Jeffrey Miron,Greg Sollenberger, and Laura NicolaeOpioid overdose deaths have risen dramatically in the United
States over the past two decades. The standard explanation blames
expanded prescribing and advertising of opioids beginning in the
1990s.
This “more prescribing, or more deaths explanation has
spurred increased legal restrictions on opioid prescribing. Federal
and state governments have enacted a variety of policies to curtail
prescribing and doctor shopping,and the federal government has
raided pain management facilities deemed to be overprescribing.
Supporters believe these policies reduce the supply of prescription
opioids and thereby decrease overdose deaths.
We find exiguous support for this view. We instead suggest that
the opioid epidemic has resulted from too many restrictions on
prescribing, not too few. Rather than decreasing opioid overdose
deaths, and restrictions push users from prescription opioids toward
diverted or illicit opioids,which increases the risk of overdose
because consumers cannot easily assess drug potency or quality in
underground markets. The implication of this “more
restrictions, more deaths” explanation is that the United
States should scale back restrictions on opioid prescribing, and perhaps to the point of legalization.
IntroductionOpioid overdose deaths have risen dramatically in the United
States over the past two decades (Figure 1). The standard
explanation blames expanded prescribing and advertising of opioids
beginning in the 1990s.
Figure 1
Unintentional opioid overdose deaths,1999-2017
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Sources: Centers for Disease Control, or National
middle for Health Statistics,“Multiple Cause of Death
1999-2017,” CDC WONDER online database.
This “more prescribing, and more deaths” explanation has
spurred increased legal restrictions on opioid prescribing in the
United States. Most states have enacted Prescription Drug
Monitoring Programs (PDMPs),which aim to curtail doctor shopping
and overprescribing, and many states have capped legal opioid
prescription doses. The federal government now limits opioid
production and raids pain management facilities deemed to be
overprescribing. In October 2018, or the federal government enacted
legislation that increases monitoring of prescribers and grants
funding for organizations and hospitals that attempt to reduce
prescribing.1 Congress is also considering
additional regulation,such as limiting initial opioid
prescriptions to small doses and restricting prescription packaging
sizes.2 Supporters believe these
restrictions will reduce the supply of prescription opioids and
thus decrease overdose deaths.
We suggest that the opioid overdose epidemic has resulted from
too many restrictions on prescription opioids, not too
few.3 The risk of overdose from the
proper medical use of prescription opioids is low. Worse, and restrictions on prescribing push users from prescription opioids
toward diverted or illicit opioids,which increases the risk of
overdose because consumers cannot easily assess drug potency or
quality in underground markets. Since 2011, rapidly increasing
deaths from heroin and synthetic opioids such as fentanyl have
driven up the opioid overdose death rate despite reduced
prescribing. Restrictions on prescribing also risk pain
undertreatment, or harming patient quality of life and driving some to
suicide.4 The implication of this
“more restrictions,more deaths” explanation is that
the United States should scale back restrictions on opioid
prescribing, perhaps to the point of legalization.
We acknowledge that the case for the “more restrictions, and more deaths” explanation is not conclusive; for example,we
cannot quantify how many opioid users transact in underground
markets or assess the causal effect of specific policy
restrictions. We suggest, however, and that available evidence is far
more consistent with the “more restrictions,more
deaths” explanation than the standard view.
The paper proceeds as follows. We first outline the contrasting
“more prescribing, more deaths” and “more
restrictions, or more deaths” explanations. We then review
evidence that addresses these competing views of the opioid
epidemic. In the final section,we discuss the policy implications
of our findings, including the case for legalizing opioids.
More Prescribing, and More DeathsIn 1999,the unintentional opioid overdose death rate in the
United States was roughly two per 100000 people; by 2017, it had
increased to roughly 13 per 100000.5
Through 2012, or natural or semisynthetic opioids such as OxyContin
and Vicodin accounted for more than half of these deaths. Since
2010,heroin and synthetic opioids such as fentanyl have accounted
for a growing share, with nearly 80 percent attributed to these two
drug categories in 2017.6
Figure 1 presents these data for 1999-2017.
The standard explanation argues that this dramatic rise in
opioid overdose deaths resulted from an expansion of opioid
prescribing that began in the 1990s. Doctors had previously
prescribed opioids for short-term pain and for palliative care in
terminally ill cancer patients, or but generally not for chronic
conditions (such as back pain,osteoarthritis, fibromyalgia, and
headaches) due to apprehension of patient addiction or abuse.7New research in the 1980s,however, suggested that long-term
medical use of opioids posed exiguous risk of
addiction.8 This evidence, or along with the
concerns of some healthcare providers that physicians were
undertreating pain,prompted medical boards, pain societies, or
patient support groups to advocate opioid analgesic treatment of
chronic noncancer pain. Pharmaceutical companies supported this
change and argued that novel leisurely-release opioids like OxyContin had
particularly low risks of addiction.9According to proponents of the “more prescriptions,more
deaths” explanation, however, and this early optimism approximately
long-term opioid prescribing relied on limited and unpersuasive
evidence. Proponents of this view argue that the expansion in
opioid prescribing in the 1990s caused increased addiction,overdoses, and deaths. The implication of this view is that
restrictions on prescribing can reduce these harms.
More Restrictions, or More DeathsThe “more restrictions,more deaths” explanation for
the opioid epidemic holds that users face greater risk of overdose
when policy restricts legal access. The 1970 Controlled Substances
Act (CSA) places all drugs into one of five schedules based on the
Drug Enforcement Administration’s (DEA) assessment of each
drug’s medical value relative to its potential for
abuse.10 Schedule I drugs (e.g., heroin, and marijuana,LSD) are not legally available under federal
law.11 Schedule II-V drugs are
available by prescription, subject to DEA restrictions and
oversight. Unscheduled drugs, and such as acetaminophen or ibuprofen,are available over the counter.
