Presentation
MDD5 - Applying Human Factors to Standalone Drug Products
SessionPoster Session 2
DescriptionIntroduction
Since the regulatory guidance on human factors engineering has become more established over the past 10 to 15 years, many medical and drug-delivery device companies have developed internal human factors teams to conduct and facilitate the work required by the Food and Drug Administration (FDA). Over this time, teams have developed skills and adapted to best industry practices to meet the requirements of not only the FDA, but health authorities globally. Although the regulatory landscape continues to change and nuanced regulatory expectations emerge, the scope of human factors work for medical devices and combination products is largely established.
Though the regulatory guidance documents specific to human factors focus on devices and combination products, the FDA has also recognized that medication error can occur with non-device products, and that packaging and labeling play a key role in ensuring a safe product when use error cannot be eliminated through design of a physical product. For example, the guidance documents Safety Considerations for Product Design to Minimize Medication Errors (2016) and Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (2022) discuss key design considerations and the human factors process and methods that may be used for evaluation. Additionally, discussion on this issue has recently been reinvigorated by the release of the 2024 draft guidance, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, in which the FDA states that the guidance may also apply to standalone drug and biologic products in certain cases.
Even with the regulatory history on this issue, many developers are still unsure of how to incorporate human factors processes into non-device development efforts, and how to adapt traditional human factors validation methods to be fit for purpose. The guidance on use-related risk analysis provides an example of a product with complex dosing, but lacks additional detail on what criteria should be used to determine when a URRA should be conducted, and subsequently, when human factors should be applied. The presentation will discuss ways to identify risk with standalone drug products and engage human factors engineers with internal stakeholders, and how to determine the appropriate scope of human factors work. Examples of successful human factors programs for standalone drug products will be included.
Human Factors Engagement
When incorporating human factors in non-traditional development efforts, barriers can emerge, particularly for pharmaceutical companies with rigid approaches established based only on the regulatory requirements for combination products. There are two important components that human factors teams should focus on: 1) improving stakeholder understanding of human factors and how it is applied as a science, not just as a regulatory tool, and 2) establishing processes for identifying when human factors engineers should be consulted. These techniques will be expanded upon during the lecture, with relevant points that include:
1) Identifying stakeholders needs to proactively address specific concerns about incorporating human factors; using real-world examples and success stories of human factors programs for standalone drug products; using risk assessment to make connections to potential safety concerns that could become problematic later in development; and raising awareness about the impact of a broader scope of human factors activities outside of the commonly understood validation study.
2) Developing internal operating procedures to establish required activities and roles/responsibilities for development teams; making connections with the right stakeholders who can identify when possible use-related issues; and creating checklists to be used during drug development that identify when to engage with human factors, for example:
- When a product is used at home
- When physical or mental impairments could impact medication compliance
- When use steps are inconsistent with standard practice
- When a unique risk has been identified that is not expected with similar drug products.
Understanding when a human factors program is needed is critical for drug developers to be prepared for potential regulatory questions and optimize safety and usability. Additionally, right-sizing efforts will save time, costs, and resources. By learning from the experiences of the presenters, human factors engineers can identify ways to improve these procedures in their own institutions.
Example - Developing Novel Labeling Solutions to Address a Unique Risk
This example illustrates one pathway for incorporation of human factors into drug development that achieved regulatory success. During clinical trials, a unique risk was identified with a drug product administered intravenously. Due to very small doses administered on a complex titration schedule, use of an IV line with an in-line filter could lead to underdosing. Human factors was contacted for a review, and completed the following activities, which will be expanded upon during the presentation:
1. Gathered data on standard hospital administration procedures to understand the user journey
2. Formalized product use-related risk assessment
3. Identified and down-selected labeling-based solutions in collaboration with packaging engineers
4. Solicited feedback on labeling strategy from clinical study stuff
5. Conducted virtual human factors assessment with product-naive participants in various locations to assess effectiveness
6. Refined and finalized labeling and drafted documentation of activities
In addition to the outcome of a successful market application with the proposed labeling solutions, the team identified key lessons learned from the project, which will also be discussed. Some benefits include using a systems approach to analyze the full scope of use (including user handoffs), designing solutions that provide multiple opportunities for error recovery, and gaining insights on the collaboration process. Future improvement opportunities will also be discussed, including identifying pathways for earlier engagement, thinking proactively about evolving regulation that might require new solutions, and looking further down the pipeline to plan for increasingly complex configurations.
