Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions

ICR 201505-0910-003

OMB: 0910-0801

Federal Form Document

Forms and Documents
ICR Details
0910-0801 201505-0910-003
Historical Active
HHS/FDA CDER
Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients' Perceptions
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 09/30/2015
Retrieve Notice of Action (NOA) 05/28/2015
  Inventory as of this Action Requested Previously Approved
09/30/2018 36 Months From Approved
6,348 0 0
1,017 0 0
0 0 0

Generic drugs are required to be pharmaceutically equivalent and bioequivalent to their brand-name therapeutic equivalents, but may differ in their physical appearance (e.g., color, shape, size, or markings). This may result in patient confusion and safety and efficacy concerns about the generic drug product, and may cause patients to change or discontinue their medication, which could lead to harmful clinical and public health consequences. Alternatively, differences in appearance may help patients identify their drugs and promote positive public health outcomes. The extent to which differences in appearance between therapeutically equivalent products create or reduce patient confusion, affect patient medication adherence, or are handled by pharmacists is currently unknown. This project will conduct a survey of pharmacists and two surveys of patients regarding their perspectives on and experiences with generic drugs that differ in appearance from previous refills of the same medication. The goals of the surveys are to provide insight into the beliefs about and experiences with changes in the appearance of generic medications, the strategies pharmacists use to notify patients of changes in appearance, and how drug appearance may be related to patient outcomes such as confidence in and adherence to medication regimens.

None
None

Not associated with rulemaking

  79 FR 61872 10/15/2014
80 FR 27691 05/14/2015
Yes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 6,348 0 0 6,348 0 0
Annual Time Burden (Hours) 1,017 0 0 1,017 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$1,372,145
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
05/28/2015


© 2024 OMB.report | Privacy Policy