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1993 Joranson DE. Guiding principles of international and federal laws pertaining to medical use and diversion of controlled substances. In: Cooper JR et al. Evaluation of the Impact of Prescription Drug Diversion Control Systems on Medical Practice and Patient Care: Possible Implications for Future Research. National Institute on Drug Abuse Technical Research Monograph 131. Rockville, MD: NIDA, 1993.

Guiding Principles of International and Federal Laws Pertaining to Medical Use and Diversion of Controlled Substances

David E. Joranson

INTRODUCTION

The title of this technical review, "Evaluation of the Impact of Prescription Drug Diversion Control Systems on Medical Practice and Patient Care: Possible Implications for Future Research," poses the question of whether efforts to reduce diversion of therapeutically useful controlled substances interfere with their appropriate medical use in patient care.

This paper will examine several sets of laws that shape public policy in this critical area. These laws create and limit the authority of government to (a) regulate medical practice, (b) make drugs available for medical use, and (c) control drug abuse and diversion. Developed over decades of democratic process, these laws establish the legal principles that determine the desirable relationship between control of drug diversion and the use of drugs in medical practice and patient care.

At the outset, it should be recalled that the use of controlled substances has an indispensable beneficial effect on public health. When controlled substances are used for legitimate medical purposes, they improve the quality of life for millions of Americans with debilitating diseases and conditions. However, when controlled substances are diverted from the legitimate distribution system, their abuse can lead to serious public health problems. Consequently, it is in the interest of public health to (a) promote and protect the appropriate medical and scientific uses of controlled substances, and (b) prevent their diversion and abuse. As will be seen, the laws of the United States direct that efforts by government to control drug abuse should not interfere with the legitimate practice of medicine or the availability of controlled substances for patient care. Achieving both purposes under the law will be referred to as "balance" (Joranson and Dahl 1990).

LAWS RELATING TO MEDICAL PRACTICE, DRUG AVAILABILITY, AND DIVERSION

Three classes of separate but related law establish a hierarchy of policy that governs medical use, drug availability, and diversion of controlled substances. The most fundamental of these laws will be discussed first.

State Law Regulates Medical Practice

The terms "medical practice" or "practice of medicine" as used in this paper refer to legitimate medical activities that involve the diagnosis and treatment of disease within a bona fide physician-patient relationship. These activities include medical decisions such as choice of therapy, choice of drug(s), amount prescribed, directions for use, and duration of therapy.

The professional practice of medicine is a privilege granted by law in each of the 50 State legislatures (Federation of State Medical Boards 1988). A physician's legal ability to prescribe drugs that are controlled substances depends on having a license to practice medicine, but also requires a separate Federal, and in some jurisdictions a State, controlled substances registration. State licensing and disciplinary boards administer the medical practice laws and have the principal governmental responsibility to protect tile public health from improper, incompetent, and unlawful practices. Medical boards define activities that constitute unprofessional conduct, including prescribing controlled substances for purposes outside of the legitimate practice of medicine.

Federal Law Approves Drugs for Medical Use

The Federal Food, Drug, and Cosmetic Act (FFDCA) is a Federal law that approves drugs for commercial marketing and medical use in the United States. This approval concludes an often lengthy process of testing to determine that a drug is effective for use in treatment of a medical condition and that it is safe to use in a human population. FFDCA drugs are available only by prescription and include the stimulants, sedative/hypnotics, hallucinogens, and opioids. These particular drugs have an abuse liability because they can produce physical and psychological dependence. Consequently, they are also subject to controlled substances law.

The following elements of the FFDCA determine the relationship between the Federal government and medical practice, and define the basic parameters of how an FFDCA drug may be used by individuals who have been licensed by the States to practice medicine.

FDA Does Not Regulate Medical Practice

Although drugs are made available under the FFDCA for use in medical practice, the Food and Drug Administration (FDA) has repeatedly determined that neither the FDA nor Congress regulates medical practice "as between the physician and patient" (Federal Register 1972). FDA policy is that good medical practice and patient interest require that physicians be free to use drugs according to their best knowledge and judgment (Federal Register 1975). The Federal courts have supported the principle that FDA does not regulate medical practice (U.S. vs. Evers 1981).

