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Reducing Medical Errors: A Review of Innovative Strategies to Improve Patient Safety.
Subcommittee on Health
Mr. James M. Hethcox M.S., R.Ph.
Mr. Chairman and Members of the
Subcommittee: I am Jim Hethcox, Vice
President of Pharmacy Practice at Cardinal Health.
I want to thank the Subcommittee for holding this very important hearing
on medical errors and for receiving testimony on products and services developed
by the private sector to assist in reducing these errors and obstacles the
industry faces in broader adoption of these and other patient safety tools. Cardinal
Health is a comprehensive provider of products and services supporting the
health care industry. The company
has over 50,000 employees serving the hospital, retail pharmacy, and
manufacturing segments of healthcare. Our
purpose is to provide essential support that helps our customers succeed in
their respective roles within patient care.
The company's mission is to be an integral partner in the delivery and
improvement of healthcare. We act
as a vital link between manufacturers and providers of patient care, providing
product development, manufacturing, and packaging services as well as
distribution, operations, and clinical improvement services.
Our products and services span the continuum of care, which includes
acute, subacute, long-term, and outpatient care settings as well as the home.
Cardinal Health is a leader in the health care industry in developing and
delivering an unparalleled array of cutting-edge products and services that
focus on improving medication safety. Cardinal
Health is committed to helping improve patient safety, and I am pleased to have
the opportunity to comment on two of the many products and services provided by
various companies within Cardinal Health that help to improve patient safety and
reduce medical errors. The first is
compliance packaging for the outpatient setting, and the other is automated
bedside verification of medication administration in the inpatient setting. Compliance Packaging
Medication
non-compliance is simply a patient failing to take his/her medications as
prescribed and represents a major health problem.
In fact, it is such a common occurrence that the National Council on
Patient Information and Education designated non-compliance as "America's
other drug problem." In the
general population, rates of medication non-compliance range from 20 to 70
percent. Most
of the Members of this Committee as well as the other people in this room are
probably personally familiar with the challenges of taking prescription
medications correctly.
This issue is
exacerbated among the elderly, as they take an increased number of prescriptions
and may have increasingly compromised physiology. It
is estimated that the average elderly person takes 17 - 24 prescriptions a year.[1]
An American Association for Retired Persons survey showed that 58 per
cent of the elderly population makes errors when taking their medications.[2]
Nearly 10 per cent of all Medicare hospital admissions are reported to be
the result of medication non-compliance.[3]
Furthermore, it has been estimated that the annual economic cost of
non-compliance exceeds $100 billion per year.[4]
Cardinal
Health is a leading provider of diversified pharmaceutical packaging services
and promotes the use of compliance packaging to help reduce medication errors
among consumers. Compliance packaging is a prepackaged, ready-to-dispense system that is used for a treatment cycle of a medication and that provides day and time reminders as well as patient education information to facilitate and motivate patients to take their medications correctly. Such packaging provides for the day and time for administration to be clearly identified on the package directly beside each dose. For example, a patient "punches out" the tablet from a blister package and takes the correct dose on the correct day at the correct time. An example of this type of compliance packaging is the packaging commonly used for birth control pills. This
type of compliance packaging encourages a patient to continue to take a
medication to the end of the originally prescribed regimen and eliminates the
need for patients to transfer their medications to other compliance containers.
It aids patients in remembering when to take their medication and readily
identifies when they have already taken a particular dose. We
believe that compliance packaging can help reduce errors of under- and
over-consumption in the outpatient setting.
When patients take prescription medications correctly at home, they are
more likely to experience positive therapeutic outcomes.
Studies have shown that compliance-improving programs have a cost-benefit
ratio as high as 1:14.[5]
When properly used, compliance packaging can help physicians and
pharmacists provide standardized medication instructions in a minimum amount of
time. A study conducted at Michigan
State University estimated that compliance packaging could save up to 1,700
hours a year in a busy retail pharmacy.[6]
This is especially important given the pharmacist shortage now facing this
country. We
believe that compliance packaging can help decrease or eliminate the following
types of non-compliance issues:
As
discussed previously, the elderly are especially at risk from medication
non-compliance because of the number of prescription and over-the-counter
medications taken in a day and the complexity resulting from different
instructions on how to take each medication.
