1

Drug Utilization for Immediate- and Modified

Release Opioids in the U.S.

Gianna C. Rigoni, Pharm.D., M.S.Epidemiologist

Division of Surveillance, Research & Communication Support

Office of Drug Safety, FDA

September 9, 2003

2

Drug Utilization Data Sources

• Outpatient Data– IMS Health, National Prescription

Audit Plus (NPA Plus)

– IMS Health, National Disease and Therapeutic Index (NDTI)

• Inpatient Data– Premier, Inc., Perspective Rx View

3

Outpatient Drug Utilization

4

National Prescription Audit

(NPA Plus)• Measures the “retail outflow” of prescriptions

from pharmacies to consumers • Includes: chain, independent, mass

merchandisers, food stores with pharmacies, mail-order*, and long-term care* pharmacies

• The number of dispensed prescriptions is obtained from a sample of approximately 22,000 pharmacies in the U.S. and is projected nationally

* Excluded from this analysis

5

Total Prescriptions Dispensed* Annually for Selected Opioids, 1998 - 2002

•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

0

20,000

40,000

60,000

80,000

100,000

120,000

1998 1999 2000 2001 2002Year

TR

x (0

00)

IMMEDIATE RELEASEOPIOIDS (Fentanyl,Hydrocodone,Hydromorphone, Morphine,Oxycodone) MODIFIED RELEASEOPIOIDS (Fentanyl,Morphine, Oxycodone)

METHADONE HCL

6

Total Prescriptions Dispensed*

Annually for Immediate-Release Opioids, 1998 - 2002

(WITH Hydrocodone & Oxycodone Combination Products)

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

90,000

100,000

1998 1999 2000 2001 2002

Year

TRx

(000

)

HYDROCODONE(Vicodin®, Lortab®, etc.)

OXYCODONE (Percocet®,Roxicodone®, etc.)MORPHINE (MSIR®, etc.)

HYDROMORPHONE(Dilaudid®, etc.)FENTANYL (Actiq)

•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

7

0

250

500

750

1,000

1,250

1,500

1,750

2,000

2,250

1998 1999 2000 2001 2002Year

TR

x (0

00)

OXYCODONE(Roxicodone®, etc.)

MORPHINE(MSIR®, etc.)

HYDROMORPHONE (Dilaudid®, etc.)

FENTANYL(Actiq®)

Total Prescriptions Dispensed* Annually for Selected Immediate-

Release Opioids, 1998 - 2002(WITHOUT Hydrocodone & Oxycodone Combination Products)

•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

8

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

1998 1999 2000 2001 2002

Year

TR

x (0

00)

OXYCODONE (OxyContin®)

FENTANYL (Duragesic®)

MORPHINE (MS Contin®,Kadian®, Oramorph SR®, Avinza®)METHADONE (Dolophine®, etc.)

•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

Total Prescriptions Dispensed*

Annually for Modified-Release Opioids & Methadone, 1998 - 2002

9

Top MD Specialties*

Prescribing Immediate-Release Opioids, 1998 vs. 2002

(WITH Hydrocodone & Oxycodone Combination Products)

MD Specialty % Prescription

sFAMILY PRACTICE 14.6%

DENTISTRY 12.2%

INTERNAL MEDICINE 12.2%

ORTHOPEDIC SURGERY 10.2%

OSTEOPATHIC MEDICINE

7.8%

EMERGENCY MEDICINE 6.1%

GENERAL SURGERY 3.6%

OBSTETRICS/GYNECOLOGY

3.2%

ALL OTHERS 30.2%

1998

2002

MD Specialty % Prescription

sDENTISTRY 15.5%

FAMILY PRACTICE 13.0%

ORTHOPEDIC SURGERY 11.5%

INTERNAL MEDICINE 11.1%

OSTEOPATHIC MEDICINE

6.7%

EMERGENCY MEDICINE 5.5%

GENERAL SURGERY 4.2%

OBSTETRICS/GYNECOLOGY

3.5%

ALL OTHERS 28.9%

•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

10

Top MD Specialties*

Prescribing Selected Immediate-Release Opioids, 1998

vs. 2002(WITHOUT Hydrocodone & Oxycodone Combination Products)

1998

2002

MD Specialty % Prescription

sHEM/ONC/NEOPLASTIC 23.4%

INTERNAL MEDICINE 17.9%

FAMILY PRACTICE 12.6%

ANESTHESIOLOGY 7.9%

OSTEOPATHIC MEDICINE

6.5%

ORTHOPEDIC SURGERY 2.6%

NEUROLOGY 2.1%

PHYSICAL MED & REHAB 2.0%

ALL OTHERS 24.8%

MD Specialty % Prescription

sINTERNAL MEDICINE 15.2%

ANESTHESIOLOGY 14.6%

FAMILY PRACTICE 13.1%

HEM/ONC/NEOPLASTIC 10.8%

OSTEOPATHIC MEDICINE

8.9%

PHYSICAL MED & REHAB

5.4%

ORTHOPEDIC SURGERY 3.5%

NEUROLOGY 2.6%

ALL OTHERS 25.9%

•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

11

Top MD Specialties*

Prescribing Modified-Release Opioids & Methadone, 1998 vs. 2002

MD Specialty % Prescription

sFAMILY PRACTICE 17.1%

INTERNAL MEDICINE 16.7%

ANESTHESIOLOGY 16.4%

OSTEOPATHIC MEDICINE 10.3%

PHYSICAL MEDICINE & REHAB

6.3%

HEM/ONC/NEOPLASTIC 6.2%

ALL OTHERS 27.1%

1998

2002

MD Specialty % Prescription

sINTERNAL MEDICINE 17.5%

ANESTHESIOLOGY 14.5%

FAMILY PRACTICE 13.9%

HEM/ONC/NEOPLASTIC 13.9%

OSTEOPATHIC MEDICINE 8.4%

PHYSICAL MEDICINE & REHAB

3.4%

ALL OTHERS 28.2%

•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

12

National Disease andTherapeutic Index

(NDTI)

