The National Health Service (Pharmaceutical Services) (Wales) Regulations 2013

PART 2 Essential Services

Essential services

3.  For the purposes of this Schedule, “essential services” (“gwasanaethau hanfodol”) means—

(a) the services described in this Part; and

(b) the activities described in this Part to be carried out in connection with those services.

Dispensing services

4.  An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting a prescription for that drug or appliance signed by a prescriber in pursuance of their functions in the health service in Wales, England, Scotland or Northern Ireland.

Dispensing of drugs and appliances

5.—(1) Subject to the following provisions of this Part, where a person presents on a prescription form—

(a) an order for drugs, not being Scheduled drugs, or for appliances, not being restricted availability appliances, signed by a prescriber;

(b) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations (drugs or medicines to be ordered only in certain circumstances), signed by, and endorsed on its face with the reference “SLS” by a prescriber; or

(c) an order for a restricted availability appliance, signed by and endorsed on its face with the reference “SLS” by a prescriber,

an NHS pharmacist must, with reasonable promptness and in accordance with any directions given by the prescriber in the prescription form, provide the drugs so ordered, and such of the appliances so ordered as he or she supplies in the normal course of his or her business.

(2) Subject to the following provisions of this Part, where any person—

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

(i) an order for drugs, not being Scheduled drugs or controlled drugs within the meaning of the Misuse of Drugs Act 1971(1), other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001(2) (which relate to controlled drugs excepted from certain prohibitions under the Regulations), signed by a repeatable prescriber,

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, not being a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001, signed by and endorsed on its face with the reference “SLS” by a repeatable prescriber,

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

(iv) an order for a restricted availability appliance, signed by, and endorsed on its face with the reference “SLS” by a repeatable prescriber,

and also presents an associated batch issue; or

(b) requests the provision of drugs or appliances in accordance with an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iv),

an NHS pharmacist must, with reasonable promptness and in accordance with any directions given by the repeatable prescriber in the repeatable prescription, provide the drugs so ordered, and such of the appliances so ordered as he or she supplies in the normal course of his or her business.

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

(a) the NHS pharmacist has that prescription in his or her possession; and

(b) that person presents, or the NHS pharmacist has in his or her possession, an associated batch issue.

Urgent supply without a prescription

6.—(1) This paragraph applies where, in a case of urgency, a prescriber requests an NHS pharmacist to provide a drug or appliance.

(2) The NHS pharmacist may provide the drug or appliance requested before receiving a prescription form or repeatable prescription in respect of that drug or appliance, provided that—

(a) in the case of a request for a drug, the drug is neither—

(i) a Scheduled drug, nor

(ii) a controlled drug within the meaning of the Misuse of Drugs Act 1971, other than a drug which is for the time being specified in Schedule 4 or 5 to the Misuse of Drugs Regulations 2001; and

(b) in the case of a request for a drug or an appliance, the prescriber undertakes to—

(i) give the NHS pharmacist a non-electronic prescription form or non-electronic repeatable prescription in respect of the drug or appliance within 72 hours of the request being made, or

(ii) give the NHS pharmacist an electronic prescription form or electronic repeatable prescription form complying with the ETP service within 72 hours of the request being made.

Preliminary matters before providing ordered drugs or appliances

7.—(1) If the person presenting the prescription form or repeatable prescription, or requesting the provision of drugs or appliances in accordance with a repeatable prescription, asks the NHS pharmacist to do so—

(a) the NHS pharmacist must give an estimate of the time when the drugs or appliances will be ready; and

(b) if they are not ready by then, the NHS pharmacist must give a revised estimate of the time when they will be ready (and so on).

