Unplanned Emergencies and Compounding

Pharmacy Stars RxCompounding Compliance B!tes weekly newsletter. Simplifying the complex world of pharmacy compounding compliance by Fred Massoomi, Pharm.D, BCSCP, FASHP

Friday June 14, 2024 Vol 1 Issue 2

USP provides the framework to establish a robust and safe compounding program for pharmaceutical compounds for when everything ‘works perfectly’.? Maintaining a ‘state of control’ is all good when one (thinks) they have control over all the processes. However, what happens when things happen that are not in your control? Power outages, facility building issues, fire alarms, water main breaks, equipment failures, etc.? Often planning for these types of events occurs at the time of the event and is often a reaction to an unplanned event.??

Health care institutions are highly encouraged by accreditation bodies to conduct an annual operational risk assessment (The Joint Commission, LD.03.08.01; EM12.02.09).? The Joint Commission defines a risk assessment as ‘An assessment that examines a process in detail including sequencing of events, actual and potential risks, and failure or points of vulnerability and that prioritizes, through a logical process, areas for improvement based on the actual or potential impact (that is, criticality) of care, treatment, or services provided."? Noting that the best written plans for known risks often do not address a specific event, as each event is unique.? The drill of proactively planning prepares sites to better understand the risks and resources available.

Risk assessments traditionally involve input from facilities, safety, administration, quality, nursing and medical staff departments.? Pharmacy may be directly involved or may be asked to submit their specific departmental risks as part of the institutional plan.? Since the medication management process exceeds the proverbial 4-walls of the pharmacy, planning for interruptions to the process should span from the entry point of medications into the institution to the patient.? The medication needs and urgency of the needs will be different between patient types.? Stratification of the patients should be considered and the risks of interruptions to their pharmaceutical care urgency should be defined; general ward patients vs. ICU patients, outpatient surgical patients vs. in-surgical patients, home infusion patients vs. infusion center patients, etc.

Medication management during times where the ‘state of control’ for compounding and for the facility are not conducive requires a keen plan of resourcefulness.? TJC provides some elements for compliance in EC.02.05.03 ‘the hospital has a reliable emergency electrical source where elements of performance checks EP 14 and EP 15 specifically address emergency backup policies for medication-based equipment; automated dispensing cabinets, refrigerators, etc.???

Pharmacy currently relies on a variety of technologies to drive operations and safety initiatives.? What if all the safeguards are taken away, would the pharmacy be able to function?? How would the medication management processes function without those automated layers of safety???

How would medications be dispensed and controlled if automated dispensing cabinets are offline due to a computer virus?? How would total parenteral nutrition products be compounded for vulnerable patients requiring specialized formulas if the TPN compounding device does not work?? How would pharmacies operate if the electronic medical record cannot be accessed or allow for the input of medication orders?? These scenarios highlight critical functions that often present themselves as individual events, but what if the total system collapses?? Would the pharmacy be able to function on a completely manual process with no technological assistance and if so for how long???

Emergency Preparedness for Compounding

Being prepared for normal operations is easy, planning for the unexpected is a good investment in time for the resiliency of a good medication management program. Establish an internal team of front-line staff with various roles within the medication process and start by defining your institution’s critical and vulnerable patient populations requiring medications.? This may seem elementary but put it in the lens of triangulating each population to the medication management processes that rely on technology for operations and safety.? Now incorporate the errors that can now arise from the lack of the technology.? Create a grid of the defined patients to the medication processes serving those patients to the technology and link a corresponding manual/alternative process.?

Develop a dynamic grid for each medication process and include the redundant options with steps to the redundancy.? Consider the following scenarios:?

