Download State Laws Regulating Prescribing of Controlled Substances

State Laws Regulating Prescribing
of Controlled Substances:
Balancing the Public Health
Problems of Chronic Pain and
Prescription Painkiller Abuse and
Overdose
Andrea M. Garcia
Introduction
According to the Institute of Medicine, chronic pain
affects at least 116 million adults in the United States
(U.S.), which is more than the total affected by heart
disease, cancer, and diabetes combined. Pain costs the
nation up to $635 billion each year in medical treatment and lost productivity. It has been conceptualized
as a public health problem due to its prevalence, seriousness, disparities, vulnerable populations, the utility
of population health strategies, and the importance of
prevention at both the population and individual levels. For many patients, treatment of pain is inadequate
due to uncertain diagnoses, societal stigma, the lack
of effective treatments, and inadequate patient and
clinician knowledge about the best ways to manage
pain.1 This article explores the inadequate treatment
of pain in the U.S. and the subsequent rise of prescription painkiller abuse, misuse, and overdoses. This is
followed by a review of the actions taken by states to
regulate the prescribing of controlled substances.
Inadequate Treatment of Pain
In the late 1990s and early 2000s, there was a heightened focus on the under-treatment of pain. Health
care providers were seen as having inaccurate and
exaggerated concerns about addiction and opioid side
effects. Coupled with the fear of being sanctioned by
regulatory boards for over-prescribing, providers also
faced concerns of being deemed overly cautious about
the use of these drugs.2 In 1999, the Oregon Board
of Medical Examiners disciplined a physician for not
Andrea M. Garcia, J.D., M.P.H., is the Director of the State
Health Policy, Association of State and Territorial Health
Officials.
42
prescribing enough medication to alleviate pain in six
of his patients.3 This was the first time a medical board
had taken such an action. At the time, the decision
was seen as underscoring the “medical community’s
changing attitudes about how doctors should help
patients deal with severe and chronic pain.”4
In 2000, the Veterans Health Administration
(VHA) launched a National Pain Management Strategy with the goal of preventing pain in persons receiving care in the VHA system. One element of that
strategy was recognizing pain as the fifth vital sign to
establish routine screening and assessment of pain.
The VHA toolkit suggests that health care providers
could be barriers to pain care due to fear of patient
addiction as well as concerns regarding the side effects
of analgesics.5 On January 1, 2001, the Joint Commission’s pain management standards went into effect
for accredited ambulatory care facilities, behavioral
health care organizations, critical access hospitals,
home care providers, hospitals, office-based surgery
practices, and long-term-care providers. The standards addressed pain assessment and management
and required organizations to recognize the right of
patients to appropriate assessment and management
of pain.6
At that time, it was suggested that treatment and
management of pain could also be improved by the
threat of tort litigation that would spotlight providers’ failures to comply with an emergent standard of
proper pain management and incentivize a change in
practice.7 In 2001, a California case brought against
a physician for failing to prescribe prescription drugs
strong enough to relieve a patient’s pain gained significant attention. The jury found that the physician
committed elder abuse by failing to adequately treat
his patient’s pain.8 While the case hinged on the state’s
journal of law, medicine & ethics
Andrea M. Garcia
elder abuse law, not on professional negligence, the
outcome meant that under-prescribing for pain could
be just as legally risky as over-prescribing.
In 2004, the Federation of State Medical Boards
passed a model policy on the use of controlled substances to treat pain. The policy encouraged state
medical boards to consider under-treatment of pain
just as serious of a violation of the standard of care
as over-treatment. It also provided that physicians
should not fear disciplinary action from state boards if
they treat pain for a legitimate medical purpose.9 Over
time, medicine’s philosophy on the treatment of pain
has shifted, and patient’s subjective reports of pain
have taken precedence over other potentially competing considerations, such as addiction.10
scription painkiller use costs health insurers up to an estimated $72.5 billion annually in direct health care costs.
