Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency (MHRA)

Name of policy document:

Consultation MLX 336 - Patient Group Directions

(1) Proposals for changes to the legislation governing the supply of Controlled Drugs by nurses and pharmacists working under Patient Group Directions
(2) Proposals to expand the use of Patient Group Directions in the independent healthcare sector in Northern Ireland
(3) Proposals to correct a technical error on use of Patient Group Directions in the private sector

Deadline for response:

15 June 2007

Background: MLX 336 sought views on proposals to expand the range of Controlled Drugs which can be supplied or administered by nurses and pharmacists working under Patient Group Directions (PGDs). It also contained proposals for changing the locations and circumstances in which they can supply or administer these medicines for the purpose of pain relief. The opportunity is also being taken to propose legislative changes to expand the use of PGDs in the independent healthcare sector in Northern Ireland and to clarify the position concerning the sale, as well as supply, of products under PGDs.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
Consultation MLX 336: Patient Group Directions

(1) Proposals for changes to the legislation governing the supply of Controlled Drugs by nurses and pharmacists working under Patient Group Directions
(2) Proposals to expand the use of Patient Group Directions in the independent healthcare sector in Northern Ireland
(3) Proposals to correct a technical error on use of Patient Group Directions in the private sector

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on Consultation MLX 336: Patient Group Directions, having received comments from interested parties amongst the Fellowship.

Whilst we have no fundamental objection to the principles, we do have some important reservations in respect of implementation.

In respect of proposal 1, we have no difficulty with morphine being added alongside diamorphine for the reasons stated.  We do, however, have some concern in respect of extending the availability of administration of powerful opiates by nurses and pharmacists.  These drugs cause many serious adverse drug reactions in hospitals even when used by doctors, and we are concerned that the Patient Group Directions (PGDs) might allow opiate administration by professionals who may be skilled in a certain direction but less competent in managing an ADR.  This is of particular importance in areas where a doctor may not be immediately available, which is, of course, one of the reasons for the legislative change.  It should therefore be more emphasised that thorough training in the management of ADRs is provided and tested amongst those health professionals who are going to administer these drugs, particularly in locations off site from hospitals.

We would also have some concerns over the assertion that PGDs are tightly controlled (see para 20) at a local level.  We therefore feel that the general principle should be that those acting upon PGDs involving powerful opiodes should have adequate training, both to recognise the appropriate indications and to spot the ADRs.  At no stage in the document is any provision provided for monitoring and auditing the outcomes of this significant change in practice.  We recommend that this should be incorporated as a statutory requirement, and it would seem to us advisable that this new change be piloted on a limited scale before being extended nationally.

We therefore support these changes in respect of enabling diamorphine to be supplied and administered by pharmacists, and morphine to be supplied and administered by nurses and pharmacists.  The current restrictions on location of supply or administration under PGD can be broadened, but we would recommend the precautionary measures detailed above.

Please note that this College replied to the MHRA on 17 April 2007 to say that we are content with the proposals to correct a technical error in the legislation on the use of Patient Group Directions in the private sector (proposal number 3).

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939

[13 June 2007]