FDA Does Not Restrict 'Off-label' Uses

The foreword to the Physician's Desk Reference recognizes that the FFDCA does not limit the manner in which a physician may use an approved drug. Once a product has been approved under the FFDCA for marketing, a physician may prescribe it (although it may not be advertised or promoted) for uses or in treatment regimens or patient populations that are not included in the approved labeling (Federal Register 1983).

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. (U.S. vs. Evers 1981)


LAWS THAT ESTABLISH DRUG DIVERSION POLICY

Three tiers of law establish policy on diversion of therapeutic drugs to nonmedical uses.

International treaties

Treaties establish the legal framework for control of international and domestic production and distribution of drugs that have an abuse liability. The principal treaties are the Single Convention on Narcotic Drugs, 1961, and the 1971 Convention on Psychotropic Substances. As a party to a treaty, a government agrees to adopt domestic laws that carry out the provisions of the treaty. Both treaties clearly recognize that many drugs with abuse liability are indispensable to the public health and that their availability for legitimate medical and scientific purposes must be ensured.

Two agencies of the United Nations have expressed concern about the effect of a country's drug laws on availability of drugs for medical purposes. The International Narcotics Control Board (INCB), the agency of the United Nations that is responsible for monitoring governments' implementation of the treaties, has concluded that opioids are not sufficiently available for legitimate medical purposes throughout the world (INCB 1989). A number of important economic and social factors are responsible, including antidrug abuse laws and regulations that unduly restrict the availability of opioids for medical use. The INCB recommended that individual governments identify these factors and take corrective action.

A World Health Organization (WHO) Expert Committee has observed that concern about drug abuse has curtailed appropriate medical use of opioids for the treatment of pain (WHO, 1990). In discussing regulatory impediments, the Expert Committee expressed concern that the legal framework adopted by individual governments may govern prescribing so strictly as to impede the proper medical use of opioids.

Federal Controlled Substances Act

While the FFDCA establishes national policy for availability of drugs for medical purposes, the Federal Controlled Substances Act (CSA) establishes a security system to prevent these drugs from being diverted from the legitimate distribution system. Congress designed the CSA with the intent that efforts by the Federal government to control diversion should not interfere with medical practice or supersede FFDCA authority over availability of approved drugs for patient care (U.S. House of Representatives 1970).

The Congress adopted the following laws in order to achieve a balanced approach to national antidrug abuse policy

  1. The CSA clearly recognizes the public health value of controlled substances. Many controlled substances are necessary to the public health. (21 U.S. Code, Section 801)
  2. The CSA does not interfere with the practice of medicine. This policy is implemented in several significant ways:
      The authority of law enforcement to regulate controlled substances depends on scientific and medical determinations.

      1. Under the CSA the Attorney General (AG) must, before initiating any proceeding to control a drug in the schedules of the CSA, request a scientific and medical evaluation of the drug from the Secretary of the Department of Health and Human Services, along with a recommendation as to whether the drug should be controlled. Congress determined in 1970 that the recommendation of the Secretary is binding on the Attorney General in regard to scientific and medical matters, as is a recommendation by the Secretary that a drug not be controlled. (21 U.S. Code, Section 811-(b))
      2. The authority of the AG to register practitioners to prescribe and dispense controlled substances depends upon prior licensing of a practitioner by State boards. With the exception of limitations on refills, the CSA does not regulate medical decisions such as the choice of drug, the prescription or the duration of therapy.
      3. The authority of the AG does not extend to the routine review and monitoring of physician prescribing. Under the CSA, prescribers are not required to maintain prescribing records.(21 U.S. Code, Section 827 (c))
      4. The CSA also provides joint authority for registration and revocation of practitioners who dispense narcotic drugs for maintenance or detoxification treatment of narcotic addicts. While the Attorney General must register an applicant, the Secretary must first determine that the applicant is qualified and will comply with treatment standards. (21 U.S. Code, Section 823 (g))
      5. The authority of the AG to investigate practitioners diversion is directed exclusively at the non-medical use of controlled substances.


Under the CSA, it is unlawful for a practitioner to prescribe or dispense a controlled substance except in the course of professional practice. The term "in the course of professional practice" defines the boundaries of practitioner investigations and prosecutions for DEA. According to the DEA, acts of prescribing or dispensing of controlled substances which are done within the course of the registrant's professional practice are, for purposes of the Controlled Substances Act, lawful. 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)

The Congress created a "closed distribution system" to help DEA identify individuals who divert controlled substances to nonmedical uses. It should be noted that this system authorized the Federal government to monitor distribution only to the retail level, just short of where the physician-patient relationship begins. The system consists of registration of all handlers of controlled substances, order forms, record keeping, security requirements and penalties for unlawful activities.

