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1989 Joranson DE, Dahl JL. Achieving balance in drug policy: the Wisconsin model. In: Hill CS Jr., Fields WS. Advances in Pain Research and Therapy, Volume 11. New York: Raven Press, 1989:197-204.

Achieving Balance in Drug Policy: The Wisconsin Model

David E. Joranson and June L. Dahl

Pain Research Group, and Department of Pharmacology, University of Wisconsin Medical School, Madison, Wisconsin 53705

The purpose of this chapter is to describe the approach used in Wisconsin to achieve a balanced controlled substances policy. This is being done by preventing diversion and abuse of prescription drugs while assuring their availability for legitimate medical purposes. The elements of this approach are Wisconsin's interagency diversion control and prevention program and the Wisconsin Cancer Pain Initiative. Several broad drug regulatory policy questions are also addressed.

WISCONSIN'S DRUG DIVERSION CONTROL PROGRAM

During the past 12 years, the Wisconsin Controlled Substances Board has developed an interagency program that has produced a dramatic reduction in the diversion and abuse of prescription drugs. The cornerstone of the program is the realization that no single agency can effectively address this complex problem. The knowledge, information, authority, and resources of a number of health, licensing, regulatory, and enforcement agencies must be coordinated in order to bring about an efficient and effective response to diversion.

Since implementation of the program, indicators of diversion and abuse such as arrests and treatment admissions-have decreased significantly, especially for most schedule II opioids, stimulants, and depressants (1). In some cases, these decreases have been accompanied by proportional decreases in prescribing. However, the prescribing of opioids such as morphine has increased substantially.

The effectiveness of the Wisconsin program has been reported in the literature (2) and recognized by federal agencies, including the White House, and by the Council of State Governments (3). In 1982, the basic design of the program was incorporated into the American Medical Association's Prescription Abuse Data Synthesis program, which is being implemented in a number of states (3,4).

These experiences have led us to the following conclusions:
  1. Diversion and prescription drug abuse can be successfully addressed within the general framework of the Uniform Controlled Substances Act, but only if there is a long-term commitment to cooperation among state and federal agencies responsible for protecting public health and safety.
  2. The problem of diversion can and should be addressed without in any way compromising legitimate medical practice or patient care.
  3. Diversion of prescription drugs should be addressed in a broad public health context in close cooperation with law enforcement.
  4. Efforts to address diversion should be evaluated and the results used to change and refine programs. Only valid and reliable measures of abuse should be used to gauge success. Prescribing levels are not valid measures of prescription drug abuse.

WISCONSIN'S CANCER PAIN INITIATIVE

The Controlled Substances Board also spearheaded a statewide effort to improve management of cancer pain. In 1984, bills were introduced in Congress to make heroin available for cancer patients. After a careful study similar to its review of the medical uses of THC (5), the Board concluded that the availability of heroin would not improve the management of cancer pain (6,7) but that major improvements would result if existing analgesics were better utilized (8-10). In designing a plan to address this complex problem, it became clear that there was no single agency with sufficient knowledge, authority, resources, or interest to address the problem. With the help of many dedicated people, the Board drew together an effort that has involved all the parties in the diversion control program and many more organizations and numerous professionals directly involved in the care of patients with cancer.

The effort has the support of the Wisconsin Legislature, the Governor, the U.S. Public Health Service, the Surgeon General, and the World Health Organization. The Wisconsin Cancer Pain Initiative has been described in several reports (11-21), including a recent complete report (22).

Underlying this effort are the realizations that health professionals often have inadequate knowledge of the diagnosis and treatment of pain, that they are excessively concerned about opioids and addiction, and that patients and the public fear opioids and addiction, even in a medical context (22). Severe pain may lead patients to consider stopping life-prolonging treatment, even to consider suicide (23,24).

Consequently, regulatory efforts that reduce the use of opioids may not only reduce the quality of life for cancer patients, but may even become life and death issues. The potential impact of federal law, state law, enforcement activities, and multiple copy prescription programs on the use of opioids will be discussed.

Federal Policy: Are Federal Laws and Regulations Impediments to Proper Prescribing and Availability of Opioid Drugs for Treatment of Cancer Pain?

