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October 14, 2003

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. 00N-1484; Safety Reporting Requirements for Human Drug
and Biological Products; Proposed Rule (68 Fed. Reg. 12406, March 14,
2003)

Dear Sir or Madam:

The Institute for Safe Medication Practices (ISMP), the nation's only
nonprofit healthcare agency devoted exclusively to medication error
prevention, wishes to comment on the Food and Drug Administration (FDA)
proposed revisions to regulations pertaining to manufacturer reporting
of medication errors with human drug and biological products. The
comments below reflect our concerns with the proposed revisions.

\(1\) Burdensome query process could lead to reduced practitioner
reporting, limited willingness to participate in follow-up, and
increased anonymous error reporting.

Currently, FDA's MedWatch Program receives the majority of its
non-industry reports of medication errors through the United States
Pharmacopeia (USP)-ISMP Medication Error Reporting Program (MERP). In
addition, many industry field reports that are sent to MedWatch are
initially stimulated by the ongoing correspondence between ISMP and the
industry. In turn, ISMP analyzes all medication error reports in
collaboration with a national multidisciplinary advisory panel, and
disseminates error prevention strategies through its biweekly and
monthly publications to millions of healthcare providers and consumers.
Although we applaud FDA's desire to rapidly identify potential problems
associated with the use of drug and biological products, we are
concerned that the proposed rules will reduce voluntary practitioner
error reporting, as well as impact the ability of organizations such as
ISMP to accurately analyze error reports and obtain crucial feedback
from reporters about the causative factors.

Specifically, ISMP is concerned that the "active query" component of the
proposal will make error reporting an onerous task for healthcare
professionals, which in turn may suppress voluntary practitioner
reporting of medication errors. Pharmaceutical manufacturers will be
required to directly contact (in person, by telephone, or other
interactive means) the initial reporter of a suspected adverse drug
reaction (SADR) or medication error. We are concerned that this contact
will involve querying the reporter for information that must be provided
on the FDA MedWatch 3500 form. However, many healthcare practitioners,
particularly those in the nation's hospitals and community pharmacies,
now find themselves overburdened with patient care responsibilities. If
they are placed in the position of choosing between complying with
requests for information from the industry, or performing their patient
care activities, the proposed rule might work to suppress voluntary
error reporting by practitioners.

Additionally, the burden of providing additional details to the industry
will likely lead to an increased number of practitioners who request
anonymity with the pharmaceutical companies when submitting error
reports to ISMP. Since a large percentage of reports originate with
ISMP, the proposal will likely mean that ISMP staff must serve as an
intermediary between the reporter and the company. Reporters who will
reveal their identity to the company will, most likely, receive
follow-up calls from ISMP as well as the company. If this is viewed as
burdensome, it could have a chilling effect on the practitioner's
willingness to cooperate. Worse, some may submit fully anonymous
reports, which will make it impossible for ISMP to perform the necessary
follow-up to learn about the causes of the error.

Practitioners may also lose enthusiasm for reporting errors and SADRs if
the industry fails to use the information to improve safety. Too often,
in response to an error report, we've received letters from
manufacturers simply stating: "Thank you for telling us about this
problem...We will enter it into our database and inform appropriate
staff ....We will continue to monitor the problem." In the meantime,
errors continue. To facilitate change, ISMP takes the time to contact
our advisory members and solicit input from other healthcare
organizations to ascertain if the problem exists elsewhere. One can't
expect the companies to solicit this type of information. If the
company's reaction to a report is without substance -- without
appropriate follow-up and improvement actions - it will be frustrating
to practitioners. This can only serve to reduce the frequency of
reporting.

\(2\) Short deadline could lead to inaccurate and incomplete follow-up.

