The effort to comply with USP <800> is time and resource-intensive, requiring significant investments in workflow shifts, and technology upgrades. Many hospitals we’ve spoken with did not have an upfront budget to meet the many hazardous drug safe handling requirements of USP <800>, <795> and <797> and must dedicate large sums to new equipment, PPE and even major building renovations to meet new, stringent compounding requirements. 

In an effort to cut expenses where possible, we’re witnessing healthcare facilities attempt to make homegrown technology solutions to replace and, in some cases, simply update outdated and ineffective safety policy documentation and communication methods like spreadsheets and even physical copies. Because the healthcare organization is utilizing existing software or current practices, the efforts are seen as “free” or at least not a major expense. 

The reality is that nothing is free. To retrofit an existing technology or protocol to solve a new problem, labor hours are needed, and typically, lots of it. 

For instance, we’ve spoken to a healthcare facility whose Willow team is drowning in piles of IT tickets related to the essential use of Epic. In order to save money on the facility’s USP <800> compliance efforts, the WIllow team is now being asked to build out a hazardous drug safe handling and disposal database in addition to their routine tasks of maintaining the system, troubleshooting technical issues and more. 

Consider the manpower needed to develop an entirely new solution in addition to the vital work these teams are doing every day. In one case, the hospital estimated it would take at least three people on the WIllow team and an informatics pharmacist who will identify what needs to be built out, create tickets for the project, and thoroughly test Epic throughout the project. For the initial setup, an average of 300 drugs and all of the safety policies for each type of administration must be added to the list and then to the potentially hundreds of ERX modifications.

The overwhelming thought is that this is just the beginning. Hospitals are still only required to reference NIOSH 2016, but many are moving to NIOSH 2020 with the 2023 list biting at their heels. The needs are constantly evolving and with USP <800> enforcement now a reality, hospitals will face another unknown set of requirements. 

This is the first in a series of blogs where we will discuss the challenges faced when working to comply with USP <800> under a non-existent or undefined budget for the technology needed to make their facility both safer and compliant. Next time, we’ll go into more detail about how a homegrown technology solution is unsustainable. We’ll share stories from hospitals we’ve talked to about their attempts at creating a solution and why they are now looking at solutions like Rhazdrugs to document and communicate their hazardous drugs' safe handling policies. 

We have an existing library of resources to address many challenges of implementing the USP <800> safe handling requirements. Check out other USP <800> Safety First blogs and recordings from our webinar series discussing all things USP <800>. 

This week at the ASHRM (American Society for Healthcare Risk Management) 2023 Conference, we learned that the Joint Commission is conducting mock surveys around hazardous drugs to prepare hospitals and healthcare systems for upcoming accreditation surveys. 

Healthcare risk management is an all-encompassing concern. As we’ve mentioned before, as a risk manager, you are tasked with protecting patients, healthcare workers, and the facility or system from the many potential risks healthcare organizations face. 

As hospitals implement Rpharmy’s Rhazdrugs solution to help comply with USP <800> and prevent healthcare workers from exposure to hazardous drugs, many have uncovered areas where further safety information or education is needed during the process. University Hospitals in Ohio is one hospital we’ve worked with recently to implement Rhazdrugs. 

University Hospitals’ Medication Safety Officer, Bridget Gegorski, oversees medication safety programs for the 21 integrated hospitals within the system, which includes the implementation of Rhazdrugs and compliance with USP <800> and the lengthy list of state and federal regulations. 

Manual to Automated
Prior to Rhazdrugs, hazardous drug safety information was documented and shared via a spreadsheet on the hospital system intranet. Not only was it difficult to find for nurses and clinicians, not to mention environmental services, but it was challenging to maintain. 

Transitioning from manual spreadsheets to an automated system has revolutionized our hazard drug safety management process. Rhazdrugs not only streamlines the process but also fosters collaboration, said Bridget. 

More involvement = Stronger Safety Protocols 
Previously, hazardous drug safety management was mostly a solo effort, often resting on Bridget. The limitations of using a spreadsheet on a shared drive restricted simultaneous work and was focused on the addition or removal of drugs. Comprehensive reviews were challenging because all of the change control landed on one person. 

Now, Rhazdrugs’ automated system allows multiple stakeholders, including our oncology medication safety officer, the clinical oncology manager, the operations oncology manager, and the oncology director, to collaboratively edit and approve changes. With five individuals now sharing the workload, the reviews are more in-depth and proactive. This shift doesn't only distribute responsibility but ensures a richer and more thorough assessment of safety protocols.

Greater End-User Awareness
The cornerstone of hazardous drug handling is ensuring that end-users are aware and have consented to the potential risks involved. This can be compared to an "informed consent clause," where staff members acknowledge they've been informed about policies, received training, and recognized that they work with hazardous drugs.

