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Reprinted by permission of Elsevier Science Inc.: Federal and State Regulation of Opioids, by David Joranson Journal of Pain & Symptom Management, Volume 5(1): S12-S23. Copyright 1990 by the U.S. Cancer Pain Relief Committee.

Federal and State Regulation of Opioids

David E. Joranson, MSSW
Policy Studies Division, Pain Research Group, University of Wisconsin Medical School, Madison, Wisconsin
Abstract
Federal and state policy governing opioids is discussed in relation to achieving balance between efforts to control drug abuse and maintain drug availability for legitimate medical purposes. Federal controlled substances law affirms the essential medical value of many drugs that are controlled substances, and states that opioids may be used for extended periods in treatment of patients with intractable pain. Providing opioids to addicts is otherwise unlawful unless the physician is separately registered to treat addiction. State laws, while they permit prescribing of opioids for pain, do not provide affirmative recognition of the medical value of controlled substances. Imprecise legal definition of terms allows patients to be confused with addicts. In addition, some states require physicians to report opioid-dependent patients to the government, regulate prescribing of Schedule II opioids more strictly, and limit the quantity of controlled substances that may be prescribed at one time. Recommendations are offered to revise state laws and to improve communication between health care professionals and regulators. J Pain Symptom Manage 1990;5:S12-S23.

Key Words
Cancer pain, drug laws, drug regulation, drug diversion, narcotic laws, controlled substance laws, uniform laws, opioid regulation, intractable pain, addition

The United States is in the midst of a war on drugs. The war is characterized by intense media coverage, new legislation every year to increase penalties, and simple messages like "just say no to drugs." The message to the U.S. public is unmistakable: drugs are dangerous and are to be avoided. As we pass through another cycle of intense concern about drugs,1 we must take care not to discard medical and scientific knowledge,2 or ignore or stigmatize those among us who benefit from their legitimate uses.3 Controlled substances are essential to the quality of life of millions of patients. This is particularly true for the opioids, which are essential for treatment of a majority of cancer patients with pain.4 A balanced national drug policy should provide ample authority to address abuse problems without interfering in the use of drugs in the medical care of patients.

Professional concern for achieving balance in drug policy emerged in 1985 from a new national organization of state drug control officials.5 Since then, the subject has received increasing attention.6,7 At the heart of this concern is the recognition that opioids are underused in the treatment of pain,8 in particular, cancer pain.9,10

Many factors contribute to physicians' underuse of opioids in the treatment of pain.11,12 Principal among these is concern about opioids and addictions 8,13,14 Increased regulation of controlled substances can change prescribing patterns15-17 as some physicians become concerned that prescribing more than a minimal dose may result in unwanted attention from regulatory agencies. Greater regulation of drugs communicates that they are dangerous, and may reinforce fears of opioids and addiction, when there is actually very little to fear.19 In exploring this problem, it is important to distinguish underprescribing related to lack of knowledge about clinical pharmacology and pain management11,12 from underprescribing related more to regulatory issues.

Thus, the potential for regulatory interference in medical practice needs to be carefully evaluated. If specific laws and regulations, federal or state, impede opioid treatment of pain, they should be changed. The drug abuse problem will not be solved by interfering with medical practice. If no regulatory impediments are found in a state, physicians should be informed so that perceptions of risk can be modified appropriately.

As discussed below, federal law does not appear to impede proper prescribing of opioids for treatment of intractable pain. 18, 20 State laws are more problematic, and one state has initiated a review of its laws and regulations.20 This article reviews how federal law regulates opioids and presents a preliminary review of state laws. The following criteria are applied to evaluate both sets of laws: Is there a clear legal basis for prescribing opioid analgesics for extended periods? Is treatment of a patient with intractable pain clearly distinguished from treatment of an addict? Can a physician prescribe an opioid in a sufficient quantity? Should a physician who prescribes opioids for intractable pain be concerned about regulatory scrutiny?

Law and the Physician

Federal and state controlled substances laws and regulations establish the parameters of legality with respect to physician prescribing of controlled substances. Federal law applies everywhere in the United States. State laws apply to individuals and to those who do business in that state. Providing drugs outside of medical practice, failure to comply with any federal or state law or regulation, including completing official forms correctly and maintaining required records, may result in investigation and warning; reprimand, loss, or suspension of controlled substances registration; license suspension, limitation, or revocation; criminal conviction, fine, or forfeiture of assets. The extent of liability will depend on the nature of the offense and whether there was a presence of criminal intent or an absence of professional diligences As a consequence, it is essential for the physician to know applicable federal and state law and also be aware of any differences in how the same conduct may be governed differently by different laws.

How Does Federal Law Regulate Opioids?

