[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23775-23777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10359]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0184]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Patient Information Prototypes
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments for research entitled ``Experimental Study of
Patient Information Prototypes.'' This study is designed to determine
based on different prototype testing whether consumers are able to
comprehend serious warnings, directions for use, drug indications and
uses, contraindications, and side effects in the material that is
presented.
DATES: Submit written or electronic comments on the collection of
information by July 6, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Management Programs (HFA-250), Food and Drug Administration, 1350
Piccard Dr., PI50-400B, Rockville, MD 20850 301-796-3792,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. ``Collection of
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and
includes agency requests or requirements that members of the public
submit reports, keep records, or provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2) (A)) requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Experimental Study of Patient Information Prototypes--New
In order to make informed decisions about health care and to use
their medications correctly, consumers need easy access to up-to-date
and accurate information about the risks, benefits and safe use of
their prescription drugs. Consumers currently receive multiple pieces
of paper with their prescription drugs from the pharmacy, containing
information that is developed and distributed through various sources.
Written prescription drug information is provided through a voluntary
effort (Consumer Medication Information)\1\ as well as through FDA
mandated use of Medication Guides\2\ and Patient Package Inserts
(PPI).\3\ Patients describe a wide range of experiences and varying
degrees of satisfaction with information currently provided at the time
medicines are received at the pharmacy. In some cases, the written
documents are difficult to read and understand, duplicative and
overlapping, incomplete or contradictory. FDA has held multiple public
meetings to solicit feedback on providing balanced, comprehensive and
up-to-date prescription drug information to consumers.
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\1\ Public Law 104-180, August 6, 1996, Title VI. Effective
Medication Guides.
\2\ 21 CFR part 208.
\3\ 21 CFR 310.501 and 310.515.
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Since 1968, FDA regulations have required that PPIs written
specifically for patients be distributed when certain prescription
drugs or classes of prescription drugs are dispensed. PPIs are required
for estrogens and oral contraceptives, are considered part of the
product labeling, and are to be dispensed to the patient with the
product. In the 1970s, FDA began evaluating the general usefulness of
patient labeling for prescription drugs resulting in a series of
regulatory steps to help ensure the availability of useful written
consumer information. Other
[[Page 23776]]
PPIs are submitted to FDA voluntarily by manufacturers and approved by
FDA, but their distribution is not mandated by regulation. In the
Federal Register of July 6, 1979 (44 FR 40016), FDA proposed
regulations that would have required written patient information for
all prescription drugs. In the Federal Register of September 12, 1980
(45 FR 60754), FDA finalized those regulations. In the Federal Register
of September 7, 1982 (47 FR 39147), the regulations were revoked based,
in part, on assurances that the effort could be handled more
efficiently within the private sector.
In the Federal Register of August 24, 1995 (60 FR 44182), FDA
proposed the Prescription Drug Product Labeling: Medication Guide
Requirements, designed to set specific distribution and quality goals
and timeframes for distributing written information to patients. In the
Federal Register of December 1, 1998 (63 FR 66378 at 66396), the agency
published a final rule that established a program under which
Medication Guides would be required for a small number of drugs
considered to pose a serious and significant public health concern (21
CFR 208.20).
Evidence suggests that both the content (e.g., organization) and
format (e.g., white space) of a document will impact the comprehension
of patient information. Research on reading behavior and document
simplification suggests that the use of less complex terminology
presented in shorter sentences with a more organized, or chunked,
structure should improve consumer processing for at least three
reasons. First, it should decrease the cognitive load engendered by the
current physician-directed format. Second, a more structured and
organized patient information document should present a less imposing
processing demand, increasing consumers' willingness and self-perceived
ability to read and understand the presented material. Research with
the format of over-the-counter (OTC) drug labels,\4\ the nutrition
facts label,\5\ and other information formats\6\ demonstrates that
information presented with section headings, graphics (such as
bullets), and other design elements is more easily read than
information presented in paragraph format. Consumers are more likely to
engage in behavior they believe they can successfully complete.\7\
Third, a patient information document that provides readers with
clearer ``signals'' regarding the most important information should
help readers prioritize the importance of the presented information.
This should increase the probability that the set of information
identified as important is subjected to more complete mental
processing, thereby increasing the communication of that
information.\8\
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\4\ Aikin, K.J., ``Consumer Comprehension and Preference for
Variations in the Proposed Over-The-Counter Drug Labeling Format,
Final Report'' (1998); Vigilante, W.J., M.S. Wogalter, ``The
Preferred Order of Over-the-Counter (OTC) Pharmaceutical Label
Components,'' Drug Information Journal, 31, 973-988, 1997.
\5\ Levy, A.S., S.B. Fein, R.E. Schucker. ``More Effective
Nutrition Label Formats Are Not Necessarily More Preferred.''
Journal of the American Dietetic Association, 92(10), 1230-1234,
1992.
\6\ Lorch, R., E. Lorch, ``Effects of Organizational Signals on
Text-Processing Strategies,'' Journal of Educational Psychology,
87(4), 537-544, 1995; Lorch, R., E. Lorch, ``Effects of
Organizational Signals on Free Recall of Expository Text,'' Journal
of Educational Psychology, 88(1), 38-48, 1996; Lorch, R., E. Lorch,
W. Inman, ``Effects of Signaling Topic Structure on Text Recall,''
Journal of Educational Psychology, 85(2), 281-290, 1993.
\7\ Wood, R., A. Bandura, ``Impact of Conceptions of Ability on
Self-regulatory Mechanisms and Complex Decision Making.'' Journal of
Personality and Social Psychology, 56(3), 407-415, 1989.
