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

PART 4 Amendments to the terms of service of suppliers of appliances

Amendments to Schedule 3 to the principal Regulations

12.  Schedule 3 to the principal Regulations is amended in accordance with regulations 13 to 22.

Amendment of paragraph 4

13.—(1) Amend paragraph 4 (dispensing of appliances) as follows.

(2) In sub-paragraph (2), for “paragraphs 5 to 7” substitute “the following provisions of this Schedule”.

(3) After sub-paragraph (2) insert—

“(3) Subject to the following provisions of this Schedule, where—

(a) any person presents a non-electronic repeatable prescription which contains—

(i) an order for appliances, not being restricted availability appliances, signed by a repeatable prescriber, or

(ii) an order for a restricted availability appliance, signed by a repeatable prescriber and including the reference “SLS”,

and also presents an associated batch issue; or

(b) a supplier of appliances receives from the ETP service an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) or (ii) and—

(i) any person requests the provision of appliances in accordance with that prescription, or

(ii) the supplier of appliances has previously arranged with the patient that the supplier will dispense that prescription on receipt,

the supplier of appliances shall, with reasonable promptness, provide such of the appliances so ordered as the supplier supplies in the normal course of business.

(4) For the purposes of this paragraph, a non-electronic repeatable prescription for appliances shall be taken to be presented even if the person who wishes to obtain the appliances does not present that prescription, where—

(a) the supplier of appliances has that prescription in the supplier’s possession; and

(b) that person presents, or the supplier of appliances has in the supplier’s possession, an associated batch issue.”.

Insertion of new paragraph 4A

14.  After paragraph 4 insert—

“Urgent supply without a prescription

4A.— (1) This paragraph applies where, in a case of urgency, a prescriber requests a supplier of appliances to provide an appliance.

(2) The supplier of appliances may provide the appliance requested before receiving a prescription form or repeatable prescription in respect of that appliance, provided that the prescriber undertakes to—

(a) give the supplier of appliances a non-electronic prescription form or non-electronic repeatable prescription in respect of the appliance within 72 hours of the request being made; or

(b) transmit an electronic prescription to the ETP service within 72 hours of the request being made.”.

Amendment of paragraph 5

15.—(1) Amend paragraph 5 (preliminary matters before providing appliances) as follows.

(2) In sub-paragraph (1), for the words from “If the person” to “an electronic prescription form” substitute “If a person specified in sub-paragraph (1A)”.

(3) After sub-paragraph (1) insert—

“(1A) A person specified in this sub-paragraph is a person—

(a) presenting a non-electronic prescription form or non-electronic repeatable prescription; or

(b) requesting the provision of appliances in accordance with an electronic prescription form or an electronic repeatable prescription.”.

(4) In sub-paragraph (2)—

(a) after “in accordance with a prescription form” insert “or repeatable prescription”;

(b) in paragraph (a), after “named on the prescription form” insert “or repeatable prescription”;

(c) in paragraph (b), after “in the case of a non-electronic prescription form” insert “or non-electronic repeatable prescription”; and

(d) in paragraph (c), after “in the case of an electronic prescription form” insert “or an electronic repeatable prescription”.

Amendment of paragraph 6

16.—(1) Amend paragraph 6 (providing appliances) as follows.

(2) For sub-paragraph (1) substitute—

“(1) Where a supplier of appliances is presented with, or receives from the ETP service, a prescription form or a repeatable prescription, the supplier of appliances shall only provide the appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 4; and

(b) in accordance with the order on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985(1) and the following provisions of this Schedule.”.

(3) In sub-paragraph (2)(a), after “named on the prescription form” insert “or repeatable prescription”.

Amendment of paragraph 7

17.—(1) Amend paragraph 7 (refusal to provide appliances ordered) as follows.

(2) Renumber the existing provision as sub-paragraph (1).

(3) In that sub-paragraph—

(a) after “ordered on a prescription form” insert “or repeatable prescription”;

(b) in paragraph (a), after “the prescription form” insert “or repeatable prescription”;

(c) for paragraph (b), substitute—

“(b) it appears to the supplier of appliances that there is an error on the prescription form or on the repeatable prescription or, in the case of a non-electronic repeatable prescription, its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the appliance would be contrary to the clinical judgement of the supplier of appliances;”; and

(d) in paragraphs (c) and (d)—

(i) after each reference to “the prescription form” insert “or repeatable prescription”, and

(ii) after each reference to “an electronic prescription form” insert “or repeatable prescription”.

