Posted on January 26, 2018 in: Professional Practice
By Sister Phyillis Klonowiski, Pharm.D., pharmacist, HealthFirst Pharmacy, Owosso
The United States Pharmacopeial Convention (USP) is something most pharmacists (outside of hospital and IV compounding pharmacies) know exists, but rarely ever directly reference. The USP is a scientific nonprofit organization that sets standards for the identity, strength, quality and purity of medicine, food ingredients and dietary supplements. These standards are enforceable by both state and federal law and are given force of law by their incorporation into existing laws by reference. We have heard of <795> (non-sterile compounding) and <797> (sterile compounding), but now on our doorstep is USP <800>. USP <800> focuses especially on healthcare worker safety in handling of hazardous drugs throughout the healthcare system. Their expert committee for USP <800> is comprised of 14 pharmacists, one epidemiologist, USP staff, the Food and Drug Administration and Centers for Disease Control and Prevention representatives who have input but no voting power. Before final implementation (currently set for December 1, 2019), there will opportunity for public comment in the fall of 2018. The date of implementation of USP <800> has been pushed back so there will comprehensive and consistent alignment with the USP <797> upgraded standards for all sterile compounding and patient safety.
USP <800> describes requirements including responsibilities of personnel handling hazardous drugs, facility and engineering controls, procedures for deactivating, decontaminating and cleaning, spill control and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled. The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developing toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. With this definition, the current listing of medications include:
92:16 antigout agents
92:08 5-alpha reductase inhibitors
92:40 gonadotropin-releasing hormone antagonists
92:32 complement inhibitors
28:16:04:20 selective serotonin uptake inhibitors
pentetate calcium trisodium
20:16 hematopoietic agents
8:18:32 nucleosides and nucleotides
28:12.92 anticonvulsants, miscellaneous
84:16 cell stimulants and proliferants
28:12:92 anticonvulsants, miscellaneous
20:12.04.08 coumarin derivatives
28:16:08:04 atypical antipsychotics
92:24 bone resorption inhibitors
Below are some of the common drugs with cautions, listed alphabetically:
These lists may not be complete and because some are designated by a drug class, there may an entire group of medications such as ARB inhibitor that comes under consideration.
Preliminary considerations may mean a biologic safety cabinets set to the side with special air exchanges to handle and count. Protective clothes may include: a gown, gloves, bootie and hair covering with mask to work with when an open bottle enters the picture. Because we are looking at oral as well as injectable medication, we are in unfamiliar territory. It pays to stay forewarned and prepared. The USP site does have free updates for your review. View that information at www.USP.org.