Industry News
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LA JOLLA, CA — Enlaza Therapeutics, the first covalent biologic platform company, today announced a $100 million Series A financing. The financing will be used to further develop Enlaza’s proprietary covalent protein technologies and to support advancement of wholly owned pipeline programs to the clinic.
The financing was led by the Life Sciences group of J.P. Morgan Asset Management’s Private Capital division, with participation from existing investors: Frazier Life Sciences, Avalon Ventures, Lightspeed Venture Partners, and Samsara BioCapital. The financing also includes new investors: Amgen Ventures, Regeneron Ventures, Bregua Corporation, Pappas Capital, and Alexandria Venture Investments. Concurrent with the financing, Stephen Squinto, Ph.D., Chief Investment Officer (CIO) of the Life Sciences group of J.P. Morgan Private Capital, was named to the Board of Directors.
“We are thrilled to close this financing with a group of new and existing investors that share our vision of creating a novel, differentiated class of protein therapeutics in oncology and other therapeutic areas,” said Sergio Duron, Ph.D., CEO of Enlaza Therapeutics. “This support will enable continued expansion of our covalent protein drug platform, establishment of a diversified pipeline that demonstrates the broad potential of this approach, and advancement of our lead assets toward clinical development.”
“Bringing covalency to the biologics market is an extremely valuable way to unlock the next generation of protein therapeutics that are safer and more tolerable and can be dosed more frequently with lower doses,” said Stephen Squinto, CIO of Life Sciences group of J.P. Morgan Private Capital. “We believe Enlaza’s platform is well positioned for many first-in-class and best-in-class opportunities and are excited to partner with this senior management team.”
Enlaza’s covalent biologic platform, called War-LockTM, creates highly specific therapeutic warheads that covalently bind to drug targets of interest. This white-space technology enables, for the first time, a covalent-acting protein drug that retains the selectivity of small-format biologics. These unique protein drugs enable specific covalent binding to an intended protein target, improving efficacy while simultaneously reducing toxicities related to sustained peripheral exposure.
The War-Lock platform has broad applications and produces therapeutic candidates with excellent drug-like properties. Protein drugs produced by the platform can be modified to incorporate various payloads and achieve specific delivery to target tissues with high fidelity. Enlaza has generated further preclinical data for its oncology drug candidates supporting the covalent mechanism of action by demonstrating efficient tumor penetration coupled with rapid systemic clearance, high tumor retention, and low off-target liabilities. These data have enabled Enlaza to develop a high-value pipeline of covalent protein drugs.
The company’s Board of Directors is comprised of Stephen Squinto, Ph.D., J.P. Morgan Private Capital; Jamie Topper, M.D., Ph.D., Frazier Life Sciences, Jay Lichter, Ph.D., Avalon Ventures; Shelley Chu, M.D., Ph.D., Lightspeed Venture Partners; Marcos Milla, Ph.D., Samsara BioCapital, and Sergio Duron, Ph.D., CEO, Enlaza Therapeutics.
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DEERFIELD, IL — Walgreens is expanding its specialty pharmacy services and investing in its capabilities as the company further grows its core pharmacy business to improve patient outcomes and provide greater value to payers and partners. The company introduced Walgreens Specialty Pharmacy, a holistic offering that expands access to care for patients with complex, chronic conditions and enables partnerships that drive profitability for Walgreens’ pharmacy business. The company is also making investments that will transform its specialty pharmacy offerings, including gene and cell therapy services.
“With approximately $24 billion in annual enterprise specialty revenue, Walgreens Specialty Pharmacy is the largest independent provider that offers the industry's most robust specialty capabilities not vertically aligned with a pharmacy benefit manager,” said Rick Gates, chief pharmacy officer, Walgreens. “We have the flexibility to contract dynamically with any payer. We can partner directly with pharmaceutical manufacturers to facilitate products to market, including limited distribution drugs, and coordinate closely with providers to ensure patients experience a smooth start to treatment.”
