Dispensing Controlled Substances for the Treatment of Pain

7/30/2019 Dispensing Controlled Substances for the Treatment of Pain

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52716 Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006/ Notices

1National Institute on Drug Abuse ResearchReport: Prescription Drug Abuse and Addiction(revised August 2005). (available at http://www.drugabuse.gov/PDF/RRPrescription.pdf).

2Office of National Drug Control Policy (ONDCP)press release, March 1, 2004.

32006 Synthetic Drug Control Strategy (availableat http://www.whitehousedrugpolicy.gov/publications/synthetic_drg_control_strat/synth_strat.pdf).

4The NSDUH report is available at http://www.oas.samhsa.gov/2k6/pain/pain.pdf. The reportextracted data from the 2004 National Survey onDrug Use and Health.

5http://dawninfo.samhsa.gov/files/TNDR07EDvisitsNonmedicalUseForWeb.pdf.

6http://monitoringthefuture.org.

7NIDA news release, December 19, 2005(available at http://www.nida.nih.gov).

8 Id.

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA286P]

Dispensing Controlled Substances forthe Treatment of Pain

AGENCY:Drug EnforcementAdministration (DEA), Justice.

ACTION: Policy Statement.

SUMMARY: On January 18, 2005, DEApublished in the Federal Register asolicitation of comments on the subjectof dispensing controlled substances forthe treatment of pain. Many of thecomments that DEA received asked theagency to elaborate on the legalrequirements and agency policy relatingto this subject. This document providessuch information.

DATES: September 6, 2006.

FOR FURTHER INFORMATION CONTACT

:Mark W. Caverly, Chief, Liaison andPolicy Section, Office of DiversionControl, Drug EnforcementAdministration, Washington, DC 20537;Telephone: (202) 3077297.

SUPPLEMENTARY INFORMATION:

Background

On January 18, 2005, the DEApublished in the Federal Register aSolicitation of Comments on the subjectof dispensing controlled substances forthe treatment of pain. 70 FR 2883. Manyof the comments sought furtherinformation about the legalrequirements and agency policy relatingto the prescribing of controlledsubstances for the treatment of pain.DEA stated in the Solicitation ofComments that it would be issuing adocument providing such informationafter reviewing the comments.Accordingly, this policy statementprovides practitioners with a recitationof the pertinent principles under theControlled Substances Act (CSA) andDEA regulations relating to thedispensing of controlled substances forthe treatment of pain.

Extent of Abuse in the United States ofControlled Prescription Drugs

The abuse (nonmedical use) ofprescription drugs is a serious andgrowing health problem in thiscountry.1 As the Administration hasannounced, recent data indicate thatprescription drug abuse, particularly ofopioid pain killers, has increased at an

alarming rate over the past decade.2Statistics published in the NationalSurvey on Drug Use and Health(NSDUH) by the Department of Healthand Human Services, Substance Abuseand Mental Health ServicesAdministration (SAMHSA),demonstrate that prescription drugsaccount for the second-most commonly

abused category of drugs, behindmarijuana and ahead of cocaine, heroin,methamphetamine, and other drugs.3

One of the areas of concern is thenumber of persons who have recently

begun abusing prescription controlledsubstances. In its NSDUH Reportpublished in June 2006,4 SAMHSAstates: In 2004, among persons aged 12or older, 2.4 million initiatednonmedical use of prescription painrelievers within the past year. This ismore than the estimated number ofinitiates for marijuana (2.1 million) orcocaine (1.0 million). Overall,

according to the NSDUH report: Anestimated 31.8 million Americans haveused pain relievers nonmedically intheir lifetimes, up from 29.6 million in2002.

Another source of data presented bySAMHSA is that collected by the DrugAbuse Warning Network (DAWN),which provides national estimates ofdrug related visits to hospital emergencydepartments. According to DAWN, for2004:

Nearly 1.3 million emergencydepartment (ED) visits in 2004 wereassociated with drug misuse/abuse.Nonmedical use of pharmaceuticals wasinvolved in nearly half a million of these EDvisits.

Opiates/opioid analgesics (pain killers),such as hydrocodone, oxycodone, andmethadone, and benzodiazepines, such asalprazolam and clonazepam, were present inmore than 100,000 ED visits associated withnonmedical use of pharmaceuticals in 2004.5

A measure of the problem amongyoung people is the 2005 Monitoring theFuture (MTF) survey conducted by theUniversity of Michigan.6 The MTFsurvey is funded by the NationalInstitute on Drug Abuse (NIDA), acomponent of the National Institutes of

Health (NIH), and measures drug abuseamong 8th, 10th, and 12th graders.

NIDA stated: While the 2005 surveyshowed a continuing general decline indrug use, there are continued high ratesof non-medical use of prescriptionmedications, especially opioid painkillers. For example, in 2005, 9.5percent of 12th graders reported usingVicodin in the past year, and 5.5 percentof these students reported usingOxyContin in the past year. 7 Inannouncing the latest MTF surveyresults, NIH Director Dr. Elias Zerhounisaid that the upward trend inprescription drug abuse is disturbing. 8

Purposes and Structure of ThisDocument

One of the chief purposes of thisdocument is to make clear that thelongstanding requirement under the lawthat physicians may prescribecontrolled substances only for legitimatemedical purposes in the usual course of

professional practice should in no wayinterfere with the legitimate practice ofmedicine or cause any physician to bereluctant to provide legitimate paintreatment. DEA also wishes to dispel themistaken notion among a small numberof medical professionals that the agencyhas embarked on a campaign to targetphysicians who prescribe controlledsubstances for the treatment of pain (orthat physicians must curb theirlegitimate prescribing of painmedications to avoid legal liability).

To achieve these aims, this documentbegins with a general summary of the

relevant legal principles and anexplanation of the role of DEA withrespect to regulation of controlledsubstances. The document thenaddresses specific issues and questionsthat have been raised on a recurring

basis by physicians who seek guidanceon the subject of dispensing controlledsubstances for the treatment of pain.

