[Federal Register Volume 79, Number 199 (Wednesday, October 15, 2014)]
[Notices]
[Pages 61872-61873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1491]


Agency Information Collection Activities: Proposed Collection; 
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.

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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 on the information collection associated with 
a survey of pharmacists and patients about their experiences resulting 
from changes in generic drug pill appearance.

DATES: Submit either electronic or written comments on the collection 
of information by December 15, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: 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.

Survey of Pharmacists and Patients: Variations in the Physical 
Characteristics of Generic Drug Pills and Patients' Perceptions--(OMB 
Control Number 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

[[Page 61873]]

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 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 United States 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.
    FDA estimates the burden of this collection of information as 
follows:

                                     Table 1--Estimated Reporting Burden \1\
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   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
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Survey of Pharmacists...........           1,000               1           1,000           0.333             333
                                                                                    (20 minutes)
Survey of Patients #1...........           1,000               1           1,000           0.333             333
                                                                                    (20 minutes)
Survey of Patients #2...........           1,000               1           1,000           0.333             333
                                                                                    (20 minutes)
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    Total.......................  ..............  ..............  ..............  ..............             999
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24365 Filed 10-14-14; 8:45 am]
BILLING CODE 4164-01-P