HOUSE COMMERCE COMMITTEE
Subcommittee on Health and the Environment
Subcommittee on Oversight and Investigations
HOUSE COMMITTEE ON VETERANS AFFAIRS
Subcommittee on Health
Hearing on "Medical Errors:
Improving Quality of Care and Consumer Information"
February 9, 2000
Rayburn House Office Building Room
2123
Washington, D. C.
Written Testimony Submitted by
Diane D. Cousins, R.Ph.
Vice President
Practitioner and Product Experience
U. S. Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
301/881-0666; DDC@usp.org
U. S. Pharmacopeia
Statement for Consideration of
the
House Committees on Commerce and Veterans Affairs
The United States Pharmacopeia (USP) is pleased to have
the opportunity to provide this statement to the House Commerce Subcommittees on Health
and Environment and Oversight and Investigations and the Veterans Affairs
Subcommittee on Health. USP strongly supports Congressional consideration of actions it
might take to ensure the significant reduction of preventable medical mistakes that occur
throughout the continuum of the prescription, dispensing, administration, and use of
medicines. USP further believes that development and implementation of federal legislation
and regulatory policies, which will direct and guide public and private initiatives at the
national, state, and local levels, must be achieved to ensure patient safety from medical
mistakes, and to reduce substantively the multi-billion dollars that such mistakes
currently cost the health care system each year.
USP comments, offered for consideration, cover the
following:
- Information about the U. S. Pharmacopeias 30-year
record of stimulating voluntary health care practitioner reporting and using the analysis
of those reports to improving patient safety.
- Background on USPs ability to affect change in drug
product labeling, packaging, and nomenclature when such are identified as contributing to
medication errors.
- An explanation of USPs new MedMARx program---a
national, Internet-based, anonymous medication error reporting system, introduced in July
1998, and now used by over 150 U.S hospitals.
- A recommendation for Congressional action that can directly
and quickly remove one of the most significant barriers to hospital and practitioner
reporting of medication errors.
USPs Medication Error Reporting Experience
Background
USP, founded in 1820, is a volunteer-based, not-for-profit
organization whose sole mission is to
promote the public health by establishing and disseminating
officially recognized standards of quality and authoritative information for the use of
medicines and related articles for professionals, patients, and consumers. It is composed
of approximately 500 members representing state associations and colleges of medicine and
pharmacy, ten agencies of the federal government, and about 75 national professional,
scientific and trade organizations, and members-at-large, including government agencies
from other countries that recognize USP standards and non-U.S. pharmacopeias. The
USPs expertise as a standards-setting body has been recognized by Congress in the
enactment of the Drug Import Act of 1848, the Pure Food and Drug Act of 1906, the Federal
Food Drug and Cosmetic Act in 1938, and by the Food and Drug Modernization Act in 1997,
and others. Standards published in the official compendia,
U. S. Pharmacopeia and National Formulary (USP-NF)
are also referenced in most state pharmacy laws governing practice.
USP began developing information relating to proper
medicine use, in 1970, as support to its
standards-setting activities. The USP DI, the
compendia of USP drug information, is today recognized by the Federal Omnibus Budget
Reconciliation Acts of 1990 and 1994 as a reimbursement resource for Medicaid Agencies
considering issues associated with off-label uses of medicines and guidance for patient
counseling. Based upon its federal recognition, and its reputation as a credible,
authoritative, and non-biased source of information developed by approximately 800
volunteer experts, USP DI® also serves as a reimbursement resource for insurers
and third party payers, and as the basis for drug formulary decisions.
The process by which drug standards and information are
developed is open, participative (notice and comment) and subject to integrity safeguards,
including conflict of interest disclosure.
USP Practitioner and Product Experience Programs
Because of our concern with the quality of drug products on
the market, in 1971, the USP co-founded the Drug Product Problem Reporting Programa
national program in which health professionals were asked to voluntarily report problems
and defects experienced with drug products on the market. Often the product problems or
defects had to do with inadequate packaging or labelinglabeling that could lead to
confusion on the part of health professionals or lead to errors; for example, look-alike
color or design labels (color and design) and sound-alike drug names. Today, we continue
to operate our Drug Product Problem Reporting, and a newer program, the Veterinary
Practitioners Reporting Program, which collect voluntary reports on human and animal drug
products.