A computerized information system tracks distribution of many controlled substances to the retail level and allows identification of unusual patterns of use which may, upon audit of required records, be found to involve diversion. These tools are intended to provide the Federal government with the information to detect leaks from the drug distribution pipeline into the illicit market, and the authority to hold individual registrants responsible for diversion.

Amendments to the CSA have strengthened the information available to detect diversion. In 1980, Congress said that it "believes that through vigorous and imaginative use of the ARCOS system, in conjunction with other drug diversion/abuse indicators such as DAWN, retail diversion activities call be identified and the individuals involved apprehended and prosecuted." (Infant Formula Act 1980)

In 1984, the Attorney General was given additional authority to deny practitioner registrations in the public interest, "to work with the States, which license and regulate physicians," to assess State diversion control capabilities, provide advice on how to strengthen controls against diversion, and establish cooperative investigations. (Dangerous Drug Diversion Control Act 1984)

The CSA is not intended to interfere with patient care or confidentiality. Patients, the last link in the distribution chain, are defined as "ultimate users" under the CSA, and are recognized as being lawfully in possession of controlled substances (21 U.S. Code, Section 801 (26)). Ultimate users are not regulated parties under the CSA and are not intended to be objects of diversion monitoring systems.

Congress also recognized the importance of patient confidentiality. Under Federal laws, patient identity may not be released to the Attorney General in cases where a Federal agency or a State or local government has acted to protect confidentiality (21 U.S. Code, Section 873 (b)).

Under the CSA, it is outside of the professional practice of medicine (and, therefore unlawful) for a physician to prescribe a narcotic drug to maintain an addict, unless the physician is separately registered to treat addiction. Congress defined "addict" as a person who is a danger to society. Thus, "addict" does not include a patient who is simply being treated with a controlled substance. This is the case even though the patient may be physically dependent on an opioid analgesic as a result of medical treatment for pain, a situation that can be mistaken for "addiction." DEA regulations and publications make it clear that a physician who prescribes opioids to treat intractable pain over extended periods is considered to be acting within the professional practice of medicine. (Code of Federal Regulations, DEA Physician's Manual)

The CSA is not intended to interfere with the availability of FDCA drugs for patient care.

The CSA authorizes the Attorney General to set an annual production quota for Schedule II drugs, including many FDA-approved stimulants, sedative/hypnotics, hallucinogens and opioids. The quota must allow for sufficient quantities to meet legitimate medical and scientific needs in the United States (21 U.S. Code, Section 826).

In a 1988 Federal administrative law proceeding, the administrator of the DEA acknowledged that the agency had set the production quota for methylphenidate (Ritalin) below the level of legitimate medical need. The official record showed that patients with legitimate prescriptions for methylphenidate had been unable to have them filled. The administrator directed his agency to recalculate the production quota, and stated:

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. Potential shortages encourage stockpiling by patients and their families as well as by wholesalers and retailers ... diversion of methylphenidate is a serious problem which DEA must take into account in setting quotas. However, the evidence of diversion of methylphenidate in 1986 does not support the need for as "lean a pipeline" as was created by the way the quotas were set in 1986. (Federal Register 1988)


The intent of Congress to avoid interference with medical practice and drug availability was restated in 1978 when Congress enacted the Psychotropic Substances Act to satisfy U.S. obligations under the Convention on Psychotropic Substances. Congress amended the CSA to say that control of psychotropic substances in the United States "should be accomplished within the framework of the procedures and criteria for classification of substances provided in the (CSA)" to ensure that "availability [of FFDCA drugs] ... for useful and legitimate medical and scientific purposes will not be unduly restricted...... Furthermore, the Congress said that nothing in the treaties is 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" (21 U.S. Code, section 801).

