April 2010 was the second National Safe Handling Month, a campaign designed to further education about the risks associated with handling hazardous drugs and safety measures that can prevent exposure to these agents. The initiative was supported by an unrestricted educational grant provided by Carmel Pharma, Inc, the maker of the PhaSeal closed-system drug transfer device (CSTD) and included regional and national educational activities. The Oncology Pharmacist recently spoke with Timothy Tyler, PharmD, FCSHP, director of pharmacy services, Comprehensive Cancer Center, Desert Regional Medical Center, Palm Springs, California, about his institution’s decision to implement a CSTD to protect their personnel.
Why is there still a need to raise awareness of safe handling?
The 2004 National Institute for Occupational Safety and Health (NIOSH) alert raised awareness of the problem, but NIOSH has no executive enforcement arm. The US Pharmacopeia (USP) <797> regulations are enforceable, but who is going to enforce them? We are all trying to comply, but we know from listservs and what we hear from our colleagues that there are facilities that are not fully complying with all of the USP <797> regulations.
And a lot of questions remain. For instance, CSTDs are mentioned in the NIOSH alert and briefly in USP <797>. We know that if these devices are truly closed systems, they are effective in reducing contamination, but some of them are filtered, not truly closed, and we don’t know if that’s acceptable.
There’s also the question of how much contamination—if any—is acceptable. At what level are we going to get into trouble? There may be multiple thresholds, and until we can say this is the unsafe level at which some percentage of the population will be at risk for developing a malignancy, people are going to ask why they should spend large sums of money to comply when it may not be necessary. The twopronged approach is to either provide reimbursement from the payers, Medicare, Medicaid, and the third-party payers, for using CSTDs or to be able to demonstrate the level at which contamination will cause harm.
So, the barriers to compliance with the standards are basically cost and the fact that we don’t know what exactly the safety threshold is. We’re running a business with very little margin left these days in healthcare. There are a lot of issues with reimbursement, so the idea of adding another expense when we’re not positive about the level of risk is not attractive to hospital or business administrators. I think people will divide into those who say “if there’s any potential risk, we want to offer personal protective equipment for all of our staff to be on the safe side,” and those who say “we don’t have the money for this unless you can demonstrate that there’s a defined risk.” One of the reasons for an awareness month is to keep raising this issue with the people who are actually involved in handling of the cytotoxins and other hazardous drugs.
At your own institution you decided to use a CSTD. What led to that decision?
Data from a study conducted at the Huntsman Cancer Center in Salt Lake City, Utah, were instrumental in making that decision. The Huntsman study showed a significant reduction in surface contamination and positive urine samples from pharmacists, technicians, and nurses after implementation of the PhaSeal system (Wick C, et al. Am J Health Syst Pharm. 2003;60:2314- 2320). In 2000, we had just moved into a fairly low-volume, brand new facility and had only one pharmacy technician preparing chemotherapy. We thought we were doing everything right and decided to do wipe testing to document it. Much to our surprise, we did test positive, which made me believe that even under the very best circumstances, you can still have contamination. When we tested again after 6 months of use of the PhaSeal system, all areas tested showed a reduction in contamination.
Did the staff accept the new device readily?
We surveyed the nurses and technicians after the first week of use and they said it slowed them down, but after 60 days of use that was no longer the case. It just became part of our standard operating procedure. It is important though to train new personnel how to use the system appropriately. It does require a concerted effort with everyone from administration to pharmacy to nursing agreeing on what the important issues are, doing the training, and sticking to it, making sure that the product is being used appropriately.
What are some of the remaining issues with safe handling?
Of course the 800-pound gorilla in the room is that nearly all of the chemotherapy vials or hazardous drug vials that come to doctors’ offices and clinics come contaminated on the outside. The manufacturers have said their hands are tied. They’re concerned that if they put vials through an extra washing that gets rid of that contamination, they’d be heating the vials, and the US Food and Drug Administration would then require them to do studies to prove that they haven’t damaged the drug inside. The Hematology/Oncology Pharmacy Association and other organizations are looking into this situation.
As I mentioned before, the cost of CSTDs remains a concern too. I think probably the only way it’s going to be solved is by mandating the use of some system. And that cost has to be reimbursed by the payer community —by Medicare, Medicaid, or thirdparty insurance companies. We need legislative involvement and we need to lobby the payer community to convince them that this is a legitimate use of technology to keep employees safe. As Luci Power stated in an editorial, “demand clean vials” (Power LA. Am J Health Syst Pharm. 2005; 62:471).