NATIONAL PRESCRIPTION DRUG ABUSE PREVENTION STRATEGY UPDATE

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1 NATIONAL PRESCRIPTION DRUG ABUSE PREVENTION STRATEGY UPDATE

2 The Ntionl Prescription Drug Abuse Prevention Strtegy: Updte is presented by nd endorsed by the following not-for-profit orgniztions: Community Anti-Drug Colitions of Americ 2 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

3 The Center for Lwful Access nd Abuse Deterrence is not-for-profit corportion nd hs pplied for recognition s tx-exempt orgniztion in ccordnce with Section 501(c)(3) of the Internl Revenue Code. The principl writers of this report were Michel C. Brnes, Esq., nd Mrin L. Hench. Editing ws conducted by Shron Kelley MS, PMD, nd Ktherine G. Scott. Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 3

4 For yers, my region Southern nd Estern Kentucky hs been ground zero for the illicit diversion nd buse of prescription drugs - nd the results hve been trgic. We ve seen fmilies torn prt by buse nd incrcertion, nd more overdose deths thn cr crshes. And now this scourge is plguing our entire country s our fstest growing drug epidemic ntionwide. CLAAD hs long-cknowledged tht we ll need to pproch this uphill bttle from multiple ngles. I m plesed to see tht CLAAD hs brought together so mny dedicted stkeholders in putting forwrd comprehensive pln to improve medicine, strengthen drug eduction, nd ensure our children hve bright, drug-free future. - U.S. Congressmn Hrold Hl Rogers (KY-05) 4 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

5 TABLE OF CONTENTS Executive Summry Introduction Bckground Trends in Prescription Drug Abuse Teens College Students Older Adults Crime Impired Driving Overdoses Policy Updte CLAAD Industry Federl Executive Brnch Office of Ntionl Drug Control Policy Food nd Drug Administrtion Drug Enforcement Administrtion U.S. Congress Sttes Conclusion Action Agend Dt Collection nd Anlysis New Technologies Medicl Eduction Sfe Storge nd Responsible Disposl Prescription Monitoring Progrms List of Abbrevitions nd Definitions References Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 5

6 EXECUTIVE SUMMARY Prescription drug buse is n epidemic in the United Sttes, with prescription pin relievers topping the list of most bused medictions. At the sme time, n estimted 116 million Americns experience chronic pin, with cost of up to $635 billion nnully. The Center for Lwful Access nd Abuse Deterrence (CLAAD) consults with experts nd works with other orgniztions to prevent prescription drug buse, ddiction, nd overdose, s well s improve ccess to tretment for people suffering from chronic pin. The Ntionl Prescription Drug Abuse Prevention Strtegy: Updte shres new informtion on the stte of prescription drug diversion, misuse nd buse in the United Sttes; detiling recent developments in the prescription drug crisis, the progrmmtic nd policy ctivities of CLAAD nd its prtner constituents, nd importnt chnges to government nd corporte policies. This report lso specifies discrete policy res tht require greter ction in the short term, nd how CLAAD nd its prtner orgniztions seek to encourge chnge. Prescription drug buse impcts students, dults nd older dults like, but ech ge group hs different drug preferences nd ptterns of buse. Notble consequences of the prescription drug buse epidemic include incresed trffic ccidents, crime nd overdoses. Emergency room visits from overdoses of prescription medictions now mtch the number of visits from overdoses of illegl drugs, such s cocine nd heroin. CLAAD, industry, nd government hve lredy tken importnt ctions to ddress this growing crisis. For exmple, the Food nd Drug Administrtion (FDA) hs required drug compnies to propose risk evlution nd mitigtion strtegies for new nd existing medictions. The phrmceuticl industry hs tken ction by developing new buse-deterrent formultions nd discontinuing sles of older formultions. CLAAD coordinted ction to improve dt collection on overdoses nd cr crshes, engged the news medi to protect ccess to ddiction tretment, nd educted federl policy mkers on the need to continue supporting stte prescription monitoring progrms. DATA COLLECTION AND ANALYSIS: Encourge better dt collection on drug-relted deths nd impired driving by identifying model stte lws nd supporting their introduction nd considertion in t lest three sttes. Support the doption of updted ICD codes to improve dt collection. Encourge legisltive mndte to exmine Medicre nd Medicid for frud nd buse. NEW TECHNOLOGIES: Evlute federl progress on encourging the development of new technologies to deter drug buse, s well s support insurnce coverge of new technology with both privte nd stte-run insurers. Support mesures tht encourge prescribers to voluntrily dopt new technology tht helps reduce drug buse. MEDICAL EDUCATION Inform Members of Congress of the benefits of mending the Controlled Substnces Act to mndte prescriber eduction in the sfe prescribing of controlled substnces. SAFE STORAGE AND RESPONSIBLE DISPOSAL Expnd secure consumer disposl progrms in police/ sheriff offices in 500 dditionl communities by distributing informtion on lw enforcement best prctices in prescription drug collection. PRESCRIPTION MONITORING PROGRAMS Bck the Allince of Sttes with Prescription Monitoring Progrms nd the PMP Center of Excellence in empowering sttes to dopt best prctices outlined in this strtegy. The 2011 Ntionl Strtegy lso includes Action Agend, which focuses on five trgeted res, listed below. CLAAD nd its colition members intend to tke the led nd dvnce these priorities in the following wys: 6 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

7 INTRODUCTION This yer, the United Sttes Centers for Disese Control nd Prevention (CDC) officilly lbeled prescription drug buse ntionl epidemic. 1 Drug overdoses hve risen five-fold over the lst decde, nd overdoses from prescription drugs now exceed those from heroin nd cocine combined. 2 According to the Substnce Abuse nd Mentl Helth Services Administrtion (SAMHSA), the number of substnce buse tretment dmissions involving pin relievers between 1998 nd 2008 incresed four-fold. 3 At the sme time, n estimted 116 million dults in the United Sttes experience chronic pin t cost of up to $635 billion nnully, ccording to report relesed in June 2011 by the Institute of Medicine of the Ntionl Acdemies. The report, Relieving Pin in Americ: A Blueprint for Trnsforming Prevention, Cre, Eduction, nd Reserch, sttes tht the U.S. helth cre system hs essentilly filed Americns living with pin nd clls for trnsformtion of the wy the United Sttes trets pin. 4 These dul public helth concerns both of which cuse inestimble humn suffering in the United Sttes must be ddressed in clculted, blnced wy. The Center for Lwful Access nd Abuse Deterrence (CLAAD) exists to develop workble recommendtions to government nd corporte decision mkers on how best to ddress the prescription drug buse crisis while providing optiml medicl cre to people in need. CLAAD nd its prtner orgniztions re working to prevent prescription drug buse, ddiction, nd overdose, s well s improve ccess to tretment for people suffering from chronic pin. Ech fll, CLAAD convenes the Ntionl Prescription Drug Abuse Prevention Policy Consensus Meeting to consult with experts nd leders of professionl ssocitions nd public helth nd sfety orgniztions from cross the country on prescription drug diversion, misuse, nd buse. During the meeting, the group discusses nd genertes consensus on policy strtegies to ddress the U.S. prescription drug buse epidemic while protecting ptient ccess to qulity cre. The Ntionl Prescription Drug Abuse Prevention Strtegy is bsed on the outcomes of the ntionl meeting. In 2009 CLAAD published the first Ntionl Prescription Drug Abuse Prevention Strtegy, setting forth numerous ctionoriented proposls bsed on expert input from leders in pin mngement, ddiction medicine, lw enforcement, nd vrious other fields. The 2010 Ntionl Prescription Drug Abuse Prevention Strtegy served s follow-on document, expnding upon the prior yer s recommendtions. The policy responses in ech Ntionl Strtegy erned the endorsements of some 25 not-for-profit public helth nd sfety orgniztions nd professionl ssocitions. Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 7

