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

The need for balance in pain policy regulation has been recognized in a consensus statement by health care providers, health care regulators, and law enforcement. See Drug Enforcement Administration, 21 Health Groups Call for Balanced Policy on Prescription Pain Medication Like OxyContin (October 23, 2001), available at <http://www.deadiversion.usdoj.gov/pubs/pressrel/newsrel_102301.pdf>..>Google Scholar

See Joranson, D.E. and Gilson, A.M., “Regulatory Barriers to Pain Management,” Seminars in Oncology Nursing, 14 (1998): 158–63. Widely publicized disciplinary cases have focused physician attention on the risks of controlled substance prescribing. See, e.g., Hoover v. Agency for Health Care Administration, 676 So. 2d 1380 (Fla. Dist. Ct. App. 1996); Hollabaugh v. Arkansas State Medical Board, 861 S.W.2d 317 (Ark. Ct. App. 1993). In a recent survey of physicians, 23.8 percent agreed with the statement, “I give my patients a limited supply of pain medication to avoid being investigated.” In the same survey, 26.4 percent of physicians admitted that they feared an investigation by regulators if they prescribed controlled substances for a chronic pain patient. See Weinstein, S.M. et al., “Physicians' Attitudes Toward Pain and the Use of Opioid Analgesics: Results of a Survey From the Texas Cancer Pain Initiative,” Southern Medical Journal, 93 (2000): 479–87.CrossRefGoogle Scholar

The terms “opioid analgesic” and “narcotic” are virtually synonymous, but the former term is used consistently by the health care community, while the latter term is used consistently by the regulatory and law enforcement community. Both terms refer to drugs that are derived from opium or are synthetic adaptations of opium. They depress the central nervous system, relieve pain, and are used by drug addicts to support their addiction. Contrary to popular belief, the use of prescribed opioid analgesics by pain patients rarely leads to addiction. See Pappagallo, M., “The Concept of Pseudotolerance to Opioids,” Journal of Pharmaceutical Care in Pain Symptom Control, 6 (1998): 95–98.CrossRefGoogle Scholar

Even in the midst of the so-called “OxyContin crisis” of 2001, the Drug Enforcement Administration reiterated the importance of balance, describing its goal as “to ensure that the legitimate users of OxyContin® continue to receive their medication while reducing its diversion and abuse.” See Drug Enforcement Administration, Working to Prevent the Diversion and Abuse of OxyContin®, at <http://www.deadiversion.usdoj.gov/pubs/brochures/alert_oxycontin/alert_oxy.htm> (last visited April 29, 2002).+(last+visited+April+29,+2002).>Google Scholar

See American Chronic Pain Association, Frequently Asked Questions, at <http://www.theacpa.org/faqs.htm> (last visited April 29, 2002).+(last+visited+April+29,+2002).>Google Scholar

Uncontrolled pain can lead to the secretion of hormones that promote tissue breakdown and fluid retention; cardiovascular responses such as tachycardia, hypertension, ischemia, and ventricular arrhythmias; slowing of peristalsis; and immune system impairment. Uncontrolled pain is considered a significant public health issue. See Hill, C.S. Jr., “Government Regulatory Influences on Opioid Prescribing and Their Impact on the Treatment of Pain of Nonmalignant Origin,” Journal of Pain and Symptom Management, 11 (1996): 287–98.CrossRefGoogle Scholar

See American Chronic Pain Association, supra note 6.Google Scholar

Pain is the most common presenting complaint of patients seeking medical assistance. Nonpharmacologic treatment options include anesthesia interventions, behavioral counseling, transcutaneous electrical nerve stimulation, acupuncture, and massage. Pharmacologic treatments include nonsteroidal antiinflammatory drugs, opioids, and adjuvant medications such as anticonvulsants and antidepressants. Opioids are primary therapeutic options, and are not to be saved until the bitter end when every other option has been tried and has failed. See Bauman, T.J., “Pain Management,” in Dipiro, J.T. et al., Pharmacotherapy: A Pathophysiologic Approach, 4th ed. (New York, McGraw-Hill, 1999): 1014–26. It is estimated that only about one-quarter of pain patients receive adequate pain relief. See Joranson, D.E. and Berger, J.W., “Regulatory Issues in Pain Management,” Journal of the American Pharmaceutical Association, 40 (2000): S1–S60.Google Scholar