The federal Controlled Substances Act (CSA) and the Federal Food, Drug and Cosmetic Act (FFDCA) are the principal laws that affect prescribing of controlled substances. These laws are administered by the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), respectively. Under the FFDCA, many drugs have been accepted as safe and effective for human use pursuant to a physician's prescription, including opioids such as codeine, hydromorphone, levorphanol, morphine, and oxycodone. These substances are also included in Schedule II of the CSA because they have a high potential for abuse. A "closed" system of accountability is established around their distribution. This system provides for registration, record keeping, and reporting,22 enabling enforcement agencies to identify the manufacturer, distributor, physician, or pharmacist who diverts controlled substances to illicit uses. Penalties are provided for violation of any requirement. It is generally recognized that the states, not the federal government, regulate the practices of medicine and pharmacy and that federal law generally defers to state law in areas that do not directly conflict with it.23

There are six aspects of the CSA that together establish federal policy on the opioid treatment of intractable pain:

1. Opioids Are Necessary to Public Health
The CSA, adopted by Congress in 1970, recognizes the medical value of many controlled substances in its findings and declarations of policy: "Many of the drugs included within this title have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people."24

2. The CSA Provides a Mechanism for External Medical Input
In 1970, comprehensive legislation, including the CSA, was introduced in Congress to combat the urgent and serious national threat of drug abuse.24 A bill drafted by the Department of Justice proposed that scientific and medical input relating to drug control decisions be provided by a scientific advisory committee appointed by the Attorney General.25 Representatives of the medical professions were deeply concerned that this would give law enforcement an inappropriate degree of authority over scientific and medical decisions.25 Following testimony from numerous physicians, scientists, and the American Medical Association, Congress adopted an alternative that required that scientific and medical determinations under the CSA be made by the Department of Health, Education and Welfare (now the Department of Health and Human Services) and that these determinations be binding on drug control decisions made by the attorney general.24 As a result, the federal CSA contains an internal mechanism that can work to assure that medical and scientific matters are considered in making drug control decisions.

3. Drug Availability Is Guaranteed
The 1970 CSA granted the Attorney General authority to establish production quotas for the controlled substances with the highest potential for abuse in order to prevent diversion from excess supplies and provide a sufficient supply for medical and scientific needs in the United States.24 This authority extends to all of the substances in Schedule II.

During 1985, in an effort to address diversion, the DEA restricted production of methylphenidate, a Schedule II substance essential for the treatment of the incapacitating diseases of attention deficit disorder and narcolepsy, to less than what was needed for legitimate medical purposes.26 Following a thorough review, the Administrator of DEA concluded, "The CSA requirement for a determination of legitimate medical need is based on the undisputed proposition that patients and pharmacies should be able to obtain sufficient quantities of methylphenidate, or of any schedule II drug, to fill prescriptions. A therapeutic drug should be available to patients when they need it. To accomplish this a smooth flow of distribution is required"26 (emphasis added).

Subsequently, the DEA has expressed willingness to grant additional quotas for new formulations of opioids for the treatment of cancer pain21 and has been recognized for its vital role in generating the U.S. government's support of the World Health Organization's cancer pain relief program.27

4. The Federal Definition of Addict Does Not Include Chronic Pain Patients
 "The term 'addict' means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction."24

Although the federal definition of addict is imprecise and fails to distinguish psychologic from physical dependence, it is a definition that cannot be easily applied to a bona fide patient being treated with opioids for chronic pain. Accordingly, such patients are not addicts under federal law and are of no particular concern to federal drug law enforcement personnel.

5. Federal Regulations Specifically Recognize Opioid Treatment of Intractable Pain
The Narcotic Addict Treatment Act of 1974 (NATA) created a separate Narcotic Treatment Program (NTP) registration for a physician lawfully to maintain or detoxify addicts with opioids.28 Under the NATA, prescribing opioids to addicts is part of the professional practice of medicine only if the physician becomes registered as an NTP. Subsequently, the DEA promulgated a regulation to distinguish opioid treatment of intractable pain from treatment of addicts: "This section is not intended to impose any limitation on a physician or authorized hospital staff to . . . administer or dispense (including prescribe) narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts."29

This regulation makes it clear that patients who need opioids for pain are not addicts and consequently would not be eligible for admission to an NTP.

6. The Size of the Prescription Is Not Restricted
Federal regulations establish requirements for what constitutes a legal prescription for controlled substances and set limits on refills.30 Neither the CSA nor federal regulations limit the amount of drug that a physician can prescribe at one time.

It is thus apparent that federal law and regulations establish a clear policy that recognizes the ability of physicians to prescribe opioids to treat intractable pain in the course of professional practice.

The Origin of State Laws

Most state drug laws are patterned after the model Uniform Controlled Substances Act (UCSA) developed by the National Conference of Commissioners on Uniform State Laws (NCCUSL).24, 31 The NCCUSL prepares model laws for states in order to establish a consistent policy framework among the states and between the states and the federal government. The UCSA, like the federal CSA, was approved in 1970 and promulgated to the states for adoption.