(2) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription—

(a) the NHS pharmacist must ask any person who makes a declaration that the person named on the prescription form or the repeatable prescription does not have to pay the charges specified in regulation 3(1) of the Charges Regulations (supply of drugs and appliances by chemists) by virtue of either—

(i) entitlement to exemption under regulation 8(1) (exemptions) of the Charges Regulations, or

(ii) entitlement to remission of such charges under regulation 4 of the Remission of Charges Regulations (remissible NHS charges),

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by regulation 8(1) of the Charges Regulations or in respect of entitlement to remission by virtue of sub-paragraphs (e) to (k) of regulation 4(2) of the Remission of Charges Regulations, and at the time of the declaration the NHS pharmacist already has such evidence available to him or her; and

(b) if no satisfactory evidence, as required by paragraph (a), is produced to the NHS pharmacist, the NHS pharmacist must endorse the form on which the declaration is made to that effect.

Providing ordered drugs or appliances

8.—(1) Where an NHS pharmacist is presented with a prescription form or a repeatable prescription, the NHS pharmacist must only provide the drugs or appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and endorsed as described in paragraph 5(1) or (2); and

(b) in accordance with the order and any directions given by the prescriber on the prescription form or repeatable prescription,

subject to any regulations in force under the Weights and Measures Act 1985(3) and the following provisions of this Part.

(2) Drugs or appliances so ordered must be provided either by or under the direct supervision of a registered pharmacist.

(3) Where the pharmacist referred to in sub-paragraph (2) is employed by an NHS pharmacist, the registered pharmacist must not be someone—

(a) who is disqualified from inclusion in a relevant list; or

(b) who is suspended from the General Pharmaceutical Council Register.

(4) If the order is for an appliance of a type requiring measuring and fitting (for example a truss), the NHS pharmacist must make all necessary arrangements—

(a) for measuring the person named on the prescription form or repeatable prescription for the appliance; and

(b) for fitting the appliance.

(5) If the order is for a drug or appliance included in the Drug Tariff, the British National Formulary (including any Appendix published as part of that Formulary), the Dental Practitioner’s Formulary, the European Pharmacopoeia or the British Pharmaceutical Codex, the drug or appliance provided must comply with the standard or formula specified therein.

(6) If the order—

(a) is an order for a drug; but

(b) is not an order for a controlled drug within the meaning of the Misuse of Drugs Act 1971 other than a drug which is for the time being specified in Schedules 4 or 5 to the Misuse of Drugs Regulations 2001,

and does not prescribe its quantity, strength or dosage, an NHS pharmacist may provide the drug in such strength and dosage as in the exercise of his or her professional skill, knowledge and care he or she considers to be appropriate and, subject to sub-paragraph (7), in such quantity as he or she considers to be appropriate for a course of treatment for a period not exceeding five days.

(7) Where an order to which sub-paragraph (6) applies is for—

(a) an oral contraceptive substance;

(b) a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs; or

(c) an antibiotic in a liquid form for oral administration in respect of which pharmaceutical considerations require its provision in an unopened package,

which is not available for provision as part of pharmaceutical services except in such packages that the minimum size available contains a quantity appropriate to a course of treatment for a period of more than 5 days, the NHS pharmacist may provide the minimum size available package.

(8) Where any drug to which this paragraph applies (that is, a drug that is not one to which the Misuse of Drugs Act 1971 applies, unless it is a drug for the time being specified in Schedules 4 or 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by an NHS pharmacist in a pack in a quantity which is different to the quantity which has been so ordered, and that drug is—

(a) sterile;

(b) effervescent or hygroscopic;

(c) a liquid preparation for addition to bath water;

(d) a coal tar preparation;

(e) a viscous preparation; or

(f) packed at the time of its manufacture in a calendar pack or special container,

the NHS pharmacist must provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(9) In this paragraph “special container” (“cynhwysydd arbennig”) means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(10) Where a drug is ordered by a prescriber in a quantity that is, or is a multiple of a quantity that is, readily available in a pack size manufactured for a marketing authorisation holder for the drug, the NHS pharmacist must provide the drug in an original pack (or in original packs) of that size which have been assembled by a manufacturer of the drug for such a marketing authorisation holder, unless—

(a) it is not possible for the NHS pharmacist to obtain such a pack (or packs) with reasonable promptness in the normal course of business; or

(b) it is not practicable for the NHS pharmacist to provide such a pack (or packs) in response to the order (for example because of patient needs or the method of administration of the drug).

