Resiliency in Pharmacy
Pharmacy Stars
Be the one who is organized and in control of USP 795 797 800 Compliance.
Friday October 11, 2024 Volume 1 Issue 19
Resiliency in Pharmacy
Resiliency: re·sil·ien·cy?ri-?zil-y?n(t)-sē?noun; an ability to recover from or adjust easily to?adversity?or change.
Hurricane Helene wreaked havoc on the Southeast U.S. last week, killing over 230 people and disrupting healthcare services. The storm has severely damaged a Baxter’s IV solution facility in North Carolina that makes most of the IV bags and peritoneal dialysis solutions used in the U.S.? With the factory out of action, hospitals are running low on IVs once again. At this point it is unclear when Baxter’s plant will be back up and running and they have started to ration IV fluids and peritoneal dialysis solutions.
How resilient is your Pharmacy? Accreditation bodies, such as The Joint Commission (TJC), strongly encourage healthcare institutions to conduct an annual operational risk assessment (TJC, LD.03.08.01; EM12.02.09).?
[ FREE WEBINAR for Non Consultants] Learn "How to perform a robust self audit of your compounding operation" from Pharmacy Stars Friday October 18, 2024 at 12 Noon Central. REPresented by Fred Massoomi, PharmD, BCSCP, FASHP Director of Professional Services and Advancement at Pharmacy Stars Note that we limit this webinar to non consultants.
ASHP and Vizient have published excellent resources on managing this round of critical shortages as hospitals across the US have already started rationing IVs to patients.? To make things possibly worse, Hurricane Milton is heading towards Florida, which could damage yet another IV manufacturing plant. The American Hospital Association is urging the Biden administration to quickly boost the supply of IV solutions for hospitals, potentially by using the Defense Production Act.?
In the center of this chaos sits pharmacy.? Shortages are not new to Pharmacy, as shortages are a chronic problem that has been well documented and charted by Erin Fox at the University of Utah.
And let’s not think this is going to get better anytime soon.? Extreme climate change could impact drug shortages with increased demands in the need for medications due to increases in climate related diseases.? To throw fuel on this ‘shortage fire’ it is not just extreme weather and other events in the US that we need to worry about, it is also abroad.? Considering a majority of active pharmaceutical ingredients and components used to make final medication products are sourced internationally.??
Hospitals have been forced to relocate patients, in turn requiring pharmacies to relocate the medication management processes. ? Meeting immediate transport needs, sterile compounded preps, non-sterile preps, controlled substances management, all while ensuring patients receive the safest medications with little to no interruptions.??
In this, pharmacy remains resilient and meets the demands of unplanned events and shortages.? The concept of a resilient pharmacy was hinted at in 1967 by Earl A Schwerman’s ‘Role of the hospital pharmacist in disaster preparedness’: “Disaster preparedness requires three ingredients-manpower, facilities and supplies. Although the hospital pharmacist’s primary responsibility in a disaster is provision of pharmaceutical supplies, he has an important multi-faceted role in disaster preparedness.”??
Noting the context of the era from Schwerman, pharmacists and pharmacy technicians make the perfect partnership in resiliency in the medication management processes.?
In a more formal requirement, Accreditation bodies, such as The Joint Commission (TJC), strongly encourage healthcare institutions to conduct an annual operational risk assessment (TJC, LD.03.08.01; EM12.02.09).? TJC defines a risk assessment as a detailed review of processes, identifying risks and points of vulnerability (weather, shortages?), and prioritizing areas for improvement. While risk assessments cannot predict every event, proactive planning helps facilities better understand potential risks and available resources.
Risk assessments typically involve input from multiple departments, including facilities, safety, administration, nursing, and medical staff. Pharmacy MUST directly participate and submit departmental risks including a list of critical drugs needed for patients being served. Since medication management extends beyond the pharmacy, plans must account for the entire process, from the shipment of medications (think alt sites for deliveries) to their delivery to patients. The urgency of medication needs varies by patient type, requiring stratification of risks (e.g., ICU patients vs. general ward patients, in transport, post transport, etc.).
During times when normal operations? such as compounding, controlled substances management and facility conditions are disrupted, a resourceful medication management plan is essential. ? Pharmacies today depend heavily on technology for safety and efficiencies in operations. A key question is how pharmacies function in an event if all automated safety systems were unavailable due to power outages or relocation of services? And how they could manage medication processes without these safeguards??
Keeping in mind that during all of these events the regulatory oversight does not go away.? The security and integrity of medications must be maintained.? State Boards of Health/Pharmacy may offer some temporary operational measures, but in the end pharmacy remains accountable.
As pharmacy teams work within the construct of limited resources, drug shortages, relocation of services, limited supplies, alternative working conditions, the teams remain resilient and continue to provide ‘pharmaceutical care’ to patients…until the next event.
Sitting in Omaha all I can think as I watch events unfold is a wholehearted ‘thank you’ to the pharmacy teams for their continued commitment to providing safe patient care during these events.
How can you reduce the stress of unannounced pharmacy inspections? Schedule a demo of Compounding360 and Keith Streckenbach, CEO of Pharmacy Stars will show you how. Get a demo today
Hey Houston, Do We Have a Problem?
Evidence: Transfer bins used to stage products/orders to be brought into the compounding areas that are broken and not cleanable.
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Cause
Transfer bins for the movement of materials get a lot of use and require some maintenance and replacement.?
Solution
Create a task and call out inspection of bins for replacement and cleaning. If the bins move in and out of the compounding area, cleaning should be between each product as a best practice.? Ensure bins are easily cleanable and have all smooth surfaces for quick and efficient cleaning.
Increasing the Gray Matter
Small- and Large-Volume Fluid Shortages – Suggestions for Management and Conservation
“This fact sheet provides potential actions for organizations to consider in managing fluid shortages”. “There is a national shortage of large-volume parenteral solutions, including but not limited to: sodium chloride injections, Lactated Ringers injection, Sterile Water for Injection, and Dextrose injections. The shortages are due to the effects of Hurricane Helene in North Carolina.”
Why this is important: Any disruption in the medication supply chain in the US is critical.? In this case where IV fluids and peritoneal dialysis solutions will be impacted, having redundancy plans for critical medications is paramount to minimize the impact to patients.
October 2024
medication reference “To provide the 2022 update to this reference, Vizient subject matter experts met to identify medications that are commonly administered via IV push or have recently experienced a drug shortage. From this initial list of 34 medications, IV push or slow IV injection information was obtained and verified with multiple tertiary resources. ”
Why this is important:? Guidance on the preserving IV solutions during times of shortages is key to preserving the supplies on hand.
October 2024
Event Not To Miss
[ FREE WEBINAR] Learn "How to perform a robust self audit of your compounding operation" from Pharmacy Stars. resented by Fred Massoomi, PharmD, BCSCP, FASHP Director of Professional Services and Advancement at Pharmacy Stars
When: Friday October 18, 2024 at 12 Noon Central
Where: Zoom
Sign Up: REGISTER HERE
The attendee is afforded the opportunity to model their own self audits upon the practices of a very seasoned consultant, who has performed hundreds of compounding operation audits.
Intended for: Director of Pharmacy, Managers of Compounding Operations Learning
Objectives:
1. Describe the pillars of consulting for compliance
2. Review the greatest difficulties of sites for compliance
3. Summarize the timeline setting process by a consultant overall effectiveness of an institutional hazardous drug program