Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions, 27691-27694 [2015-11623]
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Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices
presented coding challenges and that
these challenges have led to the creation
of subsets of LOINC to help facilitate
coding.
• Should FDA identify a LOINC
subset for its use case?
• If yes, should FDA create its own
subset or leverage existing subsets?
• Which LOINC subsets should FDA
consider?
• What steps can FDA take to
minimize the burden to sponsors and
applicants in adopting LOINC within
their organizations to support regulatory
submissions?
II. Comments
Interested persons may submit either
electronic comments to https://
www.regulations.gov or written
comments regarding this notice to the
Division of Dockets Management (see
ADDRESSES). It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
Dated: May 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
On
February 18, 2015, the Agency
submitted a proposed collection of
information entitled, ‘‘Dispute
Resolution Procedures for Science
Based Decisions on Products Regulated
by the Center for Veterinary Medicine’’
to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0566. The
approval expires on April 30, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: May 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–11608 Filed 5–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–11596 Filed 5–13–15; 8:45 am]
Food and Drug Administration
BILLING CODE 4164–01–P
[Docket No. FDA–2014–N–1491]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0509]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Dispute Resolution Procedures for
Science Based Decisions on Products
Regulated by the Center for Veterinary
Medicine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Dispute Resolution Procedures for
Science Based Decisions on Products
Regulated by the Center for Veterinary
Medicine’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
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SUMMARY:
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey of
Pharmacists and Patients; Variations
in the Physical Characteristics of
Generic Drug Pills and Patients’
Perceptions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 15,
2015.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
ADDRESSES:
PO 00000
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27691
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910-New and
title ‘‘Survey of Pharmacists and
Patients; Variations in the Physical
Characteristics of Generic Drug Pills and
Patients’ Perceptions.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Survey of Pharmacists and Patients;
Variations in the Physical
Characteristics of Generic Drug Pills
and Patients’ Perceptions (OMB Control
No. 0910—NEW)
Generic drugs make up approximately
85 percent of all human prescription
drugs prescribed in the United States.
While generic drugs are required to be
pharmaceutically equivalent and
bioequivalent to their brand-name
counterparts, generics made by different
manufacturers may differ substantially
from their brand-name therapeutic
equivalents and from each other in their
physical appearance (e.g., color, shape,
or size of pills). When pharmacists
switch generic drug suppliers, patients
refilling their generic prescriptions may
therefore experience changes in their
drugs’ appearances. These changes may
result in patient confusion and concerns
about the safety and effectiveness of the
generic drug products. Studies indicate
that patients are more likely to stop
taking their generic medications when
they experience a change in their drugs’
physical appearances, leading to
harmful clinical and public health
consequences as well as increased
health care costs from avoidable
morbidity and mortality.
To provide additional information
that may help guide regulatory policy or
pharmacy business practices, we intend
to conduct surveys of pharmacists and
patients about their perceptions about
and experiences with generic drug
product pill appearance change. These
surveys are intended to further our
understanding of the relationship
between changes in pill appearance and
non-adherence to prescribed therapeutic
regimens. The surveys may enable us to
investigate factors that may explain the
association between changes in pill
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27692
Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices
appearance and non-adherence,
including which factors could be
modified to improve the safe and
effective use of generic drugs.
We intend to survey a national cohort
of pharmacists about their experiences
with dispensing generic drug pills that
differ in appearance from previous
refills of the same medication and
dosage level (e.g., when pharmacies
switch generic suppliers). A stratified,
random sample of U.S.-licensed
pharmacists will be obtained based on
a master list from KM Lists. The target
sample includes pharmacists with
active licenses who practice in
traditional community pharmacy
settings and will be proportionally
allocated across the U.S. in relation to
the number of pharmacists in each state.
Based on an 11 percent undeliverable
rate and a 52 percent response rate,
2,161 questionnaires will be mailed to
pharmacists to obtain the 1,000
responses required for adequate
statistical power. The pharmacists’
survey will consist of a mailed
questionnaire rather than a telephone
survey or an email survey. Prior
experience conducting surveys has
shown that it is easier to guarantee
respondent anonymity using an
impersonal, mailed questionnaire with
no individual identifying information.