It should be understood that the legalstandard under the ControlledSubstances Act (CSA) for prescribingcontrolled substances to treat pain is thesame as that for prescribing controlled

substances generally: The prescriptionmust be issued for a legitimate medicalpurpose by a registered physician actingwithin the usual course of professionalpractice. The reason this documentfocuses on the prescribing of controlledsubstances for the treatment of pain isthat there has been considerable interestamong members of the public in havingDEA address this specific issue.

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52717Federal Register / Vol. 71, No. 172 / Wednesday, September 6, 2006/ Notices

921 U.S.C. 871(a); 28 CFR 0.100.10As the United States Supreme Court stated in

an early decision under the CSA, provisionsthroughout the Act reflect the intent of Congress toconfine authorized medical practice withinaccepted limits.United States v. Moore, 423 U.S.122, 141142 (1975). In Gonzales v. Oregon, 126S.Ct. 904, 925 (2006), the Court continued to cite

Moore with approval and for the proposition thatthe legitimate medical purpose requirement in theCSA ensures patients use controlled substancesunder the supervision of a doctor so as to preventaddiction and recreational abuse. The Courtfurther stated: As a corollary, the provision alsobars doctors from peddling to patients who cravethe drugs for those prohibited uses.Id

11Medical specialty boards also play a crucialrole in providing information to the public, thegovernment, and the medical profession concerningissues involving specialization and certification inmedicine. Specialty boards maintain the quality ofmedical care in the United States by developing andutilizing professional and educational standards forthe evaluation and certification of physicianspecialists.

12The first such uniform act was the UniformNarcotic Drug Act of 1932, which was eventuallyadopted by every state. That act was replaced in1970 by the Uniform Controlled Substances Act,which has been adopted by all but two states (NewHampshire and Vermont).

13

Congress expressly intended that there wouldbe a dual system of Federal-state regulation ofcontrolled substances by including in the CSA apreemption provision, 21 U.S.C. 903, which reflectsthat this field of regulation was to be shared by theFederal and state governments. Section 903 states:No provision of this subchapter shall be construedas indicating an intent on the part of Congress tooccupy the field in which that provision operates,including criminal penalties, to the exclusion ofany State law on the same subject matter whichwould otherwise be within the authority of theState * * * . At the same time, this provisionreiterates what is inherent in the supremacy clauseof the United States Constitutionthat no state mayenact a law relating to controlled substances thatpresents a positive conflict with the CSA.

14Moore, 423 U.S. at 139 (quoting juryinstruction).

15United States v. August, 984 F.2d 705, 713 (6thCir. 1992).

16United States v. Rosen, 582 F.2d 1032 (5th Cir.1978).

The Statutory Role of DEA inRegulating the Prescribing of ControlledSubstances

DEA is the agency within theDepartment of Justice responsible forcarrying out the functions assigned tothe Attorney General under the CSA.9These functions include enforcing andadministering the CSA provisionsgoverning the prescribing,administering, and dispensing ofcontrolled substances. Thus, the scopeof DEAs authority is delineated by theextent to which Congress itself regulatedcontrolled substances through theenactment of the CSA and assignedcertain functions under the Act to theAttorney General.

While the CSA is one component ofthe overall regulation of the practice ofmedicine in the United States,10 it bearsemphasis that the CSA does notregulatethe practice of medicine as a whole.Therefore, although DEA is the agency

responsible for administering the CSA,DEA does notact as the Federalequivalent of a State medical boardoverseeing the general practice ofmedicine. State laws and State licensing

bodies (such as medical licensingboards) collectively regulate the practiceof medicine.11 In contrast, the scope ofthe CSA (and therefore role of DEA) ismuch narrower. The CSA regulates onlythe segment of medical practiceinvolving the use of controlledsubstances, and DEA is correspondinglyresponsible for ensuring that controlledsubstances are used in compliance with

Federal law.In particular, DEAs role under theCSA is to ensure that controlledsubstances are prescribed, administered,and dispensed only for legitimatemedical purposes by DEA-registeredpractitioners acting in the usual courseof professional practice and otherwise

in accordance with the CSA and DEAregulations. Each State also has its ownlaws (administered by State agencies)requiring that a prescription for acontrolled substance be issued only fora legitimate medical purpose byState-licensed practitioners acting in theusual course of professional practice.

There is nothing new in this

arrangement of responsibilities betweenthe Federal and State governments. Formore than 90 years (starting with theHarrison Narcotic Act of 1914, whichwas superseded by the CSA in 1970)Federal law has placed certainrestrictions on the medical use offederally controlled substances while, atthe same time, the States have regulatedthe practice of medicine generally. Inthis respect, there has long been acertain amount of overlap between theFederal and State oversight of controlledsubstances. Beginning in the 1930s andthrough to the present, States have

adopted uniform controlled substancelaws that were designed to promotestandards that are consistent from Stateto State and in harmony with Federallaw.12 One such standard that hasalways been a fundamental part of theseuniform State laws is the requirementthat controlled substances be dispensedonly for a legitimate medical purpose bya practitioner acting in the usual courseof professional practicea requirementfirst articulated in the Harrison NarcoticAct. Accordingly, it has been the casefor more than 70 years that apractitioner who dispenses controlledsubstances for other than a legitimatemedical purpose, or outside the usualcourse of professional practice, issubject to legal liability under both Stateand Federal law.13

The Meaning of the LegitimateMedical Purpose Requirement

As stated above, the core legalstandard is that a controlled substance

may only be prescribed, administered,or dispensed for a legitimate medicalpurpose by a physician acting in theusual course of professional practice.This requirement has been construed tomean that the prescription must be inaccordance with a standard of medicalpractice generally recognized andaccepted in the United States. 14

However, Federal courts have longrecognized that it is not possible toexpand on the phrase legitimatemedical purpose in the usual course ofprofessional practice, in a way thatwill provide definitive guidelines thataddress all the varied situationsphysicians might encounter. As onecourt explained:

There are no specific guidelinesconcerning what is required to support aconclusion that an accused acted outside theusual course of professional practice. Rather,the courts must engage in a case-by-caseanalysis of evidence to determine whether a

reasonable inference of guilt may be drawnfrom specific facts.15

Similarly, another court stated:

A majority of cases [in which physicianswere alleged to have dispensed controlledsubstances without a legitimate medicalpurpose] have dealt with facts which were so

blatant that a statement of clear-cut criteriain a form useful in other cases would have

been superfluous to the decision. We are,however, able to glean from reported casescertain recurring concomitance ofcondemned behavior.16

The foregoing quotation makes aparticularly important point: that the

types of cases in which physicians havebeen found to have dispensedcontrolled substances improperly underFederal law generally involve factswhere the physicians conduct is notmerely of questionable legality, butinstead is a glaring example of illegalactivity.

