Matt Kelm, PharmD, MHA

Complying with new, more stringent requirements for personal protective equipment (PPE) under USP Chapter <800> can be done without unduly affecting the speed of batch syringe preparation, opening the door for safer workplace practices, according to a new study by Duke University Hospital researchers.

USP <800> became official on Dec. 1, 2019, but because of pending appeals on several other standards, including general chapters <795> (Pharmaceutical Compounding—Nonsterile Preparations) and <797> (Pharmaceutical Compounding—Sterile Preparations), it is considered to be only “informational and not compendially applicable” until the appeals process is completed for the other chapters.

Nevertheless, some institutions—including Duke—moved ahead with workflow changes that already had been in progress. “This chapter has been a long time coming and we’d done a great deal of planning to prepare, so we decided not to delay putting those plans in place,” said Matt Kelm, PharmD, MHA, the associate chief pharmacy officer for inpatient pharmacy services and ambulatory care services at the hospital, whose team presented the study at the ASHP 2020 Midyear Clinical Meeting & Exhibition.

This early adoption gave Duke’s pharmacy an opportunity to measure the effect of the workflow changes, including new PPE standards. Compounded nonsterile hazardous oral syringe preparation has traditionally involved relatively minimal PPE: gown and gloves for the technician preparing the syringe in the negative pressure room, and gloves for the pharmacist reviewing the syringe. Now USP <800> calls for the pharmacy technician to wear a gown and two pairs of chemotherapy gloves, as well as head, hair and shoe covers when preparing hazardous medications.

personal protective equipment (PPE) under USP 800

The Duke investigators conducted a pre- and post-modification observational study, comparing the average time in seconds it took technicians to compound oral hazardous syringe batches and pharmacists to verify the syringe batches, during two time periods: from Sept. 15 to Oct. 31 (before USP <800> implementation) and Jan. 15 to Feb. 29 (a few weeks after implementation). Technicians recorded the time they started the daily batch and when they finished, while pharmacists recorded their start and finish times for checking each daily batch. (The same three technicians prepared the batches during the two time periods.)

“We were able to detect a small time increase per dose with the new PPE and workflow,” Dr. Kelm said. Specifically, the average batch size (number of syringes) prepared by a technician in a shift fell from 60 to 52, with the average number of seconds it took to prepare each syringe increasing from 136.4 to 151.7—an increase of 15.3 seconds. Similarly, the average batch size verified by a pharmacist in a shift decreased from 57 to 40, with the average number of seconds it took to verify each syringe increasing from 12.4 to 15.6—an increase of 3.32 seconds. This difference, however, was not statistically significant (P=0.16).

“The addition of more stringent PPE and protective settings did not significantly impact technician or pharmacist time when preparing daily batches of hazardous syringes,” Dr. Kelm said. “There was a trend towards longer preparation and verification time, but adding it all up, we found that the increased time was neither statistically significant, nor probably clinically significant.”

He noted that in a batch process that takes several hours, the time required for garbing and ungarbing is a small part of the overall workflow. He also pointed out that there was significant variation in the time it took for pharmacists to verify syringes, probably due to the fact that pharmacists are frequently interrupted for other requests during the verification process.

Dr. Kelm said the most efficient approach is clearly to do all syringe preparation and checking in a single garbing, but other demands on the pharmacist and/or technician’s time may not always permit it. “We have also found that taking an ergonomic approach to donning and doffing of PPE, such as having a seating option so someone can safely don shoe covers, assists with efficiency.”

The additional PPE requirements are likely to have a more significant impact in the sterile products environment, Dr. Kelm said, but a study of that effect has not been conducted.

Kudos for Sharing Success

It’s reasonable to expect that putting new PPE requirements in place will add a little time to the compounding process, said Fred Massoomi, PharmD, the senior director, hospital and health-system pharmacy services for Visante. “It won’t be too much, but it could add up if you’re a site that compounds a great deal of products. We’ve come a long way since 2004, where we only used gloves for compounding and they weren’t even required to be sterile. One thing most folks who remember the prior changes that were made to PPE is that we didn’t do a good job of educating the nurses and the physicians about what to expect. Sharing studies like this can help them understand that adding new PPE will involve a little more time. The last thing we want is for the pharmacists and techs to be pushed to hurry up. We want them to garb appropriately so that it protects them and their patients as they are in the process of compounding and verifying.”