The pharmacists will be asked about the
frequency with which their pharmacy
changes suppliers that lead to variations
in the appearance of the generic drugs
that they dispense, as well as strategies
they use with patients to address the
transition to pills that have a different
appearance (e.g., alert stickers on pill
bottles, verbal warnings, and other
strategies). They will also be asked
about patient responses to changes in
pill appearance, including what types of
appearance changes seem to affect
patients most often (shape/color/size),
how often patients report confusion
about pill appearance, and how often
patients ultimately refuse to accept the
new product. Participation is expected
to take approximately 20 minutes.
We also intend to survey two different
patient samples using two
methodologies. The first is a telephone
survey of patients who are 50 years and
older and who take one or more generic
medications for at least one of the
following chronic conditions: Epilepsy,
diabetes, hypertension, hyperlipidemia,
depression, and HIV. The telephone
survey will be generalizable and will
consist of well-defined methods to
minimize sampling bias such as use of
random phone numbers for both
landlines and mobile phones, as well as
small-batch sampling to ensure a high
response rate that meets demographic
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diversity goals. For the second patient
survey, patients will be selected from a
proprietary research database of
commercially insured patients
containing medical and pharmacy
claims linked to health insurance
enrollment information. A nationally
representative sample of patients with at
least one chronic condition and who
experienced a change in physical
appearance of a generic pill will be
identified by the research team using
medical and pharmacy claims data.
Both patient surveys will consist of
questions covering topics similar to
those asked in the survey of pharmacists
and is intended to provide answers to
the same topic areas from patients’
perspectives. As before, topic areas will
include beliefs about generic drugs,
outcomes related to changes in generic
drug pill appearance, and strategies
used by pharmacists or doctors to alert
patients to the possibility of changes in
appearance. Participation is expected to
take approximately 20 minutes.
In the Federal Register of October 15,
2014 (79 FR 61872), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Comments submitted
raised several issues pertaining to the
proposed collection of information. We
summarize the comments and provide
our responses below:
(Comment 1) Two comments
expressed concerns related to trade
dress protection issues, noting that the
requirement that generic products differ
in appearance from the Reference Listed
Drug is well established in case law. A
pill’s physical appearance can qualify as
trade dress, protected under the Lanham
Act (Pub. L. 79–489), which functions to
distinguish between products from
different manufacturers. A drug’s
physical appearance can also be
considered a protected form of nonverbal expression under the First
Amendment. If required to change the
appearance of their medications, the
generic industry would face additional
development costs.
(Response) The purpose of these
surveys is to gather information on the
awareness of patients and pharmacists
about changes in the appearance of
medications, the frequency with which
changes in appearance occurs, strategies
that pharmacists use to inform patients
when the appearance of their
medications changes, and the outcomes
associated with these strategies. The
results of the surveys will be used to
inform the development of patient
education about differences in pill
appearance and inform the development
of education for pharmacists on
strategies to counsel patients when the
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appearance of their medications
changes. The purpose of these surveys
is not to reverse existing legal
precedents, require the generic drug
industry change the appearance of their
medications, or support the
infringement of intellectual property,
First Amendment, or any other legally
protected interests.
(Comment 2) One comment
mentioned that the term ‘‘pill’’ is used
in the Federal Register notice to
describe oral solid dosage forms such as
tablets and capsules, but is defined by
Merriam-Webster much more narrowly
to exclude tablets and capsules, which
has the potential to create confusion.
(Response) Because the FR notice is
seeking opinions from the public, we
used language accessible to the general
public. To avoid confusion, the word
‘‘pill’’ is defined in the introduction of
each survey instrument to clarify its
meaning, with the statement that the
word ‘‘pill’’ includes both tablet and
capsule dosage forms.
(Comment 3) One comment
mentioned that the survey findings may
be used by FDA to guide pharmacy
business practice, which is the
jurisdiction of the State Boards of
Pharmacy.
(Response) As stated earlier, the
purpose of these surveys is to gather
information on the awareness of
patients about changes in the
appearance of their medications, the
frequency with which changes in
appearance occurs, strategies that
pharmacists use to inform patients
when the appearance of their
medications changes, and the outcomes
associated with these strategies. The
results of the surveys will be used to
inform the development of patient
education about differences in pill
appearance and inform the development
of education for pharmacists on
strategies to counsel patients when the
appearance of their medications
changes. FDA does not intend to, itself,
guide pharmacy business practices.