It is of interest that the UCSA was initially based on the U.S. Justice Department draft mentioned earlier.25 The NCCUSL prepared the UCSA in just 1 year. (The NCCUSL has a policy to consider uniform acts at two annual meetings. The policy may be waived. See article 8 of the constitution and bylaws in ref. 31.) The UCSA was adopted before the final form of the federal law was known (the UCSA was adopted by the NCCUSL August 1-7, 1970, and the CSA was adopted by Congress on October 27, 1970). When Congress finally approved the CSA, the attorney general's "scientific advisory committee" had been replaced with binding determinations of the Department of Health, Education and Welfare.

While there is no question that the UCSA permits the medical use of controlled substances, the UCSA did not incorporate recognition of essential medical uses, which is apparent in federal law. Instead of including a provision to require scientific and medical input from another agency, the UCSA only suggested that states consider establishing the scientific advisory committee, a provision that Congress had rejected. Further, a declaration of intent recognizing the important medical value of controlled substances was not included. The UCSA did not recognize the importance of assuring drug availability within a state. A definition of addict was not needed and was not included, thus leaving the states without guidance in developing their own definition if they decided the term was needed. However, the UCSA, like the CSA, did not establish restrictions on the quantity of a prescription.

The UCSA provided state legislatures with little policy guidance for incorporating medical and scientific balance into state laws. Nearly all of the states adopted the UCSA.31 Nonetheless, there are many differences among state drug laws. In some states, former drug laws were not repealed, and many new laws have been adopted to address the drug abuse problem. Provisions of some of these laws affect the prescribing of opioids and the treatment of pain patients.

How Do States Regulate Opioids?

A complete picture of state regulation of medical practices involving opioids is complex and requires examination of several laws and regulations in each state, as well as enforcement philosophy and practices. There are at least three major sets of laws: (a) controlled substances, (b) medical practice, and (c) pharmacy practice. The administrative agency for each may have rules that may be more restrictive than federal or state law. Each state agency with authority to enforce law or rules will have its own philosophy and set of priorities. In addition, state controlled substances laws are enforced by numerous local law enforcement agencies and prosecutors.

A preliminary analysis of state controlled substances and pharmacy laws has been conducted to determine the general status of law and regulations pertaining to the prescribing of opioids in the treatment of intractable pain. State medical practice laws and state and local agency enforcement practices have not yet been studied.

Like federal law, state laws recognize the ability of a physician to prescribe controlled substances in good faith and in the course of professional practice. They recognize that some drugs have "currently accepted medical uses" for purposes of placement in the proper schedule. Unlike federal law, however, state laws generally do not contain affirmative language recognizing the essential value of controlled substances or the importance of ensuring drug availability. With some exceptions,33, 34 state laws generally do not contain provisions recognizing the opioid treatment of intractable pain.

In addition to an absence of positive language concerning medical use, there are a number of examples of state laws in which the prescribing of opioids and the treatment of chronic pain patients is restricted or regulated in ways that otherwise would be permitted or not regulated under federal law. These examples can be grouped into several categories: definition of terms, reporting of addicts, dosage unit restrictions, and additional regulation of Schedule II drugs.

Definition of Terms

There is a longstanding problem in defining terms associated with drug abuse phenomena.35, 36 Attempts to clarify the term addict have led to more terms, such as habitual user and, more recently, drug-dependent person,35 but not necessarily to more clarity. In 1988, the results of a special project to clarify substance abuse terminology were published.35 The panel of substance abuse experts associated the term "drug addict" primarily with physical dependence and drug addiction with compulsive use. In reviewing definitions of these terms in state controlled substances laws, it should be remembered that federal law, which is in effect in every state, defines an addict as an individual who is a danger to society, whose need for opioids can be legally provided only in an NTP, and for whom a physician may not prescribe opioids except in an emergency or for reasons unrelated to addiction.

As an example, the New York State Controlled Substances Act defines addict as follows: "'Addict' means a person who habitually uses a narcotic drug and who by reason of such use is dependent thereon."37 A companion provision of the law states that controlled substances may not be prescribed for an addict, except for an addict who is a bona fide patient suffering from an incurable and fatal disease such as cancer or advanced tuberculosis.38

The Texas Medical Practice Act uses but does not define the term habitual user in a regulation that threatens physicians with the loss of medical licensure if they write: "... prescriptions for or to a person known to be a habitual user of narcotic drugs . . . or to a person who the physician should have known was a habitual user of narcotic drugs...."39 In 1988, prompted by Texas physicians concerned about how this provision related to prescribing opioids for patients with intractable pain, the Texas State Board of Medical Examiners stated that the provision applied only to habituated patients for whom the repeated use of narcotics is not otherwise medically indicated.40 Subsequently, efforts by the Texas Cancer Pain Initiative resulted in enactment on September 1, 1989, of the Intractable Pain Treatment Act, which defined intractable pain and stated that physicians in Texas may treat intractable pain with opioids as they may under federal law, that hospitals or other facilities may not interfere with a physician's treatment of intractable pain, and that a physician is not subject to disciplinary action solely for treating intractable pain.