Eight years ago, in 1991, USP decided to focus more
intensely on the problem of medication errors and what it could do to prevent them. Our
focus today is on both the product and on the system in which the product is prescribed,
dispensed, administered, and used. USP does not set practice standards per se, but
practicably, many of our standards do indirectly affect professional practice and many
practice standards are based on USP-NF standards.
The USP learned that The Institute for Safe Medication
Practices (ISMP) was seeking support of a national organization to bring its program, The
Medication Errors Reporting (MER) Program, to the national level. USP agreed to coordinate
the national program for ISMP. The
MER Program is now one of four USP voluntary, spontaneous
reporting programs for health care practitioners. The MER Program is operated under the
umbrella of the USP Practitioner and Product Experience Division.
Since late 1991, the MER Program has received more than
4,000 voluntary reports of actual and potential medication errors. We also continue to
receive medication error reports through USPs other reporting programs. These
reports have identified errors in various health care delivery environments, including
hospitals, nursing homes, physicians office, pharmacies, emergency response
vehicles, and home care. Through these reports, we have seen that errors are
multi-disciplinary and multi-factorial. They can be and are committed by experienced and
inexperienced health professionals, support personnel, interns, students, and even
patients and their caregivers. Medication errors can and regularly do occur anywhere along
the continuum from prescribing to transcribing to dispensing and administration. The
causes of errors may be attributed to human error, to product names or designs, and to the
medication handling and delivery systems in which the products are used and individuals
operate and interact. For purposes of voluntary reporting, USP does not seek to limit the
types of errors that may be reported, because all information received may have some
future value in determining how to reduce or prevent errors. We do not, however, actively
solicit reports of adverse drug reactions, but USP cooperates with the Food and Drug
Administration as a MedWatch partner and refer all reports submitted to USP.
We recognize that an actual error may be reported as a
potential error because of liability concerns, or a facilitys risk management
policies, so each report is treated with the utmost seriousness by USP, no matter how it
is characterized by the reporter. As each MER report is received, it is shared with the
product manufacturer and with the Food and Drug Administration. USP does not require, in
the MER Program, that the name of the reporter, patient identity, or facility be provided.
If provided, however, USP respects the desire of the reporter to keep his or her identity
confidential and will purge the identity of the individuals or institutions named in the
report in accordance with the instructions of the reporter. Reporters are advised of any
actions resulting from their report either individually or through USPs Quality
Review publication, which is disseminated to all persons who have reported to the MER
Program and is publicly available on USPs web site.
USPs Ability to Affect Change
USP has 30 years of experience and demonstrated
effectiveness in designing and operating voluntary reporting systems for health care
professionals relating to drugs and their use, and using those data to improve product
standards and safe drug use information.
Standards-Setting Authority
Encouraging the reporting of errors is only one aspect of
USPs efforts to promote safety of the medication use system. USP evaluates and
implements, through its standards-setting authority, changes in drug products to prevent
the recurrence of errors. The following examples describe some of the changes or other
steps taken by USP in response to MER Program reports.
- Death reported due to the accidental misadministration of
concentrated Potassium Chloride Injection led to (1) changing the official USP name to
Potassium Chloride for Injection Concentrate (emphasis added) to give more
prominence to the need to dilute the product prior to use; (2) labels must now bear a
boxed warning "Concentrate: Must be Diluted Before Use;" and (3) the cap must be
black in color (the use of black caps is restricted to this drug product only), and (4)
the cap must be imprinted in a contrasting color with the words, "Must be
Diluted."
- Deaths reported due to the confusion and resultant injection
of the anticancer drug, Vincristine Sulfate for Injection, directly into the spine instead
of into the vein, resulted in changes in the requirements for packaging by pharmacies and
manufacturers preparing ready-to-use doses. Each dose, whether prepared by the
manufacturer or the pharmacist, now must be wrapped in a covering labeled "FOR
INTRAVENOUS USE ONLY" and that covering may not be removed until the moment of
injection.
- Deaths reported due to the name similarity of Amrinone
and Amiodarone have lead USP and the United States Adopted Names (USAN) Council to
consider changing the official and nonproprietary names of one, or both, products. {See
attached Quality Review: "Proposed Drug Name Changes for Error
Protection."}
- Deaths reported due to the inadvertent mix-up of
neuromuscular blocking agents (which paralyze the respiratory system) with other drugs,
have led to recommended changes in standards for labeling and packaging of the therapeutic
class of neuro-muscular blocking agent products.
