• 1st Home Infusion & Specialty Pharmacy Consulting

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Home Infusion Pharmacy

Expert End-to-End Consulting

for Establishing Advanced Home Infusion Pharmacy & Infusion Service

Your Opportunities and Challenges

Home Infusion Therapy Business Landscape:

The home infusion therapy market is rapidly expanding. In the U.S., it is valued at $9–11 billion annually, driven by a shift towards cost-effective, patient-centered care (National Home Infusion Association, 2019). Globally, the market was valued at $22.2 billion in 2018, with an expected annual growth rate of 7.2% through 2026 (Grand View Research, Inc., 2019).

Health Systems: Face pressures to deliver high-quality care while controlling costs. Third-party payers are urging a shift to cost-effective care settings like home infusion. Challenges include high operational costs, overcrowded facilities, and the need to reduce readmissions. Balancing acute care with expanding outpatient services can lead to revenue loss, strained resources, and compromised patient outcomes.

Independent Pharmacies: Confront shrinking traditional revenue streams and increased competition. The growing demand for home infusion presents an opportunity to diversify services and capture new revenue. Expanding into home infusion allows independent pharmacies to offer comprehensive care and improve their market position.

Our End-to-End Solutions

EK Specialty Pharmacy Consulting offers a comprehensive approach for health systems and independent pharmacies to successfully launch home infusion services. Our consulting services ensure a seamless process from initial planning through to full operational readiness and accreditation.

How We Help:

  • Accelerated Market Entry: Streamline every step for a faster, more confident launch of home infusion services.
  • Comprehensive Expertise: Provide guidance on critical areas including USP 797 compliance, policy development, quality assurance programs, and clinical program integration.
  • Error Prevention: Offer in-depth support to avoid costly mistakes that could delay your launch or cause compliance issues.
  • Seamless Implementation: Support everything from cleanroom build-out to licensing and accreditation to ensure smooth operations.

Partnering with EK Specialty Pharmacy Consulting positions your organization for success, driving both clinical excellence and financial growth in the expanding home infusion market.

Specialized Support for Home Infusion & Ambulatory Infusion Pharmacy Setup

EK provides specialized expertise to help you establish a home infusion pharmacy and ambulatory infusion service within your healthcare organization, covering key areas from initial planning to operations and accreditation.

The Key Process Includes, But Is Not Limited To:

  • Sterile Compounding Pharmacy Licensure: Guiding through the licensure process, ensuring strict adherence to state and federal regulations.
  • Cleanroom and Infusion Suite Build-Out: Designing and constructing state-of-the-art cleanrooms and infusion suites tailored to your specific needs.
  • Key Staff Recruitment and Training: Facilitating key staff recruitment and delivering comprehensive training to enhance skills and ensure operational excellence.
  • Sterile Compounding Policies and Procedures: Establishing robust policies and procedures critical for sterile compounding compliance and operation frameworks.
  • Quality Assurance Programs: Develop and implement quality assurance programs that comply with USP 797, USP 800, and other regulatory standards.
  • Program Development and Implementation: Developing and implementing essential programs, including Quality Assurance, Project Management, Quality Management, Compliance, and Risk Management.
  • Key Software Selection and Implementation: Analyzing your operational needs to select and implement the most effective software solutions, optimizing both operational efficiency and compliance.
  • Accreditation Support: Providing comprehensive support for both initial accreditation and re-accreditation efforts.
  • Operational Optimization: Implementing lean pharmacy methods to streamline operations and increase efficiency.
  • Performance Improvement: Driving continuous improvement measures to enhance service delivery and business performance.
  • Business Development: Strategizing for growth and financial performance.
  • Ongoing Compliance Monitoring: Ensuring continuous compliance with a robust compliance monitoring program.
Testimonials

Our Client Reviews

The Investment in EK’s Services Paid Off Quicker Than We Planned.
Our Future Growth is Not Possible Without EK Specialty Pharmacy Consulting on Our Side.
With EK Specialty Pharmacy Consulting, we achieved initial, reaccreditation and dual accreditations. EK provided us with regulatory and ongoing compliance, BOP inspections, mock surveys, management and development of clinical programs, quality improvement programs and operations management support. EK also provided Pharmacist in Charge and Pharmacist staff training and provided marketing support. All their services were conducted in an efficient professional manner with cost saving and within budget. EK’s expertise and knowledge has created opportunity for us to grow our specialty and home infusion business. The investment in their services paid off quicker than we planned. Our future growth is not possible without EK specialty pharmacy consulting on our side.

