Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration

Twelve Year Prescribing Trends for Fifteen Different Opioid, Benzodiazepine, Amphetamine, and Barbiturate Prescription Drugs Correlated with Reports of Prescription Medication Abuse and Diversion 1

Twelve Year Prescribing Trends for Fifteen Different Opioid, Benzodiazepine, Amphetamine, and Barbiturate Prescription Drugs Correlated with Reports of Prescription Medication Abuse and Diversion Sean J. Belouin, Pharm.D. Commander, United States Public Health Service Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration Janine Denis Cook, Ph.D. Clinical Chemist Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration 2

Disclosure The presenters DO NOT have an interest in selling a technology, program, product, and/or service to CME/CE professionals. CDR Sean Belouin and Dr. Janine Cook have nothing to disclose with regard to commercial relationships. The content of this presentation does not relate to any product of a commercial interest. Therefore, there are no relevant financial relationships to disclose. 3

SAMHSA s Direction Mission: : To reduce the impact of substance abuse and mental illness on America s communities. 8 Strategic Initiatives Prevention of Substance Abuse and Mental Illness Trauma and Justice Military Families Active, Guard, Reserve, and Veteran Health Reform Housing and Homelessness Health Information Technology for Behavioral Health Providers Data, Quality, and Outcomes Demonstrating Results Public Education and Support 4

Learning Objectives Summarize the changes in physician prescribing practices, both in the number of prescriptions written and the number of extended units dispensed, over the previous 12 years. Correlate the 12-year historical prescription drug trending data with prescription drug abuse databases. Correlate the 12-year historical prescription drug trending data with the prescription drug diversion databases. Compare and contrast the age and gender of the intended prescription recipients with those who are abusing and diverting prescription medications. 5

Prescription Drugs Analyzed Prescription Drug Data: 1998-2009 Prescription Drug Data: 1998 Prescription Drugs Prescription Drugs Oxycodone, hydrocodone, methadone, Fentanyl, codeine, propoxyphene, alprazolam, lorazepam, diazepam, clonazepam, temazepam, amphetamine, methamphetamine, butalbital, and temazepam, amphetamine, methamphetamine, butalbital, and phenobarbital. Combined Brand/Generic Drug Data Example: Percocet, Oxycontin, Endocet, Percodan, Tylox, Example: Percocet, Oxycontin, Endocet, Percodan, Tylox, Oxy-IR, and Oxy-Fast are several brand names containing oxycodone in addition to firms manufacturing generic oxycodone. 6

Sales Data Why it is not used in this analysis Drug Name Retail Cost for Hydrocodone / APAP 5 mg/500 mg #100 Tablets - CVS Pharmacy $59.59 ~ $ 0.60 per tablet Alprazolam 1 mg $38.39 ~ $ 0.38 per tablet Lorazepam 1 mg $66.59 ~ $ 0.67 per tablet Lipitor 20 mg $485.99 ~ $ 4.86 per tablet Retail Cost for #100 Tablets - Giant Pharmacy $27.99 ~ $ 0.28 per tablet $25.99 ~ $ 0.26 per tablet $46.99 ~ $ 0.47 per tablet $425.99 ~ $ 4.26 per tablet Retail Cost for #100 Tablets - Walmart Pharmacy $19.62 ~ $ 0.20 per tablet $19.62 ~ $ 0.20 per tablet $29.36 ~ $ 0.29 per tablet $410.36 ~ $ 4.10 per tablet Retail cost acquired from: CVS Pharmacy; Giant Pharmacy; Walmart Pharmacy; Germantown, MD: 8/23/2008. Retail cost acquired from: CVS Pharmacy; Giant Pharmacy; Walmart Pharmacy; Germantown, MD: Lipitor ranked #3 in terms of prescription drug volume in 2007 with 55.1 million prescriptions. SDI Vector One : Year 2007, Extracted 8/25/2008. Lipitor ranked #1 in terms of manufacturer drug sales in 2007 with 8.1 billion in sales. http://www.pharmacytimes.com/issues/articles/2008-05_003.asp 05_003.asp (courtesy of IMS Health) Lipitor ranked #1 in terms of manufacturer drug sales in 2007 with 8.1 billion in sales. Lipitor ranked #1 in terms of manufacture drug sales in 2009 with 5.36 billion in sales (IMS Health) 7

Analysis Breakdown Drug strength Example: hydrocodone: 2.5 mg, 3.5 mg, 4.5 mg, 5 mg, Example: hydrocodone: 2.5 mg, 3.5 mg, 4.5 mg, 5 mg, 7 mg, 7.5 mg, 10 mg Total number of prescriptions For each drug Each year: 1998 Each year: 1998-2009 Demographics for prescribing Men Women Age ranges using 10 year intervals Total volume of drug dispensed For each drug (tablets, capsules, patches, ml, etc., referred to as extended units ) Each year: 1998-2009 8

