In the 14th in a series of assessments of Healthy People
2010, Acting Assistant Secretary for Health Cristina Beato
chaired a focus area Progress Review on Medical Product Safety.
Dr. Beato noted the great benefits conferred on American society
by medical products, as well as the attendant, sometimes life-threatening
risks to health that can arise from a product’s side effects or
misapplication. The impact on society from these deleterious consequences
in terms of death, disability, and expenditures on health resources
raises medical product safety to a serious public health issue.
In conducting the review, Dr. Beato was assisted by staff of the
Food and Drug Administration (FDA), which is the lead agency for
this Healthy People 2010 focus area. Also participating
were representatives of other offices and agencies within the U.S.
Department of Health and Human Services.
Mark McClellan, then Commissioner of Food and Drugs, provided the
context for FDA’s actions to achieve the targets of the six
objectives for Medical Product Safety, each of which is addressed
by two of the five elements of FDA’s Strategic Action Plan
(SAP). Incorporated within the SAP, Dr. McClellan noted, are a number
of strategies that will promote progress toward achievement of these
objectives, including (1) enhancement of the ability to identify
risks through partnerships with healthcare systems and Federal organizations,
thereby permitting FDA to link medical records and public health
monitoring systems to identify adverse therapeutic events; (2) integration
of information technology as a strategic tool; (3) partnering with
other agencies and the private sector to improve the quality of
information given to patients about medications; (4) establishment
of an agency-wide infrastructure to communicate information about
risks; and (5) development of guidelines for industry on the content
of information about medical products.
The complete text for the Medical Product Safety focus area of
Healthy People 2010 is available at www.healthypeople.gov/document/html/volume2/17medical.htm.
The meeting agenda, data presentation (tables and charts), and other
materials for the Progress Review can be found at www.cdc.gov/nchs/about/otheract/
hpdata2010/fa17/mps.htm.
Data Trends
In opening his presentation on the status of objectives in this
Healthy People 2010 focus area, Edward Sondik, Director
of the National Center for Health Statistics, outlined the burden
imposed on American society by the misuse of medical products and
services. According to the 1999 Institute of Medicine report To
Err is Human: Building a Safer Health System, adverse medical
events (AMEs) cause an estimated 44,000 to 98,000 deaths annually
at an estimated national cost of $36.7 to $50 billion. Of all AMEs,
medication error accounts for an estimated 7,000 deaths annually,
with 2 out of 100 admittees to healthcare facilities experiencing
preventable adverse drug events (ADEs). The average increased hospital
cost of preventable ADEs is about $4,700 per admission or $2 billion
nationwide. The number of visits to hospital emergency departments
because of AMEs increased from less than 800,000 in 1992 to more
than 1.4 million in 2001.
Although complete tracking data are not yet available for developmental
objectives 17-1, 17-2, 17-3, and 17-4, partial data suggest some
trends. The proportion of children’s and general medical surgical
hospitals that were linked in integrated systems to monitor and
report AMEs associated with medical therapies decreased from 81.6
percent in 1998 to 77.4 percent in 2001 (Obj. 17-1a). Electronic
medical records were used by 19 percent of healthcare organizations
in 2003, compared with 12 percent in 2000. In 2001, 33 percent of
pharmacists in managed care and integrated health systems used such
records, compared with 31 percent in 1999 (Obj. 17-2a). Linked,
automated prescription systems were in use by pharmacists and other
dispensers in 4.3 percent of children’s and general medical
surgical hospitals in 2001. The percentage varied by facility size
from 1.1 percent of facilities having 50 to 99 beds to 20.4 percent
of those with 400 or more beds (Obj. 17-2b). In 2001, 74 percent
of patients received information from pharmacies that met guidelines
for usefulness when their new prescriptions were dispensed, the
same proportion as in 1998 (Obj. 17-4).