- Medication Error Reporting reports of deaths identified the
need to establish dosing limitations for the sedative-hypnotic Chloral Hydrate for use in
children, and for the anti-gout drug Colchicine. These dosing limitations have been
incorporated into the USP DI information in a special section in each drug monograph to
caution health professionals on each drugs proper use based upon reports of errors
received through the program.
{See attached examples of Quality Reviews that
describe other medication errors identified through the MER Program and for which USP has
identified and communicated to health care professionals information and prevention
strategies: "Three is a Crowd;" "Insulin Oversight " and
"Vincristine Sulfate Monographs Revised
Dispensing Pharmacy Practice
Affected."}
Throughout its 180-year history, USP has focused on
improving the quality of our medicines and their appropriate use. All of USPs
programs focus on these goals. The standards in the official compendia, the USP-NF,
define the identity, strength, purity, quality, packaging and labeling of drugs and their
dosage forms. The USP is a member, with the American Medical Association, American
Pharmaceutical Association, and the Food and Drug Administration of the United States
Adopted Names Council (USAN) and publishes USAN names in the USP Dictionary of Drug
USAN and International Drug Names, which is an international resource for
pharmaceutical manufacturers, regulators, and health care practitioners. As noted
elsewhere in this testimony, USP has taken actions, independently and in concert
with USAN, to change the names of drugs and dosage forms when they have resulted in
medication errors.
Reported medication errors also have brought about other
changes in USP standards and guidance to practitioners. For example, (1) USP discontinued
recognition in the USP-NF of the apothecary system, a centuries old system of
measuring weights and measures, in favor of the metric system in order to avoid
misinterpretations that led to overdoses; (2) USP has made changes in general label
requirements for marketed drug products, strengths less than one unit must be expressed as
a decimal preceded by a zero (e.g. 0.1 grams, not .1 grams) to avoid ten-fold overdoses;
and (3) USP standards also require that the strength of a product when expressed as a
whole number be shown without a zero trailing the decimal to avoid ten-fold overdoses by
the lack of recognition of the decimal point (e.g. 1mg, not 1.0 mg).
Collaborative Relationships: Food and Drug
Administration; National Association of Boards of
Pharmacy; Colleges of Pharmacy
Prior to the formation of the Food and Drug Administration
(FDA) Office of Post Marketing Drug Risk Assessment, the Agency developed a formal
mechanism for receiving and evaluating MER reportsthe Subcommittee on Medication
Errors. USP and FDA also created a joint advisory panel on the Simplification and
Improvement of Injection Labeling to reduce medication errors. The Food and Drug
Modernization Act of 1997 recognizes product labeling recommendations of that joint
initiative.
In 1991, to expand the scope of the MER Program, USP
developed a joint program with the National Association of Boards of Pharmacy. The Boards
of Pharmacy database is maintained by USP and assists each Board of Pharmacy to determine
the relative extent of errors in its state and contributes to the overall incident
collection effort.
In addition to using the MER program to stimulate changes
in enforceable standards and information, USP has used the MER information to develop
educational tools for the health professions. In 1993, a curricular resource entitled--Understanding
and Preventing Medication Errors--was distributed at no charge of colleges of pharmacy
throughout the U.S. USP also has attempted to reach the public directly to teach patients
how to protect themselves from medication errors through the development of a public
service campaignJust Ask
About Preventing Medication Errors.
National Coordinating Council for Medication Error
Reporting and Prevention
USP has worked diligently during the past eight years,
particularly in the standards-setting area, to build coalitions among health care
organizations and to provide health care expert review of medication errors. In 1995 USP
spearheaded formation of the National Coordinating Council for Medication Error Reporting
and Prevention (NCC MERP). USP is the founding organization and continues to serve as NCC
MERP Secretariat. To date, NCC MERP, comprises of 17 national organizations and federal
agencies that share a common mission to promote the reporting, understanding and
prevention of medication errors. Member organizations include practice organizations of
medicine, nursing, and pharmacy, the licensing board of pharmacy and nursing,
organizations of the pharmaceutical industry, the Department of Veterans Affairs, the
Joint Commission, regulators, the FDA, the Joint Commission on the Accreditation of
Healthcare Organizations (JCAHO), the American Hospital Association, and USP. In the years
since its inception, the Council has produced internationally recognized work products,
such as:
- a standardized definition of "medication error."