8 In November 2010, 42 individuls from round the United Sttes, representing over 30 orgniztions i from multiple sectors of society, ttended ii the 2010 Ntionl Prescription Drug Abuse Prevention Policy Consensus Meeting in Wshington, D.C. The focus of the meeting ws to discuss pst-yer policy developments, to ly out ech prticipting orgniztion s top three policy priorities, nd to updte nd refine CLAAD s recommendtions. This Ntionl Prescription Drug Abuse Prevention Strtegy: Updte shres new informtion on the stte of prescription drug diversion, misuse nd buse in the United Sttes; detiling recent developments in the prescription drug crisis, the progrmmtic nd policy ctivities of CLAAD nd its prtners, nd importnt chnges to government nd corporte policies. This document ddresses the policy topics tht re the most criticl to prescription drug buse prevention nd ugments or fine-tunes CLAAD s prior policy recommendtions, s expressed in our 2009 nd 2010 Ntionl Strtegy publictions. Finlly, the report specifies discrete policy res tht require greter ction in the coming months, nd how CLAAD nd its prtner orgniztions seek to encourge chnge. Individuls who re fmilir with the 2009 nd 2010 editions of the Ntionl Prescription Drug Abuse Prevention Strtegy will notice tht this yer s document differs from the prior versions in n importnt wy. In response to feedbck from CLAAD s colition members, the Updte is not intended s stnd-lone piece but, insted, builds upon nd refers bck to the content of the prior Ntionl Strtegy editions. This Updte identifies the ctions tht must be tken, the entities tht should ber responsibility for tking such ctions, the desired outcomes, nd ggressive yet ttinble timetbles tht reflect the urgency of our ntion s prescription drug buse crisis. The United Sttes in the midst of two public helth crises tht require the ttention nd efforts of helth cre professionls, government policy mkers, industry, lw enforcement, nd numerous other sectors of society. It is the hope of the orgniztions endorsing this Ntionl Strtegy tht prctitioners, government nd corporte decision mkers, nd other community leders will shre our sense of urgency nd use these recommendtions to ddress these criticl threts to our ntion s helth nd sfety. i Prticipnts in the 2010 Ntionl Prescription Drug Abuse Prevention Policy Consensus Meeting included the following not-for-profit nd commercil orgniztions: Americn Chronic Pin Assocition Americn Society of Anesthesiologists Americn Society for Pin Mngement Nursing Americn Society of Addiction Medicine Assocition of Recovery Schools Centocor Ortho Biotech Services LLC CNS Drug Consult Community Anti-Drug Colitions of Americ Covidien Phrmceuticls Dds Aginst Drug Delers DCBA Lw & Policy Drug Free Americ Foundtion Educting Voices Federtion of Stte Medicl Bords, Inc. Interntionl Nurses Society on Addictions Life Source Medscpe/WebMD Ntionl Allince for Model Stte Drug Lws Ntionl Assocition of Drug Diversion Investigtors Ntionl Colition Aginst Prescription Drug Abuse Ntionl Fmily Prtnership Ntionl Sheriffs Assocition Northestern University, Dep t of Phrmcy Prctice Northshore Recovery High School Opertion UNITE Oregon Prtnership PMP Center of Excellence, Brndeis University RYAN s Cuse Two Drems Outer Bnks Uth County Division of Substnce Abuse ii It is importnt to note tht these orgniztions prticiption in CLAAD s 2010 Consensus Meeting does not indicte or imply tht they hve endorsed this Ntionl Strtegy or CLAAD s policy positions in generl. Orgniztions tht hve expressly endorsed this document re noted in the preceding pges. 8 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

9 BACKGROUND Opioids re synthetic versions of opium used to tret moderte nd severe pin. 5 Americns mke up 4.6 percent of the world s popultion but use 80 percent of the globl supply of opioid pin relievers. 6 When used responsibly, opioid pin relievers re mong the most effective phrmceuticl products vilble to people with pin. 7 These medictions, nd the other medicinl products discussed in this report, cn gretly improve ptients qulity of life nd bility to function. Unfortuntely, prescription medictions re incresingly used for purposes other thn those for which they re intended nd pproved. 8 Opioids re thought to be the most common type of prescription mediction bused in the United Sttes, constituting bout 75 percent of the prescription drug buse problem. 9 In 2008, nonmedicl use of prescription pin relievers ws the second most prevlent type of illicit drug use, fter mrijun, in Americns 12 yers of ge or older. 10 Independent reserchers t Group Helth, lrge Settle-bsed helth-cre system, report tht 3 to 4 percent of Americn dults not just people with chronic pin re now using opioids. 11 As in prior itertions of this Ntionl Strtegy, this document ddresses the diversion, misuse, nd buse of ll types of medictions but plces significnt emphsis on opioid pin relievers with the expecttion tht successful responses to prescription opioid diversion, misuse, nd buse will likely lso be pplicble to other clsses of medictions. It is vitl tht the reder of this document understnd the definitions of terms used nd the distinctions mong vrious terms, such s misuse vs. buse, nd ddiction vs. dependence. To review these definitions, it is recommended tht the reder see pp. 7-8 of the 2010 Ntionl Strtegy, vilble on CLAAD s website t For the generl purposes of this rticle, the uthors hve often used the phrse prescription drug buse intending to include the distinct cts of mediction diversion nd misuse. Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 9