With respect to the measurable objectives in the focus area, 24
percent of patients in 2000 received oral counseling from prescribers
on appropriate use and potential risks of medications, representing
no change from 1998 (Obj. 17-5a). The proportion of patients receiving
such counseling from pharmacists declined from 14 percent in 1998
to 12 percent in 2000 (Obj. 17-5b). The 2010 target is for 95 percent
of patients to be in receipt of oral counseling from both prescribers
and pharmacists. From 1998 to 2001, the proportion of persons 18
years of age and older who donated blood increased from 5.5 percent
to 6.2 percent. Of four age groups, 18- to 24-year-olds gave blood
in 2001 at a rate slightly exceeding the 2010 target of 8 percent
of adults, compared with less than 2 percent of those aged 65 and
older. Whites gave blood at a rate of 7 percent, which was at least
twice the rates for blacks, Hispanics, and Asians. Years of education
completed had a positive effect on blood donation rates: persons
aged 25 years and older who had at least some college gave blood
at a rate of 7.9 percent, compared with 1.8 percent of those who
had not completed high school (Obj. 17-6).
Key Challenges and Current Strategies
Participants in the review identified a number of obstacles to
achieving the objectives and discussed activities under way to meet
these challenges, including the following:
- FDA has proposed a universal bar coding system for prescription
medicines and blood products, which is expected to reduce the rate
of medication errors.
- MedWatch, the FDA Safety Information and Adverse Event Reporting
Program, serves both healthcare professionals and the public by
providing timely clinical information about safety issues involving
medical products. The MedWatch e-list disseminates safety alerts,
recalls, withdrawals, and important labeling changes, some of which
can be triggered by input to the program from practitioners and
consumers who report serious problems they suspect are associated
with medical products they prescribe, dispense, or use.
- The Electronic Common Technical Document (eCTD), now being
adopted, will serve as an interface for industry to transfer information
fulfilling regulatory requirements to FDA.
- In cooperation with the National Library of Medicine, FDA
is setting up DailyMed, a computerized repository that stores up-to-date
and comprehensive medication information.
- Currently operational in 180 hospitals, the Medical Product
Surveillance Network (MedSUN) is an FDA pilot program to collect
data on medical device adverse events.
- Available data have not established that oral counseling
of patients about medications is more effective than written instructions.
Indeed, the advent of new avenues for acquisition of medications
(e.g., by mail order or by purchase through the Internet) has highlighted
the importance of accurate written information.
- Transfusion therapy associated with improvements in health
care, such as transplantation and cancer chemotherapy, increases
the demand for blood by about 3 to 4 percent a year. At the same
time, the number of individuals who meet donor eligibility requirements
tends to be reduced by protective measures to decrease the risk
of known or potential transfusion-transmitted infections, such as
HIV, hepatitis, SARS, West Nile virus, and dengue virus.
- Opportunities for blood drives in the workplace have been
shrinking as the collection process has become more complex and
as many downsized companies have become less willing to permit workers
to be away from their jobs for the time required for donation. An
additional cause of losses to the blood donor base is the aging
of the donor population, because this affects repeat donors, who
make up 80 percent of the donor pool and cannot easily be replaced.
- FDA has pilot-tested TRANS-Net, a Web-based monitoring system
that, when fully operational, will have the capability for identifying
local and regional shortages in the nationwide supply of blood and
blood reagents, both in times of seasonal peak demands and in times
of crisis.
- In 2003, virtually all prospective donors who carried the
West Nile virus were screened out of blood donation programs after
accelerated efforts had produced a diagnostic test in 8 months.
Approaches for Consideration
During the review, the following suggestions were made for steps
to bring about further progress toward achievement of the objectives
for medical product safety:
- Accelerate development of uniform nationwide standards for
bar coding of prescriptions for medical products.
- Explore ways to lower the cost of computerization and electronic
interchange of medical records, which constitutes a large impediment
to greater deployment of electronic record-keeping.
- Expand outreach into the private sector as part of current
partnering arrangements for electronically collecting data on adverse
therapeutic events.
- Seek to establish and implement nationwide standards for
capturing data on adverse medical events.
- Strengthen the infrastructure for preserving supplies of
blood and blood products for longer periods of time.
- To stimulate greater public participation in blood drives,
explore ways to increase donation by affinity groups, which accounts
in part for the greater proportion of college students who regularly
give blood.
Contacts for information about Healthy People 2010
focus area 17—Medical Product Safety:
- Office of Disease Prevention and Health Promotion (coordinator
of the Progress Reviews)—Nancy Stanisic (liaison to the
focus area 17 workgroup), nstanisic@osophs.dhhs.gov
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Cristina V. Beato, M.D.
Acting Assistant Secretary for Health
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