Under the new business, Walgreens Specialty Pharmacy is the only specialty pharmacy in the market with the following services and assets at scale:
- Gene and Cell Services Pharmacy and Innovation Center – a dedicated 18,000-square-foot center in Pittsburgh, PA, with services and capabilities for these emerging therapies, including innovative solutions for managing the complexity of the supply chain, logistics and financing as well as clinical and social needs management to ensure success for patients and partners.
- Four central specialty pharmacies – each holding several national pharmacy accreditations – where pharmacists and care teams across the country work together to dispense highly complex medications and help patients manage chronic or rare diseases and conditions. These pharmacies hold distinctions in oncology and rare/orphan conditions and offer patients and caregivers clinical services that drive engagement, adherence and outcomes.
- Nearly 300 community-based specialty pharmacies across the nation – more than any other pharmacy. These specialty pharmacies are strategically located near medical office buildings and health systems, closely aligning care provision with local physicians, offering patients access to specialty medications faster than the industry average, as well as services like injection training, medication side-effect management and financial assistance coordination for medications.
- More than 1,500 specialty-trained pharmacists, 5,000 patient advocacy support team members and dedicated Specialty360 teams that support all specialty condition and therapies.
- A growing roster of 240 limited distribution drugs, including 40 narrow networks and 12 exclusive limited distribution drugs.
- Walgreens Specialty Pharmacy is focused on breaking through healthcare system silos, bringing convenient access to hard-to-find medications and critical adherence support. Building upon the deep, trusted relationships Walgreens pharmacists have with providers and communities, the model enables more comprehensive care to ultimately help payers better manage specialty costs.
Specialty medications today account for more than 50% of prescription drug spend in the U.S.[1] due to the increasing prevalence of chronic disease. There is a need for disease management solutions that are treated by specialty drugs. To advance solutions, Walgreens Specialty Pharmacy enables patient access to specialized treatments through a newly formed integrated care model, driving cost savings and efficiencies in care by uniting the company’s pharmacy teams and distribution network across providers, pharmaceutical manufacturers, health plans and payers.
Walgreens is building on its decades of experience serving the specialty pharmacy needs of commercial, Medicaid, Medicare, and other government and private payers. The company provides services or access to nearly all pharmacy benefit managers and major health plans— as well as alternative payment and service models that help health plans and PBMs differentiate themselves for their clients and members.
Effective August 1, 2024, AllianceRx Walgreens Pharmacy will become Walgreens Specialty Pharmacy. Patients of AllianceRx Walgreens Pharmacy and Walgreens community-based specialty pharmacies now have access to resources that will build upon the expert care they already receive from their specialty pharmacist, including clinicians with key disease state expertise, nutritionists and care nurses. Specialty patients can also view their entire prescription profile at Walgreens, including their retail prescriptions.
“When a patient must confront a life-changing, serious health challenge and begins therapy for a chronic or complex condition, our pharmacists are right there to guide and care for them throughout their healthcare journey —from helping them order and take their medication to identifying financial assistance opportunities and working with their doctor and insurance plan to make sure they’re receiving the most coordinated care,” Gates said.
In addition, Walgreens has seen consistent growth through its wholly owned subsidiary Shields Health Solutions, the nation’s premier health system-owned specialty pharmacy accelerator. Shields specialty model provides integrated care solutions for local health systems and specialty pharmacy patients, working with over 1,000 hospitals across 45 states. The Shields business will continue supporting health systems specialty pharmacies, which complement Walgreens newly enhanced specialty pharmacy offerings.
The launch of Walgreens Specialty Pharmacy is the company’s latest initiative aimed at expanding the role its pharmacy teams play in patients’ lives and bringing their clinical expertise to help payers, providers, pharmaceutical manufacturers and partners deliver critical healthcare. It also further supports Walgreens' efforts to achieve provider status for its pharmacists given their influence and integral role in healthcare delivery.
