Outsourcing Facilities Research Articles

Improving NSAID Safety: The Role of Transdermal Ketoprofen in the Management of Musculoskeletal Pain and Inflammation

Pain and inflammation affect patients both acutely and chronically across all patient demographics. Often, the medications which are used to target musculoskeletal conditions are poorly tolerated due to various contraindications, drug interactions, and troublesome adverse events. The investigation and development of localized, externally applied NSAIDs is on the rise among researchers and pharmaceutical manufacturers, but research is still inefficient in determining the role in therapy of transdermal analgesics and anti-inflammatories. Compounding Pharmacies and FDA 503b Outsourcing Facilities aid in this critical endeavor through endogenous compounding and manufacturing (respectively) of transdermal analgesic formulations. This review summarizes the currently available data supporting the implementation of transdermal ketoprofen preparations in the management of musculoskeletal pain and inflammation. Externally applied NSAIDs are crucial in the development of pain management modalities which reduce the risk of numerous complications, including drug-drug interactions, conflicting comorbidities, and harmful systemic adverse events.

The Clinical Implications of Transdermal Baclofen in the Management of Mild-Moderate Neuropathic Pain

The pharmacotherapeutic management of chronic pain is a particular challenge for healthcare providers, as patients often require multimodal analgesia and polypharmacy in order to achieve symptomatic relief. Patient adherence, frequent dose titration, patient comorbidities, and individual characteristics can further complicate treatment and limit treatment options at the outpatient level. The therapeutic potential of localized analgesia in the treatment of chronic pain is of particular interest to healthcare providers nationwide, as it provides a necessary alternative to systemic analgesia. Compounding Pharmacies and FDA Outsourcing Facilities aid in this endeavor through endogenous compounding and manufacturing (respectively) of externally-applied pain formulations. This review summarizes the available clinical evidence supporting transdermal baclofen utilization in the symptomatic management of chronic musculoskeletal and/or neuropathic pain. The adjunctive treatment of pain from a localized perspective remains under-investigated, and the role of transdermal analgesics/antispasmodics in chronic pain management remains uncertain.

The Therapeutic Potential of Transdermal Gabapentin in the Symptomatic Management of Chronic Neuropathy

Standard pharmacotherapeutic options in the management of neuropathic pain are often poorly tolerated due to various contraindications, drug interactions, and troublesome adverse events. The investigation and pharmaceutical development of localized anti-neuropathic options is increasing among researchers and manufacturers, but results have not yet determined the role in therapy of transdermal/locally acting analgesics, anti-neuropathics, and anti-inflammatories. Compounding Pharmacies and FDA 503b Outsourcing Facilities aid in this critical endeavor through endogenous compounding and manufacturing (respectively) of transdermal analgesic formulations. This review summarizes the currently available clinical data supporting the implementation of transdermal gabapentin preparations in the management of chronic neuropathic symptoms. Transdermally applied analgesic, anti-inflammatory, and anti-neuropathic preparations are crucial in the development of pain management modalities which reduce the risk of numerous well-known complications, including drug-drug interactions, conflicting patient comorbidities, and CNS depressant effects. The adjunctive treatment of neuropathy with a transdermal analgesic/antispasmodic preparation remains under-investigated, and the role of these preparations in the management of chronic neuropathic pain remains unclear.

Considerations for developing a health-system 503B outsourcing strategy.

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. To provide guidance for health systems on how to develop a strategy for utilizing 503B outsourcing facilities for sterile product preparation. Health-system pharmacies face an increasingly complex set of challenges related to providing sterile products to patients. New United States Pharmacopeia <797> regulations, increasing drug shortages, and an ongoing pharmacy technician workforce shortage have made sterile compounding more difficult than ever for health-system pharmacies. Outsourcing of production to 503B outsourcing facilities is one strategy pharmacy leaders can use to help navigate these challenges. However, there are many factors to consider when deciding whether to outsource a product and which 503B vendors are safe and reliable. The Cleveland Clinic Health System (CCHS) has developed a robust internal structure to appropriately vet 503B outsourcing facilities for safety and reliability, as well as standardized criteria used to determine which products will be outsourced. This article describes the tools CCHS has used to evaluate 503B outsourcing vendors and to evaluate individual products to determine the pros and cons of outsourcing vs insourcing. Additionally, general considerations regarding outsourcing are described. Outsourcing to 503B facilities can be an effective strategy for navigating sterile compounding challenges but is not without some risk. Pharmacy leaders must develop a standardized approach to thoroughly evaluate 503B vendors and products to ensure their outsourcing strategy is both safe and cost-effective.

