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1993 Angarola RT, Joranson DE. More federal drug control initiatives: Are they warranted? Will they consider the patient? APS Bulletin 1993;3(2):1-2, 8-9.

More Federal Drug Control Initiatives: Are They Warranted? Will They Consider the Patient?

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

Department editors' note: There are indications that there may be major new federal initiatives during 1993 to regulate controlled substances, including the opioid analgesics. It is critically important to determine whether the seriousness of the drug diversion problem in the United States warrants greater restrictions on the prescribing and dispensing of these medications, keeping in mind that increased regulation and prescription monitoring can impede pain management.

Officials of the Drug Enforcement Administration (DEA) recently testified before the U.S. Congress that DEA needs more authority to restrict, monitor, and investigate the prescribing and dispensing of controlled substances, including the opioid analgesics. "Within the past five years our law enforcement successes have leveled off. This leveling off is directly attributable to the limits of DEA's authority at the physician/patient level" (Haislip, 1992, p. 5). The justification for new federal authority is concern about "script doctors" and addicts who forge prescriptions or "shop" various physicians for prescriptions, fill them at pharmacies, and then either abuse or sell them.

While the exact form of new regulatory and legislative proposals is unclear, they will probably involve reducing the number of refills for the opioid analgesics in schedule III, moving drugs from schedule IV to schedule III, requiring the use of special government prescription forms for all controlled substances, monitoring all controlled substances prescriptions, and setting limits on the period that a controlled substance prescription is valid.

Does today's diversion problem warrant increased restrictions on prescribing controlled substances? Is the problem getting better or worse? The only direct measure of diversion available is the amount of controlled substances stolen from pharmacies (Comptroller General of the United States, 1978). During fiscal years 1974-1976, 123.6 million doses of controlled substances were diverted to illicit use in 126,877 pharmacy thefts across the nation (Comptroller General of the United States, 1978). Does pharmacy crime continue to be a principal source of diversion today? No one seems to know, because although pharmacies are required by law to report this information to DEA, statistical reports on pharmacy crime are no longer available.

In a 1978 report to Congress, DEA estimated that 250 million to 270 million dosage units of controlled substances were diverted annually (Comptroller General of the United States, 1978). In a 1992 report, DEA estimated that approximately the same amount continues to be diverted to illicit use annually (U.S. General Accounting Office, 1992).

But DEA also has reported that diversion has declined significantly (Drug Enforcement Administration, 1990a; Haislip, 1989). Indeed, the proportion of mentions of prescription controlled substances in emergency room admissions in the Drug Abuse Warning Network (DAWN) has declined sharply. Ten years ago, prescription drugs accounted for about 75% of the top 20 controlled substances mentioned in the DAWN system (U.S. General Accounting Office, 1982). By 1989, this proportion had dropped to less than 15%, according to data from the National Institute on Drug Abuse (NIDA) (Cooper, Czechowicz, Petersen, & Molinari, 1992). Furthermore, approximately half of these mentions involved a suicide attempt which, according to NIDA, is not a valid measure of abuse and diversion.

Significant progress to address diversion has been made and is due to the additional antidiversion authority and resources given to the federal government since 1970 and also to the considerable efforts of state licensing and regulatory agencies, national organizations, and the pharmaceutical industry. The easy sources of illegal diversion, such as the "script doctor," are much less a problem today, although this may vary from state to state depending on whether diversion control has been a priority. Diversion problems do remain and these can and should be addressed by careful use of several effective and efficient systems that are currently available (American Medical Association, 1990; Chi, 1983; Collins & Zimmerman, 1992).

Nonetheless, federal agencies routinely apprise the U.S. Congress that there is a serious diversion problem. In 1992, the director of the DEA's Office of Diversion Control told Congress that "diversion of pharmaceutical controlled substances remains a major part of our national drug problem" (Haislip, 1992, p. 1).

Even though diversion is declining, practitioners should not relax their vigilance - the threat of diversion is ever present - and we continue to need programs to educate practitioners about appropriate prescribing and existing regulations. But before new laws are enacted to restrict the prescribing and dispensing of controlled substances to patients, federal and state health and law enforcement authorities should undertake a critical reappraisal of diversion in the United States. Does a declining problem warrant new federal legislation and expenditures? Is greater restriction and scrutiny of prescribing to patients justified? Is it appropriate for the federal government to regulate prescribing decisions, an area that is traditionally left to the states? Does it make sense to restrict legitimate prescribing within the medical system in order to deal with threats from addicts, forgers, and thieves who operate outside that system? These questions must be answered because increased controlled substances regulation will affect patient care.

