If you have ever been prescribed a medicine, you probably won’t be surprised to hear that Patient Information Leaflets (PILs) are too complex for patients to readily understand.
A report from the Academy of Medical Sciences (as reported by the BBC) found that, by focusing on side-effects in PILs , patients become unduly anxious about taking medicines. It is thought that this could be the reason why fewer than 50% continue taking drugs they have been prescribed by their doctor.
“They aren’t written from a consumer’s perspective” said Prof Sir John Tooke (chair of the report preparation group). Unsurprisingly, users find PILs to be impenetrable and even unreadable. Both users and Healthcare Professionals are concerned about the challenges in making sense of the plethora of information available. The report recommends the involvement of users / patients in the development of information leaflets from an early stage.
At first glance, this may seem like something that would be ideally placed to form part of a Human Factors formative study or two, during development, with a confirmation of the PIL effectiveness during the HFE Validation Study.
That would be a correct assumption.
Where Medical Device development leads, pharmaceutical product development will follow – as the Instructions for Use (IFU) for Medical Devices and Combination Products should already be developed and their effectiveness assessed throughout product development.
Ensuring that instructional materials and training are fit for purpose and understandable by the user, is an integral aspect of Human Factors Engineering for Medical Devices. Our team has designed HFE and instructional materials studies, conducted them, reported the results and influenced the development of a wide range of Medical Devices.
You may want to speak with us about how you can benefit from our wealth of experience, to ensure your PIL, training materials or IFU is truly fit for purpose and supports user/patient compliance in their healthcare. Get in touch now to get the ball rolling.