Specific Areas of Interest to theCommenters

The comments DEA received covereda variety of issues related to thedispensing of controlled substances forthe treatment of pain. While some of theviewpoints expressed in the comments

were in sharp contrast with otherviewpoints, taken as a whole, thecomments indicate there is significantinterest (among those physicians andmembers of the public who submittedcomments) in having DEA address thefollowing topics:



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17

Also of chief concern to commenters was theissuance by physicians of multiple schedule IIprescriptions. DEA addressed this issue in detail inthe August 26, 2005, Federal Register documenttitled Clarification of Existing Requirements Underthe Controlled Substances Act for PrescribingSchedule II Controlled Substances. 70 FR 50403.In addition, DEA is today publishing in the FederalRegister a notice of proposed rulemaking (DocketNo. DEA287N) that would revise the DEAregulations to allow for the issuance of multipleschedule II prescriptions under certaincircumstances.

18Federation of State Medical Boards of theUnited States, Model Policy for the Use ofControlled Substances for the Treatment of Pain(2004).

19National Institute on Drug Abuse ResearchReport: Prescription Drug Abuse and Addiction(available at http://www.drugabuse.gov/PDF/RRPrescription.pdf).

20One indication of the lack of consensus amongphysicians on this point is the following. TheAmerican Medical Association, in a publishedpolicy statement (D120.999) (Use of opioids inchronic noncancer pain), states: Furthercontrolled trials [should] be conducted on opioidtherapy in patients with chronic noncancer pain inan effort to identify best practice with regard toselection of both medication and treatmentregimens [to] identify patient characteristics thatpredict opioid responsiveness [and to] providesupport for guidelines on appropriate precautions,contraindications, and the degree of monitoringrequired in such patients.

The extent and consequences of theundertreatment of pain in the UnitedStates.

The extent and consequences ofexcessive use of opioids to treatnonsevere pain.

Providing medical and legalguidance on prescribing opioids forpain.

Elaborating on DEAs policyregarding the investigation of physiciansfor improper prescribing of controlledsubstances for pain.

Having DEA provide reassurancethat it is not targeting physicians whoprescribe controlled substances for pain.

Each of these topics is addressed inthis document.17

Comments Regarding the Use ofOpioids

The comments reflect two distinctpoints of emphasis among physicianswho specialize in the treatment of pain.For some, of paramount concern is whatthey describe as the undertreatment ofacute and chronic pain. Illustrative ofthis viewpoint, one commenter hasstated:

The undertreatment of pain is recognizedas a serious public health problem thatresults in a decrease in patients functionalstatus and quality of life and may beattributed to a myriad of social, economic,political, legal and educational factors,including inconsistencies and restrictions inState pain policies. Circumstances thatcontribute to the prevalence of undertreatedpain include: (1) Lack of knowledge ofmedical standards, current research, andclinical guidelines for appropriate pain

treatment; (2) the perception that prescribingadequate amounts of controlled substanceswill result in unnecessary scrutiny byregulatory authorities; (3) misunderstandingof addiction and dependence; and (4) lack ofunderstanding of regulatory policies andprocesses.18

One group representing severalorganizations of physicians whospecialize in treating pain commentedthat it agrees with the followingstatement made by DEA in theNovember 16, 2004, Interim PolicyStatement published in the Federal

Register (69 FR 67170): [C]hronic painis a serious problem for manyAmericans. It is crucial that physicianswho are engaged in legitimate paintreatment not be discouraged fromproviding proper medication to patientsas medically justified. However, thisgroup expressed the view that theInterim Policy Statement would have

the exact opposite effect bydiscouraging some practitioners fromproperly treating pain. The grouptherefore urged DEA to readdress thesubject in a way that will promoteproper dispensing of controlledsubstances for pain. Similar views wereexpressed in comments submitted bymany other organizations whosemissions relate to the treatment of pain.For example, an organizationrepresenting health care professionalsand patient advocates for those withcancer pain stated: We respectfullyrequest that the DEA reaffirm its support

for areas of the law that support theappropriate use of opioid analgesics forpain control and thereby reduce thefears and uncertainties of health careprofessionals who treat patients inpain. With regard to this point, NIDAhas stated in a recent report: Manyhealthcare providers underprescribeopioid pain relievers, such as morphineand codeine, because they overestimatethe potential for patients to becomeaddicted. 19

A few other commenters focusedprimarily on what they believe is theoverprescribing of opioids by somephysicians to treat pain. For example,one physician who specializes in paintreatment stated that the majority ofhigh dose narcotic prescribing is forchronic non-malignant pain, that thegrowth of this practice has beenexponential, and that there have beenmany problems associated with thispractice, including the tremendous risein abuse of prescription drugs in allsegments of the population, especiallythe youth. Along similar lines, anotherphysician commented there has been anepidemic of deaths and addictionresulting from the illicit use ofprescription narcotics, which, according

to this commenter, is due in large partto the prescribing of narcotics to amuch wider class of chronic noncancerpatients, including those with moderatesubjective ailments such as bursitis,neuralgia, arthritis, headaches, andlower back pain. Another physicianstated the large increase in the use ofprescription narcotics and deaths

related thereto seem to be coincidentwith growing advocacy for use of opioidpain medications in chronic benign painsyndromes and also coincide with themarketing of expensive new opioid drugpreparations which are aggressivelypromoted by the drug manufacturers,and with the growth of professional andaccrediting organizations that seem

determined to promote the use of opioidpain medications.