The Wisconsin Cancer Pain Initiative has received reports that cancer patients in Wisconsin and elsewhere have been treated as addicts in their quest for pain relief.20 This is not surprising considering the confusion that exists between physical and psychologic dependence and addiction. There is some evidence that pain patients have been mistakenly admitted to Narcotic Treatment Programs for addicts. The following is an excerpt from written correspondence (BE Stonecipher in 1981) from the federal government to a physician-director of an NTP who had apparently requested an exception to the regulations governing take home supplies of methadone:

... we believe it is inappropriate and probably unfair to this patient to require that she be subjected to the rigid requirements of a narcotic addiction treatment program. It appears that she became iatrogenically dependent ... this patient's analgesic needs should be cared for on a private doctor/patient relationship. Methadone, in any form, or any other analgesic may be provided by the physician on a prescription basis. The physician can then regulate the patient as he/she sees fit within accepted limits of medical practice.

Physician Reporting of Addicts

Use of terms like addict, habitual user, or habitué may result in reporting of cancer and other patients to the state. For example, the state of California had a law which for many years required physicians to register habitués to Schedule II controlled substances with the state's Bureau of Narcotic Enforcement. A study41 showed that the largest single category of habitués to opioids were individuals with diagnoses of cancer and concluded that "triplicate prescriptions plus public registration of habitués appears, therefore, to be a viable alternative to the removal of any Schedule II drugs from the commercial market."41 The habitué reporting law was subsequently repealed.

The New York State Controlled Substances Act requires physicians to report "addicts" (as defined earlier) to the Commissioner of Public Health: "It shall be the duty of every attending practitioner and every consulting practitioner to report promptly to the commissioner . . . any person under treatment if he finds that such a person is an addict or an habitual user of any narcotic drug. Such reports shall be kept confidential." 42 In 1987, a New York oncologist was investigated by the New York State Department of Health for prescribing more than a 30 day supply of Schedule II opioids, failure to write dates and patient ages on all triplicate prescriptions, not maintaining copies of triplicate prescriptions, and failure to report addicts (cancer patients) to the Commissioner of Health. Eighteen months and thousands of dollars in legal fees later, the physician was admonished by the state on condition that all provisions of law would be complied with in the future (Ronald H. Blum, MD, personal communication).

The Rhode Island Uniform Controlled Substances Act has a provision dating to 1938 that requires practitioners to report extended treatment of patients with controlled substances: "If said practitioner uses controlled substances in Schedule II in the care and treatment of any individual case for a period of three (3) months, he shall . . . report the same to the director of health, together with the name of the patient and the nature of the disease or ailment with which said patient is afflicted."43 According to Rhode Island officials, this provision has assisted in identifying "doctor shoppers."

Limitations on the Prescription Quantity

Cancer patients, especially those with advanced disease and pain, may need very large quantities of Schedule II opioids over an extended period. Federal law, the UCSA, and most states' laws do not restrict the size of such a prescription. However, some states have laws or regulations that restrict the amount to a specific number of dosage units, the supply necessary for a month, or both, whichever is less. Table 1 contains examples. In some states, the meaning of dosage unit is not defined. Some interpret dosage unit to mean a single tablet or capsule. Even though Wisconsin informally interprets dosage unit to mean the amount to be taken at one time,44 the Wisconsin Controlled Substances Board (CSB) said that the rule is an unnecessarily limiting factor in medical practice, especially in the treatment of cancer pain, and that the limitation does not appear to be useful in preventing diversion.45 The Wisconsin Cancer Pain Initiative and the CSB requested the Pharmacy Examining Board (PEB) to repeal the 120-dosage-unit language. At this writing, the PEB has proposed such a change but has not taken final action.

Quantity restrictions in one state can affect patients in other states. Some elderly fixed-income patients with advanced cancer and pain have insurance plans that use mail order pharmacies in New Jersey, a state that limits dispensing of a Schedule II substance to "30 days or 120 dosage forms, whichever is less." One Indiana physician with such patients must write a new prescription for 120 dosage units every week. Delivery to the patient is made approximately 3 weeks later. The physician reports that these patients ration their medication supply because of delays and, thus, experience moderate pain until the package arrives (Neil Irick, MD, personal communication).