(Comment 4) One comment expressed
concern that confidential patient
information from an insurance database
will be identified and shared with
Federal Government employees, which
may violate HIPAA regulations.
(Response) These surveys received
approval from the Institutional Review
Board (IRB) at the academic medical
center where the survey is being
conducted, which was accepted by
FDA’s IRB (Research In Human Subject
Committee). IRB approval ensures
compliance with human subjects’
protection laws, including HIPAA. No
FDA personnel will have access to any
identifiable patient information.
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Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices
(Comment 5) One comment suggested
that instead of conducting the study,
FDA should data mine an internal
source of data (product complaints
received from pharmaceutical
companies, healthcare providers, and
consumers) to gather information on
potential confusion and medication
mistakes.
(Response) The proposed study
focuses on patient and pharmacist
experiences and outcomes associated
with changes in pill appearance, a topic
of which patient confusion and
medication mistakes are only a part.
Although some medication mistakes
and patient confusion data may be
captured in our internal database (FDA’s
Adverse Event Reporting System), the
specific data sought from the proposed
study do not exist in this database.
(Comment 6) One comment suggested
that if the information on potential
confusion and medication mistakes
cannot be found in current databases,
FDA should request that pharmacy
school students conduct this study and
publish results in a peer-reviewed
journal to assure transparency and
reduce government spending.
(Response) High-quality surveys
require substantial resources that would
likely not be available to pharmacy
students for class projects. These
surveys are being conducted by an
academic medical institution that has
expertise in conducting surveys of
patients and health care providers,
which will provide high-quality and
valid data and assure transparency. The
results will be published in a peerreviewed journal(s) and will be made
publicly available.
(Comment 7) One comment
mentioned that these surveys will
collect data on pharmacist and patient
perceptions, which may not correlate to
actual use data and thus may not
provide meaningful information on safe
and effective use of generic drugs or
yield substantial evidence to support
adoption of any regulatory policies. The
comment noted that further
investigations will be needed to
understand how pharmacist and patient
perceptions translate to actual practices
and effects, and encouraged FDA to
consider comments to Docket No. 2013–
N–1434 in considering what further
work will be needed and the level of
evidence needed to support any
regulatory policy changes.
(Response) These surveys include
questions on patient and pharmacist
perceptions, as well as their actual
experiences and behaviors as they relate
to generic drugs and changes in drug
appearance. The survey findings will be
used to inform the development of
patient education about differences in
pill appearance and inform the
development of education for
pharmacists on strategies to counsel
patients when the appearance of their
medications changes.
(Comment 8) One comment noted that
if this study is conducted, the surveys
should be carefully crafted to collect
useful data using validated, welldeveloped methodology and
assumptions. The comment requested
the opportunity to review the proposed
surveys and to submit additional survey
questions.
(Response) Well-established survey
methods are being used in the
development and conducting of this
survey. The survey questions were
carefully crafted according to published
guidelines for survey question
development (Refs. 1 & 2) and were
further refined by an expert panel that
included individuals with pharmacyrelated professional backgrounds and
patient representatives. The survey
instruments will undergo cognitive
testing and formal pre-testing to ensure
questions are clear and answerable, and
27693
that study results are valid and useful.
A copy of the draft surveys have been
provided to the commenter.
(Comment 9) One comment noted that
the variations in the physical
appearance of drug products may help
pharmacists and patients avoid
confusion, facilitate detection of
counterfeit drug products, and serve
pharmacovigilance purposes by
providing information about the source
of a specific product. Variation in pill
appearance can also serve to notify
patients that the source of their
medication has changed. FDA should
acknowledge the ways in which
differences in pill appearance are
beneficial when determining whether
and how to conduct the survey.
(Response) The focus of these surveys
is on identifying patient and pharmacist
concerns and problems related to
changes in pill appearance, with the
goal of informing the development of
future patient and provider educational
interventions and programs to address
identified problems. However, it is
acknowledged that changes in the
physical appearance of medications
could have both negative and beneficial
effects. Therefore, questions have been
added to gauge how changes in pill
appearance may benefit pharmacists
and patients.
