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1992 Angarola RT, Joranson DE. Single-copy serialized
prescriptions: old regulation in new
clothing? APS Bulletin 1992;2(4):14-15.
Single-Copy Serialized Prescriptions: Old Regulation in New Clothing?
Laws that require physicians to use government-issued multiple-copy prescription forms
result in immediate and
significant declines in the prescribing and dispensing of the medications covered. For example,
prescriptions of
schedule II drugs for outpatients in a large Texas teaching hospital decreased by 60% after the
state adopted its triplicate prescription law in 1982 (Sigler et al., 1984). When New York extended its
multiple-copy prescription program (MCPP) to the benzodiazepines in 1989, Medicaid
prescriptions dropped by
more than 60% within 1 month (Weintraub, Singh, Byrne, Maharajik, & Guttmacher, 1991),
while prescriptions of
less effective and less safe alternate drugs, such as meprobamate, more than doubled.
Effects on medical practice
There is mounting evidence that controlled-substance medications are underused for the
treatment of pain, mental
illnesses, and a number of other conditions. The Agency for Health Care Policy and Research
has reported that only
about a half of patients receive appropriate levels of opioid analgesics to manage acute
postoperative pain (Acute Pain
Management Guideline Panel, 1992). Likewise, in one study, only 50% of the patients with
clinically significant
generalized anxiety disorders received any treatment at all and, of those who did, only 38%
received prescription
psychotherapeutic drugs (Uhlenhuth, Balter, Mellinger, Cisin, & Clinthorne, 1984).
The law enforcement and regulatory agencies that operate multiple-copy prescription
programs contend that the
primary goal of these programs is to obtain information on the prescribing
practices of physicians in order to prevent drug diversion and abuse. They do not believe
that MCPPs
inappropriately affect medical practice. In 1990, the Drug Enforcement Administration
(DEA) stated that there had
been "[no] significant complaints from practitioners or patients" in the states that operate
these prescription
monitoring programs (U.S. Department of Justice, 1990, p. 41).
Two years ago, legislation that would have required all states to implement MCPPs was
introduced in Congress.
Physicians, nurses, patients, and a large number of interested agencies and organizations,
including APS, had
become aware of the negative impact of these programs on patient care and strongly
opposed the bill, which was
ultimately defeated. In 1992, the sponsor of this bill introduced a greatly revised
Prescription Accountability and
Patient Care Improvement Act, based on the collection and electronic transmission of
dispensing information on
schedule II and IV controlled substances (HR5051, introduced April 30, 1992, by U.S. Rep.
Fortney "Pete" Stark,
D-CA). Although serious questions exist on the need for this legislation and its cost, both
in terms of financial
outlays and potential adverse effect on patients (Angarola & Joranson, 1992), electronic
data transfer systems have
one important benefit: They do not require physicians to use special prescription forms for
controlled substances
that clearly signal that a regulatory agency is scrutinizing their medical practice. The U.S.
Public Health Service
has found that the fear of having an unwanted high profile with state enforcement agencies
and licensing boards has
led some physicians to prescribe no more than
minimal (and perhaps ineffective) doses of scheduled analgesic drugs (U.S.Department of Health
and Human Services.
1986).
Single-copy prescription system
The advent of computer-based medical information collection systems makes it
unnecessary and uneconomical
for states to adopt multiple-copy prescription programs. However, a new proposal - that is, the
use of single-copy
serialized prescription forms - would combine the worst aspects of MCPPs with electronic data
transfer monitoring
systems.
A single-copy system would require prescribers to buy or otherwise obtain serialized
prescription pads from the
state. Practitioners would have to use these special forms when prescribing controlled substances
for patients. Pharmacists would enter the information on the prescription (including patient and physician
identifiers) into a computer
for transmission to a state agency. Depending on the prescribing parameters established, law
enforcement or medical
licensing authorities could use the data to mount a drug diversion investigation.
The Maryland Governor's Prescription Drug Commission has endorsed the single serialized
prescription system
as the "only means" of identifying prescription forgeries and thefts of prescription forms
(Governor's Prescription Drug
Commission, 1991). The commission provided no documentation in support of this conclusion.