In 1999, the Congress recognized the need to address this very important
issue by directing the Department of Health and Human Services to award a grant
to perform a study to determine the benefits of compliance packaging.
The formal study will commence next month led by The Ohio State
University, The University of Arizona, and Brigham and Women's Hospital to
further research the issue of compliance and how packaging can improve
seniors' ability to take their drugs as prescribed. The
study will monitor 300 Medicare patients for one full year, half receiving their
medication in traditional prescription vials and half receiving their medication
in a new, innovative "pill calendar" compliance package.
Both compliance and clinical indicators will be monitored.
Automated Medication Dispensing and Bedside
Verification
Cardinal Health recognizes
that many medication errors that occur in inpatient settings are indeed
preventable. Results from several
studies suggest that the incidence of adverse drug events (ADEs) ranges from 1
to 30 percent of all hospitalized patients, depending on the broadness of the
ADE definition used. Research shows
that up to one-third of these adverse drug events are preventable.[7]
Many of these preventable events are associated with significant rates of
morbidity and mortality and have a significant impact on hospital costs.
Patients who experience in-hospital, medication-related errors often
require 2 - 5 additional days of hospitalization at an additional cost of $2,000
- $5,000 per admission.[8] Most
errors are the result of one or more breakdowns in the system of care.
It has been estimated that there are on average 20 steps involved in the
medication-use process.[9]
When you consider that approximately 3.75 billion drug administrations
are made annually to patients in hospitals, with 20 steps per administration,
the opportunities for things to go wrong are significant.
Errors
in the medication-use process also can occur in long-term care settings.
Indeed, the risks might be greater in these settings because the patients
usually receive a greater number of drugs, and there is a limited presence of
on-site physicians and pharmacists to help clarify medication orders. Pyxis,
a Cardinal Health company, is the leading provider of automated medication- and
supply-dispensing systems for hospitals and other healthcare facilities.
Pyxis has revolutionized the way medications are distributed within these
facilities. Resembling a network of ATM machines, the technology is a point-of-care, computerized system that
automates the distribution, management, and control of medications within
hospitals and other facilities. It
allows a pharmacist to perform safety and quality checks and approve medication
orders electronically. Nurses gain
immediate access to drugs from the point-of-care cabinets on the nursing unit.
The drugs in these cabinets are packaged as unit-dose packages (i.e., a
single dose per package) and are placed in individual compartments in the
cabinet. In order to access
medications, the nurse must first authenticate his or her identity. While
this technology has greatly decreased the number of steps in the medication-use
process in the hospital and thus has significantly improved safety, our hospital
customers have been clamoring for even more patient protections in the
medication-use process. They want
to ensure that the right patient is getting the right medication
in the right dose by the right route at the right time. This
can be accomplished by utilizing bar code-scanning technology at the point of
administration, i.e., at the patient's bedside, to verify administration of
the proper medication. This verification is accomplished through the use of bar
codes on medication packages, the patient's hospital identification bracelet,
and the nurse's name badge. Once
the nurse obtains the medication for a patient, a bar code on the unit-dose
medication package is scanned with a hand-held device.
The nurse then scans the bar code on the patient's bracelet and the bar
code on his or her name badge. A
rules-driven software program hosted on a computer verifies that the right
patient is receiving the appropriate medication.
If there are any safety concerns such as a wrong drug, dosage, etc., an
alert is presented immediately notifying the nurse of the problem and thus
helping to prevent an error. This
new technology is important to patients as well as healthcare providers.
If the Chairman would allow, I have a short video of the Pyxis Veri5SM
system that I would like to play at the end of my testimony to demonstrate how
this technology works. Such
bedside, medication-verification products have only been on the market as a
complete system for approximately two years.
Hospitals choosing to implement this technology must invest in the
technology itself as well as a radio-frequency infrastructure and then train
their staff. However, the most
significant obstacle that inhibits the adoption rate for this exciting
technology is the lack of bar codes on unit-dose medications.
Presently, approximately 30 percent of the unit-dose medications have
manufacturer-printed bar codes. This
means that hospitals must either pay a third-party vendor to repackage their
unit-dose medications with bar code labeling or invest in capital equipment to
repackage and bar code the unit-dose medications within the hospital.
