The National Health Service (Pharmaceutical Services) (Appliances) (Amendment) Regulations 2009

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations make amendments to the National Health Service (Pharmaceutical Services) Regulations 2005 (“the principal Regulations”) in respect of the terms of service for pharmacists and suppliers of appliances.

Regulation 2 inserts new definitions into regulation 2 of the principal Regulations. These include a definition of “specified appliances” which are a particular group of appliances which are listed in Parts IXA, IXB and IXC of the Drug Tariff (the Secretary of State for Health’s determination of remuneration for pharmaceutical services, issued under section 164 of the National Health Service Act 2006).

Part 3 of the Regulations contains amendments to the terms of service for pharmacists, which are set out in Schedule 1 to the principal Regulations. Regulation 4 amends paragraph 6 of Schedule 1 so as to add appliances to the items that can, if certain conditions are met, be dispensed without a prescription by a pharmacist in an urgent case – and to remove the requirement that the prescriber be personally known to the pharmacist. Regulation 5 amends paragraph 9 of Schedule 1 so that pharmacists providing an appliance on a repeat prescription must satisfy themselves that there has been no change in a patient’s use of the appliance which calls for a review of treatment. Regulation 6 adds to paragraph 10 of Schedule 1 a number of additional activities that must be carried out by a pharmacist when dispensing appliances. Regulation 7 inserts a new paragraph 11A into Schedule 1 setting out what pharmacists must do when dispensing “specified appliances”. They must provide a home delivery service for these appliances and must ensure that appropriate advice is given as to their use.

Regulation 8 amends paragraph 19 of Schedule 1 to require pharmacists to refer prescriptions, or to give contact details of other pharmacists or suppliers of appliances, in any case where providing a particular appliance or providing stoma appliance customisation is not within their normal course of business. Regulation 9 extends the requirements for clinical effectiveness programmes in paragraph 26 of Schedule 1 so as to cover advice about single prescriptions for appliances and includes procedures to encourage patients who are prescribed appliances not to stockpile. Regulation 10 amends paragraph 28 of Schedule 1 to prohibit gifts or rewards where a pharmacist provides no additional services other than referring a prescription onward or providing contact details of persons who are able to provide a particular service. Regulation 11 amends paragraph 37 of Schedule 1 to ensure that Primary Care Trusts can check on arrangements concerning the provision of appliances which are made between a pharmacist and a third party.

Part 4 of the Regulations contains amendments to the terms of service for suppliers of appliances, which are set out in Schedule 3 to the principal Regulations. Regulation 13 amends paragraph 4 of Schedule 3 so as to enable a supplier of appliances to dispense repeatable prescriptions in specified circumstances and regulations 15, 16, 17 and 21(2) make a number of consequential amendments. Regulation 14 inserts a new paragraph 4A into Schedule 3 so as to enable suppliers of appliances, if certain conditions are met, to dispense appliances without prescription in urgent cases. Regulation 18 adds to paragraph 8 of Schedule 3 a number of additional activities that must be carried out by a supplier of appliances when dispensing appliances. Regulation 19 inserts a new paragraph 9A and 9B into Schedule 3. Under paragraph 9A, suppliers of appliances must provide a home delivery service for “specified appliances” and must ensure that appropriate advice is given as to their use. Paragraph 9B requires suppliers of appliances to refer prescriptions, or to give contact details of other suppliers of appliances or pharmacists, in any case where providing a particular appliance or providing stoma appliance customisation is not within their normal course of business.

Regulation 20 inserts a new paragraph 13A into Schedule 3 to impose clinical governance arrangements on suppliers of appliances, which have to include a number of specified components, such as a patient and public involvement programme. Regulation 21(3) amends paragraph 15 of Schedule 3 to prohibit gifts or rewards where a supplier of appliances provides no additional services other than referring a prescription onward or providing contact details of persons who can provide a particular service. Regulation 22 amends paragraph 24 of Schedule 3 to ensure that Primary Care Trusts can check on arrangements concerning the provision of appliances which are made between a supplier of appliances and a third party.

Part 5 contains transitional provision allowing existing contractors to choose, until the end of 31st December 2010, to comply with the previous version of their terms of service, as set out in the relevant Schedule to the principal Regulations.

An Impact Assessment has been prepared and can be obtained from www.dh.gov.uk. Copies are also available from the Department of Health, Skipton House, 80 London Road, London SE1 8LH.