(Comment 10) One comment
commended FDA for planning this
study. The commenter was also pleased
that FDA plans to conduct two separate
patient surveys to ensure that a broad
and relevant patient experience is
reflected in the results.
(Response) We thank this commenter
for the support of our study and agree
that conducting two separate patient
surveys will improve the validity and
generalizability of the results.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Surveys of pharmacists and patients on variations in the
physical characteristics of generic drug pills and patients’
perceptions
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
Hours
........................
0.333
(20 minutes)
0.3
(18 minutes)
........................
0.033
(2 minutes)
........................
0.333
(20 minutes)
0.3
(18 minutes)
........................
........................
3
2,161
9
........................
1
........................
9
Pharmacist survey completes ..............................................
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Pharmacist surveys mailed 2 ................................................
Pharmacist pretests .............................................................
1,000
1
1,000
Patient #1 survey calls .........................................................
Patient #1 surveys screened ...............................................
5,000
3,330
........................
1
........................
3,330
Patient #1 surveys eligible ...................................................
Patient #1 survey pretests ...................................................
1,200
9
........................
1
........................
9
Patient #1 survey completes ...............................................
1,000
1
1,000
Patient #2 surveys mailed 2 .................................................
2,000
........................
........................
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300
........................
111
........................
3
300
........................
27694
Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices
TABLE 1—ESTIMATED REPORTING BURDEN 1—Continued
Surveys of pharmacists and patients on variations in the
physical characteristics of generic drug pills and patients’
perceptions
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total
Hours
Survey of patients #2 ...........................................................
1,000
1
1,000
0.3
(18 minutes)
300
Total ..............................................................................
........................
........................
........................
........................
1,017
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
is determined prior to mailing the surveys; screening is not required.
2 Eligibility
References
On
February 27, 2015, the Agency
submitted a proposed collection of
information entitled, ‘‘FDA Recall
Regulations’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0249. The
approval expires on March 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
1. Woodward, C.A., ‘‘Questionnaire
Construction and Question Writing for
Research in Medical Education,’’
Medical Education, 22, pp. 345–363
(1988).
2. Fitzpatrick, R., ‘‘Surveys of Patient
Satisfaction: II—Designing a
Questionnaire and Conducting a
Survey,’’ British Medical Journal,
302(6785), pp. 1129–1132 (1991).
Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–11624 Filed 5–13–15; 8:45 am]
[FR Doc. 2015–11623 Filed 5–13–15; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2014–N–1076]
[Docket No. FDA–2014–N–1031]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Formal Dispute
Resolution; Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
FDA Recall Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘FDA Recall Regulations’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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ACTION:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Guidance for Industry: Formal Dispute
Resolution; Scientific and Technical
Issues Related to Pharmaceutical
Current Good Manufacturing Practice’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
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Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–11609 Filed 5–13–15; 8:45 am]
BILLING CODE 4164–01–P
HHS.
Notice.
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 8, 2015, the Agency submitted
a proposed collection of information
entitled, ‘‘Guidance for Industry: Formal
Dispute Resolution; Scientific and
Technical Issues Related to
Pharmaceutical Current Good
Manufacturing Practice’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0563. The approval expires on
April 30, 2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[Docket No. USCBP–2015–0020]
The U.S. Customs and Border
Protection Airport and Seaport
Inspections User Fee Advisory
Committee (UFAC)
U.S. Customs and Border
Protection, Department of Homeland
Security (DHS).
ACTION: Committee Management; Notice
of Federal Advisory Public Committee
Meeting.