The first of these alternatives drives additional operating costs while
the second alternative requires a capital investment plus the expense of
precious staff time to operate the equipment.
Further, current Food and Drug Administration (FDA) and Drug Enforcement
Administration (DEA) regulations place constraints on repackaging and relabeling
of unit-dose medications. More
specifically, third-party vendors as well as hospital systems are constrained in
packaging unit-dose medications at one facility for transfer to other hospitals,
even to hospitals within the same system. This
further impedes efficient use of both capital and human resources. We
were very encouraged to see that the FDA has indicated an intent to publish a
notice of proposed rulemaking on the issue of bar coding of pharmaceuticals.
Development of a uniform standard for the bar coding of unit-dose
medications used within the institutional setting would be extremely helpful.
However, this must be done in the most cost-effective manner possible for
both providers and pharmaceutical manufacturers.
Cardinal Health recognizes that health care costs continue to increase,
and if the regulations are too complex or rigid, we may not only increase costs
inappropriately but also unintentionally delay the implementation of this
important safety initiative. Cardinal
Health also sees a tremendous potential for utilizing automated medication
dispensing equipment and bedside verification tools in nursing homes.
Given the elderly population and the high use of pharmaceuticals in this
setting, the patient safety advantages could be most significant. However, the DEA currently prohibits "floor stock" in
nursing homes, instead requiring that drugs be prepackaged for each patient for
one month at a time. While this
site of care closely mirrors a hospital setting, it is treated through
regulations as an outpatient setting. The
current distribution system has some advantages, but it also creates a great
deal of waste and inefficiencies. The
DEA published a concept paper on the issue of automated dispensing equipment in
nursing homes over a year ago. We
would encourage additional attention to this issue.
Technology has advanced greatly over the past several years and could now
accurately inventory and distribute medications in a safe and effective manner
so as to improve the administration of medications within the nursing home
setting. Again, I appreciate the opportunity to testify about just two of the innovative patient safety tools that Cardinal Health provides to help ensure medications are used safely and appropriately. I would be pleased to answer any questions the Committee Members may have regarding my testimony. Thank you. [1]
Kreling, David H., Mott, David A., Wiederholt, Joseph B. of the University
of Wisconsin School of Pharmacy and Lundy, Janet, Levitt, Larry of The
Kaiser Family Foundation, Prescription Drug Trends: A Chartbook Update.
November 2001. [2]
Prescription Drugs: A Survey of
Consumer Use, Attitudes and Behavior. American Association of Retired
Persons, Washington, D.C., 1984. [3]
A Study of Long-Term Care in Oregon
with Emphasis on the Elderly. Oregon Department of Human Resources,
March 1981. [4]
Noncompliance with Medications: An Economic Tragedy with Important
Implications for Health Care Reform. The Task Force for Compliance,
April 1994. [5]
Smith, M. The Cost of Non-Compliance
and the Capacity of Improved Health Care Costs. In Improving
Medication Compliance, Proceedings of a Symposium. N&I
Pharmaceutical Council, 1984. [6]
Lockhart, Hugh E., Twede, Diana, Thomas, Dena Briggs, Kokikar,
Manisha P. Comparative Cost Study: Packaging of Solid Oral Pharmaceutical
Dosage Forms in Bulk and in Unit Dose Blisters. Michigan State
University School of Packaging, April 1994. [7]
Bates, DW, Cullen, DJ, Laird, N, et al. Incidence
of Adverse Drug Events and Potential Adverse Drug Events: Implications for
Prevention. Journal of the American Medical Association, 1995;
274(1):29-34. [8]
Bates, DW, Spell, N, Cullen, DJ, et al. The
Costs of Adverse Drug Events in Hospitalized Patients. Adverse Drug
Events Prevention Study Group. Journal of the American Medical
Association, 1997;
277(4):307-11. [9]
Leape, LL. The Health Profession's
Responsibility for Reducing Adverse Drug Events:
Improving the Quality of the Medication Use Process. Escovitz, A, Pathak,
DS, Schneider, PJ (eds). New York: Pharmaceutical Products Press.
1998:109-134.
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