10 TRENDS IN PRESCRIPTION DRUG ABUSE Prescription drug buse ffects teens, college students, dults nd older dults like, though their drugs of choice, perceptions, nd ptterns of behvior cn differ. The buse contributes to trffic ccidents, crime, nd overdoses, lthough dt inconsistencies cn mke drug use nd its consequences hrd to quntify. For exmple, while much of the vilble dt on drug buse trends relies on public surveys nd personl interviews, one study found tht teens were 52 times more likely to test positive for cocine thn report using it, while their prents were 6.5 times more likely to use thn report using 12. These dt collection methods ply n importnt role in ssessing the problem nd the success of responses to it, but the study illustrtes the mgnitude of potentil dt discrepncies. TEENS Prescription drug buse is serious problem for youth nd college students. Since the publiction of the 2010 Ntionl Strtegy, more dt hs been collected indicting the severity of this problem. The Prtnership t Drug-Free.org s recent survey found tht teen buse of prescription nd over-the-counter medicines remins stble. 13 One in four teens reported tking prescription drug not prescribed to them t lest once in their lives, nd more thn one in five used prescription pin reliever not prescribed to them by professionl. OxyContin in the pst month declined from 6 percent in 2004 to 1 percent in In Pthwys, Michign, the locl Ottow Substnce Abuse Prevention Colition cites decline in the percentge of 12th grde students reporting pst-month buse of prescription drugs, from 15.9 in 2007 to 12.1 in The Community Anti-Drug Colitions of Americ (CADCA) hs compiled nd published Strtegies To Prevent Prescription Drug Abuse Among Teens in Your Community to ssist communities in plnning nd implementing prevention cmpigns tilored to their own specific needs. While buse rtes remin stble, the new survey found tht teenge girls re more likely thn boys to see substnce buse s potentilly beneficil. More thn two-thirds of the girls surveyed responded positively to the sttement: using drugs helps kids del with problems t home. More thn hlf report tht drugs help teens forget their troubles. 13 Throughout the country, colitions consisting of eductors, helth cre professionls, drug buse prevention orgniztions, nd other community members hve developed loclized progrms to rise wreness bout the dngers of prescription drug buse. In Ashlnd, Kentucky, where the Crter County Drug Tsk Force nd Pthwys Inc. led prescription drug buse prevention colition, the percentge of 12th grde students reporting the use of COLLEGE STUDENTS Nonmedicl use of prescription stimulnts, like Ritlin nd Adderll, nd other medictions continues to increse on college cmpuses. A 2009 study from Drug nd Alcohol Dependence showed tht 20 percent of Americn college students hd improperly used pin medictions, stimulnts, sleeping pills, or sedtives. Some students tke stimulnts to improve their cdemic performnce, prctice referred to s cdemic doping, while others combine stimulnts with lcohol or other drugs for euphoric effect. 14 A college junior t Tufts University told his school newspper, which did feture on Adderll buse, [I tke it] whenever I hve clss or when I need to study lot. I tke it becuse 10 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

11 it focuses my thoughts nd mkes me feel driven to work. Another student dmitted to tking stimulnts with other drugs, such s lcohol iii : I feel like the combintion leds to much more controlled drunk. I m much more focused nd less sloppy, she sid. It s helpful for dy drinking or when I m plnning to drink for long period of time. It helps control my drinking, lmost. 15 Mixing prescription medictions with lcohol cn cuse nuse, vomiting, hedches, drowsiness, finting, or loss of coordintion. In the cse of certin drugs, it cn lso led to respirtory depression, com, nd deth. 16 Students my choose to buse prescription medictions becuse they re reltively esy to obtin. Sixty-one percent of college students with ADHD report diverting their medictions, which include Adderll, Ritlin nd Concert, to nother person. 17 Though students who misuse prescription stimulnts believe the drugs give them n cdemic edge, it is often cdemiclly unsuccessful students who primrily buse these drugs, nd nonmedicl prescription stimulnt use is ssocited with lower cdemic performnce. 18 Students who buse stimulnts re often more likely to buse other drugs s well. A led resercher from the University of Mrylnd stted in U.S. House of Representtives Congressionl hering in April 2011, Compred to non-users, our dt show tht nonmedicl users of prescription drugs re more likely to meet criteri for dependence on lcohol nd mrijun, skip clss more frequently, nd spend less time studying[ ]In summry, wht the reserch shows is tht nonmedicl prescription stimulnt use is n unsuccessful shortcut n ttempt to compenste for declining cdemic performnce nd is relly red flg for n underlying lcohol nd/or drug problem in college student. 18 OLDER ADULTS In older dults, pin mngement is often complicted by multiple co-morbidities, or co-occurring helth problems, which increse the likelihood of polyphrmcy. This more complex sitution lso increses the likelihood of hrmful drug interctions. Older dults re more likely to suffer from dverse events nd incresed sensitivity to the nlgesic properties of opioids. 18 In generl, substnce buse is more esily overlooked in dults ges 50 nd over becuse its symptoms often mimic other medicl nd behviorl disorders more common mong this popultion, such s dementi, dibetes, nd depression. 19 The incidence of prescription drug buse in Americns over 50 is rising, mking up 3.5 percent of ll substnce buse tretment dmissions in 2008, up from 0.7 percent in According to the Ntionl Survey on Drug Use nd Helth, older dults re more likely to primrily buse prescription pin relievers, rther thn lcohol or other drugs. 19 Lw enforcement officers re lso seeing n increse in sick nd elderly people selling prescription drugs. 20 Although this group represents only frction of delers, it remins cuse of concern. CRIME Drug diversion is defined s the trnsfer of prescription mediction from lwful to n unlwful chnnel of distribution or use. 21 With rise in demnd for diverted prescription medictions comes n increse in ssocited crime. Drug diversion in the form of phrmcy thefts nd thefts from homeowners reflect demnd for prescription medictions on the illicit mrket. Lw enforcement officils nd phrmcies ntionwide report n increse in phrmcy thefts. According to locl division of the Drug Enforcement Administrtion, Wshington Stte reported 200 phrmcy holdups in the pst three yers. 22 In Ohio, there were 68 phrmcy thefts in 2008, doubled from the previous yer. In some cses of theft, employees stel drugs, s in one instnce where young femle stole more thn 49,000 doses of hydrocodone before getting cught. In Missoul, Montn, womn successfully stole 1,900 pills worth bout $35,000 on the street. 23 Other cses re more like bnk robberies, where ssilnts hold phrmcists t knife or gunpoint. iii Another trend mong students is the combintion of energy drinks with lcohol. According to Cecile Mrczinksi, Ph.D., of Northern Kentucky University, combining energy drinks nd lcohol cn be potentilly dngerous due to the fct tht energy drinks contin pproximtely three times s much cffeine s col, nd lthough ingestion does not chnge the level of lcohol impirment, it cn ffect the consumer s perception of his or her impirment. (Join Together Stff. The Prtnership At DrugFree.org. April 11, Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 11