State Laws Regulating Prescribing of
Controlled Substances
Rise of Prescription Painkiller Abuse,
Misuse, and Overdose
States have the authority to impose additional regulatory requirements on controlled substances provided
they do not conflict with federal laws. Since 2007,
states have increasingly used their authority to address
inappropriate prescribing. There is general agreement
that prescription painkiller abuse and overdoses are
a complex problem and require a multifaceted solution. State strategies to address this complex problem have included: establishing and strengthening
prescription drug monitoring programs, regulating
pain management facilities, and establishing dosage
thresholds above which a consult with a pain specialist is required.
Today, opiate-based prescription painkillers account
for significant morbidity and mortality in the U.S.
According to the Centers for Disease Control and Prevention, prescription painkiller overdose has reached
Prescription Drug Monitoring Programs
Prescription drug monitoring programs are centralized databases used to monitor the disbursement of
For many patients, treatment of pain is inadequate due to uncertain
diagnoses, societal stigma, the lack of effective treatments, and inadequate
patient and clinician knowledge about the best ways to manage pain.
This article explores the inadequate treatment of pain in the U.S. and the
subsequent rise of prescription painkiller abuse, misuse, and overdoses.
This is followed by a review of the actions taken by states to regulate
the prescribing of controlled substances.
epidemic proportions over the past decade.11 The rise
of prescription painkiller overdoses has paralleled the
rise in supply of these drugs. In 2010, the quantity of
prescription painkillers sold to pharmacists, hospitals,
and doctors’ offices was four times larger than in 1999.
It is estimated that prescription painkiller overdoses
killed nearly 15,000 people in the U.S. in 2008, which
is more than three times the number in 1999.12
Increased opioid prescribing has also resulted in a
rise of diversion and nonmedical use of these medications. In 2010, about 12 million Americans aged 12 or
older reported that they used prescription painkillers
for nonmedical reasons within the last year.13 The rise in
abuse, misuse, and diversion of opioids is associated with
increases in emergency department visits for nonmedical
prescription drug use, opioid addiction treatment, and
neonatal abstinence syndrome rates.14 Nonmedical pre-
prescription drugs. The purpose of such programs
is to help prescribers avoid drug interactions and
identify drug-seeking behaviors, as well as to help
regulators identify clinicians with inappropriate
prescribing and dispensing patterns. Currently, 49
states have authorized the creation of prescription
drug monitoring programs. Missouri is the lone state
without an authorized program, and the state considered, but did not pass, authorizing legislation (House
Bill 1193) in 2012. Legislation, B19-966, is also pending in the District of Columbia. Prescription drug
monitoring programs vary greatly by state. Differences include: the schedules of drugs reported to the
database, where the database is housed within the
state, which prescribers and dispensers are required
to report data, how often data must be reported (i.e.,
monthly, weekly, or in real time), who has access to
the database, and whether data can be shared with
2012 public health law conference: practical approaches to critical challenges • spring 2013
43
S UPPLEMENT
other states. These provisions all play a role in determining the effectiveness of a state’s prescription drug
monitoring program.
In 2012, several states considered whether providers should be required to query the database prior to
prescribing. Kentucky, Massachusetts, New York, Tennessee, and West Virginia passed legislation making
consulting the databases mandatory. The New York
law provides that “[e]very practitioner shall consult
the prescription monitoring program registry prior
to prescribing or dispensing any controlled substance
listed on Schedule II, III, or IV…for the purpose of
reviewing a patient’s controlled substance history.”15
However, 10 exceptions were included in the final
bill. In Tennessee, prescribers are required to check
the database prior to prescribing an initial course of
treatment involving opioids or benzodiazepines and
annually as long as the patient is being treated with
the medication. Exceptions to the mandate include
courses of treatment that are seven days or fewer, hospice, and surgical procedures performed in a licensed
facility.16
Licensing and Regulating Pain Clinics
Regulating pain management clinics is an approach
taken by several states, including Florida, Kentucky,
Louisiana, Ohio, Tennessee, Texas, and West Virginia, to limit prescribing at high volume pain clinics
or “pill mills.” Some characteristics that distinguish a
“pill mill” from a legitimate pain management practice include: nonexistent or cursory patient exams,
large daily volume of patients, absence of health care
providers among clinic owners, cash-only operations,
identical prescription cocktails given to each patient,
