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Statutory Instrument 2006 No. 552The National Health Service (Local Pharmaceutical Services etc.) Regulations 2006(The document as of February, 2008) STATUTORY INSTRUMENTS2006 No. 552NATIONAL HEALTH SERVICE, ENGLANDThe National Health Service (Local Pharmaceutical Services etc.) Regulations 2006
The Secretary of State for Health makes the following Regulations in exercise of the powers conferred by sections 42(2A) and 126(4) of, and paragraphs 1(3), 2(1), 3 and 4 of Schedule 8A to, the National Health Service Act 1977[1] and sections 30, 34, 37(b), 41 and 65(1) and (2) of, and paragraph 1(2)(b) of Schedule 2 to, the Health and Social Care Act 2001[2]. Citation, commencement and application 1.—(1) These Regulations may be cited as the National Health Service (Local Pharmaceutical Services etc.) Regulations 2006 and shall come into force on 1st April 2006. (2) These Regulations apply in relation to England only[3]. Interpretation 2.—(1) In these Regulations—
(b) capable of identifying the signatory; (c) created using means that the signatory can maintain under his sole control; and (d) linked to the data to which it relates in such a manner that any subsequent change of data is detectable;
(b) relates to a particular non-electronic repeatable prescription and contains the same date as that prescription; (c) is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs or appliances ordered on the non-electronic repeatable prescription may be provided; and (d) specifies a number denoting its place in the sequence referred to in sub-paragraph (c);
(b) a Health Board or NHS trust in Scotland; (c) a Health and Social Services Board in Northern Ireland; or (d) in relation to any time prior to 1st October 2002, a Health Authority in England;
(b) in respect of whom is recorded in that register an annotation signifying that he is qualified to order drugs and appliances—
(ii) until 30th April 2006, from the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff, (iii) as an independent nurse prescriber, or (iv) as a community practitioner nurse prescriber;
(b) a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act; or (c) a decision by the Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 4 of the Abolition of the Tribunal Regulations;
(b) a person included in a pharmaceutical list; (c) a party to a general medical services contract other than a Primary Care Trust; or (d) a party to section 28C arrangements other than a Primary Care Trust or a Strategic Health Authority, whom a patient has nominated in his NHS Care Record to dispense his electronic prescriptions;
(ii) if that name consists of two or more words, any name derived from a suitable inversion of such words which is permitted by that publication; or (b) where the drug is not so described in a monograph, but has an approved name, being the name which appears in the current edition, as defined in section 103(5) of the Medicines Act 1968, of the list of names prepared and published under section 100 of that Act (lists of names), as in force at the time of the supply of the drug, its approved name;
(b) against whose name in that register is recorded an annotation signifying that he is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;
(b) data that are created in an electronic form, signed with a prescriber's advanced electronic signature and transmitted as an electronic communication to a nominated dispensing contractor by the ETP service, to enable a person to obtain pharmaceutical services or local pharmaceutical services, and does not include a repeatable prescription;
(b) a list of persons undertaking to provide general ophthalmic services or, as the case may be, pharmaceutical services prepared in accordance with regulations made under section 39, 42 or 43 of the Act[25] (which relate to regulations as to ophthalmic services, pharmaceutical services and persons authorised to provide pharmaceutical services); (c) a list of persons who undertook to provide general medical services or general dental services prepared in accordance with regulations made under section 29 or 35 of the Act[26] (which related to regulations as to general medical services and general dental services); (d) a list of persons approved for the purposes of assisting in the provision of any services mentioned in paragraph (b) or (c) prepared in accordance with regulations made under section 43D of the Act[27] (supplementary lists); (e) a services list that fell within the meaning of section 8ZA of the National Health Service (Primary Care) Act 1977[28] (lists of persons who may perform personal medical services or personal dental services); (f) a list corresponding to a services list prepared by virtue of regulations made under section 41 of the Health and Social Care Act 2001[29] (corresponding provision and application of enactments); or (g) a list corresponding to any of the above lists in Scotland or Northern Ireland;
(ii) consists of data that are created in an electronic form, signed with a repeatable prescriber's advanced electronic signature and transmitted as an electronic communication to a nominated dispensing contractor by the ETP service; (b) is issued or created to enable a person to obtain pharmaceutical services or local pharmaceutical services; and
(b) except where the conditions in paragraph 42(2) of Schedule 6 to the GMS Contracts Regulations are satisfied, Schedule 2 to the Prescription of Drugs Regulations.