Table 1
Examples of State Restrictions for Schedule II Controlled Substances
MO 30-day supply (may be increased up to 6 mo if medical reason is described on prescription)
NH 34-day supply or 100 dosage units, whichever is less (C-III also) (up to 60-day supply for amphetamine or methylphenidate if for ADD or narcolepsy)
NJ 30-day supply or 120 dosage forms, whichever is less
NY 30-day supply for C-II yr (triplicate), (except up to 3 mo if for relief of pain in patients 65 yr of age and over and suffering from diseases known to be chronic and incurable; minimal brain dysfunction in patients not more than 16 yr of age; convulsive disorders, narcolepsy, or panic disorders); same if for written Rx for C-III, IV and V; if an oral Rx for C-III, or V, up to a 5-day supply; if an oral Rx for C-IV, up to 30 days or 100 dosage units, whichever is less
RI 100 dosage units per prescription; no more than 100 dosage units may be dispensed at one time (C-II, III, IV)
SC 30-day supply or 120 dosage units, whichever is less
UT l-mo supply
WI 34-day supply or 120 dosage units, whichever is less (except up to a 90-day supply for C-III or IV anticonvulsant substance) at one time

Additional Regulation of Schedule II Controlled Substances: Multiple Copy Prescription Programs

Ten states have adopted a multiple copy prescription program (Table 2). While each program is different, all permit the state to monitor physician prescribing of Schedule II controlled substances to patients. Laws protect the confidentiality of the information and also allow it to be shared with local, state, and federal law enforcement agencies. The state of Washington uses triplicate prescriptions only in connection with a disciplinary program. In 1989, Michigan and Indiana initiated triplicate programs, and New York added all of the benzodiazepines to its program.

These programs are established to curtail diversion of Schedule II drugs "without affecting the supply of medication to the legitimate users."46 An evaluation of these programs46 has documented the following results in the affected states: (1) substantial reductions in prescribing, (2) reductions in the state's per capita consumption of Schedule II controlled substances, (3) corresponding increases in prescribing of Schedule III substances, and (4) significant reductions in physician requests for triplicate forms. Some states report revocations of physician's licences based on triplicate information, and one state reported an increase in investigative efficiency. The report46 concludes that the reductions in drug availability reflected only a reduction in drug diversion and did not adversely affect patient care, since no significant complaints were received.

Table 2
Adoption of Multiple Copy Prescription Programs

1913-1915, 1972 New York
1940 California
1943 Hawaii (duplicate)
1961 Illinois
1967 Idaho
1978 Rhode Island (duplicate)
1982 Texas
1984 Washington (discipline only)
1989 Michigan
1989 Indiana

Administrators of multiple copy prescription programs insist that they do not compromise the quality of medical care; indeed, many claim that medical practice has been improved because practitioners tend to examine their reasons for prescribing more closely, often resulting in the choice of a less potent analgesic or a smaller quantity.46 According to the aforementioned report,46 health professionals and patients rarely criticize these programs for infringing on medical care issues. In Rhode Island, medical associations have advised their memberships that the duplicate system "is not to be used as the excuse for not prescribing and that the doctor will be liable under malpractice statutes if he fails to provide necessary medication, duplicate prescription or no."46

Other examples of restrictive provisions may be found in the course of an ongoing review of controlled substances, and medical and pharmacy laws and regulations. This will be reported. One area of interest will be whether states allow physicians to use Schedule II stimulants to treat opioid-induced sedation sometimes experienced by cancer patients.

Conclusions

Laws and regulations governing controlled substances, including the opioids, place an extra burden on physicians and patients in some states. A physician can violate a state law or regulation by prescribing an opioid to a cancer patient in a way that would otherwise be permitted in another state or under federal law. An opioid-dependent pain patient is simply a patient under federal law, but may be regarded as an addict, habitual user, or drug-dependent person under some state laws. Dosage restrictions may cause problems for both physicians and patients. Additional regulation of Schedule II opioids reduces drug availability and the number of physicians able to prescribe Schedule II opioids. Together, this information supports the conclusion that opiophobia,47 the fear of using opioids, has a legal basis in some states.

The debate about balance between drug abuse control and drug availability is a classic example of two largely independent groups addressing opposite sides of the same coin, in this instance, prescription drugs. One group strives to reduce the abuse of drugs in one population, the other strives to improve medical use of drugs in another. Unfortunately, some of the methods to achieve the ends of the former may compromise the goals of the latter. Both groups have a common purpose - the improvement of quality of life for Americans.