[1] IQVIA. Global Use of Medicines 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publicat…
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MOUNT PROSPECT, IL — The National Association of Boards of Pharmacy® (NABP®) released a new RogueRx Activity Report, Injectable Weight Loss Drugs: How Illegal Online Drug Sellers Are Taking Advantage of Patients, which explores how bad actors are taking advantage of glucagon-like peptide-1 receptor agonist (GLP-1 agonist) medications "going viral." This class of drugs, including semaglutide, liraglutide, and tirzepatide, is used to treat type 2 diabetes and obesity. Among patients, these drugs are commonly known for promoting weight loss. Unfortunately, because of the drugs' popularity, criminals have seized the opportunity to illegally sell the drugs online, putting patients at risk.
These GLP-1 agonists are in high demand by patients; however, they are expensive and often not covered by insurance. In addition, some dosages of these approved drugs are on Food and Drug Administration's Drug Shortage List, meaning that the available supply cannot meet the current demand. As a result, some patients go online to find these popular medications. Illegal online sellers are exploiting this demand by offering substandard and falsified GLP-1 agonists to vulnerable patients. According to the Partnership for Safe Medicines, substandard and falsified Ozempic® has been found in at least 16 countries to date. In the report, NABP highlights the methods illegal actors use to sell substandard or falsified GLP-1 agonists:
- Criminals sell these drugs online without requiring a valid prescription and without the required pharmacy licenses.
- Some bad actors trick purchasers by mimicking legal sellers' websites, branding, or packaging.
- Others employ a non-delivery scheme, meaning patients never receive the goods they pay for online.
- Sellers may also try to skirt enforcement by advertising drugs as "peptides" with claims that they are for "research purposes only" and "not for human consumption."
Government agencies around the world are actively investigating illegal sellers, and online marketplaces and e-advertising platforms are working to remove illegal drug sellers from their platforms. NABP applauds the efforts of these agencies and organizations.
Learn how you can warn patients against illegal online sellers of GLP-1 agonists by reading the RogueRx Activity Report.
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ROCKVILLE, MD and TULSA, OK — Health technology company DrFirst, and PatchRx, a medication adherence company, announced a partnership to close the gap between a healthcare provider’s recommended medication therapy and the patient’s actual medicine-taking behavior.
This collaboration aims to mitigate the health and economic impacts of medication non-adherence, which is linked to approximately 125,000 deaths and nearly $250 billion in healthcare costs annually in the U.S. By combining prescription fill data and remote monitoring data, DrFirst and PatchRx will provide a more accurate view of patient behavior, empowering care managers and quality improvement clinicians to prioritize, monitor, and intervene with high-risk patients for clinical quality improvement initiatives, such as value-based care, chronic care management, and medication therapy management programs.
“There’s a massive data gap in healthcare between when patients fill prescriptions and when patients actually take the medication, resulting in critical adherence oversights. Combining DrFirst’s prescription fill data with our daily adherence insight gives doctors a complete picture of how well a patient is following their prescribed medication regimen with unprecedented granularity,” said Andrew Aertker, co-founder and CEO of PatchRx. “With so many complex medication routines for behavioral health issues or chronic conditions like diabetes and hypertension, this collaboration will go a long way in providing the best technology to support those patients and deliver the precise data providers need to connect with patients proactively and personally.”
PatchRx’s patented, smart pill-bottle technology has gained widespread adoption with high levels of patient engagement. The unique cap fits on the underside of any size pill bottle, gathering information securely for the patient and the patient’s care team.
This technology complements DrFirst’s population risk management solution, which provides the most accurate and clinically actionable medication history for patients enrolled in medication management programs, including prescriptions patients purchase with cash, coupons, or pharmacy prescription savings plans.
“Timing is everything when it comes to effective treatment of complex conditions,” said G. Cameron Deemer, CEO of DrFirst. “Combining our comprehensive prescription fill data with remote monitoring data from PatchRx will give providers the information they need to identify patients who are off schedule with their medications and to intervene early to provide support and prevent health complications.”
