Investigational Drug Service Research Articles

Pharmacy Workload in Clinical Trial Management: A Preliminary Complexity Assessment Tool for Sponsored Oncology and Haematology Trials

Investigational drug services need to be organised in a structured approach, especially for sites with a large number of ongoing clinical trials. The aim of this study was to develop a tool to assess the complexity of pharmacy involvement in a sponsored oncology clinical trial. Categorisation into ordinal complexity categories was used to assess the complexity of the clinical trials for consistent pharmacy grant applications. The 15 items of the tool were divided into three sections, and individual item scores were agreed upon among four pharmacists with experience in the conduct of clinical trials at two different centres. A final version of the tool, named Pharm-CAT, was approved. The pharmacists were instructed to use Pharm-CAT to assign a score to each new sponsored trial. To determine the cut-offs for the complexity categories, the scores were sorted in ascending order and the cut-offs corresponding to the first and third tertiles of the score distribution were selected. To verify the reproducibility of the results, Pharm-CAT was applied by two pharmacists independently for each trial. Pharm-CAT proved to be user-friendly. Sixty clinical trials were evaluated and a total of 120 scores were recorded. Low-complexity scores ranged from 0 to 19, medium-complexity scores ranged from 20 to 25, and high-complexity scores were 26 or higher. The average score recorded was 22.88 points. Prospective multicentre validation of Pharm-CAT is needed to confirm its applicability.

Integration of electronic project management software in an investigational drug service pharmacy within an academic medical center.

An investigational drug services (IDS) pharmacy plays a vital role in supporting clinical trial research by ensuring the safe and efficient management of investigational products. This article describes the implementation of an electronic project management software to improve an IDS pharmacy's study protocol work. The article describes the implementation of the software and how this approach addressed specific challenges, including project oversight, process standardization, documentation, reporting, accountability, and intrateam communication. We describe an electronic project management software system used to streamline and standardize the work associated with study protocols. This software provides an organized and customizable workspace to manage tasks associated with each study protocol. The software automates task creation, tracks progress, and ensures comprehensive record keeping. Additionally, the software fosters effective communication within the team and offers real-time reporting to assess team productivity and progress. We have observed improved consistency, enhanced revenue, including approximately $18,000 in additional fee capture, and increased collaboration among pharmacy team members. Implementing an electronic project management software has proven highly beneficial in the IDS pharmacy. The software has significantly improved workflow efficiency by addressing challenges in study protocol management. While initial setup and training required time and resources, the long-term benefits in project oversight, collaboration, and revenue capture justify the investment. An electronic project management software is a valuable tool in managing the complexity of study protocol activities and supports the pharmacy's crucial role in advancing clinical research.

Evaluation of a pharmacist-led workflow for the FDA Expanded Access Program.

This project aimed to characterize the resources necessary for pharmacists to support the required steps for obtaining and handling investigational drugs outside of a study protocol in the individual patient and intermediate-size population Expanded Access Program (EAP) processes. The second aim was to characterize the types of EAP requests received. This retrospective, single-center, observational study was performed by reviewing EAP requests initiated at Duke University Hospital (DUH) between August 1, 2017, and February 11, 2023. The annualized cost of unreimbursed EAP study services was projected to be approximately $196,500 at DUH for 2023. Of the 168 EAP requests submitted after the institutional policy requiring pharmacy and therapeutics (P&T) committee approval was established, 162 (96.4%) were approved by the P&T committee. Given the lack of published information on a pharmacist-led workflow related to EAP services, this study sought to share DUH's process for managing EAP requests. As there is no mechanism for reimbursement of EAP services, they can be difficult to manage given the labor resources required. Further work is needed to recoup unreimbursed investigational drug service labor costs to ensure compassionate use programs can be implemented in a manner that is financially sustainable for a health system.

Standardization of key performance indicators and metrics for investigational drug services: Consensus recommendations among IDS specialists.