Surveillance Data, Inc. (SDI) Vector One National (VONA) SDI Vector One Measures dispensing of prescriptions Information on physician specialty, patient s age and gender, and estimates for numbers of patients continuing or beginning new therapy. Integrates prescription activity from a variety of sources Retail chains, mass merchandisers, mail order pharmacies, pharmacy benefit Retail chains, mass merchandisers, mail order pharmacies, pharmacy benefit managers, provider groups. Receives over 2 billion prescription claims a year, representing over 160 million unique patients. Prescriptions captured from a sample of 59,000 pharmacies through out U.S. Pharmacies in data base account for nearly all retail pharmacies and represent nearly half of retail prescriptions dispensed nationwide. Receives all prescriptions from ~ 1/3 of stores and significant sample of prescriptions from remaining stores. 9

IMS National Sales Perspectives: Retail and Non-Retail IMS National Sales Perspectives Measures prescription drug sales data and market share Data based on national sales projections and outlets within retail and non-retail markets Retail market Chain drug stores Independent drug stores Mass merchandisers Food stores Mail service Non-retail market Clinics Non-federal hospitals Federal facilities HMOs Long-term care facilities Home health care Other miscellaneous settings 10

Channels of Distribution for Selected Prescription Drugs Sales data for oxycodone, hydrocodone, methadone, codeine, propoxyphene, alprazolam, lorazepam, diazepam, clonazepam, temazepam, amphetamine, methamphetamine, butalbital, and phenobarbital by number of tablets, capsules, and mls sold in year 2009 indicate that the majority of distribution is toward outpatient pharmacy settings* (73% or greater). The only exception is with Fentanyl in which 20% of distribution is toward outpatient pharmacy settings while 79% is toward inpatient settings. *Outpatient pharmacy settings: chain, independent, food stores with pharmacies, and mail order pharmacies. Mail order distribution accounted for approximately less then 9% for all of the manufacturers of selected prescriptions drugs. Mail order data are not included in this analysis. Source: IMS Health, IMS National Sales Perspectives. Years 2007 and 2009. Data Extracted September 30, 2010 11

Typical Stock Bottles in Retail Pharmacy CVS Pharmacy Hydrocodone 5 mg/apap 500 mg: 500 Hydrocodone 5 mg/apap 500 mg: 500 count Alprazolam 1 mg: 500 count Lorazepam 1 mg: 1000 count Giant Pharmacy Hydrocodone 5 mg/apap 500 mg: 500 Hydrocodone 5 mg/apap 500 mg: 500 count Alprazolam 0.25 mg & 0.5 mg: 500 count Lorazepam 1 mg: 500 count Walmart Pharmacy Hydrocodone 5 mg/apap 500 mg: 500 count Lorazepam 1 mg: 500 count Stock bottle inventory information acquired from: CVS Pharmacy; Giant Pharmacy; Walmart Pharmacy; Germantown, MD 12

Total Number of Dispensed Prescriptions for CODEINE and PROPOXYPHENE Containing Products Through U.S. Outpatient Retail Pharmacies, 1998-2009 35 30 Codeine Products Propoxyphene Products Propoxyphene 18,298,253-30,698,847 = -12,400,594 25 Codeine 19,296,817-31,674,324 = -12,377,507 20 15 10 39% decrease for Codeine from 1998-2009 40% decrease for Propoxyphene from 1998-2009 5 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year SDI Vector One : National (VONA). Extracted 2/2010 13 Total Prescriptions (Millions)

Total Number of Dispensed Prescriptions for Selected Agents Through U.S. Outpatient Retail Pharmacies, 1998-2009 25 20 Clonazepam 23,336,174-9,523,534 = 13,812,640 Lorazepam 22,634,097-17,148,786 = 5,485,311 Amphetamine 15,944,538-2,520,372 = 13,424,166 Diazepam 14,363,330-11,900,881 = 2,462,449 Temazepam 9,084,187-6,239,176 = 2,845,011 Fentanyl 5,295,576-1,089,424 = 4,206,152 Methadone 4,417,871-467,666 = 3,950,205 Phenobarbital 2,628,129-3,654,444 = -1,026,315 Butalbital 233,979-624,214 = -390,235 Methamphetamine 16,188-54,465 = -38,277 15 10 Clonazepam Lorazepam Amphetamine Diazepam Temazepam Fentanyl Methadone Phenobarbital Butalbital Methamphetamine Total Prescriptions (Millions) 5 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year Dispensed prescriptions for methadone have increased by approximately 845% from 1998 to 2009. 533% increase for amphetamine, 386% increase for Fentanyl, 145% increase for clonazepam, 46% increase for temazepam, 32% for lorazepam, and 21% increase for diazepam. 70% decrease for methamphetamines, 63% decrease for butalbital, and 28% decrease for phenobarbital. SDI Vector One : National (VONA). Extracted 2/2010 14