State Controlled Substances Laws

Most State controlled substances laws are based on a model called the Uniform Controlled Substances Act (UCSA). The UCSA was prepared by the National Conference of Commissioners on Uniform State Laws in 1970. The NCCUSL is a 100-year old national organization of governor-appointed lawyers who have drafted numerous model laws that have been adopted by the States. The purpose of the 1970 UCSA was to replace a plethora of antidrug abuse laws that States had adopted since the turn of the century with a single unified framework in order to achieve consistency in national drug control policy between the Federal government and the States (Uniform Controlled Substances Act 1970)

The UCSA was intended to provide the States with a policy framework that would complement the Federal law. For instance, the UCSA contained a closed distribution system to monitor drug distribution only to the retail level, parallel to the Federal system. The importance of maintaining the confidentiality of patient (ultimate user) identity was recognized; a provision stated that a physician is not required to reveal patient identity to a State agency or in any State or local civil, criminal, administrative, legislative, or other proceeding. (Uniform Controlled Substances Act 1970).

However, the UCSA did not recognize the public health benefits of controlled substances as did the CSA. Nor did the UCSA require that scientific and medical determinations be made by a competent authority-a responsibility that Congress ultimately gave to the Secretary of the Department of Health and Human Services instead of to the Attorney General. How this came to pass is of some historical interest.

The UCSA was modeled after proposed legislation in the U.S. Senate rather than the final law. The Senate bill, which was the Nixon Administration's proposal prepared by the Justice Department, sought to make the Attorney General responsible for medical and scientific decisions concerning control of drugs. Considerable controversy arose in the Congress during the summer of 1970 after the medical and scientific communities learned of this plan. When Congress adopted the final version of the CSA in October 1970, the Secretary of Health, Education, and Welfare, and not the Attorney General, had been given the responsibility for making medical and scientific decisions concerning drug control (Joranson 1990).

As Members may recall, the scientific and medical community of this Nation were greatly upset over the fact that scientific and medical decisions in the Senate bill were centered in the Department of Justice, with the Attorney General having the responsibility to make scientific and medical determinations which were not in the competency of the Department, and admittedly so. We have changed that so that the Department of Health, Education, and Welfare will determine scientific and medical decisions. This is a most important change in the whole approach as it came from the Senate.

Congressman Paul Rogers, Congressional Record, September 23, 1970.


The UCSA had, however, been adopted by the NCCUSL 3 months earlier.

Consequently, while most State controlled substances laws are similar in regulatory structure to the Federal CSA and the UCSA, they do not define authority in such a way as to achieve the balance between law enforcement and medical science that is the hallmark of Federal law. Furthermore, a number of States have not repealed narcotics statutes that were adopted in the early 1900s.

A preliminary review of State controlled substances laws has identified a number of provisions that conflict with the principles established by international, Federal, and uniform law (Joranson, February, 1990). Some of these provisions limit medical decisions and regulate or restrict prescribing and dispensing of FFDCA drugs in ways that would not be regulated under the laws of the Federal government and most other States. A summary of these provisions follows.

  1. Prescription monitoring

    Multiple Copy Prescription Programs (MCPPs), or "triplicate" prescription programs, began in the United States as early as 1913 with the program in New York. MCPPs are amendments to controlled substances laws that require physicians to use special prescriptions. MCPPs allow government agencies to monitor the appropriateness of prescribing and dispensing of controlled substances to patients. These programs generally require physicians to reveal patient identity to an agency of State government that is principally concerned with drug abuse.

    MCPP legislation may also require application of Schedule II controls to prescribing a drug without placement of the drug in Schedule II. Schedule II prescription controls require that every prescription be in writing (as opposed to being called in and reduced to writing by the pharmacist) and prohibit refills. In New York, for instance, when benzodiazepines (Schedule IV drugs) were added to the triplicate program, Schedule II prescription controls were imposed on prescribers, dispensers, and patients without the public procedure to determine the need for increased scheduling that is ordinarily required under the CSA or UCSA (Resource Guide 1990).

    The WHO Expert Committee has commented on multiple copy prescription programs that are used in some countries and in several States in the United States. Acknowledging that while these programs may reduce careless prescribing and "multiple doctoring," the Expert Committee said "the extent to which these programmes restrict or inhibit the prescribing of opioids to patients who need them should be questioned." Further, the Expert Committee expressed concerns about regulation scrutiny when it said:

    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 quantities of opioids are provided to an individual, even though the medical need for such drugs can be proved. (WHO 1990)


  2. Restricted use of approved drugs

    South Carolina's controlled substances law prohibits the prescribing of any controlled substance for a use which is not specifically approved by the FDA and included in the approved labeling (South Carolina Health Code).