There are currently no consensus guidelines on establishing metrics for investigational drug services (IDS). Because of the complexity of research protocols, it remains difficult for sites to track pharmacy productivity and create a baseline for IDS growth within the institution, as well as to perform benchmarking with peer institutions. The goal of this study was to help establish practical guidance for IDS metrics and site utility as applicable. This was a survey-based project conducted by the metrics subgroup of the Hematology/Oncology Pharmacy Association (HOPA) IDS special interest group (SIG), which was formed specifically for this analysis. Three surveys developed by the metrics subgroup were sent to members of the IDS HOPA SIG to gather metrics. The first survey included questions about what metrics IDS sites currently collect. The identified metrics were then condensed into categories. Through a consensus-based approach, standardized definitions were established and applied to future surveys. The 2 subsequent surveys sent to HOPA SIG members helped create a list of top recommended metrics that are recommended for every IDS site to track. A total of 3 surveys were sent to 75 recipients, with the response rate ranging from 24% to 38%. From these surveys and consensus with the metrics subgroup, 5 top recommended metrics were identified: (1) active protocols; (2) dispenses; (3) new clinical trials initiated; (4) patients treated; and (5) clinical interventions. These recommended metrics should serve as guidance and allow for standardization to help ensure adequate resources are available for IDS pharmacy staff. These recommendations should serve as a basis for standardization and benchmarking with peer institutions.

Evaluation of a remote hybrid staffing model for investigational drug service pharmacists.

This project compared the time to complete investigational prescription drug order verification by investigational drug service (IDS) pharmacists in an onsite vs offsite (hybrid) staffing model, evaluating the impact of remote work on verification time. Parenteral IDS drug orders from August 2019 through June 2022 were analyzed. Electronic medical records were timestamped for each order, first verification, second verification, and medication administration. The project was divided into four 6-month time periods to allow for 2 independent comparisons of onsite vs hybrid staffing models. A survey was given retrospectively to IDS pharmacists for the last hybrid timeframe to assess work satisfaction and burnout. A total of 4,398 orders were evaluated. The time from order entry to first verification was 14 minutes (n = 1,248) during the first onsite time period compared to 13 minutes (n = 1,042) during the first hybrid period (P = 0.003). The time for order verification was similar between the second onsite and hybrid periods (12 minutes [n = 1,041] vs 10 minutes [n = 1,067], respectively; P < 0.0001). The staff satisfaction survey for the hybrid model showed high levels of job satisfaction and no self-reported burnout. The remote hybrid staffing model did not result in a meaningful change in the time from order placement to medication administration within the IDS pharmacy. Hybrid staffing also resulted in greater job satisfaction among IDS pharmacists. This study highlights the benefits of implementing remote work practices in the pharmacy practice setting.

Evaluation of a decentralized investigational drug service pharmacist in a cancer clinical trial infusion unit.

Investigational drug service (IDS) oversees and manages use of investigational products. There is limited data on utility of pharmacy services in clinical trial conduct and outcomes, specifically on the value of a decentralized IDS pharmacist. This is a quasi-experimental study conducted in an oncology clinical trial infusion unit. A retrospective chart review was done to reflect current practice from January through June 2022. A decentralized IDS pharmacist was piloted in December 2022. Data collected included number and types of consults, personnel requesting the consult, and intervention performed. A satisfaction questionnaire was conducted after the pilot program. A total of 16.3% (173 of 1062 patient visits) of pharmacy consults were completed in the centralized IDS pharmacy model, while 44.5% (81 of 182 patient visits) of pharmacy consults were completed during the decentralized IDS pharmacist pilot, p < .001. Decentralized IDS pharmacist completed 77% (62/81) of the consults during the pilot period. Most common types of consults were toxicity management (20%), electronic medical record issues (17%), and tubing and drug administration issues (16%). More than 80% of respondents to the satisfaction questionnaire responded that implementation of a decentralized IDS pharmacist is acceptable, appropriate, and feasible. This pilot study demonstrated that a decentralized IDS pharmacist in an oncology clinical trial infusion unit improved accessibility to an IDS pharmacist, increased pharmacy consults relevant to patient care and optimized centralized pharmacists medication distribution workflow. Further studies are needed to evaluate patient benefits from implementing decentralized IDS pharmacist in direct patient care activities.

Investigational drugs services pharmacists education and workflow structure.