(ii) the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954, (iii) the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976, (iv) the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001[31] relating to—
(bb) physiotherapists, or (cc) diagnostic or therapeutic radiographers, or (v) the register of optometrists maintained by the General Optical Council in pursuance of section 7 of the Opticians Act 1989[32]; and (b) against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs and appliances as a supplementary prescriber;
(ii) regulations made under section 28DA (lists of persons who may perform personal medical services or personal dental services)[34] or 43D of the Act (supplementary lists) of the Act, or (iii) section 8ZA (lists of persons who may perform personal medical services or personal dental services) of the National Health Service (Primary Care) Act 1977; or (b) in relation to Scotland or Northern Ireland, suspended under provisions in force corresponding to those in or made under sections 28DA, 43D, 49I or 49J of the Act or under section 8ZA of the National Health Service (Primary Care) Act 1977, and shall be treated as including a case where a person is treated as suspended by a Primary Care Trust or, prior to 1st October 2002, by a Health Authority by virtue of regulation 6(2) of the Abolition of the Tribunal Regulations, or, in Wales, by a Local Health Board, or prior to 1st April 2003, by a Health Authority by virtue of regulation 6(2) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002[35], and "suspends" and "suspension" shall be construed accordingly; and
(2) In these Regulations, "local pharmaceutical services" means services of a kind which may be provided under section 41 of the 1977 Act[38] (arrangements for pharmaceutical services), or by virtue of section 41A of that Act[39] (arrangements for providing additional pharmaceutical services), other than practitioner dispensing services. Designation of priority neighbourhoods or premises 4.—(1) Subject to the following provisions of this regulation, a Primary Care Trust may designate neighbourhoods, premises or descriptions of premises for the purposes of paragraph 2 of Schedule 8A to the Act. (2) Where a designation has been made or varied under this regulation, the Primary Care Trust may defer consideration of all other Part 2 applications[41] in respect of the designated neighbourhood, premises or descriptions of premises, until such time as the designation is cancelled. (3) A designation must designate the neighbourhood in which, or the premises or description of the premises at which, local pharmaceutical services are to be provided under—
(b) LPS schemes that have been approved, and the proposed scheme or the approved schemes (collectively) are referred to in this regulation as the "relevant scheme".
(b) include a map showing the location of the neighbourhood or premises that have been designated. (5) A Primary Care Trust must give notice of a designation which it has made to—
(b) any Local Medical Committee formed for the area of that Primary Care Trust or of a neighbouring Primary Care Trust that is likely to be affected by the designation; (c) any person whose name is included in the pharmaceutical list of that Primary Care Trust or of a neighbouring Primary Care Trust that is likely to be affected by the designation; (d) any person who provides services under LPS arrangements or an LPS Scheme in the locality of the Primary Care Trust; (e) any person whose name is included in the dispensing doctor list of that Primary Care Trust or of a neighbouring Primary Care Trust who, in the opinion of the Primary Care Trust, is likely to be affected by the designation; and (f) any Patients' Forum serving the locality of the Primary Care Trust or of a neighbouring Primary Care Trust that is likely to be affected by the designation. (6) A Primary Care Trust may vary a designation under this paragraph if—
(b) where the designation relates to premises, the LP services to be provided under the relevant scheme are to be provided from part only of those premises; or (c) where the designation relates to a description of premises, the LP services to be provided under the relevant scheme are to be provided from certain parts only of the premises described. (7) A designation varied under paragraph (6) must designate the neighbourhood, premises or description of premises which are designated for the purposes of the designation and must satisfy the conditions specified in paragraph (4).