Example - Oral Therapies in Pediatrics
This example demonstrates the complexity of home administration in the oral therapy space for adults and children with difficulty swallowing, including those on nasogastric/gastric (NG/G) tubes. Involving human factors in the development of these projects yielded a detailed instructions for use evaluated by intended users, as well as successful submissions to health authorities. The generation of this data proved useful during some instances of information requests regarding the product’s usability from both the FDA and EMA. A summary of lessons learned from case studies including mini tablets, capsules for suspension, and stick packs/sachets containing granules for suspension will be provided. Key learnings from these home-prepared oral therapy projects included the following topics:
1. Water quality
2. The temperature of the food/liquid used for mixing
3. Quantity of food/liquid used to administer the drug and associated risk
4. Dispersion action - Is it clear what to do?
5. Preparation time considerations, including dispersion time and total in-use time, appearance of the medication, and hospital-use considerations
6. NG/G tube compatibility should be considered
7. Disposal
8. Cleaning
Additional details on learnings will be provided in the presentation.
Conclusion
Incorporating human factors programs into standalone drug or biologic developments, particularly in a large company with many stakeholders, can seem overwhelming. However, identifying the right communication channels and demonstrating the value of these activities for our patients, users, and internal stakeholders is critical to success. Not only can this lead to developers being better prepared to meet regulatory concerns and address risk, but also to helping us to make better products that are easier to use by both patients and healthcare providers. By hearing how the presenters have taken steps to do so, others may be inspired to seek out similar processes to encourage a more user-focused and patient-centric mindset across disciplines.
Since the regulatory guidance on human factors engineering has become more established over the past 10 to 15 years, many medical and drug-delivery device companies have developed internal human factors teams to conduct and facilitate the work required by the Food and Drug Administration (FDA). Over this time, teams have developed skills and adapted to best industry practices to meet the requirements of not only the FDA, but health authorities globally. Although the regulatory landscape continues to change and nuanced regulatory expectations emerge, the scope of human factors work for medical devices and combination products is largely established.
Though the regulatory guidance documents specific to human factors focus on devices and combination products, the FDA has also recognized that medication error can occur with non-device products, and that packaging and labeling play a key role in ensuring a safe product when use error cannot be eliminated through design of a physical product. For example, the guidance documents Safety Considerations for Product Design to Minimize Medication Errors (2016) and Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (2022) discuss key design considerations and the human factors process and methods that may be used for evaluation. Additionally, discussion on this issue has recently been reinvigorated by the release of the 2024 draft guidance, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, in which the FDA states that the guidance may also apply to standalone drug and biologic products in certain cases.
Even with the regulatory history on this issue, many developers are still unsure of how to incorporate human factors processes into non-device development efforts, and how to adapt traditional human factors validation methods to be fit for purpose. The guidance on use-related risk analysis provides an example of a product with complex dosing, but lacks additional detail on what criteria should be used to determine when a URRA should be conducted, and subsequently, when human factors should be applied. The presentation will discuss ways to identify risk with standalone drug products and engage human factors engineers with internal stakeholders, and how to determine the appropriate scope of human factors work. Examples of successful human factors programs for standalone drug products will be included.
Human Factors Engagement
When incorporating human factors in non-traditional development efforts, barriers can emerge, particularly for pharmaceutical companies with rigid approaches established based only on the regulatory requirements for combination products. There are two important components that human factors teams should focus on: 1) improving stakeholder understanding of human factors and how it is applied as a science, not just as a regulatory tool, and 2) establishing processes for identifying when human factors engineers should be consulted. These techniques will be expanded upon during the lecture, with relevant points that include:
1) Identifying stakeholders needs to proactively address specific concerns about incorporating human factors; using real-world examples and success stories of human factors programs for standalone drug products; using risk assessment to make connections to potential safety concerns that could become problematic later in development; and raising awareness about the impact of a broader scope of human factors activities outside of the commonly understood validation study.
