The University of Wisconsin Health System (UW Health) was required to meet the complex needs of their patients with intrathecal pain pump compounded medications. The health system looked for a partner who could quickly integrate outsourced compounding services. An established regulatory-compliant program would enhance patient outcomes while increasing pharmacy, provider, and patient satisfaction.

Regulatory challenges are evolving and complex

Regulations for outsourced pharmacy needs are critical for safe patient care but pose significant challenges to health systems that utilize 503A pharmacies for outsourced compounded medications. 

The Joint Commission requires that outsourced pharmacies meet or exceed United States Pharmacopeia (USP) Chapter 797 standards. USP 797 presents unique challenges for Category 3 compounding of sterile preparations, including increased sterility testing, staff training and competencies, and significant facility investments. Health systems must ensure that standard operating procedures (SOPs) reflect these standards, which require intensive, time-consuming administrative and operational challenges.

In search of a compounding partner

UW Health looked to find a state-of-the-art 503A compounding pharmacy to provide its patients with exceptional quality and service, as well as make it easy for patients and providers. Utilizing a 503A outsourced pharmacy presents implications from a regulatory, financial, and operational perspective. The health system needed a partner who could help minimize operational changes and streamline the necessary in-depth regulatory review. A key area in the transition would be to address the training and administrative changes related to patient-specific electronic ordering. A successful transition would mean robust customer service for key stakeholders.

AIS Healthcare (AIS): a winning solution for patients and providers

Pharmacy leaders at UW Health had a vision for quality patient care and a keen understanding of 503A outsourcing pharmacy requirements. They quickly identified AIS as a partner worthy of the regulatory and timetable challenge. As a dedicated 503A pharmacy for intrathecal medications, AIS offers an unparalleled approach to health system challenges. While maintaining the highest commitment to quality and patient safety, AIS provides flexibility to meet each system’s unique needs.

AIS provided all FDA-required regulatory documentation, as well as a robust quality report that outlined all quality control and assurance measures and outcomes. The report also included testing of Active Pharmaceutical Ingredients, stock solutions, environmental testing, and staff competency training assessments. 

AIS provided a streamlined onboarding process for the medical center, incorporating staff training and a dedicated customer engagement team. The process included pharmacy and provider training on the proprietary provider ordering portal, which allowed convenient e-prescribing for the medical center.

Exceeding expectations

Working together, AIS and the UW Health team reached their goal of fully integrating the regulatory-compliant, highly customer-centric compounding services within just 4 weeks.

Timeline for decision-making and implementation:

“Our organization was in a place where we were looking for a new vendor to quickly support our need for third-party compounded pain pumps,” said Kristin Harney, PharmD, MS, of UW Health. “The AIS team was an incredible partner in helping us set up robust systems in a short amount of time. We appreciate their partnership, expertise, and engagement across our interprofessional team members.”

Transitioning to an outsourced 503A pharmacy can be challenging, especially when accounting for the health system’s regulatory, financial, and operational considerations. Many transitions are delayed due to assessment, stakeholder involvement, training needs, and complex regulatory requirements. By partnering with AIS, UW Health overcame these challenges and became regulatory-ready and compliant, maintaining current workflows with minimal changes. 

The result: In just 4 weeks, UW Health partnered with AIS Healthcare for fully compliant, state-of-the-art compounding services that improve patient care, patient satisfaction, provider satisfaction, operational efficiency, and financial results.

AIS Healthcare provides exceptional and compliant 503A outsourcing for the highest quality and customer satisfaction. We can help your system overcome your most significant challenges with Category 3 intrathecal compounded medications. Visit aiscaregroup.com or email cjeske@aiscaregroup.com to learn more.

Contact:
Simon Castellanos
877.443.4006

Dallas, Texas – In response to recent hurricanes that devastated many communities across the Southeastern United States, AIS Healthcare, a leading provider of targeted drug delivery (TDD) and infusion care solutions, is providing additional support to physicians and patients to ensure continuity of care and access to life-saving medication. The destruction of critical infrastructure and extended power outages have created acute challenges for patients who rely on timely delivery and sustained access to medication used to treat severe chronic pain and spasticity. 