CEO/Specialty, Home Infusion PharmacyHappy Client
Accreditation Preparation Process helped to Establish a Solid Structure to Grow Our Home Infusion, Specialty Pharmacy Business
We were in a rush due to the expiration of the previous accreditation. EK helped us achieve accreditation within 4 months. EK was strategic and the process was extremely efficient. The consultant helped us simplify all processes by removing unnecessary steps that were previously in place and then implementing missing key components. The accreditation preparation process with EK tremendously helped us to establish a solid structure to grow our home infusion and specialty pharmacy business (both administrative and clinical pharmacy areas) - thanks to her hands on experience in regulatory compliance, pharmacy operations, clinical programs, marketing in specialty, home infusion pharmacy. We appreciate EK’s education. Our employees learned something valuable and were inspired by the consultant at each meeting. After the accreditation project ended (full accreditation with no deficiencies), we happily engaged EK Specialty Pharmacy Consulting for further business development in addition to ongoing maintenance. EK’s principal consultant provides a very unique service definitely beyond consulting.

Owner/Home Infusion, Specialty PharmacyHappy Client
Strategic and Dedicated Support Saved Us Tremendous Time and Resources.
Before starting the reaccreditation project with EK Specialty, we were uncertain if we were prepared for the accrediting agency survey process. The education provided by EK was exceptional. We are grateful for EK's education and guidance with the requirements and best practices of each standard. EK also compared the requirements of other accrediting bodies to incorporate them as best practices into our processes. EK consultant orchestrated everything and led the entire project from the initial diagnostic survey to the development of important programs and implementations, audits, participating PI meetings through the final walk-through mock survey. She efficiently and smoothly led the project, providing solutions to any challenge we encountered. EK consultant’s strategy and dedicated support saved us tremendous time and resources. Thanks for everything you have done for us. Your guidance has been extremely helpful and appreciated.

Compliance Officer/Specialty PharmacyHappy Client
Detailed and Personalized Service - Accreditation Project with Clear Concepts and Logistics
EK Specialty Pharmacy Consulting has been more than a consulting service. The detailed and personalized service has been vital for our accreditation project. Our reaccreditation project began with many doubts and concerns for the implementation. It grew into a project with clear concepts and logistics and today we have robust and well-defined processes. We owe this to the guidance that EK Specialty Pharmacy Consulting provided us. EK has helped us optimize everything for the benefit of our patients and our company, from our Clinical Patient Management Program to our administration guidelines and compliance standards. Today, our organization is an advanced specialty pharmacy with absolutely 100% compliance thanks to the kind guidance and additional recommendations (industry best practices, other accreditors’ requirement, etc ) EK Specialty Pharmacy Consulting provided. We'll always be grateful".

Pharmacist- Manager in Operations, Clinical Programs/Specialty PharmacyHappy Client
Not Just about Passing the Test. See Great Value of the Accreditation Preparation Process With EK
We are so glad we found EK Specialty Pharmacy Consulting for our re-accreditation preparation. We had many concerns before we started the project. EKs service was definitely not just about consulting to pass the accreditation. EK consultant truly has hands-on experience and knows every element of specialty pharmacy operations and clinical knowledge as an active pharmacist, not just accreditation and regulatory elements. We truly see the significant benefits of the preparation process through EKs genuine approach. We see great value of the accreditation preparation process with EK. With EKs help, we have outstanding specialty pharmacy programs including clinical programs that we are proud of, and we will definitely promote these services to our patients, doctors, payers and manufacturers with greater outcome data.

Clinical Pharmacist, Clinical Program Project Team Leader/Specialty PharmacyHappy Client
Mock Survey - Simulated the Actual Survey, Strategies to Correct and Finetune All Areas
Mock survey with EK’s principal consultant was a great experience. EK consultant was performing a survey that resembles the real survey process. During the mock survey process, the consultant provided strategies to finetune each preparation process and educated us on the intent of each requirement and how we can correct deficient areas. We were able to complete our re-accreditation preparation thanks to EK’s education and detailed guidance. Your guidance and support were the key to this achievement. We are very happy. Thank you again for all your guidance and your dedicated support.

HR Director, Accreditation Project team/Specialty PharmacyHappy Client
Mock Survey - Comprehensive Gap Analysis and Strategic Remediation Plans
We knew we were non-compliant in some areas but were not clear on what was truly missing or how to make remediation plans in order to pass our upcoming re-accreditation survey. EK’s mock survey and comprehensive gap analysis executive report helped us to understand the level of our compliance and gauge our readiness for our upcoming reaccreditation survey. Based on EK’s gap analysis, the consultant helped to develop a customized project master plan that helped us prioritize each key section and thus we were able to complete all tasks within the timeframe. The accurate diagnostic survey and the strategic remediation plans provided us clear guidance and solutions on what and how to correct all the deficiencies in a correct way such a short time. We are so glad that we engaged EK SRx.