Rhazdrugs helps to ensure that all healthcare workers who encounter hazardous drugs have the safety information and tools they need where they need them. From an organizational standpoint, USP <800> and OSHA require that the safety protocols are correct, clear, and easily accessible; Rhazdrugs helps show that University Hospitals meets that requirement. 

“Through our assessments, we realized that there was a need for more thorough training on respiratory protection. Some staff members believed certain face masks protected them from hazardous drug fumes, while in reality, these masks only protect compounds from contamination. The correct protection comes from equipment like N95 masks or respirators. So we created specific education to address respiratory protection and equipment,” Bridget said. 

Another area where University Hospitals recognized a need for additional information was the importance of dwell times or the amount of time that a disinfectant has to remain visibly moist on the surface being cleaned to effectively kill the targeted germs, viruses, or bacteria. Though the State Board of Pharmacy typically focuses on sterile compounding, their reviews sometimes touch on hazardous drugs. In one review, the inspector emphasized the importance of dwell times for cleaning agents, especially for products like Peridox, which, in addition to being a sporicidal, can also be used to decontaminate and deactivate hazardous drug particles. As a result, Bridget said they increased education on dwell times and made this information more widely available.

Aligning with Specialty Pharmacies 
Through the Rhazdrugs implementation, University Hospitals identified discrepancies between the standard hazardous drug review process and the process its specialty pharmacy uses. Because they handle a lot of non-formulary drugs that the standard pharmacy doesn’t, the specialty pharmacy is more conservative in labeling drugs as hazardous. Bridget and her team discovered that Lexicomp was actively expanding its list of hazardous drugs, sometimes surpassing even the NIOSH list. This discrepancy made it clear that the second phase of the Rhazdrugs rollout would require aligning our list with its specialty pharmacy department.

As University Hospitals rolls out Rhazdrugs, they are also implementing Epic as their electronic health record (EHR) platform. Once Epic is in place, Rhazdrugs will be embedded into the system so nurses can access hazardous drug safety information while they're in the Medical Administration Record (MAR). 

“(Rhazdrugs) will be a big improvement in accessibility and the amount of specific information per drug per dosage, per activity all of that,” Bridget said. 

For years, the hospital pharmacy has been at the forefront of efforts to meet USP <800> compliance, addressing its myriad physical and cultural requirements. Pharmacy’s central role in USP <800> compliance was one key takeaway from a presentation by Christopher Duphren, PharmD at Augusta University Health at the Georgia USP conference this summer. He outlined a plan for USP <800> compliance to a room full of pharmacists, many of whom are among those still planning and implementing the required safety measures outlined by USP <800>. 

As a healthcare risk management professional, you are responsible for safeguarding patients, healthcare workers, and the facility or system. This protection spans from physical injuries and deaths to costly fines and lasting damages to the hospital’s reputation. That’s a lot of ground to cover. 

The digital age has forever altered our lives for the good and also the bad by opening up people to threats that are hard to predict. As technology evolves, so do the cunning tactics of cybercriminals. From sophisticated scams targeting banks to stealthy phishing emails, the landscape of cybersecurity threats is vast and ever-changing.

At Rpharmy, we've experienced firsthand the increasing intricacies of these threats. A seemingly innocuous email was sent to one of our junior team members, appearing as if it came directly from me, the CEO. This tactic, known as CEO fraud or Business Email Compromise (BEC), is an insidious form of social engineering. Here, cybercriminals cleverly manipulate employees to spill sensitive information.

A leading cybersecurity firm, Phished, points out that in such scams, criminals impersonate high-ranking officials to exploit unsuspecting employees. Their modus operandi may range from orchestrating wire transfers and creating fake invoices to asking for bank or payroll details. Shockingly, this scam has a pervasive reach, spanning across all 50 states and 150 countries.

At Rpharmy, the initial request might have seemed benign – merely asking for a phone number. Yet, this seemingly small piece of information can be the gateway to more consequential data breaches. It's alarming to note that many colleagues, their families, and friends have reported being targeted with variations of this scam, including buying gift cards and divulging payroll account numbers.

And the risks don't just end there. Ransomware attacks compromise organizations crucial to our society's functioning - water facilities, government buildings, and, most concerningly, healthcare facilities. The data these institutions hold, especially healthcare data, is among the most sensitive. It's a treasure trove for cybercriminals, allowing them to execute fraudulent Medicare and Medicaid claims and expensive treatments.

At Rpharmy, while we don’t store patient-specific information, we're acutely aware of the ramifications if malicious entities access a hospital’s medication resource data via platforms like Formweb or Rhazdrugs. Such breaches could directly jeopardize patient care and safety.

Given the magnitude of these risks, we’ve fortified Formweb and Rhazdrugs with state-of-the-art authentication procedures, including two-factor authentication. And, because we believe in continuous improvement and transparency, here's a little inside scoop: We are in the midst of enhancing the user experience across our platforms. This initiative isn’t just about usability; it’s about harnessing cutting-edge technology to provide our users with the most secure environment possible.