The two distinct areas of emphasisreflected in the commentsthecommenters views about theundertreatment of pain and what someperceive as overprescribing of opioidsfor nonsevere ailmentsare notnecessarily mutually exclusive. To thecontrary, the comments takencollectively suggest that there may besome physicians who undertreat painand others who improperly prescribeopioids ostensibly for the treatment ofpain. (DEA presumes, however, that

most physicians provide appropriateamounts of pain medication.) Thecomments also reflect that there is a lackof consensus among physicians as to allthe circumstances that warrant the useof opioids to treat pain.20 On this latterpoint, one physician who specializes inpain treatment commented: Thetreatment of chronic nonmalignant painsyndromes with narcotic medicationsremains a controversial area with themainstream medical community. Thiscommenter suggested there is a need forrandomized, double-blind, controlledclinical trials to fully evaluate this issue.

As explained below, it is not DEAs roleto issue medical guidelines specifyingpatient characteristics that warrant theselection of a particular opioid or othermedication or regimen for the treatmentof pain.

Requests for Guidance on TreatingPatients for Pain

Many commenters expressed the viewthat it would be beneficial if physicianshad a single document providing clearguidelines on the use of controlledsubstances for the treatment of pain.Some believe such a document wouldremedy their concerns about the

undertreatment of pain by giving



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21As stated above, DEA does have the authorityand the expertise to investigate and determinewhether a prescription for a controlled substancewas issued for a legitimate medical purpose in theusual course of professional practice within themeaning of the CSA and DEA regulations.

22As set forth in FACA, a charter must be enactedbefore an advisory committee can meet. 5 U.S.C.App. 2 9(c). For an agency committee, the charter

must be filed with the head of the agency, theappropriate Senate and House of Representativesstanding committees, the Library of Congress, andthe General Services Administration Secretariat, 41CFR 1023.70. The charter must contain certaininformation, including, among other things, thefollowing: the advisory committees officialdesignation; objectives and the scope of theadvisory committees activity; the time necessary tocarry out the advisory committees purposes; adescription of the duties for which the advisorycommittee is responsible; the estimated annualcosts; the estimated frequency of the advisorycommittees meetings; and the planned terminationdate.

23See Executive Order 12838 (Termination andLimitation of Federal Advisory Committees).

24The majority of cases in which physicians losetheir DEA registrations result from actions by statemedical boards to revoke or suspend thephysicians state medical licenses.

physicians assurance that they canavoid scrutiny by Federal and Stateregulatory authorities as long as theyfollow those guidelines whenprescribing opioids. More specifically, ithas been suggested that these guidelinesshould take the form of a series ofquestions and answers to be adopted byDEA. Among the questions that have

been proposed for inclusion in theseguidelines are:

What should be the goals of painmanagement?

How can a clinician assess apatients pain?

When should a primary carephysician turn to a pain medicinespecialist to manage a patients pain?

How are opioids used to managechronic pain?

It is certainly appropriate forphysicians and medical oversight

boards to explore these types ofquestions. However, for the followingreasons, it is not appropriate for DEA toaddress these questions in the form ofa guidance document (or to endorsesuch a guidance document prepared byothers).

First, one cannot provide anexhaustive and foolproof list ofdosand donts when it comes toprescribing controlled substances forpain or any other medical purpose. Asdiscussed above, the fundamentalprinciple under both Federal and Statelaw is that a controlled substance must

be dispensed by a physician for alegitimate medical purpose in the usualcourse of professional practice.

Throughout the 90 years that thisrequirement has been a part of UnitedStates law, the courts have recognizedthat there are no definitive criterialaying out precisely what is legallypermissible, as each patients medicalsituation is unique and must beevaluated based on the entirety of thecircumstances. DEA cannot modify orexpand upon this longstanding legalrequirement through the publication orendorsement of guidelines.

Second, as stated earlier in thisdocument, DEAs authority under theCSA is not equivalent to that of a State

medical board. DEA does not regulatethe general practice of medicine. Theresponsibility for educating and trainingphysicians so that they make soundmedical decisions in treating pain (orany other ailment) lies primarily withmedical schools, post-graduate trainingfacilities, State accrediting bodies, andother organizations with medicalexpertise. Some states also havecontinuing medical educationrequirements for licensing. Physiciansalso keep abreast of the latest findings

by reading peer-reviewed articles

published in medical and scientificjournals. DEA, however, has neither thelegal authority nor the expertise toprovide medical training to physiciansor issue guidelines that constituteadvice on the general practice ofmedicine.21

For these reasons, DEA is notproposing any medical guidelines on

prescribing controlled substances for thetreatment of pain.

Whether To Form an AdvisoryCommittee

Several members of the public havesuggested that DEA form an advisorycommittee, panel, or working group todevelop and publish guidelines on theuse of controlled substances for thetreatment of pain. An agency may notutilize an advisory committee (or panelor working group) to provide advice tothe agency or prepare a document for (orin conjunction with) the agency unlessall of the procedural requirements of theFederal Advisory Committee Act(FACA) are satisfied.22 Compliance withFACA ensures, among other things, thatpersons selected by the agency to serveon the committee constitute a balancedmembership that represents a fair cross-section of viewpoints.

If DEA were to conclude thatcompelling considerations necessitatedthe formation of an advisory committeesubject to FACA, the agency would seekto do so in accordance with the law andExecutive Branch directives.23 At thistime, DEA does not believe that suchconsiderations exist warranting the

formation of such an advisorycommittee to address the dispensing ofcontrolled substances for the treatmentof pain. However, there are other meansavailable to an agency to obtain valuablepublic input. Within the boundspermissible by law, DEA remains firmly

committed to obtaining the ongoinginput of the medical community, lawenforcement officials, and otherinterested members of the public.Toward this end, the agency welcomeswritten submissions from the public onthis document and will continue toexplore other legally appropriate meansof hearing the views of interested

members of the public.

The Number of Physicians WhoPrescribe Controlled Substances inViolation of the CSA Is Extremely Smalland There Is No DEA Crackdown onPhysicians

DEA recognizes that theoverwhelming majority of Americanphysicians who prescribe controlledsubstances do so for legitimate medicalpurposes. In fact, the overwhelmingmajority of physicians who prescribecontrolled substances do so in alegitimate manner that will never

warrant scrutiny by Federal or State lawenforcement officials. Contrary to theimpression of some commenters, DEAhas not modified its criteria forinvestigating physicians or increased itsemphasis on physicians as part of theagencys overall mission. In any given

year, including 2005, fewer than one outof every 10,000 physicians in the UnitedStates (less than 0.01 percent) lose theircontrolled substance registrations basedon a DEA investigation of improper

prescribing.24 This figure alone shouldcorrect any mistaken notions about asupposed DEA crackdown onphysicians. Moreover, as mentionedabove, the responsibility for monitoringand preventing controlled substanceabuse is shared by State and Federalgovernments. Even in the rare caseswhere a physician loses his/her DEAregistration for improper prescribing, itis often State officialsnot DEAwhoinitiate the investigations.