AGENCY:
The U.S. Customs and Border
Protection Airport and Seaport
Inspections User Fee Advisory
Committee (UFAC) will meet on
Tuesday, June 2, 2015, in Washington,
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Notices]
[Pages 27691-27694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11623]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1491]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey of Pharmacists
and Patients; Variations in the Physical Characteristics of Generic
Drug Pills and Patients' Perceptions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June
15, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Survey of Pharmacists and Patients; Variations in the Physical
Characteristics of Generic Drug Pills and Patients' Perceptions.'' Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Survey of Pharmacists and Patients; Variations in the Physical
Characteristics of Generic Drug Pills and Patients' Perceptions (OMB
Control No. 0910--NEW)
Generic drugs make up approximately 85 percent of all human
prescription drugs prescribed in the United States. While generic drugs
are required to be pharmaceutically equivalent and bioequivalent to
their brand-name counterparts, generics made by different manufacturers
may differ substantially from their brand-name therapeutic equivalents
and from each other in their physical appearance (e.g., color, shape,
or size of pills). When pharmacists switch generic drug suppliers,
patients refilling their generic prescriptions may therefore experience
changes in their drugs' appearances. These changes may result in
patient confusion and concerns about the safety and effectiveness of
the generic drug products. Studies indicate that patients are more
likely to stop taking their generic medications when they experience a
change in their drugs' physical appearances, leading to harmful
clinical and public health consequences as well as increased health
care costs from avoidable morbidity and mortality.
To provide additional information that may help guide regulatory
policy or pharmacy business practices, we intend to conduct surveys of
pharmacists and patients about their perceptions about and experiences
with generic drug product pill appearance change. These surveys are
intended to further our understanding of the relationship between
changes in pill appearance and non-adherence to prescribed therapeutic
regimens. The surveys may enable us to investigate factors that may
explain the association between changes in pill
[[Page 27692]]
appearance and non-adherence, including which factors could be modified
to improve the safe and effective use of generic drugs.
We intend to survey a national cohort of pharmacists about their
experiences with dispensing generic drug pills that differ in
appearance from previous refills of the same medication and dosage
level (e.g., when pharmacies switch generic suppliers). A stratified,
random sample of U.S.-licensed pharmacists will be obtained based on a
master list from KM Lists. The target sample includes pharmacists with
active licenses who practice in traditional community pharmacy settings
and will be proportionally allocated across the U.S. in relation to the
number of pharmacists in each state. Based on an 11 percent
undeliverable rate and a 52 percent response rate, 2,161 questionnaires
will be mailed to pharmacists to obtain the 1,000 responses required
for adequate statistical power. The pharmacists' survey will consist of
a mailed questionnaire rather than a telephone survey or an email
survey. Prior experience conducting surveys has shown that it is easier
to guarantee respondent anonymity using an impersonal, mailed
questionnaire with no individual identifying information. The
pharmacists will be asked about the frequency with which their pharmacy
changes suppliers that lead to variations in the appearance of the
generic drugs that they dispense, as well as strategies they use with
patients to address the transition to pills that have a different
appearance (e.g., alert stickers on pill bottles, verbal warnings, and
other strategies). They will also be asked about patient responses to
changes in pill appearance, including what types of appearance changes
seem to affect patients most often (shape/color/size), how often
patients report confusion about pill appearance, and how often patients
ultimately refuse to accept the new product. Participation is expected
to take approximately 20 minutes.
We also intend to survey two different patient samples using two
methodologies. The first is a telephone survey of patients who are 50
years and older and who take one or more generic medications for at
least one of the following chronic conditions: Epilepsy, diabetes,
hypertension, hyperlipidemia, depression, and HIV. The telephone survey
will be generalizable and will consist of well-defined methods to
minimize sampling bias such as use of random phone numbers for both
landlines and mobile phones, as well as small-batch sampling to ensure
a high response rate that meets demographic diversity goals. For the
second patient survey, patients will be selected from a proprietary
research database of commercially insured patients containing medical
and pharmacy claims linked to health insurance enrollment information.
A nationally representative sample of patients with at least one
chronic condition and who experienced a change in physical appearance
of a generic pill will be identified by the research team using medical
and pharmacy claims data. Both patient surveys will consist of
questions covering topics similar to those asked in the survey of
pharmacists and is intended to provide answers to the same topic areas
from patients' perspectives. As before, topic areas will include
beliefs about generic drugs, outcomes related to changes in generic
drug pill appearance, and strategies used by pharmacists or doctors to
alert patients to the possibility of changes in appearance.
Participation is expected to take approximately 20 minutes.