(b) if, within a period of twelve months beginning with the date of the original designation, an application for an LPS scheme that relates to the designation has not been submitted to the Primary Care Trust for approval; (c) if the only (or only remaining) application for an LPS scheme that relates to the designation has been rejected; or (d) if there is a significant change to the neighbourhood in which, or the premises from which, the LP services are to be provided, other than a change which leads to a variation by virtue of regulation 4(6). (3) A Primary Care Trust must give notice of cancellation of a designation to those persons listed in regulation 4(5). General condition relating to all LPS schemes 7.—(1) A Primary Care Trust may only enter into an LPS scheme with—
(b) two or more individuals (whether or not practising in partnership), if each of those individuals does not fall within paragraph (2); and (c) in the case of a body corporate, if—
(ii) any director, chief executive, superintendent or company secretary of the body corporate, does not fall within paragraph (2). (2) A person falls within this paragraph if—
(b) subject to paragraph (3), he is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing or regulatory body anywhere in the world; (c) he has within a period of five years prior to the date the scheme is to be commenced or, if earlier, the date on which the scheme is to be signed, been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act[42] (disqualification of practitioners) respectively), unless his name has subsequently been included in such a list; (d) he has been convicted in the United Kingdom of—
(ii) a criminal offence other than murder, committed on or after 1st April 2006, and has been sentenced to a term of imprisonment of over six months; (e) subject to paragraph (4), he has been convicted elsewhere of an offence—
(ii) committed on or after the 1st April 2006 which would, if committed in England and Wales, constitute a criminal offence other than murder, and has been sentenced to a term of imprisonment of over six months; (f) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933[43] (offences against children and young persons with respect to which special provisions of the Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995[44] (offences against children under the age of 17 years to which special provisions apply) committed on or after 1st April 2006;
(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986[46], (iii) made a composition or arrangement with, or granted a trust deed for, his creditors unless he has been discharged in respect of it, or (iv) in the case of a body corporate, been wound up under Part IV of the Insolvency Act 1986; (i) there is—
(ii) an administration order made in respect of him under Schedule B1 to the Insolvency Act 1986[47]; (j) he has within the period of five years prior to the date the scheme is to be commenced or, if earlier, the date on which the scheme is to be signed—
(ii) been removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990[48] (powers of the Court of Session to deal with management of charities) from being concerned in the management or control of any body; (k) he has within the period of five years prior to the date the scheme is to be commenced or, if earlier, the date on which the scheme is to be signed, been subject to a disqualification order under the Company Directors Disqualification Act 1986[49] or the Companies (Northern Ireland) Order 1986[50], or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order); or (3) A person shall not fall within paragraph (2)(b) where the Primary Care Trust is satisfied that the disqualification or suspension from practising imposed by a licensing or regulatory body outside the United Kingdom does not make the person unsuitable to be—
(b) in the case of an LPS scheme with a body corporate, a director, chief executive, superintendent or company secretary of a party to an LPS scheme. (4) A person shall not fall within (2)(e) where the Primary Care Trust is satisfied that the conviction does not make the person unsuitable to be—
(b) in the case of an LPS scheme with a body corporate, a director, chief executive, superintendent or company secretary of a party to an LPS scheme. Reasons
(b) the procedure in paragraph 26 of Schedule 2 shall apply. (5) Where, pursuant to paragraph (4), the Primary Care Trust agrees to a variation of the scheme, the contractor shall—
(b) subject to paragraph (7), cease to be treated, as a health service body for the purposes of section 4 of the 1990 Act from the date that variation takes effect.
(b) paragraph (5), it shall, if it or the Primary Care Trust has referred any matter to the NHS dispute resolution procedure before it ceases to be treated as a health service body, be bound by the determination of the adjudicator as if the dispute had been referred pursuant to paragraph 22 of Schedule 2; or (c) paragraph (6), it must continue to be treated as a health service body for the purposes of the NHS dispute resolution procedure where that procedure has been commenced—
(ii) after the termination of the scheme, whether in connection with, or arising out of, the termination of the scheme or otherwise, for which purposes it ceases to be such a body on the conclusion of that procedure. Lists of LPS contractors
(b) the days on which and times at which those services are provided. Proposals 12.—(1) A Primary Care Trust may make payments of financial assistance in respect of developing LPS schemes with a view to their being included in a proposal for an LPS scheme. (2) Any person proposing to enter into an LPS scheme must supply with their proposal in writing information as to whether he, or in the case of a partnership the partners in the partnership, or where the person is a body corporate, the body corporate or any of its directors, its chief executive, its company secretary or its superintendent—
(b) has accepted a police caution in the United Kingdom; (c) has, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging him absolutely (without proceeding to conviction); (d) has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995[51] (fixed penalty: conditional offer by procurator fiscal) or agreed to pay a penalty under section 115A of the Social Security Administration Act 1992[52] (penalty as alternative to prosecution); (e) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in England and Wales; (f) is currently the subject of any proceedings which might lead to such a conviction, which have not yet been notified to the Primary Care Trust; (g) has been subject to any investigation into his professional conduct by any licensing or regulatory body, where the outcome was adverse; (h) is currently subject to any investigation into his professional conduct by any licensing or regulatory body; (i) is, or has been where the outcome was adverse, the subject of any investigation into his professional conduct in respect of any current or previous employment; (j) is the subject of any investigation by another Primary Care Trust or equivalent body, which might lead to his removal from any primary care list; (k) is to his knowledge, or has been where the outcome was adverse, the subject of any investigation by the National Health Service Counter Fraud and Security Management Service or the NHS Business Services Authority in relation to fraud; (l) either—
(ii) is currently suspended from such a list, on fitness to practise grounds, and if so, why and the name of that Primary Care Trust or equivalent body; or and if so, he must give details of any investigation or proceedings which are being or were undertaken or brought, including the nature of that investigation or proceedings, where and approximately when that investigation or those proceedings commenced, and any outcome.