DEA always had, and continues tohave, a legal obligation to investigate theextremely small fraction of physicianswho use their DEA registration tocommit criminal acts or otherwiseviolate the CSA. DEA takes thisobligation seriously because even just

one physician who uses his/her DEAregistration for criminal purposes cancause enormous harm. In the words ofone commenter: It takes only a fewuntrained or unscrupulous physiciansto create large pockets of addicts. ButDEA takes just as seriously its obligationto ensure that there is no interferencewith the dispensing of controlled



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25126 S.Ct. at 925.26 Id.

substances to the American public inaccordance with the sound medicaljudgment of their physicians. It would

be a disservice to many patients ifexaggerated statements regarding thelikelihood of a DEA investigationresulted in physicians mistakenlyconcluding that they must scale backtheir patients use of controlled

substances to levels below that which ismedically appropriate.

Furthermore, DEA does not apply agreater level of scrutiny to theprescribing of controlled substances totreat pain as compared to otherailments. Regardless of the ailment,DEA applies evenhandedly therequirement that a controlled substance

be prescribed for a legitimate medicalpurpose in the usual course ofprofessional practice. The idea thatprescribing opioids to treat pain willtrigger special scrutiny by DEA is false.

Types of Cases in Which Physicians

Have Been Found To Have Prescribedor Dispensed Controlled Substances forOther Than a Legitimate MedicalPurpose or Outside the Usual Course ofProfessional Practice

Bearing in mind that there are nocriteria that will address everyconceivable instance of prescribing, thefollowing examples of cases areprovided to explain how Federal courtsand DEA have applied the requirementthat a controlled substance be dispensedfor a legitimate medical purpose in theusual course of professional practice.

Application of the Requirement byFederal Courts

As noted above, the Supreme Courtrecently stated, in Gonzales v. Oregon,that the legitimate medical purposerequirement in the CSA ensurespatients use controlled substancesunder the supervision of a doctor so asto prevent addiction and recreationalabuse. 25 The Court further stated: Asa corollary, the provision also barsdoctors from peddling to patients whocrave the drugs for those prohibiteduses. 26

Consistent with those views, some

years ago, the United States Court ofAppeals for the Fifth Circuitsummarized the reported cases in whichphysicians had been found to haveviolated the requirement that aprescription for a controlled substance

be issued only for a legitimate medicalpurpose in the usual course ofprofessional practice. In this decision,United States v. Rosen, 582 F.2d 1032(5th Cir. 1978), the court looked at the

case law and found the followingrecurring patterns indicative ofdiversion and abuse:

(1) An inordinately large quantity ofcontrolled substances was prescribed.

(2) Large numbers of prescriptions wereissued.

(3) No physical examination was given.(4) The physician warned the patient to fill

prescriptions at different drug stores.(5) The physician issued prescriptionsknowing that the patient was delivering thedrugs to others.

(6) The physician prescribed controlleddrugs at intervals inconsistent withlegitimate medical treatment.

(7) The physician involved used streetslang rather than medical terminology for thedrugs prescribed.

(8) There was no logical relationshipbetween the drugs prescribed and treatmentof the condition allegedly existing.

(9) The physician wrote more than oneprescription on occasions in order to spreadthem out.

The same fact patterns listed by theRosen court remain prevalent todayamong the cases in which physicianshave been found to have improperlyprescribed controlled substances. Thisdoes not mean that the existence of anyof the foregoing factors willautomatically lead to the conclusionthat the physician acted improperly.Rather, each case must be evaluated

based on its own merits in view of thetotality of circumstances particular tothe physician and patient. For example,what constitutes an inordinately largequantity of controlled substances(factor (1) listed by the Rosen court) can

vary greatly from patient to patient. Aparticular quantity of a powerfulschedule II opioid might be blatantlyexcessive for the treatment of aparticular patients mild temporarypain, yet insufficient to treat the severeunremitting pain of a cancer patient.

Again, rather than focusing on anyparticular factor, it is critical to bear inmind that (i) the entirety ofcircumstances must be considered, (ii)the cases in which physicians have beenfound to have prescribed controlledsubstances improperly typically involvefacts that demonstrate blatant criminal

conduct, and (iii) the percentage ofphysicians who prescribe controlledsubstances improperly (or areinvestigated for doing so) is extremelysmall.

Application of the Requirement by DEA

Any final decision by DEA to revokeor deny a DEA registration is publishedin the Federal Register. The followingare three examples from 2005 in whichDEA revoked physicians DEAregistrations for unlawfully prescribingor dispensing controlled substances.

(The complete final orders arepublished in the Federal Register andare available online.)

Robert A. Smith, M.D. (70 FR33207)Dr. Smith gave one patientseven to ten prescriptions of OxyContinper visit on a weekly basis. Theprescriptions were written in thepatients name as well as the names of

the patients father and her fiance. Eachvisit, the patient paid Dr. Smith a $65fee for the office visit plus an additional$100 for the fraudulent prescriptions.Dr. Smith also asked the patient forsexual favors during office visits. Thepatient declined, but, as a substitute,paid another woman $100 to perform asexual act on Dr. Smith. Dr. Smithsoffice assistant also provided the patientwith blank prescriptions, in return forwhich the office assistant demandedfrom the patient $40 and OxyContintablets.

Another patient would give Dr. Smitha list of fictitious names and types ofcontrolled substances he desired, andDr. Smith would issue threeprescriptions under each name, usuallyfor Percocet, OxyContin, and Xanax, atthe same time. Dr. Smith issued

between nine and fifteen fraudulentprescriptions per visit and received$100 for each set of three prescriptions.The patient then sold the prescriptionsto a third party who, in turn, sold thedrugs on the street, all with theknowledge of Dr. Smith.