The proposed revisions also set a 15-day deadline for receipt of reports
from the industry, complete with analysis. In our experience with a
voluntary reporting program, we have seen many circumstances in which
practitioners are unable to respond to queries for more information for
weeks, even months. Quite often, reporters are not the individuals
involved in an incident. Therefore, they do not have complete knowledge
of what went wrong. Individuals who report errors to ISMP are more than
willing to track down the information, especially since they have
reported the error for altruistic reasons, not as a mandate. With a
15-day rule, practitioners may feel pressured to provide "assumptions"
when queried, and the most valuable information about the causative
factors could be lost. A minimum of 30 days, preferably 60 days, should
be allowed to ensure accurate follow-up.

\(3\) Lack of guidelines for company interaction with practitioners
could lead to counterproductive blaming.

The proposal does not offer company representative standard guidelines
for interacting with reporters after notification of an error. In our
experience, companies too often place blame on the reporter or other
practitioners involved in the error instead of accepting responsibility
for the role that their product's packaging, labeling, name, marketing,
or other product-related problem may have played a role in the error.
Products with look-alike labeling or names are an example. Many
companies simply respond that the current label in question complies
with FDA guidelines, and that practitioners simply need to "be more
careful" when reading labels. For a name-related problem, companies may
blame practitioner's poor handwriting or inattention to the label while
overlooking their responsibility for marketing a product with a name
similar to another. The document should clearly outline the company's
responsibility in analyzing errors and understanding any product-related
contribution to the error.

\(4\) Lack of expertise could lead to ineffective error analysis and
learning.

The proposal does not recognize that errors are always multifactorial,
and therefore not solely connected with the product itself. If
improvements are to be made, a high degree of expertise is required to
fully understand how various components of system breakdowns may have
contributed to the error. ISMP has analyzed thousands of errors over the
past 25 years. With our breadth and depth of experience in this area, we
firmly **disagree** with the proposal's premise that any physician,
physician assistant, pharmacist, dentist, nurse, or any individual with
some form of healthcare training has the experience and background
necessary to conduct proper error analysis. To meet the requirements set
forth in the proposal for analysis of reported medication errors,
expertise will be needed in root cause analysis and systems analysis. It
is doubtful that many industry professionals are currently trained in
these areas, or would be able to be quickly trained for this purpose. It
is critically important that those who perform the analysis possess or
seek out the necessary expertise to gain an understanding of system
causes of errors, the role of human factors, and how technology can lead
to new sources of error. Otherwise, the analysis should be outsourced to
a professional safety organization capable of this work. Without proper
analysis, wrong conclusions may be drawn, and preventive measures may
not address the underlying causes of the error. Even worse, the
manufacturer could recast some product-related issues as practice issues
since there is an inherent conflict of interest with making the
manufacturer - not an independent body - responsible for determine the
underlying causes of an error. This could lead to the detriment of the
public health.

\(5\) Cumbersome process for reporting and inability to contact a
consistent company liaison person could lead to inefficiency,
ineffective follow-up, and underreporting.

ISMP is concerned that the proposal does not require each company to
provide a toll-free telephone number so that practitioners or healthcare
organizations can expeditiously and effectively report errors. Also,
there is no requirement for each company to appoint a liaison officer
for medication error reporting. ISMP wishes to emphasize that these
components are vitally important to facilitate practitioner reporting
and follow-up by organizations like ISMP, regardless of the proposal as
written. Currently, it is difficult, if not impossible, to determine the
appropriate contact person in the company when a practitioner or
organization wants to report or discuss a problem. Additionally, company
letters acknowledging a reported problem often do not include an
employee name or signature or telephone number for follow-up contact.
Thus, it is also impossible for the practitioner to follow up with the
proper individual at the company. Based on our extensive experience with
calling companies in response to an error, company telephone operators
characteristically shift callers from one person to another in an
attempt to reach the right person. A great deal of time is wasted and,
often, someone who does not fully understand the problem is assigned
responsibility for addressing the issue.

\(6\) The definition of a medication error covers more practice-related
issues for which there may be inadequate expertise to address.