Total Number of Dispensed Prescriptions for OXYCODONE Containing Products and ALPRAZOLAM Through U.S. Outpatient Retail Pharmacies, 1998-2009 60 50 40 30 20 Alprazolam 45,685,484-24,755,600 = 20,929,884 Oxycodone 49,528,578-15,873,926 = 33,654,652 212% increase for Oxycodone from 1998-2009 10 84.6% increase for Alprazolam from 1998-2009 Alprazolam Oxycodone Products 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year Oxycodone prescriptions increased by 212% from 1998 to 2009 and alprazolam increased by 85% in the same period. SDI Vector One : National (VONA). Extracted 2/2010 15 Total Prescriptions (Millions)

Total Number of Dispensed Prescriptions for HYDROCODONE Containing Products Through U.S. Outpatient Retail Pharmacies, 1998-2009 140 101% increase from 1998-2009 120 127,800,081-63,633,476 = 64,166,605 100 80 60 40 20 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year 101% increase in prescriptions of hydrocodone being dispensed from 1998 to 2009. SDI Vector One : National (VONA). Extracted 2/2010 16 Total Prescriptions (Millions)

Total Number of Dispensed Presciptions for Various Agents Through U.S. Outpatient Retail Pharmacies, 1998-2009 140 120 100 80 60 40 Hydrocodone Products Oxycodone Products Alprazolam Clonazepam Lorazepam Codeine Products Propoxyphene Products Amphetamine Diazepam Temazepam Fentanyl Methadone Phenobarbital Butalbital Methamphetamine Total Prescriptions (Millions) 20 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year Of the selected agents, products containing hydrocodone were the top dispensed in the U.S. from 1998-2009. Dispensed prescriptions for methadone have increased by approximately 845% followed by amphetamine, Fentanyl, oxycodone, clonazepam, and hydrocodone at 533%, 386%, 212%, 145%, and 101%, respectively from 1998 to 2009. SDI Vector One : National (VONA). Extracted 2/2010 17

Age and Gender of the Intended Prescription Recipients for 2009 Prescription Drug Majority Age Range (years) Ratio Female : Males Alprazolam 51-60 (both) 2.1 Amphetamine 21-30 (females) 11-20 (males) 0.9 Butalbital 41-50 (females) 51-60 (males) 3.8 Clonazepam 51-60 (both) 1.8 Codeine 51-60 (both) 1.7 Diazepam 51-60 (both) 1.5 Fentanyl 71+ ( females) 51-60 (males) 1.9 Hydrocodone 51-60 (both) 1.4 Lorazepam 71+ (females) 51-60 (males) 2.3 Methadone 51-60 (both) 1.0 Methamphetamine 51-60 (both) 0.8 Oxycodone 41-50 (females) 51-60 (males) 1.1 Phenobarbital 0-10 (both) 1.0 Propoxyphene 61-70 (females) 71+ (males) 2.5 Temazepam 71+ (both) 1.7 18

Total Number of Extended Units (Tablets, Capsules) Dispensed for CODEINE and PROPOXYPHENE Containing Products Through U.S. Outpatient Retail Pharmacies, 1998-2009 2.5 Codeine Products Propoxyphene Products 2.0 Codeine 1,886,520,667-1,949,506,116 = -62,985,449 1.5 Propoxyphene 1,053,673,794-1,151,293,641 = -309,471,061 1.0 3% decrease for Codeine from 1998-2009 0.5 22.7% decrease for Propoxyphene from 1998-2009 0.0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year SDI Vector One : National (VONA). Extracted 2/2010 19 Number of Extended Units (Billions)