In general, the authors do not think so, nor did the Subcommittee on Drug Availability and Legislation of the Public Health Service Interagency Committee on Pain and Analgesia (25).

The Federal Controlled Substances Act (Public Law 91-513) adopted by the U.S. Congress in 1970 clearly states that many controlled substances have useful and legitimate medical purposes and are necessary to maintain the health and welfare of the American people. In spite of this fact, antidrug and drug-free messages are becoming increasingly strong. The National Association of State Controlled Substances Authorities has recently asked the White House Conference on a Drug Free America to recognize that many controlled substances are necessary to maintain public health.

The federal controlled substance regulations (26) and the Drug Enforcement Administration's (DEA) Physician's Manual (27) state that this law does not intend to limit a physician's ability to treat intractable pain with narcotic drugs during an extended period, particularly in the case of cancer patients. It appears to us that this provision of federal law is not very well known in either the medical or law enforcement community. An effort should be undertaken to correct this situation.

Aggregate production quotas are set by the DEA to avoid overproduction and excessive inventories of schedule II substances and are not intended to reduce production below legitimate medical needs. The quotas do not appear to cause shortages of products in our area, with one possible exception. Availability of a high-potency, low-volume injectable form of hydromorphone (Dilaudid HP) is extremely limited in pharmacies in Wisconsin, even though it is stocked by wholesalers. Recently, when a Madison area cancer patient needed this formulation, it was not readily available through local pharmacies. Apparently this was owing to a combination of factors having to do with the serious diversion of oral forms of hydromorphone, setting of the production quota, the manufacturer's marketing decisions, and relatively low prescription demand. This situation should be reviewed so that abuse of oral hydromorphone does not limit the availability of its high potency formulation, particularly since members of Congress thought that availability of this potent analgesic invalidated the premise on which the heroin bills were based (letter to Congressional colleagues from the chairman and ranking minority member of the U.S. House of Representatives Select Committee on Narcotics Abuse and Control, June 1984). It is important to emphasize that if shortages of needed drugs occur, the DEA and manufacturers will cooperate to make a product available quickly. The DEA Regional Offices are extremely helpful in locating and authorizing emergency shipments to meet medical needs of cancer patients.

State Policy: Are State Laws and Regulations an Impediment to Proper Prescribing and Availability of Opioid Drugs for Treatment of Cancer Pain?

Because individual states regulate medical practice, confusion about what is legal under state laws and regulations can be serious indeed. No systematic analysis has been undertaken to determine if there are states in which there are legal impediments.

Wisconsin laws do not appear to present obstacles to pain management, although greater clarity would be useful. A study of medical and pharmacy regulations concerning controlled substances is being conducted.

Most states have adopted a version of the model Uniform Controlled Substances Act (UCSA) approved in 1970 by the National Conference of Commissioners on Uniform State Laws (NCCUSL). Unlike the federal law, the model law for states did not contain specific language recognizing that many controlled substances are essential, nor did it state that narcotic treatment of intractable pain is legal. An effort is being made to clarify these matters under state laws. The NCCUSL is in the last stage of its first complete revision since 1970 of the model UCSA. The new act will be submitted for approval to the NCCUSL in July 1989 and is expected to be promulgated to all the states later in the year. As an advisor to the UCSA drafting committee, David Joranson has proposed including statutory language to make state law parallel to federal law concerning medical usefulness of controlled substances in treatment of intractable pain. The drafting committee recognized the validity of the issue, but they decided for reasons of drafting style not to include statutory language but instead only a comment. This is unfortunate. When the new UCSA is considered in each state, the following language, which parallels federal law, could be added by cancer pain advocates: "This law is not intended to impose any limitations on a physician or authorized hospital staff to administer, prescribe, or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts."

State and federal laws contain language making it unlawful to prescribe to "addicts" or "drug-dependent persons." Cancer patients have told us that they have been treated like addicts. This injustice should be rectified by removing confusion about these terms, so that the cancer patient who is physically dependent on opioids is not labeled or treated as an addict.

Enforcement: Does Enforcement of Federal and State Diversion Law Have an Effect on 'treatment of Pain with Opioids?

