Key Topic 8 - Subtopic 2: Patient support items
In many countries it is acceptable to provide items for patients as part of a patient support programme. However, the items must be directly related to the treatment and care of the patient, and must be low cost. This is so that the items are not regarded as any form of inducement for the patient to take the medicine.
Examples of acceptable items might be demonstrators for asthma medicines or a carry-case for injectables.
Consider this example
In the UK Merck Serono complained about a soft toy, water bottle and backpack offered as patient support items by Sandoz in relation to its product Omnitrope (somatropin). The product was used to treat growth hormone deficiency in children (daily injections).
In defence of each item Sandoz stated:
The backpack aids adherence by allowing the patient to store and transport their growth hormone and supporting items from one destination to another, including repeat visits, ensuring that they have all the items they need to perform each injection on a daily basis regardless of their location.
The soft toy was designed to comfort and reduce the fear associated with daily injections and thus aimed to limit intentional non- adherence.
The water bottle supported the ‘Water in School is Cool’ Campaign that was appointed by the Department of Health to research and develop the Food in Schools Water Provision guidance. Sandoz therefore considered that the availability of the water bottle for patients being treated with Omnitrope gave patients the ability to keep hydrated throughout the day and ultimately supported their general health
Before checking the ruling – think about which of these, if any, you would think was approvable for use as a patient support item (Hint: consider relevance to the treatment of GH deficiency)
Ruling
The Panel viewed the backpack and water bottle as unacceptable as they were not directly related to the treatment of the patient’s condition. In fact the product needed to be stored at 2-8 degrees Celcius and so the backpack was not suitable for its transportation.
However the Panel accepted that the soft toy would be a useful comforter for children receiving daily injections.
