Now that USP has released its long-awaited proposed revisions to General Chapter <797>—and assuming the chapter will not change significantly in its finalized form—hospital pharmacies are gearing up to meet the necessary requirements.
“Implementing the proposed revisions will come with challenges regarding costs and resources, but the safety of patients and compounding employees far outweigh these costs,” said Mary Nazzal, PharmD, the director of field operations, Kastango Consulting Group, a TRC Healthcare Company. “The USP <797> 2021 proposed revisions address many concerns, including clarifying requirements, providing expanded guidance for assigning beyond-use dates [BUDs], and renaming risk levels, which we saw in the 2019 version and are a move in the right direction for safety.”
Much Attention Paid to BUD Changes in <797>
Most of the attention regarding the proposed revisions to USP <797>—which was published in September 2021—has centered on the creation of three categories of compounded sterile preparations (CSPs) and their BUD requirements (Table). Under the proposed revisions, compounders who are willing to meet the most stringent quality assurance parameters can assign BUDs up to 180 days, Brenda Jensen, CPhT, CNMT, MBA, the chair of the USP Compounding Expert Committee, explained in a presentation at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually.
| Table. Proposed Revisions to USP Chapter <797> Categories | ||
| Category 1 CSPs | Category 2 CSPs | Category 3 CSPs |
|---|---|---|
| May be prepared in a PEC located in an unclassified segregated compounding area | Must be prepared in a cleanroom suite | Have additional requirements that must be met at all times |
| Assigned a BUD of =12 hours at controlled room temperature or =24 hours when refrigerated | May be assigned a BUD of >12 hours at controlled room temperature or >24 hours if refrigerated | May be assigned a BUD longer than established for Category 2 CSPs, up to 180 days |
| BUD, beyond-use date; CSPs, compounded sterile preparations; PEC, primary engineering control | ||
According to Ms. Jensen, the quality assurance requirements for “Category 3” CSPs include stringent sterility testing and endotoxin testing, when compounding from non-sterile starting ingredients, as well as more frequent personnel qualification evaluations, sterile garbing requirements, increased use of sporicidal disinfectants and more frequent environmental monitoring.
However, these very stringent Category 3 BUD requirements are less of a concern for many hospitals, most of which do not compound this category of CSPs, said Kenneth Jozefczyk, MS, the director of central pharmacy services, BayCare Health System, in Tampa, Fla. “I’m pretty sure we won’t be veering into this third category because it requires a significant investment in garb, equipment and workflow,” said Mr. Jozefczyk, who was not involved with the ASHP presentation.
Although Category 1 and 2 compounders do not need to meet the level of stringency required for Category 3 agents, as Ms. Jensen noted during her talk, they will still need to perform more frequent monitoring and testing than was in previous versions of USP <797>.
For example, while the still official 2008 version of USP Chapter <797> requires that surface sampling be done “periodically,” the proposed revision would require monthly surface sampling for Category 1 and 2 compounds. The proposed revisions also would mean more frequent evaluation of compounders’ competencies and more frequent media fill testing, which would require two incubators to accommodate changes in incubation temperatures.
“This update seems to be of concern to many in the field, as they often don’t have two incubators available or don’t have the space to add an additional incubator,” Dr. Nazzal said.
One tactic that some hospital pharmacies have taken when their incubation needs have exceeded their in-pharmacy capacity has been to ask their hospital’s microbiology laboratory to add “a few extra samples to their incubator, but now they’re going to need a little bit more of a formal plan to get incubator space or, in some cases, purchase incubators,” Mr. Jozefczyk said.
The Ins and Outs of Testing
Hospitals that outsource their environmental testing should prepare to perform some testing internally, said Patricia Kienle, RPh, MPA, the director of accreditation and medication safety at Cardinal Health, who was not involved with the ASHP presentation but is a member of the USP Compounding Expert Committee. “It’s unlikely that a hospital pharmacy would be able to get their certifiers to perform environmental testing every month, because of the cost and because certifiers are busy, so they’ll need to buy the equipment to do part of this testing themselves,” she said.
For these individuals, more frequent testing also will require access to a microbiologist, whether contracted or in-house, as well as additional testing kits or media, if incubating in-house, Ms. Kienle said. “I would encourage hospital pharmacies to get up to speed on this and figure out how they’re going to meet these requirements,” she added.
Changes to Ophthalmic Preparations
One concern that came up during the development of the proposed Chapter <797> centered on the revised requirements for preservative-free ophthalmic preparations. “To prevent contamination, these need to be packaged in unit-dose ophthalmic containers, but unit-dose devices are only available to manufacturers,” Ms. Jensen said. “A hospital pharmacy would need to package those preparations in unit-dose syringes instead of containers, which comes with the risk of accidentally being injected.”
The USP Compounding Expert Committee ultimately decided to allow ophthalmic compounds to be packaged in multidose containers as long as they are assigned BUDs according to the requirements for Category 1, 2 and 3 CSPs, Ms. Jensen said. “The caveat is that once opened, the container must be discarded after 24 hours when stored at room temperature and after 72 hours if stored refrigerated.”