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WASHINGTON, DC — The Department of Health and Human Services (HHS) issued a final rule revising the administrative dispute resolution (ADR) process under the 340B program. This final rule will apply to all drug manufacturers and covered entities that participate in the 340B Program, addressing the requirements and procedures for the 340B Program’s administrative dispute resolution (ADR) process.
According to the American Hospital Association, the ADR process allows all 340B-covered entities — regardless of the size of the organization or monetary value of the claim — to address claims at dispute with drug companies.
"The final rule contains several important process improvements, including a clear timeline for when ADR decisions must be made and an opportunity for reconsideration when parties are dissatisfied with the initial ADR decision," AHA General Counsel Chad Golder said. "The AHA is particularly pleased that the final rule makes clear that an overcharge claim includes instances where a drug company has limited a hospital's ability to purchase 340B drugs at or below the 340B ceiling price. This rule will help hold drug companies accountable for their rampant abuses of the 340B program and the patients it serves."
“340B Health is pleased that HRSA’s (Health Resources & Services Administration) final rule aligns with several of our recommendations for revisions and clarifications to the agency’s proposed rule," Maureen Testoni, president and CEO of 340B Health, said."We are particularly encouraged by the final rule clarifying that a covered entity’s ADR claims can include accusations that a drug company has limited the ability to purchase drugs at or below the 340B ceiling price and removing a proposed amendment to block ADR consideration of a claim similar to an issue pending in federal court. HRSA’s removal of potential conflicts of interest and unnecessary legal barriers are additional positive steps that will simplify and streamline the dispute resolution process for the benefit of all participants.”
This rule, which may be viewed in full here, will come into effect on June 18, 2024.
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CAMBRIDGE, MA – Takeda (NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO.1 The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (ENTYVIO Pen).*
The approval is based on the VISIBLE 2 Study (SC CD Trial), a Phase 3, randomized, double-blind, placebo-controlled trial, which assessed the safety and efficacy of an SC formulation of ENTYVIO as maintenance therapy in adult patients with moderately to severely active CD who had clinical response** at Week 6 following two doses of open-label vedolizumab intravenous therapy at Weeks 0 and 2.1 The primary endpoint was clinical remission*** at Week 52, which was defined as a total Crohn’s Disease Activity Index (CDAI) score of ≤150.
“Crohn’s disease is a complex and usually progressive disease for which an appropriate management plan is critical. My primary goal as a clinician is always to get patients to achieve remission. In VISIBLE 2, about half of patients treated with ENTYVIO SC achieved long-term clinical remission,” said Timothy Ritter, MD, senior medical director, Department of Research and Education, GI Alliance Research and assistant professor of medicine, TCU School of Medicine. “The data from VISIBLE 2 reaffirm the well-established efficacy profile of ENTYVIO, regardless of route of administration.”
In VISIBLE 2, a total of 409 patients were randomized at Week 6 in a double-blind fashion (2:1) to ENTYVIO 108 mg administered by SC injection or placebo every 2 weeks.1 Eligible patients included patients who had experienced an inadequate response to, loss of response to, or intolerance to at least one of the following: corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate), or tumor necrosis factor (TNF) blockers (including primary non-responders).
A statistically significant proportion of patients receiving ENTYVIO SC 108 mg maintenance therapy administered every 2 weeks achieved long-term clinical remission*** compared to patients receiving placebo (48% vs. 34%; p<0.01) at Week 52.1 In clinical studies, the ENTYVIO SC safety profile was generally consistent with the known safety profile of ENTYVIO IV, with the addition of injection site reactions (including injection site erythema, rash, pruritus, swelling, bruising, hematoma, pain, urticaria and edema) as an adverse reaction for ENTYVIO SC. The most common adverse reactions reported with ENTYVIO IV (incidence ≥3% and ≥1% higher than placebo) were nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
“The approval of subcutaneous ENTYVIO in Crohn’s disease delivers on our goal of providing treatment options that can help patients achieve remission of their ulcerative colitis or Crohn’s disease, while also providing them flexibility and choice of route of administration. With ENTYVIO Pen, patients have the option of administering their maintenance treatment at home or on the go,” said Brandon Monk, senior vice president, head, U.S. Gastroenterology Business Unit, Takeda. “Our development of a subcutaneous option demonstrates Takeda’s commitment to meeting the very real needs of those living with gastrointestinal diseases.”