12 Homeowners re nother trget for prescription drug seekers, with owners nd rel estte gents incresingly noticing medictions re missing from medicine cbinets fter open houses. Prescription drug seekers re creful to blend in, reltors sy, often wering professionl clothing nd crrying clipbord s if they re mking notes on the home. 24 All homeowners should store prescription drugs in wy tht is pproprite to their own circumstnces to prevent theft, s highlighted by the Ntionl Fmily Prtnership s ntionwide public wreness cmpign, Lock Your Meds. A commonly reported form of diversion is doctor shopping, which occurs when person seeks cre from multiple medicl prctitioners t the sme time, without mking efforts to coordinte tretment, for the purpose of obtining medictions from more thn one prescriber. The individul might keep the drugs for himself or sell them for profit in the illicit mrket. Pill mills re clinics tht hve reputtion for providing prescriptions to ptients who do not hve legitimte medicl need, or for writing prescriptions beyond the legitimtely needed number of pills or durtion of tretment. 25 Anecdotl informtion from lw enforcement officers indictes tht immedite relese oxycodone is the drug of choice for rogue prescribers operting out of pill mills. 26 IMPAIRED DRIVING According to Ntionl Highwy Trffic Sfety Administrtion (NHTSA) report relesed in 2010, 33 percent of drivers involved in ftl cr crshes, for which there were known test results, were under the influence of drugs. This figure included both illicit drugs nd prescription medictions. It is not known whether the drivers hd enough drugs in their systems to impir their driving t the time of the crsh, nd questions remin regrding the drug involvement of those not tested or tested with unknown results. 27 Drug involvement rtes in ftl cr crshes re lrgely uncler becuse drug tests frequently re not conducted, nd even if they re, the results re often unreported. In 2009, 63 percent of ftlly injured drivers ntionwide were tested for the presence of drugs. Sttes vry in the percentge of ftlly injured drivers tht re tested for drugs. In 2009, Mine did not do ny tests, nd Mississippi tested only 2 percent of ftlly injured drivers. Among those ftlly injured drivers ntionwide who were tested in 2009, 8 percent of the results re not known. Dt for Msschusetts shows unknown testing sttus for 44 percent of ftlly injured drivers in Jurisdictions differ not only in their drug testing policies, but lso in the concentrtion thresholds they use to determine the presence or bsence of drug, which mkes existing dt inconsistent. Police ccident reports lso vry by jurisdiction, creting gps in reporting nd ccurcy of dt on crshes involving drugged driving. 27 The Colition to End Needless Deth on Our Rodwys (END) hs sked sttes to ensure tht ll police ccident reports include dt on the levels of illegl nd legl substnces in drivers systems. With informtion bout the types of drugs used, times of dy nd reltionship to ccidents, public helth officils nd lw enforcement officers will be better equipped to develop pproprite public helth nd sfety responses. OVERDOSES The increse in prescription drug buse hs led to more ccidentl drug overdoses nd poisonings, mny of which result in deth. Since 1990, rtes of drug overdose deths hve incresed by roughly five times. 28 A study relesed in 2010 revels tht, between 1999 nd 2006, hospitl dmissions from unintentionl overdose of opioids nd sedtives jumped 37 percent. Suicide-relted overdoses during this period incresed by 130 percent. 11 Emergency room visits from overdoses from prescription medictions now mtch the number of visits from overdoses of illegl drugs, such s cocine nd heroin. The biggest increse in emergency visits ws from dults in their twenties Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

13 Suspicious person is going to open houses looking for Rx drugs Reltors wrned bout suspicious person 08/23/2010 By: Shnnon Kettler FLORENCE, Ky. - Reltors in Northern Kentucky re being wrned bout suspicious person showing up t open houses. According to the Northern Kentucky Assocition of Reltors, mn hs shown up t three different open houses to pose s if he is looking t the house but is relly looking for prescription drugs. He s coming into the home nd mking beeline for the rest room which obviously we cn t follow him in there nd when he comes out gives the informtion nd wlks through the house nd sys oh this is perfect nd then leves only to find out lter from the homeowner there hd been some prescription drugs tken, sid Rebecc Trout, Northern Kentucky Assocition of Reltors President. In ll the incidents, Trout sid the mn is well dressed, crrying clipbord nd gives the reltor similr story. All we know right now is tht he is pproximtely in his 40 s, hs sndy brown hir nd is driving silver Volkswgon, sid Trout. He sys he works for mjor corportion in the Cincinnti re nd tht he s stying in n upscle prtment complex in the Cincinnti re nd wnting to move to the Northern Kentucky re. Homeowners re reminded to hide vlubles nd concel personl items including prescription drugs. The Ntionl Assocition of Reltors hs lwys been very good bout creting brochures we cn shre with our clients to try nd keep them sfe nd remind them there will be strngers in your home, you need to put wy jewelry, credit crds, personl items, prescription drugs, these kinds of things becuse s much s we re with the clients we cn t follow them everywhere, sid Trout. Agents re being sked to keep n eye out for him nd to cll police if they see him. Copyright 2010 The E.W. Scripps Co. Reprinted with permission. 1 Ntionl Prescription Drug Abuse Prevention Ntionl Strtegy Prescription Drug Updte Abuse Prevention Strtegy: Updte 2

14 POLICY UPDATE In this section we discuss the most significnt policy ctions tht CLAAD, corportions, the federl government, nd stte governments hve tken since September 2010 to ddress the dul helth crises of prescription drug buse nd undertreted pin. CLAAD On n ongoing bsis, CLAAD trcks nd nlyzes politics, legisltion, nd regultion tht centers on prescription drug diversion, misuse, nd buse. We disseminte this informtion through our website nd through our electronic newsletter, Policy Brief. In ddition, CLAAD hs successfully dvnced policy recommendtions through news coverge, outrech to lwmkers, nd progrms led by constituents in the CLAAD colition. Responding to Illinois Governor Pt Quinn s pln to cut $208 million in stte funding for ddiction tretment in Februry 2011, CLAAD spokesperson ppered on Fox News Chnnel s Fox & Friends to discuss the need to preserve public support for ddiction tretment progrms. In response to significnt public outrge over Quinn s proposl, the governor s budget office greed to cut funding by lesser mounts thn those the governor initilly put forth. 30 CLAAD hs rised public wreness in the news medi through two dditionl television interviews nd over 20 rdio interviews since September Additionlly, in September 2010 CLAAD representtive spoke t the Prescription Drug Abuse Forum on Cpitol Hill. The legisltive briefing ws held by the Congressionl Prescription Drug Abuse Cucus, heded by Reps. Willim Delhunt (MA- 10), Mry Bono Mck (CA-45), nd Hl Rogers (KY-05). (Rep. Delhunt hs since retired from Congress.) The event focused on stte prescription monitoring progrm (PMP) dt shring. 31 Stte prescription monitoring progrms securely collect, monitor, nd nlyze electroniclly trnsmitted prescribing nd dispensing dt submitted by phrmcies nd dispensing prctitioners. This provides up-to-dte helthcre informtion used to support sttes efforts in eduction, reserch, lw enforcement nd buse prevention, helping to inhibit doctor shopping nd other potentilly hrmful ctivities. 32 PMPs re mnged under the uspices of stte, district, commonwelth, or territory of the United Sttes. 33 At the Cpitol Hill briefing, CLAAD s spokesperson presented the orgniztion s consensus-bsed policy recommendtions for prescription monitoring progrms s set forth in the 2010 Ntionl Strtegy. Another importnt informtion gthering tool is the Interntionl Clssifiction of Diseses (ICD) code system, used by coroners on deth certifictes to ctlog the cuse of deth. These codes currently do not include ctegories to specify the presence of prescription medictions such s opioids in n overdose deth. To understnd nd respond ppropritely to prescription drug diversion, misuse, nd buse, it is necessry to obtin more informtion bout their prevlence, the resons for them, s well s their reltionships to emergency deprtment visits nd deths. CLAAD hs clled for the federl government to fcilitte the widespred collection of more detiled informtion bout prescription drug use nd mortlity by updting the codes used to clssify cuses of deth. During the 2010 Ntionl Prescription Drug Abuse Prevention Policy Consensus Meeting, Lynn Webster, M.D., founder of the not-for-profit Life Source nd bord member of the Americn Acdemy of Pin Medicine (AAPM), identified this need nd clled for the U.S. to dopt updted ICD codes tht include non-opioid nd opioid nlgesics, mong other medictions not included in the current listings. See Figure A. Writing to the U.S. Centers for Disese Control nd Prevention, CLAAD reinforced the recommendtions of Life Source nd AAPM: [T]he dt we hve on prescription-relted deths is limited; therefore, our understnding of the cuse of the problem nd our bility to implement the most effective solutions re indequte Effective progrms to prevent deths require tht we know which drugs re most responsible for deths. Revising the U.S. dpttion of ICD codes will provide more useful 14 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