We must remember that efforts to control drug abuse can occur at the same time as efforts to reduce pain and suffering; neither should impede the other. C. Everett Koop, MD, former Surgeon General of the United States, said to the National Meeting for State Cancer Pain Initiatives; "Addiction is extremely rare when narcotic analgesics are used to treat the pain of cancer. Cancer pain patients should never be regarded as 'drug addicts' merely because analgesics are used to treat their pain. Reach out to drug abuse, regulatory and enforcement agencies and ask for their help to assure that medically needed controlled substances are adequately available for the treatment of cancer patients in pain."48

What practical steps can physicians and other health care professionals take? Several recommendations are offered:

Help Bring State Laws and Regulations Up to Date

The health care provider should become familiar with the laws and regulations that affect opioid treatment of pain. These laws and regulations should be brought up to date with the great advances in knowledge and practice that have occurred since 1970 and that are discussed elsewhere in this issue. New provisions should be included so that state laws reflect the positive framework in federal law described previously. Dosage unit restrictions and reporting of patients to the state should be eliminated. The use of terms such as addict, habitual user, and drug-dependent person should be eliminated (as in the UCSA and many states) or revised so that pain patients cannot be confused with addicts.

An opportunity to revise state controlled substances laws is at hand. The NCCUSL is revising the 1970 UCSA and will probably send it to the states late in 1990. The revised UCSA will contain many new important anti-drug-abuse provisions, including a model program for a state diversion control program. After 5 years of preparation, the new model act is anticipated to be approved late in 1990 and sent to the states. The current draft contains a comment (but not statutory language) that suggests that state law should parallel the federal regulation relating to opioid treatment of intractable pain.

At this writing, efforts to incorporate intractable pain language and a declaration of intent to recognize the important medical uses of controlled substances have not been successful. Thus, the federal CSA is a better model for medical use issues than either the 1970 UCSA or the current version of the revised UCSA. Texas' Intractable Pain Treatment Act also serves as a useful model for legislation in other states.

Seek Clarification if Risk of Sanctions Is Perceived

If a physician is concerned that prescribing the right drug, in the right amount, at the right interval for pain may result in legal sanctions, the professional response should be to seek clarification with the appropriate state agency. If the physician determines that risk of sanction exists, the response should be to marshal the medical facts and expert opinion, and propose changes that would eliminate the risk.

Communicate with the Regulatory and Licensing Officials in Each State

Health care providers should get to know their regulators and licensing officials. They should be apprised of the improvements in the treatment of pain. Health care providers can help regulators address diversion issues. The few physicians who divert controlled substances pose a threat to every physician who treats pain with opioids. Law enforcement and regulatory personnel are better able to stop a practitioner from diverting drugs if they have the full support of the medical community. The controlled substances official for each state is listed in a directory available from the National Association of State Controlled Substances Authorities (NASCSA), Iron Works Pike, P.O.Box 11910, Lexington, KY 40578.

Join the Debate About Multiple Copy Prescriptions

The DEA has encouraged every state governor to adopt multiple copy prescription programs.20 Physicians, epidemiologists, public health experts, and other health care professionals who are committed to improving the management of pain and reducing diversion should join this debate. Both sides of the issue should be carefully examined, with the benefit of as much data and experience as possible.

Become Involved in Efforts to Prevent Diversion

Physicians and other health care professionals should be alert for opportunities to prevent diversion. Con artists feign symptoms of pain convincingly. Physicians must know their patients well, and verify the identity of the patient if there is suspicion. Forgers can be deviously creative, so one should protect office or hospital prescription pads as a checkbook.

Health care providers should learn how sources of diversion can be identified and stopped, using currently available information systems and interventions. A number of sources of information have been reviewed.27, 49 The nature and extent of prescription drug abuse and diversion should be carefully studied. How much of the problem is attributable to psychic or dependence-producing variables, compared to mental illness-related motivations? Is abuse of prescription-controlled substances increasing or decreasing? Nationally, although still an important problem, there have been significant declines in the nonmedical use and morbidity associated with prescription controlled substances.50, 51 Only valid measures should be used to describe the diversion and abuse of drugs. The number of prescriptions or a state's per capita consumption of drugs are not valid measures of drug diversion or abuse.

Health care providers should become familiar with how the traditional "targeted enforcement" approach can make use of existing information systems and audits to identify the individual practitioners who divert drugs. These information systems should be used to full advantage before consideration of costly additional systems. A congressional committee reviewed efforts to address the diversion problem and concluded, "The Committee believes that through vigorous and imaginative use of the ARCOS system, in conjunction with other drug diversion/abuse indicators such as the Drug Abuse Warning Network (DAWN), retail diversion activities can be identified and the individuals involved apprehended and prosecuted."52

Regulators in each state should work with health professionals to develop interventions that are likely to be effective and appropriate to the type of transgression. The options include education, treatment, reprimand, revocation or suspension of prescribing privilege, revocation or suspension of license, or criminal sanction. No public interest is served by jailing an impaired physician, and attempts to educate a "script doctor" inspired by profit will be a waste of time and effort.

