Focus Area 17: Medical Product Safety Progress Review

1
Focus Area 17Medical Product SafetyProgress
Review

• November 5, 2003

2
Health Care Quality Framework
Source 2001 Institute of Medicine Report,
Envisioning the National Health Care Quality.
3
Estimated Annual Burden

• Adverse Medical Events
• 44,000 to 98,000 deaths
• Total national cost 36.7 to 50 billion
• Adverse Drug Events (ADE)
• 7,000 deaths due to medication error
• 2 out of 100 admissions experience preventable
  ADE
• Average increased hospital cost of preventable
  ADE 4,700 per admission or 2 billion
  nationwide

Source 1999 Institute of Medicine report, To Err
Is Human Building a Safer Health System.
4
Leading Causes of Death 2001
Total Number of Deaths 2,416,425

1. Heart disease
700,142
2. Malignant neoplasm
553,768
3. Cerebrovascular
163,538
123,013
4. Chronic lower respiratory
101,537
5. Unintentional injury
Adverse medical events (estimated) 44,000
98,000
6. Diabetes
71,372
62,034
7. Influenza and pneumonia
53,852
8. Alzheimers disease
39,480
9. Nephritis
32,238
10. Septicemia
Institute of Medicine report estimate.
Source CDC, NCHS, National Vital Statistics
System.
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Number of Emergency Department Visits for Adverse
Effects of Medical Treatment

Number of visits (thousands)
1994
1996
2001
1992
1998
2000
Note Data for 1994-2000 are 2-year averages.
Source CDC, NCHS, National Hospital Ambulatory
Medical Care Survey.
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Medical Product Safety Objectives

• 17-1 Monitoring of adverse medical events
• a. associated with medical
  therapies
• b. associated with medical devices
• 17-2 Linked, automated information systems
  used
• a. by health care professionals in
  hospitals and integrated health systems
• b. by pharmacists and other dispensers
• 17-3 Provider review of medication taken
  by patients
• 17-4 Receipt of useful information about
  prescription from
• pharmacies
• 17-5 Receipt of oral counseling about
  medication from
• a. prescribers
• b. dispensers
• 17-6 Blood donation

Developmental objectives those in red have new
baselines those in grey have no baselines.
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Adverse Drug Events
Administering -Administer right medication to
patient -Administer medication when
indicated -Inform patient about
medication -Include patient in administration
Prescribing -Diagnostic / Therapeutic decisions
made -Medication ordered -Order verified and
submitted
-Obtain medication-related history -Document
medication history
Dispensing -Review order -Process
order -Compound/ Prepare drug
Monitoring Program
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Hospitals with Monitoring Programs for Adverse
Medical Drug Events
Percent of childrens and general medical
surgical hospitals
81.6
77.4
1998
2001
Source American Society of Health Systems
Pharmacists, National Survey of Pharmacy Practice
in Acute Care Settings,.
Obj. 17-1a Developmental
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Electronic Medical Record Use by Health Care
Providers
Percent of health care organizations
2000
2002
2001
2003
Obj. 17-2a Developmental
Source Health Information and Management
Society, Annual HIMSS Leadership Survey.
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Electronic Medical Record Use by Pharmacists
Percent of managed care and integrated health
systems
33
31
2001

1999
Source American Society of Health Systems
Pharmacists, National Survey of Ambulatory Care
Responsibilities of Pharmacists in Managed Care
and Integrated Systems.
Obj. 17-2a Developmental
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Computerized Prescriber Order Entry System
Utilization 2001
Percent of childrens and general medical
surgical hospitals
Total
50-99
Less than 50
200-299
100-199
400 or more
300-399
Number of beds
Source American Society of Health Systems
Pharmacists, National Survey of Pharmacy Practice
in Hospital Settings.
Obj. 17-2b Developmental
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Receipt of Useful Information about Prescriptions
from Pharmacies
Percent of patients
74
74
2001
1998

Note 1998 data based on pilot study results.
Obj. 17-4 Developmental
Source FDA, National Survey of Prescription Drug
Information Provided to Patients.
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Receipt of Oral Counseling from Prescribers and
Pharmacists
Percent of patients
2000
1998
100
2010 Target
90
30
24
24
20
14
12
10
0
Prescribers
Pharmacists
Obj. 17-5
Source FDA, National Survey of Prescription
Medicine Information Received by Consumers .
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Blood Donations, Adults 18 Years and Over 1998
2001
Percent
2010 Target
Total
2001
1998
1999
2000
Obj. 17-6
Source CDC, NCHS, National Health Interview
Survey.
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Blood Donations by Age Group 2001
Percent
2010 Target
18-24
25-44
65
45-64
Obj. 17-6
Source CDC, NCHS, National Health Interview
Survey.
16
Blood Donations, Adults 18 Years and Over by
Race/Ethnicity and Education 2001
Percent (age-adjusted)
10
2010 Target
8
6
4
2
0
Male
Asian
Female
Hispanic
Total
Black
Less than high school
White
High school graduate
At least some college
Note Asian includes Pacific Islander Black and
White exclude persons of Hispanic origin.
Persons of Hispanic origin may be any race. Data
are age adjusted to the 2000 standard
population. Education data are for persons ages
25-64 years. I 95 confidence interval.
Obj. 17-6
Source CDC, NCHS, National Health Interview
Survey.
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Progress review data and slides can be found on
the web at
http//www.cdc.gov/nchs/hphome.htm