adventure, following clues and unraveling the mysteries of disease. As the coordinator of the Investigational Drug Service at Yale–New Haven Hospital, he is called upon to manage both small clinical trials for rare exotic diseases and large international studies with thousands of patients for the most common conditions on earth. “Not many people have the opportunity to get a sneak peek at the newest and latest treatments for so many disease states,” said Abdelghany.

Investigational drug service advanced pharmacy practice experience (APPE)

Although the Accreditation Council for Pharmacy Education (ACPE) and the American College of Clinical Pharmacy (ACCP) provide standards and guidelines for required APPEs (community pharmacy, hospital or health system pharmacy, inpatient/acute care general medicine, and ambulatory care) and there are some published descriptions of other elective APPEs, there is little information regarding the provision of an elective APPE focusing on Investigational drug service (IDS) and/or clinical research. The purpose of this paper is to describe the IDS APPE that was developed by the University of Michigan Health System (UMHS) IDS pharmacists in conjunction with the University of Michigan College of Pharmacy (UM COP). The IDS APPE is a four-week full-time program consisting of interaction with various IDS team members, topic discussions, opportunities for writing, and participation in IDS operations. Each week of the IDS APPE features a specific central theme, which includes both discussion topics and hands-on activities. While IDS practices may vary in size and scope, they all fulfill core regulatory requirements related to management of drugs used in clinical trials. Therefore, the IDS APPE description can be adapted and applied to other IDS practices in an effort to provide structure and foundation to the education of pharmacy students on an IDS APPE rotation. Further, it can be adapted into a general clinical research rotation with emphasis on the role of the pharmacist in the management of clinical trials and conduction of research for institutions that do not have a dedicated pharmacy service for clinical research (i.e., IDS).

Current Status and Future Directions for Clinical Trials Pharmacy

This survey was conducted to investigate the current status and suggest future directions for clinical trials pharmacy in Korea. A 32-item survey was distributed to 96 hospital pharmacies conducting clinical trials. The questionnaire was designed to elicit information on the following: (1) general clinical trial status of each hospital, (2) Investigational Drug Service (IDS) performance status. The response rate was 59.4% and 61.8% of the respondents carried out all the regulatory IDSs. Independent of the IDS's performance, the respondent started to feel the need for reinforcement in human resources when the number of active studies crossed 35. Analyzing the workload based on the subjective need for reinforcement in CTP, the overall CTP work execution rate was significantly higher in the 'needs reinforcement' group (p<0.05), even though this group had a 2.3 times higher workload than that in the 'current number of CTPs is adequate' group. The 'needs reinforcement' group performed more efficiently with a better understanding of IDSs, even though the group was having difficulties due to the shortage of CTPs. The lower execution rate in the 'current number of CTPs is adequate' group can be assumed to be due to the lack of understanding of the scope of IDSs. The work of CTPs should evolve into one of the specialized hospital pharmacists' roles, and a trial institution should designate at least one CTP per 40 protocols. Furthermore, the education for CTPs should be diversified into basic course and advanced course based on the IDS's performance of each hospital.

A collaborative effort to comply with USP chapter 797 for compounding sterile preparations for investigational use

A collaborative effort between two pharmacy specialty areas for ensuring compliance with United States Pharmacopeia (USP) chapter 797 for compounded sterile preparations (CSPs) is described. In September 2005, an investigational drug service (IDS) satellite was opened at a 1157-bed, level 1 trauma, academic hospital in Minnesota. After construction of the IDS satellite, a collaborative consulting service was established between the two pharmacy areas. Protocol-specific investigational medications requiring extemporaneous compounding were reviewed by both an IDS pharmacist and a hospital compounding pharmacist to provide recommendations to investigators. High-risk compounding was performed by the hospital compounding pharmacy, and patient-specific, medium- and low-risk compounding of CSP doses was performed by IDS pharmacy personnel for research participants. A small subset of investigational medications met high-risk criteria and was referred to the hospital compounding pharmacy. After final clearance from quarantine, the high-risk preparations were transferred to the inpatient IDS satellite for dispensing of patient-specific investigational medication doses. The compounding pharmacy followed standardized quality-assurance procedures to ensure sterility, purity, and endotoxin appropriateness for the investigational medications. Quality control of investigational CSPs was maintained by hand delivery of the investigational medication and documentation and disposition via hard-copy receipt on the nursing units. Based on chapter 797 requirements, the department of pharmacy's education and training changed to reflect the new compounding requirements for CSPs, including 20 hours of didactic training for aseptic manipulation skills and practical assessments of aseptic technique using growth media. A collaborative effort between two specialty areas of pharmacy services ensured compliance with USP chapter 797 requirements for compounded sterile preparations.

Improving investigational drug service operations through development of an innovative computer system

The development of a computerized system for protocol management, dispensing, inventory accountability, and billing by the investigational drug service (IDS) of a university health system is described. After an unsuccessful search for a commercial system that would accommodate the variation among investigational protocols and meet regulatory requirements, the IDS worked with the health-system pharmacy's information technology staff and informatics pharmacists to develop its own system. The informatics pharmacists observed work-flow and information capture in the IDS and identified opportunities for improved efficiency with an automated system. An iterative build-test-design process was used to provide the flexibility needed for individual protocols. The intent was to design a system that would support most IDS processes, using components that would allow automated backup and redundancies. A browser-based system was chosen to allow remote access. Servers, bar-code scanners, and printers were integrated into the final system design. Initial implementation involved 10 investigational protocols chosen on the basis of dispensing volume and complexity of study design. Other protocols were added over a two-year period; all studies whose drugs were dispensed from the IDS were added, followed by those for which the drugs were dispensed from decentralized pharmacy areas. The IDS briefly used temporary staff to free pharmacist and technician time for system implementation. Decentralized pharmacy areas that rarely dispense investigational drugs continue to use manual processes, with subsequent data transcription into the system. Through the university's technology transfer division, the system was licensed by an external company for sale to other IDSs. The WebIDS system has improved daily operations, enhanced safety and efficiency, and helped meet regulatory requirements for investigational drugs.

