Available Types of Available Types of NationalNational Drug Use Data Drug Use DataAvailable Types of Available Types of NationalNational Drug Use Data Drug Use Data

DSARM Advisory Committee MeetingDSARM Advisory Committee MeetingSilver Spring, MarylandSilver Spring, MarylandMay 18, 2005May 18, 2005

Judy Staffa, PhD, RPh, Epidemiology Team LeaderDivision of Surveillance, Research & Communication SupportOffice of Drug Safety

DSARM Advisory Committee MeetingDSARM Advisory Committee MeetingSilver Spring, MarylandSilver Spring, MarylandMay 18, 2005May 18, 2005

Judy Staffa, PhD, RPh, Epidemiology Team LeaderDivision of Surveillance, Research & Communication SupportOffice of Drug Safety

Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research

2DSARM Advisory Committee Meeting DSARM Advisory Committee Meeting May 18, 2005May 18, 2005

OverviewOverview

• Applications of drug use data • Typical questions• Challenges• Available types of data

– by question and setting of care• Summary• Future challenges

• Applications of drug use data • Typical questions• Challenges• Available types of data

– by question and setting of care• Summary• Future challenges

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Applications of drug use data in drug safetyApplications of drug use data in drug safetyApplications of drug use data in drug safetyApplications of drug use data in drug safety

• Denominators for putting AERS reports into context (e.g., reporting rates)

• Description of prescribing patterns • physicians’ specialty• patient demographics• associated diagnoses/procedures

• Insight into duration of use and concomitant use of multiple drugs

• Surveillance of risk management practices to restrict drug use

• Impact of potential medication errors

• Denominators for putting AERS reports into context (e.g., reporting rates)

• Description of prescribing patterns • physicians’ specialty• patient demographics• associated diagnoses/procedures

• Insight into duration of use and concomitant use of multiple drugs

• Surveillance of risk management practices to restrict drug use

• Impact of potential medication errors

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““$64,000 question”$64,000 question”““$64,000 question”$64,000 question”

• How many patients in the U.S. take drug A?

• How many patients in the U.S. take drug A?

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Other common questionsOther common questionsOther common questionsOther common questions

• What are the demographics of patients on drug A?

• How long do patients stay on drug A?• How often do patients take drugs A and B

together?• For what indication is drug A prescribed?

– By which types of physicians?• What drugs are being prescribed for condition

X?

• What are the demographics of patients on drug A?

• How long do patients stay on drug A?• How often do patients take drugs A and B

together?• For what indication is drug A prescribed?

– By which types of physicians?• What drugs are being prescribed for condition

X?

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ChallengesChallengesChallengesChallenges

• Fragmentation of U.S. health care system– “Pockets” of use

• Settings of care/payers/buyers• Projections to national estimates for

“pocket”• Sum across “pockets”

• Fragmentation of U.S. health care system– “Pockets” of use

• Settings of care/payers/buyers• Projections to national estimates for

“pocket”• Sum across “pockets”

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SettingsSettingsSettingsSettings

• Outpatient (Rx)– Pharmacies/Mail order– Physician Offices– Clinics

• Inpatient• Over-the-counter (OTC)

• Outpatient (Rx)– Pharmacies/Mail order– Physician Offices– Clinics

• Inpatient• Over-the-counter (OTC)

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Additional challengesAdditional challengesAdditional challengesAdditional challenges

• Secondary data sources– Administrative/billing data– Marketing data

• Newer data sources– Linkage across “data streams”

• Secondary data sources– Administrative/billing data– Marketing data

• Newer data sources– Linkage across “data streams”

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How many patients take drug A?How many patients take drug A?What are the demographics of these patients?What are the demographics of these patients?

How many patients take drug A?How many patients take drug A?What are the demographics of these patients?What are the demographics of these patients?

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How many patients/demographics?How many patients/demographics?Outpatient (Pharmacies)Outpatient (Pharmacies)

How many patients/demographics?How many patients/demographics?Outpatient (Pharmacies)Outpatient (Pharmacies)

• Traditional– National estimates of

dispensed prescriptions, projected from

• retail pharmacies• mail order• long-term care

– Patient age/gender- missing or incomplete

• Traditional– National estimates of

dispensed prescriptions, projected from

• retail pharmacies• mail order• long-term care

– Patient age/gender- missing or incomplete

• More recent– National estimate of

dispensed prescriptions and patients, projected from

• multiple data streams (pharmacies, pharmacy benefit managers, insurers)

– Patient age & gender

• More recent– National estimate of

dispensed prescriptions and patients, projected from

• multiple data streams (pharmacies, pharmacy benefit managers, insurers)

– Patient age & gender

Limitations:-Doesn’t cover all outpatient settings-”Dispensed” is not “Taken”

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How many patients/demographics?How many patients/demographics?Outpatient (Other)Outpatient (Other)

How many patients/demographics?How many patients/demographics?Outpatient (Other)Outpatient (Other)

• Physician offices– Convenience sample

of office visits from 3-4000 physicians

– National Ambulatory Medical Care Survey (NAMCS)

• Physician offices– Convenience sample

of office visits from 3-4000 physicians

– National Ambulatory Medical Care Survey (NAMCS)

• Clinics– Little available– Some J-codes in

claims – Rely on sales data

into clinics

• Clinics– Little available– Some J-codes in

claims – Rely on sales data

into clinics

Limitations: -Sample sizes are often small - unstable projections -Generalizability questionable-NAMCS data not timely enough

Limitations: -Little patient-level information-Generalizability questionable

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How many patients/demographics?How many patients/demographics?InpatientInpatient