(b) the address of each of the premises to be used by the contractor for the provision of LP services. (2) A scheme must, unless it is of a type and nature to which the particular term does not apply, contain the terms, or terms which make provision having the same effect as the terms, specified in Schedule 2.
(b) any person included in its pharmaceutical list; (c) any Local Pharmaceutical Committee formed for its area; (d) any Local Medical Committee formed for its area; (e) any Primary Care Trust or Local Health Board any part of whose locality is within two kilometres of the premises of the relevant contractor; and (f) any Patient's Forum serving the locality of the Primary Care Trust, in writing of any determination under this regulation.
(b) the fitness to practise of a pharmacist employed or engaged by the contractor. (2) If a home Primary Care Trust is of the opinion that the information does raise such a question, it must pass the information it has received to—
(b) any other Primary Care Trust on whose pharmaceutical list the contractor is included or has applied to be included; and (c) where appropriate, to the Royal Pharmaceutical Society of Great Britain. (3) If any Primary Care Trust receives information (whether pursuant to a term of an LPS scheme or otherwise) that raises any question about the fitness to practise of a pharmacist employed or engaged by a contractor or potential contractor, it must pass that information, where appropriate, to the Royal Pharmaceutical Society of Great Britain. Duty to provide information about suitability etc. 17.—(1) Subject to paragraphs (3) and (4), a contractor who provides services under a pilot scheme must by 1st October 2006 supply to its Primary Care Trust information as to whether he (in the case of an individual who is a contractor), or in the case of a partnership, the partners, or where the contractor is a body corporate, any director, chief executive, superintendent or company secretary of it—
(b) has accepted a police caution in the United Kingdom; (c) has, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging him absolutely (without proceeding to conviction); (d) has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995 (fixed penalty: conditional offer by procurator fiscal) or agreed to pay a penalty under section 115A of the Social Security Administration Act 1992 (penalty as alternative to prosecution); (e) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in England and Wales; (f) has been charged with an offence and is currently the subject of any proceedings which might lead to a conviction, which have not yet been notified to the Primary Care Trust; (g) has been subject to any investigation into his professional conduct by any licensing or regulatory body, where the outcome was adverse; (h) is currently subject to any investigation into his professional conduct by any licensing or regulatory body; (i) is to his knowledge, or has been where the outcome was adverse, the subject of any investigation by the National Health Service Counter Fraud and Security Management Service or the NHS Business Services Authority in relation to fraud; (j) is the subject of any investigation by another Primary Care Trust or equivalent body, which might lead to his removal from any primary care list; (k) is, or has been where the outcome was adverse, subject to an investigation into his professional conduct in respect of any current or previous employment; (l) either—
(ii) is currently or has been suspended from such a list, on fitness to practise grounds, and if so, why and the name of the Primary Care Trust or equivalent body; or and if so, he must give details of any investigation or proceedings which are being or were undertaken or brought, including the nature of that investigation or proceedings, where and approximately when that investigation or those proceedings commenced, and any outcome.
