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Hazardous/NIOSH Drug Alert New handling standards set for release BY ROBERT KURTZ


I


f staff at your ASC prepare and administer hazardous/NIOSH* drugs,


you are likely to be faced with some important decisions by the end of year, says Ernest Gates Jr., president of Gates Healthcare Associates, a consulting firm for the health care and pharma- ceutical industries based in Middleton, Massachusetts.


The United States Pharmacopeia’s (USP) draft chapter “<800> Hazard- ous Drugs—Handling in Healthcare Settings” (www.usp.org/usp-nf/notices/ general-chapter-hazardous-drugs- handling-healthcare-settings) was out for comments through the end of May 2015, and now it is just a matter of time until a decision will be made as to the date of publication, Gates says. USP <800> will provide stan- dards intended to protect health care personnel and the environment when hazardous/NIOSH drugs are being handled. Once the new chapter is pub- lished, federal and state enforcement and inspection activities will begin to be based on the principles adopted. “We know USP <800> will be adopted; we just do not know exactly what standards will be included,” Gates says. “It would be wise for ASCs to learn what is included in the draft chapter, and how it may affect opera- tions, and to start working to address the most likely developments.” An important first step in this effort


is for ASCs to identify whether they use any hazardous/NIOSH drugs, says Nancy Jo Vinson, RN, CASC, president of NJM Consulting in Kernersville, North


Carolina. To find out, ASCs


need to check two sources: the list of hazardous drugs attached to USP <800> and NIOSH’s list of “antineoplastic and


unintentional exposure based on preparation activities. While some exposure risks may seem obvious, others are not. For example, if you have a hazardous drug in tablet form that arrives in a large container, staff members taking tablets out are exposed to dust they could inhale. That would be a risk. ASCs will need to


develop appropriate procedures


for the safe handling of hazardous/ NIOSH drugs.”


While ASCs should take the time to read the draft chapter, they really need to have a consulting pharmacist who has knowledge of hazardous drugs and USP <800>.”


— Ernest Gates Jr. Gates Healthcare Associates


other hazardous drugs” (www.cdc.gov/ niosh/docs/2014-138/pdfs/2014-138.pdf). “While many ASCs have moved


away from stocking hazardous/NIOSH drugs, electing to receive them pre- mixed and ready to administer instead, not all have chosen this route,” Vin- son says. “For example, many ASCs still stock and prepare their own mito- mycin, which is a chemotherapy drug used frequently in ophthalmology.” In addition to determining whether hazardous/NIOSH drugs are present in your ASC, she says, you should also evaluate risks of staff exposure to these drugs. “USP <800> provides examples of potential routes of


The adoption of USP <800> might require alterations to an ASC’s physical space, Gates notes. “Per the USP <800> draft regulations, ASCs would need to store hazardous/NIOSH drugs that present themselves as a risk to personnel in a negative-pressure environment. This is a space many ASCs do not already have in their facility.” Adoption of USP <800> might


also affect other aspects of an ASC’s operations, Gates notes. This includes training and validation of staff, creation of new protocols and procedures, new engineering controls and development of a hazards education program. Vinson adds that she anticipates there might be changes to Occupational Safety and Health


Administration


requirements when USP <800> is eventually adopted.


As USP <800> comes closer to


adoption, Vinson advises ASCs not to make any decisions without perform- ing their due diligence. “While ASCs should take the time to read the draft chapter, they really need to have a con- sulting pharmacist who has knowledge of hazardous drugs and USP <800>.”


Editor’s note: This information is current as of June 29, 2015.


* NIOSH drugs are those that appear on a special list maintained by the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH).


26 ASC FOCUS SEPTEMBER 2015


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