169 Background: Per NIH U.S. National Library of Medicine, 428,103 research studies are registered globally as of September 19th, 2022. Each institution must assess its institutional readiness as the complexity and volume of clinical trial increases. Institutional readiness helps assess the capacity of an institution to adopt new technologies and policies to accept, activate, and adjust research despite the complexity of the clinical trial. Clinical research pharmacists help improve the safety and quality of the research by reviewing the scientific literature and medication-related information to develop protocols and evaluate clinical trial feasibility as part of the scientific review committee while performing supportive pharmaceutical review of the protocol, preparation, storage, dispensing, and consulting clinical coordinators and sponsors on the logistics of the trial. Investigational drug service (IDS) also oversees institutional compliance with Good Clinical Practices (GCPs) and Good Manufacturing Practices (GMPs), FDA regulations, and laws. Lack of training for pharmacists, poor safety and quality control, lack of resources, and unstandardized approach to the management of investigational drug products can lead to discrepancy, delay in care, and ultimately, harm to the patient. This study will address the deficiency of institutional readiness to conduct clinical trials with investigational agents and introduce policies and procedures needed to be followed by pharmacists or pharmacy technicians to conduct research. Methods: To explore the challenges in clinical trials and compare work efficiency, work productivity, and growth in the investigational drug service (IDS) pharmacy. This study is conducted at a single-health system compromised of 7 satellite investigational pharmacy from June 2021 to August 2022. Interventions include Epic/Beacon training, CITI training, annual compounding competencies, protocol and procedure development, and Vestigo implementation. Data for inclusion was identified from (where Dr. Ayoubi got data from) were extracted and analyzed. Results: 71% decrease in # of protocols on the priority list to amend protocols. Informatics pharmacists build 190 protocols in one year. Revenue has doubled in one year. Productivity increased as time to verify is reduced by 9.43 minutes to verify an order and time to dispense is reduced by 31.3 min. Number of clinical trials designated to each pharmacist increased from 3-4 to 20 productions per month. Number of investigational drugs ordered increased by 89 last year. Conclusions: Education and Training remain one of the main set back to clinical trials growth, and proper training and education are the pillars to conducting clinical trials in a safe manner and promote growth.

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

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. This project seeks to develop and validate complexity categories based on CST scores. Vizient member institutions in IDS assigned a CST complexity score and a perceived complexity category (low, medium, or high) for study initiation and maintenance. Receiver operating characteristic (ROC) curve analysis defined the best CST score cutoff points for each complexity category. Comparing the CST-assigned to the user-perceived complexity category determined whether the CST-assigned complexity category aligned with practitioner assignment. A total of 322 responses were used to determine complexity score categories. The AUC values for study initiation and maintenance were 0.79 (P < 0.001) for the low/medium boundary and 0.80 (P < 0.001) for the medium/high boundary, suggesting the performance of the CST is good. The agreement between CST-assigned and user-perceived complexity categories was 60% for study initiation and 58% for maintenance. The Kendall rank correlation coefficient between the raters and ROC categories was strong, with a value of 0.48 for study initiation and 0.47 for maintenance. Development of the CST allows IDS pharmacies to objectively measure the complexity of clinical trials, which is a significant step towards assessing workload and guiding resource allocation.

Evaluating the effects of a global pandemic on the operation of an investigational drug service.

This study is an analysis of the changes to workload and operations of UNC Health's investigational drug service (IDS) brought about by the coronavirus disease 2019 (COVID-19) pandemic. Workload statistics were collected and analyzed for trend changes to illustrate operational changes necessitated by the COVID-19 pandemic within the IDS pharmacy at UNC Health. Multiple workload metrics declined at the beginning of the COVID-19 pandemic, followed by an increase in the metrics for many categories as the pandemic continued. Notably, monthly inventory added initially decreased by 37.5%, later leveling off but showing increased variability. Fills dispensed and monitoring visits both decreased by 34.5% from the first quarter (Q1) to Q2 of 2020. Both metrics returned to or slightly exceeded prepandemic levels by the end of the study period in March 2021. Patient enrollment decreased 76% from February to May 2020 before dramatically increasing in Q3 of 2020 and Q1 of 2021 with the initiation of COVID-19 vaccine studies. The average time to study startup increased for trials not related to COVID-19 and decreased for COVID-19-related trials. There has been no major impact on the number of open protocols throughout the course of the pandemic. Despite initial decreases in workload following the start of the COVID-19 pandemic, IDS operations returned to and, in some cases, exceeded prepandemic levels.