In the Federal Register of October 15, 2014 (79 FR 61872), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Comments submitted raised several issues
pertaining to the proposed collection of information. We summarize the
comments and provide our responses below:
(Comment 1) Two comments expressed concerns related to trade dress
protection issues, noting that the requirement that generic products
differ in appearance from the Reference Listed Drug is well established
in case law. A pill's physical appearance can qualify as trade dress,
protected under the Lanham Act (Pub. L. 79-489), which functions to
distinguish between products from different manufacturers. A drug's
physical appearance can also be considered a protected form of non-
verbal expression under the First Amendment. If required to change the
appearance of their medications, the generic industry would face
additional development costs.
(Response) The purpose of these surveys is to gather information on
the awareness of patients and pharmacists about changes in the
appearance of medications, the frequency with which changes in
appearance occurs, strategies that pharmacists use to inform patients
when the appearance of their medications changes, and the outcomes
associated with these strategies. The results of the surveys will be
used to inform the development of patient education about differences
in pill appearance and inform the development of education for
pharmacists on strategies to counsel patients when the appearance of
their medications changes. The purpose of these surveys is not to
reverse existing legal precedents, require the generic drug industry
change the appearance of their medications, or support the infringement
of intellectual property, First Amendment, or any other legally
protected interests.
(Comment 2) One comment mentioned that the term ``pill'' is used in
the Federal Register notice to describe oral solid dosage forms such as
tablets and capsules, but is defined by Merriam-Webster much more
narrowly to exclude tablets and capsules, which has the potential to
create confusion.
(Response) Because the FR notice is seeking opinions from the
public, we used language accessible to the general public. To avoid
confusion, the word ``pill'' is defined in the introduction of each
survey instrument to clarify its meaning, with the statement that the
word ``pill'' includes both tablet and capsule dosage forms.
(Comment 3) One comment mentioned that the survey findings may be
used by FDA to guide pharmacy business practice, which is the
jurisdiction of the State Boards of Pharmacy.
(Response) As stated earlier, the purpose of these surveys is to
gather information on the awareness of patients about changes in the
appearance of their medications, the frequency with which changes in
appearance occurs, strategies that pharmacists use to inform patients
when the appearance of their medications changes, and the outcomes
associated with these strategies. The results of the surveys will be
used to inform the development of patient education about differences
in pill appearance and inform the development of education for
pharmacists on strategies to counsel patients when the appearance of
their medications changes. FDA does not intend to, itself, guide
pharmacy business practices.
(Comment 4) One comment expressed concern that confidential patient
information from an insurance database will be identified and shared
with Federal Government employees, which may violate HIPAA regulations.
(Response) These surveys received approval from the Institutional
Review Board (IRB) at the academic medical center where the survey is
being conducted, which was accepted by FDA's IRB (Research In Human
Subject Committee). IRB approval ensures compliance with human
subjects' protection laws, including HIPAA. No FDA personnel will have
access to any identifiable patient information.
[[Page 27693]]
(Comment 5) One comment suggested that instead of conducting the
study, FDA should data mine an internal source of data (product
complaints received from pharmaceutical companies, healthcare
providers, and consumers) to gather information on potential confusion
and medication mistakes.
(Response) The proposed study focuses on patient and pharmacist
experiences and outcomes associated with changes in pill appearance, a
topic of which patient confusion and medication mistakes are only a
part. Although some medication mistakes and patient confusion data may
be captured in our internal database (FDA's Adverse Event Reporting
System), the specific data sought from the proposed study do not exist
in this database.
(Comment 6) One comment suggested that if the information on
potential confusion and medication mistakes cannot be found in current
databases, FDA should request that pharmacy school students conduct
this study and publish results in a peer-reviewed journal to assure
transparency and reduce government spending.
(Response) High-quality surveys require substantial resources that
would likely not be available to pharmacy students for class projects.
These surveys are being conducted by an academic medical institution
that has expertise in conducting surveys of patients and health care
providers, which will provide high-quality and valid data and assure
transparency. The results will be published in a peer-reviewed
journal(s) and will be made publicly available.