In March 1989, a
group of federal and state law enforcement and regulatory officials, convened under the auspices
of the DEA, issued
a report entitled "Fraudulent Prescription Orders" (U.S. Department of Justice, 1989). This
expert panel identified
six prevention/education measures a state could take before considering the use of special
prescription forms to deal
with this potential problem. It also identified eight legislative initiatives that government could
adopt before
implementing a special prescription form system. No one has presented any evidence that
supports the need for
a serialized prescription system to prevent prescription forgeries or theft.
In spite of this fact, Maryland's drug commission has drafted regulations implementing the
proposed single-copy
prescription system. The commission maintains that "it is not the purpose of the ... regulations to
deter or inhibit the
prescribing of proper and adequate dosages of appropriate medications for the relief of pain"
(Governor's Prescription
Drug Commission, 1991, p. 1). An associate professor at the Johns Hopkins Oncology Center,
who served as a consultant to the Governor's Prescription Drug Commission, has stated that "unfortunately, the
regulations ... are quite
likely to significantly 'deter or inhibit' narcotic prescriptions to patients in genuine need of these
drugs" (S.A.
Grossman, MD, personal communication to Commission Chairman Robert Goldman, July
8,1991). The chief of the
Maryland Bureau of Drug Enforcement recently called for the state to adopt these regulations as
soon as possible (T.H.
Carr, personal communication to Nelson J. Sabatini, Secretary, Maryland Department of Health
and Mental Hygiene,
March 26,1992).
A single-copy serialized prescription system will likely have the same chilling effect on the
prescribing of medically
indicated controlled-substance medications as has occurred with multiple-copy prescription
programs. It would send
an unmistakable message to physicians that (a) prescribing these drugs could give them an
unwanted high profile with
the police or licensing authorities and, therefore, (b) there is danger in ordering more than a
minimal amount of
medically justified controlled substances for patients in pain or suffering from other
disorders.
APS member alert
The American Pain Society and its members were extremely effective in defeating a
federally mandated MCPP
initiative in 1990 and may already have been influential in ensuring that federal law does not
encourage another form
of paper-based information collection. (Rep. Stark has dropped a provision from his recently
introduced prescription
accountability legislation that would have encouraged states to evaluate the benefits of a single-copy prescription system.) APS members should be equally alert
to the threat
posed at the state level by a single-copy serialized prescription svstem that would certainly result
in the
reduced use of opioid analgesics and other controlled substances for the treatment of
pain.
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.
Governor's Prescription Drug Commission.
(1 991). Schedule II prescription tracking: Single serialized prescription regulations.
Baltimore: Author.
Sigler, K.A., Guernsey, B.G. Ingrim, N.D., Buesing, A.S., Hokanson, J.A., Galvan, E., &
Doutré, W.E. (1984). Effect of a
triplicate prescription law on prescribing of schedule II drugs, American Journal of
Hospital Pharmacy, 41, 108-11
1.
Uhlenhuth, E.H., Balter, M.B., Mellinger, G.D., Cisin, I.H., & Clinthorne, J. (1984).
Anxiety disorders: Prevalence and treatment. Current Medical Research & Opinion, 8 (Suppl. 4), 37-46.
U.S. Department of Health and Human Services. Public Health Service. Interagency
Committee on Pain and Analgesia. (1986,
Feb. 3). Report of the Subcommittee on Drug Availability and Legislation.
Washington, DC: Author.
U.S. Department of Justice Drug Enforcement Administration. (1989, March). Fraudulent
prescription orders.
(Committee Report from the Fourth National Conference, San Diego). Washington, DC:
Author.
U.S. Department of Justice Drug Enforcement Administration. (1990). Multiple copy
prescription program resource
guide. Washington, DC: U.S. Government Printing Office.
Weintraub, M., Singh, S., Byrne. L., Maharajik, K., & Guttmacher, L. (1991).
Consequences of the 1989 New York state
triplicate benzodiazepine prescription regulations. Journal of the American Medical Association,
266, 2392-2397.