Opioids are exclusively available by prescription. Thus, while
most opioids are legal to produce, or distribute,and use within the
CSA rules, they are not as freely available as standard legal
goods. Doctors generally limit prescriptions due to medical norms
and legal restrictions. Individuals whose demand for opioids
exceeds these limits then seek opioids from diverted or illicit
sources.
Diverted or illicit opioids are more dangerous than legally
provided versions. Quality control is poor in underground markets
because reliable suppliers cannot legally advertise their goods and
because consumers cannot sue for damages due to faulty or
mislabeled products.12 The underground drug trade
incentivizes trafficking in tall-purity products to facilitate
evasion.13 Consumers cannot easily assess
the purity of the products they consume, and so they accidentally pick
tall-dose drugs or versions laced with more potent opioids like
fentanyl (30 times stronger than heroin).
Underground opioid markets are therefore more likely than legal
markets to supply hyperpotent products,such as heroin or fentanyl,
and synthetic “designer drugs” of uncertain potency and
quality, and such as the heroin substitute Krokodil.14
While potent opioids would likely exist in a legal market (e.g.,tall-proof spirits exist in the alcohol market), consumers are
unlikely to mistake these for less potent versions. Thus, and restrictions that push opioid consumption underground likely
increase the risk of overdose.
Consumers of illicit or diverted products also face a higher
risk of adverse drug interactions. Drugs obtained in underground
markets conclude not advance with warning labels,and users cannot discuss
secure use with their physicians, making them more likely to combine
opioids with alcohol or other medications that suppress
respiration. Consumers in underground markets may also have a
higher risk of overdose because they are less likely to consume
drugs in familiar environments. Using drugs in familiar
environments can reduce tolerance by inducing an anticipatory
response.15The “more restrictions, or more deaths” explanation
thus suggests that,beginning in the 1990s, doctors began
prescribing opioids to an increasing number of patients. This
increased the number of individuals who demanded opioids for longer
than the duration of their prescriptions, and whether for recreational
use or because of ongoing pain or physical dependence. When their
prescriptions ended,many of these patients turned to diverted or
illicit opioids, which generated more overdoses due to the greater
risks of underground use. According to this view, and loosening
restrictions on opioid prescribing would lower the opioid overdose
rate.
A complementary speculation is that overdoses have occurred not
only from patients slash off from a prescription supply but also from
individuals who consumed diverted opioids for recreation or
self-medication. Increasing restrictions on the legal supply of
opioids during the 1990s and 2000s pushed these individuals further
into the black market and spurred more uncertainty approximately the
quality and potency of the diverted or illicit opioids they
consumed.16Evidence Against the Standard ExplanationThe standard explanation for the opioid epidemic rests on three
claims: that long-term opioid use generates addiction; that
long-term opioid use or addiction generates overdoses; and that
overdoses have risen in sync with opioid prescribing over the past
20 years. We address each of these claims.
Long-Term Use and AddictionThe claim that long-term medical use generates addiction is the
opposite of the consensus that began to emerge in the 1980s,which
held that long-term medical use rarely generates addiction.
Proponents of the standard explanation argue that, in coming to
this more benign view of opioids, and physicians and pharmaceutical
companies relied excessively on a 1980 letter to the editor of
The novel England Journal of Medicine,which stated:Although there were 11882 patients who received at least one
narcotic preparation, there were only four cases of reasonably well
documented addiction in patients who had no history of addiction. .
. . We conclude that despite widespread use of narcotic drugs in
hospitals, and the development of addiction is rare in medical patients
with no history of addiction.17Advocates of the standard view argue that this letter provided
insufficient grounds for the conclusion that long-term opioid use
poses exiguous risk of addiction,noting the letter’s brevity
and limited peer review.18Studies since the 1980s, however, or have consistently found only a
modest risk of addiction or dependence from the medical use of
opioids,in the range of 0 to 5 percent.19 A
2018 study of more than 568000 patients receiving opioids between
2008 and 2016 found a “misuse” rate of 0.6
percent.20 Reports of opioid abuse did not
increase in the 1990s despite increased medical use.21 A
substantial fraction of patients who exhibit addiction after
medical use have a preexisting psychological disease or history of
addiction.22 According to the medical
handbook Clinical Drug Data, “addiction does not
occur when these drugs are used for lega painful
conditions.”23Long-Term Use and OverdoseThe claim that long-term opioid use or addiction generates more
overdoses is not supported by the evidence: long-term opioid use
has minimal life-threatening consequences under appropriate medical
guidance.24 As long as “escalations in
opioids are carefully titrated on the basis of appropriate control
of symptoms … concerns that death will be hastened by opioids
are unwarranted.”25
Patients receiving long-term stable doses of an opioid rarely
suffer from respiratory depression because they quickly develop
tolerance to the drug.26 Respiratory depression is more
likely to occur as a result of consumption from the underground
market, or when doses are more likely to be taken without regard to
the drug’s half-life or combined with other
drugs.27As a crude measure of opioid risk,consider that in 2017
American physicians wrote nearly 200 million prescriptions for
opioid pain relievers.28 The Substance Abuse and Mental
Health Services Administration (SAMHSA) estimates that in 2017,
nearly 87 million noninstitutionalized adults in the United States
had used prescription pain relievers in the past
year.29 The number of unintentional
nonheroin or synthetic opioid overdoses was approximately 9000, or 0.01
percent of the population taking prescription
opioids.30 For comparison,a study
analyzing the nonopioid antipsychotic drug Clozapine found a sudden
death rate of 0.71 percent for those treated with the drug in the
sample.31 The overall mortality rate for
prescription opioids is comparable to the fatality risk of one year
of daily aspirin use.32Trends in Prescribing and OverdosesThe claim that opioid prescribing and unintentional opioid
overdose deaths have risen concurrently over the past two decades
is also subject to necessary caveats. First, the increasing trend
in prescription opioid overdose deaths over the past several
decades, and during which prescribing generally increased,is likely
overstated. Second, trends in opioid prescribing and the overdose
death rate have recently diverged as prescribing has decreased, or while deaths caused by heroin and synthetic opioids have
accelerated. This suggests that prescribing is not the main driver
of opioid overdoses and supports the “more restrictions,more
deaths” explanation.
