,,ii #aadth ,,congress #b;d ,session ,s4 #cjge ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #af1 #bjaf ,mr4 ,durbin introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to establish programs related to prevention of prescription opioid misuse1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,addiction ,prevention and ,responsible ,opioid ,practices ,act4 #b4 ,opioid action plan 7a7 ,advisory ,committee 7#a7 ,new drug application ,except as provided in paragraph 7#d71 prior to the approval of a new drug that is an opioid under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 the ,commissioner of ,food and ,drugs shall refer such drug to an advisory committee of the ,food and ,drug ,administration to seek recommendations from such ,committee4 7#b7 ,pediatric opioid labeling ,the ,commissioner of ,food and ,drugs shall convene the ,pediatric ,advisory ,committee of the ,food and ,drug ,administration to seek recommendations from such ,committee regarding a framework for the inclusion of information in the labeling of drugs that are opioids relating to the use of such drugs in pediatric populations before such ,commissioner approves any labeling changes for drugs that are opioids intended for use in pediatric populations4 7#c7 ,public health exemption ,if the ,commissioner of ,food and ,drugs finds that referring a new opioid drug or drugs to an advisory committee of the ,food and ,drug ,administration as required under paragraph 7#a7 is not in the interest of protecting and promoting public health1 and has submitted a notice containing the rationale for such a finding to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 or if the matter that would be considered by such advisory committee with respect to any such drug or drugs concerns bioequivalence1 sameness of active ingredient1 or other criteria applicable to applications submitted under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 the ,commissioner shall not be required to refer such drug or drugs to an advisory committee as required under paragraph 7#a74 7#d7 ,sunset ,unless ,congress reauthorizes paragraphs 7#a7 and 7#b71 the requirements of such paragraphs shall cease to be effective on ,october #a1 #bjbb4 7b7 ,education for prescribers of opioids ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 as part of the ,food and ,drug ,administration's evaluation of the ,extended-,release_/,long-,acting ,opioid ,analgesics ,risk ,evaluation and ,mitigation ,strategy1 and in consultation with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,director of the ,national ,institutes of ,health1 the ,administrator of the ,agency for ,healthcare ,research and ,quality1 the ,administrator of the ,drug ,enforcement ,administration1 and relevant stakeholders1 shall develop recommendations regarding education programs for prescribers of opioids required to be disseminated under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 including recommendations for which prescribers should participate in such programs and how often participation in such programs is necessary4 7c7 ,guidance ,not later than #a year after the date of enactment of this ,act1 the ,commissioner of ,food and ,drugs shall issue guidance on if and how the approved labeling of a drug that is an opioid and is the subject of an application under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 may include statements that such drug deters abuse4 #c4 ,opioid informational documents 7a7 ,in general ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #eje-a the following3 #eje-b4 ,opioid informational documents 7a7 ,development of materials ,the ,commissioner shall develop informational documents describing to consumers of opioid drugs the risk factors for opioid-related harm1 and shall submit such documents to the ,director of the ,centers for ,disease ,control and ,prevention for approval4 7b7 ,labeling requirement ,the manufacturer of any opioid drug approved under section #eje shall ensure that the appropriate informational documents developed under subsection 7a71 and approved by the ,director of the ,centers for ,disease ,control and ,prevention1 are included in the labeling of such drug4 4 7b7 ,enforcement ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7dd7 ,if it is an opioid drug and the labeling does not include the informational documents required under section #eje-b4 4 #d4 ,strengthening considerations for ,,dea narcotic quotas ,section #cjf of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbf7 is amended by adding at the end the following3 7i7 7#a7 ,in fixing manufacturing quotas under this section the ,attorney ,general shall take into consideration the impact of the manufacturing quotas on diversion and efforts to reduce the costs1 injuries1 and deaths associated with the abuse of prescription opioids and heroin in the ,united ,states4 7#b7 7,a7 ,not later than #a year after the date of enactment of this subsection and every year thereafter1 the ,attorney ,general shall publish the approved manufacturing quota for each manufacturer of fentanyl1 oxycodone1 hyrdocodone1 oxymorphone1 and hyrdomorphone for that year4 7,b7 ,for any year in which the approved manufacturing quota for a manufacturer for any substance described in subparagraph 7,a7 is higher than the approved manufacturing quota