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Maximizing the Value of Electronic Prescription Monitoring Programs

Published online by Cambridge University Press:  01 January 2021

David B. Brushwood
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Extract

There is general agreement that the “principle of balance” should guide controlled substance policy and regulation in the United States. Although the diversion of controlled substances from medical to nonmedical purposes is a significant public health problem, overly aggressive controlled substance regulation has been shown to have an unintended deterrent effect on appropriate controlled substance use, including pain management with opioid analgesics. The promotion of effective pain management and the reduction of substance abuse are equally important regulatory objectives. Neither regulatory objective need be sacrificed to achieve the other. Rather, the two objectives must be balanced with each other to assure that necessary pain management is encouraged while drug abuse is curtailed.

Approximately 75 million people in the United States suffer from severe pain. Fifty million of these suffer chronic pain, and 25 million suffer acute pain from trauma or surgery. Pain is not merely an uncomfortable symptom.

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Article
Information
Journal of Law, Medicine & Ethics , Volume 31 , Issue 1 , Spring 2003 , pp. 41 - 54
Copyright
Copyright © American Society of Law, Medicine and Ethics 2003

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References

The importance of creating a balanced system in which regulatory control of medications does not interfere with legitimate medicine has long been recognized. The federal law that establishes the framework for controlled substances regulation begins with the statement, “Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American People.” 21 U.S.C. § 801(1) (2001). The “principle of balance” was first articulated by David Joranson and June Dahl. See Joranson, D.E. and Dahl, J.L., “Achieving Balance in Drug Policy: The Wisconsin Model,” in Hill, C. S. Jr., and Fields, W.S., eds., Advances in Pain Research and Therapy, vol. 11 (New York: Raven Press, 1989). The principle has been promoted by the Wisconsin Pain & Policy Studies Group, which has developed guiding principles for analysis of statutes and regulations based on the principle of balance. See Joranson, D.E. et al., Achieving Balance in Federal and State Pain Policy: A Guide to Evaluation (Madison: The Pain & Policy Studies Group, University of Wisconsin Comprehensive Cancer Center, 2000), available at <http://www.medsch.wisc.edu/painpolicy/eguide2000/index.html>.Google Scholar
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Nonmedical drugs such as cocaine, marijuana, and methamphetamine are significantly abused drugs, but the abuse of medical drugs is equally problematic. There is evidence that approximately 2.6 million individuals abused prescription opioids in 1999. See National Institute on Drug Abuse, Prescription Drugs: Abuse and Addiction, NIH Publication No. 01–4881 (July 2001), available at <http://165.112.78.61/ResearchReports/Prescription/Prescription.html>..>Google Scholar
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The federal Controlled Substances Act (21 U.S.C. §§ 801 et seq.) establishes a closed system of distribution for drugs classified as controlled substances. Records must be kept from the time a drug is manufactured to the time it is dispensed. Those who are authorized to prescribe, dispense, and otherwise control access to these drugs are required to register with the Drug Enforcement Administration (DEA). Drugs that make their way outside this closed system are said to have been “diverted” from the system and people responsible for diversion are in violation of the law. See American Society of Law, Medicine & Ethics, Pain & The Law: Statutes & Regulation, at <http://www.painandthelaw.org/statutes/index.php> (last visited April 29, 2002). In reality, there is nothing at all closed about the system. The fact that pharmaceutical products are easily available for purchase “on the street” betrays the otherwise apparent security within the system.+(last+visited+April+29,+2002).+In+reality,+there+is+nothing+at+all+closed+about+the+system.+The+fact+that+pharmaceutical+products+are+easily+available+for+purchase+“on+the+street”+betrays+the+otherwise+apparent+security+within+the+system.>Google Scholar