(Comment 7) One comment mentioned that these surveys will collect
data on pharmacist and patient perceptions, which may not correlate to
actual use data and thus may not provide meaningful information on safe
and effective use of generic drugs or yield substantial evidence to
support adoption of any regulatory policies. The comment noted that
further investigations will be needed to understand how pharmacist and
patient perceptions translate to actual practices and effects, and
encouraged FDA to consider comments to Docket No. 2013-N-1434 in
considering what further work will be needed and the level of evidence
needed to support any regulatory policy changes.
(Response) These surveys include questions on patient and
pharmacist perceptions, as well as their actual experiences and
behaviors as they relate to generic drugs and changes in drug
appearance. The survey findings will be used to inform the development
of patient education about differences in pill appearance and inform
the development of education for pharmacists on strategies to counsel
patients when the appearance of their medications changes.
(Comment 8) One comment noted that if this study is conducted, the
surveys should be carefully crafted to collect useful data using
validated, well-developed methodology and assumptions. The comment
requested the opportunity to review the proposed surveys and to submit
additional survey questions.
(Response) Well-established survey methods are being used in the
development and conducting of this survey. The survey questions were
carefully crafted according to published guidelines for survey question
development (Refs. 1 & 2) and were further refined by an expert panel
that included individuals with pharmacy-related professional
backgrounds and patient representatives. The survey instruments will
undergo cognitive testing and formal pre-testing to ensure questions
are clear and answerable, and that study results are valid and useful.
A copy of the draft surveys have been provided to the commenter.
(Comment 9) One comment noted that the variations in the physical
appearance of drug products may help pharmacists and patients avoid
confusion, facilitate detection of counterfeit drug products, and serve
pharmacovigilance purposes by providing information about the source of
a specific product. Variation in pill appearance can also serve to
notify patients that the source of their medication has changed. FDA
should acknowledge the ways in which differences in pill appearance are
beneficial when determining whether and how to conduct the survey.
(Response) The focus of these surveys is on identifying patient and
pharmacist concerns and problems related to changes in pill appearance,
with the goal of informing the development of future patient and
provider educational interventions and programs to address identified
problems. However, it is acknowledged that changes in the physical
appearance of medications could have both negative and beneficial
effects. Therefore, questions have been added to gauge how changes in
pill appearance may benefit pharmacists and patients.
(Comment 10) One comment commended FDA for planning this study. The
commenter was also pleased that FDA plans to conduct two separate
patient surveys to ensure that a broad and relevant patient experience
is reflected in the results.
(Response) We thank this commenter for the support of our study and
agree that conducting two separate patient surveys will improve the
validity and generalizability of the results.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Surveys of pharmacists and
patients on variations in the Number of
physical characteristics of Number of responses per Total annual Average burden Total Hours
generic drug pills and patients' respondents respondent responses per response
perceptions
----------------------------------------------------------------------------------------------------------------
Pharmacist surveys mailed \2\... 2,161 .............. .............. .............. ..............
Pharmacist pretests............. 9 1 9 0.333 3
(20 minutes)
Pharmacist survey completes..... 1,000 1 1,000 0.3 300
(18 minutes)
Patient #1 survey calls......... 5,000 .............. .............. .............. ..............
Patient #1 surveys screened..... 3,330 1 3,330 0.033 111
(2 minutes)
Patient #1 surveys eligible..... 1,200 .............. .............. .............. ..............
Patient #1 survey pretests...... 9 1 9 0.333 3
(20 minutes)
Patient #1 survey completes..... 1,000 1 1,000 0.3 300
(18 minutes)
Patient #2 surveys mailed \2\... 2,000 .............. .............. .............. ..............
[[Page 27694]]
Survey of patients #2........... 1,000 1 1,000 0.3 300
(18 minutes)
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,017
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Eligibility is determined prior to mailing the surveys; screening is not required.
References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov.
1. Woodward, C.A., ``Questionnaire Construction and Question Writing
for Research in Medical Education,'' Medical Education, 22, pp. 345-
363 (1988).
2. Fitzpatrick, R., ``Surveys of Patient Satisfaction: II--Designing
a Questionnaire and Conducting a Survey,'' British Medical Journal,
302(6785), pp. 1129-1132 (1991).
Dated: May 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11623 Filed 5-13-15; 8:45 am]
BILLING CODE 4164-01-P