• Power Loss: Sites should have an extreme interest in their facility emergency back-up power plan and should define exactly which pieces (assets) of the medication management equipment are on the system; do not assume that a ‘Red Outlet’ means emergency power. Test and verify.?(a) Bonus: Understand the transfer time gap from static power to the backup power system and the transition back to static power. These gaps can range from seconds to minutes. (b) Bonus: Understand the emergency lighting set up. Most acute care pharmacies do not have windows and when the lights go out, there is absolute NO VISIBLE ANYTHING, NADA! This can be somewhat terrifying inside a cleanroom suite where there may be moments of absolute darkness. (c) Bonus: Understand how the pharmacy can be secured without power locking systems. And on the opposite, ensure doors with automated opening systems can operate manually without power.
• Room Temperature, Refrigeration, Freezers, and Ultracold Freezers: yes it has happened to most of us, losing power or just having one of these systems die happens.? Not to harp on the importance of monitoring the temperature then having to call each manufacturer for each drug in the unit or units at some point in the down process.? Sites should have a very clear SOP for when these units are down, offline or just dead.? The SOP should include when products need to be moved to an alternate (redundant) storage system, and if not defined, what are the critical steps that must be taken to maintain the integrity of the medications.? Note that when temps rise in spaces where drugs and supplies are stored (think elevated room temperatures; above 78°F) sites should be thinking about the medications and supplies and their overall integrity.? I listed Ultracold Freezer units as in most cases sites do not have a redundancy plan for these units.? Think about alternative storage options that may include investigating your pathology laboratory, partner hospitals, specialty pharmacies, etc.
• Primary Engineering Control offline.? USP has allowances for reduced beyond use dates for Immediate Use compounding for non-hazardous sterile preparations depending on the? availability of alternative PECs or not.? If these units go off-line, sites should have a clear plan on when they come back on-line: including enhanced cleaning and when recertification may be necessary.
• Containment- Primary Engineering Control offline. Redundancy can be built into the system through redundant locations (satellite containment-segregated compounding areas with a C-PEC), hospitals/clinics within the system, and contracting with a 503A compounding pharmacy.? USP <800> gives little to no redundancy options when engineering controls are not functioning.? If these units go off-line, sites should have a clear plan on when they come back on-line: including enhanced cleaning and when recertification may be necessary.? Also, consider if the exhaust fan units (on the roof) are functioning to specifications required for the C-PECs to work appropriately and pressures are maintained within specified ranges.
• Cleanroom suite room pressure loss.? This event can occur if an HVAC unit goes off-line or a component of the HVAC system goes offline due to unplanned maintenance/power-blips, in times when the fire alarm is activated, or, if in-ceiling fan-drive HEPA units are not functioning.? With the exclusion of sterile hazardous drugs,? USP has allowances for reduced beyond use dates for Immediate Use and Category 1 compounding for sterile preparations depending on what equipment is available.
• Cleanroom suite completely unusable.? This situation may occur when the facility's mechanical systems need to be accessed directly above the cleanroom suite and the ceiling may need to be completely opened.? The redundancy plan could be to relocate the non-hazardous compounding services to an alternative location within the department and apply Immediate Use BUDs, or relocation of the sterile compounding services to an alternative location within the building or alternate facility.
• Water Loss. If the pharmacy loses water due to an internal issue or a more broader issue with the facility’s water supply (as is the case in Atlanta, GA), sites may have to use bottled water to perform hand hygiene for compounding followed by hand sanitizing procedures prior to donning sterile gloves.
• EMR Downtime: Sites with an EMR generally have a ‘downtime’ viewer system for basic functions.? Keying into EMR downtime requires an understanding of the EMR interfaces with integrated medication management processes such as ADCs new and discontinued medication orders, smart pump interfaces, TPN compounding devices order interfaces, sterile compounding robotics interfaces, IV-workflow systems, temperature monitoring systems.? Test the manual plan for each of these co-dependent systems as individual systems: i.e. manual logs of temperatures for each medication refrigerator.
• Facility Shut Down & Evacuation can occur due to an event such as a? post-tornado incident (yes this has happened multiple times in Missouri and Iowa over the past few years) or other natural and man-made events.? This would be an ‘all hands-on deck’ situation, and pharmacies need to be able to manage the medications for patients in a very dynamic situation as patients are transferred.? Depending on the event and the severity, medications (particularly controlled substances) may need to be secured and accounted for during and after the event.

Most pharmacy departments have an emergency call down list which is integrated into a facility emergency list.? As part of the Pharmacy call list ensure there is an up to date call list for manufacturers emergency numbers for issues for critical equipment for medications and an emergency contact number for the certification company for off-hour services.

Once the event has occurred and a plan for achieving normal operations is developed, utilize USPs standards for ensuring all conditions defined for compounding are met.? This may involve additional cleaning, ensuring the HVAC system is back to satisfactory operating conditions, repair/replacement of equipment and the use of your certifier to assist.

It is the responsibility of sites to ensure that the conditions of the medications are suitable for patient use and that employees are safe.? Planning, continually assessing risks and education of the emergency plan makes unscheduled events less traumatic.

Dare to Share That SOP

This week’s SOP to share is when things do not go as planned.? We are sharing the Pharmacy Stars Controlled Environment SOP for sterile compounding.? Use the template for the guidance based on USP standards but modify and personalize to include attributes of your departmental and institutional Vulnerability and Risk Assessment planning.??

Link : Compounding Environment SOP

Hey Houston, Do We Have a Problem?

Cause: Pharmacy spaces are extremely limited.? During times of shortages sites may need to increase on hand inventory!? Inventory may get pigeonholed into undesirable places. What's wrong here?

Last week the main problems are (1) blocking first air and (2) touching critical sites as seen in the picture below.

Increasing the Gray Matter

California Board of Pharmacy Revisions to Compounding Requirements

The California Board of Pharmacy has announced and released a draft copy of the state specific compounding guidelines.? There will be an opportunity to listen in on the review of the standards on June 18, 2024.? Here is the link to the WebEx information, which is also available on the board’s website: https://dca-meetings.webex.com/dca-meetings/j.php?MTID=mb0fd7e5e75e8caacb851a36528b6c826

Why this is important: State Boards of Pharmacy inspections include both national and state developed statutes.? Individuals working in pharmacy must keep up with all regulatory changes for compliance and patient safety.

June 8, 2024

Foster Competency with IVWF Systems

(PPP Mag article link ) “Implementing bar coding and IV workflow (IVWF) technology has dramatically decreased rates of medication errors in both hospitals and community pharmacies over the last decade.”

Why this is important: Knowledge of IV workflow systems and the early introduction of this technology to pharmacy technicians and interns in training will assist with adoption of the technology.

May 2024