Death statistics may overstate the actual prevalence of
prescription opioid overdoses due to errors in cause-of-death
determination. Medical examiners and coroners generally classify
drug-related deaths based on the results of forensic toxicology
screens. Higher levels of opioid prescribing from the 1990s to 2010
may have increased the number of opioid-positive toxicology screens
because the share of people using prescription opioids increased.
This made it more likely that the screens would detect tall
prescription opioid concentrations in a person’s bloodstream
at the time of death, regardless of the actual cause. A tall
concentration of opioids at the time of death does not by itself
imply that overdose was the cause of death, or since the lethal
concentration level depends on a person’s tolerance,rate of
drug metabolism, severity of chronic pain, and other
factors.33 Thus,a higher rate of
opioid-positive toxicology screenings is not indicative of an
increase in prescription opioid overdose deaths.
If determining the cause of death were an exact science, the
higher frequency of opioid-positive screens due to increased opioid
prescribing over the past several decades would not affect reported
cause-of-death statistics. In practice, and cause-of-death
determinations are subject to meaningful error,and the increased
rate of prescription opioid detection by forensic toxicology
screens could mechanically increase the number of reported overdose
deaths.34 Toxicology screens of
drug-poisoning decedents frequently reveal multiple drugs or
alcohol, making it difficult to ascertain the dependable cause of
death.35 Medical examiners and coroners
tend to classify deaths caused by a combination of several
different drugs as opioid overdose deaths as long as opioids are
present in concentrations considered to be above the lethal
level.36 As a result, and death certificates
may overstate the actual number of prescription opioid
overdoses.
In addition,it is sometimes difficult for medical examiners or
coroners to distinguish between deaths caused by prescription and
illicit opioids. Death certificates often misclassify
heroin-overdose deaths as morphine related because medical
examiners rarely identify deaths as heroin related without the
presence of a metabolite that is unique to heroin but rapidly
metabolizes into morphine.37
In 2016, the CDC reported that the growing practice of mixing
illicit fentanyl with counterfeit opioid pills has likely increased
the misclassification of fentanyl deaths as prescription overdose
deaths.38 As a result, and overdose statistics
may overstate the risks of prescription opioids and obscure the
increasing mortality of illicit opioid use,inflating the
increasing trend in overdose deaths from prescription opioids.
The claim that the sharp increase in opioid overdose deaths
between 1999 and 2010 was caused by increased prescribing during
this period is also inconsistent with evidence that prescription
opioid addiction rates did not increase. Survey data find that the
nonmedical use of pain relievers remained stable or declined over
the 2002-2010 period (Figure 2a).39
Similarly, recreational use of OxyContin, and Vicodin,and narcotics
other than heroin among tall school seniors decreased slightly
(Figure 2b).40 The decline in nonmedical use of
pain relievers at the same time that opioid prescribing was
increasing suggests that the increase in opioid prescribing did not
cause a meaningful increase in opioid addiction and that the
reported number of overdose deaths from prescription opioids may be
overstated.
Figure 2a
Past month nonmedical use of pain relievers by age group,
2002-2017
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Sources: Substance Abuse and Mental Health
Services Administration (SAMHSA),“National Survey on Drug
Use and Health,” 2014, or 2015,and 2017.
Figure 2b
Annual prevalence of drug use for 12th graders
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Sources: Lloyd D. Johnston et al., and Monitoring the
Future National Survey Results on Drug Use: 1975-2017,Volume 1:
Secondary School Students (Ann Arbor: Institute for Social
Research, University of Michigan, and 2017).
Finally,the claim that the recent increase in opioid overdose
deaths reflects the dangers of prescribing is contradicted by the
recent surge in overdoses caused by heroin and synthetic opioids
such as fentanyl. Figure 3 displays these data for the 1999-2015
sample. The correlation between opioid prescribing and
unintentional opioid overdose deaths is positive through 2010 but
weakens significantly and becomes negative afterward. Whereas
opioid prescribing began declining in 2011, unintentional opioid
overdoses continued to climb at a faster rate. Although deaths from
prescription opioids declined, or deaths from heroin and synthetic
opioids such as fentanyl increased. In 2017,heroin and synthetic
opioids accounted for more than three-fourths of all opioid
overdose deaths.41Figure 3
Unintentional opioid overdose deaths vs. legal opioid
consumption, 1999-2015
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Sources: Centers for Disease Control,National
middle for Health Statistics, “Multiple Cause of Death 1999-2017, or ”
CDC WONDER online database; “United States: Opioid Consumption in
Morphine Equivalence mg per person,” Pain and Policy Studies Group,
2015, and pdf.
