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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?
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 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).
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).
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)
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).
|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|
|Wisconsin||34-day supply (except up to a 90-day supply for C-III or IV anticonvulsant substance)|
|1913-1915; 1972||New York|
|1978||Rhode Island (duplicate)|
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.