In Wisconsin and other states, it has been reported that the conduct of some state investigators has had an intimidating effect on prescribing and dispensing by medical and pharmacy practitioners. Such conduct, although it may be exceptional, is unacceptable. Licensing board investigators and enforcement personnel need our strong support and cooperation to stop diversion and abuse of the same drugs patients need for pain and other medical problems. Investigation of a high prescriber is warranted especially if there are other indications of suspicious activity. In Wisconsin, the Controlled Substances Board's inquiry stops if the high prescriber is an oncologist and if no other problems are apparent. Nevertheless, some physicians and pharmacists who are completely innocent will be investigated. In general, these practitioners should have nothing to fear if their medical or pharmacy practice is sound. Improper investigations and prosecutions are more likely to occur if state policy on treatment of severe pain and the definition of "addiction" provide unclear guidance for investigators. An effort should be made to identify, evaluate, and correct any problems of investigator encroachment into the legitimate medical practice of cancer pain management.

Multiple-Copy Prescription Programs: Should All States Adopt Programs Requiring Physicians to Use Government Prescription Forms for Controlled Substances, as Suggested by DEA in Recent Letters to State Governors?

In an effort to deal with prescription drug diversion, some states have adopted legislation that requires physicians to use special state-supplied two- or three-part prescription blanks for schedule II drugs, including the potent opioid analgesics. These so-called "triplicate" or "multiple-copy prescription programs" are just one approach to addressing part of the diversion problem. Wisconsin and other states are successfully dealing with diversion without adopting an additional level of regulation over schedule II drugs. Success can be achieved if agencies work together to use all available information to evaluate the problem and outcomes, and if diversion control is an ongoing state priority.

It must be borne in mind that additional regulation of schedule II controlled substances may aggravate the already serious underuse of opioids in treatment of cancer pain. "Triplicate prescription" programs have been shown to reduce prescribing levels. For example, following implementation of the Texas program in 1981, schedule II prescriptions dropped by 53% (28). It is even more interesting that Texas' national rank in per capita consumption of hydromorphone dropped from 8 to 28 between 1980 and 1982; oxycodone, from 22 to 45; morphine, from 44 to 49. On the other hand, codeine, a schedule III nontriplicate prescription opioid, increased in rank from 33 to 23 (28).

The DEA's position is that these reductions indicate a reduction in prescription drug diversion and did not adversely affect patient care because no significant complaints were received (28). Unfortunately, no data were presented to support the contention that there were reductions in prescription drug abuse.

Any evaluation of the effects of additional regulation of opioids should recognize that cancer pain is already seriously undertreated; that schedule II opioids, the mainstay of therapy for severe cancer pain, are underprescribed for this purpose; that some physicians tend to be opiophobic, are not well trained in pain management, and are overly concerned about addiction; and that the public and patients have fearful attitudes about opioids and addiction. It is not surprising that there are few complaints when new laws are passed restricting use of controlled substances in the name of controlling drug abuse.

SUMMARY

Medical and public health interests should take a strong role to achieve a balanced controlled substances policy, one that effectively prevents the abuse of prescription drugs while assuring their availability for legitimate medical purposes. The possibility that patients are not receiving adequate pain relief is not a matter that can be dismissed for lack of complaints. Prescribing by physicians is not a crime statistic. The laws that govern controlled substances should provide jail sentences for "script doctors" but should act as a fortress around good medical practice. The war on drug abuse can and must be fought alongside the war on disease, pain, and suffering; one must not be allowed to impede the other.

ACKNOWLEDGMENTS

We are grateful for the financial support provided to the Wisconsin Cancer Pain Initiative by the Interagency Committee on Pain and Analgesia of the U.S. Public Health Service and for the recognition given by the World Health Organization.

We express our appreciation to the individuals and organizations who make possible Wisconsin's diversion control program and Cancer Pain Initiative. They give of their time and expertise to improve the quality of life in Wisconsin. Particularly noteworthy have been the dedication and tireless efforts of Amy Bachmann, Diane Engber, and Jeanne Dosch, who have helped to staff these programs.

REFERENCES

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  4. PADS technical manual. Chicago, IL: American Medical Association Department of Substance Abuse, 1988.
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