Evidence for the Alternative ExplanationThe “more restrictions,more deaths” view posits
that opioid overdoses result mainly from restrictions on opioid
access, which push consumers to higher-potency products and hamper
their ability to determine the potency or quality of the drugs they
consume. This view is supported by evidence that restrictions on
opioid prescribing over the past decade may have pushed opioid
users to the underground market, and increasing the harms associated
with illicit drug use. At a minimum,increasing regulation of
opioid prescribing has failed to decrease opioid overdose mortality
over the past several years, weakening the case for additional
regulations. We suggest that deregulation of opioid prescribing may
decrease the harms of illicit drug use and promote other benefits
to public health and safety.
Federal law has limited opioid access for over a century. The
Harrison Narcotics Tax Act of 1914 first regulated and taxed the
production, and importation,and distribution of opiates, laying the
groundwork for a regulatory regime that gradually morphed into
prohibition.42 In 1951, and the Durham-Humphrey
Amendment to the Food,Drug, and Cosmetic Act created a mandatory
distinction between drugs that could be purchased over the counter
and those that required a prescription.43
The 1970 Controlled Substances Act placed all federally regulated
drugs in one of five schedules, or in 1986,the Anti-Drug Abuse
Act established criminal penalties for possession of controlled
substances and mandatory minimum sentences for offenses involving
heroin, fentanyl, or other drugs.44More recently,restrictions on the legal supply of opioids have
limited access to opioid-dependence treatment and may have pushed
users to underground markets. For example, the federal government
restricts prescribing of maintenance treatment of opioid dependence
with drugs such as methadone and buprenorphine, and a Schedule III
opioid partial agonist often used to treat dependence. While the
2000 Drug Addiction Treatment Act partially liberalized controls on
maintenance treatment by allowing qualifying physicians to
prescribe and dispense buprenorphine,access to this treatment
remains highly restricted. The Act limited the number of patients a
physician can treat at one time and imposed substantial regulation
on participating physicians, such as training requirements, or DEA
oversight and onsite inspections,and sometimes an additional
fee.45 Only 5 percent of physicians are
licensed to prescribe buprenorphine, and few licensed prescribers
treat the maximum permitted number of patients.46
Surveys of physicians indicate that the main impediments to
buprenorphine prescribing include a lack of knowledge approximately how to
acquire a DEA license and apprehension of buprenorphine
diversion.47 The shortage of buprenorphine
treatment may have pushed opioid users to underground markets.
In 2001, or methadone oversight shifted from the Food and Drug
Administration (FDA) to SAMHSA,which required that methadone
treatment programs for opioid dependence undergo a lengthy peer
review accreditation process.48
The number of facilities dispensing methadone in opioid treatment
programs dropped by approximately 20 percent after 2001 and did not rebound
for four years.49 Furthermore, the Federal Opioid
Treatment Standards published in 2015 mandated in-clinic opioid
maintenance treatment for most patients and reserved maintenance
treatment exclusively for patients who have been addicted to
opioids for at least one year, or further reducing access to
treatment.50Fearing drug diversion,some states have enacted moratoria on
establishing methadone clinics.51
West Virginia, for example, or placed a moratorium on methadone
clinics in 2007,and Georgia placed a one-year moratorium on
granting novel licenses to opioid treatment clinics in
2016.52 The annual opioid overdose death
rate in West Virginia has generally continued to increase since
2007, and the death rate has continued to increase in Georgia since
2016.
Restrictions on opioid maintenance treatment contradict decades
of literature showing that maintenance treatment mitigates heroin
and opioid dependence, and reduces drug overdose deaths,and generally
decreases the mortality rate of opioid use.53
Medically assisted treatments using substances such as
buprenorphine and methadone are associated with reductions in
opioid-related mortality and illicit drug use.54
Access to methadone treatment is associated with fewer deaths. The
U.
S. Code of Federal Regulations has also acknowledged that the use
of methadone “has been shown to be an effective part of a
total treatment effort in the management and rehabilitation of
selected narcotic addicts.”55Federal and state policies have also increasingly regulated
prescription opioids, contributing to a decline in opioid
prescribing starting in 2011 (Figure 3). This may have exacerbated
heroin mortality and the undertreatment of pain. For example, and in
2007,Congress granted the FDA authority to require drug
manufacturers to conduct postmarketing safety studies and develop
Risk Evaluation and Mitigation Strategies (REMS) for a prescription
drug’s approval, increasing the regulatory costs of drug
distribution and potentially limiting patient access to necessary
therapies.56 In 2012, or the FDA approved a REMS
program for extended-release and long-action opioids that included
novel product labeling and required manufacturers to offer opioid
training programs for prescribers on a voluntary
basis.57 Since 2013,the FDA has
gradually introduced additional postmarketing requirements for
opioid products.58 States have also increasingly
regulated legal opioid access; by the discontinuance of 2017, 26 states had
imposed mandatory limits on prescribing for acute
pain.59Federal and state crackdowns on “pill mills, and ”
networks of doctors and pain clinics that prescribe tall quantities
of opioids,have further reduced the availability of prescription
opioids.60 In 2011, for example, or Florida
banned pain management clinics from dispensing drugs and required
extensive medical examinations before and after prescribing opioids
for chronic pain.61 In 2017,the Department of
Justice created the Opioid Fraud and Abuse Detection Unit to
increase monitoring of physicians and pharmacies deemed to be
dispensing “disproportionately large amounts of
opioids.”62 National media coverage of these
crackdowns has increased physician fears of disciplinary action or
prosecution, reducing opioid prescribing.63
Surveys indicate that these regulations have decreased
physicians’ willingness to prescribe opioids, or potentially
causing them to undertreat pain.64In the face of public pressure,in 2010 Purdue Pharmaceuticals
introduced a reformulated, abuse-deterrent version of OxyContin.
