USP 800 Sets New “National Professional Standard"

The United States Pharmacopeia (USP) revealed that more than 8 million U.S. healthcare workers are exposed to hazardous drugs each year and that more than 12 billion doses of hazardous drugs are handled by U.S. providers each year, with pharmacists and pharmacy technicians at the top of the list. 

Community pharmacies have been dispensing hazardous drugs long before the potential for harm (due to low dose, long-term exposure) was known. Exposure to a hazardous drug is often inadvertent and unknown to the employee. There is some surprise when presented with the list of hazardous drugs, which includes pharmaceuticals that you may handle on a daily basis, including: fluconazole, fluoxetine, carbamazepine, warfarin and oral contraceptives. There are more than 400 hazardous drugs and their unique dosage forms. 
Occupational exposure to hazardous drugs, or their residue, can be an everyday experience and the true effect of this exposure is unknown for many and may result in both acute and chronic health issues due to trace exposure to hazardous drugs. Acute toxicity may present as nausea, rashes, hair loss, kidney damage, hearing loss and cardiac toxicity. Long-term effects may include cancer, infertility, and other reproductive health issues. Certain populations, including, those that are immunosuppressed, and women and men of childbearing age may therefore be more at risk.
This occupational exposure extends to everyone working in the pharmacy, from the pharmacists and pharmacy technicians who handle HDs, to those who work at the pharmacy counter or in the receiving and delivery areas. The exposure risk extends to anyone who may come into contact with HD particles or residue. 
Exposure can occur:
  • thru the skin or oral mucosa when counting and pouring
  • by inhalation of dust particles when splitting a tablet or when working with an uncoated tablet that simply creates a lot of dust
  • by ingestion if eating or with hand to mouth contact without cleaning or hand washing
  • by injection, as is the case with an accidental needlestick
Different activities in the pharmacy come with different levels of potential risk:
  • dispensing a unit of use or a blister package of a hazardous drug may have a very low risk of exposure 
  • counting and pouring an uncoated hazardous drug tablet or capsule increases the risk  
  • splitting a hazardous drug tablet where dust can be created creates potential for increased exposure
  • cleaning a spill of a liquid hazardous drug introduces another level of risk  
The key is developing good practices to contain or greatly reduce risk. Per OSHA, the safe handling of hazardous drugs in accordance with USP 800 is now considered a “national professional standard” as a pharmacy process “to protect the safety and health of employees”. A USP 800 compliance program is a necessary step to protect the health and safety of your employees, patients in your pharmacy, and the environment. It can also help reduce employer liability from frivolous lawsuits through employee training, competency documentation and employee acknowledgements. 

PAAS National® is committed to serving community pharmacies and helping keep hard-earned money where it belongs. Contact PAAS today at (608) 873-1342 or to see why PAAS USP 800 Compliance Program membership might be right for you.
By Trenton Thiede, PharmD, MBA, President at PAAS National®, expert third party audit assistance and FWA/HIPAA compliance.
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