Or will it? Over the past several years, clinicians and researchers have expressed serious concerns that strict prescription monitoring impedes appropriate prescribing and patient care (Angarola & Wray, 1989; Foley, 1989; Hill, 1989; Joranson, 1990; Max, 1990; Portenoy, 1990). Enforcement and regulatory agencies have altered practice patterns through vigorous investigation of physicians for what was considered to be inappropriate prescribing of opioids for pain (Benton, 1993; Hill, 1989; McIntosh, 1991a; McIntosh, 1991b; Nowak, 1992). Is this impact on practice recognized? Federal enforcement agencies - those that advocate multiple-copy prescription programs (MCPPs) and report to Congress on the diversion problem - regard as baseless the concerns about the effect of regulatory scrutiny on medical practice and patient care.
Nothing in the multiple copy program limits or restricts medical judgment as to which drug or amount to prescribe. They must simply write the prescription on a different form. A physician with a legitimate practice does not abandon the professional training, oath, and duty to 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. (DEA, 1990a, pp. 40-42)

Furthermore, the U.S. General Accounting Office (GAO), in a report requested by the congressional author of national MCPP legislation, defended these programs and concluded that "Claims by medical, pharmaceutical, and patient organizations that prescription drug monitoring programs adversely affect a physician's ability to practice medicine or compromise patient care or confidentiality have not been substantiated" (U.S. General Accounting Office, 1992).

Is there evidence that controlled substances regulation and enforcement interferes with medical practice and patient care? The following points should be considered:


How do APS members feel about the effect of drug regulation on their prescribing? Recently, researchers at the University of Pittsburgh School of Medicine surveyed the physician members of the American Pain Society about their use of opioids in chronic noncancer pain. One hundred responses were received, representing 12% of the membership. Members were asked if they underprescribe opioids due to regulatory pressures rather than for strictly medical reasons. While 44% of the respondents disagreed with this statement, a total of 40% agreed that their prescribing was in fact influenced by legal concerns (Turk & Brody, 1992; Turk, personal communication, 1992).

Further evidence that physicians perceive regulatory scrutiny to be a risk comes from the fact that two states, Texas and California, have recently adopted laws to protect physicians who prescribe opioids for intractable pain from investigation by their medical boards.

Is there any reason for physicians to be concerned about scrutiny by their licensing agency? To explore this question, the University of Wisconsin Pain Research Group surveyed the members of state medical boards (Joranson et al., 1992).

Board members were asked to give their opinion on the legality of prescribing opioids for more than several months to chronic pain patients with and without cancer. Only 75% of medical board members were confident that prescribing opioids for chronic cancer pain was both legal and acceptable medical practice. Fourteen percent felt it was legal but would discourage it, and 5% believed the practice was illegal. If the patient's chronic pain did not involve a malignancy, only 12% were confident that the practice was both legal and medically acceptable; 47% would discourage it, and nearly a third believed the practice was illegal. Eighty percent of the medical board members stated that their medical board was the agency most likely to investigate physicians for improper prescribing of controlled substances in their state. These data suggest that perceived risks of regulatory scrutiny may be well founded.

Does the risk of regulatory scrutiny impede pain management? Does the declining nature of the diversion problem justify new federal controlled substances legislation? Should the federal government become more involved in the regulation of prescribing to patients? Are there effective, less costly, and less intrusive ways to identify and resolve current diversion problems? The answers to these questions will be crucial in determining the regulatory environment for prescribing controlled substances for many years to come.

David F. Musto, in his book The American Disease: Origins of Narcotic Control (1987), chronicled the history of narcotic drug policy in the United States, with particular attention to the major swings between drug tolerance and intolerance. He pointed out that the perception of a serious problem resulted in new drug laws when the drug problem was not well documented and even appeared to be declining: "It is important for us to know the history of drug abuse in America if we are to make wise decisions concerning drug abuse now and in the future. When we are in the middle of a drug crisis, however, we tend to forget this history" (Musto, 1987, p. ix).

References

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Angarola, R.T., & Wray, S.D. (1989). Legal impediments to cancer pain treatment. In C.S. Hill Jr. & W.S. Fields (Eds.), Advances in pain research and therapy, Vol. 11 (pp. 213-231). New York: Raven Press.

Benton, O. (1993). Innocent victims of the drug war? APS Bulletin, 3(l),17-19.

Berina, L.F., Guernsey, B.G., Hokanson, J.A., Doutré, W.H., & Fuller, L.E. (1985). Physician perception of a triplicate prescription law. American Journal of Hospital Pharmacy, 42, 857-859.

Chi, K.S. (1983). Prescription drug abuse control: The Wisconsin approach. (Innovations: Reports in Health, Education, and Social Services, April). Lexington, KY: The Council on State Governments.

Collins, T.M., & Zimmerman, D.R. (1992). Programs for monitoring inappropriate prescribing of controlled drugs: Evaluation and recommendations. American Journal of Hospital Pharmacy, 49, 1765-1768.

Comptroller General of the United States. (I 978). Retail diversion of legal drugs: A major problem with no easy solution. DEA report (#GGD-78-22) issued March 10, 1978. Washington, DC: U.S. Government Printing Office.

Cooper, J.R., Czechowicz, D.J., Petersen, R.C., & Molinari, S.P. (1992). Prescription drug diversion control and medical practice. Journal of the American Medical Association, 268, 1306-131 0.

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.

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Ferrell, B.R., McCaffery, M., & Rhiner, M. (1992). Pain and addiction: An urgent need for change in nursing education. Journal of Pain and Symptom Management, 7(2),117-124.

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Haislip, G.R. (1992, July 29). Statement on pharmaceutical drug diversion before the Select Committee on Narcotics Abuse and Control, Charles B. Rangel, Chairman. Testimony submitted in support of the hearings on "Pill Mills, Medical Fraud, and the Diversion of Pharmaceuticals," Washington, DC.

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