15 informtion for reserchers, which should led to more effective interventions nd fewer deths. 34 Representtives Rogers nd Bono Mck, co-founders of the Congressionl cucus on Prescription Drug Abuse, moved swiftly to express congressionl support for CDC ction on the mtter by sending their own letters supporting such chnges. As of September 2011, the CDC hs not nnounced ny plns to updte or mend ICD codes to permit better dt collection in response to the prescription drug buse epidemic. Figure A Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 15

16 INDUSTRY The phrmceuticl industry hs responded to the demnd for pin relief products in innovtive wys tht cknowledge nd ccount for the U.S. prescription drug buse epidemic. As described on pp of the 2009 Ntionl Strtegy nd pp of the 2010 Ntionl Strtegy, severl phrmceuticl compnies hve invested hevily in reserching nd developing buse-deterrent opioid formultions, novel opioid delivery systems, nd non-opioid medicinl products. One type of buse-deterrent formultion incorportes physicl brriers tht mke it difficult to chew, crush or dissolve pills for the purposes of buse, while others contin phrmcologicl ingredients tht negte the effect of the ctive opioid when someone tmpers with the mediction. In April 2010, the Food nd Drug Administrtion (FDA) pproved Purdue Phrm s New Drug Appliction for reformultion of OxyContin (oxycodone HCI controlledrelese) Tblets. The reformultion, OxyContin OP, ws designed to be bioequivlent to the originl formultion, OxyContin OC, but more difficult to mnipulte for purposes of intentionl buse. Upon introduction of OxyContin OP to the U.S. mrket in 2010, Purdue Phrm cesed mrketing the originl formultion. 35 Following the relese of the reformulted Oxycontin, public helth nd sfety officils in Kentucky, Virgini, nd New York reported surge in the diversion nd illegl use of nother opioid, oxymorphone, which officils speculte hs replced OxyContin s the prescription drug of choice for intentionl busers. 36, 37, 38 In My 2011, the president of the Ntionl Assocition of Drug Diversion Investigtors (NADDI) sid necdotl reports from the orgniztion s members indicted tht the illicit demnd for the newer formultion of OxyContin ppered to be lower thn pst demnd for the prior formultion. 39 These preliminry, non-scientific reports suggest but do not prove tht the newer formultion of OxyContin is less ttrctive to intentionl drug busers thn the prior formultion. Given tht epidemiologicl studies hve not been completed, it is uncler whether new formultions of opioids such s OxyContin OP re effective buse deterrents. 40 Though Purdue Phrm no longer mrkets its prior OxyContin formultion, Wtson Phrmceuticls, Impx Lbortories, nd Rnbxy Lbortories hve requested FDA pprovl to mrket generic versions of the drug. At issue before the FDA is whether OxyContin OC ws removed from the mrket for sfety resons. A determintion tht the prior formultion ws removed for sfety resons could prevent generics from entering the mrket. The lw firm Hunton & Willims, presumbly on behlf of Wtson Phrmceuticls, hs urged the FDA to disregrd intentionl buse of OxyContin OC in mking its determintion. 41 Beyond reformultions, industry reserch is focusing on other new technologies tht could provide opioid pin relief while reducing possibilities for buse s well s overdose. Preliminry studies on mediction tht would relese n ctive opioid only when exposed to correct conditions in the gstrointestinl trct hve yielded positive results. Another technology under investigtion would protect ginst orl overdose by limiting the systemic exposure of n ctive opioid when multiple doses re tken t the sme time. Non-opioid pin relievers in investigtionl stges re lso showing promise for treting moderte to severe pin. Industry reserchers re hopeful tht new clss of pin therpies my be the most importnt development in pin tretment since spirin cme into generl use t the end of the nineteenth century. 42 The new products re biologics, mening they re derived from living sources, in contrst to drugs, which re chemiclly synthesized (exmples of other biologics re vccines, tissues, nd cellulr nd gene therpies). 43 The new tretments re injectble ntibodies tht block protein clled nerve growth fctor (NGF), which is ssocited with pin nd is often present in inflmed tissues, such s rthritic joints. 42 Accordingly, the clss is known s NGF-trgeting ntibodies, or nti-ngf drugs. Phrmceuticl reserchers re conducting trils of NGFtrgeting ntibodies in treting cncer pin nd chronic pncretitis, though reserch suffered setbck in December The FDA plced hold on clinicl trils for other conditions, such s osteorthritis, chronic low bck pin, nd dibetic nerve pin, fter some ptients in the trils needed joint replcements. Industry representtives speculte tht the pin relief the therpies provided ws so significnt tht ptients incresed their physicl ctivity nd ccelerted dmge to their joints. 42 The drug testing industry hs developed tool to help prescribers interpret ptients drug test results to determine 16 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

17 whether they re tking their opioid medictions s directed. The resource is bsed on dtbse of more thn 1,000 people with chronic pin nd enbles prescribers to compre specific ptient s test results with the results of ptients known to comply with their helth cre providers directions. Whether these technologicl nd scientific dvnces be new opioid formultions or delivery systems, other non-opioid medicinl products, or drug testing technologies, they must be incorported into universl precutions pproch to prescribing. The best prctices ssocited with universl precutions in prescribing re described in detil on pp of the 2009 Ntionl Strtegy nd include ssessment of ptient risk nd ongoing monitoring of ptient opioid therpy. The C.A.R.E.S. Allince, collbortion mong industry, provider orgniztions, nd ptients, hs responded to the cll for universl precutions in opioid prescribing by providing helth cre professionls free prctice resources covering topics from ssessing pin to discussing withdrwl syndrome with ptients. 44 See Figure B. A recent study of 281 primry cre physicins (PCPs), found tht mjority of primry cre physicins do not use forml risk ssessment or monitoring tools when prescribing opioids; when they do, they typiclly find tht they re more likely to underestimte, rther thn overestimte, the risk for buse by these ptients. 45 Mgdlen Anitescu, MD, PhD, n ssistnt professor of nesthesi nd criticl cre t the University of Chicgo Medicl Center, studied the effects of rndom drug tests on opioid complince. Anitescu tllied how often her ptients intentionlly bused or unintentionlly misused prescribed opioids before nd fter implementing stringent policies, the centerpiece of which ws rndom urine testing for controlled substnces. The dt showed tht complince rose from 48 to 74 percent s mesured by discrepncies between drug dosges prescribed nd urine test results. Prescribers who fil to dopt new therpies nd tools to mitigte risk when it is ssessed s high could be plcing themselves in position of exposure to potentil mlprctice libility. 7 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 17