Another individual visited Dr. Smiththree times in less than a three-weekperiod, obtaining fraudulent

prescriptions each time. The individualpaid Dr. Smith $500 for 15 prescriptionsfor Xanax, OxyContin, and Percocet,which were written under five differentfictitious patient names.

James S. Bischoff, M.D. (70 FR12734)Dr. Bischoff took a 16-year-oldhigh school student to an out-of-townphysician specialist for emergencymedical treatment after the boys handwas cut in an accident. When thespecialist did not recommend treatmentwith a controlled substance, Dr. Bischoffwrote the boy a prescription for 100OxyContin, which Dr. Bischoff

personally took to a pharmacy to befilled. Dr. Bischoff delivered only 20tablets to the boy, unlawfully divertingthe remaining 80 tablets. Around thesame time, Dr. Bischoff wrote anotherprescription in the boys name for 120Adderall tablets. Dr. Bischoff also filledthis prescription himself at a pharmacy

but never delivered the tablets to theboy. Later, Dr. Bischoff wrote anotherprescription in the name of the boy for120 Adderall tablets. The boysstepmother learned that the boy wastaking the medication only after she



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discovered the bottle a couple of weekslater. She then checked with thepharmacy and discovered that Dr.Bischoff had written and personallyfilled multiple fraudulent prescriptionsfor controlled substances in the namesof the boys family members, tellingpharmacists that he was a close friendand that the purported patients were too

busy to get to the pharmacy. In addition,Dr. Bischoff ordered approximately46,000 dosage units of schedule III andIV controlled substances from asupplier, and he was unable to accountfor 32,000 dosage units.

John S. Poulter, D.D.S. (70 FR24628)Local law enforcementauthorities were called after Dr. Poulterwas observed parked in front of aconvenience store injecting himself withDemerol. Dr. Poulter failed a fieldsobriety test, admitted to injectinghimself with Demerol, and later pleadedguilty to State felony charges of

unlawful possession of a controlledsubstance. The plea was held inabeyance for three years pending Dr.Poulters successful completion of amonitoring program for impairedprofessionals. In addition to thecriminal proceedings, his Stateprofessional licensing board took action

based on the Demerol incident andseveral instances of improper use ofFentanyl. Dr. Poulter entered into a five-year probationary agreement with theState board, agreeing to abstain frompersonal use of mood-alteringsubstances. Before completing theseprobationary periods, Dr. Poulter was

involved in an automobile accident inwhich he drove his car off the road afterhaving injected himself with Fentanyland Demerol. Responding officers andmedical personnel found himincoherent and very confused, andthere were visible needle marks on hisarm and hands. A search of theautomobile revealed a used syringe anda plastic container holding Demerol andFentanyl.

These three recent cases provideillustrations of some of the mostcommon behaviors that result in loss ofDEA registration: Issuing prescriptions

for controlled substances without a bonafide physician-patient relationship;issuing prescriptions in exchange forsex; issuing several prescriptions atonce for a highly potent combination ofcontrolled substances; charging feescommensurate with drug dealing ratherthan providing medical services; issuingprescriptions using fraudulent names;and self-abuse by practitioners.

In another recent case, United Statesv. Singh, 390 F.3d 168 (2d Cir. 2004), aphysician who claimed to specialize inpain management was convicted

following a jury trial of improperlyprescribing a controlled substance inviolation of the CSA. The court ofappeals, which upheld the conviction,described the nature of the physiciansprescribing practice as follows (id. at176):

Singh developed a scheme that enablednurses to see patients alone, to issueprescriptions for schedule II controlledsubstances, and to bill for such services. Heand the other physicians would pre-sign thetriplicate forms and provide them to non-physician personnel to use during patientvisits. These employees, although not trainedor legally authorized to do so, filled in all therequired prescription informationdrugtype, dosage, and quantityand provided theprescriptions to the patients.

It appears that the physicians at thepractice, including Singh, signed entire

books of triplicate prescription forms inblank without even knowing the identities ofthe patients to whom the prescriptions would

be issued or the nature or dosage of the drugto be prescribed. * * *

Data extracted from Singhs office recordsrevealed that the nurses issued prescriptionsfor at least 76,000 tablets of schedule IIcontrolled substances when Singh was notpresent in the practice suite.

Thus, Singh is another example of aprosecution based on blatant criminalconduct by a physician, and it shouldcause no concern for any legitimate painspecialist or other physician whoproperly prescribes controlledsubstances.

Commencement of Investigations

On the subject of when DEA mightcommence an investigation of possibleimproper prescribing of controlledsubstances, several commenters soughtelaboration on DEAs statements in theNovember 16, 2004 Interim PolicyStatement. In that document, DEAstated, among other things:

[I]t is a longstanding legal principle thatthe Government can investigate merely onsuspicion that the law is being violated, oreven just because it wants assurance that itis not.United States v. Morton Salt Co., 338U.S. 632, 642643 (1950). It would beincorrect to suggest that DEA must meetsome arbitrary standard or thresholdevidentiary requirement to commence aninvestigation of a possible violation of the[CSA].

The foregoing is a correct statement ofthe law, and DEA is not unique in thisregard. All law enforcement agenciesFederal and Statehave long beengoverned by this same principle. Thereason DEA mentioned thislongstanding maxim in the InterimPolicy Statement was to correct anearlier publication attributed to DEAthat embodied a contrary view.

While those who commented on thesubject of investigations generally

acknowledged that DEA had properlystated the law, some asserted that, bydoing so, the agency might have causedsome physicians to fear the prospect of

being investigated and therebydiscouraged them from providingproper pain treatment. DEA believes,however, physicians will understandthat correctly stating the legal standard

which has historically applied toregulatory agencies is no cause foralarm. DEA does not use itsinvestigatory authority in an arbitrarymanner. Further, as DEA has repeatedlystated in this document and elsewhere,there is no crackdown or increasedemphasis on investigating physicians,and the statistics bear that out. In 2005,as in prior years, only a tiny fraction ofphysicians (less than one in tenthousand) lost their registration basedon a DEA investigation of improperprescribing of controlled substances.

