ASH Clinical News ACN_4.14_Full Issue_web | Page 146
Workplace Violence
to implement. For example, one inner-city hospital felt
better enforcement of visiting hours would be helpful, while
another opted to install lockers for patients and visitors be-
cause they found that theft was leading to physical violence.
Behavioral interventions included active-shooter training
and debriefing with all staff at the time of an incident.
Six months after implementation, there was a signifi-
cant reduction in violent events in the intervention units
compared with the control units (incident rate ratio [IRR]
= 0.48; 95% CI 0.29-0.80; p<0.01). At two years, the risk for
violence-related injury remained lower on the units that
developed data-driven interventions (IRR=0.37; 95% CI
0.17-0.83; p<0.01). Also, while the incident rates of violence-
related injury increased significantly on control units, rates
on intervention units remained stable.
As a labor and employment lawyer representing health-
care employers, Mr. Glasser is a strong proponent of preven-
tion plans. “It is particularly important for hospitals and
other health-care facilities to be prepared because they are
dealing with intimate and often one-on-one relationships
between patients and health-care workers,” he stressed. “The
families also are involved, so there are many people and
S:7”
Manufactured for: Celgene Corporation
Summit, NJ 07901
POMALYST ® , REVLIMID ® , THALOMID ® , and
POMALYST REMS ® are registered trademarks of
Celgene Corporation.
Pat. http://www.celgene.com/therapies
© 2005-2018 Celgene Corporation All rights reserved.
POM_HCP_BSv.009 04/2018
Pregnancy Exposure Registry
Inform females that there is a Pregnancy Exposure
Registry that monitors pregnancy outcomes in
females exposed to POMALYST during pregnancy
and that they can contact the Pregnancy Exposure
Registry by calling 1-888-423-5436 [see Use in
Specific Populations (8.1)].
Venous and Arterial Thromboembolism
Inform patients of the risk of developing DVT, PE, MI,
and stroke and to report immediately any signs and
symptoms suggestive of these events for evaluation
[see Boxed Warning and Warnings and Precautions
(5.3)].
Hematologic Toxicities
Inform patients on the risks of developing neutropenia,
thrombocytopenia, and anemia and the need to
report signs and symptoms associated with these
events to their healthcare provider for further
evaluation [see Warnings and Precautions (5.5)].
Hepatotoxicity
Inform patients on the risks of developing
hepatotoxicity, including hepatic failure and death,
and to report signs and symptoms associated with
these events to their healthcare provider for
evaluation [see Warnings and Precautions (5.6)].
Severe Cutaneous Reactions Including
Hypersensitivity Reactions
Inform patients of the risk for angioedema and
severe skin reactions such as SJS, TEN and DRESS
and to report any signs and symptoms associated
with these events to their healthcare provider for
evaluation [see Warnings and Precautions (5.7)].
Dizziness and Confusional State
Inform patients of the potential risk of dizziness and
confusional state with the drug, to avoid situations
where dizziness or confusional state may be a
problem, and not to take other medications that
may cause dizziness or confusional state without
adequate medical advice [see Warnings and
Precautions (5.8)].
Neuropathy
Inform patients of the risk of neuropathy and to
report the signs and symptoms associated with
these events to their healthcare provider for further
evaluation [see Warnings and Precautions (5.9)].
Second Primary Malignancies
Inform the patient that the potential risk of developing
acute myelogenous leukemia during treatment with
POMALYST is unknown [see Warnings and
Precautions (5.10)].
Tumor Lysis Syndrome
Inform patients of the potential risk of tumor lysis
syndrome and to report any signs and symptoms
associated with this event to their healthcare
provider for evaluation [see Warnings and
Precautions (5.11)].
Smoking Tobacco
Advise patients that smoking tobacco may reduce
the efficacy of POMALYST [see Use in Specific
Populations (8.8)].
Dosing Instructions
Inform patients on how to take POMALYST [see
Dosage and Administration (2.1)]
• POMALYST should be taken once daily at about
the same time each day.
• Patients on hemodialysis should take POMALYST
following hemodialysis, on hemodialysis days.
• POMALYST may be taken with or without food.
• The capsules should not be opened, broken, or
chewed. POMALYST should be swallowed whole
with water.