The difficulty of distinguishing between legitimate patients and drug seekers has led to the use of pain agreements between patients and physicians. In the agreement, patients commit to specific appropriate behaviors, in exchange for which physicians commit to providing care. Sometimes inaccurately referred to as “pain contracts,” these agreements are not legally binding, but they help patients understand how to behave so as to avoid being labeled a drug seeker. See Burchman, S.L. and Pagel, P.S., “Implementation of a Formal Treatment Agreement for Outpatient Management of Chronic Nonmalignant Pain with Opioid Analgesics,” Journal of Pain and Symptom Management, 10 (1995): 556–63.CrossRefGoogle Scholar

See Patel, A.T. and Ogle, A.A., “Diagnosis and Management of Acute Low Back Pain,” American Family Physician, 61 (2000): 1779–86.Google Scholar

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

The Alliance of States with Prescription Monitoring Programs lists the participating states as California, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, New Mexico, New York, Oklahoma, Rhode Island, Texas, Utah, Washington, and West Virginia. States with Prescription Monitoring Programs (March 2001), available at <http://www.nascsa.org/Rxmonitor/montable.pdf>..>Google Scholar

See Joranson, D.E. et al., “Pain Management and Prescription Monitoring,” Journal of Pain and Symptom Management, 23 (2002): 231–38.CrossRefGoogle Scholar

See Manchikani, L.M., Brown, K.R., and Singh, V., “National All Schedules Prescription Electronic Reporting Act (NASPER): Balancing Substance Abuse and Medical Necessity,” Pain Physician, 5 (2002): 294–319. See also Peine, S.I., ed., Drug Enforcement Administration, Prescription Accountability Resource Guide, rev. ed. (September 1998), available at <http://www.deadiversion.usdoj.gov/pubs/program/rx_account/index.html>.CrossRefGoogle Scholar

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

A description of each state's electronic prescription monitoring program is provided in A Closer Look at State Prescription Monitoring Programs. Peine, S. I., ed., Drug Enforcement Administration, A Closer Look at State Prescription Monitoring Programs (April 2000), available at <http://www.deadiversion.usdoj.gov/pubs/program/rx_monitor/index.html> [hereinafter cited as DEA Report]. [hereinafter cited as DEA Report].' href=https://scholar.google.com/scholar?q=A+description+of+each+state's+electronic+prescription+monitoring+program+is+provided+in+A+Closer+Look+at+State+Prescription+Monitoring+Programs.+Peine,+S.+I.,+ed.,+Drug+Enforcement+Administration,+A+Closer+Look+at+State+Prescription+Monitoring+Programs+(April+2000),+available+at++[hereinafter+cited+as+DEA+Report].>Google Scholar

Under the mandate of the Omnibus Budget Reconciliation Act of 1990 (OBRA-90), 21 U.S.C. § 1396r-8(g)(2)(A)(ii)(II) (2001), states that wish to participate in the Medicaid prescription benefit program must require that pharmacists make a reasonable effort to acquire and record information about a patient's medical condition and medication history. This requirement clearly places pharmacists in a better position to provide care to patients and to prevent costly problems with drug therapy. However, the failure of the legislation to provide for the confidentiality of this sensitive pharmacist-maintained information is a serious omission. See Quick, B.J., “The Cost of the Omnibus Budget Reconciliation Act of 1990,” Journal of Pharmacy Law, 2 (1994): 145–61.Google Scholar

See Doe v. SEPTA, 72 F.3d 1133 (3rd Cir. 1995) (noting that it is now possible from looking at an individual's prescription records “to determine that person's illnesses, or even to ascertain such private facts as whether a woman is attempting to conceive a child through the use of fertility drugs”).Google Scholar

See Mowery, G.M., “A Patient's Right of Privacy in Computerized Pharmacy Records,” University of Cincinnati Law Review, 66 (1998): 697–736.Google Scholar