In this era of relentless cyber threats, we at Rpharmy pledge to stay vigilant, proactive, and committed to safeguarding your trust. If you are ever concerned about the safety of your Formweb or Rhazdrugs sites, please contact us directly at (800) 467-1907. 

As the Manager of Pharmacy Contract-Utilization for standalone clinics and hospitals within the growing Ochsner Health system, Charlotte Dixon uses Rpharmy’s Formweb as a source of truth when evaluating drug and formulary requests from clinicians and hospitals.

Formweb is the cloud-based medication resource platform trusted by Ochsner to house system-wide formulary and safety information for their multi-state system of hospitals and clinics. 

Clinic Requests
When clinics contact Charlotte asking if they can prescribe a specific drug to patients, Charlotte first checks with Formweb. 

“I try to do pre-work before escalating clinic requests to the MUSE (Medication Use Safety and Education) team. I check Formweb to see if these items are formulary and if they are approved for what the clinic needs,” Charlotte said.

The MUSE team works with many constituents within the extensive Ochsner system - both within the clinics and the hospitals - to evaluate drugs, review existing drugs for updates, document safety requirements and determine the education necessary for the drug to be used at their facilities. 

Before sending the drug request to the MUSE team, Charlotte checks for these things in Formweb: 

1. Is it formulary?
2. Is it approved in this service line? 
3. Is all drug information accurate? 
4. Has anything changed with this drug?  
5. Are any approvals in process for this drug? 

Depending on the answers, Charlotte either approves the clinic’s drug request or can work with the requester and MUSE to file a formulary request. 

For example, a clinic requests a drug for a specific procedure. Charlotte reviews Formweb for Ochsner’s policies and requirements when administering this drug. She can also access the vendor requirements that must be fulfilled before the provider can access the requested drug. By accessing all of this information quickly in Formweb, Ochsner’s single source of medication information, Charlotte can provide accurate information and help prevent med errors or any other accidental risk.

Also, as new clinics join the system, Formweb makes it easy to evaluate the new clinics’ drug lists and provide the safety information needed for those drugs. She can also determine what service line their drugs have been approved for or if there is an exception and add them to Formweb accordingly. Formweb also ensures a consistent record of drugs and documentation when employees leave or move positions, which reduces the risk that someone accesses or administers a drug in an unapproved or harmful way. 

Integrating New Hospitals
Charlotte also manages contracts and purchasing for Ochsner’s hospitals. This includes existing and newly acquired hospitals joining the Ochsner system-wide formulary. As new hospitals integrate their formulary or request drugs not in the Ochsner formulary, Charlotte refers to Formweb throughout the process. 

Charlotte says that with Formweb, she can walk new hospital staff through the process of checking for the drug and then requesting it if it’s not already approved in the formulary. Because it is the single source of truth, she feels confident that she can provide the most up-to-date and accurate drug information to all of her constituents so they can then make the best decisions for their patients. 

In a recent example, a clinician requested a drug where one of the indications required REMs (Risk Evaluation and Mitigation Strategy) and one indication did not. Charlotte referenced Formweb to verify that the drug was on the Ochsner formulary and, if so, review which indications were approved and what safety requirements were listed. She did confirm that their formulary did include the requested drug - one indication was labeled with REMs and another was not. Because Formweb includes the ability to label drugs with REMs as well as specific safety information, Charlotte was able to communicate this critical safety information to the clinic. 

Formweb also reduces the time spent by doctors requesting a drug. By checking Formweb when a doctor requests it, Charlotte can provide the information needed to enable the doctor to make a vital treatment decision. Suppose the initial drug is not in the Ochsner formulary. In that case, the doctor can determine if it is worth the time to put in the request, which may mean taking a risk that the drug will not be approved for formulary or, even if approved, might result in a significant delay of patient treatment. Based on the information Charlotte provides from Formweb, the doctor may need to seek other treatment options. 

Bottomline: 
Because all of their formulary information is housed alongside safety information and policies, Formweb saves Charlotte time and creates efficiencies as she collaborates with other teams across the Ochsner Health system, including MUSE, clinicians, and pharmacists, to review and approve drug requests.

Our Safety First blog on “Should, Shall and Must,” as used in the USP <800> hazardous drug safety requirements, continues to be one of our most searched-for and visited blogs. Therefore,  we decided to write another blog exploring the topic in a little more depth to hopefully provide additional guidance on a topic that still causes confusion and concern. 

As you are well aware, ensuring safety in healthcare facilities goes beyond patient care; it also involves the important work of protecting healthcare workers from hazardous drug exposure. However, in an age of digital health and advanced technology, it's alarming that there are still healthcare professionals who resort to scouring the internet for safety information when dealing with hazardous drugs. This poses risks not only to their health but also to the overall safety standards of healthcare environments.