Training workload in the investigational drug service of a university hospital center.

Training represents a considerable portion of research activities and is vastly different for each clinical trial. This variation is partially explained by the lack of detailed regulations surrounding training procedures, which hinders the ability of investigational drug service (IDS) staff to plan their workload. The aim of this study was to quantify the workload associated with trial-specific training of IDS staff. The secondary aim was to identify the factors associated with training complexity. A retrospective study was carried out in the IDS of a mother and child university hospital. Trial-specific documents on which the pharmacy staff was trained were analyzed. Workload was calculated by measuring reading time. The readability of each document was determined by the Flesch Reading Ease score. The complexity of the trials was established using the scoring method of Calvin-Lamas et al. The influence of the following factors on training was assessed by analysis of variance: sponsor type, research phase, and research focus by medical specialty. A total of 93 clinical trials and 433 documents were included. Investigator's brochures were the longest (a mean [SD] of 107 [46] pages; P < 0.0001) and most difficult documents to read (mean [SD] readability score, 25.5 [4.4]; P < 0.0001). Trials with industry sponsors required a significantly longer overall reading time (mean [SD], 12.26 [6.72] hours; P < 0.0001). On average, a mean (SD) of 9.42 (7.16) hours of reading were necessary to train one employee for a clinical trial. This study is the first to document reading time necessary for training of IDS staff. The training workload varied by sponsor type, while the research phase and medical specialty had little impact. IDS units would benefit from a tool that could identify complex trials.

Adapting investigational drug services during a pandemic: Recommendations for future preparedness from the Hematology/Oncology Pharmacy Association Investigational Drug Services Special Interest Group.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

National Comprehensive Cancer Network investigational drug service consensus recommendations

In an effort to expedite the publication of articles , AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Evaluation of drug cost avoidance resulting from conduct of cancer clinical trials in a community-based oncology practice.

66 Background: Aim: To prospectively evaluate cost avoidance during routine conduct of cancer clinical trials in a community based integrated delivery network (IDN) consisting of a health services provider group, a health insurance plan and a hospital system. Only 2%–7% of adult cancer patients participate in clinical trials nationwide [1]. Inadequate funding and concerns about financial viability have been identified as factors that impede clinical trial accrual in the community oncology setting. ‘Cost-avoidance’, defined as dollars that would have been spent to purchase medications but were not spent because of study-related interventions [3] has been proposed as one mechanism to overcome this. Methods: Anti-cancer and hematology drugs provided by intergroup as well as pharmaceutical industry-based trial sponsors to patients enrolled in oncology clinical research were tabulated. Analysis of cost avoidance was restricted to patients covered by the IDNs health plan. Additionally, drugs provided by the trial sponsor were included in the analysis only if they represented a normal standard of care for the disease state. Cost avoidance was defined as the net ingredient cost of the drugs that would have been spent by the health plan for patient care if drugs provided by trial sponsors were not available. Results: Between January 2020 and April 2021, 25 patients covered by the IDN were recruited into clinical trials. Cost savings resulted from 7 targeted and immuno-oncology medications. Net cost avoidance in 2020 was $1,229,798 while that in 2021 till date has been $892,783. The realized cost savings has allowed recruitment of additional clinical research staff as well as expansion of clinical research to rural regional sites served by the IDN. Conclusions: Anticancer drugs provided free of charge by clinical trial sponsors render significant cost savings, ensuring viability and even expansion of oncology clinical research in community based IDNs.

Participation in ENSEMBLE phase III multicenter clinical trial of Ad26.CoV2.S, a COVID-19 vaccine: An investigational drug services perspective.