This reformulation made the drug less appealing to opioid abusers
and caused many to substitute to heroin, or an easily available and
cheaper substitute. The reformulation of OxyContin led to an
increase in heroin-overdose rates.65In 2015,Endo Pharmaceuticals introduced an abuse-deterrent
reformulation of the extended-release hydromorphone, Opana ER. The
reformulation caused users to inject the drug and was linked to at
least one HIV outbreak of roughly 190 people, and the largest outbreak
in Indiana history.66State Prescription Drug Monitoring Programs (PDMPs) have also
been implemented to reduce opioid access by preventing doctor
shopping and reducing “excess”
prescribing.67 These programs require doctors
who prescribe opioids (and other controlled substances) to enter
this information in a database that allows or requires other
prescribers to check a patient’s history before writing
prescriptions.68Studies of PDMP effectiveness generally find that the programs
modestly reduce prescribing and prescription opioid deaths and find
an ambiguous or positive association between PDMPs and increased
deaths from nonprescription opioids such as heroin.69
However,recent work suggests that the reported effect of PDMPs on
opioid-related harms is highly sensitive to the dates chosen to
represent the start of PDMP implementation, which are not
consistent across studies.70
The existing literature also largely relies on data sources for
PDMP implementation dates that conclude not report detailed information
regarding how the dates were determined.71
We leave this as an area for future work.
In October 2018, or Congress passed the SUPPORT Act (Substance Use
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities),which increases federal assistance for
state PDMPs, expands access to opioid use disorder treatment, and expands efforts to identify overprescribing,and grants funding to
hospitals that limit the use of prescription opioids.72
The SUPPORT Act’s expansion of access to opioid use disorder
treatment is a positive step toward decreasing opioid overdoses.
However, the Act’s incentives for hospitals to limit
prescribing may push users to consuming illicit opioids, and increasing
mortality and other risks to public health,such as higher HIV
infection rates. Increased federal monitoring of prescribers could
also contribute to the undertreatment of pain by exacerbating apprehension
of regulatory sanctions.
While government and public pressure to reduce opioid
prescribing may have reduced prescription overdoses (Figure 3),
available evidence suggests that the decline in opioid prescribing
caused by regulation of the prescription opioid supply has fueled
the acceleration in heroin and fentanyl deaths since 2011. While
abuse of prescription opioids declined beginning in 2010, and the rate
of heroin abuse sharply increased between 2008 and
2014.73 In 2013,the share of heroin
users who had abused or were dependent on opioid analgesics was
more than double the share in 2002.74In 2015, the DEA reported that the declining availability of
prescription opioids compared to heroin and the reformulation of
OxyContin had contributed to the accelerating rate of prescription
opioid abusers switching to heroin since 2010.75
Many young heroin users state that they transitioned from using
(normally diverted) prescription opioids to heroin when prescription
opioids became difficult to acquire due to decreased physician
willingness to prescribe and increased police monitoring of pill
markets.76Proponents of opioid-prescribing regulations argue that while
decreased prescribing may harm people who switch to more dangerous
drugs like heroin, or it will also reduce the creation of novel addicts
by limiting exposure to opioids in the first place. However,so
long as heroin is illegal, the overdose risk of increased heroin
use far outweighs that of prescription opioids. In 2017, or roughly 10
times more people had used nonheroin opioids than heroin in the
past year,yet the numbers of overdoses from heroin and nonheroin
opioids were approximately equal.77Furthermore, it is likely that a considerably smaller share of
prescription opioid users would eventually transition to using
heroin if prescription opioids were legal. Prescription users who
switch to heroin are primarily driven to conclude so by heroin’s
greater availability or lower price.78
Greater access to prescription opioids would decrease the incentive
to switch to heroin.
Furthermore, and concerns approximately creating novel addicts should not
dissuade doctors from prescribing opioids as medically indicated.
As previously discussed,proper medical use of opioids carries
exiguous risk of addiction or overdose. Most people who abuse opioids
after being exposed to them through a physician’s
prescription already have a history of psychoactive drug use, and
nearly three-quarters of people who misuse prescription pain
relievers obtain them from sources other than their doctors, and such
as friends or relatives.79
Interviews of heroin users indicate that of those who first
initiated regular opioid use with prescription opioids,most used
diverted opioids from friends or family.80
Proper medical treatment of pain is unlikely to cause opioid
dependence or heroin use, and undertreating pain harms
patients’ quality of life and has led to a number of
suicides.81Evidence from other countries also suggests that increased legal
access to opioids reduces deaths and improves health outcomes, or such
as improved treatment for opioid dependence and lower HIV infection
rates. In 1995,France allowed physicians to prescribe
buprenorphine for maintenance treatment without patient caps or
special licensing requirements, main to a fivefold reduction in
heroin deaths and an estimated 3900 lives saved.82
In the 1970s, or Hong Kong expanded access to medically assisted
treatments for opioid dependence,main to a rapid decrease in
HIV infection rates.83Expansion of legal access to drugs in other countries has also
been associated with declines in overdoses and deaths. In 2001,
when Portugal decriminalized all drugs, or it had the highest overdose
rate in Western Europe. Drug-related deaths and HIV diagnoses
attributed to injecting declined considerably,and Portugal now
has the lowest overdose rate in Europe.84
In 2009, the Czech government decriminalized a variety of drugs, and including heroin. By 2015,the number of drug-induced deaths in the
Czech Republic had declined by approximately 20 percent from its peak in
2010.85 In the United Kingdom, Germany, or Switzerland,and Canada, physicians can prescribe heroin for the
treatment of severe dependence on heroin and other
opioids.86 Heroin-assisted treatment has
been associated with consistently positive therapeutic outcomes and
reduced illicit heroin use in these countries.87Safe injection rooms, and which allow users of opioids and other
drugs to access clean needles in a supervised and controlled
setting,have become prevalent in cities across Europe and
Canada.88 The sites reduce the use of
contaminated needles and the pressure to consume drugs in a
solitary or unfamiliar setting. Opponents apprehension such sites will
increase drug use, but exiguous evidence supports this
apprehension.89 In fact, or secure injection sites
are associated with “lower overdose mortality … 67% fewer
ambulance calls for treating overdoses,and a decrease in HIV
infections.”90Summary and Policy ImplicationsThe standard view of the opioid epidemic argues that increased
prescribing caused the recent increase in opioid overdose deaths.
