# Presentation: 450307

## Examining Patterns of Long-Acting Opioid Drug Use: Targeting Risk Management

- Gianna C. Rigoni, Pharm.D., M.S.
- Epidemiologist
- Division of Surveillance, Research & Communication Support
- Office of Drug Safety, CDER, FDA
- June 15, 2004

- * The views expressed are those of the presenter and not necessarily those of the FDA.

## The views expressed in this presentation are those of the presentor, and do not necessarily reflect the views of the Food and Drug Administration

## Background

- Risk management plans (RMPs) are being used to assist in the management of abuse and misuse of opioid analgesics
- Drug utilization patterns of existing opioid products can assist in understanding which physicians prescribe these products, as well as diagnoses these products are used to treat, in order to target risk management programs
- As new opioid analgesics enter clinical practice, it is necessary to examine the clinical environment in which they will enter

## Objectives

- Examine the use of long-acting opioids to understand the impact of current risk management strategies
- Determine how many prescriptions are dispensed, who is prescribing these products, and for what indications, so we can effectively target prescribers with these risk management plans

## Opioids of Interest

**Immediate-Release **_**single-entity**_** formulations**
- Oxycodone HCl
- Roxicodone®, Roxicodone Intensol, M-Oxy, Percolone®, Endocodone, OxyIR®, Oxydose, OxyFast® & all generic manufacturers
- Morphine Sulfate
- MSIR®, Roxanol®, AstramorphTM PF, Duramorph®, InfumorphTM, RMS® & all generic manufacturers
- Hydromorphone HCl
- Dilaudid® & all generic manufacturers
- Fentanyl Citrate
- Actiq®, Sublimaze®
**Long-Acting **_**single-entity**_** formulations**
- Oxycodone HCl
- OxyContin® & all generic manufacturers
- Fentanyl Citrate
- Duragesic®
- Morphine Sulfate
- MS Contin®, Avinza®, Kadian®, Oramorph® SR & all generic manufacturers
- Methadone HCl
- Dolophine®, Methadose® & all generic manufacturers

## FDA Labeled Indications for Long-Acting Opioids

- Management of moderate to severe chronic pain, when a continuous, around-the-clock analgesic is needed for an extended period of time
- Not for pain in the immediate post-operative period (unless patient was on prior to surgery)
- Not for PRN pain relief
- Single-entity Oxycodone products
- Single-entity Fentanyl products
- Single-entity Morphine products
- Relief of severe pain, detoxification, and temporary maintenance treatment of narcotic addiction
- Single-entity Methadone products

## Methods

## Methods

- Outpatient drug utilization data analyzed from January 1999 – December 2003
- Data Sources
- IMS Health, National Prescription Audit *Plus* (NPA *Plus**)*
- IMS Health, National Disease and Therapeutic Index (NDTI)

## 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

## National Disease andTherapeutic 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 ~3,000 office-based physicians in the U.S. and projected nationally

## Results

## Total Prescriptions Dispensed* Annually for Selected Single-Entity Immediate-Release Opioids, 1999 - 2003

- Total Prescriptions Dispensed* Annually for _Selected Single-Entity Immediate-Release_ Opioids, 1999 - 2003

- Source: IMS Health, National Prescription Audit PlusTM, Year 1999 to 2003, Data Extracted April 2004

## Total Prescriptions Dispensed* Annually for Long-Acting Opioids & Methadone, 1999 - 2003

- Source: IMS Health, National Prescription Audit PlusTM, Year 1999 to 2003, Data Extracted April 2004

- Total Prescriptions Dispensed* Annually for _Long-Acting_ Opioids & _Methadone_, 1999 - 2003

## Top MD Specialties* Prescribing Selected Single-Entity Immediate-Release Opioids, 1999 vs. 2003

**1999**

**2003**

| MD Specialty | % Prescriptions |
| --- | --- |
| INTERNAL MEDICINE | 13.1% |
| FAMILY PRACTICE | 9.7% |
| HEM/ONC/NEOPLASTIC | 7.9% |
| ORTHOPEDIC SURGERY | 7.7% |
| DENTISTRY | 7.3% |
| OSTEOPATHIC MEDICINE | 6.3% |
| ANESTHESIOLOGY | 5.2% |
| OB/GYN | 4.6% |
| ALL OTHERS | 38.2% |

| MD Specialty | % Prescriptions |
| --- | --- |
| INTERNAL MEDICINE | 15.0% |
| FAMILY PRACTICE | 14.2% |
| ANESTHESIOLOGY | 10.3% |
| OSTEOPATHIC MEDICINE | 8.5% |
| HEM/ONC/NEOPLASTIC | 7.5% |
| ORTHOPEDIC SURGERY | 4.9% |
| PHYSICAL MED & REHAB | 4.4% |
| EMERGENCY MEDICINE | 2.7% |
| ALL OTHERS | 32.5% |

- Source: IMS Health, National Prescription Audit PlusTM, Year 1999 to 2003, Excluding Long-Term Care & Mail Order Channels, Data Extracted April 2004

## Top MD Specialties* Prescribing Long-Acting Opioids & Methadone, 1999 vs. 2003

| MD Specialty | % Prescriptions |
| --- | --- |
| FAMILY PRACTICE | 17.6% |
| ANESTHESIOLOGY | 16.2% |
| INTERNAL MEDICINE | 15.6% |
| OSTEOPATHIC MEDICINE | 10.7% |
| PHYSICAL MEDICINE & REHAB | 6.8% |
| HEM/ONC/NEOPLASTIC | 5.2% |
| ALL OTHERS | 27.9% |

**1999**

**2003**

| MD Specialty | % Prescriptions |
| --- | --- |
| ANESTHESIOLOGY | 15.3% |
| FAMILY PRACTICE | 14.1% |
| INTERNAL MEDICINE | 13.9% |
| HEM/ONC/NEOPLASTIC | 10.2% |
| OSTEOPATHIC MEDICINE | 9.3% |
| PHYSICAL MEDICINE & REHAB | 4.2% |
| ALL OTHERS | 33.0% |

- Source: IMS Health, National Prescription Audit PlusTM, Year 1999 to 2003, Excluding Long-Term Care & Mail Order Channels, Data Extracted April 2004

## Indications* Associated with Selected Single-Entity Immediate-Release Opioids, 1999 vs. 2003

- * Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1999 to 2003, Data Extracted April 2004.

- Surgical Procedures include post-op exams
- Musculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.
- Other Pain includes migraine, headache, calculi, fractures, etc.

## Indications* Associated with Long-Acting Opiates & Methadone, 1999 vs. 2003

- * Source: IMS Health, National Disease and Therapeutic IndexTM , Year 1999 to 2003, Data Extracted April 2004.

- Surgical Procedures include post-op exams
- Musculoskeletal Pain includes back pain, myalgias, osteoarthritis, rheumatoid arthritis, etc.
- Other Pain includes migraine, headache, calculi, fractures, etc.

## 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

## Ongoing Investigations

- Explore longitudinal prescription claims data to identify possible surrogates for abuse and misuse in outpatient settings
- Doctor shopping
- Pharmacy shopping
- Lag time between refills
- Multiple narcotic analgesics in claims
- Examine inpatient billing data to better understand drug utilization patterns in inpatient settings

## Conclusions

- Drug use data may reflect actual use of products in real-world settings and can be used to target risk management
- Drug use data can also identify changes in physician specialties and indications for treatment over time
- Drug utilization data can also be helpful in the pre-approval phase to examine drug use for similar products used in clinical practice