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1992 Angarola RT, Joranson DE. State controlled substances
laws and pain control. APS
Bulletin 1992;2(3):10-11, 15.
State Controlled-Substances Laws and Pain
Control
Robert T. Angarola, Esq.; David E. Joranson, MSSW
The recent Agency for Health Care Policy and Research Clinical Practice
Guideline on acute pain
management concluded that "opioid analgesics are the cornerstone of pharmacological
postoperative pain
management" (Acute Pain Management Guideline Panel, 1992, p. 17). This finding mirrors the
results of many
studies and, more important, clinical experience in the proper handling of pain. The World
Health Organization has
termed morphine, codeine, and other opioids "essential drugs" that should be available in all
countries to treat medical
conditions. At the same time, these drugs can produce physical and psychological dependence
and have well-recognized abuse liability. This has led to their scheduling under international,
national, and state controlled-substances laws.
In the United States, the Congress and state legislatures have placed the most potent
analgesics, such as morphine,
hydromorphone, and fentanyl, in schedule II of the federal and state Controlled Substances Acts
(CSA). At the federal
level, schedule II controls do not appear to be overly burdensome on medical practice. The
primary impact on patients
results from the prohibition on prescription refills. (Prescriptions for schedule III and IV drugs
may be refilled five
times in a 6-month period; schedule V controlled substances may be dispensed without
prescription.) However, several
states have imposed significantly greater controls over the medical use of these substances,
including dosage size
limitations and the requirement of government-issued prescribing forms (duplicate or triplicate
prescriptions). States
also have the legal authority to schedule or reschedule a particular drug, that is, to place a
federally unscheduled
substance under state control or move a drug to a higher schedule, usually depending on actual
abuse within the
state.
Effects of controls
These state controls, particularly multiple copy prescriptions, have an obvious and
immediate impact on the
prescribing and dispensing of the medications covered. There was a 64% reduction in the
prescribing of schedule II
controlled substances, mainly opioid analgesics, after imposition of a triplicate prescription
program in Texas, a 57%
reduction in Rhode Island, a 54% reduction in New York, a 50% reduction in Idaho (United
States Department of
Justice, 1987). Some state regulators and law enforcement officials claim that these statistics
demonstrate that opiates
were being overprescribed and misprescribed, and that reductions in prescription forgeries and
"doctor shopping"
accounted for the dramatic drops noted. In their opinion, schedule II controls not only reduced
drug abuse and
diversion, but also improved physicians' prescribing practices.
There is clearly much debate over the meaning of these statistics. In Texas, the adoption of
its triplicate prescription
system in 1982 resulted in increased use of schedule III codeine and hydrocodone combinations
(Tylenol with Codeine , Empirin with Codeine, Vicodin) for pain control (Berina, Guernsey, Hokanson, Doutré,
& Fuller, 1985).
Experience has shown that the more a controlled substance is used in medical practice, the more
it will appear in
monitoring systems such as the Drug Abuse Warning Network (DAWN). This is due, in part, to
the fact that DAWN
considers a suicide attempt to be a drug abuse indicator. The wider the availability of an opiate
or other controlled
or noncontrolled substance, the more likely it will be used in a suicide attempt. In addition, if
abusers find it more
difficult to obtain a schedule II drug, they often will turn to schedule III and IV compounds to
meet their
needs.
This apparently has happened in Texas. On April 8, 1992, the Texas Board of Pharmacy
petitioned the Board of
Health to reschedule all dosage forms of hydrocodone from schedule III to schedule II of the
state controlled
substances act. (The Board of Pharmacy also requested that carisoprodol [Soma (R)], butorphanol
[Stadol (R)], and
nalbuphine [Nubain (R)] be made schedule IV drugs. None of these medications is controlled under
the federal CSA.)
