The National Health Service (Pharmaceutical Services) Regulations 2005

PART 2 ESSENTIAL SERVICES

Essential services

3.  For the purposes of these Regulations, “essential services” 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.  A pharmacist shall, 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 prescriptions for drugs or appliances by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service.

Dispensing of drugs and appliances

5.—(1) In this Part, “signed” includes signature with a prescriber’s advanced electronic signature.

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

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

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

(ii) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, signed by a prescriber and including the reference “SLS”, or

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

(b) subject to sub-paragraph (4), the pharmacist receives from the ETP service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii) and—

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

(ii) the pharmacist has previously arranged with the patient that he will dispense that prescription on receipt,

a pharmacist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as he supplies in the normal course of his business.

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

(a) any person 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), 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 a repeatable prescriber and including the reference “SLS”,

(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 a repeatable prescriber, and including the reference “SLS”,

and also presents an associated batch issue; or

(b) the pharmacist receives from the ETP service an electronic repeatable prescription which contains an order of a kind specified in paragraph (a)(i) to (iv) and—

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

(ii) the pharmacist has previously arranged with the patient that he will dispense that repeatable prescription on receipt,

a pharmacist shall, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as he supplies in the normal course of his business.

(4) A pharmacist shall not provide under an electronic prescription form 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.

(5) For the purposes of this paragraph, a non-electronic repeatable prescription for drugs or appliances shall 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 pharmacist has that prescription in his possession; and

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

Urgent supply without a prescription

6.  Where, in a case of urgency, a prescriber personally known to a pharmacist requests him to provide a drug, the pharmacist may provide that drug before receiving a prescription form or repeatable prescription, provided that—

(a) that drug is not a Scheduled drug;

(b) that drug is not 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

(c) the prescriber undertakes to—

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

(ii) transmit to the ETP service within 72 hours an electronic prescription.

Preliminary matters before providing ordered drugs or appliances

7.—(1) If a person specified in paragraph (2) asks the pharmacist to do so—

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

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

(2) The persons referred to in paragraph (1) are a person—

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

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

(3) Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription the pharmacist shall 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) or (1A) of the Charges Regulations by virtue of either—

(a) entitlement to exemption under regulation 7(1) of the Charges Regulations; or

(b) entitlement to remission of charges under regulation 5 of the Remission of Charges Regulations,

to produce satisfactory evidence of such entitlement, unless the declaration is in respect of entitlement to exemption by virtue of sub-paragraph (a), (c), (d), (e), (f) or (g) of regulation 7(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 5(1)(e) or (2) of the Remission of Charges Regulations, and at the time of the declaration the pharmacist already has such evidence available to him.

(4) If, in the case of a non-electronic prescription form or non-electronic repeatable prescription, no satisfactory evidence, as required by sub-paragraph (3), is produced to the pharmacist, the pharmacist shall endorse the form on which the declaration is made to that effect.

(5) In the case of an electronic prescription, the pharmacist shall transmit to the ETP service—

(a) in a case where exemption from or remission of charges is claimed for all or some of the items included in the prescription, a record of—

(i) the exemption category specified in regulation 7(1) of the Charges Regulations or the ground for remission under regulation 5 of the Remission of Charges Regulations which it is claimed applies to the case, and

(ii) whether or not satisfactory evidence was produced to him as required by sub-paragraph (3);

(b) in any case where a charge is due, confirmation that the relevant charge was paid; and

(c) in a case of a prescription for or including contraceptive substances, confirmation that no charge was payable in respect of those substances.

Providing ordered drugs or appliances

8.—(1) Where a pharmacist is presented with, or receives from the ETP service, a prescription form or a repeatable prescription, the pharmacist shall only provide the drugs or appliances so ordered—

(a) if the prescription form or repeatable prescription is duly signed and completed as described in paragraph 5(2) or (3); 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(3) and the following provisions of this Part.

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

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

(a) who—

(i) has been disqualified under section 46(2)(b) of the Act (or under any corresponding provision in force in Scotland or Northern Ireland) from inclusion in the pharmaceutical list of a Primary Care Trust (or, in Scotland, of a Health Board or, in Northern Ireland, of a Health and Social Services Board), and

(ii) is the subject of a declaration under section 46(2)(c) of the Act (or any corresponding provision in force in Scotland or Northern Ireland) that he is not fit to be engaged in any capacity in the provision of pharmaceutical services; or

(b) who is suspended.

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

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

(b) 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 shall 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 Schedule 4 or 5 to the Misuse of Drugs Regulations 2001,

and does not prescribe its quantity, strength or dosage, a pharmacist may provide the drug in such strength and dosage as in the exercise of his professional skill, knowledge and care he considers to be appropriate and, subject to sub-paragraph (7), in such quantity as he 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 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 Schedule 5 to the Misuse of Drugs Regulations 2001), ordered by a prescriber on a prescription form or repeatable prescription, is available for provision by a 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 pharmacist shall, subject to sub-paragraph (9), provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.

(9) A pharmacist shall not provide, pursuant to sub-paragraph (8), a drug in a calendar pack where, in his opinion, it was the intention of the prescriber who ordered the drug that it should be provided only in the exact quantity ordered.

(10) In this paragraph—

(a) “calendar pack” means a blister or strip pack showing the days of the week or month against each of the several units in the pack; and

(b) “special container” means any container with an integral means of application or from which it is not practicable to dispense an exact quantity.

