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1994 Joranson DE, Gilson AM. Controlled substances, medical practice and the law. In: Schwartz HI. Psychiatric Practice Under Fire: The Influence of Government, the Media and Special Interests on Somatic Therapies. Washington, DC: American Psychiatric Press, Inc., 1994:173-194.

CHAPTER EIGHT

Controlled Substances, Medical Practice, and the Law

David E. Joranson, M.S.S.W.
Aaron Gilson, M.S.

The development of drug control policy in the United States has been characterized by vacillation between tolerance and intolerance toward drugs (Musto 1987). Today's war on drugs is distinguished by intense media coverage of drug-related crime, new antidrug laws, and efforts to educate schoolchildren and the public to "just say no" to drugs. The message is clear: Drugs are dangerous and must be avoided. The United States continues to have significant drug abuse problems that must be addressed, but we should be careful not to reject the medical benefits of drugs or restrict the ability of physicians to care for patients.

Antidrug efforts are directed not only at the illegal controlled substances such as marijuana, heroin, and cocaine, but also at the legal controlled substances that have important medical uses: the opioids (narcotics), stimulants, and sedative hypnotics. These efforts involve media campaigns against perceived overprescribing (Safer and Krager 1992), vigorous enforcement efforts against suspect prescribers (Benton 1993; Hill 1989; McIntosh 1991a, 1991b; Nowak 1992), regulations to increase restrictions on prescribing (Weintraub et al. 1991), and federal proposals to monitor all prescribing to patients of all controlled substances (Stark 1990).

When controlled substances are used for medical purposes, they can provide great improvements in the quality of life for millions of people with debilitating diseases and conditions, including pain, severe anxiety, narcolepsy, and epilepsy. However, when diverted from the legitimate distribution system, the nonmedical use of controlled substances can lead to serious public health problems. For example, there are a small percentage of practitioners who abuse their privilege to prescribe and are a source of drugs for addicts and the illicit market. Consequently, it is in the public interest to protect the medical uses of controlled substances while at the same time preventing their diversion and abuse. Public policy should recognize the dual effect of controlled substances on public health to obtain the broadest medical benefit while reducing the risks of diversion and abuse.

There is troubling evidence that some controlled substances laws and regulations and their enforcement interfere with medical practice and patient care. In this chapter we explore whether controlled substances laws and regulations achieve an appropriate balance between controlling abuse and protecting medical use. The primary focus is on the opioids (narcotics) that are used in the somatic treatment of pain, in particular pain due to cancer.

Tragically, cancer pain is often undertreated. Several factors impede pain management, including inadequate preparation of health care professionals, the low priority given to pain management, and the effects of antidrug policies. Although most, if not all, cancer pain can be relieved (Foley 1985; Takeda 1987), it is estimated that one-half to three-quarters of cancer patients with pain are inadequately treated and that nearly 25% die with severe unrelieved pain (Daut and Cleeland 1982). The mainstay of cancer pain management is opioid therapy (World Health Organization 1986). Efforts to improve pain management and eradicate misuse and abuse of prescription controlled substances take place in a medical and regulatory environment characterized by misinformation about opioids. Misinformation about opioids and exaggerated fears of addiction are prevalent among the professions and medical regulators and are partly responsible for the undertreatment of pain (Ferrell et al. 1992; Jaffe 1989; Jasinski 1989; Joranson et al. 1992; Morgan 1986).

The Framework of Controlled Substances Policy

Three tiers of law establish the policy framework that governs the medical use and diversion of controlled substances: 1) international treaties, 2) federal laws and regulations, and 3) state laws and regulations. As will be seen, international and federal laws clearly recognize the principle that a balance should be maintained between controlling drug abuse and ensuring that controlled substances are available for medical use. However, most state laws do not achieve this balance and, in some instances, interfere with medical practice.

International Treaties, Drug Control, and Medical Use
Treaties provide the basic legal framework for controlling international and domestic production and distribution of drugs that have been determined to have an abuse liability. The principal treaties recognize that many controlled substances are indispensable to public health and that their availability for legitimate medical and scientific purposes must be ensured. These treaties are the Single Convention on Narcotic Drugs, 1961 (United Nations 1977b), and the Convention on Psychotropic Substances, 1971 (United Nations 1977a). In becoming a party to a treaty, a government agrees to ensure the availability of controlled substances for medical purposes. Most, but not all, of the governments of the world have acceded to these treaties (International Narcotics Control Board 1991).