One commenter suggested DEA

should announce it will only commencean investigation when it has evidencethat the physician is prescribing in amanner outside of accepted medicalstandards. To adopt such a standardwould conflict with longstanding law,as previously noted. In addition, from apractical perspective, such a standardwould be impossible to apply becausethe agency cannot knowprior tocommencing an investigationwhetherthe activity was proper or improper.Gathering preliminary information isessential to determining whether a full-scale investigation isor is not

warranted. By stating the governing law,however, DEA is not suggesting that itinvestigates every instance ofprescribing in order to rule out thepossibility of illegal activity. To thecontrary, the agency recognizes thatnearly every prescription issued by aphysician in the United States is for alegitimate medical purpose in the usualcourse of professional practice.

Other Recurring Questions

What is fueling the recent increase inprescription drug abuse?

There are a variety of factors that maybe contributing to the increase inprescription drug abuse. The Director ofNIDA recently testified before Congress:

The recent increase in the extent ofprescription drug abuse in this country islikely the result of a confluence of factors,such as: Significant increases in the numberof prescriptions; significant increases in drugavailability; aggressive marketing by thepharmaceutical industry; the proliferation ofillegal Internet pharmacies that dispensethese medications without properprescriptions and surveillance; and a greater



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27The NIDA testimony, which was presented July26, 2006, before the House Subcommittee onCriminal Justice, Drug Policy, and HumanResources, Committee on Government Reform,appears in full on NIDAs Web site at http://www.drugabuse.gov/Testimony/7-26-06Testimony.html.

28The GAO report, Prescription DrugsOxyContin Abuse and Diversion and Efforts toAddress the Problem, GAO04110 (December2003), is available at http://www.gao.gov/new.items/d04110.pdf.

29A detailed discussion of this issue is containedin the above-referenced GAO report, PrescriptionDrugs OxyContin Abuse and Diversion and Effortsto Address the Problem. The manufacturersstatement to Congress in response to the GAOreport is available at http://reform.house.gov/UploadedFiles/9-13-2005%20Purdue%20Testimony.pdf. In 2001, FDAannounced that it had worked with themanufacturer of OxyContin to make changes to thedrugs labeling, including a black box warning,

which FDA states is intended to lessen the chancethat OxyContin will be prescribed inappropriatelyfor pain of lesser severity than the approved use orfor other disorders or conditions inappropriate fora schedule II narcotic. FDA Talk Paper: FDAStrengthens Warnings for OxyContin (July 25,2001), available at http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01091.html.

30The survey was conducted by the NationalCenter on Addiction and Substance Abuse atColumbia University, which published the resultsin a comprehensive report on prescription drugabuse entitled: Under the Counter: The Diversionand Abuse of Controlled Prescription Drugs in theU.S. (available at http://www.casacolumbia.org/absolutenm/articlefiles/380-under_the_counter_-_diversion.pdf).

3121 CFR 1306.04(a); United States v. Moore,supra.

social acceptability for medicating a growingnumber of conditions.27

Increased availability ofprescription drugs and sharing amongfamily and friendsThe United StatesGovernment Accountability Office(GAO) published a report in 2003 on theabuse of the most prescribed brandname narcotic medication for treating

moderate-to-severe pain.28

The reportstates: The large amount of [the drug]available in the marketplace may haveincreased opportunities for abuse anddiversion. Both DEA and [themanufacturer of the drug] have statedthat an increase in a drugs availabilityin the marketplace may be a factor thatattracts interest by those who abuse anddivert drugs.

The 2006 Synthetic Drug ControlStrategy states:

Preliminary data suggest the most commonway in which controlled substanceprescriptions are diverted may be throughfriends and family. For example, a person

with a lawful and medical need for someamount of a controlled substance uses onlya portion of the prescribed amount. Then afamily member complains of pain, and theformer patient shares excess medication.Alternatively, for a family member addictedto controlled prescription drugs, the mereavailability of unused controlled substanceprescriptions in the house may prove to bean irresistible temptation.

Ease of access via the InternetIt isbecoming increasingly easy for personsof any age to obtain controlledsubstances illegally by means of theInternet. Numerous Web sites based inthe United States and abroad sell

controlled substances to anyone willingand able to provide a credit cardnumber. Some of these Web sites do notrequire a prescription. Others willprovide the buyer with an illegitimateprescription simply by having the buyerfill out an online questionnaire withoutseeing a physician. As the 2006Synthetic Drug Control Strategy states,the anonymity of the Internet and theproliferation of Web sites that facilitateillicit transactions for controlledsubstance prescription drugs have givendrug abusers the ability to circumventthe law as well as sound medical

practice. Improper prescribingAs the 2006Synthetic Drug Control Strategy states:

The overwhelming majority ofprescribing in America is conductedresponsibly, but the small number ofphysicians who overprescribecontrolled substancescarelessly at

best, knowingly at worsthelp supplyAmericas most widespread drugaddiction problem. Although theproblem exists, the number of

physicians responsible for this problemis a very small fraction of those licensedto prescribe controlled substances in theUnited States.

Drug formulation and marketingOne of the recommendations in the2006 Synthetic Drug Control Strategy isto [c]ontinue to support the efforts offirms that manufacture frequentlydiverted pharmaceutical products toreformulate their products so as toreduce diversion and abuse, and to[e]ncourage manufactures to exploremethods to render * * * pain controlproducts, such as OxyContin, less

suitable for snorting or injection.Whether the marketing of certainopioids has contributed to abuse anddiversion has also been an area ofdiscussion.29

What are some of the common methodsand sources of diversion?

Diversion of prescription drugscontaining controlled substances occurson a variety of levels. Some controlledsubstances are stolen directly frommanufacturers and distributors.Diversion also occurs at the retail levelwith thefts from, and robberies of,pharmacies. In one survey of over 1,000

pharmacists nationwide, 28.9 percentreported that they had experienced atheft or robbery at their pharmacieswithin the past five years.30 A verysmall percentage of physicians also

contribute to the problem of diversionby intentionally, or unintentionally,providing controlled substances to thosewho are themselves drug abusers or whosell the drugs for profit.