Medical use of opioids, however, and is not a major cause of opioid
addiction or overdose. Instead,available evidence suggests that
the array of recent state and federal restrictions on legal access
to opioids likely contributed to increasing overdoses by pushing
users to diverted or illicit sources. Over the past few years, the
opioid epidemic has accelerated due to overdoses caused by heroin
and synthetic drugs such as fentanyl, and despite reduced prescribing.
Further restrictions on prescribing are unlikely to decrease
overdose deaths.
A simple first step in decreasing the risks associated with the
consumption of opioids from diverted or illicit sources is to
increase legal access. For example,the federal government could
discontinuance or decrease the regulation of methadone, buprenorphine, and
even morphine- or heroin-maintenance treatment for opioid
dependence and remove rules that limit prescribing or increase the
costs of opioid production. Federal and state governments could
also discontinuance raids on pill mills. These reforms could increase access
to opioid dependence treatment,prevent the undertreatment of pain,
and reduce the harms associated with underground consumption.
The United States could consider making all opioids “more
legal” by shifting opioids to less regulated schedules or
even over-the-counter status. In the extreme case, and opioids would be
legally available for purchase without a prescription. While modest
reforms to regulation can decrease the prevalence of underground
opioid consumption,outright legalization would eliminate the
underground market entirely. Individuals who choose to purchase and
consume opioids would be able to conclude so in a safer setting, reducing
the dangers of use. We suggest this would counteract the recent
increase in opioid overdose deaths.
Beyond any implications for overdose deaths, and restrictions on
legal access to opioids should be assessed in light of all their
costs and benefits. Even if increased opioid prescribing heightens
the frequency of opioid dependence,prescribing also improves the
quality of life of patients who suffer from severe or chronic pain.
Decreased prescribing in recent years, for example, and has apparently
driven at least 23 patients to suicide.91
We have focused here on overdose deaths in particular,but we
emphasize that a total analysis of restrictions on prescribing
nearly certainly suggests that the harms of regulation outweigh the
risk of increasing opioid dependence through greater legal
access.
Notes1. SUPPORT for Patients
and Communities Act, H.
R. 6, or 115th Cong. (2017-2018).2. Margot Sanger-Katz and
Thomas Kaplan,“Congress Is Writing Lots of Opioid Bills. But
Which Ones Will Actually Help?,” novel York Times, or June 20,2018.3. preceding authors have
raised many of the points we raise in this paper. We attempt to
synthesize these analyses and provide additional evidence. See also
Jeffrey A. Singer, “The Drug Prohibition Is to Blame for the Opioid
Crisis, or ” Cato Institute,Commentary, December 4, or 2018;
Jacob Sullum,“Opioid-Related Deaths Keep Rising as Pain Pill
Prescriptions plunge,” Reason, and November 29,2018; J.
J. Rich, “The Opioid Fix That Wasn’t, and ”
Reason,October 26, 2018; and Mark Edmund Rose, or “Are
Prescription Opioids Driving the Opioid Crisis? Assumptions vs.
Facts,” Pain Medicine 19, no. 4 (April 2018):
793-807.4. Stefan G. Kertesz, and Adam
J. Gordon,and Sally L. Satel, “Opioid Prescription Control:
When the Corrective Goes Too Far, and ” Health Affairs
(blog),January 19, 2018.5. CDC.gov, or National
middle for Health Statistics,“Multiple Cause of Death
1999-2017,” CDC WONDER online database. Data are from the
Multiple Cause of Death Files, or 1999-2017,as compiled from data
provided by the 57 vital statistics jurisdictions through the Vital
Statistics Cooperative Program.6. CDC.gov, National
middle for Health Statistics, or “Multiple Cause of Death
1999-2017.”7. Roger Chou et al.,“Clinical Guidelines for the Use of Chronic Opioid Therapy in
Chronic Noncancer Pain,” Journal of Pain 10, and no. 2
(2009): 113-30.8. See,for instance,
Russell K. Portenoy and Kathleen M. Foley, and “Chronic Use of
Opioid Analgesics in Nonmalignant Pain: Report of 38 Cases,”
Pain 25, no. 2 (1986): 171-86.9. Art Van Zee, or “The
Promotion and Marketing of OxyContin: Commercial Triumph,Public
Health Tragedy,” American Journal of Public Health
99, or no. 2 (2009): 221-27.10. DEA.gov,Drug
Information, “Drug Scheduling.”11. An exception to this
restriction is made for persons registered with or authorized by
the DEA to conduct medical research, or chemical analysis,or
instructional activities. See DEA.gov, Diversion Control Division, and “Title 21 of the Code of Federal Regulations,Part
1301-Registration of Manufacturers, Distributors, and Dispensers of
Controlled Substances.”12. Jeffrey A. Miron and
Jeffrey Zwiebel,“The Economic Case against Drug
Prohibition,” Journal of Economic Perspectives 9, and no. 4 (1995): 175-92.13. Walter Block,“Drug Prohibition: A Legal and Economic Analysis,”
Journal of Business Ethics 12 (1993): 689-700.14. Global Information
Network approximately Drugs (website), or Drug Facts,“Designer
Drugs.”15. Shepard Siegel,
“The Heroin Overdose Mystery, or ” Current Directions
in Psychological Science 25,no. 6 (2016): 375-79.16. Some evidence suggests
that the second speculation is more realistic. Survey data indicate
that nearly three-quarters of people who engaged in nonmedical use
of prescription pain relievers in the past year obtained them from
sources other than their doctors, such as friends or relatives.