The International Narcotics Control Board, the United Nations agency responsible for monitoring governments' compliance with the treaties, has reported that opioids are not sufficiently available for legitimate medical purposes throughout the world and that this is due in part to antidrug abuse laws and regulations that unduly restrict the availability of opioids for medical use (International Narcotics Control Board 1989).

A World Health Organization expert committee has also expressed concern that the fear of drug abuse has curtailed appropriate medical use of opioids, particularly for the treatment of cancer pain (World Health Organization 1990); laws are so strict in some countries that physicians cannot prescribe morphine for cancer pain. The expert committee commented on "multiple copy prescription programs" that are used in several countries as well as in several states in the United States.

The extent to which these programmes restrict or inhibit the prescribing of opioids to patients who need them should be questioned.... Health care workers may be reluctant to prescribe, stock or dispense opioids if they feel that there is a possibility of their professional licenses being suspended or revoked by the governing authority in cases where large quantifies of opioids are provided to an individual, even though the medical need for such drugs can be proved. (World Health Organization 1990, p. 39)
Thus, although the purpose of the international treaties is to ensure availability of drugs for medical use, restrictive laws in some countries limit the use of opioids for the treatment of pain. To what extent do laws and regulations in the United States maintain a balance between the control of drug abuse and the appropriate medical use of opioid analgesics or other controlled substances?

Federal Law and Medical Practice
THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
The Food and Drug Administration (FDA) has approved opioids, stimulants, and sedative hypnotics as safe and effective for medical use and commercial marketing under the Federal Food, Drug, and Cosmetic Act of 1962. This act does not restrict a physician's prescribing either to labeled indications or to recommended doses. This policy is clearly stated in the foreword to the Physician's Desk Reference (1993). Once a product has been approved under the Federal Food, Drug, and Cosmetic Act for marketing, a physician may prescribe it for uses, in treatment regimens, or in patient populations that are not included in the approved labeling (Federal Register 1983). Appropriate medical practice and patient interest require that physicians be free to administer drugs according to their best knowledge and judgment (Federal Register 1975).

New uses for drugs are often discovered, reported in medical journals and at medical meetings, and subsequently may be widely used by the medical profession.... When physicians go beyond the directions given in the package insert it does not mean they are acting illegally or unethically, and Congress does not intend to empower the FDA to interfere with medical practice by limiting the ability of physicians to prescribe according to their best judgment. (United States v. Evers 1981)
In addition, the federal courts have supported the principle that the FDA does not regulate medical practice (United States v. Evers 1981). It is generally recognized that the states, not the federal government, regulate the practice of medicine and that federal law generally defers to state law in areas where there is not a direct conflict (see amendments to the Federal Food, Drug, and Cosmetic Act 1962).

THE CONTROLLED SUBSTANCES ACT
Opioids, stimulants, and sedative hypnotics are additionally subject to controlled substances laws because of their abuse liability. The federal Controlled Substances Act (CSA) (1970) parallels the international treaties, by regulating production and distribution and prohibiting nonmedical use of controlled substances, while clearly recognizing their medical value to public health. The CSA states that "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" (p. 834).

Controlled substances are placed in five schedules. Drugs with no accepted medical use are placed in Schedule I and are available only for scientific research. Drugs that have been approved for medical use are placed in Schedules II-V according to potential for abuse, with drugs having the highest potential for abuse assigned to Schedule II. Although prescriptions for certain controlled substances must be in writing, and refills are limited, the fact that a drug has been approved for medical use does not change when it becomes a controlled substance.