for a manufacturer for the substance in the previous year1 the ,attorney ,general shall publish a report explaining why the public health benefits of increasing such quota outweigh the consequences of having an increased volume of such substance available for sale1 and potential diversion1 in the ,united ,states4 7,c7 ,for any substance described in subparagraph 7,a7 that is approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act after the date of enactment of this subsection1 the ,attorney ,general shall publish a report explaining what factors were taken into consideration in setting the manufacturing quota for the substance4 7#c7 ,not later than #ij days after the date of enactment of this subsection1 the ,attorney ,general shall submit to ,congress a report on-- 7,a7 how the ,attorney ,general will ensure that the process of fixing manufacturing quotas under this section takes into consideration efforts to reduce the costs1 injuries1 and deaths associated with the abuse of prescription opioids and heroin2 7,b7 formal steps that will be taken to improve data collection from approved drug collection receptacles1 mail-back programs1 and take-back events on the volume and class of controlled substances that are collected2 and 7,c7 how the information described in subparagraphs 7,a7 and 7,b7 will influence the quota-setting process of the ,attorney ,general in the following year4 4 #e4 ,continuing medical education and prescription drug monitoring program registration for prescribers ,section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7 is amended by adding at the end the following3 7k7 7#a7 ,the ,attorney ,general shall not register1 or renew the registration of1 a practitioner under subsection 7f7 who is licensed under ,state law to prescribe controlled substances in schedule ,,ii1 ,,iii1 or ,,iv1 unless the practitioner submits to the ,attorney ,general1 for each such registration or renewal request1 a written certification that-- 7,a7 7i7 the practitioner has1 during the #a-year period preceding the registration or renewal request1 completed a training program described in paragraph 7#b72 or 7ii7 the practitioner1 during the applicable registration period1 will not prescribe such controlled substances in amounts in excess of a #gb-;hour supply 7for which no refill is available72 and 7,b7 the practitioner has registered with the prescription drug monitoring program of the ,state in which the practitioner practices1 if the ,state has such program4 7#b7 ,a training program described in this paragraph is a training program that-- 7,a7 follows the best practices for pain management1 as described in the ,guideline for ,prescribing ,opioids for ,chronic ,pain as published by the ,centers for ,disease ,control and ,prevention in #bjaf1 or any successor thereto2 7,b7 includes information on-- 7i7 recommending non-opioid and non-pharmacological therapy2 7ii7 establishing treatment goals and evaluating patient risks2 7iii7 prescribing the lowest dose and fewest number of pills considered effective2 7iv7 addictive and overdose risks of opioids2 7v7 diagnosing and managing substance use disorders1 including linking patients to evidence-based treatment2 7vi7 identifying narcotics-seeking behaviors2 and 7vii7 using prescription drug monitoring programs2 and 7,c7 is approved by the ,secretary of ,health and ,human ,services4 4 #f4 ,report on prescriber education courses for medical and dental students ,each school of medicine1 school of osteopathic medicine1 and school of dentistry participating in a program under title ,,iv of the ,higher ,education ,act of #aife 7#bj ,u4,s4,c4 #ajgj;a et seq471 as a condition for such participation1 shall submit an annual report to ,congress on any prescriber education courses focused specifically on pain management and responsible opioid prescribing practices that such school requires students to take1 and whether such courses are consistent with the most recently published version of the ,guideline for ,prescribing ,opioids for ,chronic ,pain of the ,centers for ,disease ,control and ,prevention4 #g4 ,requirements under ,prescription ,drug ,monitoring ,programs 7a7 ,in general ,beginning #a year after the date of enactment of this ,act1 each ,state that receives funding under the ,harold ,rogers ,prescription ,drug ,monitoring ,program established under the ,departments of ,commerce1 ,justice1 and ,state1 the ,judiciary1 and ,related ,agencies ,appropriations ,act1 #bjjb 7,public ,law #ajg-gg2 #aae ,stat4 #gdh71 the controlled substance monitoring program under section #cii,o of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#c71 or the ,prescription ,drug ,overdose3 ,prevention for ,states program of the ,centers for ,disease ,control and ,prevention shall-- 7#a7 require practitioners1 or their designees1 in the ,state to consult the database of the prescription drug monitoring program before writing prescriptions for controlled substances 7as such term is defined in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb77 in schedule ,,ii1 ,,iii1 or ,,iv under section #bjb of such ,act 7#ba ,u4,s4,c4 #hab72 7#b7 require dispensers of controlled substances in schedule ,,ii1 ,,iii1 or ,,iv1 or their designees1 to input data into the database of the prescription drug monitoring program within #bd hours of