Dr. Amos Chery, FACHE, Pharm.D., MBA, DPLA, CLSSBB, is the Director of Pharmacy Operations & Regulatory Compliance at MedStar Washington Hospital Center. A U.S. Air Force veteran, he has over 14 years of experience across military, inpatient, outpatient, and home infusion settings. He has led initiatives in medication safety, controlled substance management, and lean process improvement. Previously, he held leadership roles at Children’s National Hospital, United Healthcare, and Suburban Hospital. He holds a Pharm.D., an MBA from Johns Hopkins, and a Lean Six Sigma Black Belt certification.
Through this article, Chery explores the evolving landscape of pharmacy operations, highlighting the integration of technology, automation, and AI, along with the growing role of outsourcing in addressing medication shortages. He discusses key challenges in healthcare automation, from data privacy to system interoperability, while emphasizing the need for adaptive regulatory frameworks to support personalized medicine and biologics.
Chery also underscores the importance of continuous training for pharmacy staff, ensuring they remain equipped with the latest knowledge and skills. He concludes by advocating for a proactive compliance strategy—one that integrates compliance into the innovation process, fosters collaboration, and leverages technology to drive efficiency without compromising regulatory integrity.
From Military Service To Pharmacy Leadership: A Career Defined By Innovation And Impact
My career began in the United States Air Force as a commissioned officer (Captain). After my military service, I transitioned into various roles, including clinical pharmacist and manager of ambulatory pharmacy services.
With over 14 years of experience in the pharmacy field across diverse settings—military, inpatient, outpatient, and home infusion—I have successfully implemented new ambulatory pharmacy programs and lean processes. These initiatives have reduced medication errors, resolved controlled substance discrepancies, captured revenue, and improved employee engagement.
I held various roles in my previous positions, ranging from clinical pharmacist to ambulatory clinical pharmacy services manager. Additionally, I have a certification as a Lean Six Sigma Master Black Belt and am a Fellow of the American College of Healthcare Executives.
Key Challenges Of Automation In Healthcare: Balancing Innovation With Compliance And Efficiency
A. The first concern that comes to mind is data privacy and security. Automated systems collect a lot of information, and it is essential to ensure that the data is secure and adheres to regulatory standards such as the Health Insurance Portability and Accountability Act (HIPPA).
B. The second challenge is system interoperability. Integrating legacy systems with newer ones may pose challenges, adding another layer of difficulty while maintaining regulatory compliance with federal and state laws.
C. Regulatory Compliance is one of the most crucial challenges. Automated systems must comply with both federal and state laws.
D. Operational efficiency comes to mind because new technologies often disrupt workflows and require significant adjustments (staff training, downtime procedures, etc.)
E. Cost and Resource Allocation: Automated systems require capital investment, including ongoing maintenance that can strain resources.
F. Downtime is always a concern with new technologies. Once the system is down, patient care might be impacted. Leaders need to implement downtime procedures to prevent interruptions in patient care that might negatively affect the Centers for Medicare and Medicaid Services (CMS) metrics.
The Future Of Healthcare: Adapting Regulations And Payment Models For Personalized Medicine And Biologics
Personalized medicine and biologics will change healthcare practice, payments and regulations. New regulations will need to be implemented to leverage the utilization of these products. Insurance companies need to remodel their payment systems and formularies. Finally, new rules should address patient access to these novel products to ensure health equity.
Empowering Pharmacy Staff: The Role Of Training, Certification, And Continuing Education
Technologies have created many options to equip pharmacy staff with knowledge and skills. Initial training is one of the most critical steps to ensure that the pharmacy staff teaches and retains the correct abilities. Annual training or recertifications are also crucial in keeping staff updated on new information and best practices. Boards of pharmacy require licensed pharmacists and pharmacy technicians to complete several continuing education hours to renew their licenses, which include specific pharmacy topics to ensure pharmacy staff stays informed of best practices and new regulations. Finally, just-in-time training helps update the pharmacy staff’s skills.
Trends Shaping Pharmacy Operations: The Rise Of Technology And Outsourcing
1. Increased Use Of Technology, Automation, And Artificial Intelligence (AI):
• Accuracy and Precision: Technology enhances accuracy and precision in medication dispensing by eliminating manual processes.
• Efficiency: While technology can improve efficiency, calculating the return on investment can be challenging.
• Addressing Workforce Shortages: Automation and AI help mitigate the shortage of trained and qualified pharmacy personnel, ensuring patient demand is met.
2. Outsourcing:
• Utilization of 503B Companies: Medication shortages, such as the recent intravenous fluid shortage, have led hospitals to modify practices to conserve supplies. This trend may increase the reliance on 503B outsourcing facilities to meet demand.
Strengthening Compliance While Driving Innovation: A Proactive Approach
One key piece of advice for organizations aiming to strengthen their compliance strategies while fostering innovation is to integrate compliance into the innovation process from the outset, meaning:
1. Encourage cross-functional collaboration between the compliance, legal and innovation teams. This will ensure compliance is embedded in the new project instead of being an afterthought.
2. Engage the end-users or front-line staff early in the process. They possess anecdotal information that can be crucial for the project’s success.
3. Continuous education and training will help create a culture where compliance is seen as a facilitator of innovation rather than a barrier, reinforcing its importance.
4. Technology and Artificial Intelligence can help monitor real-time compliance (temperature monitoring). When used correctly, these tools can identify issues early, allowing us to make quick adjustments.
5. Create an agile compliance framework that will allow companies to remain compliant while implementing innovations in an environment with changing regulations.