Today's medical and psychiatric practitioners are probably more familiar with legal restrictions over controlled substances prescribing than they are with the legal provisions that were included in the CSA to ensure that drug law enforcement does not interfere with medical practice. For many years prior to the adoption of the CSA in 1970, narcotic prescribing was marked by controversy between drug law enforcers and physicians (Musto 1987). This controversy reached its pinnacle in 1970 during congressional consideration of the new Controlled Substances Act. Congress was considering legislation drafted by the Bureau of Narcotics and Dangerous Drugs in the Department of Justice. The bill proposed that the Department of Justice and an advisory committee appointed by the attorney general would be solely responsible for making the scientific and medical findings necessary to place a drug under the control of the CSA (Committee on Ways and Means 1970). There was deep concern in the scientific and medical community when it was learned that this bill would give law enforcement complete authority over scientific and medical decisions (Committee on Ways and Means 1970). Following testimony from numerous physicians, the American Medical Association, and the American Psychiatric Association, Congress adopted a different bill that placed the responsibility for medical and scientific determinations in the Department of Health, Education, and Welfare (now the Department of Health and Human Services) and specified that its determinations were binding on drug control decisions made by the attorney general (Controlled Substances Act 1970). Other provisions of law and legislative history make it clear that the CSA is not intended to interfere either with medical practice or the availability of these drugs for patient care (Joranson 1990a; United States House of Representatives 1970).

The availability of controlled substances for medical purposes is ensured.
In an effort to control diversion from excessive manufacture of drugs, the CSA gives the Drug Enforcement Administration (DEA) authority to set production quotas for a number of opioids, stimulants, and sedative hypnotics. Quotas must accommodate all legitimate medical and scientific needs (Controlled Substances Act 1970). In one instance, however, the DEA tried to stop diversion of methylphenidate at the retail level by setting a very low production quota. This action led to an official statement of the principle of "undisputed proposition of drug availability":

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.... The harshest impact of actual and threatened shortages falls on the patients who must take methylphenidate, not on the manufacturers to whom the quotas directly apply. Actual drug shortages, or even threatened ones, can seriously interfere with patients' lives and those of their families. (Federal Register 1988, pp. 50593-50594; italics added)
In addition to recalculating the quotas for methylphenidate, the DEA has expressed willingness to grant additional quotas for opioids to respond to improvements in the treatment of cancer pain (Max 1989).

Medical practice is not regulated by the CSA. The states, not the federal government, have the authority to regulate medical practice. This authority is based on the police power in state constitutions and underlies the medical practice acts that are designed to protect the public health and safety (Parmet 1989). The CSA was not intended to supersede the authority of the Federal Food, Drug, and Cosmetic Act (United States House of Representatives 1970) and provides no authority for the DEA to regulate medical decisions such as the indications for which a drug may be prescribed and the amount or the duration of therapy.

However, the DEA promulgated a regulation in 1986 that could negatively affect medical practice in the care of cancer patients. The regulation placed the new synthetic tetrahydrocannabinol product (THC) into Schedule II following its approval for medical use by the FDA (Federal Register 1986). Because of the drug's chemical relation to marijuana, the regulation stated that physicians who choose to prescribe the drug for other than the specifically labeled use (for the treatment of cancer chemotherapy-induced nausea and vomiting that is unresponsive to other modalities) may subject themselves to investigation for possible violation of the CSA. The DEA argued that the policy was necessary to comply with United States treaty obligations governing marijuana and THC under the Convention on Psychotropic Drugs. Many medical organizations objected to this interference in medical decisions and in FDA policy that allows off-label prescribing. Any rationale for the DEA policy disappeared when THC's international classification was changed to reflect its medical use, but the regulation has not been repealed.

Further, the Pharmacist's Manual (United States Department of Justice 1986) lists indications "which may indicate that a purported prescription order was not issued for a legitimate medical purpose in the course of the physician's professional practice" (p. 31), including "Does the purported prescription order contain an indication other than one found in the package insert?" (p. 32).

The DEA's enforcement authority is intended to be concentrated on those practitioners who engage in unlawful use of controlled substances outside of medical practice. Indeed, it is unlawful for a practitioner to prescribe a controlled substance except in the course of professional practice. The phrase in the course of professional practice defines the boundaries of practitioner investigations and prosecutions for the DEA.

It matters not that such acts might constitute terrible medicine or malpractice. They may reflect the grossest form of medical misconduct or negligence. They are nevertheless legal. On the other hand, any act of prescribing, dispensing or distributing of a controlled substance other than in the course of the registrant's professional practice is an illegal distribution of that controlled substance, subject to the same penalties as if the drug were sold by the lowest pusher on the street. (Stone 1983, p. 23)
The intent of the CSA to avoid interference with medical practice was reaffirmed in 1978 when Congress enacted a law to satisfy United States obligations under the Convention on Psychotropic Substances. In so doing, Congress determined that control of psychotropic substances (e.g., tetrahydrocannabinol, benzodiazepines) in the United States should be accomplished within the framework of the CSA to ensure that their availability "for useful and legitimate medical and scientific purposes will not be unduly restricted" (Controlled Substances Act 1970, p. 836). Further, the law stated that nothing in the treaties was to "interfere with ethical medical practice in this country as determined by the secretary of Health and Human Services on the basis of a consensus of the American medical and scientific community" (p. 836).