Advanced Practice Programs in Hospital Pharmacy –Investigational Drug Services

The Director's Forum series is written and edited by Michael Sanborn and Robert Weber and is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. Another specific goal of this column is to address many of the key challenges that pharmacy directors face today, while providing information to foster growth in pharmacy leadership and patient safety. This month's Forum focuses on developing a pharmacy-based investigational drug service in a hospital pharmacy department. As part of a patient-centered pharmacy department, a investigational drug service can significantly contribute to the research mission of a hospital.

Joint-Effort Clinical Pharmacy Services in Rural Hospitals

Studies in the literature support the practice of having clinical pharmacists work in direct patient care and the value of these services within the health care system.1,2 Although most pharmacists want to provide pharmaceutical care in collaboration with other health care professionals, some hospitals lack the staff that would be necessary. In Canada, the burden of a recently documented shortage of pharmacists3 has been felt across the country, but it has also prompted the innovative use of pharmacy technicians and expansion of their role.4-6 For example, some rural hospitals have empowered pharmacy technicians to fulfill medication dispensing requirements in rural settings, without on-site pharmacists. A clinical pharmacy technician has been described as a technician who takes on the clerical responsibilities of the pharmacist7 (including medication historytaking, 6 drug-use evaluation, investigational drug services,4 and clinical management tasks5), thereby allowing the pharmacist to provide more clinical services. Most experiences with this practice model have been in larger centres where pharmacists are on site.4-6 Rural centres present a unique opportunity to enhance patient care at sites where a pharmacy technician is present but clinical pharmacy services would not otherwise be possible. This model may free up pharmacist time for other tasks, enhance patient care, increase the number of proactive interventions by an off-site pharmacist, and increase utilization of pharmacy technicians’ skills at a time when pharmacists are in short supply. With direction and training, technicians would be able to alert nurses to potential pharmaceutical problems and triage problems for the clinical pharmacist (i.e., assign values to problems and alert the pharmacist according to their severity and urgency). Technicians would also be able to collect information more efficiently, giving off-site pharmacists more time to review patients at their own sites. A project was conceived whereby an off-site pharmacist would work with on-site pharmacy technicians to provide clinical pharmacy services intended to optimize patient care. The purpose of the project was to increase and assist with pharmacists’ clinical interventions by educating pharmacy technicians to identify clinical pharmacy problems and collect patient information.

U.S. pharmacist finds calling in international HIV studies

Vivian Rexroad of Johns Hopkins University in Baltimore has found an unusual niche as the go-to pharmacist for university researchers setting up HIV prevention trials in the developing world. Rexroad, a clinical pharmacist in the university’s investigational drug service, said she got her first

Dispensing investigational drugs: regulatory issues and the role of the investigational drug service.

Dispensing investigational drugs: regulatory issues and the role of the investigational drug service.

Economic benefits of investigational drug services at an academic institution.

The drug cost avoidance and revenue associated with the provision of investigational drug services (IDSs) at an academic institution were studied. The study protocols and dispensing data for the investigational drug studies conducted at the institution over two fiscal years (2000-01 and 2001-02) were reviewed. Revenue generated was calculated for all studies, and drug cost avoidance was calculated for studies in which patients were likely to have been treated with active drug had they not been included in the study. Of 139 studies in which the IDS was involved, 107 (77%) were eligible for the cost avoidance analysis. The total drug cost avoidance plus revenue over the two fiscal years was $5,300,428. The annualized drug cost avoidance plus revenue was $2.6 million. Cost avoidance varied with the type of study and the disease category involved. An IDS accounted for substantial drug cost avoidance over two fiscal years.

Are Investigational Drugs Getting you Down? One Hospital's Solution to the Increasing Number of Clinical Research Studies

This article describes the process and results of employing an Investigational Drug Service Pharmacist (IDSP) to coordinate pharmacy support for clinical drug studies. In 1998, a Clinical Research Center (CRC) was established to coordinate all research at a 407-bed Baltimore teaching hospital, resulting in an increase in studies requiring pharmacy support. By the end of 1998, there was a backlog of nine studies awaiting review for feasibility and impact on pharmacy resources. A lack of communication between departments further impeded the process. In March 1999, a part-time pharmacist was hired to coordinate all drug studies; the pharmacist's salary was paid by the CRC. Primary responsibilities of the position were protocol review, staff education, and drug accountability. Dispensing was still handled by staff pharmacists. After three years, results were as follows: 72 studies were reviewed, 41 were opened for enrollment, 8 were in preparation, 16 were completed. Two studies alone have saved the pharmacy department over $80,000 in drug acquisition costs. The efforts of the IDSP have helped the CRC to more than double its growth, with gross income from studies of $533,712 in 2001 compared with only $237,663 in 1998. The IDSP has improved communication between the CRC and pharmacy and expedited study initiation. It has also made the CRC more attractive to prospective sponsors, since one pharmacist works directly with study coordinators. With more physicians interested in carrying out research and hospital budgets becoming tighter, the part-time IDSP position represents an important means of supporting these endeavors without increasing fiscal burdens.