Culture of Safety in Pharmacy
Weekly newsletter on compounding compliance.

Culture of Safety in Pharmacy

Friday October 18, 2024 Volume 1 Issue 20

Culture of Safety in Pharmacy

Safety: safe·ty??sāf-tē?; noun: the condition of being safe from undergoing or causing hurt, injury, or loss; verb: to protect against failure, breakage, or accident

In healthcare, the notion of "safety" often brings to mind thoughts of preventing medical errors, for pharmacy preventing medication errors, protecting patients from harm, and ensuring consistent, quality care. However, creating that?culture of safety?goes way beyond just posting signage, wearing pins, implementing safety protocols, purchasing automation and implementing checklists—it's about fostering an environment where every member of the healthcare team feels responsible for and empowered to contribute to patient safety.


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On one my last long bike rides for this year, I stopped by the Fort Calhoun (Nebraska) Nuclear Power Plant; which is being decommissioned due to aging out and damage from the 2011 Missouri flood which resulted in a localized fire.? As I rolled down the entrance road of the nuclear power plant on my bike I was met with this signage.


To be met with the next sign, which sets the stage and puts into context safety as being an individuals’ choice.


And the sign that really hit me, and made we wonder what life would be like if we had signs like these at the employee entrances to healthcare facilities!?


The last sign really makes the point for this worksite, and it gives folks a choice and an ‘out’.? Basically, giving the individual the direction to ‘exit’ if they choose to not be part of the culture of safety….thank goodness for that at a nuclear power plant!

This example brings to mind a question, what really is a ‘culture of safety’? Generically, a?culture of safety?refers to an organizational commitment to consistently prioritize safety at every level—from front-line staff to top management. It emphasizes the importance of clear communication, teamwork, accountability, and a learning-based approach to mistakes. Everyone, regardless of their role, must be engaged in recognizing safety risks and acting on them.

Putting the slant of healthcare on this definition, what would we want for the key elements of a true and practicing Safety Culture? Please note this all referenced below, but I am sure most of you know it well.

  1. Transparency and Communication:?Open communication is the backbone of a safety culture. When healthcare providers feel comfortable reporting mistakes, near-misses, or concerns without fear of punishment, the organization can learn from these incidents to prevent future harm.
  2. Non-Punitive Environment:?Mistakes are inevitable, but in a healthy culture of safety, they are seen as opportunities for learning, not grounds for blame. A non-punitive approach encourages staff to report errors or potential hazards, knowing they won't face immediate punishment. This shift is crucial for understanding system weaknesses rather than just focusing on individual errors.??
  3. Leadership Commitment:?A safety culture starts at the top. When leadership actively prioritizes patient safety, it sets the tone for the rest of the organization. Leaders need to provide resources, training, and support to ensure that safety practices are integrated into daily operations.
  4. Continuous Learning and Improvement:?Healthcare is massively complicated, and even with the best intentions, errors do happen. A proactive safety culture focuses on continuous improvement. Teams regularly review incidents, conduct root cause analyses, and adjust their protocols to adapt to new challenges or changing environments.? And the information is shared with the team; refer to bullet #1


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The ‘Mr. Obvious’ benefits of a robust safety culture include improved patient outcomes by having patient less likely to experience preventable harm, such as medication errors, infections, or surgical complications; healthcare staff well-being by feeling supported by the workplace that is committed to safety, reducing stress and burnout, fostering a healthier work environment.? And lastly, reducing costs by preventing errors meaning less rework, fewer malpractice claims, and lower insurance premiums.

Some key examples of a Safety Culture in Action that are commonly noted for medications include (of course not limited to):

  1. Medication Safety Initiatives:?One of the key areas where a culture of safety plays a significant role is in medication safety. Hospitals that prioritize safety invest in automated dispensing systems, automated compounding devices/robotics, barcode scanning, sterile and non-sterile compounding spaces, and standardized labeling processes to reduce the chances of medication errors. Of course, always fostering an open dialogue between pharmacists, nurses, doctors and other healthcare providers to ensure that issues such as unclear medication orders or potential drug interactions are caught early.
  2. Simulation-Based Training:?Many hospitals now use simulation training to prepare staff for real-world emergencies. By practicing in a controlled, risk-free environment, teams can hone their responses to crises, identifying gaps in communication or protocol. It builds teamwork and reinforces a culture of safety, where staff feel confident in handling emergencies without fear of making mistakes; (think about new folks to medications and the compounding of life saving <also life taking> medications);
  3. Leadership Accountability:?Leadership really demonstrating their commitment to safety by being actively involved in safety initiatives, allocating resources to safety programs, and addressing issues when they arise.?

Building a?culture of safety?in healthcare isn't a one-time event—it's an ongoing journey that requires commitment, transparency, and teamwork. When everyone, from the top down, is engaged in prioritizing safety, the results are clear: better patient outcomes, a more satisfied healthcare workforce, and a stronger, more resilient healthcare system.

References:

  1. Institute of Medicine (US) Committee on Quality of Health Care in America. (2000).?To Err Is Human: Building a Safer Health System. National Academies Press.
  2. World Health Organization (WHO). (2009).?WHO Guidelines for Safe Surgery 2009.
  3. Kohn, L. T., Corrigan, J. M., & Donaldson, M. S. (Eds.). (2000).?To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press.
  4. Agency for Healthcare Research and Quality (AHRQ). (2019).?Patient Safety Culture Survey.


Hey Houston, Do We Have a Problem?

Evidence: Continuous pressure monitoring device, magnehelic, is not functioning.


Cause

First note, the unit does not have a calibration sticker or notification listed.? Common causes, the filter on the room side static pressure sensor is clogged or wetted, and hose to the magnehelic device is kinked or disconnected.? In addition, the unit may be just kaput and require replacement.

Solution

Work with your certification company to remotely triage, repair and/or replace.?


Increasing the Gray Matter

FDA’s Temporary Policies for Compounding Certain Parenteral Drug Products

As of October 10, 2024, pursuant to section 319(a) of the Public Health Service Act (PHS Act), Department of Health and Human Services (HHS) Secretary Becerra has determined that public health emergencies (PHEs) exist as a result of the consequences of Hurricane Helene in the States of North Carolina, Florida, Georgia, Tennessee, and South Carolina, and as a result of the consequences of Hurricane Milton in the State of Florida.”

Why this is important: FDA has provided guidance for USP and other agencies to work within to address this disruption in the medication supply chain in the US.? In this case where IV fluids and peritoneal dialysis solutions will be impacted have redundancy plans for critical medications is paramount to minimize the impact to patients.

October 2024

Operational Considerations for Sterile Compounding by Pharmacy Compounders Not Registered as Outsourcing Facilities During Public Health Emergencies and Natural Disasters?

October 16, 2024: USP developed a document for Operational Considerations for Sterile Compounding by Pharmacy Compounders Not Registered as Outsourcing Facilities During Public Health Emergencies and Natural Disasters.”

Why this is important:? USP is providing guidance on compounded drugs if a patient’s medical need cannot be met by an FDA-approved drug or, under certain circumstances, if the FDA-approved drug is not available (in the case of the recent hurricanes).? USP has also given free access to the following IV Solution Monographs once sites have registered with USP.

-Dextrose injection

-Sodium Chloride injection

-Sodium Chloride irrigation

-Sodium Chloride compounded injection

-Sterile Water for Injection

-Sterile Water for Irrigation

-Lactated Ringer’s injection

October 2024


Event Not To Miss TODAY

[ 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

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