What is known and objectiveSince WHO declared the pandemic of COVID‐19, vaccines have been developed to fight against this infectious disease. Coordination and participation of investigational drug services to facilitate a phase III COVID‐19 vaccination clinical trial are described and discussed, with novel interventions coordinating the dispensing processes in the trailer settings.CommentOnce the study has reached phase III, the large number of participants and fast enrolment would contribute to the vaccine development.What is new and ConclusionThe investigational drug service (IDS) performed responsibilities in clinical and trailer units, and minimized workflow disturbances to maximize validity during the dispensing process. The advantages of mobile units and trailers increase flexibility of participants, broaden service area and improve feasibility, especially in minority and underserved communities. The UCM IDS team performs responsibilities in both clinical and mobile unit settings, the IDS team is able to facilitate and expand the enrolment to the minority population in underserved communities.

Use of failure modes and effects analysis to mitigate potential risks prior to implementation of an intravenous compounding technology.

DisclaimerIn an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.PurposeThe purpose of this study was to identify potential failure points in a new chemotherapy preparation technology and to implement changes that prevent or minimize the consequences of those failures before they occur using the failure modes and effects analysis (FMEA) approach.MethodsAn FMEA was conducted by a team of medication safety pharmacists, oncology pharmacists and technicians, leadership from informatics, investigational drug, and medication safety services, and representatives from the technology vendor. Failure modes were scored using both Risk Priority Number (RPN) and Risk Hazard Index (RHI) scores.ResultsThe chemotherapy preparation workflow was defined in a 41-step process with 16 failure modes. The RPN and RHI scores were identical for each failure mode because all failure modes were considered detectable. Five failure modes, all attributable to user error, were deemed to pose the highest risk. Mitigation strategies and system changes were identified for 2 failure modes, with subsequent system modifications resulting in reduced risk.ConclusionThe FMEA was a useful tool for risk mitigation and workflow optimization prior to implementation of an intravenous compounding technology. The process of conducting this study served as a collaborative and proactive approach to reducing the potential for medication errors upon adoption of new technology into the chemotherapy preparation process.

Rethinking the Drug Distribution and Medication Management Model: How a New York City Hospital Pharmacy Department Responded to COVID-19.

Beginning in March 2020, New York City began the fight against coronavirus disease 2019. Health care workers were faced with a disease that led to significant morbidity and mortality with no proven therapies. As hospitals became inundated with patients and underwent rapid expansion of capacity, resources such as drugs, protective and medical equipment, and hospital staff became limited. Pharmacists played a critical role in the management of clinical care and drug delivery during the pandemic. As members of the department of pharmacy within NewYork‐Presbyterian Hospital, we describe our experiences and processes to overcome challenges faced during the pandemic. Strict inventory management through the use of daily usage reports, frequent communication, and minimization of waste was critical for the management of drug shortages. The creation of guidelines, protocols, and restrictions were not only used to mitigate drug shortages, but also helped educate health care providers and guided medication use. Managing technology through setting up new automatic dispensing cabinets to address hospital expansions and modifying the electronic order entry system to include new protocols and drug shortage information were also vital. Additional key pharmacist functions included provision of investigational drug service support and training of pharmacists, prescribers, nurses, and respiratory therapists to educate and standardize medication use. Through implementation of operational and clinical processes, pharmacists managed critical drug inventory and guided patient treatment. As the pandemic continues, pharmacists will remain vital members of the multidisciplinary team dedicated to the fight against the virus.

A practical approach to assess the hazardous exposure potential of investigational drugs.

A method to evaluate the hazardous exposure potential of investigational drugs was developed in order to comply with hazardous drug handling standards. New nationwide standards require health-system pharmacies to recognize potential occupational risks and protect employees from any hazardous exposure. United States Pharmacopeia general chapter 800 (USP<800>) provides recommendations on handling precautions for commercial hazardous drugs. Recommendations for investigational drugs are less clear, with USP<800> suggesting more widespread protections when information is deemed insufficient to assess the risk. The investigational drug services pharmacy at a freestanding pediatric hospital developed a method to evaluate the hazardous potential of investigational drugs in order to determine the likelihood that a drug held an occupational handling risk. The goal of the project was to ensure compliance with hazardous drug handling standards and provide adequate employee protection while minimizing the financial burden on the health-system pharmacy. Investigational drugs that meet any of 4 defined criteria should be subject to hazardous drug handling precautions until adequate safety data are available.

