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Combating the Prescription Painkiller Epidemic: A National Prescription Drug Reporting Program
Published online by Cambridge University Press: 06 January 2021
Abstract
Prescription painkiller abuse is the fastest growing drug problem in the United States. In the past year, approximately one out of twenty Americans reported misuse or abuse of prescription painkillers. Several factors contribute to the prescription painkiller epidemic. Drug abusers use various methods—such as doctor shopping, paying with cash, and filling prescriptions in different states—to avoid detection and obtain prescription painkillers for illegitimate uses. A few rogue physicians and pharmacists, lured by substantial profits, enable drug abusers by illegally prescribing or supplying controlled substances. Even ethical physicians rarely have adequate training to recognize and address prescription drug abuse, and as a result, prescribe painkillers to patients who are not using them for legitimate medical purposes. Similarly, although the majority of pharmacies have taken steps to combat drug abuse and reduce prescription painkiller dispensing, under current reporting systems, pharmacists lack visibility into several important indicators of drug abuse. As a result, even the most vigilant pharmacists find it extremely difficult to identify and detect drug abuse with certainty.
While state governments have established prescription drug monitoring programs (PDMPs) to crack down on prescription drug abuse, these programs have proven to be inadequate. The programs currently suffer from inadequate data collection, ineffective utilization of data, insufficient interstate data sharing, and constraints on sharing data with law enforcement and state agencies. By contrast, third-party prescription payment systems run by pharmacy benefit managers (PBMs) or health insurers have been effective in detecting prescription drug abuse. This paper suggests that a national prescription drug reporting program building on existing PBM networks could be significantly more effective than existing state PDMPs in detecting prescription drug abuse.
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References
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31 Id.
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44 Id.
45 Id.
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47 See infra Part III.B.
48 See infra Part III.C.
49 See infra Part III.C.2.
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51 Id.
52 Id.
53 Id. Other categories include “Wrote Fake Prescription,” “Stole from Doctor's Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.” Id. at 29 n.1.
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57 See id.
58 Id.
59 Id.
60 Id.
61 U.S. Gov't Accountability Office, GAO-11-699, Medicare Part D: Instances of Questionable Access to Prescription Drugs (2011), available at http://www.gao.gov/assets/590/585424.pdf.
62 Id. at 9.
63 Id.
64 Id. at 12 tbl.2.
65 Id.
66 Id. at 15.
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68 Id.
69 Id.
70 Id.
71 See Steve Miller, Fighting Rx Abuse and the Cash-Claims Loophole, Healthcare Insights (May 7, 2013), http://lab.express-scripts.com/industry-updates/fighting-prescription-drug-abuse-and-the-cash-claims-loophole/.
72 See id.
73 See Ctr. for Program Integrity, Dep'T of Health & Human Servs., Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in Medicaid 4-5 (2012), available at http://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/MedicaidIntegrityProgram/downloads/drugdiversion.pdf.
74 Kristin M. Finkllea et al., Cong. Research Serv., R42593, Prescription Drug Monitoring Programs 4-5 (2013), available at http://www.fas.org/sgp/crs/misc/R42593.pdf.
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76 Id.
77 Prescription Drug Diversion: Combating the Scourge: Hearing Before the Subcomm. on Commerce, Mfg. & Trade of the Comm. on Energy & Commerce, 112th Cong. 7 (2012) (statement for the record of Aaron Haslam, Sr. Ass't Att’y Gen., Office of the Ohio Att’y Gen.), available at http://democrats.energycommerce.house.gov/sites/default/files/documents/Testimony-Haslam-CMT-Prescription-Drug-Diversion-2012-3-1.pdf.
78 The Kaiser Comm’n on Medicaid & the Uninsured, Five Facts About the Uninsured 1 (2012), available at http://www.kff.org/uninsured/upload/7806-05.pdf.
79 See Doctors Claim Pharmacy Chain Refusing to Fill Pain Meds, WSB-TV Atlanta (Sept. 13, 2013), http://www.wsbtv.com/news/news/local/doctors-claim-pharmacy-chain-refusing-fill-pain-me/nR98n/.