*Please refer to “U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis”, dated September 27, 2023.
**Clinical response is defined as a ≥70-point decrease in Crohn’s Disease Activity Index (CDAI) score from baseline (Week 0).1
***Clinical remission is defined as CDAI score of ≤150 at Week 52.1
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INDIANAPOLIS, IN – Eli Lilly and Company (NYSE: LLY) announced positive topline results of the SURMOUNT-OSA phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo, achieving the primary endpoints. Percentage change in AHI was a key secondary endpoint in both studies. AHI records the number of times a person's breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate the severity of obstructive sleep apnea (OSA) and the effectiveness of treatment outcomes. Tirzepatide is the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) treatment for chronic weight management, commercialized as Zepbound® in the U.S. and Mounjaro® in some global markets outside the U.S.
SURMOUNT-OSA Study 1 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were not on positive airway pressure (PAP) therapy for 52 weeks. For the efficacy estimandi, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 27.4 events per hour compared to a mean AHI reduction from baseline of 4.8 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 55.0% compared to 5.0% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 18.1% from baseline, compared to 1.3% from baseline for placebo.
SURMOUNT-OSA Study 2 evaluated tirzepatide in adults with moderate-to-severe OSA and obesity who were on and planned to continue to use PAP therapy for 52 weeks. In this population for the efficacy estimand, at 52 weeks, tirzepatide led to a mean AHI reduction from baseline of 30.4 events per hour compared to a mean AHI reduction from baseline of 6.0 events per hour for placebo. In key secondary outcomes, tirzepatide led to a mean AHI reduction from baseline of 62.8% compared to 6.4% from baseline for placebo; tirzepatide also led to a mean body weight reduction of 20.1% from baseline, compared to 2.3% from baseline for placebo.
The weight loss observed at 52 weeks with tirzepatide (10 mg and 15 mg) across the two studies was nearly 20% in a patient population that was comprised of approximately 70% males, who are known to achieve less weight loss with incretin therapy than females.
OSA is a sleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep, which can lead to apnea or hypopnea and a potential decrease in oxygen saturation and/or waking from sleep. OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and type 2 diabetes.
"OSA impacts 80 million adults in the U.S., with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated," said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. "Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease."
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LOUISVILLE, KY — ScionHealth announced today they will begin purchasing certain bulk drugs from Mark Cuban’s Cost Plus Drug Company (“Cost Plus Drugs”) and delivered to Safecor Health’s SafecorLogics program. The integrated approach, combining the expertise of three organizations, will enable ScionHealth to deliver exceptional value to patients while ensuring the sustainability of its healthcare delivery model.
Cost Plus Drugs was launched in January 2022 with the mission of providing cheaper pharmaceuticals by eliminating middlemen and offering a transparent pricing model. The company’s Cost Plus Drugs Marketplace launched in 2023 to bring this same philosophy to healthcare business purchasers. “Everyone should be able to access their prescriptions at affordable and transparent prices,” said Dr. Alexander Oshmyansky, CEO at Cost Plus Drugs. “We are thrilled to work with ScionHealth as one of our initial health system partnerships and look forward to our work together with their team and Safecor Health.”
Since September of 2023, ScionHealth has worked with Safecor Health as a strategic supply chain partner through Safecor Health’s SafecorLogics program. SafecorLogics was developed to help healthcare systems centralize their own unit-dose supply chains, giving them greater cost savings and mitigating waste while optimizing staffing and operations. ScionHealth expanded its utilization of the program in January of 2024.