To address these near-term supply chain disruptions, AIS Healthcare is increasing capacity at its pharmacies in Texas and Mississippi, which were not impacted by the hurricanes. This additional production capacity is intended to meet the demand of physicians and patients who use other pharmacies and may be struggling to access their medication. 

“Our thoughts are with all the communities in the Southeast that have experienced immense tragedy and destruction over the last several weeks,” said Simon Castellanos, CEO of AIS Healthcare. “We see it as our responsibility to support physicians and patients in the one area we can – ensuring continuity of care by making essential medications available. Our pharmacy teams have been working around the clock to add capacity and respond to physicians and patients who cannot wait to have their next prescription filled. I’m proud of the work we have done and believe it is absolutely crucial we take action to provide essential medication in times of crises. We are committed to doing whatever is necessary to help all physicians, patients, and our industry during this difficult time.” 

AIS Healthcare is dedicated to prioritizing the health and safety of all patients in need of care during this period of recovery. To support those who are recovering from hurricanes Milton and Helene, the American Red Cross is accepting donations here.  

About AIS Healthcare

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com

CONTACT: 
Jud Hall
877.443.4006

Dallas, TX- AIC, a division of AIS Healthcare, now offers ALYGLO™, manufactured by GC Biopharma, for the treatment of patients with primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID).

The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized infusion services to patients in their home or in an infusion suite setting. This new immunoglobulin (Ig) therapeutic option will expand AIC’s ability to better serve PI patients. 

“We are excited to add ALYGLO™ to our expansive list of Ig infusion therapies,” said Jud Hall, President of AIC. “AIC is proud to partner with GC Biopharma to offer this extra-purified IVIg replacement therapy as another treatment option to patients nationwide”, added Stan Singley, Vice President of Trade & Procurement.”

Approved by the U.S Food and Drug Administration in 2023, ALYGLO™ is now available at all AIC locations (Valdosta, GA; Birmingham, AL; Panama City, FL; Cockeysville, MD; and Dallas, TX). 

Like all AIC patients, those with PI will receive a high level of care from AIC, including 24/7 access to clinical and support staff. Every patient is assigned a dedicated team of professionals, including clinical pharmacists, home infusion nurses, RN clinical review specialists, and patient access specialists to provide support throughout the treatment process. 

For physicians, AIC is more than a specialty pharmacy. We are a full-service care delivery partner, and we have contracts with multiple immunoglobulin suppliers, like GC Biopharma. These contracts help us ensure prescribed therapies are always in stock. We also work directly with patients, insurance companies, and physician offices to secure all needed insurance authorizations and approvals. 

AIS Healthcare is dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other infusion services providers. 

Physicians interested in AIC care services should contact their AIC representatives to get started or visit us at www.aiscaregroup.com/our-divisions/infusion-care/

About AIS Healthcare

As the leading provider of infusion care solutions and targeted drug delivery, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com.

About GC Biopharma

GC Biopharma is a global biopharmaceutical company, and a pioneer in the field of specialty pharmaceuticals. It is committed to improving the lives of people around the world and has built a global network of professionals and facilities to make this vision a reality.

GC Biopharma manufactured its first plasma-derived therapy in South Korea in 1971. Since then, the company has grown to become one of the top pharmaceutical manufacturers of plasma therapeutics in the world, distributing to more than 50 countries.

Throughout its history, which spans more than half a century, GC Biopharma has focused heavily on plasma-derived drug products. With one of the largest plasma manufacturing facilities in the world, it is devoted to developing new drugs to achieve its mission and vision.

CONTACT: 
Jud Hall
877.443.4006

Stan Singley to serve as Vice President of Trade & Procurement for AIC

Dallas, Texas – AIC, a division of AIS Healthcare, today announced the hiring of Stan Singley as Vice President of Trade and Procurement. In this role, Stan will help drive AIC’s growth and expansion strategy in partnering with pharmaceutical manufacturers to gain limited distribution and sole source access for specialty drugs.

“We are thrilled to welcome a highly respected industry veteran with more than 20+ years of experience in immunology and rare diseases,” said Jud Hall, President at AIC. “Stan will bring a valuable perspective in partnering with internal and external stakeholders as we further develop and execute our trade strategy.”