80 Paulozzi et al., Vital Signs, supra note 14, at 1489.
81 Will James, Report Faults Doctors: Long Island Grand Jury Blames Physicians, Pharmacists for Epidemic of Abuse, WALL ST. J. (May 25, 2012), http://online.wsj.com/news/articles/SB10001424052702304707604577424644089095720.
82 Coal. Against Ins. Fraud, Prescription for Peril: How Insurance Fraud Finances Theft and Abuse of Addictive Prescription Drugs 8 (2007), available at http://www.insurancefraud.org/downloads/drugDiversion.pdf.
83 Id.
84 Id. at 9.
85 Id.
86 Id. at 12.
87 Id. at 13.
88 Id.
89 Id. at 12.
90 Workers’ Comp PBMs Struggle to Find Words to Discourage Physician Dispensing, DRUG BENEFIT NEWS (Oct. 5, 2012), http://aishealth.com/sites/all/files/marketplace_pdf_samples/dbn100512_1.pdf.
91 Id. at 1.
92 Id. at 3.
93 Timothy W. Martin & Arian Campo-Flores, New Front Opens in Florida Pill War, WALL ST. J. (Mar. 8, 2012), http://online.wsj.com/news/articles/SB10001424052970203961204577267310025935508.
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95 Id.
96 Id.
97 Id.
98 Id.
99 Id.
100 Id.
101 Nat’l Ctr. on Addiction & Substance Abuse at Columbia Univ., Under the Counter: the Diversion and Abuse of Controlled Prescription Drugs in the U.S. 138 (2005), available at http://www.casacolumbia.org/download.aspx?path=/UploadedFiles/tt3bl4lk.pdf.
102 Id.
103 Id.
104 Id.
105 Id.
106 Press Release, Workers Comp. Research Inst., Pennsylvania: Nearly 1 in 9 Injured Workers Who Started Narcotics Were Still Using Them 3-6 Months Later, Says New WCRI Study (Oct. 2, 2012), available at http://www.wcrinet.org/media_release_10.2.12_PA_longer_term_use_opioids.html.
107 Id.
108 Id.
109 See Barry Meier, Tightening the Lid on Pain Prescriptions, N.Y. Times (Apr. 9, 2012), http://www.nytimes.com/2012/04/09/health/opioid-painkiller-prescriptions-pose-danger-without-oversight.html?pagewanted=all&_r=0.
110 See Office of Diversion Control, Dep't of Justice, United States Summary for Retail Drug Purchases by Grams Weight: Reporting Period 01/01/2006 TO 12/31/2006 (2008), available at https://web.archive.org/web/20080829180605/http://www.deadiversion.usdoj.gov/arcos/retail_drug_summary/2006/06_rpt7.pdf.
111 See Nat’l Inst. on Drug Abuse, Prescription Drugs: Abuse and Addiction 2 (2011), available at http://www.drugabuse.gov/sites/default/files/rrprescription.pdf.
112 See, e.g., Holiday CVS, L.L.C., 77 Fed. Reg. 62,315, 62,323 (Dep't of Justice Oct. 12, 2012) (notice) (including testimony by CVS officials that CVS took “various actions” to ensure that CVS did not contribute to the elevated level of drug abuse in Florida).
113 See id. at 62,335 (including expert testimony that a pharmacist must “ensure that controlled substances continue to be available for legitimate medical and scientific purposes while preventing diversion into the elicit market”).
114 Id. at 62,318.
115 Id. at 62,326 n.11.
116 Id. at 62,318.
117 Carmen DeNavas-Walt et al., U.S. Census Bureau, Income, Poverty, and Health Insurance Coverage in the United States: 2012 22 (2013), available at http://www.census.gov/prod/2013pubs/p60-245.pdf.
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119 Gillette, supra note 94.
120 Linden Barber, DEA's Uneasy Relationship with Oxycodone, DEA Chronicles (Apr. 4, 2013), http://deachronicles.quarles.com/2013/04/dea_uneasy_with-oxycodone/.