Compliance Manager and PI coordinator/Specialty Pharmacy Happy Client
Staff Training with Clarity and Competency with Confidence
EK Consultant trained us in all aspects of accreditation standards, CA Pharmacy law, USP797 and USP800. I am very fortunate to have received this training. She helped our pharmacy correct all non-complaint areas. It was a breeze when the board of pharmacy inspector visited us for the sterile compounding license inspection. We also received our accreditation report with no deficiencies. With EK specialty pharmacy consulting, we now have clarity and confidence for ongoing compliance.

Pharmacist in Charge/Home Infusion, Specialty PharmacyHappy Client
Disease Specific PM Program built in Rx software - Highly Effective, Efficient, Cost Saving
EK consultant helped us develop our distinguished Patient Management (PM) program, specifically tailored to our business model, our current operations including our software programs. We were able to build a platform in our software program without purchasing an additional clinical program platform which would have cost tons and double our personnel time in order to manage two different programs. Our disease specific PM program is highly effective and covers every single accreditation requirement. This program saves our pharmacist a tremendous amount of time as well as our patient time to complete all clinical activities. With our program, we were able to perform clinical assessments for over 400 patients for the past 3 months for our 2020,2021 active patients.

Clinical Pharmacy Program Manager/Specialty PharmacyHappy Client
Distinguished Patient Management Program- Our Best Marketing Strategies
EK consultant helped us develop an exceptional clinical patient management program and build the patient record system in our pharmacy software. It is a highly effective program that allows us to take excellent care of our specialty patients by using specific disease protocols. It is perfectly streamlined to our operations. As an important part of our marketing strategies, we introduce our PM program to our patients and to the providers, including physicians and hospital case managers.

Pharmacist in Charge/Specialty, Home Infusion PharmacyHappy Client
QM Program to Monitor Every Aspect Of Our Services
Excited to Share Proven High Quality Outcome Data With Any Stakeholders
EK consultant helped us to develop an outstanding QM/PI Program. She started the project with extensive education about all aspects of the QM program, then helped us to implement each program. With EKs guidance, we were able to collect, track, trend and analyze meaningful data on each key area. Since we developed this program with EK, we utilize our QM program to monitor every aspect of our services, our compliance and operational efficiency and to promote outcomes. She educated us to clearly understand that all accreditation requirements are organically connected to each other, which ultimately improves the quality of all aspects of our specialty pharmacy services. All makes sense! We are excited to share proven high quality outcome data with any stakeholders including patients, providers, payers and manufacturers.

QM Program Director, Clinical pharmacist/Specialty PharmacyHappy Client
Successfully Implemented Essential Programs in Such Limited time, Our Compliance Level is Close to 100%.
"Our re-accreditation preparation project started with EKs diagnostic survey. EK consultant provided extensive education on each accreditation standard domain so we could have a clear understanding of requirements vs recommendations accurately. EKs comprehensive gap analysis report helped us to accurately diagnose the level of compliance and prioritize tasks to remediate gaps identified. Our consultant was very thorough and listened to our business needs prior to making recommendations. EK created a master plan and helped us develop key programs that fit our business model and our operations. With EKs guidance, we successfully implemented these essential programs in such a limited time and our compliance level is close to 100%. EK consultant was absolutely a vital member of our team along with our three excellent pharmacists, compliance officer and HR director, EK's process has been truly exceptional and key to our success in achieving and maintaining our now near perfect compliance level."

Pharmacist in Charge/Specialty PharmacyHappy Client
Mock Survey – A Key Part of Accurate Diagnosis and Plans for Corrections, Improvement
EK’s mock survey was outstanding and the mock survey itself helped us greatly. It was like we were going through a real survey. EK principal consultant simulated the actual survey from the opening conference, thorough review of entire policies and each required document in detail, staff interview during facility tour, process observations, citing deficiencies all the way to the closing conference. Throughout the mock survey, the consultant provided strategies to correct all deficient areas and refine each area. We learned so much through EKs mock survey and we were able to put all the remaining puzzles together to complete our re-accreditation preparation with greater confidence and clarity. I truly believe the mock survey was a key part of us being able to understand where we were in terms of compliance and with EK's help establish/implement a plan to improve it.

Pharmacist in Charge/Specialty, Compounding, LTC Pharmacy Happy Client

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