Sunday 12 February 2017

Administration of prescription only medicines - settling a dispute, the final part

Further scrutiny of the Human Medicines Regulations 2012 and discussion yesterday with expert colleagues has brought me to the conclusion that I was wrong.  This causes me much distress.  Not that I could be wrong, I sometimes am though not that often, but because the Regs leave the administration of non-parenteral POMs effectively unregulated.

In most healthcare settings additional governance is delivered by treating non-parenteral POMs in the same way as parenteral POMs, so administered by health professionals and prescribed or authorised under PGD.  Ambulance services appear to be the only health sector allowing unregistered staff to administer non-parenteral POMs under a local protocol.

Hmm.

Friday 10 February 2017

Administration of prescription only medicines - settling a dispute: part 2

Ah well, my initial idea didn't stand up in court.  I accept @aptaim's comment that 'administration' inherently contains an element of supply and 'supply' (as defined in the Regs) does not apply.

I'm reviewing the other relevant Provisions of the Regs to see if anything negates the interpretation used by ambulance services.  I've not found anything yet...

If this interpretation is not negated then it opens up a spectrum of opportunities for administration of non-parenteral POMs by a range of persons operating within a regulated service under local protocol.

Hmm




Thursday 9 February 2017

Administration of prescription only medicines - settling a dispute

It's common practice in ambulance services for staff members, both registered and unregistered, to administer non-parenteral Prescription Only Medicines to patients under the 'authority' of locally drawn up organisational guidelines.  The argument is that anyone can legally administer a non-parenteral POM and the ambulance service can 'possess' the POMs so no further legal authority is required to administer them.  This article in the Journal of Paramedic Practice covers the rationale.

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 rest my case...