Streamlining and cycle time reduction of the startup phase of clinical trials

ObjectiveThe startup phase of a clinical trial (CT) plays a vital role in the execution of new drug development. Hence, the aim of this study is to identify the factors responsible for delaying the CT startup phase. Further, it focuses on streamlining and reducing the cycle time of the startup phase of newly sponsored CTs.MethodsThirteen sponsored CTs conducted between 2016 and 2017 at the Clinical Research Department of King Fahad Medical City, Riyadh, Saudi Arabia, were considered for this study. Eight trials were analyzed to identify the data specific to startup metrics using the FOCUS–PDCA cycle (Find an improvement area–Organize a team–Clarify current practices–Understand the source of variation/problem–Select a Strategy–Plan–Do–Check–Act). Six measures incorporated in the metrics were (1) date of initial contact with site to the signing of confidentiality agreement, (2) date of receiving questionnaire from sponsor to date of its completion, (4) time taken to review protocol and approve investigational drug service form, and (5) time taken to study protocol and approve pharmacy and pathology and clinical laboratory medicine 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 (SD) time was calculated for each metric before and after implementation of the intervention protocol to analyze and compare percentage reduction in the mean cycle time of CTs. Data were represented as mean (SD), and the P value was calculated for each metric. The significance level was set at P < 0.05.ResultsOf the various potential factors of delay identified through fishbone analysis, the two major ones were lack of a well-defined timeline for approval and review of the study protocol and inconsistent IRB meetings. After introduction of the new intervention protocol, the entire CT life cycle was reduced by 45.6% (mean [SD], 24.8 [8.2] weeks vs. 13.5 [11.6] weeks before and after the intervention, respectively).ConclusionVarious factors are responsible for the delay of the startup phase of CTs, and understanding the impact of each element allows for optimization and faster execution of the startup phase of CTs.

Assessing the Economic Value of Pharmacy Resident Participation in an Investigational Drug Service

Purpose: Completion of postgraduate residency training gives pharmacists an opportunity to gain advanced practice experience, yet the availability of these positions is often limited. Through participation in an investigational drug service (IDS), residency programs may be able to expand learning experiences while demonstrating a financial benefit to the institution. The purpose of this assessment is to examine the economic value generated by pharmacy resident involvement within an IDS. Methods: This was a single-center retrospective record review. All resident dispensations within the IDS from January 1, 2016, to December 31, 2017, were evaluated for cost avoidance, revenue, and waived revenue. Cost avoidance was defined as the cost of medications the institution would have incurred had the sponsor not provided therapies free of charge. Medical center contract acquisition costs were used to determine cost avoidance. Total economic value accounted for the personnel costs of resident dispensations. Descriptive statistics were utilized for all assessments. Results: A total of 444 resident dispensations occurred during the study period on 15 IDS protocols. The total cost avoidance for resident dispensations was US$144 898. Total revenue for these dispensations was US$1424, and waived revenue fees totaled US$17 625. After accounting for the personnel cost of dispensations by the residents, the total economic value of resident participation in the IDS was US$159 150. Conclusion: Resident participation in the IDS contributed economic value to the institution. The IDS provides a unique learning experience for the pharmacy residents, cost savings for the institution, and supports the advancement of patient care.

Implementation of a pharmacy technician residency program in a tertiary care teaching hospital.

Leveraging pharmacy technicians to take on advanced roles can enable pharmacists to practice at the highest level of their license. Technicians trained through traditional venues may not have the necessary knowledge and skills to adequately take on these roles. To meet this need, a technician residency program was developed and implemented in a health-system pharmacy. The technician residency program was designed to develop competency in the medication use process as assessed through achievement of 30 objectives based on successful completion of rotations, projects, and didactic examination. The program duration was 50 weeks with rotations which included compounding, technician-check-technician cart fill and floor stock replenishment, investigational drug services, regulatory compliance, and other functions. The resident also completed several projects to improve data analytics, communication, and leadership skills. By the end of the program, the residency program director and preceptors determined that the resident achieved 83% (25/30) of objectives and had developed competency in the medication use process superior to technicians with several years of experience. The resident was ultimately hired in a specialty technician position and was found to perform effectively in that role. The program allowed the technician resident to gain a comprehensive understanding of health-system pharmacy practice and continue to develop skills and abilities that would typically take several years of work experience to be achieved.