I dispute that this is a correct interpretation of the Human Medicines Regulations 2012, as if this were the case there would be limited need for the exemptions in Part 12 Chapter 3 - for instance why do other healthcare services bother using Patient Group Directions for administration of non-parenteral POMs if a local protocol would do?
So I refreshed my memory of the HMR and gave it some thought. Here is my understanding of the Regs.
Provision 214 states:
(1) A person may not sell or supply a prescription only medicine except in accordance with a prescription given by an appropriate practitioner.
(2) A person may not parenterally administer (otherwise than to himself or herself) a prescription only medicine unless the person is -
(a) an appropriate practitioner other than an EEA health professional; or
(b) acting in accordance with the directions of such an appropriate practitioner.
- From 214-2 it can be deduced that a person MAY administer a non-parenteral POM without being either an appropriate practitioner or acting in accordance with the directions of one.
- Sale, supply and administer are three distinct activities, defined in the Regs.
- A person could administer a POM to a patient, with no additional authority, providing the patient legally possessed the POM.
- If the patient didn't possess the POM, the person would need to SUPPLY the POM to the patient prior to administering it. Supply is not permitted under 214-1.
I object your honour!
ReplyDeleteI put it to you that m'learned friend has added an additional 'supply' function to the definition of 'administer' and refer you to the HMR12 general exemptions in paragraph 8 and to the split in these functions outlined in 18(7) and (8).
M'learned friend's case seemingly hinges on administration being a function that can only occur if the medicine is in the legal possession of the patient. If a patient already legally holds a POM then this would have been previously dispensed, and labelled according to the directions of the original prescriber. What then of medicines in the legal possession of an organisation (by way of wholesale dealing) and its staff (by way of delegated authority) - can these not be directly administered to a patient?
Furthermore, if it were the case that a medicine was supplied to a patient before administration , then would the requirements of Schedule 5 of The Medicines (Marketing Authorisations etc) Regulations 1994 number 3144 apply, and therefore all medicines for administration must be labelled fully as if it were dispensed from a pharmacy?
Your witness... 😉
I note your points @aptaim and will look further at the Provisions of the Regs that you mention as didn't comprehensively do so for my refresh.
ReplyDeleteNote, for a patient to have legal possession of a POM this does not require the POM to have been prescribed and dispensed for them, they may have been issued it under a PGD or via an emergency supply for instance.
I accept your comment that 'supply' as legally defined doesn't represent the transfer of ownership of the POM that takes place during administration.
The issue still begs the queston - why have other organisations not interpreted the Regs in this way, so avoiding the need to have PGDs etc and enabling them to use unregistered staff to admnister POMs?
No worries - to be fair mine wasn't well researched at all: was too busy fielding mini shredded-wheat's fired from the kids, so will be interested in outcomes.
ReplyDeleteGood shout on alternative routes of patient possession - however in those instances mentioned they must still be appropriately labelled as per regulations (except if under PGD for immediate administration IIRC) so point should still stand about directions/authority.
However we agree on the key point - if this scenario is truly the case, why isn't it widely applied and why do PGDs (for example) exist? My gut feeling is that it's about legislation, professional regulation/standards, good governance and demonstrable patient safety taken *as a whole* - i.e. just because we can, doesn't mean we should...
Look forward to your digging!
Have been looking at the other provisions in the Regs and not found anything yet that appears to contradict the assumption that a non-parenteral POM can be administered by any person.
ReplyDeleteSeems a bit lax on the regulatory front in my opinion, relying on good quality governance procedures to protect patients.