filling a qualifying prescription1 as required by the ,attorney ,general and the ,secretary of ,health and ,human ,services1 including patient identifier information1 the national drug code of the dispensed drug1 date of dispensing the drug1 quantity and dosage of the drug dispensed1 form of payment1 ,drug ,enforcement ,administration registration number of the practitioner1 ,drug ,enforcement ,administration registration number of the dispenser2 7#c7 allow practitioners and dispensers to designate other appropriate individuals to act as agents of such practitioners and dispensers for purposes of obtaining and inputing data from the database for purposes of complying with paragraphs 7#a7 and 7#b71 as applicable2 7#d7 provide informational materials for practitioners and dispensers to identify and refer patients with possible substance use disorders to professional treatment specialists2 7#e7 establish formal data sharing agreements to foster electronic connectivity with the prescription drug monitoring programs of each ,state 7if such ,state has such a program7 with which the ,state shares a border1 to facilitate the exchange of information through an established technology architecture that ensures common data standards1 privacy protection1 and secure and streamlined information sharing2 7#f7 notwithstanding section #cii,o7f77#a77;,b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#c7;f77#a77;,b771 authorize direct access to the ,state's database of the prescription drug monitoring program to all ,state law enforcement agencies1 ,state boards responsible for the licensure1 regulation1 or discipline of practitioners1 pharmacists1 or other persons authorized to prescribe1 administer1 or dispense controlled substances2 and 7#g7 in order to enhance accountability in prescribing and dispensing patterns1 not fewer than #d times per year1 proactively provide informational reports on aggregate trends and individual outliers1 based on information available through the ,state prescription drug monitoring program to-- 7,a7 the ,state entities and persons described in paragraph 7#f72 and 7,b7 the ,medicaid agency1 workers compensation programs1 and the department of public health of the ,state4 7b7 ,transparency in ,prescribing ,practices and ,intervention for ,high ,prescribers 7#a7 ,state reporting requirement ,each ,state that receives funding under the ,harold ,rogers ,prescription ,drug ,monitoring ,program established under the ,departments of ,commerce1 ,justice1 and ,state1 the ,judiciary1 and ,related ,agencies ,appropriations ,act1 #bjjb 7,public ,law #ajg-gg2 #aae ,stat4 #gdh71 the controlled substance monitoring program under section #cii,o of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhj;g-#c71 or the ,prescription ,drug ,overdose3 ,prevention for ,states program of the ,centers for ,disease ,control and ,prevention shall1 twice per year1 submit to the ,secretary of ,health and ,human ,services and the ,administrator of the ,drug ,enforcement ,administration-- 7,a7 a list of all practitioners and dispensers who1 in the applicable reporting period1 have prescribed or dispensed schedule ,,ii1 ,,iii1 or ,,iv opioids in the ,state2 7,b7 the amount of schedule ,,ii1 ,,iii1 or ,,iv opioids that were prescribed and dispensed by each individual practitioner and dispenser described in subparagraph 7,a72 and 7,c7 any additional information that the ,secretary and ,administrator may require to support surveillance and evaluation of trends in prescribing or dispensing of schedule ,,ii1 ,,iii1 or ,,iv opioids1 or to identify possible non-medical use and diversion of such substances4 7#b7 ,annual report ,not later than #a year after the date of enactment of this ,act1 and annually thereafter1 the ,secretary of ,health and ,human ,services1 in consultation with the ,administrator of the ,drug ,enforcement ,administration1 the ,secretary of ,defense1 the ,secretary of ,veterans ,affairs1 and the ,director of the ,indian ,health ,service1 shall submit to ,congress1 and make public1 a report identifying the geographic areas with the highest rates of opioid prescribing in the ,nation1 by zip code4 7#c7 ,development of action plan 7,a7 ,initial plan ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with the ,administrator of the ,drug ,enforcement ,administration1 the ,secretary of ,defense1 the ,secretary of ,veterans ,affairs1 and the ,director of the ,indian ,health ,service1 shall submit to ,congress a plan of action1 including warning letters and enforcement mechanisms1 for addressing outliers in opioid prescribing practices and ensuring an adequate ,federal response to protect the public health4 7,b7 ,updated plan ,the ,secretary of ,health and ,human ,services shall submit to ,congress updates to the plan of action described in subparagraph 7,a71 as such ,secretary1 in consultation with the heads of agencies described in such subparagraph1 determines appropriate4 7c7 ,definitions ,in this section1 the terms dispenser and practitioner have the meanings given such terms in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb74 7d7 ,authorization of appropriations ,in addition to any other amounts appropriated to carry out the ,prescription ,drug ,overdose3 ,prevention for ,states program of the ,centers for ,disease ,control and ,prevention1 for