Treatment of addiction is distinguished from treatment of intractable pain. It is essential to differentiate between prescribing opioids for intractable pain and prescribing them for addiction. When Congress adopted the new CSA, it also settled a long controversy between drug law enforcement and health officials about the lengths a physician could go in prescribing opioids to narcotic addicts (United States House of Representatives 1970). Congress decided that prescribing opioids for narcotic addiction was outside of professional practice and, therefore, unlawful under the CSA, unless the physician was specifically registered in the Narcotic Treatment Program to use methadone to maintain or detoxify narcotic addicts. Consequently, the definition of addict becomes critically important, particularly in view of long-standing problems in defining terms associated with drug abuse phenomena. The CSA defines addict as a person who "habitually uses any narcotic drug so as to endanger the public morals, health, safety, or who is so far addicted to the use of narcotic drugs as to have lost power of self-control with reference to his addiction" (Controlled Substances Act 1970, p. 836).

The CSA definition of addict is imprecise and does not parallel the definition of drug dependence of the World Health Organization (1969) or the DSM-IV (American Psychiatric Association 1994). The definition does not distinguish an addict from a patient who is simply physically dependent on an opioid for pain management. However, controlled substances regulations promulgated by the DEA make it clear that a physician who prescribes opioids to treat intractable pain over an extended period is considered to be acting within the professional practice of medicine.

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. (Code of Federal Regulations, Title 21 Part 1306.07 [c], April 1988)
State Laws and Prescribing of Controlled Substances
Like federal law, state controlled substances laws prohibit nonmedical use of controlled substances. Unlike federal law, most state controlled substances laws, although they permit prescribing, do not explicitly recognize either the public health benefits of controlled substances or the need to balance their control by ensuring availability for medical purposes. In fact, some state laws and regulations that have been enacted to deal with drug abuse and diversion clearly interfere with medical practice and patient care.

Today's state controlled substances laws are based on a 1970 model law called the Uniform Controlled Substances Act (UCSA). The purpose of the 1970 UCSA was to repeal a plethora of antidrug laws that individual states had adopted since the turn of the century and replace them with a single unified framework to achieve consistency in national drug control policy (National Conference of Commissioners on Uniform State Laws 1970). But instead of establishing a federal-like balance of power between law enforcement and medical science, the UCSA only mentioned in a prefatory note that states could consider establishing an advisory committee to the regulatory agency, an alternative that was rejected by the Congress. The UCSA did not mention the importance of ensuring the availability of controlled substances. A definition of addict was also not included, leaving the states without a uniform definition, such as had been developed by the World Health Organization (1969). The UCSA, like the CSA, did not regulate medical decisions such as the quantity of a drug that may be prescribed at one time.

Although the UCSA was adopted in some form in most states, a number of states did not repeal old laws. In addition, some states have adopted new laws and regulations that restrict prescribing and dispensing of FDA-approved drugs. For example, South Carolina's controlled substances law prohibits the prescribing of any controlled substance for a use other than approved by the FDA, and the use of methadone as an analgesic is restricted to patients in hospitals (South Carolina Health Code 1984). A review of state-controlled substances law reveals additional examples of nonuniform provisions that interfere with the use of controlled substances in medical practice (Joranson 1990a). The following are several examples:

PAIN PATIENTS MAY BE CONFUSED WITH ADDICTS
It should be recalled that federal law, which is applicable in every state, defines addict as an individual who is a danger to society, whose need for opioids can be legally provided for only by specially registered narcotic treatment programs, and for whom a physician may not prescribe opioids unless for pain. A number of state definitions allow confusion of an addict with a pain patient who is only physically dependent on an opioid (Joranson 1990a). However, physical dependence is a common physiologic consequence of using opioids to treat chronic pain and should not be confused with addiction (American Pain Society 1992). For example, the New York State Controlled Substances Act defines addict as "a person who habitually uses a narcotic drug and who by reason of such use is dependent thereon" (New York State Controlled Substances Act, Sect 3302. 1, p. 467). A companion provision states that controlled substances may not be prescribed for an addict, unless he or she is a "bona fide patient suffering from an incurable and fatal disease such as cancer or advanced tuberculosis" (New York State Controlled Substances Act, Sect 3351 [b], p. 524). Some states require physicians to report to the government those patients who have been treated longer than several months with a Schedule II controlled substance. New York requires these people to be reported on a special state form as addicts (Joranson 1990a). These laws are similar to one in California that was enacted many years ago, apparently as an alternative to "the removal of abusable Schedule II drugs from the commercial market" (Tennant 1981, p. 193). The law required physicians to report habitues to the state's Bureau of Narcotic Enforcement. Before repeal, the largest single category of habitues to opioids that had been reported were individuals with diagnoses of cancer (Joranson 1990a).

THE QUANTITY PRESCRIBED MAY BE LIMITED TO LESS THAN MEDICALLY INDICATED
Although federal law does not limit the amount that can be prescribed, a number of states have restricted the number of dosage units that can be dispensed to as little as 100 dosage units or a 5-day supply (Joranson 1990a) (see Table 8-1). Since it is not uncommon for a cancer patient to take 30-50 pills a day for pain management, prescriptions must be dated every 2 or 3 days. Restricting the prescription amount to less than the medical needs of the patient can result in greater expense to obtain more frequent prescriptions as well as additional dispensing fees. Unfortunately, pain management may also be affected. One Indiana physician has a number of cancer pain patients who need large quantities of opioids and whose insurance plan requires the use of a mail-order pharmacy in New Jersey (which limits dispensing to 120 dosage units per prescription). This physician, whose prescriptions are mailed to New Jersey every few days, reports that his patients ration their medication because of delays in delivery (Joranson 1990a). As a result, these patients experience pain that could be relieved if they had a predictable and sufficient supply of medication.

In Wisconsin, the Controlled Substances Board found that the " 120 dosage units or a 34-day supply whichever is less" rule was confusing and unnecessarily limited prescribing of controlled substances, especially in the treatment of cancer pain. Further, the rule was not useful in preventing diversion (Joranson and Bachman 1988). In cooperation with the Pharmacy Examining Board, the rule was amended in 1991 to delete the 120 dosage unit restriction.

Limitations on the number of dosage units for controlled substance prescriptions are not confined to laws and regulations. Mail-order pharmacy members of the American Managed Care Pharmacy Association have guidelines that specify that dispensing of Schedule II controlled substances must be limited to the amount necessary to meet the legitimate medical needs of the patient.

The dispensing of Schedule II substances should be limited to a 30 day supply, or 120 dosage units, whichever is less.... These maximum quantity limitations enable the patient to obtain a reasonable quantity of controlled substances to assist in an established medical regimen. (American Managed Care Pharmacy Association, undated, p. 3)
American Managed Care Pharmacy Association materials state that these guidelines are consistent with the policies of the DEA, although as stated previously, neither federal law nor the DEA regulations limit the quantity of a Schedule II prescription. Nevertheless, the DEA wrote to the American Managed Care Pharmacy Association in 1990: "The DEA commends the efforts your members have made to the implementation of the Guidelines. The Office of Diversion Control is pleased to offer our continued support of your Association" (American Managed Care Pharmacy Association, undated, p. 3).

Table 8-1. Examples of state restrictions for Schedule II controlled substances
State Restriction
Missouri 30-day supply (may be increased up to 6 months if medical reason is described on prescription)
New Hampshire 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)
New Jersey 30-day supply or 120 dosage forms, whichever is less
New York 30-day supply for C-II (triplicate) (except up to 3 months if for relief of pain in patients 65 years of age or over and suffering from diseases known to be chronic and incurable; minimal brain dysfunction in patients not more than 16 years 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
Rhode Island 100 dosage units per prescription; no more than 100 dosage units may be dispensed at one time (C-II, III, IV)
South Carolina 30-day supply or 120 dosage units, whichever is less
Utah 1-month supply
Wisconsin 34-day supply (except up to a 90-day supply for C-III or IV anticonvulsant substance)