The Development of the Outsourced Facility Service Market in the EU

The Facility Service (FS) industry lacks comprehensive scientific reports due to its fragmented representation in the NACE industry classification system in the EU. This article addresses this gap by offering insights into the FS market's turnover, number of companies, and employees. The study examines the development of turnover, company count, and employee numbers in the outsourced FS sector in the EU and the five major European economies since 2008. The European norm EN 15221:4 defines FS activities, which were cross-referenced with Eurostat's economic data to identify relevant FS services. Extensive data quality checks were conducted to ensure accuracy. From 2008 to 2018, the FS sector's size in terms of turnover and companies was estimated and compared across countries. Findings reveal that the EU's FS sector reached a turnover of over 1142 billion in 2017, with nearly 2 million companies and over 15 million employees. Despite the 2008/2009 financial crisis, the FS sector in the EU demonstrated stability compared to the broader economy in the selected countries.

Practices and challenges of safety management in outsourced facilities management

Introduction: Outsourcing is a commonly occurring organizational activity, but one associated with negative occupational safety outcomes. Improving the management of safety in workplaces where contractors are employed is vital, but under-researched in the service sectors. The aims of this paper were to investigate both the practices and challenges of safety management in outsourced facility management (FM), an important global service sector. Method: Twenty-three semi-structured interviews were conducted with clients and contractors in three different FM outsourcing arrangements between large corporations in the UK. Data were thematically coded against frameworks derived from existing literature to identify deployed safety management practices and reveal challenges associated with safety management in these outsourced relationships. Results: Safety management practices in outsourced FM conformed to known practices clustering into four previously identified categories (planning, selecting, on-site working, and checking). A fifth category (reviewing) was not observed. Operating across national boundaries, applying national contracts locally, working with mandated KPIs, and contract specifications all created new challenges for safety management not previously reported. Other known challenges associated with economic pressure and disorganization were observed. Conclusion: Safety management practices observed in safety critical industries also apply in FM. However, the challenges of safety management in these three cases included regulatory failures that have not been routinely identified in other empirical studies of safety in outsourcing arrangements. Practical application: Adopting widely accepted safety management practices support safer working in outsourced FM and encourage cross-sector learning. New challenges for safety management noted here encourage consideration of unintended consequences of contract terms and conditions, require corporate agreement on how to ensure safety compliance when working transnationally, and a review of decision-making and processes and procedures to enable effective and safe working locally.

Outsourced Facility Management (OFM) Services to Creating Global Competitiveness

In a time of increasing globalization and fierce competition in the market, being competitive has become essential for companies in a variety of sectors. Providers of Outsourced Facilities Management (OFM) services, which include everything from space management to security and maintenance, are essential in helping businesses streamline their operations and concentrate on their core business. The strategic value of outsourcing Facilities Management services is gaining more attention and adaption as the business landscape gets complicated and complex. This increased adoption of the OFM services creates opportunities thus resulting in the presence of both local and global players in this industry. Local outsourced facilities management service providers are encountering a progressively competitive market in today’s business scene. To assess and improve the competitiveness of local OFM service providers fighting to gain market shares against global industry giants, this study explores the idea of critical success factors (CSFs). CSFs stand for those critical areas in which a company must succeed to meet its objectives and beat out rivals. CSFs are essential for comprehending the unique factors that allow local OFM service providers to not only endure but also prosper in a complex network of markets. Additionally, local outsourced facilities management services providers must evaluate their abilities, performance, and competitiveness in comparison to well-established global facilities management leaders that are present in the country. By comparing with these industry giants, local suppliers can establish a baseline and initiate research to gain useful insights, direction, and positioning. This will help them improve their global competitiveness and survival at least at the local industry level. This study examines the rationale for comparing a local supplier against the industry’s critical success factors (CSF) with global companies and emphasizes the potential advantages gained from conducting such a comparison. Keywords: competitiveness, outsourced facility management, property management, critical success factors, integrated facility management

A Compounding Problem: Pharmaceutical Importation and Drug Production in the United States

Abstract Drug shortages are not a new phenomenon in the United States. Current policies and regulations can be improved to better utilize drug compounding facilities to ensure patient safety, provide practical standards for the interstate market, and focus on patient needs in the marketplace. Adjustments in regulation and incentives such as performance-based bonuses are necessary to encourage registration for 503B outsourcing facilities and address shortages for less profitable drugs. Diversity of drug supply sources is also of the utmost importance to secure the trade of essential medicines in times of drug shortages through a globally diverse supply chain along with a strong system for domestic drug manufacturing and compounding facilities.