How many patients/demographics?How many patients/demographics?InpatientInpatient

• Traditional– None

• Traditional– None

• More recent– National estimates of

discharges in which drug was billed

– Discharge-level age & gender, diagnosis and procedure data

• More recent– National estimates of

discharges in which drug was billed

– Discharge-level age & gender, diagnosis and procedure data

Limitations:-No link to drug indication-Double-counting of patients-“Billed” is not “Administered”-Some areas missing - surgery, radiology-Unclear universe - e.g., pediatrics

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How many patients/demographics?How many patients/demographics?Over-the-counter drugsOver-the-counter drugs

How many patients/demographics?How many patients/demographics?Over-the-counter drugsOver-the-counter drugs

• Traditional– Use sales data as proxy

• Traditional– Use sales data as proxy

• More recent– Household survey data

projected nationally

• More recent– Household survey data

projected nationally

Limitations: -Not patient-level

Limitations: -Unknown

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How long do patients stay on drug A?How long do patients stay on drug A?How often do patients take drugs A and B How often do patients take drugs A and B

together?together?

How long do patients stay on drug A?How long do patients stay on drug A?How often do patients take drugs A and B How often do patients take drugs A and B

together?together?

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Duration/concomitancy?Duration/concomitancy?OutpatientOutpatient

Duration/concomitancy?Duration/concomitancy?OutpatientOutpatient

• Traditional– Longitudinal patient-level

insurance claims data

• Traditional– Longitudinal patient-level

insurance claims data

• More recent– Longitudinal data linked

across data streams, including pharmacy-based

– Includes cash payors

• More recent– Longitudinal data linked

across data streams, including pharmacy-based

– Includes cash payors

Limitations: -National estimates not possible-Generalizability questionable-Not all drugs covered-”Dispensed” is not “taken”

Limitations: -Unknown

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Duration/concomitancy?Duration/concomitancy?InpatientInpatient

Duration/concomitancy?Duration/concomitancy?InpatientInpatient

• Traditional– None

• Traditional– None

• More recent– Day of stay billing detail

for drugs and procedures

• More recent– Day of stay billing detail

for drugs and procedures

Limitations: - National estimates not possible-Generalizability questionable-Indication unknown-”Billed” is not “administered”

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For what indication is drug A prescribed?For what indication is drug A prescribed?By which types of physicians?By which types of physicians?

What drugs are being prescribed for condition X?What drugs are being prescribed for condition X?

For what indication is drug A prescribed?For what indication is drug A prescribed?By which types of physicians?By which types of physicians?

What drugs are being prescribed for condition X?What drugs are being prescribed for condition X?

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Indication/specialty?Indication/specialty?OutpatientOutpatient

Indication/specialty?Indication/specialty?OutpatientOutpatient

• Traditional– National estimates of

prescribing practices from marketing data

– NAMCS

• Traditional– National estimates of

prescribing practices from marketing data

– NAMCS

• More recent– Electronic medical

records– E-prescribing

• More recent– Electronic medical

records– E-prescribing

Limitations: - Sample size small-Generalizability questionable- NAMCS data not timely

Limitations: -Generalizability questionable- Research-ready?

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Indication/specialty?Indication/specialty?InpatientInpatient

Indication/specialty?Indication/specialty?InpatientInpatient

• Traditional– None

• Traditional– None

• More recent– Hospital billing data

• attending/consulting physician specialty

• all discharge

diagnoses

• More recent– Hospital billing data

• attending/consulting physician specialty

• all discharge

diagnoses

Limitations: -No linkages *prescriber drug *drug indication

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SummarySummarySummarySummary

• Our knowledge of drug use in the U.S. is largely setting-specific

• Drug use data varies in detail across settings

– Outpatient pharmacy - patient/Rx-level Most detail– Outpatient physician office - visit-level– Inpatient - discharge-level– OTC - pilot work on patient-level data– Outpatient clinics - sales only Least detail

• Our knowledge of drug use in the U.S. is largely setting-specific

• Drug use data varies in detail across settings

– Outpatient pharmacy - patient/Rx-level Most detail– Outpatient physician office - visit-level– Inpatient - discharge-level– OTC - pilot work on patient-level data– Outpatient clinics - sales only Least detail

Intermediate detail

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Future ChallengesFuture ChallengesFuture ChallengesFuture Challenges• Increased coverage of other care settings

– Operating room/radiology– Hospital outpatient clinics (e.g., chemotherapy)– Staff model HMOs– Home health care/long term care– Over-the-counter drugs (patient-level)

• Increased coverage of special populations– Elderly (Medicare Part D)– Pediatrics– Pregnant women– HIV-infected (specialty pharmacies)

• Further linkage across care settings– Outpatient - inpatient

• Increased coverage of other care settings– Operating room/radiology– Hospital outpatient clinics (e.g., chemotherapy)– Staff model HMOs– Home health care/long term care– Over-the-counter drugs (patient-level)

• Increased coverage of special populations– Elderly (Medicare Part D)– Pediatrics– Pregnant women– HIV-infected (specialty pharmacies)

• Further linkage across care settings– Outpatient - inpatient

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AcknowledgementsAcknowledgementsAcknowledgementsAcknowledgements

• Drug Use Specialists– Laura Governale– Michael Evans– David Moeny– Kendra Worthy

• Drug Use Specialists– Laura Governale– Michael Evans– David Moeny– Kendra Worthy

• Epidemiologists– Aaron Mendelsohn– Sigal Kaplan– Andrea Feight– Tarek Hammad

• Contracts Specialists– Katrina Garry– Martha O’Connor– Kathy Rios

• Epidemiologists– Aaron Mendelsohn– Sigal Kaplan– Andrea Feight– Tarek Hammad

• Contracts Specialists– Katrina Garry– Martha O’Connor– Kathy Rios