  3. Restrictions on prescription quantities

    A number of State controlled substances laws or regulations limit the amount of an FFDCA drug that can be dispensed at one time to as little as 100 dosage units or a 5 day supply. These provisions can impede drug availability to patients with chronic conditions that require extended therapy with controlled substances.

  4. Inappropriate definitions

    Some States define "addict" or "drug dependent person" to include patients who are physically dependent on opioids or other controlled substances.

  5. Reporting of patients

    Several States require physicians to report to the government any patients who have been treated for more than several months with a Schedule II controlled substance. New York requires these patients to be reported as addicts. Failure to report patients as addicts is a violation of State law.

Revision of the Uniform Controlled Substances Act (1990)

The NCCUSL revised the UCSA in 1990 and urged States to bring their laws up to date with many changes that had been made to the CSA since 1970. The 1990 UCSA updates and refines the basic drug abuse control framework, provides new legal tools to address drug trafficking, and also addresses several shortcomings of the 1970 UCSA with regard to medical uses of controlled substances (Uniform Controlled Substances Act 1990).

  1. Benefits of drugs are recognized

    The 1990 USCA recognizes that controlled substances are essential to public health in the prefatory note, although not in the statutory language. NCCUSL drafting rules generally do not permit the inclusion of findings and declarations as appear in the Federal CSA. A suggestion for statutory language for a findings and declarations section has been made (Joranson 1990).

  2. Patients are not confused with addicts

    As in 1970, the term "addict" is not used. However, since some States still use such terms, a comment which follows the definition section of the 1990 UCSA urges States to assure that definitions in its controlled substances laws do not allow patients who are physically dependent on opioids for the treatment of pain to be confused with addicts, habitual users, or drug dependent persons.

  3. Use of opioids for intractable pain is recognized

    The 1990 UCSA contains a provision which clarifies that opioid treatment of intractable pain is, for the purposes of controlled substances law, considered part of the professional practice of medicine and therefore outside the scope of controlled substances law.

  4. A diversion control program is created

    A new statutory provision creates an interagency diversion control program to focus the information and authority of Federal and State agencies on identification and prosecution of individuals who are responsible for diverting controlled substances to illicit uses. This provision will assist States to make efficient use of existing resources before considering new and expensive prescription monitoring programs.

  5. Confidentiality is protected

    A 1970 UCSA provision that recognized the confidentiality of patient records is included once again. This provision states that a practitioner is not required to report the identity of patients to a State agency.

The 1990 UCSA has been provided to the legislature in each State for consideration. Consideration of the 1990 UCSA by a legislature is an opportunity for health professionals to help to improve their State's overall approach to drug abuse and to address and correct any problems with an unbalanced approach to the medical use of controlled substances.

SUMMARY OF GUIDING PRINCIPLES

Several guiding principles can be distilled from the laws that govern medical practice, drug availability, and diversion.

  1. A primary purpose of controlled substances laws is to decrease diversion of the FFDCA drugs that have an abuse liability. These laws and their enforcement must not interfere in the practice of medicine or unduly restrict the availability of therapeutic drugs for legitimate medical and scientific purposes.

  2. The purpose of law enforcement is to administer the controlled substances law, in some cases jointly with health authorities; to use the information provided by law to identify individuals who divert controlled substances outside of the lawful practice of medicine; and to use the authority provided by law to bring violators to justice.

  3. The purpose of health authorities is to make all scientific and medical determinations under controlled substances law. If an issue arises concerning the appropriate medical use of an FDA-approved drug, it should be resolved within the medical and scientific community, not by law enforcement agencies.

  4. If additional restriction of the prescribing or dispensing of drugs beyond the level of control associated with a particular schedule is deemed necessary, such additional control should be accomplished using CSA/UCSA drug control procedures to increase scheduling. This will assure compliance with the intent of Congress that the appropriateness of controls on therapeutic drugs be guided by competent medical and scientific expertise.

  5. Although State laws are generally permitted to be more restrictive than Federal law, States have been urged to use uniform law to achieve a consistent national drug policy framework that balances drug control and drug availability.