Total Number of Extended Units (Tablets, Capsules) Dispensed for Selected Agents Through U.S. Outpatient Retail Pharmacies, 1998-2009 1,600 1,400 1,200 1,000 800 600 400 Clonazepam 1,378,286,065-536,253,144 = 842,032,921 Lorazepam 1,230,362,331-882,526,240 = 347,836,091 Amphetamine 773,054,881-144,579,107 = 628,475,774 Diazepam 722,501,967-587,456,074 = 135,045,893 Temazepam 306,249,958-198,206,971 = 108,042,987 Fentanyl 78,803,304-9,270,472 = 69,532,832 Methadone 744,414,415-56,523,481 = 687,890,934 Phenobarbital 302,265,856-424,943,500 = -122,677,644 Butalbital 10,931,150-24,346,844 = -13,415,694 Methamphetamine 2,939,389-4,558,479 = -1,619,090 Clonazepam Lorazepam Amphetamine Diazepam Temazepam Fentanyl Methadone Phenobarbital Butalbital Methamphetamine Number of Extended Units (Millions) 200 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year Number of extended units being dispensed for methadone has increased by approximately 1217% from 1998 to 2009. 750% increase for Fentanyl, 435% increase for amphetamines, 157% increase for clonazepam, 55% increase for temazepam, 39% increase for lorazepam, and 23% increase for diazepam. 55% decrease for butalbital, 36% decrease for methamphetamine, and 29% decrease for phenobarbital. SDI Vector One : National (VONA). Extracted 2/2010 20

Total Number of Extended Units (Tablets, Capsules) Dispensed for OXYCODONE Products and ALPRAZOLAM Through U.S. Outapient Retail Pharmacies, 1998-2009 4.5 4.0 Oxycodone Products Alprazolam 3.5 Alprazolam 2,852,814,635-1,386,860,472 = 1,465,954,163 3.0 Oxycodone 3,880,950,427-724,526,625 = 3,156,423,502 2.5 2.0 1.5 1.0 436% increase for Oxycodone from 1998-2009 106% increase for Alprazolam from 1998-2009 0.5 0.0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year SDI Vector One : National (VONA). Extracted 2/2010 21 Number of Extended Units (Billions)

Total Number of Dispensed Prescriptions for HYDROCODONE Containing Products Through U.S. Outpatient Retail Pharmacies, 1998-2009 140 101% increase from 1998-2009 120 127,800,081-63,633,476 = 64,166,605 100 80 60 40 20 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year 101% increase in prescriptions of hydrocodone being dispensed from 1998 to 2009. SDI Vector One : National (VONA). Extracted 2/2010 22 Total Prescriptions (Millions)

Total Number of Extended Units (Tablets, Capsules) Dispensed for HYDROCODONE Containing Products Through U.S. Outpatient Retail Pharmacies, 1998-2009 9 214% increase from 1998-2009 8 8,409,041,900-2,673,924,174 = 5,735,117,726 7 6 5 4 3 2 Number of Extended Units (Billions) 1 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year 214% increase in number of extended units of hydrocodone being dispensed from 1998 to 2009. SDI Vector One : National (VONA). Extracted 2/2010 23

Rank of Selected Prescription Drugs in Market based on Prescription Volume for Year 2009 Drug Rank Hydrocodone w/ APAP 1 Lisinopril 2 Simvistatin 3 Alprazolam 9 Oxycodone w/ APAP 19 Clonazepam 31 Lorazepam 33 Propoxyphene/APAP 46 Diazepam 56 Temazepam 91 Amphetamine Salt Combo 115 Codeine w/ promethazine 144 Fentanyl Transdermal 169 Methadone 175 Butalbital/APAP/Caffeine 180 Phenobarbital 257 Methamphetamine not listed Source: SDI Vector One : National. Extracted 2/25/10. File: VONA 2010-24 Top Drugs Dispensed 2-25-10.xls Hydrocodone/APAP is the number one dispensed prescription drug out of 7829 based on prescription volume for year 2008. In year 2009, over 120 million prescriptions were dispensed for hydrocodone/apap followed by lisinopril with 74.5 million and 73 million for simvistatin. 24

Total Number of Extended Units (Tablets and Capsules) Dispensed for Various Agents Through U.S. Outpatient Retail Pharmacies, 1998-2009 9 8 7 6 5 4 3 2 Hydrocodone Products Oxycodone Products Alprazolam Clonazepam Lorazepam Codeine Products Propoxyphene Products Amphetamine Diazepam Temazepam Fentanyl Methadone Phenobarbital Butalbital Methamphetamine Number of Extended Units (Billions) 1 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year Hydrocodone products are the most commonly dispensed in terms of extended units. Dispensed extended units of hydrocodone products, oxycodone products, and alprazolam have gradually increased over the past 12 years. SDI Vector One : National (VONA). Extracted 2/2010 25

Janine Denis Cook, Ph.D. Clinical Chemist Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration 26

Sean J. Belouin, Pharm.D. Commander, United States Public Health Service Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Prevention, Substance Abuse and Mental Health Services Administration Janine Denis Cook, Ph.D. Clinical Chemist Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Prevention, Substance Abuse and Mental Health Services Administration Hina Mehta, Pharm.D. Drug Use Data Analyst Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration 27