The Role of Human Factors Engineering in Combination ......Product Design. Human Factors. Post-market Surveillance/ signals. Guidance/ Work Groups/ AC/etc. 14 HF Evaluation of Drug,

1

The Role of Human Factors Engineering in Combination

Product Post Approval Changes

QuynhNhu Nguyen, MSAssociate Director for Human Factors

Division of Medication Error Prevention and AnalysisCenter for Drug Evaluation and Research (CDER)

2

DisclaimerFor work prepared by US government employees

representing their agencies, there is no copyright and these work products can be reproduced freely.

Reference to any marketed products is for illustrative purposes only and does not constitute endorsement by

the U.S. Government, the Department of Health and Human Services, or the Food and Drug Administration.

3

“I’m Not an Idiot”

https://www.youtube.com/watch?v=nvwR74XpKUM

4

Swallowing Capsules for Inhalation

5

Drug-device combinations with complex controls or unexpected device operation can lead to medication errors

Complex Product Design

Original user instructions: Where to apply patch?

7

Revised user instructions

8

What is a Medication Error?A medication error is 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

National Coordinating Council for Medication Error Reporting and Prevention. Available at: www.nccmerp.org. Accessed 12/30/2014

9

Definition of Human FactorsErgonomics (or human factors) is the scientific discipline concerned with the understanding of interactions among humans and other elements of a system, and the profession that applies theory, principles, data and methods to design in order to optimize human well-being and overall system performance.

International Ergonomics Association (IEA)

10

Medication Error Prevention and HFAppropriate

Medication Use/ Optimize Human

Well Being

Medication Error Prevention

HF

11

Who Looks at Medication Errors?

• Created in 1999• Scientists and healthcare professionals with varied

backgrounds• 53 employees• Aligned by therapeutic areas• Leads CDER review pertaining to medication error

prevention and analysis for drug and therapeutic biologics

Division of Medication Error Prevention and Analysis (DMEPA)

12

DMEPA Mission

To increase the safe use of drug products by minimizing use error that is related to the

naming, labeling, packaging, or design of drug products

13

DMEPAMission

Proprietary Names

Labels/ Labeling/

Packaging/ Product Design

Human Factors

Post-market Surveillance/

signals

Guidance/ Work Groups/

AC/etc.

14

HF Evaluation of Drug, Biologic, and Combination Products in CDER

DMEPA is the lead for review of human factors submissions (e.g., protocols, study reports, etc.) within CDER

• Evaluate HF submissions for drugs, biologics, and combination products regulated by CDER

• OSE/DMEPA will identify the need for and issue inter-center consults to the CDRH Human Factors Team as needed

• OSE/DMEPA consults Patient Labeling Team in the Office of Medical Policy for the review of Instructions for Use (IFU) in the IND phase

15

Drug Development Process & Human Factors Considerations for Commercial

(to-be-marketed) Product

Preclinical Testing Phase 1 Phase 2 Phase 3 Phase 4

FILE IND FILE NDA/BLA for FDA review

Human factors (HF) product design, preliminary analyses, formative work, and HF validation testing

***DMEPA involvement (can be as early as pre-IND phase)

Continual updates to the Use-Related Risk Analysis (URRA)

16

Considerations for Changes

• Postmarket development• Respond to postmarket use-related safety

reports, complaints or problems• Meet needs of an expanded indication or user

population

16

17

Conduct updated use-related risk analysis

• Does the design change alter the user interface in any way (e.g., audible, tactile, color recognition, user instructions, etc.)?

• Does the design change alter an existing critical task or add a new critical task?

• Does the design change alter the users or their knowledge base?

18

Case Study #1*• Drug ABC is already approved on the market in

a single-dose vial for use by healthcare providers

• Sponsor X wants to introduce a prefilled syringe presentation for laypersons for at-home use

• What should Sponsor X be thinking about???

Is the product’s presentation and its user interface safe and effective for the intended users, uses, and use environments?

*This is a fictitious product intended for illustrative purposes only

19

Case Study # 1Some Considerations for Sponsor X

• Dosing:– What is the dose for Drug ABC? – Is the product single-dose where users administer the

entire contents?– Would users need more than one syringe to administer

intended dose?• Intended user group(s):

– Is the indicated population naïve to prefilled syringes?• Design of prefilled syringe user interface:

– Is there anything about the user interface that makes this product unique?

20

Case Study # 1: What if…

The dosing for Drug ABC was weight-

based?

21

Case Study #1: Some Considerations for Sponsor X

• Are there specific instructions on calculating the doses?

• Are there graduation marks on the prefilled syringe? Are the increments appropriate to achieve the required doses?

• Does the dosing require users to expel drug out of the syringe to achieve the required dose?

• Is the indicated population naïve to prefilled syringes?

Drug ABC was weight-based?

22

Case Study # 1: What if…Drug ABC was for emergency use and users needed to assemble the syringe (i.e., attach the needle to the body of the syringe) prior to administration?

23

Case Study #13: Some Considerations for Sponsor X

• Design of the product user interface: is product assembly feasible during an emergency situation?

• Is the indicated population naïve to prefilled syringes?

Drug ABC was for emergency use and required pre-assembly?

24

Draft Guidance -Issued September 2018

25

6 Types of Submissions

1. Use-Related Risk Analysis2. HF Validation Study Protocol*3. HF Validation Study Results Report*4. Threshold Analyses5. Comparative Use HF Study Protocol6. Comparative Use HF Study Results Report*labeling comprehension protocols/reports are subset of these types.

60-day goal date

26

Updated 356h Form

If the submission contains Human Factors (HF) information, select ‘Yes.’ HF information may include a study protocol, results report, use-related risk analysis, or justification for no HF validation study.

27

Updated 1571 FormCheck “other” if you have a use-related risk analysis, HF results report, etc.

Check here if you have a protocol for a HF validation study

28

Questions?

[email protected]