PRESCRIPTION MONITORING PROGRAMS INTERFERE WITH MEDICAL PRACTICE

Multiple copy prescription programs (MCPPs), or "triplicate" prescription programs, began in the United States with the New York program in 1913 (see Table 8-2). These programs are established to curtail diversion of Schedule II drugs "without adversely affecting the supply of medication to the legitimate user" (United States Department of Justice 1987, p. 4). MCPPs typically require physicians and pharmacists to use a special multipart government prescription form so that prescribing and dispensing of certain drugs to patients can be monitored by a designated state regulatory or enforcement agency. MCPPs differ from state to state. For example, the New York law provides that prescriptions for all drugs subject to the triplicate program must be written and are not refillable; these are controls that are reserved for Schedule II drugs under the CSA and UCSA. The result is that Schedule II prescription controls were imposed on the benzodiazepines (Schedule IV) when New York added these drugs to the triplicate prescription program in 1989.

The DEA reports that implementation of MCPPs results in prescription decreases of 50% or more in the period following implementation, reduction in the state's per capita consumption of the substances, and significant reduction in physician requests for triplicate forms in successive years. Administrators of MCPPs insist that these programs do not compromise the quality of medical care; indeed, they claim that medical practice has been improved because practitioners tend to examine more closely their reasons for prescribing and often choose a less potent analgesic or a smaller quantity (United States Department of justice 1987). The DEA strongly supports implementation of legislation to adopt these programs in all states (United States Department of Justice 1987, 1990).

Table 8-2. Multiple copy prescription programs
Year State
1913-1915; 1972 New York
1940 California
1943 Hawaii (duplicate)
1961 Illinois
1967 Idaho
1978 Rhode Island (duplicate)
1982 Texas
1989 Michigan
1989 Indiana


The Risk of Regulatory Scrutiny

Researchers, clinicians, and policy specialists have expressed concern that strict prescription monitoring can interfere with appropriate prescribing and limit patient care (Angarola and Wray 1989; Foley 1989; Hill 1989; Joranson 1990a; Max 1990; Portenoy 1990). Indeed, researchers have reported that an MCPP hampered the prescribing of Schedule II opioids for terminally ill patients with chronic pain (Berina et al. 1985). The substitution of weaker opioids in lower schedules for more potent opioids was encouraged by an MCPP (Sigler et al. 1984). Furthermore, factors such as "excessive regulation" and "reluctance to prescribe" were identified as significantly greater barriers to pain management by physicians who treat cancer patients in states with MCPPs than by physicians in states without these programs (Von Roenn et al. 1993). Of the physician members of the American Pain Society who responded to a survey, 40% agreed that their prescribing of opioids for chronic nonmalignant pain was influenced by legal concerns (D. C. Turk, personal communication to D. E. Joranson, December 1992; Turk and Brody 1992). A pilot study found that more than one-half of physicians surveyed reported that they would reduce the dose or quantity, reduce the number of refills, or choose a drug in a lower schedule because of concern about regulatory scrutiny (Weissman et al. 1991).

Although documented, these concerns are not necessarily recognized as valid by regulatory agencies:
Nothing in the multiple copy program limits or restricts medical judgement as to which drug or amount to prescribe. They must simply write the prescription on a different form.... Physicians do not abandon their professional training, oath, and duty to their patients because a prescription for a specific drug requires a state-issued prescription blank.... The concern about MCPPs interfering in the management of pain is frequently raised in reference to, specifically, cancer pain. The word cancer evokes an emotional, fearful response in most people, and this fear and emotion have been exploited by MCPP opponents.... The management of pain is not influenced by MCPPs, rather, it is a function of physician education. (United States Department of Justice 1990, pp. 40-42)
To explore further whether there is valid cause for physicians to perceive risk associated with investigation by regulatory agencies, we studied a sample of the members of state medical examining boards throughout the United States (Joranson et al. 1992). State medical boards administer medical practice laws and have the duty to protect the public health from substandard, incompetent, and unlawful practices. These boards determine what constitutes unprofessional conduct and have the authority to grant, suspend, deny, limit, or revoke a license to practice medicine.