In its petition, the pharmacy board claimed that hydrocodone was a significant drug of abuse in
Texas and that forged
prescriptions for hydrocodone were a continuing and significant problem. The pharmacy board
received testimony
from the Houston Police Department, the Drug Enforcement Administration (DEA), and the
Texas Department of
Public Safety Narcotics Service. The pharmacy board concluded that "the moving of
hydrocodone to a Schedule II
controlled substance, which would require a triplicate prescription, would virtually eliminate the
problem of forged
prescriptions and significantly reduce the availability of this drug for illegal purposes" (petition
letter, Fred S. Brinkley
Jr., RPh MBA, Executive Director/Secretary of the Texas Board of Pharmacy, April 8,
1992).
The pharmacy board may well be correct. There could be a drop in prescription forgeries
and hydrocodone abuse
if these compounds are rescheduled. However, as demonstrated, schedule II controls also would
reduce significantly
the use of hydrocodone combinations for legal purposes.
Alternatives to controls
By definition, controlled substances can be abused. That is why they are controlled.
Legitimately produced opioid
analgesics and other psychoactive drugs, however, are prescribed and dispensed under a tightly
regulated distribution
system. Several states have shown that by using available information, and existing investigative
and enforcement
authority, they can eliminate the "vector" of diversion (i.e., the unscrupulous, unwary, or
uneducated physician or
pharmacist) and radically reduce the prescription drug abuse problem. This occurs without
harming the innocent
patient who needs a controlled substance for the effective treatment of his or her medical
condition. Adding drugs
to a triplicate prescription system tends to lead diverters and abusers to find substitute
compounds. Placing a drug in
a higher schedule does not by itself rid the state of the sources of diversion or eliminate the
prescription forger. If
Texas places hydrocodone in schedule II, will abusers turn to essential medicines such as
schedule III codeine combinations or schedule IV benzodiazepines? Carried to its logical conclusion, successive
rescheduling would result in
having all abusable medications end up in schedule II.
The Texas authorities highlight the problem of forged prescriptions and claim that triplicate
prescriptions would
help eliminate this practice. That could be true but at what cost to the legitimate patient? There
are effective
alternatives to triplicate prescriptions to address the problem of prescription forgery. In 1990, the
DEA Committee
on Fraudulent Prescription Orders recommended seven measures that states could take to deal
with this issue. The
first six included setting up pharmacy and healthcare professional awareness programs and
forgery alert systems,
distributing information materials on forged prescriptions, and using nonreproducible
prescription pads. Triplicate
prescriptions were mentioned as the last possibility. Physicians, pharmacists, manufacturers,
and regulators need to
work together to deal with prescription forgeries. Several states, including Missouri and
Wisconsin, have instituted
effective programs that have addressed the problem without placing additional regulatory
limitations on legitimate
prescribing.
Restricting access, not abuse
It has been shown that schedule II controls sharply reduce the availability of the
medications covered. This is
particularly true for opioid analgesics that are the "cornerstone" of effective pain management.
The Texas Board of
pharmacy and other regulatory agencies are concerned about the overall health of' all their
citizens. Professionals in
pain management and patient groups, however, should work with these agencies to ensure that
actions aimed at
reducing drug abuse are focused on the diverters and the abusers rather than on restricting access
to the
medicines.
People suffering from pain or mental illness did not choose the diseases that afflict them.
They should not have
to suffer because a controlled substance is the appropriate treatment for their medical condition.
As the undertreatment
of pain becomes increasingly understood by health professionals and patients, regulators should
be sensitive to
possible negative medical consequences that can arise from actions to further restrict opioid
analgesics and other FDA-approved controlled substances.
References
Acute Pain Management Guideline Panel. (1992). Acute pain management: Operative
or medical procedures
and trauma. Clinical practice guideline. (AHCPR Publication No. 92-0032). Rockville,
MD: Agency for
Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human
Services.
Berina, L.F., Guernsey, B.G., Hokanson, J.A., Doutré, W.H., & Fuller, L.E. (1985). Physician
prescription of a
triplicate prescription law. American Journal of Hospice Pharmacy, 42,
857-859.
United States Department of Justice: Drug Enforcement Administration. (1987).
Multiple copy prescription
program resource guide. Washington, DC: U.S. Government Printing Office.
