As USP looms, access your compliance of medication compounding standards now
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October 1, 2018
Examine your hospital’s medication compounding process and your compliance level with upcoming standards as The Joint Commission (TJC) signals its increasing focus on compounding as a problem area.
In January, TJC unveiled a Medication Compounding Certification (MCC) program that’s open to all compounding pharmacies, not just those with TJC accreditation. The accreditor also called upon healthcare providers to work toward the elimination of medication compounding–related infections (MCRI) like the 2012 meningitis outbreak connected to a Boston company. Almost 800 patients were infected and more than 70 died.
“The health care community, including The Joint Commission, recognize that as the need for compounded medications continues to grow it is more important than ever to ensure safe policies and procedures are being appropriately and effectively implemented to prevent patient harm,” wrote Robert Campbell, PharmD, TJC field surveyor, in a TJC blog post in April.
Meanwhile, the U.S. Pharmacopeial Convention’s (USP) Chapter <800> “Hazardous Drugs; Handling in Healthcare Settings,” will become fully enforceable by regulators on December 1, 2019. Its regulations aim to protect the 8 million American healthcare workers who are potentially exposed to hazardous vapors/particles from the substances used in compounding each year. The chapter talks about the physical environment and equipment needed to maintain sterility and avoid inadvertently contaminating the employee. USP also has other extant chapters on sterile compounding, such as Chapters <797> and <795>.
In 2015, CMS adopted many of the standards of USP <797> into its State Operations Manual, Appendix A, which is the interpretive guidelines for its surveyors.
Complexity and risk
Many hospitals, clinics, and pharmacies compound their own medicines for a variety of reasons. Sometimes the medicine patients need isn’t available commercially. Sometimes they’re mixed together so the patient will only need one IV instead of two. Commonly, medicines are mixed into large-volume solutions.
And while the Boston case was exceptionally horrific in scope, every compounding facility runs risks when trying to compound safe drugs.
Kurt Patton, MS, RPh, former director of accreditation services for TJC and founder of Patton Healthcare Consulting in Naperville, Illinois, says the big risk of compounding IV products is failing to maintain the product’s sterility. When that happens, bacteria or molds could be introduced into the patient’s system.
“To try and make a sterile product you can deliver intravenously is not as easy as making an oral product,” says Patton. “Keeping or maintaining sterility is the difficult challenge, but it’s essential when you’re talking about a product going directly into the bloodstream. If you or I ate a product that contained some contamination, once it got into the GI tract, to a large extent our GI tract helps protect us. But if you deliver that same bacteria into the bloodstream, you don’t have that same level of protection.”
“When not mixed in sterile conditions, compounded medicines can cause multiple types of infections, including bacterial bloodstream infections and cases of fungal meningitis,” he adds.
Patton says that compounding regulations are inherently complex, which is why facilities often struggle with them. Usually with new requirements, it’s a matter of just changing a process or requiring some education. However, compounding is an issue that seems to touch almost every area of the hospital, including air handling, exits, entries, pass-through areas, cleaning, employee health, receiving, spill management, competency, product validation, and employee attire.
With USP <800> set to go into effect in 2019, hospitals should expect to add a layer of complexity to the process. Still, Patton says the new chapter is needed.
“The main advantage [of USP <800>], though, is that it’ll make product preparation safer for the employees involved in either preparing or administering these medications,” he says. “These medications are by themselves sometimes toxic to the healthcare worker. The USP <800> regulations are designed to help protect the healthcare worker while at the same time ensuring delivery of a sterile product.”
Hospitals will need to go through a cost-benefit analysis to determine if they want to upgrade their environment and equipment to comply with Chapter <800>. For small hospitals and clinics that don’t need many hazardous drugs, the smart choice might be to use an off-site compounder instead of trying to design an environment to compound their own medications.
Issues and improvements
Common problems hospitals and clinics have, says Patton, include defects in the physical design of the compounding environment—for example, a room’s air pressure being positive when it should be negative, or vice versa. There can be defects in techniques used, creating air turbulence in the laminar flow hood where the compounds are made. And there can be problems with policies and procedures: lack of sufficient detail, poor implementation of well-written procedures, a defect in the competency validation process, or missed deadlines.
“[It’s] just adding more procedural details on how to prepare those products,” he says. “[For example,] sometimes you want to reuse needles in that environment. How long can you reuse them? When do you throw them out? Do you permit the reuse of needles? Things like that.”
Policies often fail to specify where equipment and materials should be placed inside the laminar flow hood, he notes.
“There’s actually degrees of [air] turbulence you can create that you have to analyze ahead of time to determine where the best place to put that compounding device is,” says Patton. “In the compounding hood, there is a laminar flow of air out of the hood to prevent particles from getting into the compounding area. If you place a piece of equipment in there, it creates a turbulence in the air current and may affect the ability of the air flow to keep the environment particle-free.”
For that reason, policies and procedures should cover where items are placed in the hood (e.g., “approximately 5 inches from the right wall,” etc.).
“Then you work from left to right,” he says. “The left-to-right concept is just a standardized approach to getting out the products you need to compound; [materials] on your left, doing the work and placing completed product to the right. Having a standardized approach is always best.”
Because it’s often hard to tell if a patient is getting ill because of a contaminated IV or something else, there aren’t many hard numbers on how many people are harmed due to compounding errors.
“Say a patient’s in an ICU setting and they spike a fever,” Patton says. “Patients might spike a fever because they’re sick for some reason, their physical condition is deteriorating, and you might not have ever realized it was due to some sort of contamination that had been introduced in the process.”
Patton doesn’t think there’s a way to track the exact number of compounding harms. That said, he does believe there’s a way to track the odds of a mistake.
“One of the things that hospitals are doing is taking some products and testing them,” he says. “You can test them if they’ve not been used on a patient and they have now expired. You can see if they maintained sterility during the shelf life of the product.
“Also testing the workers. They do something called the Media-Fill Test where the worker is adding products to IVs and then testing that IV to see if it grows out any contamination. And they increase the complexity of the IV product in terms of how many manipulations it requires, just to ensure that the technique staff is using is maintaining sterility. I think doing those kinds of preventive analyses will help prevent some patients from getting these contaminations.”
Get to work
Every facility will find it valuable to self-assess its level of compliance with the upcoming compounding standards, says Patton, regardless of where your state regulations are headed.
“Knowing where you stand against current practices allows you to plan, budget, and progressively make incremental improvements,” he says. “Waiting until the state mandates something creates chaos and confusion, and more importantly no time to budget improvements appropriately. If you then reach the point where you think you are in pretty good shape, then I would advise inviting The Joint Commission to come do this certification for them. That might validate your perception of excellence or provide an opportunity to further improve the process.”
For those preparing for the anticipated implementation of USP Chapter <800>, Joint Commission Resources has a self-assessment tool available on its website.
“When you work in a hospital, you often face roadblocks because of competing priorities and organizational inertia,” Patton says. “Keeping up with requirements such as these for compounding takes perseverance, steady and continuous improvement. While you might not make everything perfect this year, making it better is still a worthwhile accomplishment.”
Editor’s note: A version of this article first appeared in Inside the Joint Commission, an H3.Group publication.