18 Opioid Clinicl Mngement Checklist A Compnion to the Opioid Clinicl Mngement Guide In order to optimize the effectiveness of opioid nlgesics nd improve ptient outcomes, clinicins my consider the following: q Document n effective ptient evlution including ssessment of risk of misuse, buse, ddiction, nd overdose, including: q Comprehensive physicl exmintion with dignostic testing q Chrcteriztion of pin nd its impct q Approprite dignostic tests to ssess the underlying pin condition nd determine the suitbility of tretment with non-opioid therpy q A thorough ptient history including ssessment of psychosocil fctors nd fmily history q Assessment of risk of buse using ptient nd fmily history of substnce buse nd vlidted risk ssessment tools such s the Opioid Risk Tool (ORT) q Structure opioid therpy to ccommodte identified risk q Individulize the selection of opioid to be prescribed, initil dosing, nd titrtion bsed on ech ptient s helth sttus, prior opioid exposure (including degree of opioid tolernce), ttinment of therpeutic gols, nd predicted or observed hrms q Strtify ptients to help determine who my be sfely mnged in the primry cre setting (see Figure 1 on bck) q Counsel ptients on the risks nd benefits of opioid therpy s well s on sfe use nd hndling, including proper disposl (encourge them to red the product Mediction Guide) q Gin informed ptient consent to opioid therpy with full knowledge of tretment gols, expecttions, potentil risks, nd tretment lterntives Sponsored by: Figure B 1 Ntionl Prescription Drug Abuse Prevention Ntionl Strtegy: Prescription Drug Updte Abuse Prevention Strtegy Updte 2

19 FEDERAL EXECUTIVE BRANCH Office of Ntionl Drug Control Policy In April 2011, the Office of Ntionl Drug Control Policy (ONDCP) relesed the federl government s pln to reduce prescription drug buse in the United Sttes. The ONDCP document, entitled Epidemic: Responding to Americ s Prescription Drug Abuse Crisis, focuses on expnding stte-bsed prescription monitoring progrms (PMP s); removing unused medictions from homes; educting ptients nd helth cre providers; nd reducing the prevlence of pill mills nd doctor-shopping through lw enforcement. 47 The intent of the federl government s pln is to estblish collbortive federl effort to reduce prescription drug diversion, misuse, nd buse. 48 Indeed, the document clls for coordintion nd coopertion t the federl level mong the following deprtments nd gencies: Deprtment of Helth nd Humn Service, Food nd Drug Administrtion, Ntionl Institute on Drug Abuse Deprtment of Justice, Drug Enforcement Administrtion (DEA) Deprtment of Defense Deprtment of Veterns Affirs Environmentl Protection Agency The federl pln reflects ttention on the prt of ONDCP to the substntive policy recommendtions of experts nd constituency groups committed to ddressing prescription drug buse while protecting ptient ccess to cre. An nlyticl comprison of the federl government s Epidemic: Responding to Americ s Prescription Drug Abuse Crisis with the Ntionl Prescription Drug Abuse Prevention Strtegy shows tht the federl government dopted 19 out of 20 vitl policy recommendtions mde by ntionl leders in drug buse prevention nd pin cre. See Figure C. A score of 95 percent (n A on typicl scholstic grding scle) is excellent especilly for government. Food nd Drug Administrtion A key component of the new ONDCP pln centers on the FDA s cll for risk evlution nd mitigtion strtegies, or REMS, for long-cting nd extended-relese opioids, reflecting ONDCP s coordintion of the vrious deprtments nd gencies of the federl government to help ddress the ntionl prescription drug buse epidemic. In 2007, Congress pssed The Food nd Drug Administrtion Amendments Act (FDAAA), giving the FDA incresed uthority to impose new requirements on phrmceuticl mnufcturers to help ensure the benefits of drug outweigh its risks. The FDA my now, under specific circumstnces, require compnies with medictions on the mrket, or seeking pprovl to introduce medictions to the mrket, to propose REMS. The FDA must pprove these REMS for the drug to remin vilble or become vilble to ptients in the U.S. In July 2010, joint meeting of the FDA Anesthetic nd Life Support Drugs Advisory Committee, nd the Drug Sfety nd Risk Mngement Advisory Committee convened to discuss n FDA proposl for common REMS for ll long-cting nd extended-relese opioids. 49 Greter detils on the issues surrounding REMS for long-cting nd extended-relese opioids re set forth on pp of the 2010 Ntionl Strtegy. During the July 2010 meeting, the committee members dvised the FDA tht mndtory eduction for prescribers in the res of sfe prescribing nd detection of ddiction nd buse should be primry component of ny REMS progrm for the sub-clss. Under current federl lw, prescribers must register with the DEA every three yers for uthority to prescribe controlled substnces. 50 DEA registrtion is predicted only on stte professionl licensure. 51 The FDA dvisory committees recommended tht dditionl professionl eduction be mndtory nd suggested tht the requirement be linked to the existing system of controlled-substnce prescriber registrtion with the DEA. 49 Since the relese of the 2010 Ntionl Strtegy the FDA continued its intensively delibertive stkeholder consulttion process to elicit public input s to how to pproch REMS for ll long-cting nd extended-relese opioids. Among the mny questions confronting the FDA ws whether REMS requirements should be identicl for the entire sub-clss of drugs, or whether REMS should provide for degree of uniformity within the sub-clss while ddressing medictionspecific risks. In connection with the relese of the ONDCP pln in April 2010, the FDA nnounced its guidelines for REMS governing extended-relese nd long-cting opioid medictions. The guidelines re lrgely consistent with the recommendtions set forth on pp of the 2010 Ntionl Strtegy. The FDA hs sked the mnufcturers of long-cting nd extended-relese opioids to submit REMS proposls contining the following elements: 48 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 19

20 How does the Administrtion s pln stck up ginst the Ntionl Prescription Drug Abuse Prevention Strtegy? 95% A CLAAD Policy Recommendtion Ntionl Strtegy yer, pge Yes No Comments ONDCP pln pge Blnce dul gols of 1) minimizing buse nd 2) ensuring ptient ccess to medictions, 2009, p. 14 p. 1-2 Improve public wreness through grssroots, multi-medi eductionl cmpign, 2009, p. 33 The federl gov t plns to work with privtesector groups. p. 4 Mndtory prescriber eduction in sfe prescribing, monitoring for buse, nd referrls to tretment, 2010, p. 30 The federl gov t hs sked Congress to require eduction for DEA registrtion. p. 3 Continue providing federl ssistnce to sttes seeking to implement nd optimize prescription monitoring progrms (PMPs), 2009, p. 26 PMP s in ll 50 sttes + DC, 2010, p. 27 The federl gov t expressly supports the NASPER grnt progrm nd indirectly endorses the HRPDMP grnt progrm. p. 6-7 p. 6 Interstte dt shring, 2010, p. 27 p. 6 Rel-time dt ccess, 2010, p. 27 p. 6 Mndtory PMP trining for prescribers nd dispensers, 2010, p. 27 p. 6 Include VetAff, DoD dt, 2010, p. 27 p. 6 Provide compenstion to prescribers who check the PMP, 2010 p. 25 The federl gov t is exploring the fesibility of this concept. Use secure technology to verify ptient identity nd merge prescribing, dispensing, nd other helth informtion, 2009, p. 27 p. 7 Secure, convenient consumer mediction disposl options, 2010, p. 37 DEA is formulting regultions to expnd consumer options. p. 8 Trining nd resources for lw enforcement, 2009, p. 16 Expnd SBIRT to primry cre settings, 2010, p. 45 DoJ will provide trining for sttes with the highest need. p. 8 The federl gov t will work with helth cre providers to increse SBIRT wreness nd trining. p. 6 Support reserch into novel medicinl products to tret pin 2010, pp The federl gov t will expedite reserch through grnts. p. 4 Provide guidnce to industry on the development nd ssessment of buse-deterrent products, 2010, p. 21 p. 10 Grnt priority review to novel medicinl products to tret pin, 2010, p. 23 p. 4 Provide for preliminry buse-deterrent product lbeling bsed on lbortory tests nd humn buse libility studies, 2010, p. 22 N/A Request industry collbortion on Mediction Guides nd communiction plns for long-cting nd extended-relese opioids 2010, p. 20 p. 3* Ensure the REMS for long-cting nd extended-relese opioids will ddress the risks of ech individul mediction, 2010, p. 19 p. 3* *During conference cll on April 20, 2011, FDA provided constituency groups detiled informtion on the federl government s REMS-relted requests to mnufcturers of long-cting nd extended relese opioids. Figure C 20 Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