See United States v. Acklen, 690 F.2d 70 (6th Cir. 1982) (concluding that pharmacists and distributors subject to the Controlled Substances Act have a reduced expectation of privacy in their records, and that the government may inspect these records without a search warrant by obtaining only an administrative inspection warrant). See also Stone v. City of Stow, 593 N.E.2d 294 (Ohio 1992) (holding that “since a pharmacy is a pervasively regulated business,” the pharmacist has “a reduced expectation of privacy in the prescription records he or she keeps”).Google Scholar

The Code of Ethics of the American Pharmaceutical Association, the national professional association of pharmacists, states: “With a caring attitude and a compassionate spirit, a pharmacist focuses on serving the patient in a private and confidential manner.” However, state laws do not recognize this requirement for pharmacists as consistently as they do a similar confidentiality requirement for physicians established by the American Medical Association. The ethical principle of confidentiality in pharmacy does not have the same level of legal authority as does the same principle for physicians. See Mowery, , supra note 21, at 717.Google Scholar

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Within this program, all Schedule II drugs could be prescribed only through use of a government-issued triplicate form. The form identified the prescribing physician, the dispensing pharmacy, the drug and dosage, and the name, address, and age of the patient. One copy of the form was retained by the physician, the second by the pharmacist, and the third was forwarded to the New York State Department of Health. Id. at 593.Google Scholar

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Washington v. Glucksberg, 521 U.S. 702 (1997).Google Scholar

Vacco v. Quill, 521 U.S. 793 (1997).Google Scholar

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The report states: “Several states have enacted ‘prescription monitoring programs’ that require the physician to issue prescriptions for controlled substances in certain schedules using only special government-issued single-copy, duplicate or triplicate forms. Studies show that these policies may deter legitimate prescribing of opioids.” Id. at 12.Google Scholar

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Shepherd, L., “Looking Forward with the Right of Privacy,” Kansas Law Review, 49 (2001): 251–320.Google Scholar

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See Meisel, A., “Pharmacists, Physician-Assisted Suicide, and Pain Control,” Journal of Health Care Law & Policy, 2 (1999): 211–42 (“To the extent that the United States Supreme Court's decisions rejecting a constitutional right to physician-assisted suicide can be viewed as creating a constitutional right to palliative care, this right must also extend to pharmacists' dispensing as well as physicians’ prescribing.”).Google Scholar

See Furrow, B.R., “Pain Management and Provider Liability: No More Excuses,” Journal of Law, Medicine & Ethics, 29, no. 1 (2001): 28–51. (“Treatment and management of pain by both physicians and institutional providers can be improved by the threat of tort litigation, which would spotlight providers’ failures to comply with an emergent standard of proper pain management.”).CrossRefGoogle Scholar

See Nist, J.B., “Liability for Overprescription of Controlled Substances: Can It Be Justified in Light of the Current Practice of Undertreating Pain?,” The Journal of Legal Medicine, 23 (2002): 85–113 (“For years there was a general feeling in the medical community that the best way to avoid liability would be to prescribe as little pain medication as possible.”).CrossRefGoogle Scholar

Stark, S.E., “Bio-Ethics and Physician Liability: The Liability Effects of Developing Pain Management Standards,” St. Thomas Law Review, 14 (2002): 601–40 (Referring to the rule of the Florida Board of Medicine, adopted almost verbatim from the Federation of State Medical Board's Guidelines for the Use of Controlled Substances in the Treatment of Pain, the author states: “The rule does not, as a whole, appear to provide any great comfort to physicians regarding their pain management practices and may actually result in a lack of uniformity in physicians pain management practices. Indeed, it could further chill physicians in their pain management efforts and reduce effective pain management.”).Google Scholar

See 21 C.F.R. § 1306.04 (2001).Google Scholar

See United States v. Singh, 54 F.3d 1182 (4th Cir. 1995) (holding that to convict a physician of unlawful prescribing of controlled substances, the government must prove, among other things, that the physician acted knowingly and intentionally).Google Scholar

See United States v. Henry, 727 F.2d 1373 (5th Cir. 1984) (holding that to convict a pharmacist of unlawful dispensing of controlled substances, the government must prove, among other things, that the pharmacist had reason to believe that the prescription was not issued in the usual course of professional treatment).Google Scholar

