Combination Product Patient Training: How are Patients Trained and Who Conducts the Training?

摘要

Patients are frequently prescribed a medication that must be administered either by a nasal spray, an inhaler, or a self-injection device. These devices are classified as combination devices by the Food and Drug Administration (FDA) and the Medical Device Regulations (MDR). However, there has been an issue of who and how do these patients get trained. It has long been the stance of the pharmaceutical companies they will not provide training because they provide an Information for Use (IFU) and/or a demo on their website. The issues with eitherof these means is that neitherthe FDA, nor the MDR permit them as mitigation for use errors. And, in human factors testing there are considerable numbers of use errors when patients attempt to use the devices.