Newcomers to the field of diversion control need to know that effective diversion control depends upon cooperative efforts. A report to Congress concluded, "A comprehensive approach using law enforcement, education, and professional peer pressure is the best hope for controlling these drugs. This approach requires commitment by medical and pharmaceutical associations, State and local governments, and the Federal government."53 No single agency or organization has sufficient resources to address the problem. State laws provide for agencies to cooperate and exchange information. If key agencies do not cooperate fully, opportunities to address diversion will be forfeited, and the range of diagnostic information and interventions will be narrowed accordingly. A cooperative, coordinated effort among the responsible agencies and professions will reduce diversion.54 The last step in the process to control diversion is to evaluate and report results, and recommend actions to refine the program.

Physicians in Multiple Copy Prescription States Should Get the Forms

Physicians in states with multiple copy prescriptions who anticipate treating any patients with moderate to severe pain outside of a hospital should have the necessary prescription forms available. Patient groups may include those with fractures, cancer, kidney stones, and sickle cell crisis, as well as postsurgical patients. No patient should ever suffer needless pain because a physician does not have the proper prescription pad.

State Boards Should Clarify and Communicate Their Policy on Opioids and Chronic Pain

Physicians and other regulated health care professionals should ask their state licensing agencies to issue positive statements to their licensees about the treatment of pain with opioids. An advisory from the Texas medical licensing authority is an example.40

Get Involved with State Cancer Pain Initiatives

Physicians, pharmacists, nurses, social workers, and their professional societies and licensing agencies should get involved in a state cancer pain initiative. Information about starting initiatives can be obtained from: Wisconsin Cancer Pain Initiative, 3675 Medical Sciences Center, 1300 University Avenue, Madison, WI 53706. In addition, the writer is interested in receiving information and comment about issues raised in this paper.

References

1. David F. Musto, MD, Professor of the History of Medicine at the Yale School of Medicine, describes periods of intolerance in American narcotics policy and expresses his concern that we must remain alert to the potentially harmful consequences of antidrug sentiment. See Musto DF. The American disease: origins of narcotic control. New York: Oxford University Press, 1988.

2. A government publication to be used for developing antidrug programs in the nation's schools listed the negative consequences for using illicit drugs as well as those with medical uses, but failed to mention that drugs such as morphine possessed any legitimate uses. See U.S. Department of Education. What works: schools without drugs. Washington, DC: USDE, 1987.

3. The resolution of NASCSA to the White House Conference on a Drug Free America to incorporate into its final report clear recognition that the proper use of drugs (as approved by the U.S. Food and Drug Administration) is essential to the health and welfare of the American public was ignored. See National Association of State Controlled Substances Authorities, Council of State Governments. Resolution 87-11: use of controlled substances for legitimate medical purposes. Lexington, KY: NASCSA, 1987.

4. World Health Organization. Cancer pain relief. Geneva: WHO, 1986.

5. Williams RL. Achieving balance between drug control and drug availability. American Pharmaccutical Association. Washington, DC, 1985. Unpublished paper presented at the National Conference for Controlled Substances Authorities, Orlando, FL, August 13, 1985.

6. American Medical Association. Balancing the response to prescription drug abuse: a national symposium on medicine and public policy. Chicago, IL: 1989 (in press).

7. Advances in pain research and therapy, vol 11: drug treatment of cancer pain in a drug-oriented society. New York: Raven Press, 1989.

8. Marks EM, Sachar EJ. Undertreatment of medical inpatients with narcotic analgesics. Ann Intern Med 1973;78:173-181.

9. Daut RL, Cleeland CS. The prevalence and severity of pain in cancer. Cancer 1982;50:1913-1918.

10. Bonica JJ. Cancer pain: a major national health problem. Cancer Nurs 1978; 1:313-316.

11. Cleeland CS. Barriers to the management of cancer pain. Oncology 1987(suppl):19-26.

12. Dahl JL, Joranson DE, Engber DE, Dosch J. A report on the Wisconsin Cancer Pain Initiative. J Pain Symptom Manage 1988;3(suppl):Sl-S20.

13. Cleeland CS, Cleeland LM, Dar R. Rinehart LL. Factors influencing physician management of cancer pain. Cancer 1986;58:796-800.

14. Charap AD. The knowledge, attitudes and experience of medical personnel treating pain in the terminally ill. Mt Sinai J Med (NY) 1978;45:561-580.

15. Huber SL, Patry RA, Hudson HD. Influencing drug use through prescribing restrictions. Am J Hosp Pharm 1982;39: 1898-1901.

16. Sigler KA, Guernsey BG, Ingrim NB, et al. Effect of a triplicate prescription law on prescribing of schedule 11 drugs. Am J Hosp Pharm 1984;41:108-111.

17. Berina LF, Guernsey BG, Hokanson JA, Doutre WH, Fuller LE. Physician perception of a triplicate prescription law. Am J Hosp Pharm 1985;42:857-859.