[See Quality Review: National Council Focuses on Coordinating Error Reduction
Efforts "
- a categorization index to classify medication errors by the
severity of the outcome to the patient
- a taxonomy of medication errors
- recommendations to reduce the error prone aspects of
prescription writing; product labeling and packaging; and broad recommendations related to
the dispensing and administration phases of the medication use process.
The Council is now re-examining how the standardized
definitions noted above and in the attached Quality Review: "Use
CautionAvoid Confusion" can be honed, based upon experience gained from the MER
and MedMARx (see below) Programs to provide clearer differentiation between categories. In
addition the Council is examining issues of process failures in the use of verbal orders,
benchmarking and inter-organizational comparisons, and error rates.
Ad hoc Advisory Panel on Medication Errors
In 1996 USP appointed an Advisory Panel on Medication
Errors, an interdisciplinary group of health care practitioners who: review reports
submitted to the USP Medication Errors Reporting Program; make recommendations for USP
standards-setting; and make recommendations and participate in the activity of the NCC
MERP. Mr. Michael Cohen, ISMP President, served as the first chair of this Panel and
continues to serve as a member.
In 2000, USP will constitute a new expert committee on
"Safe Medication Use" that will fulfill a broader scope of responsibilities of
the Advisory Panel that it will replace. The new expert
committee will review data and provide guidance for the
development of best practice solutions that will result in the reduction and prevention of
medication errors.
USP DI and Drug Information Expert Advisory Panels
The USP DI database is recognized internationally as
containing the most up-to-date and authoritative information on off-label uses, warnings,
contraindications, etc. New USP programs that will enrich the USP DI database will focus
on the special needs to standardize products and develop information for neonatal,
pediatric, and geriatric patients and populations. A unique contribution of the pediatric
effort, developed in conjunction with experts in pediatric medicine communications is the
"Ten Guiding Principles on the Use of Medicines by Children and Adolescents."
These principles have been distributed broadly and are being used in educational materials
by pharmaceutical manufacturers and volunteer organizations. [See Guiding Principles Ruler
enclosed.]
USPs MedMARx Program
In early 1998, USP developed a nationwide program for
hospitals to report medication errors. Hospitals were eager to submit reports to USP if
reporting could be done anonymously and in a standardized format that would allow
hospitals to track trends, and compare their data to other participating hospitals.
USPs goal was to develop a model for hospitals first, ensure success of the model,
then broaden the model to include other health care settings, e.g. long-term and
ambulatory care settings, and other types of reporting such as medical error and adverse
drug reactions.
On July 27, 1998, USP made MedMARx available to
hospitals nationwide. MedMARx (pronounced med marks) is an
internet-accessible, anonymous reporting program that enables hospitals to voluntarily
report, track and trend data incorporating nationally standardized data elements (i.e.,
definitions and taxonomy) of the USP Medication Errors Reporting Program, the National
Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), and the
American Society of Health-System Pharmacists. MedMARx is structured to support an
interdisciplinary systems-approach to medication error reduction and fosters a
non-punitive environment for reporting.
Hospitals are encouraged to use MedMARx as part of the
organizations internal quality improvement process, thereby extending their
"peer-review" group to the group of hospitals in the program. Hospitals review
the errors entered by other institutions in "real time" and also can view any
reported action taken by another institution in response to an error or to avoid future
similar errors. This feature affords institutions the opportunity to examine errors in a
proactive manner. For example, the institution can review the error profile of a drug or
class of drugs before a product is added to the institutions formulary to determine
if certain risk prevention measures or training programs should be instituted prior to the
drugs availability within the institution. Or, if the error profile is significantly
serious, a determination to not stock the drug can be made. MedMARx also supports
the performance improvement standards of the Joint Commission on the Accreditation of
Healthcare Organizations (JCAHO), which requires institutions to look outward at the
experiences of others in order to reduce risk.
Currently over 150 hospitals have enrolled in the MedMARx
program and other progressive hospitals and health systems are joining rapidly. Profiles
of the participants show that hospitals of various types and sizes spanning fewer than 50
beds to approximately 1000 beds are enrolled. MedMARx hospitals include institutions of
the Department of Veterans Affairs and the Department of Defense, and state-owned
facilities.