See Rich, B.A., “A Prescription for the Pain: The Emerging Standard of Care for Pain Management,” William Mitchell Law Review, 26 (2000): 1–91 (suggesting that a clinician who does not use available measures to improve the quality of care may have violated the standard of care even if the custom of the profession has not been to use such measures). See also Crowley, P.C., “No Pain, No Gain? The Agency for Health Care Policy & Research's Attempt to Change Inefficient Health Care Practice of Withholding Medication from Patients in Pain,” Journal of Contemporary Health Law & Policy, 10 (1994): 383–403 (“As one of the AHCPR's first completed clinical practice studies the guideline on pain management is in a prime position to change the standard of care for pain treatment at the initial stages of health care reform in the United States.”).Google Scholar

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See Alliance of States with Prescription Monitoring Programs, The Goals of Prescription Monitoring (October 26, 1999), available at <http://www.nascsa.org/Rxmonitor/Goals.pdf> [hereinafter cited as ASPMP Report].+[hereinafter+cited+as+ASPMP+Report].>Google 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

Joranson, and Gilson, , supra note 3, at 160. See also Angarola, R.T. and Wray, S.D., “Legal Impediments to Cancer Pain,” in Hill, C.S. Jr. and Fields, W.S., eds., Advances in Pain Research and Therapy, vol. 11 (New York: Raven Press, 1989) (concluding from their review of a recent study of ink-on-paper prescription monitoring programs that nothing in the data “suggested that there had been any reduction in abuse of Schedule II drugs, the purpose of the triplicate prescription requirement”).Google Scholar

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See Alpers, A., “Criminal Act or Palliative Care? Prosecutions Involving the Care of the Dying,” Journal of Law, Medicine & Ethics, 26, no. 4 (1998): 308–31. See also State of Oregon v. Ashcroft, 2002 U.S. Dist. LEXIS 6695 (D. Or. 2002) (invalidating directive of U.S. Attorney General that declared that prescribing controlled substances to assist patient death is not a legitimate medical purpose); Johnson v. tally, 887 P.2d 1262 (N.M. Ct. App. 1994) (civil rights action brought by a pharmacist against a local prosecutor who initiated criminal proceedings against the pharmacist after the pharmacist followed the instructions of the prosecutor and dispensed medication pursuant to a fraudulent prescription in cooperation with a drug diversion investigation).CrossRefGoogle Scholar

See Wastila, L.J. and Bishop, C., “The Influence of Multiple Copy Prescription Programs on Analgesic Utilization,” Journal of Pharmaceutical Care in Pain and Symptom Management, 4, no. 3 (1996): 3–19; Hill, Jr., supra note 7.Google Scholar

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See Haislip, G.R., “Impact of Drug Abuse on Legitimate Drug Use,” in Hill, C.S. Jr., and Fields, W.S., eds., Advances in Pain Research and Therapy, vol. 11 (New York: Raven Press, 1989): At 209. There is certainly an element of this view that is agreed to by all. The disagreement is over whether prescription monitoring programs are one of many barriers to pain management, not whether they are the only barrier. There are many factors other than prescription monitoring programs that pose barriers to effective pain management. See Martino, A.M., “In Search of New Ethic for Treating Patients with Chronic Pain: What Can Medical Boards Do?,” Journal of Law, Medicine & Ethics, 26, no. 4 (1998): 332–49.Google Scholar

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See DEA Report, supra note 18, at “Chilling Effect.”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

Evaluation of a physician's prescribing should be “based on the physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing.” Id.Google Scholar

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ARCOS is an “automated, comprehensive drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution to point of sale or distribution at the dispensing/retail level.” See Drug Enforcement Administration, ARCOS Background, at <http://www.deadiversion.usdoj.gov/arcos/background.htm> (last visited December 2, 2002). ARCOS data provide a denominator for calculating the rate of diversion (or, correspondingly, the rate of appropriate use) of controlled substances within a specific zip coded geographic area.+(last+visited+December+2,+2002).+ARCOS+data+provide+a+denominator+for+calculating+the+rate+of+diversion+(or,+correspondingly,+the+rate+of+appropriate+use)+of+controlled+substances+within+a+specific+zip+coded+geographic+area.>Google Scholar

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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