1. Available Types of National Drug Use Data DSARM Advisory Committee Meeting Silver Spring, Maryland May 18, 2005 Judy Staffa, PhD, RPh, Epidemiology Team Leader Division of Surveillance, Research & Communication Support Office of Drug Safety DSARM Advisory Committee Meeting Silver Spring, Maryland May 18, 2005 Judy Staffa, PhD, RPh, Epidemiology Team Leader Division of Surveillance, Research & Communication Support Office of Drug Safety Center for Drug Evaluation and Research

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

3. DSARM Advisory Committee Meeting May 18, 2005 3 Applications 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

4. DSARM Advisory Committee Meeting May 18, 2005 4 “$64,000 question” How many patients in the U.S. take drug A?

5. DSARM Advisory Committee Meeting May 18, 2005 5 Other 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?

6. DSARM Advisory Committee Meeting May 18, 2005 6 ChallengesChallenges 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”

7. DSARM Advisory Committee Meeting May 18, 2005 7 SettingsSettings 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)

8. DSARM Advisory Committee Meeting May 18, 2005 8 Additional 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”

9. DSARM Advisory Committee Meeting May 18, 2005 9 How many patients take drug A? What are the demographics of these patients?

10. DSARM Advisory Committee Meeting May 18, 2005 10 How many patients/demographics? 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 Limitations: -Doesn’t cover all outpatient settings -”Dispensed” is not “Taken”

11. DSARM Advisory Committee Meeting May 18, 2005 11 How many patients/demographics? 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 Limitations: -Sample sizes are often small - unstable projections -Generalizability questionable -NAMCS data not timely enough Limitations: -Little patient-level information -Generalizability questionable

12. DSARM Advisory Committee Meeting May 18, 2005 12 How many patients/demographics? Inpatient Traditional –None Traditional –None 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

13. DSARM Advisory Committee Meeting May 18, 2005 13 How many patients/demographics? Over-the-counter drugs Traditional –Use sales data as proxy Traditional –Use sales data as proxy More recent –Household survey data projected nationally Limitations: -Not patient-level Limitations: -Unknown

14. DSARM Advisory Committee Meeting May 18, 2005 14 How long do patients stay on drug A? How often do patients take drugs A and B together?

15. DSARM Advisory Committee Meeting May 18, 2005 15 Duration/concomitancy? Outpatient 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 Limitations: -National estimates not possible -Generalizability questionable -Not all drugs covered -”Dispensed” is not “taken” Limitations: -Unknown

16. DSARM Advisory Committee Meeting May 18, 2005 16 Duration/concomitancy? Inpatient Traditional –None Traditional –None More recent –Day of stay billing detail for drugs and procedures Limitations: - National estimates not possible -Generalizability questionable -Indication unknown -”Billed” is not “administered”

17. DSARM Advisory Committee Meeting May 18, 2005 17 For what indication is drug A prescribed? By which types of physicians? What drugs are being prescribed for condition X?

18. DSARM Advisory Committee Meeting May 18, 2005 18 Indication/specialty? Outpatient 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 Limitations: - Sample size small -Generalizability questionable - NAMCS data not timely Limitations: -Generalizability questionable - Research-ready?

19. DSARM Advisory Committee Meeting May 18, 2005 19 Indication/specialty? Inpatient Traditional –None Traditional –None More recent –Hospital billing data attending/consulting physician specialty all discharge diagnoses Limitations: - No linkages *prescriber drug *drug indication

20. DSARM Advisory Committee Meeting May 18, 2005 20 SummarySummary 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

21. DSARM Advisory Committee Meeting May 18, 2005 21 Future 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

22. DSARM Advisory Committee Meeting May 18, 2005 22 AcknowledgementsAcknowledgements 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