Prescription fraud is another commonsource of diversion. This occurswhenever prescriptions for controlledsubstances are obtained under false

pretenses, including when prescriptionsare forged or altered, or when someonefalsely claiming to be a physician callsin the prescription to a pharmacy.

Doctor shopping is anothertraditional method by which diversionoccurs. Some drug abusers visitmultiple physicians offices and falselypresent complaints in order to obtaincontrolled substances.

What are the potential signs to aphysician that a patient might beseeking drugs for the purpose of abuseor diversion?

Many physicians have requested a listof the possible indicators that a patientmight be seeking controlled substancesfor the purpose of diversion or abuse.DEA has provided this type of list invarious publications over the years.While not an exhaustive list, thefollowing are some of the common

behaviors that might be an indicationthe patient is seeking drugs for thepurpose of diversion or abuse:

Demanding to be seen immediately; Stating that s/he is visiting the area and

is in need of a prescription to tide her/himover until returning to the local physician;

Appearing to feign symptoms, such as

abdominal or back pain, or pain from kidneystones or a migraine, in an effort to obtainnarcotics;

Indicating that nonnarcotic analgesics donot work for him/her;

Requesting a particular narcotic drug; Complaining that a prescription has been

lost or stolen and needs replacing; Requesting more refills than originally

prescribed; Using pressure tactics or threatening

behavior to obtain a prescription; Showing visible signs of drug abuse,

such as track marks.

What are the general legalresponsibilities of a physician to preventdiversion and abuse when prescribingcontrolled substances?

In each instance where a physicianissues a prescription for a controlledsubstance, the physician must properlydetermine there is a legitimate medicalpurpose for the patient to be prescribedthat controlled substance and thephysician must be acting in the usualcourse of professional practice.31 This isthe basic legal requirement discussed



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3221 U.S.C. 823(f).

33Morton Salt, 338 U.S. at 642643 (anadministrative agency charged with seeing that thelaws are enforced may investigate merely onsuspicion that the law is being violated, or even justbecause it wants assurance that it is not.).

34United States v. Rosen, 582 F.2d at 1036.

35SAMHSA Publication No. 043904. Availableat http://dpt.samhsa.gov/reports/index.htm.

above, which has been part of Americanlaw for decades. Moreover, as acondition of being a DEA registrant, aphysician who prescribes controlledsubstances has an obligation to takereasonable measures to preventdiversion.32 The overwhelming majorityof physicians in the United States whoprescribe controlled substances do, infact, exercise the appropriate degree ofmedical supervisionas part of theirroutine practice during office visitstominimize the likelihood of diversion orabuse. Again, each patients situation isunique and the nature and degree ofphysician oversight should be tailoredaccordingly, based on the physicianssound medical judgment and consistentwith established medical standards.

What additional precaution should betaken when a patient has a history ofdrug abuse?

As a DEA registrant, a physician hasa responsibility to exercise a muchgreater degree of oversight to preventdiversion and abuse in the case of aknown or suspected addict than in thecase of a patient for whom there are noindicators of drug abuse. Under nocircumstances may a physician dispensecontrolled substances with theknowledge they will be used for anonmedical purpose or that they will beresold by the patient. Some physicianswho treat patients having a history ofdrug abuse require each patient to signa contract agreeing to certain termsdesigned to prevent diversion andabuse, such as periodic urinalysis.While such measures are not mandated

by the CSA or DEA regulations, they canbe very useful.

Can a physician be investigated solelyon the basis of the number of tablets

prescribed for an individual patient?

The Supreme Court has longrecognized that an administrativeagency responsible for enforcing the law

has broad investigative authority,33 andcourts have recognized that prescribingan inordinately large quantity ofcontrolled substances can be evidenceof a violation of the CSA.34 DEAtherefore, as the agency responsible foradministering the CSA, has the legalauthority to investigate a suspiciousprescription of any quantity.

Nonetheless, the amount of dosageunits per prescription will never be a

basis for investigation for theoverwhelming majority of physicians.As with every other profession,however, among the hundreds ofthousands of physicians who practicemedicine in this country in a mannerthat warrants no government scrutinyare a handful who engage in criminal

behavior. In rare cases, it is possible thatan aberrant physician could prescribesuch an enormous quantity of controlledsubstances to a given patient that thisalone will be a valid basis for

investigation. For example, if aphysician were to prescribe 1,600(sixteen hundred) tablets per day of aschedule II opioid to a single patient,this would certainly warrantinvestigation as there is no conceivablemedical basis for anyone to ingest thatquantity of such a powerful narcotic ina single day. Again, however, such casesare extremely rare. The overwhelmingmajority of physicians who concludethat use of a particular controlledsubstance is medically appropriate for agiven patient should prescribe theamount of that controlled substancewhich is consistent with their sound

medical judgment and accepted medicalstandards without concern that doing sowill subject them to DEA scrutiny.

Can methadone be used for paincontrol?

Methadone, a schedule II controlledsubstance, has been approved by the

FDA as an analgesic. While a physicianmust have a separate DEA registration todispense methadone for maintenance ordetoxification, no separate registrationis required to prescribe methadone forpain. However, in a document entitledMethadone-Associated Mortality:Report of a National Assessment,SAMHSA recently recommended thatphysicians need to understandmethadones pharmacology andappropriate use, as well as specificindications and cautions to considerwhen deciding whether to use thismedication in the treatment of pain. 35This recommendation was made in lightof mortality rates associated withmethadone.

Obtaining Further Input FromPhysicians and Other Health CareProfessionals

In developing policies and rules

relating to the use of controlledsubstances in the treatment of pain,DEA is firmly committed to obtaininginput on an ongoing basis fromphysicians and other health careprofessionals authorized to prescribeand dispense controlled substances, aswell the views of Federal and Stateagencies, professional societies, andother interested members of the public.DEA welcomes the written commentsthat any such persons might wish tosubmit in response to this document.DEA will also continue to evaluatewhether it would be beneficial to obtain

the additional views of physiciansthrough in-person meetings, to theextent permissible under FACA.

Dated: August 28, 2006.

Michele M. Leonhart,

Deputy Administrator.

[FR Doc. E614517 Filed 9506; 8:45 am]

BILLING CODE 441009P


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Dispensing Controlled Substances for the Treatment of Pain