(b) which has included it or to which it has applied to be included in a pharmaceutical list. (4) No information need be provided under paragraph (1) by a contractor that is a corporate body where that corporate body has already provided the information that it would otherwise provide under paragraph (1) to a relevant home Primary Care Trust—
(b) under Part 3 of Schedule 4 to the Pharmaceutical Services Regulations. (5) For the purposes of this regulation, the "relevant home Primary Care Trust" means the Primary Care Trust in which the registered office in England of the contractor is located.
(b) has been agreed prior to 1st April 2006 but is not to take effect until on or after 1st April 2006, but before 1st October 2006, shall take effect on the date it is due to take effect but as an LPS scheme. (2) Any LPS scheme that has taken or takes effect by virtue of paragraph (1) is, for the purposes of these Regulations, also a "transitional agreement".
(b) accordingly, regulation 4(6) to (9), 5 and 6 shall apply to that designation as those provisions apply to a designation made from 1st April 2006 under regulation 4. Consequential amendments to secondary legislation Duty of Primary Care Trust in relation to local pharmaceutical services 1.In section 15 of the Act[55] (which relates to the duties of Primary Care Trusts and Local Health Boards in relation to family health services)—
(b) omit subsections (1ZC) and (1ZD). Supply of goods and services by the Secretary of State
(b) subsection (4) shall apply as if for paragraph (ab) there were substituted the following paragraph—
Use of accommodation
Assistance and Support
Recognition of Local Pharmaceutical Committees
(iv) the persons mentioned in sub-paragraph (i) above and the persons providing local pharmaceutical services under LPS schemes in the Primary Care Trust's area,"; (b) after subsection (3), there were inserted the following subsection—
Functions of Local Pharmaceutical Committees
(ii) in paragraph (aa), for "section 44(B2)(b)(ii)" there were substituted "section 44(B2)(b)", and (iii) after paragraph (aa) there were inserted the following paragraph—
(b) subsection (1C) shall apply as if, for "(B2)(b)(ii)" there were substituted "(B2)(b)(ii), (iii) or (iv)". Special arrangement as to payment of remuneration
(b) after the definition of "LPS arrangements" there were inserted the following definition—
Charges for the supply of drugs to treat venereal disease General provisions 1.—(1) The contractor must comply with all relevant legislation, including—
(b) regulation 3 of the Patients' Forums (Functions) Regulations 2003[67] in so far as it relates to the entry and inspection of premises from where local pharmaceutical services are provided. (2) The contractor must comply with the relevant provisions of the Drug Tariff.
(b) the relevant Strategic Health Authority; or (c) the Secretary of State. (4) To the extent that the provisions of the terms required by this Schedule impose a requirement on a contractor in respect of an activity which could only, or would normally, be undertaken by a natural person—
(ii) if he employs or engages a registered pharmacist in connection with the provision of local pharmaceutical services under his LPS scheme, the contractor must either comply with that requirement or secure compliance with that requirement by the registered pharmacist he employs or engages; and (b) if the contractor is not a natural person, that contractor must secure compliance with that requirement by the registered pharmacists it employs or engages, and references in this Schedule to a contractor shall be construed accordingly.
(ii) those appliances must be supplied in accordance with the provisions of the Notes, and the List of Technical Specifications, which appear at the beginning of Part IX of the Drug Tariff, which apply at the time of supply; and (b) where the local pharmaceutical services to be provided include the supply of chemical reagents, the only chemical reagents which may be supplied are those listed from time to time in Part IXR of the Drug Tariff. (3) Where an LPS scheme is limited to the provision of services—
(b) to persons residing in a particular place (for example persons in a specified residential home), the contractor must not provide local pharmaceutical services to persons other than those so specified.
(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 restricted availability appliance, signed by a prescriber and including the reference "SLS"; or (b) the contractor receives from the ETP service an electronic prescription form which contains an order of a kind specified in paragraph (a)(i) to (iii), and—
(ii) the contractor has previously arranged with the patient that it will dispense that prescription on receipt, a contractor must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as it supplies in the normal course of its business. (2) Where an LPS scheme includes the provision of repeat dispensing services, subject to any provisions of the LPS scheme included pursuant to paragraph 2 and the following provisions of this Schedule—
(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 an appliance, not being a restricted availability appliance, 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
(ii) the contractor has previously arranged with the patient that it will dispense that repeatable prescription on receipt, a contractor must, with reasonable promptness, provide the drugs so ordered, and such of the appliances so ordered as it supplies in the normal course of its business. (3) A contractor must 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.