A total of 627 medical board members were surveyed in 1991 with the cooperation of the Federation of State Medical Boards of the United States. We obtained a 49% response rate. The mean age of the respondents was 55, and they had received their medical degrees between 1926 and 1987; the median year was 1961. The physician board members were asked to rank the opioid analgesics they would and would not recommend for management of moderate to severe cancer pain. These regulator-physicians tended to prefer drugs like aspirin and acetaminophen alone or in combination with codeine instead of the potent opioids like morphine and hydromorphone that are preferred for moderate to severe pain. This may be an example of the customary prescribing patterns that have been discussed by Morgan (1986) in his treatise on "opiophobia." Further, most of the board members indicated that "addiction" includes physical dependence. Only 10% chose psychological dependence alone.

Board members were also asked to give their opinion on the legality of prescribing opioids for more than several months to chronic pain patients with and without cancer. Only 75% of medical board members were confident that prescribing opioids for chronic cancer pain was both legal and acceptable medical practice; 14% felt it was legal but would discourage it; and 5% believed the practice to be illegal. If the patient's chronic pain was from a nonmalignant source, only 12% were confident that the practice was both legal and medically acceptable; 47% would discourage it; and nearly 33% would investigate the practice as illegal. If the patient had a history of drug abuse, the perception that prescribing opioids was illegal greatly increased. The fact that 80% of the medical board members stated that their medical board was the agency most likely to investigate improper prescribing of controlled substances in their state underscores the significance of these data.

Overall, the survey suggested that medical board members lack knowledge about the use of opioids and other controlled substances to manage pain. To varying degrees they would also discourage or investigate the prescribing of opioid analgesics for intractable pain, particularly if the patient does not have cancer but especially if the patient had a history of drug abuse. It is important to recognize that the presenting problem in each scenario was pain, not addiction. There was also confusion about the definition of addiction. Addiction is not established by the presence of physical dependence or tolerance, but rather by psychological dependence (American Pain Society 1992). Given these results, it is not hard to understand why physicians might avoid extended opioid prescribing for a patient with pain. In fact, concerns have been expressed about vigorous investigations of physicians for what was considered to be appropriate prescribing of opioids for pain (Benton 1993; Hill 1989; McIntosh 1991a, 1991b; Nowak 1992).

Conclusions and Future Directions

If it is in the public interest that drugs meet rigorous standards of effectiveness and safety, it should be of equal interest to public health that drug laws and regulations be held to the same standards (Woods 1990). In fact, efforts are emerging to examine controlled substances policy as it relates to the prescribing of opioids for pain and to take appropriate action (Joranson 1990a). The Federation of State Medical Boards and the American Pain Society have sponsored educational symposia for medical regulators, and some medical boards are issuing new prescribing policies in the area of pain management (Joranson et al. 1992). The DEA has issued a statement that controlled substances should be prescribed when there is a legitimate medical need (United States Department of Justice 1990). Ultimately, if state and federal agencies have reasonable policies that are communicated to physicians, it may be possible to reach the ideal circumstance in which physicians will not view as a threat inquiries from these agencies about their prescribing.

A revised UCSA was given to the states in 1990 in an effort to help bring state controlled substances laws up to date with many new drug control provisions in the federal CSA and to improve the balance between drug control and medical use of controlled substances (National Conference of Commissioners on Uniform State Laws 1990). The 1990 UCSA 1) gives modest recognition to the medical value of controlled substances-alternative language has been suggested to emphasize this key principle (Joranson 1990b); 2) urges states to ensure that their definition of terms does not allow patients who are physically dependent on opioids for the treatment of pain to be confused with addicts; 3) clarifies that opioid treatment of intractable pain is part of medical practice and thus outside the scope of controlled substances violations; and 4) establishes a model interagency diversion control program to coordinate the use of existing information, authority, and resources to identify and prosecute individuals who are responsible for diverting controlled substances to illicit uses. The progress to balance state-controlled substances laws could be facilitated if professional organizations were to take an interest in adoption of the 1990 UCSA in their respective state legislatures.

As we pass through another cycle of intense concern about drugs, we must take care not to discard medical and scientific knowledge nor to ignore or stigmatize those among us, especially those with chronic illnesses, who benefit from the essential medical uses of controlled substances. Controlled substances are essential to the quality of life of millions of patients. A balanced drug policy should provide ample authority to address diversion problems without interfering in the use of controlled substances in the medical care of patients. Drug laws have a dual purpose; achieving both ends must be emphasized, for only in this way will the greatest health benefit be realized.

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