Agency problems in facility management (FM) outsourcing in the Ghanaian retail sector

Purpose The aim of this study is to examine the agency problems that arise between retail property owners and outsourced facility management (FM) service vendors in Ghana. Design/methodology/approach This study was carried out using telephone and face-to-face interviews. Nine facility managers (n =9) and six retail property owners (n = 6) purposively selected participated in the interviews. The responses from the interviews were analysed using content analysis. To begin with the analysis, the recorded audio for each respondent during the interviews was transcribed to augment what was written during the interviews. The next step was the development of a coding framework where each of the agency problems was assigned unique codes and grouped under themes. Each response was assigned a predefined code based on the agency problems identified in the literature. The research team discussed the consistency of the thematic codes assigned to each of the responses to ensure that each response was captured under the appropriate agency problem theme it best represents. Findings The results showed that agency problems in FM outsourcing in the Ghanaian retail sector are related to disagreement on expenditure associated with maintenance and repairs and improper tenant information sharing and use by FM service providers. Based on the findings, it is recommended that property owners explore the mixed approach to FM to mitigate the risks of complete outsourcing of FM services. It is also recommended that a clear path on how tenant information can be shared be pre-agreed in FM contracts. Originality/value This study provides new literature relating to agency problems in outsourcing and may be the first of its kind for FM in the Ghanaian retail industry. The findings could serve as a starting point for service providers and their principals to find common grounds to understand each other and mitigate the agency problems that could arise and their overall impact on performance.

FACTORS AFFECTING OUTSOURCING DECISIONS FOR FACILITY MANAGEMENT SERVICES

This research aimed to explore factors that affect outsourcing decisions for Facility Management (FM) services in Thailand. It was based on the result of 290 respondents authorized to make decisions on outsourcing Facility Management services. Due to differences in each business field, factors that affect outsourcing decisions were also dissimilar. The goal of decisions, in general, was to choose outsourcing services instead of using in-house resources which reflected business needs in terms of management, strategy, economics, or others to help facilitate and increase the competition level. The results of decision makers' perceptions showed that important factors in different industries considerably varied. The most important factors were management and quality factors which were strongly supported by the Core Competency theory. Meanwhile, the Transaction Cost Economics theory was still significant but not regarded as a top priority for business concerns in the present uncertain period.

Reuse of shipping materials in the intravitreal bevacizumab supply chain: feasibility, cost, and environmental impact

BackgroundIntravitreal injections are the most common ophthalmic procedure worldwide and are also a prime opportunity for waste reduction. This study analyzes the feasibility, environmental impact, and cost of reusing shipping materials for intravitreal injection medications, as compared to wasting coolers and cold packs after single-use.MethodsIn this prospective pilot study, shipping materials (cardboard boxes, polystyrene foam coolers, and cold packs) from repackaged bevacizumab delivered to our clinic (500 doses per week) were saved and reused over a 10-week study period. The shipping supplies were photographed and inspected for defects at point of care (Twin Cities, MN), and returned via standard ground shipping to the outsourcing facility (Tonawanda, NY).ResultsPolystyrene foam coolers (n = 3) survived 10 roundtrips between the outsourcing facility and retina clinic (600 mi each way), although wear-and-tear was visible in the form of marks and dents. Cold packs (n = 35) were less durable, lasting 3.1 ± 2.0 roundtrips. Total carbon dioxide equivalent (CO2e) emissions were reduced 43%, by reusing shipping materials (12.88 kgCO2e per 1000 bevacizumab doses), as compared to the standard practice of disposing containers after single-use (22.70 kgCO2e per 1000 bevacizumab doses), and landfill volume was reduced by 89%. Cost savings from reusing containers offset expenses incurred with return shipping and extra handling in the reuse cohort (net savings: $0.52 per 1000 bevacizumab doses).ConclusionsReusing shipping supplies can be cost neutral, with less CO2e emissions and reduced landfill. Robust environmental benefit is possible if retina clinics partner with manufacturers to reuse shipping containers.