(b) that person presents, or the contractor has in its possession, an associated batch issue. (5) Where a contractor has made arrangements, as part of an LPS scheme, with a Primary Care Trust for the provision of an Independent Prescribing Service, and a pharmacist independent prescriber is authorised or required both to prescribe and to dispense a drug or appliance to a person under those arrangements, the pharmacist independent prescriber shall—
(b) in connection with doing so, act in accordance with paragraphs 8 and 9; (c) record the order on a prescription form; (d) provide the drug or appliance in a suitable container; (e) only provide a drug specified in Schedule 2 to the Prescription of Drugs Regulations where the conditions specified in paragraph 42(2) of Schedule 6 to the GMS Contracts Regulations are satisfied; and (f) only provide a restricted availability appliance if the patient is a person, or it is for a purpose, specified in the Drug Tariff, but a contractor must not provide drugs or appliances ordered by a pharmacist independent prescriber under his LPS scheme unless it has made such arrangements.
(b) who is subject to a national disqualification; or (c) who—
(ii) is the subject of a declaration under section 46(2)(c) of the Act (or any corresponding provision in Scotland or Northern Ireland) that he is not fit to be engaged in any capacity in the provision of pharmaceutical services. Urgent supply without a prescription
(b) the 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—
(ii) transmit to the ETP service within 72 hours an electronic prescription. Preliminary matters before providing ordered drugs or appliances
(b) if they are not ready by then, the contractor shall give a revised estimate of the time when they will be ready (and so on). (2) A person referred to in paragraph (1) is a person—
(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, a contractor 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) or (1A) of the Charges Regulations by virtue of either—
(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 contractor already has such evidence available to him.
(ii) whether or not satisfactory evidence was produced to it as required by sub-paragraph (3); (b) in any case where a charge is due, confirmation that the relevant charge was paid; and Providing ordered drugs or appliances
(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[71] and the following provisions of this Schedule.
(b) fitting the appliance. (3) 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 relevant standard or formula specified therein.
(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 contractor may provide the drug in such strength and dosage as in the exercise of its professional skill, knowledge and care it considers to be appropriate and, subject to sub-paragraph (5), in such quantity as it considers to be appropriate for a course of treatment for a period not exceeding 5 days.
(b) a drug, which is available for supply as part of local 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 local 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 contractor may provide the minimum size available package.
(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 contractor must, subject to sub-paragraph (7), provide the drug in the pack whose quantity is nearest to the quantity which has been so ordered.
(b) "special container" means any container with an integral means of application or from which it is not practicable to dispense an exact quantity. (9) Except as provided in sub-paragraph (10), a contractor must not provide a Scheduled drug in response to an order by name, formula or other description on a prescription form or repeatable prescription.
(b) it appears to the contractor that—
(ii) in the circumstances, providing the drugs or appliances would be contrary to the contractor's clinical judgement; (c) the contractor 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 (2) A contractor 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.
(b) it 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) it 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 contractor must only provide the drugs or appliances ordered if it is satisfied—
(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 Further activities to be carried out in connection with the provision of dispensing services
(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—
(ii) returning unwanted drugs or appliances to the pharmacy for safe destruction; (c) 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;
(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 (c); (e) if it 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; and Additional requirements in relation to electronic prescribing
(b) where the ETP service is not available through its 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 contractor. (2) Where the ETP service is available through its pharmacy, the contractor must, if requested to do so by any person, enter in that person's NHS Care Record—
(b) where the person does have a nominated dispensing contractor—
(ii) a further dispensing contractor, chosen by that person. (3) Paragraph (2)(b)(ii) does not apply if the number of nominated dispensing contractors for that person would thereby exceed the maximum number permitted by the ETP service.