purposes of enhancing the utilization1 interoperability1 and integration of ,state prescription drug monitoring programs1 there are authorized to be appropriated #gj1jjj1jjj for each of fiscal years #bjag through #bjba4 #h4 ,development of new pain-related measures under the ,medicare hospital value-based purchasing program to eliminate financial incentives to over-prescribe opioids ,section #ahhf7o77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7o77#b77;,b77 is amended-- 7#a7 in clause 7i77,,ii71 by inserting 1 subject to clause 7iii71 after shall2 and 7#b7 by adding at the end the following new clause3 7iii7 ,development of new pain-related measures 7,i7 ,moratorium until new measures applicable ,for value-based incentive payments made with respect to discharges occurring during fiscal year #bjah and each subsequent fiscal year 7before the first fiscal year in which new measures are applicable under subclause 7,,ii77cc771 the ,secretary shall ensure that measures selected under subparagraph 7,a7 7such as measures related to the ,hospital ,consumer ,assessment of ,healthcare ,providers and ,systems survey7 do not include measures based on any assessments by patients1 with respect to hospital stays of such patients1 of-- 7aa7 the need of such patients1 during such stay1 for medicine for pain2 7bb7 how often1 during such stay1 the pain of such patients was well controlled2 or 7cc7 how often1 during such stay1 the staff of the hospital in which such stay occurred did everything they could to help the patient with the pain experienced by the patient4 7,,ii7 ,development of new measures 7aa7 ,development ,not later than #c years after the date of enactment of this clause1 the ,secretary shall develop measures of patient experience of care with respect to pain management that balance the breadth of effective pain management tools with awareness for the role of over-prescribing 7including1 if appropriate1 opioid-seeking behaviors7 in the prescription opioid epidemic4 7bb7 ,consultation ,the ,secretary shall consult with relevant stakeholders in developing measures under item 7aa74 7cc7 ,application for value-based incentive payments ,for value-based incentive payments made with respect to discharges occurring during a fiscal year beginning on or after the date on which the ,secretary develops new measures under item 7aa71 the ,secretary shall ensure that measures selected under subparagraph 7,a7 7such as measures related to the ,hospital ,consumer ,assessment of ,healthcare ,providers and ,systems survey7 include such new measures4 4 #i4 ,national ,academy of ,medicine ,study 7a7 ,study ,the ,secretary of ,health and ,human ,services shall enter into a contract with the ,national ,academy of ,medicine to carry out a study on the addition of coverage under the ,medicare program under title ,,xviii of the ,social ,security ,act of alternative treatment modalities 7such as integrative medicine1 including acupuncture and exercise therapy1 neural stimulation1 biofeedback1 radiofrequency ablation1 and trigger point injections7 furnished to ,medicare beneficiaries who suffer from acute or chronic lower back pain4 ,such study shall1 pursuant to the contract under this paragraph1 include an analysis of-- 7#a7 scientific research on the short-term and long-term impact of the addition of such coverage on clinical efficacy for pain management of such beneficiaries2 7#b7 whether the lack of ,medicare coverage for alternative treatment modalities impacts the volume of opioids prescribed for beneficiaries2 and 7#c7 the cost to the ,medicare program of the addition of such coverage to treat pain and mitigate the progression of chronic pain1 as weighed against the cost of opioid use disorder1 overdose1 readmission1 subsequent surgeries1 and utilization and expenditures under parts ,b and ,d of such title4 7b7 ,report ,not later than #a year after the date of enactment of this ,act1 pursuant to the contract under subsection 7a71 the ,national ,academy of ,medicine shall submit to ,congress a report on the study under subsection 7a74 7c7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated such sums as may be necessary4 #aj4 ,excise tax on opioid pain relievers 7a7 ,in general ,subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #daib4 ,opioid pain relievers 7a7 ,in general ,there is hereby imposed on the manufacturer or producer of any taxable active opioid a tax equal to the amount determined under subsection 7b74 7b7 ,amount determined ,the amount determined under this subsection with respect to a manufacturer or producer for a calendar year is #a cent per milligram of taxable active opioid in the production or manufacturing quota determined for such manufacturer or producer for the calendar year under section #cjf of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbf74 7c7 ,taxable active opioid ,for purposes of this section-- 7#a7 ,in general ,the term taxable active opioid means any controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb71 as in effect on the date of the enactment of this section7 manufactured in the ,united ,states which is opium1 an opiate1 or any derivative thereof4 7#b7 ,exclusions 7,a7 ,other ingredients ,in the case of a product that includes a taxable active opioid and another ingredient1 subsection 7a7 shall apply only to the