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Welsh Statutory Instrument 2005 No. 1013 (W.67)The National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2005(The document as of February, 2008) STATUTORY INSTRUMENTS2005 No. 1013 (W.67)NATIONAL HEALTH SERVICE, WALESThe National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2005
The National Assembly for Wales in exercise of the powers conferred by sections 41, 42, 43 and 126(4) of the National Health Service Act 1977[1] hereby makes the following Regulations: Citation, commencement, interpretation and application 1. - (1) These Regulations are called the National Health Service (Pharmaceutical Services) (Amendment) (Wales) Regulations 2005 and will come into force on 1 April 2005. (2) In these Regulations -
(3) These Regulations apply in relation to Wales only.
(ii) the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of (the registers and registration) of the Pharmacy Act 1954[3], or (iii) the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976[4], or (iv) the part of the register maintained by the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001[5] relating to -
(bb) physiotherapists, (v) radiographers: diagnostic or therapeutic; 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;". (3) For the definition of "terms of service" substitute -
(b) in relation to doctors who provide pharmaceutical services, in Parts 1 and 6 of Schedule 2.". (4) In the appropriate places in the alphabetical order, insert the following definitions -
(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[9] of the 1997 Act, and shall be treated as including a case where a person is treated as suspended by a Local Health Board, or prior to 1 April 2003, a Health Authority by virtue of regulation 6(2) of the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002[10], or, in England by a Primary Care Trust or, prior to 1 October 2002, by a Health Authority by virtue of regulation 6(2) of the Abolition of the National Health Service Tribunal (Consequential Provision) Regulations 2001[11], and "suspends" and "suspension" shall be construed accordingly;". (5) Omit the following definition -
Amendment of regulation 4 of the principal Regulations
Omission of regulation 16A of the principal Regulations.
Amendment of Part I of Schedule 2 to the principal Regulations
Substitution of Part II of Schedule 2 to the principal Regulations Essential Services 3.For the purposes of these Regulations, "essential services" means -
(b) the activities described in this Part to be carried out in connection with those services. Dispensing services
(b) an order for a drug specified in Schedule 2 to the Prescription of Drugs Regulations, 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, a chemist shall, 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 supplies in the normal course of his business.
(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 a chemist shall, 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 supplies in the normal course of his business.
(b) that person presents, or the chemist has in his possession, an associated batch issue. Urgent supply without a prescription
(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 Schedules 4 or 5 to the Misuse of Drugs Regulations 2001; and the prescriber undertakes to give the chemist a prescription form or repeatable prescription in respect of the drug within 72 hours.
(b) if they are not ready by then, the chemist shall 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 -
(ii) entitlement to remission of such charges under regulation 4 of the Remission of Charges Regulations, 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 chemist already has such evidence available to him; and Providing ordered drugs or appliances
(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[13] and the following provisions of this Part.
(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 chemist (for example a truss), the chemist shall make all necessary arrangements -
(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 shall comply with the 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 Schedules 4 or 5 to the Misuse of Drugs Regulations 2001, and does not prescribe its quantity, strength or dosage, a chemist 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.
(c) a drug, which is available for supply as part of pharmaceutical services only together with one or more other drugs; or (d) 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 chemist 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 chemist shall, subject to sub-paragraph (9), 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. (11) Except as provided in sub-paragraph (12), a chemist shall 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 chemist 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 chemist's clinical judgement; (c) the chemist 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) A chemist 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.
(b) he does not have any associate 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 more than six months previously; (f) if the repeatable prescription was signed 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 chemist shall only provide the drugs and appliances so ordered if he 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 in respect of whom the prescription was written has 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 persons to whom they provide drugs or appliances on -
(ii) returning unwanted drugs or appliances to the pharmacy for safe destruction; (c) provide appropriate advice to persons 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;
(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 sub-paragraph (d); (f) undertake appropriate training in respect of repeat prescribing, having regard to any recommendations in respect of such training set out in the Drug Tariff;
(ii) where a patient is refused the drugs or appliances pursuant to paragraph 9; (j) 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; Disposal service in respect of unwanted drugs
(b) a residential care home, the chemist shall accept the drugs and dispose of them in accordance with sub-paragraph (3).
(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; (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 Local Health Board has in place for regular collection of the drugs from his premises by or on behalf of the Local Health Board.
(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
(b) it appears to the chemist that the person -
(ii) is at risk of coronary heart disease or high blood pressure, or (iii) smokes or is overweight, the chemist 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 -
(b) by referring the person to other sources of information or advice. (3) A chemist 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 -
(b) follow-up care for the person who has been given the advice. Public health campaigns
(b) where requested to do so by the Local Health Board, record the number of people to whom he or his staff have provided information as part of one of those campaigns. Signposting
(b) another provider, of which the chemist 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 chemist shall provide contact details of that provider to that person and shall, in appropriate cases, refer that person to that provider.