21 Prescriber eduction: Until federl lw is mended to tie new eductionl requirements to DEA registrtion, mnufcturers should offer grnts to continuing eduction (CE) providers to enble helth cre professionls voluntrily to tke sfe prescribing courses nd get CE credits for free. Ptient eduction: Mnufcturers should shorten nd improve mediction guides using consumer-friendly lnguge describing sfe use nd disposl. Eductionl mterils should include content common to the long-cting nd extended-relese opioid subclss s whole, s well s specific informtion unique to ech mnufcturer s own mediction. The FDA must pprove in dvnce ny eductionl mterils mnufcturers intend to use s prt of their REMS. The federl government filed to implement the vitl recommendtion lid out on pp of the 2010 Ntionl Strtegy tht clled for the FDA to grnt interim lbeling, bsed on dt from lbortory tests nd humn buse-libility studies, to new drug formultions designed to deter certin forms of intentionl buse. The qundry tht the FDA hs not yet ddressed is the vicious cycle of indequte lbeling of buse-deterrent opioid formultions. Phrmceuticl mnufcturers cnnot collect dequte epidemiologicl informtion to support buse-deterrent lbeling of their novel opioid products becuse FDA restrictions prevent the mnufcturers from educting prescribers of the drugs tmper-resistnt fetures. Prescribers, therefore, re not wre of the novel fetures of, nd do not dopt, the new medictions, so the inbility of mnufcturers to collect epidemiologicl dt nd request more descriptive lbeling continues in perpetuity. But for this omission on FDA s prt, the government would hve erned 100 percent perfect score for dopting the vitl policy recommendtions mde by ntionl leders in drug buse prevention nd pin cre in the Ntionl Strtegy. 47 See Figure C. Drug Enforcement Administrtion As recommended in prior Ntionl Strtegy editions, government nd not-for-profit entities re encourging sfe storge nd responsible disposl of medictions. On September 25, 2010, the Drug Enforcement Administrtion s ntionwide tke-bck dy collected more thn 121 tons of unused medicine. Officils offered people cross the country free, nonymous, nd legl wy to get rid of potentilly dngerous medictions. 52 Given the success of the federl government s first mediction disposl event, the DEA hosted nother tke-bck dy on April 30, With prescription drug buse on the rise, such tke-bck events help rise wreness nd reduce the number of unnecessry medictions tht could fll into the hnds of criminls nd busers. The Ntionl Fmily Prtnership s Lock Your Meds cmpign hs led severl successful public wreness progrms to encourge people to secure their medictions in wy tht is pproprite to their own circumstnces. U.S. CONGRESS As the prescription drug epidemic hs risen in the public consciousness, federl legisltors hve lso begun to tke more concrete nd decisive ction. Mny people keep their medictions long fter they need them. A resercher t the University of Uth Helth Sciences Center in Slt Lke City found tht of 213 individuls prescribed opioid pin relievers fter surgery for urologicl condition, two-thirds hd leftover pills few weeks lter. Ninety-one percent were keeping those leftovers in their medicine cbinets. The results suggest tht prescribers should prescribe fewer pills to strt, given tht leftover pills pose dnger of being stolen, bused, or ccidentlly misused nd need to be disposed of properly. On October 12, 2010, President Obm signed into lw the Secure nd Responsible Drug Disposl Act of 2010, S Sponsored by Sentors Amy Klobuchr (MN) nd John Cornyn (TX), the lw empowers sttes nd privte entities to institute responsible drug tke-bck progrms in ccordnce with rules to be estblished by the DEA. The lw lso requires the United Sttes Sentencing Commission to review federl sentencing guidelines pplicble to individuls who receive controlled Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 21

22 substnces s prt of disposl progrm but divert them for illegl purposes rther thn properly disposing of them. 54 Progrms tht llow individuls to return controlled substnces to uthorized third prties for disposl 55 re extremely importnt both for bringing ttention to the need for sfe storge, nd providing vehicle for responsible disposl. Under the new lw, individuls will hve more convenient nd regulrly vilble options for sfe disposl. The DEA is currently formulting rules for implementtion of the lw nd is expected to complete the rulemking before My The 2010 Ntionl Strtegy clled for the federl government to provide consumers with sfe nd convenient wys to dispose of outdted nd unwnted medictions, nd expressly recommended tht phrmcies be uthorized to serve s mediction disposl loctions (see pp ). Sentor Klobuchr, in Sente hering on My 24, 2011, expressed her expecttion tht phrmcies be uthorized to ccept unwnted medictions for disposl s prt of the rules. For most communities, the gretest chllenge will be in securing funding for ongoing mediction disposl progrms. In October 2010, U.S. Sentor Chrles Grssley of Iow, the rnking minority member of the Sente Finnce Committee, which oversees Medicid nd Medicre, urged the Deprtment of Helth nd Humn Services (HHS) to investigte the prescription rtes of doctors who prescribe powerful medictions extrordinrily often. It is estimted tht some $60 billion to $90 billion in txpyer money is lost ech yer to Medicre frud. 56 Leding up to his request to HHS, Grssley conducted his own investigtion into how much Medicid nd Medicre money ws spent on ntipsychotics nd pin relievers in ech of the pst two yers, specificlly honing in on the 10 doctors who wrote the most prescriptions for eight commonly bused drugs. The purpose ws to drw ttention to outlying cses tht could be cses of frud or intentionl diversion of prescription medictions. One Florid physicin wrote 96,685 prescriptions for mentl helth drugs in 21-month period; nother physicin verged 25 prescriptions per dy for Xnx. 57 As discussed on p. 12 of the 2010 Ntionl Strtegy, stte Medicid progrms should keep up-to-dte dtbses on Medicid providers nd beneficiries, record debrred providers nd institutions, nd detect duplicte enrollment of beneficiries cross stte lines. In My 2011, U.S. Sentor Sherrod Brown of Ohio introduced the Stop Trfficking of Pills (STOP) Act, S. 882, which would mndte lock-in progrms to ensure tht high-risk prescription drug users receiving Medicid or Medicre benefits ccess their medictions only through one prescriber nd one phrmcy. Medicid, Medicre, nd privte insurnce compnies cn ply vitl role in preventing prescription drug diversion nd buse by nlyzing dt to identify nd reserch extreme outliers using multiple providers nd obtining quntities of medictions beyond tht which could be therpeuticlly necessry, nd requiring them to select one prescriber, one dispenser, or both. The Centers for Disese Control nd Prevention mde similr recommendtions in 2010 to privte insurnce providers nd phrmcy benefit mngers. 59 Medicre, stte Medicid progrms, nd privte insurnce compnies cn lso help ddress prescription drug buse by providing coverge for the new medicinl tretments nd drug testing technologies described in the preceding pges s prt of the updte on industry ctivity. The 112th Congress of the United Sttes convened on Jnury 5, The U.S. House of Representtives chose Congressmn Rogers to serve s chirmn of the powerful Appropritions Committee, which hs jurisdiction over the federl spending. Rep. Rogers is founding member of the Congressionl Prescription Drug Abuse Cucus. He hs chmpioned funding for prescription monitoring progrms for yers nd works with CLAAD colition member Opertion UNITE in his home district to reduce the rmpnt prescription drug buse problem. Representtives Rogers, Bono Mck, nd Lynch re-estblished the bi-prtisn Congressionl Cucus on Prescription Drug Abuse in the 112th Congress. The voluntry cucus tkes the led in Congress on promoting innovtive policies to ddress prescription drug buse. 60 In Mrch 2011, U.S. Rep. Vern Buchnn (FL-13) proposed bill, H.R. 1065, which would reclssify hydrocodone combintion medictions, such s Vicodin nd Lortb, from Schedule III to the more restrictive Schedule II, in n effort to prevent diversion nd buse of the drugs. Buchnn s Pill Mill Crckdown Act of 2011 would lso toughen federl penlties for people who operte pill mills by doubling the prison sentence from 10 to 20 yers, nd tripling the fine from $1 million to $3 million Ntionl Prescription Drug Abuse Prevention Strtegy: Updte

