Healthy People 2010 Focus Area 17:

Medical Product Safety

Progress ReviewOctober 19, 2007

• Definition

Injuries due to medical management (rather than the disease process).

• Causes• Drugs/medications

• Properly administered• Overdose/misadministered

• Medical/surgical complications• Diagnostic/procedural errors• Medical devices

• Proper use• Malfunctions

Adverse Medical Events

Overview

• Adverse Medical Events

• $58,766 per event

• $113,280 per event involving negligence

• 10.9 million ambulatory care visits

• Including 1.8 million (4.4%) ER visits

• Adverse Drug Events (ADEs)

• At least 1.5 million preventable ADEs in the US annually

• In hospital ADEs• At least $3.5 billion in total annual cost

• Additional $8,750 per stay

Monitoring and Analyzing Events

17-1a Monitoring and analyzing adverse events associated with medical therapies

Electronic Medical Record (EMR) and Computerized Prescriber Order Entry (CPOE) Use

17-2a EMR use by health care providers in health care organizations

17-2b EMR use by pharmacists in managed care and integrated health systems

17-2c CPOE use by general and children’s hospitals

17-2d CPOE use by urban acute care facilities

Consumer Receipt of Information

17-4 Receipt of useful information about prescriptions from pharmacies

17-5a, b Receipt of oral counseling about medications from prescribers & pharmacists

Blood Donation

17-6 Blood donations

Medical Product Safety Objectives

* Percent of targeted change achieved is between -10% and 10%.

Improving

Little or no change *Target met or exceeded

No trend data

0

2

4

6

8

10

12

14

16Visits per 1,000 population

ED Visits for Adverse Effects of Medical Treatment for Adults 65

Years and Over

Note: ED is defined as an Emergency Department.SOURCE: National Ambulatory Medical Care Survey; National Hospital Ambulatory Medical Care Survey, CDC, NCHS.

1992 1993-4 1995-6 1997-8 1999-00 2001-2 2003-4 2005

All adverse effects

Medical/surgicalcomplications

Drugs

3

1013

35

2830

56

25

0

20

40

60

34%22%27%17%

65+ yrs45-64 yrs18-44 yrs0-17 yrs

Patient Age Distribution

Percent of patients Adverse Effects Accidental Overdose/Misadministration

Adverse Drug-Related Events by Patient Age, 2004

45-64 yrs 65+ yrs0-17 yrs 18-44 yrs

Note: Adverse Effects are unexpected or negative effects of drugs properly administered in therapeutic or prophylactic dosage. Accidental Overdose/Misadministration refer to the wrong drugs being given or taken in error, or drugs taken inadvertently.SOURCE: AHRQ, Center for Delivery, Organization, and Markets, Healthcare Cost and Utilization Project, Nationwide Inpatient Sample, 2004.

0

20

40

60

80

100

Obj. 17-1a

Percent of hospitals

General and Children’s Hospitals that Monitor Adverse Drug Events

SOURCE: National Survey of Pharmacy Practice in Acute Care Settings, American Society of Health System Pharmacists (ASHP).

2010 Target: 90

Increase desired

1998 2001 2003

0

10

20

30

40

Electronic Medical Record Use by Providers in Health Care

OrganizationsPercent of providers

Note: Health care organizations include stand-alone and multi-system hospitals, physician offices, mental/behavioral health facilities, long-term care facilities, and home-health agencies.SOURCE: Annual HIMSS Leadership Survey, Healthcare Information and Management Systems Society. Obj. 17-2a

2010 Target: 18

Increase desired

2000 2001 2002 2003 2004 2005 2006 2007

0

2

4

6

8

10

2001 2002 2003 2004 2005 2006

Computerized Prescriber Order Entry Use by General and Children’s

HospitalsPercent of hospitals

Note: * Data are not available for 2002. In 2004, in response to the crash, failure and subsequent placement on hold of one large hospital’s group CPOE system, several other hospitals and hospital groups followed suit and placed their implementation on hold. SOURCE: National Survey of Pharmacy Practice in Hospital Settings, American Society of Health System Pharmacists (ASHP).

Obj. 17-2c

2010 Target: 6

Increase desired

*

0

5

10

15

20

25

Percent of hospitals 2001 2006

Total <50 50-99 100-199 200-299 300-399 400+

Number of Staffed Beds

SOURCE: National Survey of Pharmacy Practice in Hospital Settings, American Society of Health System Pharmacists (ASHP).

Computerized Prescriber Order Entry System Use by Size (General and

Children’s Hospitals)

0

2

4

6

8

10

Computerized Prescriber Order Entry Use by Urban Acute Care Facilities

Percent of facilities

Note: An urban acute care facility is defined as a short-term Medicare certified hospital. SOURCE: The Leapfrog Group Hospital Patient Safety Survey, The Leapfrog Group for Patient Safety. Obj. 17-2d

2010 Target: 7

Increase desired

2003 2004 2005 2006

Prescribers Pharmacists

2010 Target: 95

Increase desired

100

90

80

70

60

50

40

30

20

10

0

Percent of patients

Patient Receipt of Verbal Counseling about Medications

Obj. 17-4, 5a & 5b

200420001998

Note: Estimates reflect patient receipt of information on how much and how often to take medication, precautions and side effects.SOURCE: National Survey of Prescription Medicine Information Received by Consumers, FDA Obj. 17-5a & 5b

Total

HispanicBlackAsianWhite

18-24 yrs*

25-44 yrs*

45-64 yrs*

65+ yrs*

FemaleMale

Persons w/DisabilityPersons w/o Disability

Blood Donations, 2006

Increase desired

2010 Target: 8

0 5 10

15 Percent (age adjusted)

Obj. 17-6

= 95% confidence interval. Note: Data are for adults aged 18 years and over who have donated blood in the past 12 months. * Not age-adjusted. The categories black and white exclude persons of Hispanic origin. Persons of Hispanic origin may be any race. Respondents were asked to select one or more races. Data for the single race categories are for persons who reported only one racial group. SOURCE: National Health Interview Survey (NHIS), CDC, NCHS.

0

2

4

6

8

10

1998 2000 2002 2004 2006

Millions of units

Blood Supply Adequacy

Note: Represents allogeneic collections. Available collections are composed of those units that have passed all laboratory tests and are available for transfusion.SOURCE: 2005 Nationwide Blood Collection and Utilization Survey Report, HHS.

1989 1992 1994 1997 1999 2001 20040

10

11

12

13

14

15 Collections

Available Collections

Transfusions

Summary

• Emergency department visits for adverse events (especially medical/surgical complications) among persons 65+ are increasing

• Consumer receipt of verbal counseling regarding medications remains far below the HP 2010 target

• EMR and CPOE usage is increasing and has exceeded the HP 2010 targets

• Demand is approaching supply for blood donations

Progress review data and slides

are available on the web at:

http://www.cdc.gov/nchs/hphome.htmhttp://www.cdc.gov/nchs/hphome.htm