• Instruct patients that if they miss a dose of
POMALYST, they may still take it up to 12 hours
after the time they would normally take it. If
more than 12 hours have elapsed, they should
be instructed to skip the dose for that day. The
next day, they should take POMALYST at the
usual time. Warn patients not to take 2 doses
to make up for the one that they missed.
many interests to account for.”
Certain legislators are trying to make prevention a pri-
ority on the federal level. In March 2018, Rep. Ro Khanna
(D-CA) introduced the Health Care Workplace Violence
Prevention Act, which would direct the Secretary of Labor
to issue an OSHA rule that requires certain health-care
employers, including hospitals, outpatient settings or
clinics, psychiatric clinics, rehabilitation hospitals, and
long-term care hospitals, to adopt comprehensive violence-
prevention plans. Ultimately, this obligation will extend to
home health and hospice agencies.
The bill piggybacks on California legisla-
tion enacted in 2014 that directs Cal/OSHA
to develop workplace violence-prevention
plans. The California bill went into effect in
2017 and, by April 1, 2018, all health-care
facilities in the state were required to have
issued their plans to all employees.
The federal bill has 28 cosponsors
(27 Democrats and 1 Republican) but is
thought to have little chance of passing
through Congress.
“There is a definite tension between
what is going on in California – where em-
ployers are obligated to establish strategies
and mechanisms to ensure worker safety –
and the actions on the federal level to secure
the rights of patients,” Mr. Glasser observed.
The Centers for Medicare and Medicaid
Services and the Joint Commission have
established regulations regarding the use of
restraints or seclusion – strategies that hos-
pitals and clinics might employ to protect
their workers or other patients. “It will be
interesting to see how these tensions play
out in California, in particular,” he added.
Despite the efforts of hospital administra-
tors, federal legislators, or individual practi-
tioners, violence in the health-care workplace
will never be eliminated completely, but the
experts who spoke with ASH Clinical News
agreed that it is time to act far more decisively
against the issue and make conscientious and
focused attempts to reduce its frequency and
impact. —By Debra L. Beck ●
REFERENCES
1. Phillips JP. Workplace violence against health care workers in the United
States. N Engl J Med. 2016;374:1661-9.
2. The Joint Commission, Workplace violence prevention: implementing
strategies for safer healthcare organizations.” Accessed September 29,
2018, from www.jointcommission.org/workplace_violence_prevention_
implementing_strategies_for_safer_healthcare_organizations/.
3. Federal Register. “Prevention of workplace violence in healthcare
and social assistance: a proposed rule by the Occupational Safety
and Health Administration.” Accessed October 19, 2018, from
www.federalregister.gov/documents/2016/12/07/2016-29197/
prevention-of-workplace-violence-in-healthcare-and-social-assistance.
4. OSHA. Guidelines for preventing workplace violence for healthcare
and social service workers. Accessed September 27, 2018, from
www.osha.gov/Publications/osha3148.pdf.
5. U.S. Department of Justice. Special report: workplace violence, 1993-
2009. Accessed September 29, 2018, from www.bjs.gov/content/
pub/pdf/wv09.pdf.
6. American Hospital Association. Cost of community violence to hospitals
and health systems, July 26, 2017.” Accessed September 27, 2018, from
www.aha.org/system/files/2018-01/community-violence-report.pdf.
7. OSHA. OSH Act of 1970, SEC. 5. Duties. Accessed October 20, 2018, from
https://www.osha.gov/laws-regs/oshact/section5-duties.
8. Hanson GC, Perrin NA, Moss H, et al. Workplace violence against
homecare workers and its relationship with workers health outcomes: a
cross-sectional study. BMC Public Health. 2015;15:11.
9. Gomaa AE, Tapp LC, Luckhaupt SE, et al. Occupational traumatic injuries
among workers in health care facilities — United States, 2012–2014.
MMWR Morb Mortal Wkly Rep. 2015;64:405-10.
10. Arnetz JE, Hamblin L, Russell J, et al. Preventing patient-to-worker
violence in hospitals: -outcome of a randomized controlled intervention.
J Occup Environ Med. 2017;59:18-27.
December 2018