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1992 Angarola RT, Joranson DE. Legislating proper pain management. APS Bulletin 1992;2(1):13-15.

Legislating Proper Pain Management

Robert T. Angarola, Esq.; David E. Joranson, MSSW

The purpose of this column is to keep APS members abreast of issues and developments that relate to pain treatment and the legal system. One major area of interaction stems from the laws that govern the prescribing of opioid analgesics. From time to time, concerns about drug abuse have led to legislative proposals to place further restrictions on the use of these drugs, which already are subject to the most stringent provisions of state and federal controlled substances laws. In assessing the benefits and risks of such legislation, healthcare professionals, legislators, and other policymakers should recall that the basic purpose of controlled substances laws is to prevent the nonmedical use of these drugs, while not to interfere in their medical use (U.S. House of Representatives, 1970)

In August 1990, U.S. Representative Fortney H. "Pete" Stark (D-CA) introduced legislation that would have required states to adopt multiple-copy prescription programs (MCPPs) for all controlled substances at the risk of losing federal Medicare funds. MCPPs require physicians to use government-issued duplicate or triplicate forms when prescribing the drugs in question. It is well documented that MCPPs result in an immediate and substantial decrease in the number of prescriptions written (Angarola, 1990). A major goal of the 1990 legislation was to save "billions of dollars" that allegedly were being wasted by the misuse and diversion of controlled substances. Numerous health-related organizations, including cancer pain groups and the American Pain Society, opposed the legislation due to its potentially negative impact on patient care. APS President Robert Addison stated, "One documented barrier to effective management of cancer pain is the perception of risk associated with opioid use. Many years of government attention to and public concern about narcotic abuse have resulted in excess caution in the use of opioids to treat cancer pain. The American Pain Society believes that additional legislative measures to regulate prescribing will exacerbate these concerns, thereby limiting cancer patients' access to an adequate level of care" (R.G. Addison, personal communication with the Honorable Henry A. Waxman, Chairman, Subcommittee on Health and Environment, U.S. House of Representatives, October 8, 1990). Congress did not approve this legislation during its 1990 session, in large measure because of opposition by patient and healthcare groups who were concerned about potential negative effects on patient care.

In November 1991, Congressman Stark circulated a "discussion draft" of alternative legislation he proposed to introduce in early 1992 to deal not only with controlled substance diversion but also the underuse of these same drugs for conditions such as cancer pain treatment. Rep. Stark is seeking the advice and counsel of healthcare organizations on the draft bill. The primary aim of the new proposal is to encourage states to adopt legislation that will require computerized collection, monitoring, and analysis of all controlled substance prescriptions. States would use this information to detect diversion and abuse as well as to target underprescribing.

Provisions of the proposed legislation

Rep. Stark's proposed legislation would require pharmacists to report electronically to a central repository the name and quantity of all controlled substances dispensed, patients' names or identification numbers (such as a driver's license number, a Social Security number, or a number from a state-issued patient ID card), and prescribers' and dispensers' names or identities. Pharmacists also will have to provide the specialty of the prescriber. The information would be encrypted in an effort to protect confidentiality. A new board, responsible to the director of the state health agency, would have access to the information and could disclose it to local, state, and federal drug law enforcement agencies and state licensing boards when illegal diversion or "inappropriate" prescribing was suspected. The program would be funded, at least initially, by $20 million in fees collected from the pharmaceutical manufacturing industry.

Within 1 year of funding, a panel of health professionals would develop "practice parameters" for the prescribing of controlled medications. The board would use these parameters to establish "exception criteria" and generate lists of physicians who have prescribed Schedule II, III, IV, or V controlled substances "outside the expected norms for a prescriber practicing a particular specialty or field of health care." If the board determines that there is reasonable cause for further inquiry into a possible violation of controlled substances law, it can disclose the information to a variety of law enforcement or licensing agencies.

The state health agency is also to use the practice parameters to identify instances of underprescribing, specifically in the areas of cancer pain, AIDS-related pain, narcolepsy, epilepsy, sickle-cell anemia, mental illnesses, and other medical conditions for which controlled substances are indicated. Furthermore, the state agency would contact physicians whose patients might be "needlessly addicted" (this term is not defined) and refer them for substance abuse treatment.

The draft legislation also suggests mechanisms to improve professional practice and patient care. The Department of Health and Human Services (DHHS) is to set up a 900-number National Patient Care Improvement Hotline, which patients, health professionals, and government officials could use to discuss the medical use of all controlled substances. DHHS would convene a National Commission on Special Medical Needs to develop new initiatives to deal with over- and underprescribing of controlled substances. DHHS also would develop a brochure and printed patient inserts to help educate patients on the appropriate use of these drugs and the steps to be taken in case of improper use.

Finally, DHHS is to undertake studies on the costs and benefits of electronic data transmission (EDT) systems as compared to multiple copy prescription programs. The draft legislation singles out states currently operating triplicate prescription programs for funding if they would consider transferring to an EDT system. DHHS is to develop model initiatives for states to address the problem of prescription forgeries. The draft bill gives particular encouragement to the use of government-issued prescription forms for controlled substances that are serially numbered.

