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Structural Iatrogenesis - A 43-Year-Old Man with "Opioid Misuse"

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Abstract

Audio Interview Interview with Dr. Scott Stonington on structures within medicine that may systematically harm patients. (09:27)Download When he gets tangled in new restrictive policies on opioid prescribing, a factory worker with severe rheumatoid arthritis, whose pain must be managed for him to perform his job, ends up buying oxycodone from a friend.
Perspective
The
NEW ENGLAND JOURNAL
of
MEDICINE
February 21, 2019
n engl j med 380;8 nejm.org February 21, 2019
701
r. O., a 43-year-old man with se-
vere, destructive rheumatoid arthri-
tis, had been receiving acetamin-
ophen–hydrocodone at low doses
from his primary care provider
(PCP) for 15 years. He worked in
an auto-parts factory in south-
eastern Michigan, and pain con-
trol was essential to maintaining
his employment. His pain had
been well managed on a stable
regimen, and he had not shown
evidence of opioid use disorder.
In 2011, his primary care clinic
began requiring patient–provider
agreements (“pain contracts”) and
regular urine drug testing. Mr. O.
participated willingly, and his
tests were consistently negative for
unprescribed substances. In 2014,
his insurance company began to
require annual prior authorization
for all controlled-substance ref ills.
Although there were small delays
in receiving medication once a
year when the authorization was
due, the patient was able to keep
his pain level stable on his usual
regimen.
In 2016, Mr. O.’s PCP retired,
and his care was transferred to
another PCP in the same off ice,
who followed the patient’s exist-
ing pain-management plan. The
same year, the insurance company
began requiring more frequent
prior authorizations and then that
prescriptions be sent to the phar-
macy every 15 days. The new PCP
was occasionally late providing
these prescriptions and approv-
ing prior authorizations because
of the required multistep interac-
tions with the insurance compa-
ny. Mr. O. did not own a car and
had diff iculty making frequent
trips to the pharmacy. He began
to have several-day gaps in medi-
Case Studies in Social Medicine
Structural Iatrogenesis — A 43-Year-Old Man
with “Opioid Misuse”
Scott Stonington, M.D., Ph.D., and Diana Coffa, M.D.
Structural Iatrogenesis
M
PERSPECTIVE
702
Structural Iatrogenesis
n engl j med 380;8 nejm.org February 21, 2019
cation. During these gaps, he ex-
perienced severe pain and mild
withdrawal, as a result of which
he performed poorly at work and
received a citation. He became very
concerned about losing his job.
Mr. O. made an appointment
with his PCP and requested an
increase in his number of pills,
wanting to “stockpile pills so that
I’ll never run out.” The PCP noted
that Mr. O. seemed nervous dur-
ing the conversation. She noted
in the chart that the interaction
“made her uncomfortable.” She
knew that the previous PCP had
reported that Mr. O. had shown
no evidence of opioid misuse, but
in the current environment of vig-
ilance regarding the risks posed
by opiates, she did not feel com-
fortable increasing the number of
pills.
Three months later, the patient
submitted a urine sample that
tested positive for unprescribed
oxycodone. When the PCP dis-
cussed the result with Mr. O., she
learned that he had obtained oxy-
codone from a friend during one
of his gaps in medication. The
following month, oxycodone was
once again found in his urine. Al-
ready overwhelmed by the frequent
need for prior authorizations, and
noting that Mr. O. had “violated
his contract” by submitting two
urine samples containing unpre-
scribed opioids, the PCP referred
him to a local pain clinic.
The wait time for an appoint-
ment at the clinic was 4 months.
The PCP continued to provide pre-
scriptions during that period, plan-
ning to stop prescribing as soon
as Mr. O. had his first appoint-
ment. When he arrived at the pain
clinic, Mr. O. learned that it had a
policy of not prescribing opioids
for the first two visits. Facing a
prolonged period without his usu-
al regimen, and having previously
failed to obtain any “extra” aceta-
minophen–hydrocodone from his
PCP, Mr. O. began purchasing his
full narcotic regimen (in the form
of oxycodone) from a friend.
PERSPECTIVE
703
Structural Iatrogenesis
n engl j med 380;8 nejm.org February 21, 2019
Social Analysis Concept: Structural Iatrogenesis
Through a series of events, Mr.
