Methadone Use by yurtgc548

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									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

                                                               1
   Drug Utilization Data Sources
• Outpatient Data
   – IMS Health, National Prescription Audit PlusÔ
     (NPA PlusÔ)
   – IMS Health, National Disease and Therapeutic
     IndexÔ (NDTIÔ)
• Inpatient Data
   – Premier, Inc., Perspective Rx ViewÔ


                                                     2
Outpatient Drug Utilization




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              National Prescription Audit
                                         Ô
                                (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

                                                             4
* Excluded from this analysis
                                                                                                                                     *
       Total Prescriptions Dispensed
     Annually for Selected Opioids, 1998 - 2002




                                                                                                                                              5
•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 Immediate-Release Opioids, 1998 - 2002
                                         (WITH Hydrocodone & Oxycodone Combination Products)




                                                                                                                                              6
•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
   Selected Immediate-Release Opioids, 1998 - 2002
                                     (WITHOUT Hydrocodone & Oxycodone Combination Products)




                                                                                                                                              7
•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




                                                                                                                                              8
•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.
                                                                                           *
         Top MD Specialties Prescribing
        Immediate-Release Opioids, 1998 vs. 2002
                                        (WITH Hydrocodone & Oxycodone Combination Products)



                               1998                                                                            2002
             MD Specialty                      % Prescriptions                              MD Specialty                     % Prescriptions
   DENTISTRY                                           15.5%                       FAMILY PRACTICE                                    14.6%
   FAMILY PRACTICE                                     13.0%                       DENTISTRY                                          12.2%
   ORTHOPEDIC SURGERY                                  11.5%                       INTERNAL MEDICINE                                  12.2%
   INTERNAL MEDICINE                                   11.1%                       ORTHOPEDIC SURGERY                                 10.2%
   OSTEOPATHIC MEDICINE                                 6.7%                       OSTEOPATHIC MEDICINE                               7.8%
   EMERGENCY MEDICINE                                   5.5%                       EMERGENCY MEDICINE                                 6.1%
   GENERAL SURGERY                                      4.2%                       GENERAL SURGERY                                    3.6%
   OBSTETRICS/GYNECOLOGY                                3.5%                       OBSTETRICS/GYNECOLOGY                              3.2%
   ALL OTHERS                                          28.9%                       ALL OTHERS                                         30.2%




                                                                                                                                              9
•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.
                                                                          *
Top MD Specialties Prescribing Selected
  Immediate-Release Opioids, 1998 vs. 2002
                                    (WITHOUT Hydrocodone & Oxycodone Combination Products)



                               1998                                                                            2002
             MD Specialty                      % Prescriptions                              MD Specialty                     % Prescriptions
   HEM/ONC/NEOPLASTIC                                  23.4%                       INTERNAL MEDICINE                                  15.2%
   INTERNAL MEDICINE                                   17.9%                       ANESTHESIOLOGY                                     14.6%
   FAMILY PRACTICE                                     12.6%                       FAMILY PRACTICE                                    13.1%
   ANESTHESIOLOGY                                       7.9%                       HEM/ONC/NEOPLASTIC                                 10.8%
   OSTEOPATHIC MEDICINE                                 6.5%                       OSTEOPATHIC MEDICINE                               8.9%
   ORTHOPEDIC SURGERY                                   2.6%                       PHYSICAL MED & REHAB                               5.4%
   NEUROLOGY                                            2.1%                       ORTHOPEDIC SURGERY                                 3.5%
   PHYSICAL MED & REHAB                                 2.0%                       NEUROLOGY                                          2.6%
   ALL OTHERS                                          24.8%                       ALL OTHERS                                         25.9%




                                                                                                                                              10
•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.
                                                                                           *
      Top MD Specialties Prescribing
   Modified-Release Opioids & Methadone,
                                                               1998 vs. 2002

                               1998                                                                            2002

              MD Specialty                       % Prescriptions                            MD Specialty                       % Prescriptions
   INTERNAL MEDICINE                                      17.5%                  FAMILY PRACTICE                                        17.1%
   ANESTHESIOLOGY                                         14.5%                  INTERNAL MEDICINE                                      16.7%
   FAMILY PRACTICE                                        13.9%                  ANESTHESIOLOGY                                         16.4%
   HEM/ONC/NEOPLASTIC                                     13.9%                  OSTEOPATHIC MEDICINE                                   10.3%
   OSTEOPATHIC MEDICINE                                   8.4%                   PHYSICAL MEDICINE & REHAB                              6.3%
   PHYSICAL MEDICINE & REHAB                              3.4%                   HEM/ONC/NEOPLASTIC                                     6.2%
   ALL OTHERS                                             28.2%                  ALL OTHERS                                             27.1%




                                                                                                                                             11
•Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.
          National Disease and
           Therapeutic Index
                     (NDTIÔ)
• 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

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                                                                                       *
           Indications Associated with
        Immediate-Release Opioids, 1998 vs. 2002
                                                     (WITH Hydrocodone & Oxycodone Combination Products)




  Surgical Procedures include post-op exams
  Musculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.
  Other Pain includes migraine, headache, calculi, fractures, dental pain, complications of pregnancy, etc.
                                                                                                                                                           13
* Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.
                                                                   *
                 Indications Associated with Selected
                 Immediate-Release Opioids, 1998 vs. 2002
                                                (WITHOUT Hydrocodone & Oxycodone Combination Products)




  Surgical Procedures include post-op exams
  Musculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.
  Other Pain includes migraine, headache, calculi, fractures, dental pain, complications of pregnancy, etc.
                                                                                                                                                           14
* Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.
                                                                *
            Indications Associated with Modified-
            Release Opioids & Methadone, 1998 vs. 2002




  Surgical Procedures include post-op exams
  Musculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.
  Other Pain includes migraine, headache, calculi, fractures, dental pain, complications of pregnancy, etc.
                                                                                                                                                           15
* Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1998 to 2002, Excluding Long-Term Care & Mail Order Channels, Data Extracted August 2003.
Inpatient Drug Utilization




                             16
                                                         Ô
   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
                                                               17
       % of All Surgical Procedures* Associated with a Modified-
        Release Opioid Billed the Day of or Day After Surgery




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


                                                                                                                    18
* Source: Premier, Inc., Perspective Rx ViewTM, Excludes Discharge Diagnoses of Neoplasms, Extracted August 2003.
  % of the Top 3 Surgical Procedures* Associated with a Modified
      -Release Opioid Billed the Day of or Day After Surgery




                                  N = 277 Hospitals           N = 406 Hospitals           N = 402 Hospitals




                                                                                                                    19
* Source: Premier, Inc., Perspective Rx ViewTM, Excludes Discharge Diagnoses of Neoplasms, Extracted August 2003.
                      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
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                         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


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