• Collects data on drug products and indications mentioned during office-based physician visits

• Provides descriptive information on profiles and trends of diagnoses, patients, and treatment patterns occurring in office-based practice

• Data are gathered from a panel of 2,000-3,000 office-based physicians in the U.S. and projected nationally

13

Indications* Associated with Immediate-Release Opioids,

1998 vs. 2002 (WITH Hydrocodone & Oxycodone Combination Products)

* Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

11,033

13,712

9,408

12,883

7,216

10,388

1,248 1,176

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

P-D

rug

Use

s (0

00)

Other Pain Surgical Procedures Musculoskeletal Pain Neoplasms

Diagnoses

1998

2002

Surgical Procedures include post-op examsMusculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.Other Pain includes migraine, headache, calculi, fractures, dental pain, complications of pregnancy, etc.

14

Indications* Associated with Selected Immediate-Release

Opioids, 1998 vs. 2002 (WITHOUT Hydrocodone & Oxycodone Combination Products)

213

279

397

202

340

169

359

84

0

50

100

150

200

250

300

350

400

450

P-D

rug

Use

s (0

00)

Neoplasms Other Pain MusculoskeletalPain

Surgical Procedures

Diagnoses

1998

2002

* Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

Surgical Procedures include post-op examsMusculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.Other Pain includes migraine, headache, calculi, fractures, dental pain, complications of pregnancy, etc.

15

Indications* Associated with Modified-Release Opioids &

Methadone, 1998 vs. 2002

504

2,092

651

1,174

794

944

139

386

0

250

500

750

1,000

1,250

1,500

1,750

2,000

2,250

P-D

rug

Use

s (0

00)

MusculoskeletalPain

Other Pain Neoplasms Surgical Procedures

Diagnoses

1998

2002

* Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.

Surgical Procedures include post-op examsMusculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.Other Pain includes migraine, headache, calculi, fractures, dental pain, complications of pregnancy, etc.

16

Inpatient Drug Utilization

17

Premier Perspective Rx View

• Information on inpatient use of drugs from approximately 400 acute, short-stay, non-federal hospitals belonging to Premier GPO

• Includes demographic and pharmacy billing information, as well as diagnoses and procedures for every discharge from 2000 - 2002 – No linkages between procedures and drugs– We can only identify if a billing for a drug and a

procedure occurred on the same day

• Patients with a discharge diagnosis associated with any type of cancer were excluded from this analysis

18

% of All Surgical Procedures* Associated with a Modified-Release Opioid Billed the Day of or

Day After Surgery

50%

34%

12%

4%

48%

39%

9%

4%

47%

37%

11%

5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

% o

f Su

rgic

al P

roce

dure

s

2000 2001 2002

Year

Morphine

Fentanyl

Oxycodone

No Modified-Release Opioid

* Source: Premier, Inc., Perspective Rx ViewTM, Excludes Discharge Diagnoses of Neoplasms, Extracted August 2003.

N = 39,896 Surgeries N = 59,966 SurgeriesN = 62,516 Surgeries

19

% of the Top 3 Surgical Procedures* Associated with a Modified-Release Opioid Billed the Day of

or Day After Surgery

58%

42%

36%

62%

49%

35%

64%

50%

35%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

% o

f Sur

gica

l Pro

cedu

res

2000 2001 2002

Year

MusculoskeletalOperations

GenitourinaryOperations

DigestiveOperations

* Source: Premier, Inc., Perspective Rx ViewTM, Excludes Discharge Diagnoses of Neoplasms, Extracted August 2003.

N = 277 Hospitals N = 402 HospitalsN = 406 Hospitals

20

Limitations• Outpatient Drug Use Data

– Data on dispensed prescriptions include prescriptions filled in the retail pharmacy setting only

• Mail order pharmacy, long-term care & methadone maintenance clinics are not included

– Data on indications for opiate use reflect office-based physicians’ prescribing based on a small sample of physicians

• Inpatient Drug Use Data– Billing of medications/procedures as proxy

for actual clinical care may be imprecise– Represents only patients admitted in to the

hospital that have a surgical procedure

21

Conclusions• Use of opioids appears to be increasing in

outpatient settings and is widespread in inpatient settings

• Primary care providers continue to be the leading prescribers of opioids in the outpatient setting

• Indications for the outpatient use of opioids– Immediate-release opioids (WITHOUT hydrocodone & oxycodone

combination products)

• Other Pain Cancer-Related Pain– Modified-release opioids

• Cancer-Related Pain Musculoskeletal Pain

• Post-operative indications for the inpatient use of opioids – Apparent substantial use of modified-release opioids for

post-op musculoskeletal procedures• Modified-release oxycodone constitutes most of this use