The USP commitment to MedMARx is broader than merely
collecting data. In the coming year, USP will enroll champion hospitals participating in
MedMARx in a long-term project to propose indicators of quality in the medication use
process and to identify best practice standards and best process standards
for the medication-use system.
A Recommendation for Congressional Action
USP is heartened by the national attention resulting
from release of the Institute of Medicine ReportTo Err is HumanBuilding a
Safer Health System." USP is particularly gratified at the immediate action being
taken by the House Commerce Committees Subcommittees on Health and Environment and
Oversight and Investigations and the House Committee on Veterans Affairs
Subcommittee on Health. We are pleased to offer the following specific recommendations:
- Focus Attention on the Quality of Health Care System
As the first step in preventing medication errors, the
priority should be on fixing the system, not the blame. The IOM report is clear that
mandatory programs at state and federal levels have not effectively captured the full
number of errors occurring. The report argues that the public needs some assurance of a
minimum level of protection (i.e., through reporting, investigations and follow-up) and
that health care organizations need to be "incentivized" to improve patient
safety. In fact, mandatory reporting could provide a false sense of protection if the
mandatory programs are no more effective than those already in existence. Therefore,
perhaps the question at this time should be: "What needs to be done to improve the
quality of healthcare systems that will provide these assurances and incentives?"
Numbers and statistics from such mandatory programs may not be as useful to the public
and, in fact, may erode the confidence of the public if shear numbers are used as a gauge
of quality. What confidence can a citizen have in the health care system when the error
profiles for both (or maybe the only) rural hospital(s) in their area show that harmful
errors have occurred there? "To Err Is Human" leads us to believe that no
hospital is likely to be error free. The fact that a harmful error has not yet occurred in
a facility is no assurance that it will not occur, or that it has, in fact, occurred but
has not been recognized as such or reported. To better serve the public, it would be far
more useful to have the knowledge and assurance that the hospital has adopted safer
processes and best practices when errors have occurred in order to reduce the possibility
of errors. We believe a system that provides a public indicator that these best practices
are adopted, in effect a facilitys "report card," would be a more
effective tool for consumers to help choose the best and safest health care facilities for
themselves and their families.
A national voluntary reporting system ensuring
confidentiality in support of the above framework should help accomplish this by reporting
and documenting actions taken in response to an error. A more robust database will also
provide opportunities for risk prevention and designing error out of medication use
processes. As an incentive to report, information submitted to the system should be
treated as privileged per federal statute as is currently the case in states that provide
for peer-review protection. What should be mandated for hospitals and other healthcare
facilities is not reporting, per se, but the development of quality control systems (of
which reporting is a part) that implement these best practices and improvements to prevent
and correct system weaknesses. For example, the federal government can create a public
report card using the inspection and survey processes of state boards of pharmacy, HCFA,
and JCAHO. Incentives for facilities can be provided by third party payers and insurers
that require the adoption of such standards and practices into every healthcare system as
a contingency of reimbursement under Medicare and Medicaid programs.
Finally, under all circumstances, every victim and/or the
family should have the legal right to be told by the health care professional or facility
if an error has been committed in the deliverance of their care that has resulted in harm
to the patient, increased hospitalization, or medical or therapeutic intervention.
- Protect the Confidentiality of Data Submitted to National
Voluntary Reporting Programs
Among the IOM Reports discussions and recommendations
is recognition that the absence of federal or state protection from disclosure of
medication error reported information poses a major barrier to voluntary reporting of
errors, or potential errors. Health care practitioners are concerned about reprisals and
practitioners and health care institutions and delivery systems are concerned about
liability. USP believes, therefore, that Congress can make a significant contribution to
the development and successful implementations of systems that facilitate voluntary
medication error reporting and tracking through immediate consideration of legislation
that would protect information developed in connection with error reporting by hospitals
and other institutions and health care settings. USP currently is developing such
legislative language for House and Senate consideration.
Conclusion
In closing, I wish to assure Committee and Subcommittee
members that USP shares with Congress the goal of a safe medication use system. USP has
made a public and long-term commitment to working proactively with all stakeholders toward
that goal. We particularly look forward to working with Congressional leadership on the
issue of fostering effective systems that support best practices, accountability, and
confidentiality to stimulate greater reporting, analysis, and system changes to
prevent medication and medical errors and to ensure confidence in our health care delivery
system.
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