2) Developing internal operating procedures to establish required activities and roles/responsibilities for development teams; making connections with the right stakeholders who can identify when possible use-related issues; and creating checklists to be used during drug development that identify when to engage with human factors, for example:
- When a product is used at home
- When physical or mental impairments could impact medication compliance
- When use steps are inconsistent with standard practice
- When a unique risk has been identified that is not expected with similar drug products.
Understanding when a human factors program is needed is critical for drug developers to be prepared for potential regulatory questions and optimize safety and usability. Additionally, right-sizing efforts will save time, costs, and resources. By learning from the experiences of the presenters, human factors engineers can identify ways to improve these procedures in their own institutions.
Example - Developing Novel Labeling Solutions to Address a Unique Risk
This example illustrates one pathway for incorporation of human factors into drug development that achieved regulatory success. During clinical trials, a unique risk was identified with a drug product administered intravenously. Due to very small doses administered on a complex titration schedule, use of an IV line with an in-line filter could lead to underdosing. Human factors was contacted for a review, and completed the following activities, which will be expanded upon during the presentation:
1. Gathered data on standard hospital administration procedures to understand the user journey
2. Formalized product use-related risk assessment
3. Identified and down-selected labeling-based solutions in collaboration with packaging engineers
4. Solicited feedback on labeling strategy from clinical study stuff
5. Conducted virtual human factors assessment with product-naive participants in various locations to assess effectiveness
6. Refined and finalized labeling and drafted documentation of activities
In addition to the outcome of a successful market application with the proposed labeling solutions, the team identified key lessons learned from the project, which will also be discussed. Some benefits include using a systems approach to analyze the full scope of use (including user handoffs), designing solutions that provide multiple opportunities for error recovery, and gaining insights on the collaboration process. Future improvement opportunities will also be discussed, including identifying pathways for earlier engagement, thinking proactively about evolving regulation that might require new solutions, and looking further down the pipeline to plan for increasingly complex configurations.
Example - Oral Therapies in Pediatrics
This example demonstrates the complexity of home administration in the oral therapy space for adults and children with difficulty swallowing, including those on nasogastric/gastric (NG/G) tubes. Involving human factors in the development of these projects yielded a detailed instructions for use evaluated by intended users, as well as successful submissions to health authorities. The generation of this data proved useful during some instances of information requests regarding the product’s usability from both the FDA and EMA. A summary of lessons learned from case studies including mini tablets, capsules for suspension, and stick packs/sachets containing granules for suspension will be provided. Key learnings from these home-prepared oral therapy projects included the following topics:
1. Water quality
2. The temperature of the food/liquid used for mixing
3. Quantity of food/liquid used to administer the drug and associated risk
4. Dispersion action - Is it clear what to do?
5. Preparation time considerations, including dispersion time and total in-use time, appearance of the medication, and hospital-use considerations
6. NG/G tube compatibility should be considered
7. Disposal
8. Cleaning
Additional details on learnings will be provided in the presentation.
Conclusion
Incorporating human factors programs into standalone drug or biologic developments, particularly in a large company with many stakeholders, can seem overwhelming. However, identifying the right communication channels and demonstrating the value of these activities for our patients, users, and internal stakeholders is critical to success. Not only can this lead to developers being better prepared to meet regulatory concerns and address risk, but also to helping us to make better products that are easier to use by both patients and healthcare providers. By hearing how the presenters have taken steps to do so, others may be inspired to seek out similar processes to encourage a more user-focused and patient-centric mindset across disciplines.
Event Type
Poster Presentation
TimeTuesday, April 14:45pm - 6:15pm EDT
LocationFrontenac Foyer