Recently, Singley served as National Account Manager for Grifols USA, where he was responsible for partnering with key stakeholders to develop and execute channel strategy with key biological distributors, national specialty pharmacies, GPOs and health systems for their plasma-derived & hyperimmune products. Prior to Grifols, Stan was a successful sales professional and manager, culminating in his role as National Accounts Director, over the course of 12 years with Baxter BioScience. In this role, he successfully managed and continued to grow their plasma-derived, recombinant, oncology and biosurgery businesses.

“I’m excited to join the nationally accredited home infusion teams at AIC to further enhance the company’s efforts to advance chronic, rare and specialty therapies requiring complex clinical management,” said Stan Singley, Vice President of Trade & Procurement for AIC. “I truly believe, when the stakes are high for patients, that AIC can rise to the occasion with our comprehensive and differentiated care model and teams.”

Singley holds a Bachelor of Science in Business Administration degree from the University of Alabama. 

AIC is dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other infusion services providers. Physicians interested in AIC care services should contact their AIC representatives to get started or visit us at www.aiscaregroup.com/our-divisions/infusion-care/

About AIS Healthcare

Advancing quality. Improving lives.

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com.

The DEA requires pharmacies like AIS Healthcare (“AIS”) to have a Power of Attorney (POA) in place in order to dispense controlled substances and opioid-based medications directly to a treating practitioner’s clinic.

As the largest and leading provider of intrathecal controlled substances, AIS prioritizes patient safety and well-being. We support measures to strengthen the chain of custody and security involved in the dispensing of these medications. The POA requirement mitigates safety concerns around leaving packages on patients’ doorsteps where they can be exposed to weather, stolen or diverted. Millions of prescriptions go missing from home delivery every year.

This POA requirement is effective now and is only required one time for each patient. This is not a requirement that is AIS-specific. It needs to be followed by every pharmacy. The DEA has made clear that shipping to a practitioner’s clinic is the much better way to do business. But for any pharmacy to do that, the DEA insists that a POA be in place. 

The POA needs to be signed by a DEA registered treating practitioner and the patient. The POA must comply with the laws of the state where the medication is being dispensed. Depending on the state, the POA will require the signatures of both the patient and the treating practitioner to be witnessed and/or notarized. By following this process, you and AIS can ensure compliance with the DEA and state law. 

Unfortunately, the DEA prohibits pharmacies to dispense controlled substances to a nurse or other intermediary who would then transport the medication to the patient’s home for administration. As of September 15, 2024, AIS stopped dispensing controlled substances to our nurses so they can take them to patients’ homes. Instead, patients are being referred to their respective clinics. Please note that our Home Connect Nursing Program will continue to serve home patients who are not receiving controlled substances. 

Obviously, this change will impact pharmacies like AIS, and the treating practitioners and patients we serve. We do offer in-office nursing support through our Clinic Connect Program. That means we can have an RN, with extensive experience, perform pump refills and other services in the clinic-setting with a treating practitioner’s oversight. 

It is clear that the DEA believes shipping controlled substances to nurses could put the prescribing practitioner, the nurse and the pharmacy in legal jeopardy. Under current law, pharmacies have two options. They can ship to the prescribing practitioner’s clinic, provided a POA is in place. Or they can ship directly to the patient, which, as mentioned above, is filled with risk. Clearly, the clinic model is the preferred approach which is consistent with how AIS is positioned. 

We stand ready to handle any in-home patients (currently served by AIS or another pharmacy) who need to transition to the clinic setting. 

Our Care Connect nurses are on call 24×7 to answer questions and help care for patients.

If you have any questions or require further clarification regarding the DEA’s POA requirement or have any concerns about transitioning patient care to the clinic setting, please contact us at 877.443.4006. Our mission is to remain the market leader in targeted drug delivery, and to continue to put patient safety and well-being first. 

If you have additional questions, please click below.

Contact:
Simon Castellanos
877.443.4006

Dallas, Texas – AIS Healthcare, the leading provider of targeted drug delivery (TDD) and infusion care solutions, is proud to announce that it has been named a 2023 Pioneer in URAC’s Leaders in Performance Measurement (LPM) recognition program.

URAC is one of the nation’s leading independent health care accreditation organizations, with certification programs that set the highest standards in quality and safety.