(11) Except as provided in sub-paragraph (12), an NHS pharmacist must not provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription.

(12) Where a drug has an appropriate non-proprietary name and it is ordered on a prescription form or repeatable prescription either by that name or by its formula, an NHS pharmacist may provide a drug which has the same specification notwithstanding that it is a Scheduled drug, provided that where a Scheduled drug is in a pack which consists of a drug in more than one strength, such provision does not involve the supply of part only of the pack.

(13) Where a drug which is ordered as specified in sub-paragraph (12) combines more than one drug, that sub-paragraph must apply only if the combination has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not.

(14) An NHS pharmacist must provide any drug which he or she is required to provide under this paragraph in a suitable container.

Refusal to provide drugs or appliances ordered

9.—(1) An NHS pharmacist may refuse to provide the drugs or appliances ordered on a prescription form or repeatable prescription where—

(a) the NHS pharmacist reasonably believes that it is not a genuine order for the person named on the prescription form or the repeatable prescription (for example because he or she reasonably believes the form has been stolen or forged);

(b) it appears to the NHS pharmacist that there is an error on the prescription form or on the repeatable prescription or its associated batch issue (including a clinical error made by the prescriber) or that, in the circumstances, providing the drugs or appliances would be contrary to the NHS pharmacist’s clinical judgement;

(c) the NHS pharmacist or other persons on the premises are subjected to or threatened with violence by the person presenting the prescription form or repeatable prescription, or by any person accompanying that person; or

(d) the person presenting the prescription form or repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence.

(2) An NHS pharmacist must refuse to provide a drug ordered on a prescription form or repeatable prescription where the order is for a prescription only medicine which the prescriber was not entitled to prescribe.

(3) An NHS pharmacist must refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) he or she has no record of that prescription;

(b) he or she does not, in the case of a non-electronic repeatable prescription, have any associated batch issue and such batch issue is not presented to him or her;

(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 a drug or appliance had been provided pursuant to the prescription and the prescription was signed more than 6 months previously;

(f) the repeatable prescription was signed more than one year previously;

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

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

(4) Where a patient requests the supply of drugs or appliances ordered on a repeatable prescription (other than on the first occasion that he or she makes such a request), an NHS pharmacist must only provide the drugs and appliances so ordered if he or she is satisfied—

(a) that the patient in respect of whom the prescription was written—

(i) is taking or using, and is likely to continue to take or use, the drug or appliance appropriately, and

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

(b) that the medication regimen of, or manner of utilisation of the appliance by, the patient in respect of whom the prescription was written 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 in respect of whom the prescription was written which indicate the need or desirability of reviewing the patient’s treatment.

Further activities to be carried out in connection with the provision of dispensing services

10.—(1) In connection with the services provided under paragraph 4, an NHS pharmacist must—

(a) ensure that appropriate advice is given to patients about any drugs or appliances provided to them—

(i) to enable them to utilise the drugs or appliances appropriately, and

(ii) to meet the patient’s reasonable needs for general information about the drugs or appliances;

(b) provide appropriate advice to persons to whom they provide drugs or appliances on—

(i) the safe keeping of the drugs or appliances, and

(ii) returning unwanted drugs or appliances to the pharmacy for safe destruction;

(c) when providing drugs to patients in accordance with a repeatable prescription, provide appropriate advice in particular on the importance of only requesting those items which they actually need;

(d) 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;

(e) provide a patient with a written note of any drug or appliance which is owed, and inform the patient when the drug or appliance becomes available;

(f) keep and maintain records—

(i) of drugs and appliances provided, where it is necessary or desirable to do so in order to facilitate the continued care of the patient;

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

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

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

(h) if he or she takes possession of a repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue;

(i) 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);

(j) destroy any surplus batch issues relating to drugs or appliances—

(i) which are not required, or

(ii) where a patient is refused the drugs or appliances pursuant to paragraph 9;

(k) ensure that where a person is refused drugs or appliances pursuant to paragraph 9(1)(b), (2), (3) or (4), the patient is referred back to the prescriber for further advice;

(l) where a patient is provided with drugs or 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;

(m) notify the prescriber of any refusal to provide drugs or appliances pursuant to paragraph 9(4);

(n) when providing appliances, provide a patient with a written note of the NHS pharmacist’s name, address and telephone number; and

(o) when providing specified appliances, comply with the additional requirements set out in paragraph 11.