(4) After sub-paragraph (1) insert—

“(2) A supplier of appliances shall refuse to provide appliances ordered on a repeatable prescription where—

(a) the supplier has no record of that prescription;

(b) the supplier does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and it is not presented to the supplier;

(c) it is not signed by a repeatable prescriber;

(d) to do so would not be in accordance with any intervals specified in the prescription;

(e) it would be the first time an appliance had been provided pursuant to the prescription and the prescription was signed (whether electronically or otherwise) more than six months previously;

(f) the repeatable prescription was signed (whether electronically or otherwise) more than one year previously;

(g) the expiry date on the repeatable prescription has passed; or

(h) the supplier has been informed by the repeatable prescriber that the prescription is no longer required.

(3) Where a patient requests the supply of appliances ordered on a repeatable prescription (other than on the first occasion that the request is made), a supplier of appliances shall only provide the appliance ordered if satisfied that—

(a) the patient to whom the prescription relates—

(i) is using and is likely to continue to use the appliance appropriately, and

(ii) is not suffering from any side effects of the treatment which indicate the need or desirability of reviewing the patient’s treatment;

(b) the manner of utilisation of the appliance by the patient to whom the prescription relates has not altered in a way which indicates the need or desirability of reviewing the patient’s treatment; and

(c) there have been no changes to the health of the patient to whom the prescription relates which indicate the need or desirability of reviewing the patient’s treatment.”

Amendment of paragraph 8

18.—(1) Amend paragraph 8 (further activities to be carried out in connection with the provision of dispensing services) as follows.

(2) Renumber the existing provision as sub-paragraph (1).

(3) In that sub-paragraph, for paragraphs (c) to (e) substitute—

“(c) when providing appliances to patients in accordance with a prescription form or repeatable prescription—

(i) provide appropriate advice in particular on the importance of only requesting those items which they actually need, and

(ii) for those purposes, have regard to the details contained in the records maintained under paragraph (f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;

(d) provide a patient with a written note of any appliance which is owed, and inform the patient when it is expected that the appliance will become available;

(e) provide a patient with a written note of the supplier’s name, address and telephone number;

(f) keep and maintain records—

(i) of appliances provided, in order to facilitate the continued care of the patient,

(ii) in appropriate cases, of advice given and any interventions or referrals made (including clinically significant interventions in cases involving repeatable prescriptions), and

(iii) of notes provided under paragraph (d);

(g) undertake appropriate training in respect of repeat dispensing, having regard to any recommendations in respect of such training set out in the Drug Tariff;

(h) if the supplier takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

(i) if the supplier provides an appliance under an electronic prescription, provide the patient, if the patient so requests, with a written record of the appliances ordered on that prescription and, in the case of an electronic repeatable prescription, of the number of occasions on which it can be dispensed;

(j) maintain records of repeatable prescriptions in such a form as to provide a clear audit trail of supplies under the repeatable prescription (including dates and quantities supplied);

(k) destroy any surplus batch issues relating to appliances—

(i) which are not required, or

(ii) where a patient is refused an appliance pursuant to paragraph 7;

(l) ensure that where a person is refused appliances pursuant to paragraph 7(1)(b), (2) or (3), the patient is referred back to the prescriber for further advice;

(m) where a patient is provided with appliances under a repeatable prescription, notify the prescriber of any clinically significant issues arising in connection with the prescription and keep a record of that notification;

(n) notify the prescriber of any refusal to provide appliances pursuant to paragraph 7(3); and

(o) when providing specified appliances, comply with the additional requirements set out in paragraph 9A.”.

(4) After sub-paragraph (1) insert—

“(2) Where, on presentation of a prescription form or repeatable prescription in connection with the dispensing of appliances under paragraph 4, a supplier of appliances is unable to provide an appliance, or stoma appliance customisation is required and the supplier of appliances is unable to provide that, the supplier of appliances shall—

(a) if the patient consents, refer the prescription form or repeatable prescription to another supplier of appliances or to a pharmacist; or

(b) if the patient does not consent to a referral, provide the patient with contact details of at least two people who are pharmacists or suppliers of appliances who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to the supplier.”.