Recently, URAC developed the Leaders in Performance Measurement awards program to highlight the URAC-accredited organizations that are using performance measurement to improve the health and well-being of the populations they serve. Their Pioneer Award recognizes the commitment of AIS Healthcare to promote trust in the quality of care delivered through performance measurement activities.

“We are humbled and honored to have been named a 2023 Pioneer by URAC,” said Simon Castellanos, AIS Healthcare CEO. “This recognition is a testament to the dedication and cohesiveness of our entire company. I could not be prouder of this team and their unwavering commitment to ensuring quality, sterility, and excellence across all our pharmacy operations.

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. This accomplishment underscores the company’s commitment to going beyond what’s expected to advance quality care and improve the lives of patients.

AIS Healthcare is also dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other compounding pharmacies and infusion services providers.

Learn more at aiscaregroup.com

Advancing quality. Improving lives.

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com

About URAC

Founded in 1990, URAC is the independent leader in promoting healthcare quality through leadership, accreditation, measurement and innovation. URAC is a nonprofit organization using evidence-based measures and developing standards through inclusive engagement with a range of stakeholders committed to improving the quality of healthcare. Our portfolio of accreditation and certification programs span the healthcare industry, addressing healthcare management, healthcare operations, health plans, pharmacies, telehealth providers, physician practices and more. URAC accreditation is a symbol of excellence for organizations to showcase their validated commitment to quality and accountability.

Contact:
Simon Castellanos
877.443.4006

Dallas, Texas – AIS Healthcare, a leading provider of targeted drug delivery (TDD) and infusion care solutions, is proud to recognize May as National Nurses Month. This month and throughout the year, AIS Healthcare celebrates the dedication of nurses who devote themselves to protecting and enhancing the well-being of those in need of care. 

Nurses play a critical role in healthcare delivery in the United States and across the world. Thanks to advancements in medical science and technology, their role has expanded, often serving as a first point of contact for patients. AIS Healthcare nurses hold certifications in specialty infusion care and undergo advanced and ongoing clinical training, allowing them to provide patients with the best possible care. AIS Healthcare’s Advanced Nursing Solutions team is led by experienced professionals who understand what it takes to advance quality of life and improve health outcomes for patients afflicted with chronic pain and complex medical conditions. 

“National Nurses Month gives us an opportunity to celebrate the pivotal role of nurses and their commitment to improving patient lives,” said Simon Castellanos, CEO of AIS Healthcare. “AIS Healthcare’s nurses deliver comprehensive care services and build strong connections and relationships that enable patients to better thrive in their communities and homes. We are grateful for their selfless dedication today and every day.” 

AIS Healthcare’s Advanced Infusion Care (AIC) and TDD divisions utilize innovative healthcare solutions to manage patients’ needs. Collaboration between physicians and the AIS nursing team ensures the efficient delivery of patient-specific services and enhances the care experience for patients managing complex conditions.

Nurses change patient lives for the better. During National Nurses Month and throughout the year, AIS Healthcare encourages individuals, communities, and organizations to show their appreciation for nurses. To learn more about AIS Healthcare’s leading nursing program, visit here.

About AIS Healthcare 

Advancing quality. Improving lives.

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com

Contact:
Simon Castellanos
877.443.4006

Dallas, Texas – AIS Healthcare, a leading provider of targeted drug delivery (TDD) and infusion care solutions, is proud to recognize the week of April 29 as Patient Experience Week. AIS Healthcare provides comprehensive care services for patients across the country and works to ensure health practices meet or exceed state and industry standards. These practices allow AIS to enhance the patient experience and obtain the best possible healthcare outcomes. 

Established in 2014, Patient Experience Week is a time for the healthcare community – nurses, doctors, administrative staff, executives, and patients alike – to show appreciation for the industry professionals who commit themselves to making the patient experience safe and comfortable for all. 

“AIS Healthcare is pleased to recognize Patient Experience Week and is grateful for our staff who dedicate their time, energy, and care to the patients we are proud to serve,” said Simon Castellanos, CEO of AIS Healthcare. “From our 24/7 on-call nursing and pharmacy services to our in-home personalized care, we are dedicated to making patients feel comfortable and cared for.”

