Bryan Prince knows that USP can be a bitter pill for the independent pharmacist to swallow. The owner of Lab·Red Pharmacy Consultants who is an expert in cleanroom design, chemical handling and workflow understands the challenges pharmacy owners face as they try to balance a commitment to worker safety with the realities of running a business.
Prince also lent his expertise to the recently released Hazardous Drug Consensus Statement, a joint effort of the Pharmacy Compounding Accreditation Board (PCAB) and industry leaders on the handling of hazardous drugs per USP guidelines.
Set to become official – i.e., enforceable by a regulatory entity such as a state board of pharmacy – on July 1, 2018, USP describes practice and quality standards for handling hazardous drugs (as identified by National Institute for Occupational Safety and Health, or NIOSH) in healthcare settings.
“The reality is it’s a huge financial investment,” Prince said about USP , noting that many pharmacists are wondering where they will find the space and/or the money to redesign or expand their cleanrooms/storage areas to meet requirements.
“We’ve got four different aspects of compounding,” Prince explained, “which equals four different rooms: USP , non-sterile, nonhazardous; USP sterile nonhazardous. Now we’re going to add on USP , non-sterile hazardous, and USP , sterile hazardous.
Think of it from the independent pharmacy owner’s perspective, he said: “You’re telling me I’ve got to have four separate rooms? Where am I going to find that space?”
From a broader perspective, though, can’t one assume that pharmacists already understand the risks and thus are doing the right things when it comes to HD handling?
“I’ve heard this: ‘Bryan, I’ve been doing this (HD compounding) for 20 years, and I’m OK.’ Then I’ve heard the flip side: The gentleman who said ‘After 20 years of doing this, I had some tumors removed.’ He couldn’t pinpoint it, but he felt like it was exposure to chemicals.
“At a conference, I met a young woman who said, ‘I’ve had three miscarriages. Do you think that’s because I work in a compounding pharmacy and I handle chemicals?’ And I told her ‘I can’t make that determination for you.’
“But the reality is, I think this is the next ‘mesothelioma’ waiting to happen,” Prince said, adding that he wonders why there aren’t yet legal ads on TV to the tune of: ‘If you’ve been working in a compounding pharmacy for X number of years and suffer from Y or Z …”
While Prince believes that USP is long overdue, he believes the need for it is stronger than ever. “Where we are today is different from where we were five years ago. There are more and more stories of exposure. The whole meningitis outbreak (scores of deaths traced to contaminated steroid injections from New England Compounding Center) kicked this thing off full throttle. The government took it and went to the next level with it.
“Did the independent pharmacy industry need some sort of regulatory change as it relates to chemical handling? Absolutely. I’m always going to be on the side of the fence that says this has been a long time coming,” which may be in opposition to the pharmacy owner, he acknowledged.
“But we have to get to a place where we understand that chemicals are dangerous.”
Bryan Prince will be presenting during a workshop sponsored by ACHC’s Accreditation University on July 25-26 at Fairleigh Dickinson University School of Pharmacy and Health Sciences in Teaneck, NJ. This PCAB Sterile and Non-Sterile Compounding and USP Compliance Workshop will provide pharmacy personnel with a comprehensive overview of the accreditation process and a standard-by-standard review of the requirements for each, along with a detailed examination of USP and guidelines. For more information and to register, visit accreditationuniversity.com or contact Chelsie Rigsbee at 919-785-1214 or crigsbee@achc.org.