Pandemic-Led Imperative Shift To Digital Transformation – A Critical Analysis

The coronavirus pandemic is essentially reshaping global businesses. At the onset of the pandemic andthrough its consecutive lockdown phases customers dramatically shifted towards online channels, so didcorporates and businesses in each vertical. They responded quick to fill in the gap. The consolidation of corebusiness with outsourcing facilities is the result of an invasive pace of digital transformation of business, aresult of pandemic-led imperative shift in business models.Another issue was that the pandemic speedily locked in countless individuals to 'work from home' (WFH).This created an on-the-spot challenge for a majority of the organizations to produce secure system access toemployees. It witnessed a peremptory reset of organizations to digitization with a new aspect for evolvingdefinition of job roles or modified job description for contemporary corporates. Also, most evidently, ahybrid work-model has emerged that has redefined several corporate rules and processes. The establishedcorporates, tech-driven start-ups, however, managed to support a mass-scale digital training. Thetechnology industry continues to record a positive graph in growth curve in FY2021. However, amongstvarious socio-economic implications of this change, technologically a growing trend to adopt the 3 Cs ofCloud Computing, Collaboration and Cybersecurity to manage the massive data is already visible. Added tothis, a subsequent transition to blockchain for supply change management is vividly noticeable amongstenterprises. This quick adoption of digitization enhanced dependency on advanced digital solutions likecloud computing, amongst others. The resultant rising of the latest job roles that needs technologicallyversatile employees is another ever-changing situation in this context. This research paper deals in thisaspect of the changing trends and tries to critically analyse certain paraphernalia associated to the presenttransformation.

FDA program aims to protect the public against unsafe compounded drugs

As part of FDA’s Compounding Incidents Program, pharmacists can share with the agency any identified potential issues with compounded products. The mission of the program is to protect the public from unsafe compounded drugs, and FDA is emphasizing the important role pharmacists play in reporting any adverse events or complaints related to compounding to them. “Pharmacists are in a unique position to learn about issues or concerns associated with compounded products due to close relationships with their patients and communication with providers,” said Shannon N. Glueck, PharmD, RPh, acting branch chief with FDA’s Office of Compounding Quality and Compliance. Compounded drugs serve an important role in fulfilling unmet needs. Four descriptions can be used to decide whether a product is considered to be compounded:▪The provider stated that the medication required customization for patient-specific needs.▪The pharmacy or physician mixed several ingredients to create a product tailored to the needs of the patient.▪The product label states “This is a compounded drug” and that it was produced by an outsourcing facility.▪The manufacturer is listed as a 503B outsourcing facility online. However, these drugs are not approved by FDA and can present potential safety concerns to patients. For example, in 2012, contaminated intrathecal and intra-articular drugs compounded at the New England Compounding Center in Massachusetts resulted in hundreds of cases of fungal meningitis and more than 60 patient deaths. In response to this case, amendments were made to the Federal Food, Drug, and Cosmetic Act as it relates to compounded drugs. FDA has implemented programs such as Compounding Incidents Program aimed at enforcing these provisions. The program tracks, reviews, and addresses adverse events and complaints related to compounded drugs. FDA pharmacists review reports from multiple sources (e.g., FDA’s Adverse Event Reporting System, FDA’s Division of Drug Information, state regulatory authorities, etc.) daily to identify cases related to compounded drugs or compounding firms. “These issues can range from product quality concerns to adverse events or complications from the use of a compounded product,” said Glueck. “What may seem like an individual patient experience could actually be a signal of a larger safety concern.” Once a case is determined to be compounding-related, it is entered into a searchable database and additional research is conducted to further evaluate the case. The case findings are then presented and various actions can be taken to ensure an appropriate response that protects the public from unsafe compounded drugs. “With pharmacists, other health care professionals, and consumers providing information on issues relating to compounded products, FDA can better identify trends, locate the source of the issue through investigation, and take action as necessary,” she said. “However, FDA cannot take action without becoming aware of such issues. The majority of the safety signals investigated by FDA and those posted on the FDA website as Compounding Risk Alerts were identified from reports of potential issues with compounded products. It is these reports from the public that allow FDA to mitigate the safety issue and prevent further patient harm,” said Glueck. FDA’s Human Drug Compounding website (fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding) contains many useful resources related to compounding, including an overview of compounding regulations, links to FDA guidance documents, memoranda of understanding and Federal Register notices, online training programs pertaining to sterile and non-sterile compounding, and more. A recent AJHP article about the Compounding Incidents Program includes helpful tips on how to report an adverse event associated with a compounded drug on FDA’s MedWatch form, such as providing as much detail as possible about the event and selecting the most appropriate product type (with “Compounded” listed as one of the choices). “As pharmacists ourselves, we work hard each and every day at the FDA to assure the safety and quality of compounded products and to protect patients from unsafe and ineffective compounded products,” said Glueck. “We appreciate the pharmacists and other health care professionals who partner with us to help make that happen.”