Issues for consideration

The goal of the draft legislation-to reduce drug diversion while improving patient care-is commendable. The next year will allow the concerned groups and the Congress to work together to determine whether this legislation is a cost-effective means of achieving these outcomes. By circulating a "discussion draft," Rep. Stark has demonstrated that he would welcome receiving comments on the advisability of adopting or modifying his proposals. Pain specialists should consider at least the following issues in developing their positions on this bill:

Need: Prescribed controlled substances are abused and, in some states, may pose a serious public health problem; however, both the National Institute on Drug Abuse and the Drug Enforcement Administration have reported significant declines in prescription drug abuse and diversion over the past decade. In large part, this has been due to the effectiveness of existing federal and state diversion detection programs, backed up by appropriate enforcement, regulatory, and educational actions. The design for the proposed program and its procedures are untested. The Oklahoma State Police have operated an EDT system for Schedule II drugs since January 1991, but no formal evaluation of its effectiveness is yet available. Is it appropriate for the federal government to fund this approach to diversion control above all others, particularly when programs proved to be effective have been in place for years and existing monitoring systems are underutilized?

Practice parameters: Parameters implies limits or boundaries of acceptability. Is it appropriate for states to develop practice limits for all medical uses of controlled substances? Could such a process reliably distinguish between acceptable and unacceptable clinical practice? How would this relate to the process the Agency for Health Care Policy and Research is using to develop treatment guidelines for conditions such as cancer pain? Could practice parameters be used reliably to establish exception criteria that will target diversion, as well as inappropriate prescribing and underprescribing, using only prescription information and practice specialty? What is the risk of false positives? How would such a process apply to uses of controlled substances for which there is no current medical consensus (e.g., the use of opioids for nonmalignant pain)? Absence of medical consensus does not make such use clinically unacceptable or illegal. What is the risk that such interventions will disturb medical practice and foster overly conservative practice?

Needless addiction: Is it possible to use the prescription and prescriber specialty information to identify patients who are "needlessly addicted"? There is great confusion over the meaning of the term addiction. State laws define these and related terms inconsistently (Joranson, 1990); some laws equate addiction to physical dependence, which is an expected outcome of chronic pain management with opioid analgesics.

Privacy concerns: Is it appropriate to collect and computerize identifying information for all patients who receive controlled substance prescriptions? If so, are there sufficient protections for the privacy of medical records and patient identity? If diversion is suspected, the draft legislation would allow disclosure of this information to many local, state, and federal enforcement agencies and regulatory agencies.

Cost: Will the estimated $20 million needed to start up the program be a one-time payment or an annual fee? Will it increase as more states adopt EDT systems and other drugs are included for monitoring? Will states, practitioners, or patients be expected to absorb any costs, now or later? Could these monies be spent more wisely in strengthening enforcement and regulatory efforts or in meeting other healthcare needs?

Duplication: Would this program duplicate the information-gathering provisions of the Drug Use Review (DUR) initiative that was approved in the last Congress and is scheduled for state-level implementation in 1993? The DUR concept relies on and supports the use of EDT systems in pharmacies. An evaluation of this and similar programs might be warranted before funding another prescription monitoring system.

Educational initiatives: Are educational programs such as a telephone hotline, a national commission, a brochure, and patient package inserts effective ways to improve medical practice and patient care? Are they duplicative of other federally sponsored initiatives (Kessler, 1991)? Would it be preferable to provide grants for evaluating existing initiatives aimed at improving prescribing practices for all medications? Who will pay for these initiatives?

Serialized prescriptions: The draft legislation encourages states that now have multiple copy prescription programs to switch to EDT systems for prescription data collection and to consider the use of serially numbered prescription forms issued by the government. MCPPs have decreased prescribing by at least 50% in states in which they operate. Would the replacement of multiple copy prescription programs by an EDT system, coupled with government-issued serialized prescription forms, have a similar effect?

Uniform Controlled Substances Act: How would the proposed legislation relate to the current consideration by state legislatures of the recently revised Uniform Controlled Substances Act (UCSA)? APS members have participated in the drafting of the UCSA. This model law is a balanced approach to addressing drug trafficking, abuse, and diversion as well as the medical use of opioids to treat intractable pain. APS has supported the enactment of the UCSA at the state level as a positive framework for management of controlled substances in a manner consistent with federal law.

Authors' Note: Representative Pete Stark's discussion draft legislation has raised a number of important issues in a positive manner; the congressman has asked for advice and comments from the health community. APS members should take an active part in the upcoming discussions on this legislation. Copies of the draft legislation can be obtained from Congressman Stark, 239 Cannon House Office Building, Washington, DC 20515, 202/1225-5065.

References

Angarola, R.T. (1990). Availability and regulation of opioid analgesics. Advances in Pain Research and Therapy, 16, 613-524.

Joranson, D.E. (1990). Federal and state regulation of opioids. Journal of Pain and Symptom Management, 5(l), S12-S23.

Kessler, D.A. (1991). Communicating with patients about their medications. New England Journal of Medicine, 325(23), 1650-1652.

U.S. House of Representatives. (1970). Comprehensive Drug Abuse Prevention and Control Act of 1970. House Report No. 91-1444, September 10, 1970. Washington, DC: Author.