ISMP is also concerned about the proposed definition of a medication
error:

"Any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in the control of
the health care professional, patient, or consumer. Such events may be
related to professional practice, health care products, procedures, and
systems including: Prescribing; order communication; product labeling,
packaging, and nomenclature; compounding; dispensing; distribution;
administration; education; monitoring; and use."

This definition includes errors that are more directly related to
practice issues than to product issues. ISMP does not believe that
pharmaceutical companies or FDA are properly positioned, or in a
position of authority, to manage practice-related errors. Neither the
companies nor FDA will be able to adequately address practice-related
questions or error prevention recommendations with reporters. Instead,
FDA and the companies should concentrate their efforts on product issues
such as drug packaging, nomenclature, and labeling, and safety
organizations like ISMP, patient safety coalitions, professional
organizations, and local expert groups should address those issues as
well as practice-related issues. Therefore, the definition of medication
errors as it relates to this proposal should reflect the appropriate
product-related focus. Also, if FDA encourages a broad array of errors
as described in the currently proposed definition, there could be a
significant reduction in the number of practice-related errors reported
to other voluntary reporting systems, such as the MERP. Practitioners
could, rightly so, resist any suggestion of duplicate reporting.

\(7\) Focus on frequency of reports, not quality of reports, could
undermine crucial proactive error-reduction efforts.

The proposal requires companies to submit every reported incident, from
a "near miss" to a serious error. It seems that FDA plans to use the
frequency of reported problems as an indication of whether action is
warranted. Equal concern is not apparent for the quality of the reports,
nor is it apparent that a single event could stimulate change. ISMP has
repeatedly demonstrated in ongoing publications that even the first
"near miss" product issue might be an important indication that a
serious product-related problem exists, and, that action should be taken
immediately, depending on what the potential outcome of that near miss
may be.

**Requirement of a \"full data set\" as proposed does not provide for
data regarding contributing factors leading to a medication error**

In analyzing errors, it is important to understand contributing factors.
The proposed rule indicates that submissions will require a full data
set including completion of all the applicable elements on FDA Form
3500A (or the Vaccine Adverse Event Reporting System (VAERS) form for
proposed § 600.80(a)) (or on a Council for International Organizations
of Medical Sciences (CIOMS) I form for reports of foreign SADRs)
including a concise medical narrative of the case (i.e., an accurate
summary of the relevant data and information pertaining to an SADR or
medication error). While Form 3500A includes information such as the
suspected medications, patient information, date and description of the
event, relevant tests/laboratory data, other relevant patient history
and the outcome attributed to the adverse event, it does not include
space for inclusion of factors that may have contributed to the
medication error. It would be important for FDA to have a separate form
for reporting medication errors since the questions are different than
those that need to be asked for SADRs.

\(9\) Lack of guidelines for product problems involving more than one
manufacturer could lead to inaction and underreporting.

In the proposal, guidance is needed for product errors that involve more
than one manufacturer. For example, many product issues involve
look-alike or sound-alike drug names, or look-alike labeling, with
products from different companies. If the practitioner reports the
problem to one company, who is responsible for notifying the other
involved company or companies? Does it fall on the two companies to
communicate? This responsibility should not fall on the reporter, or
once again, it could lead to frustration and a decrease in the number of
reports.

In closing, ISMP believes that practitioner reporting should be
encouraged to independent organizations that will share the information
with the industry as well as the FDA. The industry should forward
reports it receives to the FDA but should not be expected to provide an
unbiased and independent analysis of the reports. We believe that a
great burden will be placed on the industry in an area in which they do
not have expertise.

We hope that these comments will be helpful. As previously mentioned, we
certainly support the ultimate goal of the proposal, but we believe the
proposed rule as written may have a detrimental effect on voluntary
medication error reporting.

Thank you.

![](media/image2.png){width="1.625in"
height="0.8555555555555555in"}Sincerely yours,

Michael R. Cohen, RPh, MS, ScD

President

MRC/hc