The Latest Prescription Trends for Controlled Prescription Drugs

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The Latest Prescription Trends for Controlled Prescription Drugs September 1, 2015 Christopher M. Jones PharmD, MPH Senior Advisor Office of Public Health Strategy and Analysis Office of the Commissioner Food and Drug Administration

Overview Data source Opioid analgesics Benzodiazepines Stimulants Opioid use disorder medication assisted treatments Conclusions 2

Data Source Data from IMS Health National Prescription Audit National Prescription Audit Extended Insights 3

OPIOID ANALGESICS 4

Opioid analgesic prescriptions dispensed from US retail pharmacies, Q42009-Q22015 70,000,000 ER/LA Opioid Analgesics All Opioid Analgesics 60,000,000 Number of Dispensed Prescriptions 50,000,000 40,000,000 30,000,000 20,000,000 10,000,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2009 2010 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2012 2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 5 Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015

Opioid analgesic prescriptions dispensed from US retail pharmacies for select opioids, Q42009-Q22015 % of All Opioids hydrocodone oxycodone tramadol morphine fentanyl Dispensed in Q2-2015 35,000,000 30,000,000 Number of Prescriptions Dispensed 25,000,000 20,000,000 15,000,000 10,000,000 40.8% 24.6% 17.8 5,000,000 2.2% 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 6 2009 2010 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2012 2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015 3.7%

Opioid analgesic prescriptions dispensed from US retail pharmacies by provider specialty, 2010-2014 2010 2011 2012 2013 2014 Number of Prescriptions Dispensed 120,000,000 100,000,000 80,000,000 60,000,000 40,000,000 20,000,000 0 7 Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015

Percent 50 45 40 35 30 25 20 15 10 5 0 Percentage of opioid analgesic prescriptions dispensed from US retail pharmacies by specialty, 2010 vs 2014 2010 2014 8 Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015

Opioid analgesic prescriptions dispensed from US retail pharmacies by gender, August 2014-July 2015 Male 41.3% Female 58.7% 9 Source: IMS Health National Prescription Audit Extended Insights Data Extracted 8/24/2015

Opioid analgesic prescriptions dispensed from US retail pharmacies by age group, August 2014-July 2015 Age 60+ 34.6% Ages 0-19 2.8% Ages 20-39 20.8% Source: IMS Health National Prescription Audit Extended Insights Data Extracted 8/24/2015 Ages 40-59 41.8% 10

BENZODIAZEPINES 11

Benzodiazepine prescriptions dispensed from US retail pharmacies, Q42009-Q22015 25,000,000 Alprazolam Lorazepam Diazepam All Benzodiazepines Number of dispensed prescriptions 20,000,000 15,000,000 10,000,000 5,000,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2009 2010 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2012 2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 12 Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015

Benzodiazepine prescriptions dispensed from US retail pharmacies by provider specialty, 2010-2014 60,000,000 2010 2011 2012 2013 2014 Number of dispensed prescriptions 50,000,000 40,000,000 30,000,000 20,000,000 10,000,000 0 Primary Care Physicians Nurse Practitioners/Physician Psychiatrist/Psychologists Other Assistants Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015 13

Percentage of benzodiazepine prescriptions dispensed from US retail pharmacies by specialty, 2010 vs 2014 70 2010 2014 60 50 Percent 40 30 20 10 0 Primary Care Physicians Nurse Practitioners/Physician Psychiatrist/Psychologists Other Assistants 14 Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015

Benzodiazepine prescriptions dispensed from US retail pharmacies by gender, August 2014-July 2015 Male 33.1% Female 66.9% 15 Source: IMS Health National Prescription Audit Extended Insights Data Extracted 8/24/2015

Benzodiazepine prescriptions dispensed from US retail pharmacies by age group, August 2014-July 2015 Age 60+ 38.2% Ages 0-19 1.8% Ages 20-39 18.7% Source: IMS Health National Prescription Audit Extended Insights Data Extracted 8/24/2015 Ages 40-59 41.4% 16

STIMULANTS 17

Stimulant* prescriptions dispensed from US retail pharmacies, Q42009-Q22015 16,000,000 Amph/Dextroamph Methylphenidate All Stimulants * Number of dispensed prescriptions 14,000,000 12,000,000 10,000,000 8,000,000 6,000,000 4,000,000 2,000,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2009 2010 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2012 2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 * includes: amphetamine, amphetamine-dextroamphetamine, dextroamphetamine,, dexmethylphenidate, lisdexamfetamine, methamphetamine, methylphenidate, pemoline Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015 18