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

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; or

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

Additional requirements in relation to specified appliances

11.—(1) This paragraph sets out the additional requirements referred to in paragraph 10(1)(o) relating to the provision of specified appliances.

(2) An NHS pharmacist who dispenses specified appliances in the normal course of business must provide a home delivery service in respect of those appliances and, as part of that service—

(a) the NHS pharmacist 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 NHS pharmacist must provide a reasonable supply of appropriate supplementary items (such as disposable wipes and disposal bags) and—

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

(b) if the NHS pharmacist believes it is appropriate to do so, must—

(i) refer the patient to a prescriber, or

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

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

(5) Where an NHS pharmacist provides a telephone care line in respect of the dispensing of any specified appliance, the NHS pharmacist must 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 Wales, or the website address of NHS Direct Wales(4), are made available to patients through that telephone care line.

(6) For the purposes of this paragraph—

“expert clinical advice” (“cyngor clinigol arbenigol”), 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” (“cyfnodau y tu allan i oriau”), in relation to a pharmacy, means the periods outside the periods during which the NHS pharmacist—

(a)

is obliged to provide pharmaceutical services at the pharmacy by virtue of paragraph 22(1) or 26(1); or

(b)

does provide pharmaceutical services at the pharmacy in accordance with a notification under paragraph 22(2).

Disposal service in respect of unwanted drugs

12.  An NHS pharmacist must, to the extent paragraph 13 requires and in the manner described in that paragraph, accept and dispose of unwanted drugs presented to him or her for disposal.

Basic procedure in respect of unwanted drugs

13.—(1) Subject to sub-paragraph (2), where a person presents to an NHS pharmacist or any of the NHS pharmacist’s staff any drugs provided for a patient in, and which have been kept in—

(a) a private household; or

(b) a residential care home,

the NHS pharmacist must accept the drugs and dispose of them in accordance with sub-paragraph (3).

(2) An NHS pharmacist must not be required to accept any drugs for disposal unless the Local Health Board in whose pharmaceutical list the NHS pharmacist is included has made arrangements with the NHS pharmacist for the collection and disposal of drugs of that description.

(3) On receipt of the drugs, the NHS pharmacist must—

(a) where required to do so by the Local Health Board or by a waste disposal contractor retained by the Local Health Board, separate solid drugs or ampoules, liquids and aerosols from each other;

(b) store the drugs in containers provided by the Local Health Board, or by a waste disposal contractor retained by the Local Health Board for the purpose of storing drugs of that description; and

(c) comply with any other statutory requirements in respect of storing or the disposal of drugs of that description (meeting those requirements are therefore an essential service for the purposes of these Regulations),

and must co-operate with any suitable arrangements that the Local Health Board has in place for regular collection of the drugs from the NHS pharmacist’s premises by or on behalf of the Local Health Board.

Further activities to be carried out in connection with the disposal of unwanted drugs

14.  In connection with the services provided under paragraph 12, an NHS pharmacist must—

(a) ensure that he or she and any of his or her staff, are aware of the risks associated with the handling of waste drugs and the correct procedures to be used to minimise those risks; and

(b) ensure that he or she and any of his or her staff have readily available and close to any place where waste drugs are stored appropriate protective equipment, including gloves, overalls and materials to deal with spillages.

Promotion of healthy lifestyles

15.  An NHS pharmacist must, to the extent paragraphs 16 and 17 require, and in the manner set out in those paragraphs, promote public health messages to members of the public.