O.’s therapeutic relationship with
his PCP deteriorated, and he be-
came compelled to obtain medi-
cations outside the medical set-
ting, which in turn increased his
risk of overdose, as well as his risk
of arrest for possession of unpre-
scribed opioids. This shift was
not precipitated by physiological
changes in Mr. O.’s disease, need
for medication, or personal attri-
butes. Rather, it was caused by
structural forces outside his con-
trol, ranging from clinic policies
(pain agreements, a drug-testing
initiative, a moratorium on pre-
scribing) to corporate bureaucra-
cies (insurance companies, fac-
tory management) to larger-scale
social forces (poverty, lack of avail-
ability of transportation, lack of
opportunities for work appropri-
ate for someone with a painful
condition).
We call this type of harm
“structural iatrogenesis” (see box).
Drawing on a long history of so-
cial science scholarship,1 the use
of the term “structure” empha-
sizes that Mr. O.s poor outcome
was determined by social forces
and structures outside his con-
trol. The term “iatrogenesis” spe-
cifically focuses on the harmful
role of bureaucratic structures
within medicine itself. In Mr. O.’s
case, many of these structures
had been instituted to protect pa-
tients at risk for opioid use disor-
der: clinicians acted according to
prevailing standards of care in
chronic pain management; his
prior clinic’s pain contract and
urine drug screens were meant
to prevent deviation from pre-
scribed opioid use that might
place him at risk for overdose or
addiction; the pain clinic’s proto-
col of delayed prescribing was
meant to prevent patients from
“shopping” for opioid prescrip-
tions; prior authorizations required
by the insurance company were
intended to reduce overprescrip-
tion of potentially harmful (and
costly) medications. But these sys-
tems were not beneficial to Mr.
O. in the context of his economi-
cally and socially precarious life,
which was shaped by a lack of
transportation and a need to per-
form painful manual labor for
economic survival.
Structural iatrogenesis is a type
of “structural violence,” defined
as the systematic inf liction of dis-
proportionate harm on certain
people by large-scale social forces
such as resource distribution and
hierarchies of race, gender, or lan-
guage.2
,
3
“Iatrogenesis” points to
the causation of such harm by
bureaucratic systems that are
potentially under clinicians’ or
health systems’ control.
4
Clinical Implications: Stopping Structural Iatrogenesis
Clinicians who identify structural
iatrogenesis may alter structures
or create action plans to prevent
them from causing harm. Gen-
eralizing from Mr. O.’s case, we
would offer the following ap-
proach:
1. Recognize and alter structures
that systematically harm patients.
Clinicians may be the f irst to
identify a structure that is sys-
tematically harming patients and
can then advocate for or directly
effect change. For example, in
the 1980s, the Food and Drug
Administration and physician or-
ganizations recommended that
women undergo pelvic exams be-
fore receiving hormonal contra-
ception. Some clinicians noted
that these exams were a barrier to
contraceptive access and stopped
requiring them in their own clin-
ics. By the 1990s, these local
changes led to removal of the
recommendation from national
policy, which increased access to
contraception and rates of effec-
tive use.
5
Similarly, if Mr. O.’s PCP no-
ticed that her clinic’s opioid-pre-
scribing policy generated frequent
gaps in medication coverage for
patients in general, she could
have advocated for a new ap-
proach. It’s important, however,
to avoid the pitfall of thinking
that structural harm emerges
only from “broken” systems. All
structures carry a risk of harm,
even when they are functioning
“properly.” The policy in Mr. O.s
PCP’s office might have been
working well for most patients,
but it turned out to be a poor fit
for Mr. O.
2. Bend policies according to con-
text. Attempts to standardize clin-
ical care in order to ensure high
quality often inadvertently lump
complex phenomena into sim-
Structural iatrogenesis is
the causing of clinical harm
to patients by bureaucratic
systems within medicine,
including those intended
to benefit them.
PERSPECTIVE
704
Structural Iatrogenesis
n engl j med 380;8 nejm.org February 21, 2019
plistic categories. Such oversim-
plification, in turn, can create
structures within clinical care
that harm patients more than
help them. By questioning how
such categories (such as “opioid
misuse”) apply to particular pa-
tients and types of patients, cli-
nicians can work to reduce the
risk of structural iatrogenesis.
