PCAB-accredited Pharmacy Specialties & Clinic of Sioux Falls, SD, achieved an additional recognition in September when it became the first to receive ACHC’s new Distinction in Hazardous Drug Handling (HDH).
The Distinction in HDH gives ACHC- and PCAB-accredited pharmacies a means to demonstrate compliance with criteria set forth in USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings. While not set to go into effect until 2019, many pharmacies are taking proactive steps to ensure preparedness with these guidelines aimed at protecting pharmacist and patient safety.
Below, PS&C President Cheri Kraemer talks about her pharmacy’s experience preparing for and undergoing the HDH survey, and offers advice for those who may be considering it.
ACHC: Why did you decide to make your facility USP <800> compliant?
Kraemer: I have always tried to protect my employees from chemicals they work with on a daily basis and I have had a powder room for making capsules and hormones since 2010 so I just decided to finish the entire process since the deadline was July 1, 2018*, and I wanted to be ready. I would rather be first to act than last when dealing with employee safety. (*The implementation date has since been postponed until December 1, 2019.)
ACHC: What were some of your biggest challenges?
Kraemer: I decided to move the cleanroom, which required a remodel. We had glass walls and ledges in our old cleanroom, so to make it more efficient for cleaning, we built out a new cleanroom with a hard top, epoxy painted walls, and concave floors.
ACHC: What surprises did you encounter?
Kraemer: The expense; it is always hard to know what things will cost. So to prepare, I sold my retail pharmacy portion to a local retail chain in order to have money to remodel and do this all properly. We are compounding only now. We do less than 5% sterile but I feel ready to do more now that we have gone through all the inspections. I know many compounding pharmacies are dropping sterile because of the expense to make the changes needed. I want patients in South Dakota and our surrounding states to have access to all areas of compounding.
ACHC: What was easier than you thought?
Kraemer: The hazardous area was quite easy for me because I had a room separated already for many years. I just needed to vent the hoods outside and designate the area hazardous; separate chemicals; change gowning procedures; and rethink all the various workflow processes. An example is that you need more equipment. We needed a second ointment mill to put in the hazardous room for topiramate pediatric suspensions made from commercial tablets.
ACHC: What pearls of wisdom might you share with a pharmacy in the beginning stages of preparation for USP <800>?
Kraemer: Consider the hoods you will purchase before the buildout. We did not make the ceiling in our sterile hazardous room high enough. It should have been 1 foot taller to accommodate the new BioView hood. I could not have known that because I did not realize the hood I was getting to put in there was so tall. The hood should be raised up for comfort.
ACHC: How do you feel about ACHC’s approach to addressing USP <800>?
Kraemer: I thought it was very thorough. Going in to USP <800> certification, the Distinction in Hazardous Drug Handling, I had questions about the extra waste we will create using so many more chemo items. It was really nice to have Jon Pritchett with ACHC and Brenda Jensen with Compound Consultants to work with regarding some of these details.
ACHC: Do you feel that the Distinction in HDH standards adequately addressed the chapter?
Kraemer: Yes, I was very ready for the inspection after working through the requirements set forth by ACHC/PCAB.
ACHC: Where do you see the compounding industry going? Do you think that hazardous drug handling will continue to be a topic of conversation?
Kraemer: I am ready for HD handling across the board, sterile and non-sterile. I feel that if I could do this, everyone can do this and should do it sooner rather than later. It is about safety to your employees, which should be the most important thing to consider when compounding with bulk chemicals and handling other NIOSH list medications. I feel the sooner this all gets in place, the better for everyone in our industry.