121 See infra Figure 2.
122 Barber, supra note 120.
123 Drug Enforcement Admin., Aggregate Production Quota History for Selected Substances (last updated Oct. 2, 2013), available at http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
124 See Gillette, supra note 94.
125 See Council of State Gov’ts, Interstate Information Sharing: Prescription Drug Monitoring Programs 1 (2010), available at http://knowledgecenter.csg.org/drupal/system/files/CapitolResearch_PDM.pdf.
126 See id.
127 R.G. Dunlop, Pharmacists Have to Share Responsibility, Authorities Say, Louisville Courier-Journal (June 4, 2012), http://www.courier-journal.com/article/20120604/NEWS01/107100020.
128 Id.
129 Id.
130 See Draft National Average Retail Prices (NARP) Data and Draft National Drug Acquisition Cost (NADAC) Data, MEDICAID.GOV, http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Benefits/Prescription-Drugs/Survey-of-Retail-Prices.html (select the NARP file and NADAC file zip folders) (last updated Nov. 21, 2013) (comparing NARP per unit of Medicaid and other third-party insurers with NARP per unit of cash).
131 Dunlop reported that Dr. Jones was the first pharmacist in Kentucky to be sanctioned for knowingly filing improper prescriptions. See Dunlop, supra note 127.
132 See Significant Dates in U.S. Food and Drug Law History, FDA, http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm (last updated Nov. 6, 2012).
133 See Janssen, Wallace F., Outline of the History of U.S. Drug Regulation and Labeling, 36 Food Drug & Cosm. L.J. 410, 424-26 (1981)Google Scholar.
134 See id.
135 Pure Food and Drugs Act, ch. 3915, 34 Stat. 768, 772 (1906), repealed by Food, Drug, and Cosmetic Act, ch. 675, § 902, 52 Stat. 1040, 1059 (1938) (codified as amended at 21 U.S.C. §§ 301–399 (2012)).
136 See id. §§ 7–8, 34 Stat. at 769-71.
137 Harrison Narcotics Act, ch. 1, 38 Stat. 785 (1914), repealed by Controlled Substances Act, Pub. L. No. 91-513, 84 Stat. 1242 (1971) (codified as amended in scattered sections of 21 U.S.C.).
138 Id. § 2, 38 Stat. at 786.
139 Id. § 2(a).
140 See id. § 2(b).
141 Food, Drug, and Cosmetic Act, ch. 675, §§ 50-503, 52 Stat. 1040, 1049-52 (1938), (current version at 21 U.S.C. § 351–353 (2012)).
142 See id. § 503(b), 52 Stat. at 1051 (1938) (current version at 21 U.S.C. § 353(b) (2012)).
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146 See 21 U.S.C. §§ 801–904 (2012). Much of the discussion in this section is drawn from Congressional Research Service Report R40548. Brian T. Yeh, Cong. Research Serv., R40548, Legal Issues Relating to the Disposal of Dispensed Controlled Substances (2010), available at http://assets.opencrs.com/rpts/R40548_20101019.pdf; see also Drug Enforcement Admin., U.S. Dep't of Justice, Practitioner's Manual—An Informational Outline of the Controlled Substances Act (2006) [Hereinafter Drug Enforcement Admin., Practitioner's Manual], available at http://www.deadiversion.usdoj.gov/pubs/manuals/pract/pract_manual012508.pdf.
147 21 U.S.C. § 812 (2012).
148 See Drug Enforcement Admin., Practitioner's Manual, supra note 146, at 5-6.
149 See id.
150 See id.
151 See id.
152 See id.
153 See id.
154 See id. An expanded list of controlled substances can be found at the DEA website. Controlled Substances Schedules, Office of Diversion Control, U.S. Dep't of Justice, http://www.deadiversion.usdoj.gov/schedules/index.html#list (last visited Nov. 16, 2013).
155 See 21 U.S.C. §§ 822, 841(a)(1) (2012).
156 See id. § 829.
157 21 C.F.R. § 1306.04(a) (2013).
158 YEH, supra note 146, at 6.
159 For background on the CSA regulatory requirements, see James E. Nichols & Brian T. Yeh, Cong. Research Serv., RL34635, The Controlled Substances Act: Regulatory Requirements (2008), available at http://assets.opencrs.com/rpts/RL34635_20081028.pdf.