User satisfaction with outsourced facility management (FM) services in multi-tenanted shopping malls in Ghana

PurposeThis study aims to assess the satisfaction of users with outsourced facility management (FM) services in multi-tenant shopping malls (SMs) in Accra, Ghana.Design/methodology/approachThis study measured user satisfaction (US) with 15 FM services using the perception of internal users about the attitude and courtesy of the personnel who provide the services, the reliability of the services, their responsiveness and their competence. This study used survey data from 117 users who have actively used these services for at least 12 months using structured questionnaires. The data was descriptively analysed to assess the perceived satisfaction of the users in five SMs.FindingsThe results showed that users were satisfied with the delivery of all 15 services (each had a mean above 3.0 which is the benchmark satisfaction point). The findings also showed high levels of service quality with the four dimensions of satisfaction investigated.Originality/valueThis study demonstrates US with outsourced FM services for multi-tenant SMs in Ghana. Practically, property owners, potential investors and other stakeholders can rely on the findings for effective FM strategy decision-making. Facility managers can rely on these findings to review their service delivery for the better.

Analysis on outsourcing service behavior of rice pest and disease control based on Heckman selection model-A case study of ten counties in Fujian Province.

Under the background of relatively slow agricultural labor transfer and land circulation, agricultural production outsourcing has become the main means of agricultural modernization. In order to provide a beneficial perspective for appropriately expanding the scale of rice control outsourcing services, we investigated the situation of rice control outsourcing in ten counties of Fujian Province, and analyzed the factors influencing rice farmers' decision-making and control degree by using Heckman model. First of all, the main factors affecting farmers' participation in outsourcing are agricultural labor force, whether family members are cooperative members, planting area, proportion of grain income, degree of organization of outsourcing team, region and so on. Secondly, agricultural labor force, cooperative members, planting area, part-time behavior, mechanical efficiency of prevention and control organization, and region are the main factors affecting the scale of control outsourcing. Thirdly, from a regional perspective, the rice farmers in northern and Western Fujian are more dependent on outsourcing services consumption compared with the rice farmers in Southern Fujian. These results have a clear impact on policymakers, indicating that policy and measures should encourage the prevention and control of the nature of cooperation, and improve the advanced nature of outsourcing facilities of plant protection equipment, thereby effectively improving the professional level of rice pest and disease control.

Gender Bias in Medicine: “How Women Continue to Get the Shaft When It Comes to Testosterone Therapies”

Gender Bias in Medicine: “How Women Continue to Get the Shaft When It Comes to Testosterone Therapies”

Online questionnaire on genetic testing for intractable diseases in Japan: response to and issues associated with the revised medical care act.

In Japan, most genetic testing for intractable diseases has been conducted in research laboratories in the past. However, since the Revised Medical Care Act came into effect on December 1, 2018, genetic testing in compliance with this act has become a major issue. To collect information on this topic, we conducted an online survey of members of the research groups for intractable diseases, which play a central role in medical care and research on intractable diseases with the support of the Ministry of Health, Labor and Welfare, five months after the enactment of the act. We separated the surveyed facilities into those that conducted genetic testing in their own laboratories ("testing facilities") and those that outsourced genetic testing ("outsourcing facilities"). Ninety-five and 66 responses regarding genetic testing were obtained from the testing and outsourcing facilities, respectively. Genetic analysis was the most commonly conducted genetic testing method, accounting for 60% or more of the tests. At the testing facilities that conducted comprehensive analysis with a next-generation sequencer, the number of target diseases for genetic testing was observed to be higher. In these testing facilities, more than 70% were research laboratories. In contrast, at the outsourcing facilities, testing was outsourced to registered clinical laboratories in many cases or to research laboratories. The proportion of genetic testing covered by public medical insurance at the outsourcing facilities was two times higher than that at the testing facilities. The importance of quality control for genetic testing was generally well acknowledged, but there was apprehension regarding the increased cost and burden on staff of quality control assurance, and many testing facilities viewed genetic testing as difficult. The research groups could handle the examination and interpretation of the genetic testing results, and many groups gathered and registered patient information. Within the intractable disease medical support network, there was a relatively large number of collaborations, with studies supported by the Japan Agency for Medical Research and Development (AMED) and Initiative on Rare and Undiagnosed Diseases (IRUD) projects. There were many requests for genetic testing to be covered by public medical insurance. In the future, the implementation of genetic testing using a next-generation sequencer at clinical laboratories with guaranteed quality control and the development of a system for collaboration with research groups will be necessary.

