Ms Anne Marie Seymour:

On specific generic substitution, there is no communication from the Department. Pharmacists are the medicines experts. They have spent five years studying in this area and they use their professional judgment in making that decision around a patient. There is legislation around what a pharmacist is required to do and it is part of their code of conduct. It would be the regulator who would issue specific guidance in that kind of space.

If we are moving out to therapeutic substitution, which is this medicines substitution protocol, the framework would be built where we would call a shortage, there is clinical guidance and there are clinical experts to look at it. They will identify things like what questions one should ask a patient, what are the risks of this substitution, what one needs to do, how one needs to document it, and the timeframe of it, because hopefully it would be for a short period of time. That would be clearly called out and would be done for each case. The secondary legislation would just lay out what needs to be done but then in each case, that process will be followed to ensure patient safety, and to make it easier for the patient to access these.