Number of dispensed prescriptions Stimulant* prescriptions dispensed from US retail pharmacies by provider specialty, 2010-2014 20,000,000 18,000,000 16,000,000 14,000,000 12,000,000 10,000,000 8,000,000 2010 2011 2012 2013 2014 6,000,000 4,000,000 2,000,000 0 Primary Care Physicians Nurse Psychiatrist/Psychologists Pediatrics Other Practitioners/Physician Assistants 19 * includes: amphetamine, amphetamine-dextroamphetamine, dextroamphetamine,, dexmethylphenidate, lisdexamfetamine, methamphetamine, methylphenidate, pemoline Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015

35 Percentage of stimulant* prescriptions dispensed from US retail pharmacies by specialty, 2010 vs 2014 2010 2014 30 25 20 Percent 15 10 5 0 Primary Care Physicians Nurse Psychiatrist/Psychologists Pediatrics Other Practitioners/Physician Assistants * includes: amphetamine, amphetamine-dextroamphetamine, dextroamphetamine,, dexmethylphenidate, lisdexamfetamine, methamphetamine, methylphenidate, pemoline Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015 20

Stimulant* prescriptions dispensed from US retail pharmacies by gender, August 2014-July 2015 Female 44.8% Male 55.2% *includes: amphetamine, amphetamine-dextroamphetamine, dextroamphetamine,, dexmethylphenidate, lisdexamfetamine, methamphetamine, methylphenidate, Pemoline, modafinil, armodafinil, caffeine, Source: IMS Health National Prescription Audit Extended Insights Data Extracted 8/24/2015 21

Ages 40-59 18.2% Stimulant* prescriptions dispensed from US retail pharmacies by age group, August 2014-July 2015 Age 60+ 4.6% Ages 0-19 45.3% Ages 20-39 31.9% *includes: amphetamine, amphetamine-dextroamphetamine, dextroamphetamine,, dexmethylphenidate, lisdexamfetamine, methamphetamine, methylphenidate, Pemoline, modafinil, armodafinil, caffeine, Source: IMS Health National Prescription Audit Extended Insights Data Extracted 8/24/2015 22

OPIOID USE DISORDER MEDICATION ASSISTED TREATMENTS 23

Buprenorphine* prescriptions dispensed from US retail pharmacies, Q42009-Q22015 3,000,000 All Buprenorphine Suboxone & generics Subutex & generics Zubsolv Bunavail Number of dispensed prescriptions 2,500,000 2,000,000 1,500,000 1,000,000 500,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2009 2010 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2012 2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 24 *Does not include Butrans or Buprenex (or generics) Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015

Percentage of buprenorphine* prescriptions dispensed from US retail pharmacies by specialty, 2010 vs 2014 60.0 2010 2014 50.0 40.0 Percent 30.0 20.0 10.0 0.0 Primary Care Physicians Addiction Medicine/Psychiatry/Psychology Other *Does not include Butrans or Buprenex (or generics) Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015 25

Naltrexone* prescriptions dispensed from US retail + pharmacies, Q42009-Q22015 160,000 Vivitrol All Naltrexone 140,000 Number of dispensed prescriptions 120,000 100,000 80,000 60,000 40,000 20,000 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2009 2010 2010 2010 2010 2011 2011 2011 2011 2012 2012 2012 2012 2013 2013 2013 2013 2014 2014 2014 2014 2015 2015 * Naltrexone is also approved for use in alcohol dependence. Thus, not all prescriptions were used for opioid dependence +The number of prescriptions dispensed for Vivitrol from specialty pharmacies is approximately 3-4x that from US retail pharmacies. Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015 26

Percentage of naltrexone* prescriptions dispensed from US retail pharmacies + by specialty, 2010 vs 2014 60 2010 2014 50 40 Percent 30 20 10 0 Primary Care Physicians Nurse Practitioners/Physician Addiction Other Assistants Medicine/Psychiatry/Psychology * Naltrexone is also approved for use in alcohol dependence. Thus, not all prescriptions were used for opioid dependence +The number of prescriptions dispensed for Vivitrol from specialty pharmacies is approximately 3-4x that from US retail pharmacies. Source: IMS Health National Prescription Audit, Data Extracted 8/24/2015 27

Conclusions The number of prescriptions dispensed for opioid analgesics has declined in recent years The number of prescriptions dispensed for benzodiazepines has been relatively consistent The number of prescriptions dispensed for stimulants has increased in recent years The number of prescriptions dispensed for both naltrexone and buprenorphine has increased in recent years There is variation in prescribing by provider specialty and patient gender and age across the examined drug classes 28

Questions? Christopher.M.Jones@fda.hhs.gov The findings in this presentation do not represent the official position of the US Food and Drug Administration, the Department of Health and Human Services, or the U.S. Government 29