Insertion of new paragraphs 9A and 9B

19.  After paragraph 9 insert—

“Additional requirements in relation to specified appliances

9A.— (1) This paragraph sets out the additional requirements referred to in paragraph 8(1)(o) relating to the provision of specified appliances.

(2) A supplier of appliances who dispenses specified appliances in the normal course of business shall provide a home delivery service in respect of those appliances and, as part of that service—

(a) the supplier of appliances must offer to deliver the specified appliance to the patient’s home;

(b) if the patient accepts that offer, the delivery must be made with reasonable promptness and at such time as is agreed with the patient;

(c) the specified appliance must be delivered in a package which displays no writing or other markings which could indicate its content; and

(d) the manner of delivery of the package and any supplementary items required by sub-paragraph (3) must not convey the type of appliance being delivered.

(3) In any case where a specified appliance is provided (whether by home delivery or otherwise), the supplier of appliances shall provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—

(a) shall ensure that the patient may, if the patient wishes, consult a person to obtain expert clinical advice regarding the appliance; or

(b) if the supplier of appliances believes it is appropriate to do so, shall—

(i) refer the patient to a prescriber, or

(ii) offer the patient an appliance use review service.

(4) If the supplier of appliances is unable to provide an appliance use review service in accordance with sub-paragraph (3)(b)(ii), the supplier must give the patient the contact details of at least two people who are pharmacists or suppliers of appliances who are able to arrange for the service to be provided, if these details are known to the supplier of appliances.

(5) Where a supplier of appliances provides a telephone care line in respect of the dispensing of any specified appliance, the supplier shall ensure that during out of hours periods—

(a) advice is made available to patients through that telephone care line; or

(b) the telephone number of NHS Direct National Health Service Trust, or website address of NHS Direct National Health Service Trust on line, are made available to patients through the telephone care line.

(6) For the purposes of this paragraph—

“expert clinical advice”, in relation to a specified appliance, means advice which is given by a person who is suitably trained and who has relevant experience in respect of the appliance;

“out of hours periods”, in relation to each of the premises from which a supplier of appliances has undertaken to provide pharmaceutical services, means the periods outside the periods during which the supplier of appliances is obliged to provide pharmaceutical services by virtue of paragraph 10 or 13A.

Signposting

9B.— (1) Where, on presentation of a prescription form or repeatable prescription, a supplier of appliances is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within the supplier’s normal course of business, the supplier of appliances shall—

(a) if the patient consents, refer the prescription form or repeatable prescription to another supplier of appliances or to a pharmacist; and

(b) if the patient does not consent to a referral, provide the patient with contact details of at least two people who are pharmacists or suppliers of appliances who are able to provide the appliance or stoma appliance customisation (as the case may be), if these details are known to the supplier.

(2) The supplier of appliances shall, in appropriate cases, keep and maintain a record of any information given or referral made under sub-paragraph (1) and that record shall be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by the supplier of appliances; and

(b) follow-up care for the person who has been given the information or in respect of whom the referral has been made.”.

Insertion of new paragraph 13A

20.  After paragraph 13 insert—

“Clinical governance

13A.— (1) A supplier of appliances shall, in connection with all the pharmaceutical services the supplier of appliances provides, participate, in the manner reasonably required by the Primary Care Trust, in an acceptable system of clinical governance.

(2) For these purposes a system of clinical governance is “acceptable” if it is considered acceptable by the Secretary of State and comprises the following components—

(a) a patient and public involvement programme, which includes—

(i) a requirement that the supplier of appliances produces in an approved manner a practice leaflet containing approved particulars in respect of each of the premises from which the supplier provides pharmaceutical services,

(ii) a requirement that the supplier of appliances publicises the NHS services that are available at or from such premises,

(iii) a requirement that the supplier of appliances undertakes an approved patient satisfaction survey annually, in an approved manner,

(iv) the monitoring arrangements of the supplier of appliances in respect of appliances owed to patients but which are out of stock,

(v) an approved complaints system (which meets the requirements of this Schedule),

