Hospital Pharmacy - June 2018 - 132

763850
editorial2018

HPXXXX10.1177/0018578718763850Hospital PharmacyAndrews and Dill

Editorial
Hospital Pharmacy
2018, Vol. 53(3) 132-133
© The Author(s) 2018
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https://doi.org/10.1177/0018578718763850
DOI: 10.1177/0018578718763850
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USP <800>
Stephen R. Andrews1 and Jennifer L. Dill2
Guidance regarding safe handling of hazardous drugs has
been a century in the making. Research in the modern chemotherapy era began in the 1930s with nitrogen mustard
treatments for lymphoma.1 A letter published in a 1970
Pediatrics issue by a Hematology resident asked for hazards
and handling precautions to be published over concern from
toxicity due to skin contact with chemotherapy.2 In 1990,
approximately 60 years after research started with chemotherapy, the American Society of Health-System Pharmacists
(ASHP) published the first criteria for classification of hazardous drugs. The original National Institute for Occupational
Safety and Health (NIOSH) list of hazardous drugs was published in 2004 and now includes drugs other than chemotherapy, highlighting that hazardous drugs require a broader
scope than previously recognized.3 By the close of 2019, the
new United States Pharmacopeia (USP) Chapter 800:
Hazardous Drugs-Handling in Health Care Settings (USP
<800>) will become the official standard almost 90 years
after cytotoxic medications were first used.4
The original criterion for hazardous drugs defined by ASHP
was an outcome of an Occupational Safety and Health
Administration (OSHA) inspection of a California pharmacy5:
1.
2.
3.
4.
5.

Carcinogenicity in animal models, in the patient population, or both as reported by the International
Agency for Research on Cancer
Teratogenicity in animal studies or treated patients
Fertility impairment in animal studies or treated patients
Evidence of serious organ or other toxicity at low
doses in animal models or treated patients
Genotoxicity defined as mutagenicity and clastogenicity in short-term test systems

NIOSH broadened the defining criteria and added an
additional category to account for drugs released onto the
market after the NIOSH list creation:
1.
2.
3.
4.
5.
6.

Carcinogenicity
Teratogenicity or developmental toxicity
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity
Structure and toxicity profiles of new drugs that
mimic existing hazardous drugs

The NIOSH list has historically been updated biannually,
although it is currently about 4 years behind at the date of

this publication with the 2016 list including all drugs on the
market up to the end of 2013. USP <800> requires each
entity to maintain a list of hazardous drugs that is reviewed
annually to include all NIOSH medications the entity uses.4
Furthermore, if a new drug enters the market or is used on an
investigational basis, NIOSH criteria must be applied to
determine whether a drug is hazardous. If no information on
the drug exists, by default it is to be considered hazardous.
This presents a significant challenge for entities implementing USP <800> as there will be almost 7 years of new drugs
on the market by the time of implementation on December 1,
2019, and education to personnel is required with each new
drug added to the hazardous drug list.
The simple goal of exposure reduction is complicated by
the reality that exposure to hazardous drugs can occur at any
step in the process from procurement to administration. USP
<800> applies to all health care personnel who handle hazardous drugs and all entities that store, prepare, transport, or
administer hazardous drugs.4 Operationalization of the standard requires either treating all hazardous drugs on the NIOSH
list according to USP <800> standards or conducting a risk
assessment of every drug, the results of which would allow the
entity to deviate from treating select drugs as hazardous under
USP <800>. While all hazardous drug active pharmaceutical
ingredients (APIs) and antineoplastics requiring manipulation
cannot be exempt from this requirement, any drug in a final
dosage form or not in Table 1 of the NIOSH list can have handling procedures that differ from USP <800> standards. The
first step in risk assessment is to identify why the drug has
been classified as hazardous to avoid making decisions based
on convenience for handling hazardous drugs per current practice, negating the spirit of the standard and leaving personnel
and patients at increased risk of complications from hazardous
drug exposure. As USP <800> will drastically change how
drugs are handled, timely education and buy-in from health
care personnel, especially pharmacists, will help drive the
time-sensitive implementation of standards.
An 18-month delay to the original implementation date not
only gives entities who handle hazardous drugs extra time to
1

The University of Kansas Health System, Kansas City, USA
The University of Kansas, Kansas City, USA

Corresponding Author:
Stephen R. Andrews, PGY2 Drug Information Resident, The University
of Kansas Health System, 4000 Cambridge Street, Mailstop 4040, Kansas
City, KS 66160, USA.
Email: sandrews3@kumc.edu

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