23 U.S. Sentor Jy Rockefeller (WV) proposed the Prescription Drug Abuse Prevention nd Tretment Act of 2011, S. 507, in Mrch The bill would require helth cre prctitioners to prticipte in 16 hours of trining every three yers to obtin DEA registrtion to prescribe opioids. The bill lso clls for the publiction of opioid dosing guidelines nd more thorough mortlity reporting. 69 Rep. Bono Mck, long with Rep. Rogers nd Rep. Lynch, introduced the Ryn Creedon Act of 2011, H.R. 2119, to require ll prescribers of controlled substnces to hve miniml eduction or trining relted to buse nd ddiction. The bill is nmed fter Ryn Creedon, who lived in Congresswomn Bono Mck s district nd died t ge 21 of n opioid overdose. His mother, Kthy Creedon, testified t n April 2011 House Energy nd Commerce subcommittee hering chired by the congresswomn. The mndtory professionl eduction provisions of both the Prescription Drug Abuse Prevention nd Tretment Act nd the Ryn Creedon Act re consistent with the recommendtions of the FDA s Anesthetic nd Life Support Drugs nd Drug Sfety nd Risk Mngement dvisory committees, ONDCP, nd the 25-plus orgniztions tht endorsed the 2010 Ntionl Strtegy. Prescription monitoring progrms re now ctively used in 35 sttes nd re uthorized in 13 others. See Figure D. U.S. Rep. Michel Grimm (NY-13) in Mrch 2011 introduced bill tht would uthorize the Drug Enforcement Administrtion to estblish secure ntionwide prescription monitoring progrm to provide prescribers nd phrmcists interstte prescription dt in rel time. 63 Grimm s bill comes too lte. Policymkers should support the existing stte progrms, rther thn strting over with new, potentilly bureucrticlly-cumbersome federl progrm during time of federl budget deficits nd spending cuts. Stte progrms cn be interconnected to form n effective interstte PMP network vi the prescription monitoring informtion exchnge (PMIX) progrm, which ws initilly mde possible by n pproprition of Congress to the Deprtment of Justice in Those funds hve mde it possible for the Bureu of Justice Assistnce (BJA) to begin estblishing networks tht shre prescription informtion cross stte borders. Other, industry-funded interstte dt shring progrms lso exist. STATES Current ffirs nd legisltion relted to prescription drug buse in certin sttes hve erned significnt mount of ntionl ttention. Severl sttes held high-level summits focused on prescription drug buse. Others pssed comprehensive legisltion to ddress the problem. Florid, now known s the flmingo express, hs been under incresing scrutiny from other sttes nd federl legisltors for its inbility to control pill mills nd the chnneling of drugs outwrd to surrounding sttes. 65 Florid suffers from mssive public helth problem stemming from the diversion nd buse of prescription medictions. The Florid Medicl Exminers Commission reports Florid s deths in 2009 from oxycodone were up 26 percent from 2008, while deths from illegl drugs like heroin nd cocine declined bout 20 percent. Overll, prescription drug overdoses killed nerly 1,270 Floridins in the first hlf of Florid mde hedlines repetedly erly in 2011 s its new governor took im t the stte s budding PMP, rguing ginst the tool becuse of privcy concerns nd funding constrints. Mintining tht it is not the stte s responsibility to trck individuls mediction history, 67 Florid Governor Rick Scott thretened to block funding for the stte s prescription monitoring progrm. After number of stte governors nd members of Congress wrote to Scott, urging him to reconsider his position on the stte s PMP, Scott nnounced t the April 2011 U.S. House Energy nd Commerce subcommittee hering on prescription drug buse chired by Rep. Bono Mck tht he would not block the progrm. Governor Scott of Florid lso rejected highly publicized dontion from Purdue Phrm, the mkers of OxyContin, to py for the stte s PMP, nd in My 2010, the Florid legislture pssed H.B prohibiting phrmceuticl compny funding for the stte s PMP. The ctions of Florid s governor nd legislture in refusing industry funding for the stte s PMP re consistent with the best prctices lid out by the PMP Center of Excellence t Brndeis University. On My 24, 2011, the U.S. Sente Judiciry Subcommittee on Crime nd Terrorism held hering on prescription drug buse entitled, Responding to the Prescription Drug Epidemic: Ntionl Prescription Drug Abuse Prevention Strtegy: Updte 23

24 Sttus of Prescription Drug Monitoring Progrms (PDMPs) VT WA OR NV CA ID AZ UT MT WY CO NM ND MN SD WI NE IA IL KS MO OK AR MS NY MI PA OH IN WV VA KY NC TN SC GA AL ME NH MA RI CT NJ DE MD DC AK TX LA FL Opertionl PDMPs HI Encted PDMP legisltion, but progrm not yet opertionl Legisltion pending GU Reserch is current s of September 13, 2011 Figure D 1 Ntionl Prescription Drug Abuse Prevention Ntionl Strtegy: Prescription Drug Updte Abuse Prevention Strtegy Updte 2

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