6 Policy
Pharmacy Practice News • January 2022
Sterile Compounding
Revised USP <797> Will Call for More Resources By David Wild
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ow that USP has released its longawaited 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
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
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. 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 see USP <797>, page 9
The 10 Principles of Compounding Ergonomics By David Wild
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lthough 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 To avoid repetitive motion injuries, IV workflow equipment should be within have to read documents with easy reach while preserving the direct compounding area. small fonts or perform close visual inspection, working at motions of your job is critical,” Dr. Tribble said. Assess eye level is better than having to bend or extend the compounding area and ensure compounders have the neck.” the clearance needed to do their work, he advised. Reduce excessive motion. “Wrist extension and Move, exercise and stretch. “Doing anything in inflection are probably the two things we do one place for a long time in one position can most when manipulating syringes, so you want to be cause injuries, so you really want to find ways to sure these motions are not exaggerated because it move, stretch and exercise,” he said. Break times can lead to repetitive strain injury,” he said. When should be scheduled, and staff can be rotated drawing multiple doses from large compounding through the cleanroom. vials, a spike adapter and rearranging the working layout to keep the direct compounding area clear can Maintain a comfortable environment. “I’ve minimize the amount of reaching. been in a few cleanrooms where the fan drivers of a hood were out of balance to the point that Minimize fatigue and static load. “If you can someone using a gravimetric system couldn’t get the provide compounders with footrests and other scale to settle because the vibrations were so bad,” accommodations that permit occasional shifting of Dr. Tribble said. Resolve these issues, because physifoot or leg positions and that are easy to disinfect, cal vibrations and noise can also prompt workaround that may keep them more comfortable for longer behaviors that, in turn, lead to inappropriate posture. periods of time,” Dr. Tribble said. For more information, visit the Occupational Minimize pressure points. Squeezing fingers or Health and Safety Agency for Healthcare’s ergonomleaning arms and legs against edges of work ics guide for hospital pharmacies (www.osha.gov/ surfaces can lead to injuries. Padding is the best ergonomics). 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
Dr. Tribble reported that he is an employee and shareholder of BD.
