1.5.1 Legal Regulation of Opioids

The Federal government attempts to ensure the availability of opioid analgesics for legitimate medical and scientific purposes while controlling the abuse and illegal diversion of such substances -(Shapiro, in press, a). The Controlled Substances Rct (CSA) is one of the principal Federal laws that affects the use and availability of controlled substances, including opioid analgesics. The CSA provides for the registration of all handlers of controlled substances, as well as for the labeling, order forms, recordkeeping, and reporting of substances or their use; these activities enable enforcement agencies to identify manufacturers, distributors, clinicians, and pharmacists who divert controlled substances for illicit uses. The CSA also includes provisions that explicitly aim to avoid interference with the availability of U.S. Food and Drug Administration (FDA)-approved drugs for legitimate purposes. The CSA does not restrict a clinician's medical decision about which drug to prescribe, in what amounts, or -~or what duration, although it does prohibit physicians from prescribing opioids to maintain narcotic addiction unless the physician is separately registered to treat addiction. "Addict" is defined in the CSA as one who habitually uses an opioid drug so as to endanger public health or safety or one who has lost control over opioid use (Controlled Substances Act, 21 U.S.C., sec. 802). This definition rarely applies to a patient being treated with opioids for cancer pain (Kanner and Foley, 1981). Furthermore, Federal controlled substances regulations clarify that the Federal law is not intended to impose limitations on a physician's ability to prescribe opioid analgesics to persons with intractable pain in situations where no relief or cure is possible or none has been found after reasonable efforts (21 CFR 1306.07(c)).

State laws vary greatly, and many restrict or regulate the prescribing of opioids in the treatment of pain in ways that Federal law does not. For example, many State drug diversion laws contain ill-defined terms that in effect restrict opioid prescribing (Joranson, 1990). Other State laws also regulate pain treatment by restricting medication prescriptions to a specific number of dosage units or to a l-month supply, or by monitoring the prescription of controlled substances through multiple-copy prescription programs. WHO has observed that although multiple-copy prescription programs are intended to reduce careless prescribing, "Health care workers may be reluctant to prescribe, stock or dispense opioids as 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" (World Health Organization, 1990). In States with formal cancer pain initiatives, health professionals have worked with State agencies to identify and remove legal impediments to the use of controlled substances for cancer pain (Dahl, Joranson, Engber, et al., 1988).

A 1990 revision of the Uniform Controlled Substances Act addresses the legitimate use of controlled substances by recognizing that the prescribing, administering, and dispensing of opioid analgesics for intractable pain is part of professional medical treatment. It states that if terms such as addict, habitual user, and drug-dependent person are used in States' statutes, definitions of these terms should clearly indicate that they do not apply to patients receiving controlled substances pursuant to a practitioners order (Uniform Controll Substances Act, 1990). Each State legislature has received the revision from the Uniform Law Commissioners.

The panel recommends that laws and regulatory policies aimed at diversion control not hamper the appropriate use of opioid analgesics for cancer pain. Clinicians are responsible for knowing how controlled substances are regulated in their States. Such information can be obtained from State medical, nursing, and pharmacy licensing boards (see Angarola, 1990; Joranson, 1990 and Shapiro, in press, a, for additional information on the regulation of analgesic drugs).

Related Chunks

Barriers to Effective Pain Management

Cost and Reimbursement for Pain Management

Administration Methods

Oral

Rectal

Intraventricular

Patient-Controlled Analgesia (PCA)

Bisphosphonates and Calcitonin

Index