(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
(b) on changes to the patient's lifestyle. (2) The chemist shall, in appropriate cases, keep and maintain a record of any advice given under sub-paragraph (1) and that record shall be in a form that facilitates -
(b) follow-up care for the person to whom or in respect of whom the advice has been given. Pharmacy opening hours: general 21. - (1) A chemist shall ensure that pharmaceutical services are provided at each of the premises from which he has undertaken to provide pharmaceutical services -
(b) if his Local Health Board, or on appeal the National Assembly for Wales, has directed (either under this Part or on or before 31 March 2005) that he may provide pharmaceutical services at the premises for fewer than 40 hours per week, provided that he provides those services at set times and on set days, at the times and on the days so set; (c) if his Local Health Board, or on appeal the National Assembly for Wales, has directed on or before 31 March 2005 that he must provide pharmaceutical services at the premises for more than 40 hours per week, at set times and on set days, at the times and on the days so set; or (d) if his Local Health Board, or on appeal the National Assembly for Wales, has directed under this Part that he must provide pharmaceutical services at the premises for more than 40 hours per week -
(ii) as regards the additional hours for which he is required to provide pharmaceutical services by virtue of that direction, at the days on which and the times at which he is required to provide pharmaceutical services during those additional hours, as set out in that direction, but a Local Health Board may, in appropriate circumstances, agree a temporary suspension of services for a set period, where it has received three months notice of the proposed suspension. (2) At each of the premises from which a chemist has undertaken to provide pharmaceutical services, he shall exhibit -
(b) at times when the premises are not open, a notice based on information provided by the Local Health Board, legible from outside the premises, specifying the addresses of other chemists, included in the pharmaceutical list and the times at which drugs and appliances may be obtained from those addresses. (3) A chemist shall, on request, submit a return to the Local Health Board setting out -
(b) the pharmaceutical services which he ordinarily provides at each of those premises, but all chemists, if they are on a pharmaceutical list on 1 April 2005, shall supply such a return to the Local Health Board by 1 July 2005 and shall state in that return if the days and times submitted represent a change to the days on which and the times at which they provided pharmaceutical services at those premises prior to 1 April 2005.
(b) the pharmaceutical services which he is ordinarily to provide at those premises, he shall supply the Local Health Board with a return informing it of the change.
(b) he shall not change -
(ii) the pharmaceutical services which he is ordinarily to provide at those premises, as set out in that return or application, for a period of at least three months after that return or application was received by the Local Health Board. (6) Where a chemist is prevented by illness or other reasonable cause from complying with his obligations under sub-paragraph (1), he shall, where practicable, make arrangements with one or more chemists whose premises are situated in the neighbourhood for the provision of pharmaceutical services during that time.
(b) he uses all reasonable endeavours to resume provision of pharmaceutical services as soon as practicable; (8) Planned refurbishment of a pharmacy is neither a "reasonable cause" for the purposes of sub-paragraph (6) nor a "reason beyond the control of the chemist" for the purposes of sub-paragraph (7).
Matters to be considered when issuing directions in respect of pharmacy opening hours
(b) other likely users of his pharmacy, for pharmaceutical services, it may carry out an assessment as to whether to issue a direction requiring the chemist whose pharmacy it is to provide pharmaceutical services at the pharmacy at set times and on set days (which may include Christmas Day, Good Friday and bank holidays).
(b) allow him 30 days within which to make written representations to the Local Health Board about the proposed changes. (3) After considering any representations made in accordance with sub-paragraph (2)(b), the Local Health Board shall -
(b) confirm any existing direction setting the days on which and the times at which the chemist must provide pharmaceutical services at the pharmacy provided that the existing direction would meet the requirements of sub-paragraphs (4) and (5) if it were issued under this paragraph; or (c) either -
(ii) in a case where there is no existing direction, issue no direction, in which case, by virtue of paragraph 21(1)(a), the pharmacy will need to be open for not less than 40 hours each week. (4) Where a Local Health Board issues a direction under sub-paragraph (3) in respect of a pharmacy that is required to be open -
(ii) as regards the additional hours for which he is to provide pharmaceutical services, the days on which and times at which he is required to provide those services during those additional hours, but it shall not set out in that direction the days on which or the times at which he is to provide pharmaceutical services during hours which are not additional hours; or (5) The Local Health Board shall not issue a direction under sub-paragraph (3) that has the effect simply of requiring a pharmacy to be open for 40 hours each week on set days and at set times (that is, the direction must have the effect of requiring a pharmacy to be open for either more or less than 40 hours each week).
(b) the chemist's right of appeal under sub-paragraph (7). (7) A chemist may, within 30 days of receiving notification under sub-paragraph (6) appeal in writing to the National Assembly for Wales against any direction issued or any other action taken under sub-paragraph (3) which sets new days on which or times at which the chemist is to provide pharmaceutical services.
