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American Pain Society
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Glenview, IL 60025
Robert T. Angarola, Esq., and David E. Joranson, MSSW, Department Editors
Robert T. Angarola; F. Gail Bormel
Last year, the pain management community helped defeat a Drug Enforcement Administration (DEA) legislative proposal that would have required all U.S. physicians to use special government-issued prescription forms for all controlled substances. DEA's proposal would also have eliminated oral prescriptions for schedule III analgesics, such as codeine and hydrocodone combinations (Angarola, 1995). States such as California and Rhode Island have recently reviewed the efficiency and effectiveness of their multiple-copy prescription programs. These states are now considering removal of these requirements in part because they have a negative impact on effective pain management. Several state licensing boards have also issued policy statements to encourage the appropriate use of opioid analgesics and other controlled substances (Joranson, 1995b). These developments have encouraged other states to take similar action.
A recent report issued by Cancer Care, Inc., could form the basis for positive changes in New York's regulation of controlled medications, particularly opioid analgesics. On the other hand, proposed model legislation supported by the National Association of State Controlled Substances Authorities (NASCSA) could have the opposite effect.
Cancer Care, Inc., is a New York-based, nonprofit social service agency that provides supportive services to cancer patients and their families. It recently issued Improving Access to Pain Medications in New York: A Proposal for Discussion and Action. This report documented and analyzed the significant difficulties that New York State residents face in gaining access to controlled pain medications. Cancer Care's recommendations build on those of the New York State Task Force on Life and the Law, which had as its main focus of consideration the legalization of physician-assisted suicide (Cancer Care, Inc., 1995; New York State Task Force on Life and the Law, 1994). Both Cancer Care and the task force concluded that lawmakers should remove legal and regulatory barriers to pain relief to help end unnecessary suffering by improving patient care, thus reducing the need for assisted suicide.
Cancer Care conducted interviews with cancer patients and their families and with prescribers and pharmacists. Based on the information gained in these interviews, Cancer Care concluded that New York's laws need to change. The Cancer Care report also recognized that many other factors lead to inadequate pain management, including lack of clinician knowledge, reimbursement difficulties, and misperceptions surrounding opioid use.
In recent years, several states have recognized these problems and taken action to promote proper treatment. Florida, Colorado, Washington, California, Texas and other states have adopted laws that recognize the use of controlled substances to treat intractable pain, and a number of state medical boards have adopted guidelines that recognize the need for opioid use in pain management (Joranson, 1995a; Joranson, 1995b).
Cancer Care conducted a careful analysis of New York's laws and regulations governing the use of controlled medications and proposed specific revisions. It found that the state is far stricter than federal requirements and that New York's requirements place an onerous burden on prescribers and pharmacists, ultimately reducing access to pain medications. Cancer Care recommended eliminating the state's requirement that practitioners report certain cancer patients to the Department of Health because legally they could be considered “addicts” or “habitual users of narcotic drugs” (New York Public Health Law, Article 33, 3372). New York State law defines the term addict as “a person who habitually uses a narcotic drug and who by reasons of such use is dependent thereon,” and habitual user as “any person who is, or by reason of repeated use of any controlled substance is in danger of becoming, dependent upon such substance” (New York Public Health Law, Article 33, 3302 [1], [17]). Under these definitions, cancer patients who are treated for chronic pain with opioids and become physically dependent on them by law could be considered addicts, and therefore, reportable to the government.
Cancer Care also proposed specific revisions to other laws that restrict dispensing of controlled substances. New York currently prohibits practitioners from issuing an additional prescription for a controlled substance until all but a 7-day supply of the previous prescription is exhausted (New York Code of Rules and Regulations, Title X, 80.67[c], 80.69[c]). This requirement ignores potential dosing changes in pain management therapy and whether a patient has ready access to a pharmacy, particularly during a vacation or travel. In addition, Cancer Care proposed an amendment-consistent with federal law-that would permit pharmacists to partially fill prescription medication for patients who are in long-term care facilities. Current New York law only allows the partial filling of controlled prescriptions for cancer patients who are in hospital programs.