AIS Healthcare uses innovative healthcare solutions to make the treatment process intuitive and helpful for all. AIS services act as an extension of physicians’ practices, enhancing the care experience for both patients and providers. 

AIS maintains the highest possible quality of medications and carries dual accreditation from URAC and the Accreditation Commission for Health Care (ACHC), setting it apart as an industry leader in targeted drug delivery and infusion care.

To learn more about AIS Healthcare’s services, visit here

About AIS Healthcare

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com

Contact:
Simon Castellanos
877.443.4006

Dallas, Texas – AIS Healthcare, a leading provider of targeted drug delivery (TDD) and infusion care solutions, is proud to recognize March 25-31 as National Physicians Week. This week and throughout the year, we celebrate the dedication of physicians who selflessly devote their time and energy to ensure the health and well-being of those in need of care.

Physicians are vital to this country’s healthcare system, offering essential services to millions of individuals facing chronic illnesses and complex conditions. The physicians AIS Healthcare partners with are integral to delivering the highest quality care to vulnerable patient populations across the country. Collaboration between physicians and AIS Healthcare ensures that patients receive their specialized medications in a timely and efficient manner. AIS is proud to work with doctors to advance the quality of patient care and improve lives in the process. 

“National Physicians Week is an opportunity to recognize the never-ending dedication and hard work of doctors across the country” said Simon Castellanos, CEO of AIS Healthcare. “At AIS Healthcare, we work with doctors every day to enhance the quality of care for the patients we serve. Today, we celebrate their countless contributions to patients and communities.” 

AIS Healthcare uses innovative healthcare solutions to make the treatment process intuitive and helpful for all. AIS services act as an extension of physicians’ practices, enhancing the care experience for both patients and providers. 

During National Physicians Week, AIS Healthcare encourages everyone to show their appreciation for the physicians in their lives. Whether through a kind gesture or a heartfelt thank you, this week is an opportunity to show our appreciation for the selflessness and dedication of the nation’s doctors. To learn more about AIS Healthcare and our work with doctors in supporting patients nationwide, visit here

About AIS Healthcare 

Advancing quality. Improving lives.

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com

CONTACT: 
Jud Hall
877.443.4006

Dallas, Texas – AIC, a division of AIS Healthcare, now offers GLASSIA and ARALAST NP, manufactured by Takeda, for the treatment of adult patients with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI (alpha1-antitrypsin deficiency).

The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized infusion services to patients in their home or at an infusion suite setting. The addition of these therapy options expands AIC’s ability to better serve patients with alpha1-antitrypsin deficiency.

“We’re excited and proud to be able to add Takeda’s Alpha₁ therapies to our growing portfolio of infusion therapies,” said Jud Hall, President at AIC. “The addition of GLASSIA and ARALAST NP can help us provide patients with more options to meet individual treatment needs.” 

Approved by the U.S. Food and Drug Administration (FDA) in 2010 and 2002, respectively, GLASSIA and ARALAST NP are Alpha1-Proteinase Inhibitors (Human) (Alpha1-PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha1-PI. ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI.

The effect of augmentation therapy with GLASSIA, ARALAST NP, or any Alpha1-PI product on pulmonary exacerbations and on the progression of emphysema in Alpha1-PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA or ARALAST NP are not available. GLASSIA and ARALAST NP are not indicated as therapies for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

Both GLASSIA and ARALAST NP are now available at all AIC locations (Valdosta, Georgia; Birmingham, Alabama; Panama City, Florida; Dallas, Texas). 

Like all AIC patients, those with alpha1-antitrypsin deficiency will receive a high level of care from AIC, including 24/7 access to clinical and support staff. 

Every patient is assigned a dedicated team of professionals, including clinical pharmacists, home infusion nurses, RN clinical review specialists and patient onboarding specialists to provide support throughout the treatment process. 

For providers, AIC is a full-service care delivery partner. We also work directly with patients, insurance companies, and provider offices to secure all needed insurance authorizations and approvals. 

AIC is dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other infusion services providers. 

Physicians interested in AIC care services should contact their AIC representatives to get started or visit us at www.aiscaregroup.com/our-divisions/infusion-care/

About AIS Healthcare

Advancing quality. Improving lives.

As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.

Learn more at aiscaregroup.com.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.