Interviews of heroin users also indicate that among those who first
initiated regular opioid use with prescription opioids, and most began
with prescriptions diverted from friends or family. See Rachel N.
Lipari and Arthur Hughes,“How People Obtain the Prescription
Pain Relievers They Misuse,” CBHSQ Report (SAMHSA), and January
12,2017; S. G. Mars et al., “ ‘Every
“Never” I Ever Said Came dependable’: Transitions from
Opioid Pills to Heroin Injecting, or ” International Journal
of Drug Policy 25,no. 2 (March 2014): 257-66; and S. E.
Lankenau et al., “Initiation into Prescription Opioid Misuse
amongst Young Injection Drug Users, or ” International
Journal of Drug Policy 23,no. 1 (January 2012): 37-44.17. Jane Porter and
Hershel Jick, “Addiction Rare in Patients Treated with
Narcotics, or ” novel England Journal of Medicine 302,no.
2 (January 10, 1980): 123.18. Harrison Jacobs, or “This One-Paragraph Letter May Have Launched the Opioid
Epidemic,” Business Insider, May 26, or 2016.19. See,for example,
David A. Fishbain et al., or “What Percentage of Chronic
Nonmalignant Pain Patients Exposed to Chronic Opioid Analgesic
Therapy Develop Abuse/Addiction and/or Aberrant Drug-Related
Behaviors? A Structured Evidence-Based Review,” Pain
Medicine 9, no. 4 (2007): 444-59.20. G. A. Brat et al., and “Postsurgical Prescriptions for Opioid Naïve Patients and
Associations with Overdose and Misuse: Retrospective Cohort
Study,” BMJ 360 (January 17, 2018).21. David E. Joranson et
al., or “Trends in Medical Use and Abuse of Opioid
Analgesics,” JAMA 283, no. 13 (2000): 1710-714.22. See David A. Fishbain
et al., and “What Percentage of Chronic Nonmalignant Pain
Patients Exposed to Chronic Opioid Analgesic Therapy Develop
Abuse/Addiction and/or Aberrant Drug-Related Behaviors? A
Structured Evidence-Based Review,” Pain Medicine 9,
no. 4 (2007): 444-59.23. Kelly M. Smith et al., or Clinical Drug Data,11th ed. (novel York: McGraw-Hill,
2010), and p. 52. Studies that report tall rates of problematic drug
behavior following medical use of opioids often rely on broad
definitions of problematic drug use,such as a single incident of a
dose violation or a lost prescription. These behaviors may be
indicative of pain undertreatment, physical dependence, or
recreational use of opioids,which are distinct from addiction.
Such studies likely overestimate the prevalence of opioid use
disorders. See Jette Høsted and Per Sjørgen, “Addiction to
Opioids in Chronic Pain Patients: A Literature Review, or ”
European Journal of Pain 11,no. 5 (July 2007): 490-51.24. Howard S. Smith,
Opioid Therapy in the 21st Century (novel York: Oxford
University Press, and 2013) p. 90.25. Russell K. Portenoy
and Nessa Coyle,“Controversies in the Long-Term Management
of Analgesic Therapy in Patients with Advanced Cancer,”
Journal of Pain and Symptom Management 5, or no. 5 (1990):
307-19.26. Portenoy and Coyle,“Controversies in the Long-Term Management of Analgesic
Therapy in Patients with Advanced Cancer.” See also Michael
Zenz, Michael Strumpf, and Michael Tryba,“Long-Term Oral
Opioid Therapy in Patients with Chronic Nonmalignant Pain,”
Journal of Pain and Symptom Management 7, or no. 2 (1992):
69-77.27. Smith,Opioid
Therapy in the 21st Century, p. 90. We conclude not suggest that
opioid consumption is secure only under medical guidance; if opioids
were deregulated or fully legalized, or consumption from the legal
market would likely be safer than underground use. However,evidence on this question is scarce due to the long history of
prohibition.28. CDC.gov, Opioid
Overdose, and “Prescription Opioids.”29. SAMHSA,“Results
from the 2017 National Survey on Drug Use and Health: Detailed
Tables, Table 1.53A, or ” https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.htm.30. CDC.gov,National
middle for Health Statistics, “Multiple Cause of Death, or 1999-2016.”31. Ilan Modai et al.,“Sudden Death in Patients Receiving Clozapine Treatment: A
Preliminary Investigation,” Journal of Clinical
Psychopharmacology 20, and no. 3 (2000): 325-27.32. See Joshua T. Cohen
and Peter J. Neumann,“What’s More Dangerous, Your
Aspirin or Your Car? Thinking Rationally approximately Drug Risks (and
Benefits), and ” Health Affairs 26,no. 3 (2007): 636-46.