Prescription linked intervention

16.—(1) Where a person using a pharmacy—

(a) presents a prescription form or repeatable prescription to an NHS pharmacist; and

(b) it appears to the NHS pharmacist that the person—

(i) has diabetes,

(ii) is at risk of coronary heart disease or high blood pressure, or

(iii) smokes or is overweight,

the NHS pharmacist must, as appropriate, provide advice to that person with the aim of increasing that person’s knowledge and understanding of the health issues which are relevant to that person’s personal circumstances.

(2) Advice given under sub-paragraph (1) may be backed up, as appropriate—

(a) by the provision of written material (for example leaflets); and

(b) by referring the person to other sources of information or advice.

(3) An NHS pharmacist must, in appropriate cases, keep and maintain a record of advice given pursuant to this paragraph, and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by the NHS pharmacist; and

(b) follow-up care for the person who has been given the advice.

Public health campaigns

17.  An NHS pharmacist must, at the request of the Local Health Board on whose pharmaceutical list the NHS pharmacist is included, ensure that—

(a) he or she and any of his or her staff participate, in the manner reasonably requested by the Local Health Board, in up to six campaigns in each calendar year to promote public health messages to users of the NHS pharmacist’s pharmacy; and

(b) where requested to do so by the Local Health Board, record the number of people that have been provided information as part of one of those campaigns.

Signposting

18.  An NHS pharmacist must, to the extent paragraph 19 requires and in the manner set out in that paragraph, provide information to users of the NHS pharmacist’s pharmacy about other health and social care providers and support organisations.

Service outline in respect of signposting

19.—(1) Where it appears to an NHS pharmacist or his or her staff, having regard to the need to minimise inappropriate use of health and social care services and of support services, that a person using the NHS pharmacist’s pharmacy—

(a) requires advice, treatment or support that the NHS pharmacist cannot provide; but

(b) another provider, of which the NHS pharmacist is aware, of health or social care services or of support services is likely to be able to provide that advice, treatment or support,

the NHS pharmacist must provide contact details of that provider to that person and must, in appropriate cases, refer that person to that provider.

(2) Where, on presentation of a prescription form or repeatable prescription, an NHS pharmacist is unable to provide an appliance or stoma appliance customisation because the provision of the appliance or customisation is not within the NHS pharmacist’s normal course of business, the NHS pharmacist must—

(a) if the patient consents, refer the prescription form or repeatable prescription to another NHS pharmacist or to an NHS appliance contractor; or

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

(3) Where appropriate, a referral under this paragraph may be made by means of a written referral note.

(4) The NHS pharmacist must, in appropriate cases, keep and maintain a record of any information given or referral made under this paragraph and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by the NHS pharmacist; and

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

Support for self-care

20.  An NHS pharmacist must, to the extent paragraph 21 requires and in the manner set out in that paragraph, provide advice and support to people caring for themselves or their families.

Service outline in respect of support for self-care

21.—(1) Where it appears to an NHS pharmacist or his or her staff, having regard to the need to minimise the inappropriate use of health and social care services, that a person using the NHS pharmacist’s pharmacy would benefit from advice from the NHS pharmacist to help the person manage a medical condition (including, in the case of a carer, to help the carer in assisting in the management of another person’s medical condition), the NHS pharmacist must provide advice to the person using the pharmacy as regards managing the medical condition, including as appropriate advice—

(a) on treatment options, including advice on the selection and use of appropriate drugs which are not prescription only medicines; and

(b) on changes to the patient’s lifestyle.

(2) The NHS pharmacist must, in appropriate cases, keep and maintain a record of any advice given under sub-paragraph (1) and that record must be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by the NHS pharmacist; and

(b) follow-up care for the person to whom or in respect of whom the advice has been given.

(1)

1971 c. 38. See section 2(1)(a) of that Act which defines “controlled drug” for the purposes of that Act.

(2)

S.I. 2001/3998 (as amended).

(3)

1985 c. 72.

(4)

NHS Direct Wales telephone number 0845 46 47, website address www.nhsdirect.wales.nhs.uk.