  6. The confidentiality of patient-identifying information should be respected.


CONCEPTUAL FRAMEWORK FOR EVALUATING DIVERSION CONTROL PROGRAMS

From the foregoing, two general standards can be proposed for use in evaluating the diversion control programs that will be discussed during this technical review. One writer has commented that 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). The answers to the following questions will help to gauge the effectiveness and safety of diversion control programs.

Effectiveness

Is the diversion program aimed directly at identifying and stopping diverters? How effective is the program? Is the program designed to make use of the information, authority, and resources that are available from a number of State and Federal agencies? Is there a cooperative agreement to coordinate the use of these resources? Does implementation of the diversion program result in reductions in valid measures of diversion and abuse of prescribed controlled substances? Are these reductions significant?

Safety

How safe is the diversion program? Does the program philosophy and design complement the basic principles of balance as previously outlined? Or, does the program extend controlled substances law into monitoring prescribing and ultimate users? Does the program aim to decrease the availability of controlled drugs or to regulate medical decisions? Does it shift patterns of prescribing or diversion to other drugs which may be less safe or effective? Do monitoring and enforcement activities result in identification of "false positives," i.e., reporting of patients as addicts, or investigation or prosecution of practitioners who are simply prescribing according to medical need?

CONCLUSION

International and Federal law recognize the public health value of controlled substances and establish a clear expectation that government efforts to reduce diversion of these drugs should not interfere with their beneficial medical uses. The overarching purpose is to improve public health; the war on drug abuse must not impede the prevention and treatment of disease, pain and suffering.

REFERENCES

Laws 21 U.S. Code, Section 801 to end.
Controlled Substances Act, Public Law 91-513, 84 Stat 1242.
Dangerous Drug Diversion Control Act of 1984. Report 98-835, 1984.
Federal Food, Drug, and Cosmetic Act, Public Law 87-871, 76 Stat 780.
Federal Register 16503 (1972).
Federal Register 15393 - 94 (1975).
Federal Register 2673 (1983).
Federal Register 50591 - 97 (1988).
South Carolina Health Code, Section 44-53-360(c).

Other References

Congressional Record Vol. 116, Part 25. p. 33304.

Federation of State Medical Boards of the United States. A Guide to the Essentials of a Modern Medical Practice Act, 1956, 1970, 1985, 1988.

Infant Formula Act of 1980. House of Representatives Report by the Committee on Interstate and Foreign Commerce, 1980.

Joranson, D.E. Federal and State Regulation of Opioids. J Pain Symptom Manage 5(l): S12-S23, 1990.

Joranson, D.E. A new drug law for the states: an opportunity to affirm the role of opioids in cancer pain relief. J Pain Symptom Manage 5(5) 333-336, 1990.

Joranson, D.E. and Dahl, J.L. Achieving balance in drug policy: the Wisconsin model. In: Hill, C.S., Jr. and Fields, W.S., eds. Advances in Pain Research and Therapy, Vol. 11. New York: Raven Press, Ltd. 1989.

National Conference of Commissioners on Uniform State Laws. Uniform Controlled Substances Act, 1970.

Physicians' Desk Reference. Oradell, NJ: Medical Economics Company 1991.

Stone, S.E. the investigation and prosecution of professional practice cases under the controlled substances act: introduction to professional practice case law. Drug Enforcement, Spring, 1983.

United Nations. Convention on Psychotropic Substances, 1971.

United Nations. International Narcotics Control Board. Demand for and Supply of Opiates for Medical and Scientific Needs. ISBN 92-1-148079-5 1989.

United Nations. Single Convention on Narcotic Drugs, 1961.

U.S. vs. Evers, 643 F. 2d 1043 (5th Circuit, 1981).

U.S. Department of Justice Drug Enforcement Administration. Multiple Copy Prescription Programs Resource Guide, March 1990.

U.S. House of Representatives Report No. 91-1444. Comprehensive Drug Abuse Prevention and Control Act of 1970. Washington, DC: Supt. of Docs., U.S. Govt. Print. Off. September 1970.

Woods, J. Abuse liability and the regulatory control of therapeutic drugs: untested assumptions. Drug Alcohol Depend, 25:229-233, 1990.

World Health Organization. Cancer Pain Relief and Palliative Care,WHO Expert Committee Report. Geneva, Switzerland, 1990