“Across the industry and particularly in hospital settings, we are facing the challenges of rising drug and supply costs and navigating staffing shortages,” said Rob Jay, ScionHealth’s Chief Executive Officer. “ScionHealth is continually looking for innovative approaches to address these issues while advancing the delivery of high-quality, patient-centered care and well-being to our communities. SafecorLogics has already been an effective solution to help us address these challenges. Now, by introducing Cost Plus Drugs, we are confident we’ll see even more success managing drug costs and enhancing care delivery across the ScionHealth network.”
Steve Fischbach, Safecor Health’s Chief Executive Officer, echoed this sentiment, saying “We are proud to partner with innovative companies like ScionHealth and we are excited to expand that partnership with products from Cost Plus Drugs. It’s a great fit for the SafecorLogics program and we’re sure it will lead to meaningful savings for ScionHealth.”
The drugs ScionHealth purchases in bulk from Cost Plus Drugs will be delivered to Safecor Health's unit-dose packaging centers where they will be packaged, stored, and shipped same-day as requested by ScionHealth's locations.
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Anders Hedlund is currently the CEO of Nolsterby Invest AB, the largest shareholder in Pharmacolog. Nolsterby Invest AB is an investment company in the healthcare sector and has been invested in Pharmacolog since 2017. Since 2023, Anders Hedlund is also a current Board Member of Pharmacolog, a position he plans to maintain.
Erik Hedlund, Chairman of the Board and main owner of Pharmacolog: "We are in a transformational process to become a serial acquirer within the healthcare sector. There is a lot of work to be done although we have made progress during the quarter by, for instance, divesting the Druglog product line. Recently, we also announced our intention to change the name of the company. Anders Hedlund’s main task will be to lay the ground for the new business direction. His extensive experience and network in the healthcare and financial industry make him suitable for this task.”
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IRVING, TX – Vizient, Inc. released recommendations focused on mitigating common risks, identifying national guidelines and utilizing existing resources to ensure preparedness for an active shooter event. The recommendations were made by a task force of 40 Vizient network executives from 27 organizations across the country. The recommendations and rationales bring attention to organizational tactics that were found by the task force to be lacking or inconsistent. View active shooter preparedness resources.
"It is an uncomfortable topic to discuss but it is vital that hospitals address the issue of a potential active shooter event," said Susan Chishimba, Vizient Member Networks senior director. "Planning for the unthinkable will invariably save lives."
The recommendations are based in part on the results of a recent Vizient provider customer health system survey that revealed disparities in active shooter protocols. While 98% of hospital system respondents said they have enacted an active shooter protocol, preparedness varied. Only 24% have discussed a dedicated plan to ensure continuity of care for critically ill patients. Of those, very few use a "secure-preserve-defend" doctrine in which staff first prioritize locking down or barricading their patient care areas. The results of the survey are published in the American Journal of Disaster Medicine. View a summary of the survey findings, Assessing Active Shooter Preparedness in U.S. Hospital Systems.
The recommendations from the task force focus on appropriate communication, secure access, management of critically ill patients who are unable to run, hide and fight, and include tactics for addressing post-event trauma. The online resources, which comprise recommendations and rationales for communication, physical security, plan and response, drills and simulations and a post-event response, include:
- Using appropriate language when broadcasting an event, with attention to both internal and external communication.
- Integrating access control, video surveillance, alarms, and other supportive technology to reduce the risk of active shooters gaining access to secure areas.
- Investing in shot-detection technology that would alert local law enforcement as soon as shots are fired.
- Considering the need for hemorrhage control procedure and supplies as a critical element of an organization’s response plan.
- Focusing on the importance of post-event recovery in order to restore safety, rebuild confidence and foster resilience.
"Active shooter events are a tragic and unfortunate reality," said Jodi Eisenberg, associate vice president, Vizient Member Networks. "It’s critically important to have a comprehensive plan in place — even if it’s one you hope you never have to use."