(b) undertake appropriate training in respect of repeat dispensing, having regard to any recommendations in respect of such training set out in the Drug Tariff; (c) if it takes possession of a non-electronic repeatable prescription or an associated batch issue, securely store that repeatable prescription or associated batch issue; (d) 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); (e) destroy any surplus batch issues relating to drugs or appliances—
(ii) where a patient is refused the drugs or appliances pursuant to paragraph 7; (f) 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 Information to be provided for the Primary Care Trust's lists
(b) the days on which and times at which those services are provided. Clinical governance
(b) nominating the contractor as its dispensing contractor (or one of them) in his NHS Care Record. (2) Promising, offering or providing an auxiliary aid in relation to the supply of drugs or a home delivery service is not a gift or reward for the purposes of sub-paragraph (1).
(b) has accepted a police caution in the United Kingdom; (c) has, in summary proceedings in Scotland in respect of an offence, been the subject of an order discharging him absolutely (without proceeding to conviction); (d) has accepted a conditional offer under section 302 of the Criminal Procedure (Scotland) Act 1995[72] (fixed penalty: conditional offer by procurator fiscal) or agreed to pay a penalty under section 115A of the Social Security Administration Act 1992[73] (penalty as alternative to prosecution); (e) has been convicted elsewhere of an offence, or what would constitute a criminal offence if committed in England and Wales; (f) has been charged with an offence and is currently the subject of any proceedings which might lead to a conviction, which have not yet been notified to the Primary Care Trust; (g) has been subject to any investigation into his professional conduct by any licensing or regulatory body, where the outcome was adverse; (h) is currently subject to any investigation into his professional conduct by any licensing or regulatory body; (i) is to his knowledge, or has been where the outcome was adverse, the subject of any investigation by the National Health Service Counter Fraud and Security Management Service or NHS Business Services Authority in relation to fraud; (j) is the subject of any investigation by another Primary Care Trust or equivalent body, which might lead to his removal from any primary care list; (k) is, or has been where the outcome was adverse, subject to an investigation into his professional conduct in respect of any current or previous employment; (l) either—
(ii) has been suspended from such a list, on fitness to practise grounds, and if so, why and the name of that Primary Care Trust or equivalent body; or and if so, he must give details of any investigation or proceedings which are being or were undertaken or brought, including the nature of that investigation or proceedings, where and approximately when that investigation or those proceedings commenced, and any outcome.
(b) which has included it or to which it has applied to be included in a pharmaceutical list. (2) For these purposes, the "relevant home Primary Care Trust" means the Primary Care Trust in which the registered office of the contractor is located.
(b) provides that any such recovery of an overpayment is without prejudice to any investigation of any alleged breach of the scheme; and (c) provides that the remuneration arrangements under the scheme, referred to in sub-paragraphs (1) and (2), are subject to any right the Primary Care Trust may have to set off against any amount payable to the contractor, any amount—
(ii) which it is entitled to withhold under the terms of the scheme (including terms of the Drug Tariff applied by the scheme). Local resolution of disputes
(b) the contractor so wishes (even if the Primary Care Trust does not agree). (2) In the case of a dispute referred to the Secretary of State under sub-paragraph (1)—
(b) the parties must agree to be bound by any determination made by the adjudicator. NHS dispute resolution procedure
(b) in accordance with paragraph 21(1) (where the scheme is not an NHS contract). (2) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send to the Secretary of State a written request for dispute resolution which must include or be accompanied by—
(b) a copy of the scheme; and (c) a brief statement describing the nature and circumstances of the dispute. (3) Any party wishing to refer a dispute as mentioned in sub-paragraph (1) must send the request under sub-paragraph (2) within a period of three years beginning with the date on which the matter giving rise to the dispute happened or should reasonably have come to the attention of the party wishing to refer the dispute.
(b) pass to the person or persons so appointed any documents received from the parties pursuant to sub-paragraph (2), (5) or (7). (9) For the purpose of assisting him in his consideration of the matter, the adjudicator may—
(b) consult other persons whose expertise he considers will assist him in his consideration of the matter. (10) Where the adjudicator consults another person under sub-paragraph (9)(b), he must notify the parties accordingly in writing and, where he considers that the interests of any party might be substantially affected by the result of the consultation, he must give to the parties such opportunity as he considers reasonable in the circumstances to make observations on those results.
