Lecture 5 - Human factors

Question 1

what is the definition of human factors?

Answer 1

human factors’ refers to how a person will interact with the systems surrounding them, including the technology they use. This will very much depend on the design of that technology, what education and training that person has, and the environment in which they will be using the technology

Question 2

wha tapes of products are human factors considered in?

Answer 2

Products relying on self-administration;
Inhalers
Injections
Combination products

For small molecules or biological products;
Involves the use of a device

Question 3

why are drug device combinations used?

Answer 3

improve patient compliance, improve ergonomics/ suability

Question 4

why do we consider human factors in drug development?

Answer 4

Ensure interindividual consistency
- Dose delivered
- Success in administering the dose
- Safety and efficacy profile

Reduce the risk of error
- Accidental under/overdose
- Patient compliance

Reduce the risk of injury

Question 5

what is the process for device development and information sources

Answer 5

Observations (Ethnography/field research)
Interviews
Focus groups
Failure modes and effects analysis
User testing

Question 6

what are the steps in the device development process?

Answer 6

disovery, prototype, pre clincial, clinical,regualtory, launch, post marketing. key considerations and tests part of the drug discovery development are biocompatability, toxicology, extractables and leachables, degradation, shelf life, human factors

Question 7

give an example of a device development process

Answer 7

1. Identification of userbase & context
2. Known use issues
3. Risk assessment of use/potential errors
4. Formative and summative evaluation
5. Post-marketing surveillance

Question 8

what are different users of devices?

Answer 8

Patients
Caregivers
Prescribers
Nurses
Pharmacists, Pharmacy technicians

Question 9

what are mportant considerations in the development of a pharmaceutical device

Answer 9

Route of administration
Single vs multi-dose
Ready to use vs reconstitution
Aesthetics
Total amount of drug per unit

Question 10

what can go wren in drug user interactions?

Answer 10

Misuse
Accidental overdose
Accidental exposure
Injection failure
Mechanical failure

Question 10

what are educational accesses for device usage

Answer 10

Instruction leaflets
Clinics
Pharmacists
Apps
Patient groups