onsite dispensing, and a single facility as source of
all patients’ magnetic resonance images.17 Pain management clinics are defined as prescribing controlled
substances to a majority (51 percent) of patients for
the treatment of chronic pain. Exceptions to this definition vary, but often include: hospitals, hospice programs, medical schools or training institutions, and
ambulatory surgery facilities. The laws provide for
state oversight of pain management clinics through
registration or licensure, allow or require state inspection of the facilities, and require that they be owned by
a licensed physician who meets specific education and
training criteria in pain management.18
Establishing Dosage Thresholds
On March 25, 2010, Washington Governor Chris Gregoire signed Engrossed Substitute House Bill 2876 into
law. Washington’s opioid prescribing law is now considered the strictest in the country, as it goes beyond
regulating providers practicing in pain clinics and
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applies broadly to any provider who prescribes opioids for chronic, non-cancer pain, though acute pain
from surgery, hospice, and palliative care are exempt
from the law. The bill required five state health care
boards — medical, osteopathic, nursing, dental, and
podiatric — to adopt new rules, including dosage standards, for chronic, non-cancer pain management. The
rules established a dosage threshold mandating that
primary care providers consult with board-certified
pain specialists prior to prescribing daily morphineequivalent doses of 120 mg or greater.19 The criteria
to be considered a “pain specialist” are outlined in the
rules along with consultation exemptions for exigent
circumstances. Providers may also be exempt from
the consultation requirement if they have completed
continuing education hours on chronic pain management with at least two hours dedicated to long-acting
opioids.20
Discussion
It is too early to fully understand the impact these laws
will have on prescription painkiller abuse, misuse, and
overdoses and patient access to pain treatment. A
review of peer-reviewed research on prescription drug
monitoring programs published between 2001 and
2011 concluded that prescription drug monitoring
programs reduce “doctor shopping,” change prescribing behavior, and reduce prescription drug abuse.21 A
2012 study found that while opioid abuse was increasing over time, the rate of increase was slower in states
with prescription drug monitoring programs.22 However, additional research is needed to determine the
effectiveness of new state laws mandating prescriber
use of prescription drug monitoring programs.
The Drug Enforcement Administration has indicated that Florida’s laws limiting the ability of doctors
to dispense controlled substances at pain clinics has
drastically decreased oxycodone purchases by doctors
in the state.23 There are concerns, however, that providers will limit prescribing of controlled substances
to treat pain to fewer than 51% of their patients to
avoid having to be licensed by the state as a pain clinic.
There are also concerns raised regarding access to care
as a result of Washington State’s requirement for a
consult with a pain specialist above a specified dosage. Primary care providers are often the first line of
care for patients with pain. Pain is a fairly new medical specialty, making these specialists difficult to find.
This is particularly of concern in rural areas where the
number of specialists is especially limited.
Providers want the freedom to use their clinical
decision-making to treat patients, and some feel these
new requirements are over-regulating the practice of
medicine. State medical boards are being encouraged
journal of law, medicine & ethics
Andrea M. Garcia
to do more to address physicians who over-prescribe.
One governor has acknowledged that he is unhappy
with his state medical board for not doing more to rein
in doctors who contribute to the prescription drug
abuse epidemic.24 Physicians in Florida and California are facing criminal prosecution in connection with
patient overdoses, leaving some medical professionals
in fear that this will have a chilling effect on the legitimate use of pain medication for legitimate reasons.25
Conclusion
Pain affects millions of Americans and contributes
greatly to national morbidity, mortality, and disability
rates. The pendulum has swung in recent years from
a focus on the under-treatment of pain to addressing
prescription drug overdose morbidity and mortality
through various policy and regulatory approaches. As
states continue to explore policy options to address
prescription drug abuse and misuse, it will be important to evaluate the impact these approaches are having, both in reducing painkiller abuse, misuse, and
overdoses and on legitimate access to pain care.
Note
The views expressed in this article are exclusively those of the
authors and do not necessarily reflect those of the Association of
State and Territorial Health Officials.
Resources
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for Transforming Prevention, Care, Education and Research
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