The label of “opioid misuser,” for
example, negatively affected Mr.
O.’s care by failing to acknowl-
edge reasons that he might be
acquiring medications outside
the clinic.
Similarly, clinic policies that
penalize patients for arriving late
to appointments disproportion-
ately harm people who don’t own
a car or control their work sched-
ule. And policies of rewarding
clinicians on the basis of quanti-
tative measures of practice quali-
ty, such as reductions in glycated
hemoglobin levels, may ignore
complex disease interactions and
the social factors contributing to
diabetes and may create an in-
centive for clinicians to drop
particularly sick patients. In-
stead, one might identif y patients
with particular vulnerabilities
and adjust policies on the basis
of their life context.
3. Address implicit agendas head-
on. Mr. O.’s care deteriorated
when he was labeled an “opioid
misuser.” This designation was
putatively a clinical diagnosis,
but it also marked a tacit catego-
ry shift from “good patient” to
“bad patient,” reflecting the mix-
ing of clinical reasoning with
moral judgment. Similarly, the
insurance company’s rationale
for requiring more frequent pre-
scriptions mixed a harm-reduc-
tion agenda (reducing risk for ad-
diction and death) with a profit
motive (reducing payouts for
medications). Mr. O’s poor clini-
cal outcome was due in part to
tensions between these implicit
agendas. Clinicians often con-
sider such agendas to be outside
their purview, but given that they
have such a signif icant impact on
clinical outcomes, it may be
more effective clinically to iden-
tify these agendas, assess their
interactions, and decide which
ones to prioritize. The staff of
Mr. O.s clinic, for example,
could recognize the moral judg-
ment involved in the diagnosis of
“opioid misuse” and instead set
an explicit goal of identifying be-
haviors that could increase a pa-
tient’s risk of addition, overdose,
or dangerous side effects. They
could then assess whether their
established protocols were
achieving that goal and how to
balance it with other goals.
Case Follow-up
At Mr. O.s next visit, his PCP ex-
pressed concern about risks of
overdose and legal harm from
use of unprescribed oxycodone.
She persuaded him to return to
the pain clinic, and in the mean-
time she agreed to continue pre-
scribing his opioids. A medical
assistant appealed for an exemp-
tion to the insurance company’s
15-day prescription rule, citing
Mr. O.s lack of
transportation, frag-
ile work circum-
stances, and long-
standing treatment. At the time
we wrote this article, it remained
unclear whether these modifica-
tions would stabilize Mr. O.’s
treatment and prevent his use of
unprescribed opioids.
The editors of the Case St udies in Social
Medicine are Scott D. Stonington, M.D., Ph.D.,
Seth M. Holmes, Ph.D., M.D., Helena Hansen,
M.D., Ph.D., Jeremy A. Greene, M.D., Ph.D.,
Keith A. Wailoo, Ph.D., Debra Malina, Ph.D.,
Stephen Morrissey, Ph.D., Paul E. Farmer,
M.D., Ph.D., and Michael G. Ma rmot, M.B.,
B.S., Ph.D.
The patient’s initial and some identifying
characterist ics have been changed t o protect
hi s pr iv ac y.
Disclosure forms provided by the authors
are available at NEJM.org.
From the Departments of Anthropology and
Internal Medicine, University of Michigan,
and the Veterans Administration Medical
Center, Ann Arbor (S.S.); and the Depar t-
ment of Family and Community Medicine,
University of California, San Francisco, San
Francisco (D.C.)
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struction of rea lity: a t reatise in the sociol-
ogy of knowledge. New York: Anchor Books,
1966.
2. Bourgois P, Holmes SM, Sue K, Quesa-
da J. Structura l vulnerabilit y: operat ional-
izing t he concept to address hea lth dispar-
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4. Metzl JM, Ha nsen H. Structural compe-
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with st igma and inequal ity. Soc Sci Med
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5. Harper C, Ba listreri E, Boggess J, Leon
K, Darney P. Provision of hormonal contra-
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nation: t he fi rst stop demonstration project.
Fam Plann Perspect 2001; 33: 13-8.
DOI: 10.1056/NE JMp1811473
Copyright © 2019 Massachusetts Medical Society.
Structural Iatrogenesis
An audio interview
with Dr. Stonington
is available at NEJM.org
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