160 See 21 U.S.C. § 822.
161 See id. § 824(a).
162 See Garcia, Andrea M., State Laws Regulating Prescribing of Controlled Substances: Balancing the Public Health Problems of Chronic Pain and Prescription Painkiller Abuse and Overdose, 41 J.L. Med. & Ethics 42, 43-44 (supp. 2013)Google ScholarPubMed.
163 See Prescription Drug Overdose: State Laws, CDC, http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/index.html (last updated July 11, 2012).
164 See Law: Physical Exam Required, CDC, http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/exam.html (last updated July 9, 2012).
165 Id.
166 Law: Prescription Limits, CDC, http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/rx_limits.html (last updated July 9, 2012).
167 See id.
168 See Prescription Drug Overdose: State Laws, CDC, http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/index.html (last updated July 11, 2012); see also Cumulative Number of States Authorizing Prescription Drug Abuse-Related Laws by Type of Law, United States, 1970-2010, CDC, http://www.cdc.gov/homeandrecreationalsafety/Poisoning/laws/cumul_laws_graph_text.html (last updated July 9, 2012).
169 See Law: Doctor Shopping, supra note 54.
170 See id.
171 Law: Requiring Patient Identification Before Dispensing, CDC, http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/id_req.html (last updated July 11, 2012).
172 Id.
173 Law: Tamper-Resistant Form Laws, CDC, http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/forms.html (last updated July 9, 2012).
174 Law: Regulating Pain Clinics, CDC, http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/laws/pain_clinic.html (last updated July 9, 2012).
175 See Karen Blumenschein et al., Review of Prescription Drug Monitoring Programs in the United States, Ky. Cabinet for Health & Fam. Servs. 6-7 (June 2010), http://chfs.ky.gov/NR/rdonlyres/85989824-1030-4AA6-91E1-7F9E3EF68827/0/KASPEREvaluationPDMPStatusFinalReport6242010.pdf.
176 Finkllea et al., supra note 74, at 2.
177 Id. at 3.
178 See Prescription Drug Diversion: Combating the Scourge: Hearing Before the H. Subcomm. on Commerce, Mfg., & Trade of the H. Energy & Commerce Comm., 112th Cong. (2012) (statement of R. Gil Kerlikowske, Office of Nat’l Drug Control Policy), available at http://www.whitehouse.gov/sites/default/files/ondcp/rgk_prescription_drug_abuse_testimony_030112.pdf.
179 See Status of Prescription Drug Monitoring Programs (PDMPs), Alliance of States with Prescription Monitoring Programs (Oct. 17, 2012), http://web.archive.org/web/0131024072819/http://pmpalliance.org/pdf/pmp_status_map_2012.pdf (accessed by searching URL in Internet Archive index).
180 See Clark et al., supra note 5, at 14-15.
181 Id. at 16.
182 A PBM is a third-party administrator of prescription drug programs. It is responsible for paying and processing prescription drug claims. It also acts to improve patient outcomes by, among other activities, monitoring drug utilization; it also controls prescription drug costs for clients by developing and maintaining a drug formulary, contracting with pharmacies, and negotiating discounts and rebates with drug manufacturers.
183 Clark et al., supra note 5, at 16.
184 Id.
185 Id. at 15.
186 Id.
187 Id.
188 Id.
189 Id. at 27.
190 Id.
191 Nat’l Alliance for Model State Drug Laws, Compilation of State Prescription Monitoring Programs (2012) [hereinafter NAMSDL, Compilation], available at http://www.namsdl.org/library/2B06B87E-1372-636C-DD54EFC909A6AEE1/.
192 Id.
193 Id.
194 Clark et al., supra note 5, at 41.
195 John Woodrow Cox, Florida Drug Database Intended to Save Lives is Barely Used by Doctors, Tampa Bay Times (Oct. 6, 2012), http://www.tampabay.com/news/health/florida-drug-database-intended-to-save-lives-is-barely-used-by-doctors/1255062.