18. Interagency Committee on Pain and Analgesia: report of subcommittee on drug availability and legislation. Rockville, MD, U.S. Department of Health and Human Services, 1986.

19. Porter J,Jick H. Addiction rare in patients treated with narcotics. N Engl J Med 1980;302:123.

20. Joranson DE, Dahl JL. Achieving balance in drug policy: the Wisconsin model. In: Hill CS Jr, Fields WS, eds. Advances in pain research and therapy, vol 11. New York: Raven Press, 1989.

21. Haislip GR. Impact of drug abuse on legitimate drug use. In: Hill CS Jr, Fields WS, eds. Advances in pain research and therapy, vol 11. New York: Raven Press, 1989.

22. See generally Code of federal regulations, Title 21 Part 1300 to end. Washington, DC: U.S. Government Printing Office.

23. See, eg, Section 202 of the 1962 Amendments to the Federal Food, Drug and Cosmetic Act. Public Law 87-871, 76 Stat 780.

24. Controlled Substances Act, Public Law 91-513, 84 Stat 1242.

25. Controlled Dangerous Substances, Narcotic and Drug Control Laws: Hearings before the U.S. House of Representatives Committee on Ways and Means. Washington, DC: U.S. Government Printing Office, 1970.

26. Fed Register, 1988;53:242(50591-50597).

27. Max MB. Pain relief and the control of drug abuse: conflicting or complementary goals? In: Hill CS Jr, Fields WS, eds. Advances in pain research and therapy, vol 11. New York: Raven Press, 1989.

28. Narcotic Addict Treatment Act of 1974, P.L. 93-281. U.S. House of Representatives report no. 93-884. Washington, DC, March 19, 1974.

29. Code of Federal Regulations, Title 21 Part 1306.07(c).

30. Code of Federal Regulations. Title 21 Part 1306.

31. National Conference of Commissioners on Uniform State Laws. 1986-1987 Reference Book. Chicago.

32. National Conference of Commissioners on Uniform State Laws. Uniform Controlled Substances Act. St. Louis, MO, August 1-7, 1970.

33. The Maryland Controlled Dangerous Substances Act was adopted in 1970 before the UCSA and apparently used the findings and declarations from the draft CSA in its own similar section. Thus, Maryland law recognizes that many controlled substances have a useful purpose and are necessary to the health of the people of Maryland. The same section states that one of the purposes of the law is to "insure their availability for legitimate medical and scientific purposes." See Maryland Controlled Dangerous Substances Act, Article 27, Sect 276(a).

34. Because New Jersey apparently incorporates federal regulations into its own regulations, it has a provision relating to the treatment of intractable pain which is identical to federal regulations. See New Jersey Administrative Code, 8:65-7.7(c).

35. Rinaldi RC, Steindler EM, Wilford BB, Goodwin D. Clarification and standardization of substance abuse terminology: preliminary communication. JAMA 1988;259:355-397.

36. Jaffe JH. Misinformation: euphoria and addiction. In: Hill CS Jr, Fields WS, eds. Advances in pain research and therapy, vol 11. New York: Raven Press, 1989.

37. New York State Controlled Substances Act, Sect 3302.1.

38. New York State Controlled Substances Act, Sect 3350- 1.

39. Rules of the Texas State Board of Medical Examiners, Sect 3.08(4)(C).

40. Narcotic drug prescribing. Tex State Bd Med Exam Newslett 1988;10:2.

41. Tennant F. The California registration system for habitués to schedule II drugs. In: Harris LS, ed. Problems of drug dependence 1980. Proceedings of the 42d Annual Scientific Meeting of the Committee on Problems of Drug Dependence (pub. no. ADM 81-1058). Washington, DC, U.S. Government Printing Office, 1981.

42. New York State Controlled Substances Act, Sect 3372.

43. Rhode Island Uniform Controlled Substances Act, Sect 21-28-3.20.

44. State of Wisconsin Controlled Substances Board Medical Examining Board and Department of Regulation and Licensing. A guide to prescribing controlled substances in Wisconsin. Madison, WI, 1988.

45. Joranson DE, Bachmann A. Option paper. Madison, WI: Wisconsin Department of Health and Social Services Controlled Substances Board, 1988.

46. U.S. Department of Justice, Drug Enforcement Administration. Multiple copy prescription programs resource guide. Washington, DC: U.S. Government Printing Office, 1987.

47. Morgan JP. American opiophobia: customary underutilization of opioid analgesics. Adv Alcohol Subst Abuse 1986;5: 163-173.

48. Koop CE. Statement on the occasion of the first national meeting for state cancer pain initiatives. Madison, WI, July 7, 1989.

49. PADS Technical Manual. Chicago: American Medical Association Department of Substance Abuse, 1988.