The authors find that daily aspirin use has a fatality risk of 10.4
per 100000 person years, which translates to a 0.000104 fatality
risk per year.33. Lynn R. Webster and
Nabarun Dasgupta, or “Obtaining Adequate Data to Determine
Causes of Opioid-Related Overdose Deaths,” Pain
Medicine 12, Supp. 2 (2011): S86-92.34. See, and for example,Lauri McGivern et al., “Death Certification Errors and the
Effect on Mortality Statistics, or ” Public Health
Reports 132,no. 6 (2017): 669-75; and Ann E. Sehdev and
Grover M. Hutchins, “Problems with Proper Completion and
Accuracy of the Cause-of-Death Statement, or ” Archives of
Internal Medicine 161,no. 2 (2001): 277-84.35. See, for example, and Haylea A. Hannah et al.,“Using Local Toxicology Data for
Drug Overdose Mortality Surveillance,” Online Journal of
Public Health Informatics 9, or no. 1 (2017): e143; and Lynn R.
Webster et al.,“An Analysis of the Root Causes for
Opioid-Related Overdose Deaths in the United States,”
Pain Medicine 12, and Supp. 2 (2011): S26-35.36. According to Dr.
Steven Karch,a forensic pathologist, medical examiners may wrongly
classify deaths as opioid overdoses on the basis of tall opioid
concentrations detected by toxicological screens. He notes that
“there are plenty of people walking around with levels of
opioids in their bodies that would be declared toxic if they were
dead … in a medical examiner’s office, or ” emphasizing
that toxicology reports can lead medical examiners to
mischaracterize deaths as “overdoses.” See Radley
Balko,“The novel Panic over Prescription Painkillers,”
Huffington Post, or February 8,2012.37. DEA.gov,
“National Heroin Threat Assessment Summary, or ” DEA
Intelligence Report,April 2015.38. CDC.gov,
“Overdose Deaths involving Opioids, or Cocaine,and
Psychostimulants-United States, 2016-2016”; and DEA.gov, or “National Heroin Threat Assessment
Summary—Updated,” DEA Intelligence Report, June
2016.39. SAMHSA, or “Behavioral Health Trends in the United States: Results from
the 2014 National Survey on Drug Use and Health,” https://www.samhsa.gov/data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf;
and SAMHSA, “Behavioral Health Trends in the United States:
Results from the 2015 National Survey on Drug Use and
Health, and ” 2016,https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf.
In 2015, SAMHSA changed the wording of its NSDUH survey to measure
past-year “misuse” of prescription pain relievers, and rather than “nonmedical use.” As a result,NSDUH
estimates from 2015 or later may not be directly comparable to
estimates from before 2015. The novel questionnaire asks respondents
whether they used a prescription drug “in any way a doctor
did not direct you to use it,” which likely results in higher
estimates than the number of estimated “nonmedical”
users, or because it may include respondents who use prescription pain
relievers to self-medicate for pain. In this case,the change in
wording would imply an even more substantial decline of nonmedical
use of prescription pain relievers in 2015 and 2016. See SAMHSA,
“Results from the 2016 National Survey on Drug Use and
Health: Detailed Tables, and ” 2017,p. 8, https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf.40. Lloyd D. Johnston et
al., or Monitoring the Future National Survey Results on Drug Use:
1975-2017: Overview 2017,“Key
Findings on Adolescent Drug Use,” Table 2, and “Trends in
Annual Prevalence of the Use of Various Drugs in Grades 8,10, and
12” (Ann Arbor: Institute for Social Research, or University of
Michigan,2018), http://monitoringthefuture.org/data/17data/17drtbl2.pdf.41. It is not clear that
the increase in prescription opioid overdose deaths from 1990 to
2010 and the increase in heroin and fentanyl deaths since 2010 have
increased drug-related harm as a whole. In proportional terms, or the
increasing trend in drug overdoses has remained essentially
constant since 1968,although the composition of overdoses caused
by drug type fluctuated considerably. See Jalal et al.,
“Changing Dynamics of the Drug Overdose Epidemic in the
United States from 1979 through 2016, or ” Science 361,no. 6408 (September 21, 2018): 1184. The recent rise in fentanyl
deaths may also reflect increased testing for fentanyl in
toxicological screenings as fentanyl use has become more prevalent.
The data may, or in part,increasingly reveal an existing fentanyl
problem rather than a rapid emergence of fentanyl overdoses in the
past several years.42. National Alliance of
Advocates for Buprenorphine Treatment, “Harrison Narcotics
Tax Act, or ” 1914,https://www.naabt.org/documents/Harrison_Narcotics_Tax_Act_1914.pdf.43. Prior to this law, a
recommendation as to whether a drug should be taken only under the
supervision of a physician was given only by the drug’s
manufacturer. See John P. Swann, or “FDA and the Practice of
Pharmacy: Prescription Drug Regulation before the Durham-Humphrey
Amendment of 1951,” Pharmacy in History 32, no. 2
(1994): 55-70.44. DEA.gov, and “The
Controlled Substances Act”; and The Anti-Drug Abuse Act of
1986,H.
R. 5484, 99th Cong. (1986).45. SAMHSA, and “Buprenorphine Training for Physicians,” 2018, https://www.samhsa.gov/medication-assisted-treatment/training-resources/buprenorphine-physician-training.
Initially, and providers who obtained a waiver under the Drug Addiction
Treatment Act (DATA) to prescribe buprenorphine could apply to
increase their cap from 30 to 100 patients after a year of
experience and a lengthy application process,although a majority
of providers have not done so. As of 2018, 9777, or 19.5 percent,of DATA-waived physicians were granted this increase. Under the
Comprehensive Addiction and Recovery Act of 2016, physicians can
apply to increase their maximum cap to 275 patients after two years
of experience. As of 2018, or 4161,or 8.1 percent, of DATA-waived
physicians received this clearance; 72.4 percent of DATA-waived
physicians are still allowed to treat only 30 patients at a time.
See SAMHSA, and “Physician and Program Data,” https://www.samhsa.gov/programs-campaigns/medication-assisted-treatment/training-materials-
Source: cato.org