(11) Except as provided in sub-paragraph (12), a pharmacist shall 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, a 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 shall apply only if the combination has an appropriate non-proprietary name, whether the individual drugs which it combines do so or not.

(14) A pharmacist shall provide any drug which he is required to provide under paragraph 5 in a suitable container.

Refusal to provide drugs or appliances ordered

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

(a) the 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 reasonably believes it has been stolen or forged);

(b) it appears to the pharmacist 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 drugs or appliances would be contrary to the pharmacist’s clinical judgement;

(c) the 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 requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or by any person accompanying that person; or

(d) the person presenting the prescription form or repeatable prescription or requesting the provision of drugs or appliances in accordance with an electronic prescription form or a repeatable prescription, or any other person accompanying that person, commits or threatens to commit a criminal offence.

(2) A pharmacist shall 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) A pharmacist shall refuse to provide drugs or appliances ordered on a repeatable prescription where—

(a) he has no record of that prescription;

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

(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 (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) where he 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 makes such a request), a pharmacist shall only provide the drugs or appliances ordered if he is satisfied—

(a) that the patient to whom the prescription relates—

(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 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.

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

10.  In connection with the services provided under paragraph 4, a pharmacist shall—

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

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

(e) keep and maintain records—

(i) of drugs and 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 sub-paragraph (d);

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

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

(h) if he provides a drug or appliance under an electronic prescription, provide the patient, if he so requests, with a written record of the drugs or 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;

(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 in pursuant to paragraph 9;

(k) ensure that where a person is refused drugs or appliances pursuant to paragraphs 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; and

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

Additional requirements in relation to electronic prescribing

11.—(1) A pharmacist shall, if requested to do so by any person—

(a) explain to him the ETP service, whether or not it is a service which is available through his pharmacy; and

(b) where the ETP service is not available through his pharmacy, provide him with contact details of at least two pharmacies in his area through which the service is available, if these details are known to the pharmacist.

(2) Where the ETP service is available through his pharmacy, the pharmacist shall, if requested to do so by any person, enter in that person’s NHS Care Record—

(a) where the person does not have a nominated dispensing contractor, the dispensing contractor chosen by that person; and

(b) where the person does have a nominated dispensing contractor—

(i) a replacement dispensing contractor, or

(ii) a further dispensing contractor,

chosen by that person.

(3) Paragraph (2)(b)(ii) shall not apply if the number of nominated dispensing contractors for that person would thereby exceed the maximum number permitted by the ETP service.

(4) Regulation 72(a) to (c) shall apply to a request under this paragraph as it applies to an application to a chemist for pharmaceutical services.

Disposal service in respect of unwanted drugs

12.  A pharmacist shall, to the extent paragraph 13 requires and in the manner described in that paragraph, accept and dispose of unwanted drugs presented to him for disposal.

Basic procedure in respect of unwanted drugs

13.—(1) Subject to paragraph (2), where a person presents to a pharmacist or any of his 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 pharmacist shall accept the drugs and dispose of them in accordance with sub-paragraph (3).

(2) A pharmacist shall not be required to accept any drugs for disposal unless the Primary Care Trust in whose list he is included has made arrangements for the collection and disposal of drugs of that description.

(3) On receipt of the drugs, the pharmacist shall—

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

(b) store the drugs in containers provided by the Primary Care Trust, or by a waste disposal contractor retained by the Primary Care Trust, 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 shall co-operate with any suitable arrangements that the Primary Care Trust has in place for regular collection of the drugs from his premises by or on behalf of the Primary Care Trust.

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

14.  In connection with the services provided under paragraph 12, a pharmacist shall—

(a) ensure that he and any staff he has, 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 and any staff he has, 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.  A pharmacist shall, 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 non-electronic prescription form or non-electronic repeatable prescription to a pharmacist or requests the provision of drugs or appliances in accordance with an electronic prescription; and

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

(i) has diabetes,

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

(iii) smokes or is overweight,

the pharmacist shall, 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) A pharmacist shall, in appropriate cases, keep and maintain a record of advice given pursuant to this paragraph, and that record shall be in a form that facilitates—

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

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

Public health campaigns

17.  A pharmacist shall, at the request of its Primary Care Trust, ensure that—

(a) he and any staff he has, participate, in the manner reasonably requested by his Primary Care Trust, in up to six campaigns in each calendar year to promote public health messages to users of his pharmacy;

(b) where requested to do so by the Primary Care Trust, he records the number of people to whom he or his staff have provided information as part of one of those campaigns.

Signposting

18.  A pharmacist shall, to the extent paragraph 19 requires and in the manner set out in that paragraph, provide information to users of its pharmacy about other health and social care providers and support organisations.

Service outline in respect of signposting

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

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

(b) another provider, of which the 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 pharmacist shall provide contact details of that provider to that person and shall, in appropriate cases, refer that person to that provider.

(2) Where appropriate, a referral under paragraph (1) may be made by means of a written referral note.

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

(a) auditing of the provision of pharmaceutical services by the 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.  A pharmacist shall, 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 a pharmacist or his staff, having regard to the need to minimise the inappropriate use of health and social care services, that a person using his pharmacy would benefit from advice from the pharmacist to help him 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 pharmacist shall 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 pharmacist shall, in appropriate cases, keep and maintain a record of any advice given under paragraph (1), and of any drugs supplied when the advice was given, and that record shall be in a form that facilitates—

(a) auditing of the provision of pharmaceutical services by the 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. Schedule 4 has been amended by S.I. 2003/1432.

(3)

1985 c. 72.