196 Clark et al., supra note 5, at 16.
197 The National Community Pharmacists Association echoed this concern in testimony given March 1, 2012 before a House Energy and Commerce subcommittee. Prescription Drug Diversion: Combating the Scourge: Hearing Before the Subcomm. on Commerce, Mfg. & Trade of the H. Comm. on Energy & Commerce, 112th Cong. 116 (2012) (statement of Joe Harmison, Pharmacist, Owner, DFW Prescriptions).
198 Clark et al., supra note 5, at 26.
199 Id. at 27.
200 For a map showing the operational status of PDMPs in the states, see NAMSDL, Compilation, supra note 191.
201 See Monitoring Prescriptions in Real Time Slashes Opioid Abuse, Psychiatric News (Oct. 15, 2012), http://alert.psychiatricnews.org/2012/10/monitoring-prescriptions-in-real-time.html.
202 Crady deGolian & Ann Kelly, Interstate Information Sharing: Prescription Drug Monitoring Programs, Council of State Gov’ts 1 (May 10, 2010), available at http://www.csg.org/policy/documents/CapitolResearch_PDM.pdf.
203 See Karen Blumenschein et al., supra note 175, at 24.
204 deGolian & Kelly, supra note 202, at 1.
205 Clark et al., supra note 5, at 50.
206 The NAMSDL is a section 501(c)(3) organization funded by Congressional appropriations and serves as a resource in developing model state drug laws. Interstate Sharing of Prescription Monitoring Database Information, NAMSDL (Oct. 17, 2011), http://www.namsdl.org/library/2BA908DC-1372-636C-DD0EDA3313BE8CF8/.
207 Id.
208 Michael Booth, Drug Registry Often Ignored Despite Growing Painkiller Abuse, DENVER POST (Oct. 17, 2012), http://www.denverpost.com/news/ci_21788638.
209 Clark et al., supra note 5, at 35-36.
210 Id. at 36.
211 See id. at 35-36.
212 Interstate Sharing of Prescription Monitoring Database Information, supra note 206.
213 See, e.g., Felisa Cardona, Lawmakers May Cancel State Database Used to Fight Prescription-drug Abuse, Denver Post (Mar. 7, 2011), http://www.denverpost.com/news/ci_17553082; Kathleen Haughney, Funding for Drug-abuse Database is in Doubt, SUN-SENTINEL (Sept. 30, 2012), http://articles.sun-sentinel.com/2012-09-30/news/fl-drug-database-in-trouble-20120930_1_drug-database-prescription-drug-abuse-florida-pdmp-foundation; Carol Ostrom, New Prescription Monitoring Draws Complaints, SEATTLE TIMES (Jan. 2, 2012), http://seattletimes.com/html/localnews/2017147316_prescriptions04m.html.
214 Nat’l Council for Prescription Drug Programs, Pharmacy: A Prescription for Improving the Healthcare System 9 (Oct. 2009), available at http://www.ncpdp.org/pdf/NCPDP_white_paper.pdf.
215 NCPDP History and Impact, Nat’l Council for Prescription Drug Programs, http://www.ncpdp.org/WP.aspx (last visited Nov. 29, 2013).
216 Nat’l Council for Prescription Drug Programs, supra note 214, at 10.
217 Id.
218 Id. at 9.
219 National Provider Identification Standard, CMS (2013), http://www.cms.gov/Regulations-and-Guidance/HIPAA-Administrative-Simplification/NationalProvIdentStand/index.html?redirect=/NationalProvIdentStand/.
220 See Found. of Res. & Educ., Report on the Use of Health Information Technology to Enhance and Expand Health Care Anti-Fraud Activities 6 (2005), available at http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_031699.pdf.
221 Press Release, Express Scripts, Express Scripts Unveils Comprehensive Fraud, Waste and Abuse Program for Workers’ Compensation Clients (Feb. 27, 2012), available at http://phx.corporate-ir.net/phoenix.zhtml?c=69641&p=irol-newsArticle&ID=1665762&highlight=.
222 Id.
223 Cash for Prescriptions Needs Attention, MetroNews (Oct. 4, 2012), http://wvmetronews.com/2012/10/04/cash-for-prescriptions-needs-attention/.
224 Id.