(vi) a requirement that the supplier of appliances co-operates appropriately with visits by an authorised representative of any relevant local involvement network and takes appropriate action following the outcome of such visits,

(vii) a requirement that the supplier of appliances co-operates appropriately with any reasonable inspection or review that the Primary Care Trust or any relevant statutory authority wishes to undertake, and

(viii) the monitoring arrangements of the supplier of appliances in respect of the supplier’s compliance with the Disability Discrimination Act 1995(2);

(b) a clinical audit programme (normally of five days) twice in each financial year;

(c) a risk management programme, which includes—

(i) arrangements for ensuring that all stock is procured and handled in an appropriate way,

(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately,

(iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents,

(iv) appropriate standard operating procedures, including standard operating procedures in respect of dispensing appliances, repeatable prescriptions and providing advice and support to people caring for themselves or their families,

(v) appropriate waste disposal arrangements for clinical and confidential waste,

(vi) identifying a clinical governance lead person in respect of each of the premises from which the supplier provides pharmaceutical services,

(vii) appropriate child protection procedures, and

(viii) the monitoring arrangements of the supplier of appliances in respect of the supplier’s compliance with the Health and Safety at Work etc. Act 1974(3);

(d) a clinical effectiveness programme, which includes arrangements for ensuring that appropriate advice is given by a supplier of appliances—

(i) in respect of the provision of appliances in accordance with a prescription form or repeatable prescription, or

(ii) to people caring for themselves or their families,

and arrangements for ensuring that the supplier, when giving advice to any patient on a matter mentioned in paragraph (d)(i), has regard to the details contained in the records maintained under paragraph 8(1)(f) in respect of the provision of appliances and prescribing pattern relating to the patient in question;

(e) a staffing and staff management programme, which includes—

(i) arrangements for appropriate induction for staff and locums,

(ii) appropriate training for all staff in respect of any role they are asked to perform,

(iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services,

(iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of services as part of the health service, including continuing professional development for registered pharmacists, registered nurses and registered pharmacy technicians and any necessary accreditation in respect of the provision of directed services, and

(v) arrangements for addressing poor performance (in conjunction with a Primary Care Trust as appropriate); and

(f) a use of information programme, which includes—

(i) appropriate arrangements (having regard to issues both of rights of access to information and of confidentiality) to support both health care delivery and clinical governance,

(ii) appropriate arrangements in respect of compliance with “Confidentiality: the National Health Service Code of Practice”(4),

(iii) the monitoring arrangements of the supplier of appliances in respect of the supplier’s compliance with the Data Protection Act 1998(5) and with regard to patient confidentiality, and

(iv) appropriate training for staff with regard to compliance with the Data Protection Act 1998 and patient confidentiality.

(3) For the purposes of sub-paragraph (2), “approved” means approved by the Secretary of State.”.

Amendments of paragraph 15

21.—(1) Amend paragraph 15 (inducements etc.) as follows.

(2) In sub-paragraph (1)—

(a) for “A supplier of appliances or his staff shall not give” substitute “Neither a supplier of appliances nor any person employed or engaged by a supplier of appliances shall give”; and

(b) in paragraph (a), after “a prescription form” insert “or repeatable prescription”.

(3) After sub-paragraph (2) insert—

“(3) Neither a supplier of appliances nor any person employed or engaged by a supplier of appliances shall accept or receive any gift or reward in respect of only—

(a) providing contact details of alternative pharmacists or suppliers of appliances pursuant to paragraph 8(2)(b), 9A(4) or 9B(1)(b); or

(b) referring a prescription form or repeatable prescription to another supplier of appliances or pharmacist pursuant to paragraph 8(2)(a) or 9B(1)(a) and providing no additional service in connection with the item on that prescription.”.

Amendment of paragraph 24

22.  In paragraph 24(1) (inspections and access to information), in paragraph (b)(i), after “patient care and treatment,” insert “including any arrangement made with a person in respect of provision of appliances,”.

(1)

1985 c. 72.

(2)

1995 c. 50.

(3)

1974 c. 37.

(4)

This Code of Practice is available on the Department of Health’s website, www.dh.gov.uk.

(5)

1998 c. 29.