The role of outsourcing facilities in overcoming drug shortages

BackgroundThe Drug Quality and Security Act passed in 2013 created a new voluntary category of compounders, referred to as outsourcing facilities. The regulatory landscape allows these facilities to compound on a larger scale in comparison with the typical compounding pharmacies, which positions them to potentially serve a role in overcoming drug shortages. ObjectiveThe purpose of this article is to identify the number of drug products on shortage as reported by the Food and Drug Administration (FDA) that were also compounded by outsourcing facilities. MethodsAll current and resolved drug shortages through January 27, 2020, as reported by FDA, were compared with the 503B product reports from July 2018 through June 2019 submitted to FDA by outsourcing facilities. The active pharmaceutical ingredient (API) and dosage form for each product on shortage were compared with the 503B product reports to identify similarities. ResultsThere were 344 unique APIs on the FDA drug shortage list and 774 unique APIs on the 503B product reports. After comparison of the APIs on the drug shortage list with those on the product reports, 27% of unique APIs (74 of 272) were included on both lists, and of these, 18% (50 of 272) of the APIs on the drug shortage list were compounded by outsourcing facilities in the same dosage form as what was on shortage. ConclusionThe regulatory landscape positions outsourcing facilities to play an important role in providing access to medications while on shortage. However, when comparing the drugs on shortage as reported by FDA with the 503B product reports, there was minimal overlap. Additional research into why outsourcing facilities are not taking on a larger role in overcoming drug shortages should be explored.

Outsourcing facilities and their place in the U.S. drug supply chain

The purpose of this commentary is to describe the ideal role of 503B outsourcing facilities in the U.S. drug supply chain. We also address the challenges that 503B outsourcing facilities are facing that limit their utilization and offer possible solutions. Section 503B outsourcing facilities are emerging contributors in compounding owing to their ability to compound large quantities of medication without requiring patient-specific prescriptions. As such, they play a valuable role in the U.S. drug supply chain. The use of outsourcing facilities to compound ready-to-use drug products is gaining traction in hospitals and other health care systems. Outsourcing facilities help hospitals that are facing time and cost constraints owing to the evolving regulatory landscape around compounding. Although outsourcing facilities are assets to the drug supply chain, there are several challenges to their use. The lack of a finalized 503B Bulks List has led to outsourcing facilities being overly cautious in compounding products using bulk drug substances. In addition, the time between Food and Drug Administration (FDA) inspections is undefined, and a lack of follow-up information regarding concerns identified during an inspection may result in uncertainties about the current state of the outsourcing facility. Health care providers, outsourcing facilities, and FDA need to work together to ensure that patients are provided the drugs they need in a safe and effective way.

Dynamic pharmacy leadership during the COVID-19 crisis: Optimizing patient care through formulary and drug shortage management

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 coronavirus disease 2019 (COVID-19) pandemic has created unprecedented challenges for health systems around the world. We describe our approach to adapting the pharmacy leadership structure to address critical medication shortages through innovative data analysis, procurement strategies, and rapid implementation of medication policy.SummaryYale New Haven Health deployed a system incident management command structure to effectively respond to the COVID-19 crisis. System pharmacy services adopted a similar framework to enable efficient communication and quick decision-making in key domains, including drug procurement and policy. By refining a model to project health-system medication needs, we were able to anticipate challenges and devise alternative treatment algorithms. By leveraging big data and creating a system knowledge base, we were able to consolidate reporting and coordinate efforts to ensure system success. Various procurement strategies were employed to ensure adequate supply, including frequent communication with our wholesaler, sourcing direct from suppliers, outsourcing of sterile products compounding to registered 503B outsourcing facilities, and acquisition of active pharmaceutical ingredients for compounding of essential medications. Strategic positioning of pharmacists within the health system’s incident command response teams and rapid adaption of drug use policy governance fueled accelerated response and nimble implementation. Communication was streamlined and executed via multiple outlets to reach a broad audience across the health system.ConclusionWith medication shortages posing a threat to patient care, dynamic pharmacy leadership proved essential to providing patient care at the height of the COVID-19 pandemic. System alignment and the rapid adaption of the existing framework for drug shortage management and medication use policy were crucial to success in crisis response.