As we approach the December 1 implementation date for USP <800> hazardous drugs (HDs), there are some basic questions that independent pharmacists haven’t had clear answers to: Will USP <800> affect my retail pharmacy? Can I still provide nonsterile compounding services to my patients? Who is monitoring compliance with USP <800>? To date, most of the focus for USP <800> has been on HDs used in compounding, and the possible need for a negative pressure room. So let’s answer those questions and clear up a few other items. First, any pharmacy that has any type of HD, as identified on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, needs to comply with USP <800>. Second, in USP <800> there are different elements for those retail pharmacies that only dispense HDs, those where HDs are being compounded in a nonsterile environment, and those where HDs are being compounded in a sterile environment.
Sterile vs Nonsterile Compounding And The NIOSH HD List
If the pharmacy compounds hormones, or is doing sterile compounding, there must be a negative pressure lab/room. Are there enough hormone prescriptions to justify the cost of installing a negative pressure room?
If the facility doesn’t do compounding, but is a retail or a long-term care (LTC) pharmacy, does it need a negative pressure lab/room? What requirements of USP <800> need to be met? Better yet, how and where do we begin? Start with identifying all HDs in the inventory that are on the NIOSH list. There are three tables within the NIOSH list: Table 1 – Antineoplastic drugs; Table 2 – Non-antineoplastic drugs; and Table 3 – Non-antineoplastic drugs that primarily have adverse reproductive effects. Next, inventory all of the HDs on the pharmacy shelves, noting the drug name, form (tablet, capsule, liquid, or manufacturer packaging), and on which NIOSH table it appears. Then, we recommend creating a designated spot for the HDs away from the other stock, complete with an HD storage area sign. The next step is the most crucial from a regulatory point of view for retail and LTC facilities: The pharmacy must have performed an assessment of risk.
Pharmacy Hazardous Drug Assessment of Risk
The assessment of risk must contain the following information: the drug name; the NIOSH table it is listed on; if the HD is in the manufacturer’s packaging; what form the HD is in (tablet, capsule, liquid); whether the pharmacy staff has to “manipulate” the product or not; and what “containment strategies” are required. We are recommending the assessments of risk be kept in a binder so they are easily accessible for annual recertifications and inspections. If a pharmacy fails to have this assessment for each HD, the retail or LTC pharmacy cannot dispense any HD without the negative pressure lab/room. Please note: This assessment will be the first document a state board of pharmacy inspector or state environmental protection inspector will request. And yes, there are two different state agencies inspecting pharmacies for compliance with USP <800>.
Hazardous Drugs and Counting and Dispensing Automation
At this point, the HDs have been identified, inventoried, and segregated, and the assessments of risk have been completed. From now on, the pharmacy must maintain separate counting tools for HDs. We recommend keeping counting trays and spatulas in the HD storage area, so when an HD is pulled to dispense, the counting tools are conveniently located. You may be wondering, “How do I clean and dispose of these items?” Clean the tools with a cleaning wipe, such as Cavicide or Clorox wipes.
Hazardous drugs cannot be used in mechanical pill counters or robots, as per USP <800> Section 12. Why? HDs can chip and create a powder residue left in the mechanical parts that cannot be reached for decontamination. State environmental protection agencies can cite the pharmacy and publicly declare that the pharmacy has dispensed contaminated medications. Beware: These agencies are al- ready visiting pharmacies across the country, asking where the pharmacy stores warfarin and what happens to expired warfarin.
Safe Handling of Expired Hazardous Drugs
Did you know expired hazardous drugs become hazardous waste? If you do have an expired HD, it needs to be disposed of in accordance with the RCRA. Disposal costs can make DIR (direct and indirect remuneration) fees look small. Talk to your returns company to see if it has an EPA disposal process and a permit. If not, contact Stericycle for the disposal of hazardous waste. The pharmacy also must update its OSHA Hazard Communication Program and annual training. To save money and stress, ensure HDs received from your wholesaler have an expiration date at least a year away. If less than a year, the pharmacist in charge must determine if the pharmacy can use the contents within the next nine months; if not, return to sender.
USP <800> Impacts Your Pharmacy
In summary, USP <800> affects every pharmacy, no matter what type of practice setting. Now is the time to start preparing. Take the time to read the USP <800> guidelines; create the required policies and procedures; complete an assessment of risk form; and update your hazardous communication program and training. R.J. Hedges & Associates can provide a complete solution for hazardous drugs. For more information, please visit www.RJHedges.com/HazardousDrugs. CT
Jeff Hedges, C.D.M.E., is president and CEO of R. J. Hedges & Associates of New Florence, Pa.