Insurance companies, prescription benefit managers, and other third-party payers may maintain centralized records of controlled substance dispensing, and they may deny payment for excessive or inappropriate prescribing. However, their focus is generally on cost containment, not on drug abuse prevention. Enrollees in such programs may pay cash for their prescriptions and avoid having the prescriptions become part of the program database. Programs managed by third-party payers may reduce the abuse of controlled substances, but that is not their primary purpose and they are not an adequate substitute for a comprehensive program that aggregates data on dispensing from all pharmacies for all drugs and all patients. See Hoffmann, D.E., “Pain Management and Palliative Care in the Era of Managed Care: Issues for Health Care Providers,” Journal of Law, Medicine & Ethics, 26, no. 4 (1998): 267–89.CrossRefGoogle Scholar
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The structure and process goals generally relate to non-controversial matters such as data collection techniques, security, and data management.Google Scholar
The clearest statement to this effect is from the Alliance of States with Prescription Monitoring Programs, which says: “States’ laws generally must balance the promotion of the safe use of controlled substances for the provision of medical care with the need to impede illegal and harmful activities involving these pharmaceuticals. Prescription monitoring programs are tools used by states to assist in the achievement of these goals.” See ASPMP Report, supra note 50. The report of the Wisconsin Pain & Policy Studies Group is also quite clear in saying that “[t]he purpose of PMPs [prescription monitoring programs] is to reduce the diversion of prescription controlled substances…. Prescription monitoring is not intended to interfere with medical practice and attempts are made to make it minimally intrusive.” See Joranson, et al., supra note 14, at 233. Clearly stated program goals are far more elusive in the DEA report, although one can infer from the report's extensive discussions of both the deterrent effect on abuse and the lack of deterrence of appropriate use that these are both goals of the program. See DEA Report, supra note 18, at “Historical Background.”Google Scholar
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Addiction and pseudoaddiction are easily confused, but they are very different. Addiction is a neurobehavioral syndrome that results in psychological dependence and “is characterized by compulsive use despite harm.” Pseudoaddiction is a “pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management that can be mistaken for addiction.” See Federation of State Medical Boards of the United States, Inc., Model Guidelines for the Use of Controlled Substances for the Treatment of Pain (adopted May 2, 1998), available at <http://www.medsch.wisc.edu/painpolicy/domestic/model.htm>..>Google Scholar
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DEA Form 106 must be executed by any registrant who experiences a theft or significant loss of controlled substances through means such as burglary, robbery, loss in transit, or employee theft. These leaks from the closed system of controlled substance distribution are relevant to electronic prescription monitoring programs because they may explain the sudden appearance of pharmaceutical products “on the street,” and relieve any concerns that may otherwise be expressed regarding the actions of physicians and pharmacists as the source of the pharmaceutical products. All 106 forms are sent by registrants to the DEA. See Drug Enforcement Administration, “Controlled Substance Theft or Loss,” Pharmacist's Manual, 8th ed. (January 2001), available at <http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/secure/cs_theft.htm>' href=https://scholar.google.com/scholar?q=DEA+Form+106+must+be+executed+by+any+registrant+who+experiences+a+theft+or+significant+loss+of+controlled+substances+through+means+such+as+burglary,+robbery,+loss+in+transit,+or+employee+theft.+These+leaks+from+the+closed+system+of+controlled+substance+distribution+are+relevant+to+electronic+prescription+monitoring+programs+because+they+may+explain+the+sudden+appearance+of+pharmaceutical+products+“on+the+street,”+and+relieve+any+concerns+that+may+otherwise+be+expressed+regarding+the+actions+of+physicians+and+pharmacists+as+the+source+of+the+pharmaceutical+products.+All+106+forms+are+sent+by+registrants+to+the+DEA.+See+Drug+Enforcement+Administration,+“Controlled+Substance+Theft+or+Loss,”+Pharmacist's+Manual,+8th+ed.+(January+2001),+available+at+>Google Scholar
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Marketed under the tradename Soma, but also available as a generic product, carisoprodol is a noncontrolled skeletal muscle relaxant that is metabolized to meprobamate, a controlled substance. It is subject to abuse and should be used with caution in patients who have a history of substance abuse. See Reeves, R.R. et al., “Caridoprodol (Soma): Abuse Potential and Physician Unawareness,” Journal of Addictive Diseases, 18 (1999): 51–56.CrossRefGoogle Scholar
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