(b) any written observations made in response to a request under sub-paragraph (7), but only if they are made within the specified period; (c) any oral representations made in response to an invitation under sub-paragraph (9)(a); (d) the results of any consultation under sub-paragraph (9)(b); and (e) any observations made in accordance with an opportunity given under sub-paragraph (10). (12) In this paragraph, "specified period" means such period as the Secretary of State must specify in the request, being not less than two, nor more than four weeks beginning with the date on which the notice referred to is given, but the Secretary of State may, if she considers that there is good reason for doing so, extend any such period (even after it has expired) and, where she does so, a reference in this paragraph to the specified period is to the period as so extended.
(b) notifies the contractor in writing of the wording of the proposed variation and the date upon which that variation is to take effect, and, where it is reasonably practicable to do so, the date that the proposed variation is to take effect must be not less than 14 days after the date on which the notice under paragraph (b) is served on the contractor.
(b) with more than one individual (whether or not practising in partnership), any of those individuals; or (c) with a body corporate—
(ii) any director, chief executive, superintendent or company secretary of the body corporate, falls within sub-paragraph (2) during the existence of the scheme. (2) A person falls within this sub-paragraph if—
(b) subject to sub-paragraph (3), he is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing or regulatory body anywhere in the world; (c) he is removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act[78] (disqualification of practitioners) respectively), unless his name has subsequently been included in such a list; (d) he has been convicted in the United Kingdom of—
(ii) a criminal offence other than murder, committed on or after 1st April 2006, and has been sentenced to a term of imprisonment of over six months, (e) subject to sub-paragraph (4), he has been convicted outside the United Kingdom of an offence—
(ii) committed on or after 1st April 2006, which would if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months; (f) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933[79] (offences against children and young persons with respect to which special provisions of this Act apply) or Schedule 1 to the Criminal Procedure (Scotland) Act 1995[80] (offences against children under the age of 17 years to which special provisions apply) committed on or after 1st April 2006;
(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986[82], unless that order has ceased to have effect or has been annulled, (iii) made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it, or (iv) been wound up under Part IV of the Insolvency Act 1986; (i) there is—
(ii) an administration order made in respect of him under Schedule B1 to the Insolvency Act 1986[83]; (j) he has been—
(ii) removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990[84] (powers of the Court of Session to deal with management of charities) from being concerned in the management or control of any body; (k) he is subject to a disqualification order under the Company Directors Disqualification Act 1986[85], the Companies (Northern Ireland) Order 1986[86] or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order); (3) A Primary Care Trust shall not terminate the scheme pursuant to sub-paragraph (2)(b) where it is satisfied that the disqualification or suspension imposed by a licensing or regulatory body outside the United Kingdom does not make the person unsuitable to be—
(b) in the case of a scheme with a body corporate, a director, chief executive, superintendent or company secretary of the body corporate. (4) A Primary Care Trust shall not terminate the scheme pursuant to sub-paragraph (2)(e) where it is satisfied that the conviction does not make the person unsuitable to be—
(b) in the case of a scheme with a body corporate, a director, chief executive, superintendent or company secretary of a contractor. Termination by the Primary Care Trust: patient safety and material financial loss
(b) the contractor's financial situation is such that the Primary Care Trust considers that the Primary Care Trust is at risk of material financial loss. Termination and the NHS dispute resolution procedure
(b) protect itself from material financial loss. (3) In a case falling within sub-paragraph (1), where—
(b) the contractor invokes the NHS dispute resolution procedure before the end of the period of notice referred to in sub-paragraph (1); and (c) the contractor notifies the Primary Care Trust in writing that it has done so, subject to paragraph (5), the scheme shall not terminate at the end of the notice period but instead shall only terminate in the circumstances specified in sub-paragraph (4).
(b) the contractor ceases to pursue the NHS dispute resolution procedure, whichever is the sooner.
(b) protect itself from material financial loss, sub-paragraphs (3) and (4) shall not apply and the Primary Care Trust shall be entitled to confirm, by written notice to be served on the contractor, that the scheme will nevertheless terminate at the end of the period of the notice it served pursuant to paragraph 29(1) or 30. Amendment of the Pharmaceutical Services Regulations 1.The Pharmaceutical Services Regulations are amended in accordance with this Part. Amendment of regulation 2 2.In regulation 2[87] (interpretation), in paragraph (1)—
(b) after the definition of "equivalent lists", insert the following definition—
(b) an ESP pilot scheme;"; (d) in the definition of "LPS chemist", after "a pharmacy pilot scheme", insert "or an LPS scheme";
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