The report also evaluated the New York law that established the triplicate prescription system. This law mandated that practitioners purchase and use government-issued prescription forms to prescribe opioids and benzodiazepines. Cancer Care recommended that the state assess the impact of this requirement and consider replacing it as soon as possible with a less intrusive system, such as an electronic prescription monitoring system. Cancer Care based this recommendation on interviews with practitioners that revealed their frustration over the system's demand on time, the uncertainty of its utility in preventing drug abuse, and the constant perceived threat of surveillance and legal sanction. In fact, state authorities reported a 54% reduction in schedule II prescribing after the implementation of New York's triplicate system in 1978 (Drug Enforcement Administration, 1987). A study in the Journal of the American Medical Association found a 71% decrease in anxiolytic prescribing in New York 6 months after those drugs were included in the monitoring program (Weintraub, Singh, Byrne, Maharaj, & Guttmacher, 1991). There are no studies to confirm that these figures reflect only reductions in diversion or abuse.
Recently, other states reviewed their triplicate prescription systems and considered alternatives. The Indiana legislature, for example, has repealed its triplicate program (Angarola & Joranson, 1994a). California is actively planning to substitute an electronic monitoring system for its triplicate program, which has been in existence since 1939. Rhode Island has recently drafted a bill to eliminate its duplicate program (Angarola, 1995; Angarola & Joranson, 1994a).
In November 1995, the National Association of State Controlled Substances Authorities formally adopted its Prescription Accountability Act, a model act that provides guidelines for state legislatures who want to implement a controlled substances prescription monitoring system (NASCSA, 1995). Among the act's recommended provisions are the following:
NASCSA strongly recommended that states use both government-issued prescriptions and electronic monitoring, claiming that serialized prescription systems are “extremely effective in controlling the misuse and diversion of controlled substances without affecting legitimate medical practice and patient care” (NASCSA, 1995, p. 1). The facts, however, do not bear out this claim. Government-issued prescription forms in single, duplicate, or triplicate form, all have the same effect-an immediate and dramatic reduction in the medical use of the medications covered, primarily opioid analgesics (Angarola & Joranson, 1992, 1994a).
Although there is progress in some states to remove unduly restrictive legal barriers to appropriate pain management, efforts continue elsewhere to impose additional regulatory constraints. Healthcare professionals in the pain management field have demonstrated that they can exert a major impact on whether legislatures adopt new restrictive prescribing laws. For example, in Maryland, members of APS and several professional societies challenged a bill to implement a triplicate system and it was soundly defeated (Angarola & Joranson, 1994b). The same can be true with single-copy prescription proposals. Cancer Care's proposals in New York deserve strong support from the pain treatment community. On the other hand, proposals that will block access to drugs needed for effective pain management should be defeated. Members of the American Pain Society and others concerned about pain should make their voices heard.
Angarola, R.T. (1995). DEA proposes controlled substances monitoring act. APS Bulletin, 5(3), 5, 22.
Angarola, R.T., & Joranson, D.E. (1992). State controlled-substances laws and pain control. APS Bulletin, 2(3), 10-11, 15.
Angarola, R.T., & Joranson, D.E. (1994a). Recent developments in pain management and regulation. APS Bulletin, 4(1), 11-12.
Angarola, R.T., & Joranson, D.E. (1994b). California sponsors pain summit; Maryland fends off new regulations. APS Bulletin, 4(3), 11-12.
Cancer Care, Inc. (1995). Improving access to pain medications in New York: A proposal for discussion and action. New York: Author.
Drug Enforcement Administration. (1987). Multiple copy prescription programs resource guide. (Report from the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control). Washington, DC: U.S. Government Printing Office.
Joranson, D.E. (1995a). Intractable pain treatment laws and regulations. APS Bulletin, 5(2), 1-3, 15-17.
Joranson, D.E. (1995b). State medical board guidelines for treatment of intractable pain. APS Bulletin, 5(3), 1-2.
National Association of State Controlled Substances Authorities. (1995). Prescription accountability act. West Columbia, SC: Author.
New York Code of Rules and Regulations, Title X, Part 80.
New York Public Health Law, Article 33, Title I; IV-VI.
New York State Task Force on Life and the Law. (1994). When death is sought: Assisted suicide and euthanasia in the medical context. New York: Author.
Weintraub, M., Singh, S., Byrne, L., Maharaj, K., & Guttmacher, L. (1991). Consequences of the 1989 New York State triplicate benzodiazepine prescription regulations. Journal of the American Medical Association, 266, 2392-2397.
Robert Angarola was director of the United States Cancer Pain Relief Committee and a partner in the law firm of Hyman, Phelps & McNamara, PC, in Washington, DC. Gail Bormel is an associate with the same firm.
