Pharmacy News

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:

  1. Oncology medications both oral and injectable 
  2. HIV and hepatitis C antiviral medications oral and injectable
  3. Sexual hormones: testosterone, estrogen and their derivatives, i.e., birth control
  4. The hematology stimulants: epoetin, filgrastim, etc.
  5. Autoimmune therapy: dupilumab, anakinra, certolizumab, etanercept, golimumab, etc.
  6. Interferon and other neurologics
  7. Non-oncology with reproductive affects
  8. The non-oncologic with pregnancy/reproductive warnings:

Drug

AHFS classification

clonazepam

28:12:08 benzodiazepines

colchicine

92:16 antigout agents

dinoprostone

76:00 oxytocics

dronedarone

24:04:04 antiarrythmics

dutasteride

92:08 5-alpha reductase inhibitors

ergonovine/meth- ylergonovine

76:00 oxytocics

finasteride

92:08 5-alpha reductase inhibitors

fluconazole

8:18.08 azoles

ganirelix

92:40 gonadotropin-releasing hormone antagonists

gonadotropin, chorionic

68:18 gonadotropins

icatibant

92:32 complement inhibitors

mentropins

68:18 gonadotropins

methyltestos- terone

68:08 androgens

mifepristone

76:00 oxytocics

misoprostol

56:28.28 prostaglandins

nafarelen

68:18 gonadotropins

oxytocin

76:00 oxytocics

paroxetine

28:16:04:20 selective serotonin uptake inhibitors

pentetate calcium trisodium

NA

plerixafor

20:16 hematopoietic agents

ribavirin

8:18:32 nucleosides and nucleotides

telavancin

8:12:28 glycopeptides

testosterone

68:08 androgens

topiramate

28:12.92 anticonvulsants, miscellaneous

tretinoin

84:16 cell stimulants and proliferants

ulipristal

68:12 contraceptives

valproate/valproic acid

28:12:92 anticonvulsants, miscellaneous

vigabatrin

28:12:92 anticonvulsants, miscellaneous

voriconazole

8:14.08 azoles

warfarin

20:12.04.08 coumarin derivatives

ziprasidone

28:16:08:04 atypical antipsychotics

zoledronic acid

92:24 bone resorption inhibitors

zonisamide

28:12:92 anticonvulsants, miscellaneous

 

Below are some of the common drugs with cautions, listed alphabetically:

Generic

Trade Drug

clonidine

Catapress

conjugated estrogens

Premarin

divalproex

Depakote ER

estradio

Estrace

etanercept

Embrel

febuxostat

Uloric

finesteride

Proscar

fluconazole

Diflucan

methotrexate

Rheumatrex tab

methylprednisolone

Medrol

paroxetine

Paxil

phenytoin

Dilantin

prednisolone

Omnipred

prednisone

Deltasone

raloxifene

Evista

testosterone topical

Androgel

topiramate

Topamax

waarfarin

Coumadin

spironolactone

Aldactone


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


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