portion of such product that is a taxable active opioid4 7,b7 ,drugs used in addiction treatment ,the term taxable active opioid shall not include any controlled substance 7as so defined7 which is used exclusively for the treatment of opioid addiction as part of a medication-assisted treatment4 4 7b7 ,clerical amendments 7#a7 ,the heading of subchapter ,e of chapter #cb of the ,internal ,revenue ,code of #aihf is amended by striking ,medical devices and inserting ,other medical products4 7#b7 ,the table of subchapters for chapter #cb of such ,code is amended by striking the item relating to subchapter ,e and inserting the following new item3 ,subchapter ,e4 ,other medical products 4 7#c7 ,the table of sections for subchapter ,e of chapter #cb of such ,code is amended by adding at the end the following new item3 ,sec4 #daib4 ,opioid pain relievers4 4 7c7 ,effective date ,the amendments made by this section shall apply to calendar years beginning after the date of the enactment of this ,act4 #aa4 ,opioid consumer abuse reduction program 7a7 ,opioid take-,back program ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7 is amended by adding at the end the following3 7h7 7#a7 ,the ,attorney ,general shall establish a national take-back program for the safe and environmentally responsible disposal of controlled substances4 7#b7 ,in establishing the take-back program required under paragraph 7#a71 the ,attorney ,general-- 7,a7 shall consult with the ,secretary and the ,administrator of the ,environmental ,protection ,agency2 and 7,b7 may coordinate with ,states1 law enforcement agencies1 water resource management agencies1 manufacturers1 practitioners1 pharmacists1 public health entities1 transportation and incineration service contractors1 and other entities and individuals1 as appropriate4 7#c7 ,the take-back program established under paragraph 7#a7-- 7,a7 shall-- 7i7 ensure appropriate geographic distribution so as to provide-- 7,i7 reasonably convenient and equitable access to permanent take-back locations1 including not less than #a disposal site for every #be1jjj residents and not less than #a physical disposal site per town1 city1 county1 or other unit of local government1 where possible2 and 7,,ii7 periodic collection events and mail-back programs1 including public notice of such events and programs1 as a supplement to the permanent take-back locations described in subclause 7,i71 particularly in areas in which the provision of access to such locations at the level described in that subclause is not possible2 7ii7 establish a process for the accurate cataloguing and reporting of the quantities of controlled substances collected2 and 7iii7 include a public awareness campaign and education of practitioners and pharmacists2 and 7,b7 may work in coordination with ,state and locally implemented public and private take-back programs4 7#d7 ,from time to time1 beginning in the second calendar year that begins after the date of enactment of this subsection1 the ,secretary of the ,treasury shall transfer from the general fund of the ,treasury an amount equal to one-half of the total amount of taxes collected under section #daib of the ,internal ,revenue ,code of #aihf to the ,attorney ,general to carry out this subsection4 ,amounts transferred under this subparagraph shall remain available until expended4 4 7b7 ,funding of substance abuse programs ,from time to time1 beginning in the second calendar year that begins after the date of enactment of this ,act1 the ,secretary of the ,treasury shall transfer from the general fund of the ,treasury an amount equal to one-half of the total amount of taxes collected under section #daib of the ,internal ,revenue ,code of #aihf1 as added by this ,act1 to the ,director of the ,center for ,substance ,abuse ,treatment of the ,substance ,abuse and ,mental ,health ,services ,administration for programs of the ,center1 including the ,block ,grants for ,prevention and ,treatment of ,substance ,abuse program under subpart ,,ii of part ,b of title ,,xix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjjx-#ba et seq47 and ,programs of ,regional and ,national ,significance4 ,amounts transferred under this subsection shall remain available until expended4 #ab4 ,,gao study ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall conduct a study evaluating the various ,state laws1 commercial insurance methods1 and existing research on requirements that place limitations on opioid prescribing practices and provide analysis on best practices to address over-prescribing of opioids1 while ensuring that individuals who need such opioids can access them safely4 ,such study shall provide recommendations1 including with respect to-- 7#a7 limiting first-time opioid prescriptions to a patient for acute pain to a #gb-;hour supply2 7#b7 allowing patients or practitioners to request that a prescription for a schedule ,,ii opioid be partially filled by a pharmacist2 and 7#c7 pain management treatment contracts between practitioners and patients that establish informed consent regarding the expectations1 risks1 long-term effects1 and benefits of the course of opioid treatment1 treatment goals1 the potential for opioid misuse1 abuse1 or diversion1 and requirements and responsibilities of patients1 such as submitting to a urine drug screening4