Despite that accommodation, “the chatter in the field is that this update will significantly impact those who prepare non-preserved ophthalmic CSPs,” Dr. Nazzal said. “Many of these CSPs are antibiotics and given over seven to 14 days, so they are noncompliant with the requirement [for a maximum BUD of 72 hours].”
To be compliant, she said, pharmacies would need to build more robust processes—such as Chapter <51> on antimicrobial effectiveness testing and Chapter <1207> on container closure integrity testing—and potentially dispense separate multiple containers to accommodate the need for shorter BUDs.
“I am sure the USP committee will get tons of feedback on this section, and I look forward to seeing what they come up with,” she said.
Noting that the proposed USP <797> revisions are open for public comment until Jan. 31, 2022, Dr. Nazzal said, “I hope that USP and compounding pharmacies can agree on the standards in the next release, so that pharmacies are not afraid to move forward. The longer we wait for the final version, the longer patients may be subjected to suboptimal care by compounding pharmacies doing things they should not be doing.”
Ms. Jensen and Ms. Kienle are members of the USP Compounding Expert Committee. Ms. Kienle noted that her comments are her own. Dr. Nazzal and Mr. Jozefczyk reported no relevant financial disclosures.
The 10 Principles of Compounding Ergonomics
Although compounding medications can be rewarding, the repetitive tasks involved can strain the muscles and joints. In light of the risk for injury, one expert who spoke on the topic at the ASHP 2021 Midyear Clinical Meeting and Exhibition, held virtually, emphasized the importance of preventing musculoskeletal injuries before they occur.
“Every colleague I have talked to has at least one associate with an injury, and recovery can take months and be debilitating for activities of daily living as well as for work,” said Dennis Tribble, PharmD, the director of clinical innovations and medical affairs for Medication Management Systems at BD.
To help prevent compounding-related injuries, Dr. Tribble shared 10 principles of compounding ergonomics:
Work in a neutral posture. “The first and foremost notion in ergonomics is maintaining an appropriate posture and an ‘S-curve,’ to the spine,” Dr. Tribble said. To help achieve this, use chairs with lumbar support and orient work to keep elbows at the side and to avoid excessive reaching or leaning.
Reduce excessive force. “The force required to push 20 mL through a 27-gauge syringe with a 1.5-inch needle over 20 seconds is about 10 pounds, and you can imagine the stress it places on the hands and wrists to do that tens or hundreds of times a day,” Dr. Tribble said. To mitigate this effect, he recommended using the smallest syringe possible to deliver a dose along with the largest needle that will also avoid coring, and to consider using a spike adapter for multiple draws from the same vial. Pharmacy pumps and IV robotics can also help reduce the force required with repetitive dose preparation and delivery, he said.
Keep everything within easy reach. “It can be tricky to put everything in the hood within arm’s reach, but you really want to do that,” Dr. Tribble said. For example, IV workflow equipment should be within easy reach while preserving the direct compounding area.
Work at the proper height. “Ordinarily, work at elbow level is the most ergonomic, but there are exceptions,” he said. “If you have to read documents with small fonts or perform close visual inspection, working at eye level is better than having to bend or extend the neck.”
Reduce excessive motion. “Wrist extension and inflection are probably the two things we do most when manipulating syringes, so you want to be sure these motions are not exaggerated because it can lead to repetitive strain injury,” he said. When drawing multiple doses from large compounding vials, a spike adapter and rearranging the working layout to keep the direct compounding area clear can minimize the amount of reaching.
Minimize fatigue and static load. “If you can provide compounders with footrests and other accommodations that permit occasional shifting of foot or leg positions and that are easy to disinfect, that may keep them more comfortable for longer periods of time,” Dr. Tribble said.
Minimize pressure points. Squeezing fingers or leaning arms and legs against edges of work surfaces can lead to injuries. Padding is the best option to mitigate this.
Provide clearance. “We don’t often think of this when we think about ergonomics, but providing an unobstructed ability to perform the ordinary motions of your job is critical,” Dr. Tribble said. Assess the compounding area and ensure compounders have the clearance needed to do their work, he advised.
Move, exercise and stretch. “Doing anything in one place for a long time in one position can cause injuries, so you really want to find ways to move, stretch and exercise,” he said. Break times should be scheduled, and staff can be rotated through the cleanroom.
Maintain a comfortable environment. “I’ve been in a few cleanrooms where the fan drivers of a hood were out of balance to the point that someone using a gravimetric system couldn’t get the scale to settle because the vibrations were so bad,” Dr. Tribble said. Resolve these issues, because physical vibrations and noise can also prompt workaround behaviors that, in turn, lead to inappropriate posture.
For more information, visit the Occupational Health and Safety Agency for Healthcare’s ergonomics guide for hospital pharmacies (www.osha.gov/ergonomics).