\8\ Lorch, R., E. Lorch, ``Effects of Organizational Signals on
Text-processing Strategies, '' Journal of Educational Psychology,
87(4), 537-544, 1995; Lorch, R., E. Lorch, ``Effects of
Organizational Signals on Free Recall of Expository Text,'' Journal
of Educational Psychology, 88(1), 38-48, 1996; Lorch, R., E. Lorch,
W. Inman, ``Effects of Signaling Topic Structure on Text Recall,''
Journal of Educational Psychology, 85(2), 281-290, 1993.
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As part of FDA's efforts to improve the patient information
received with prescription drugs, a Risk Communications Advisory
Committee meeting was held on February 26 and 27, 2009. At this
meeting, committee members discussed issues such as the ones described
previously in this document and listened to stakeholder problems
regarding the design and distribution of patient information. Following
the advisory committee meeting, the working group created four
prototypes to aid discussion at a public workshop to be held later in
the year.
This public workshop was held on September 24 and 25, 2009. During
the workshop stakeholders from industry, consumer advocacy, and
academia converged to discuss desirable features for a single-document
patient leaflet, if that were to be developed, consumer tested and
distributed. Participants were divided into six groups to address the
pros and cons of the four prototypes with the goal of deciding which
features participants appreciated and did not appreciate. Additional
information on the September 24 and 25, 2009, public workshop, is
available at http://www.fda.gov/Drugs/NewsEvents/ucm168106.htm.
Given the information obtained from workshop participants, the
working group refined several prototypes and designed a study to
investigate the usefulness of three possible patient information
formats from a user perspective. The results of this study will inform
FDA as to the usefulness and parameters of various format options for
the patient information documents.
II. Description of the Project
This project is designed to test different ways of presenting
information about prescription drugs to patients who have obtained a
prescription. The information used will be based on a fictitious
medication for the treatment of rheumatoid arthritis, ankylosing
spondylitis, and plaque psoriasis. Data collection will occur via
computer at training and testing facilities with orientation and
debriefing conducted by interviewers. Participants will include adults
who have been diagnosed with one of the conditions the fictitious drug
treats. Participants will be prescreened to obtain a reasonable
representation of health literacy, including those who score at the
lower end of the scale. Questionnaire measures will include open- and
closed-ended questions. Extensive pretesting of materials and stimuli
will be conducted to refine the experimental stimuli and dependent
measures and to ensure the stimuli meet minimum communication
requirements and are delivering expected messages.
Proposed Study Design and Protocol
The study is experimental and will have two independent variables
in a 3 x 2 design. The independent variables are Format (3 levels: Drug
Facts, Minimal Column, and Column Plus) and Order (2 levels: Warning
first and Indication first).
[[Page 23777]]
Format
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Order Drug Facts Minimal Column Column Plus
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Warning first ........................... ........................... ...........................
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Indication first ........................... ........................... ...........................
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The Order manipulation will vary the primacy of the boxed warning
information versus the paragraph about the uses to the drug. In terms
of Format, the Drug Facts format will follow the conventions of the
existing OTC labeling. The Minimal Column condition will contain
information in two columns with only basic information in the sections
regarding information patients should tell their doctors. The Column
Plus condition will also present information in two columns, but will
include additional contextual information in the sections about what
information patients should report to their doctors.
Participants with relevant medical conditions will be randomly
assigned to one of the six experimental conditions and each participant
will see only one version of the patient information. Participants will
be prescreened to represent a range of health literacy levels,
including a portion with low literacy. Thus, all participants in the
study will have been diagnosed with rheumatoid arthritis, ankylosing
spondylitis, or plaque psoriasis and at least 30 percent of the sample
will fall in the lower range of literacy. Because the average reading
level in the United States is estimated to be 8th grade\9\ and it is
recommended that consumer medication information be written at a 5th
grade reading level,\10\ the low literate cohort will consist of
consumers who have 5th to 8th grade reading skills. Education level is
not a reliable substitute for literacy testing. At screening, the
participants will be assessed for literacy level using a validated
instrument.
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\9\ Cotunga N., C.E. Vickery, K.M. Carpenter-Haefele,
``Evaluation of Literacy Level of Patient Education Pages in Health-
Related Journals,'' Journal of Community Health, 30(3), 213-219,
2005.
\10\ Andrus, M.R., M.T. Roth, ``Health Literacy: A Review,''
Pharmacotherapy, 22(3), 282-302, 2002.
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An additional small study will be conducted via the Internet to
determine whether electronic prototype presentation alters the
processing of the information in any way. Two-hundred individuals with
the same characteristics of the original sample (e.g., medical
condition and literacy levels) will be recruited over the Internet and
will complete the same questionnaire as original participants.
FDA is undertaking this study because it does not yet have
sufficient evidence-based research relating to patient needs, or
whether those needs are being effectively met. Research related to the
functionality and effectiveness of written patient information
consistently identifies the importance of performance-based testing as
well as content based testing, which enables the evaluation of
materials in order to assure their utility and identify issues in
content format, or design. Development of new prescription drug patient
materials must be based on consumer testing that focuses on utility to
the patient and comprehension of material in the broadest audience
possible. FDA has developed three prototypes in order to user test
prescription drug information with consumers in order to achieve this
goal. For further information, contact Elizabeth Berbakos (see FOR
FURTHER INFORMATION CONTACT).
The burden table reflects up to three pretests of 180 individuals
each, 900 participants in the main study, and 200 participants in the
followup study involving electronic administration.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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21 CFR Annual Frequency Total Annual Hours per
Section No. of Respondents per Response Responses Response Total Hours
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540 1 540 20/60 178
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900 1 900 25/60 369
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200 1 200 25/60 82
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Total 629
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10359 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S