(b) if he has appealed under sub-paragraph (7), not later than 8 weeks after the date on which he receives his notification under sub-paragraph (9). Determination of pharmacy opening hours instigated by the chemist
(b) keeps the total number of hours the same. (2) Where a chemist makes an application under paragraph (1), as part of that application he shall provide the Local Health Board with such information as the Local Health Board may reasonably request in respect of any changes to the needs of the people in the neighbourhood, or other likely users of the pharmacy, for pharmaceutical services that are material to the application.
(b) confirm any existing direction setting the days on which and the times at which the chemist must provide pharmaceutical services at the pharmacy provided that the existing direction would meet the requirements of sub-paragraphs (5) and (6); (c) either -
(ii) in a case where there is no existing direction, issue no direction, in which case, by virtue of paragraph 21(1)(a), the pharmacy will need to be open for not less than 40 hours each week. (5) Where a Local Health Board issues a direction under sub-paragraph (4) in respect of a pharmacy that is required to be open -
(ii) as regards the additional hours for which he is to provide pharmaceutical services, the days on which and the times at which he is required to provide those services during those additional hours, but it shall not set out in that direction the days on which or the times at which he is to provide pharmaceutical services during hours which are not additional hours; or (6) The Local Health Board shall not issue a direction under sub-paragraph (4) that has the effect simply of requiring a pharmacy to be open for 40 hours each week no set days and at set times (that is, the direction must have the effect of requiring a pharmacy to be open for either more or less than 40 hours each week).
(b) the chemist's right of appeal under sub-paragraph (9). (9) A chemist may, within 30 days of receiving a notification pursuant to sub-paragraph (8), appeal in writing to the National Assembly for Wales against any action under sub-paragraph (4) which has the effect of refusing an application under this paragraph or granting it only in part.
(b) if he has appealed under sub-paragraph (9), not earlier than 30 days after the date on which he receives his notification under sub-paragraph (11). (13) Where an application under sub-paragraph (1) -
(b) is in respect of a direction that was in existence on 31 March 2005 to require the applicant to provide pharmaceutical services at a pharmacy for more than 40 hours per week, and at set times and on set days, if the Local Health Board fails to determine the application within 60 days of receiving it, in accordance with sub-paragraph (3), that application shall be deemed to have been granted, as from three months from the date on which the application was received by the Local Health Board.
(b) is in respect of a direction that was in existence on 31 March 2005 to require the applicant to provide pharmaceutical services at a pharmacy for more than 40 hours per week, and at set times and on set days, until that application (including any appeal) is determined or deemed to have been granted, paragraph 22(1)(a) shall apply in respect in respect of the application as if for "40" there were substituted "30". Clinical governance 25. - (1) A chemist shall, in connection with all the pharmaceutical services provided by him, participate, in the manner reasonably required by his Local Health Board, in an acceptable system of clinical governance. (2) For these purposes a system of clinical governance is "acceptable" if it is considered acceptable by the National Assembly for Wales and comprises the following components -
(ii) a requirement that the chemist publicises the NHS services that are available at or from his pharmacy, (iii) a requirement that the chemist should undertake an approved patient satisfaction survey annually, in an approved manner, (iv) monitoring arrangements for drugs or appliances owed to patients but which are out of stock, (v) an approved complaints system (which meets the requirements of this Part), (vi) a requirement that the chemist co-operates appropriately with Local Community Health Council visits and takes appropriate action following the outcome of such visits, (vii) a requirement that the chemist co-operates appropriately with any reasonable inspection or review that the Local Health Board or any relevant statutory authority wishes to undertake, and (viii) monitoring arrangements for compliance with the Disability Discrimination Act 1995[14]; (b) a clinical audit programme (normally of five days), which includes at least one pharmacy-based audit and one multi-disciplinary audit agreed by his Local Health Board in each financial year;
(ii) arrangements for ensuring that all equipment used in the provision of pharmaceutical services is maintained appropriately, (iii) an approved incident reporting system, together with arrangements for analysing and responding to critical incidents, (iv) appropriate standard operating procedures, including standard operating procedures in respect of repeatable prescriptions and providing advice and support to people caring for themselves or their families, (v) appropriate waste disposal arrangements (in addition to those required under paragraphs 12 and 13) for clinical and confidential waste, (vi) a clinical governance lead person in respect of each pharmacy, (vii) appropriate child protection procedures, and (viii) monitoring arrangements for compliance with the Health and Safety Act 1974; (d) a clinical effectiveness programme, which includes arrangements for monitoring the effectiveness of the advice given by a chemist in respect of repeatable prescriptions or to people caring for themselves or their families;
(ii) appropriate training for all staff in respect of any role they are asked to perform, (iii) arrangements for the checking of qualifications and references of all staff engaged in the provision of NHS services, (iv) arrangements for identifying and supporting the development needs of all staff engaged in the provision of services as part of the health service including continuing professional development for registered chemists and any necessary accreditation in respect of the provision of directed services , and (v) arrangements for addressing poor performance (in conjunction with a Local Health Board as appropriate); (f) a use of information programme, which includes -
(ii) the chemist's monitoring arrangements in respect of his compliance with the Data Protection Act 1998 and with regard to patient confidentiality, and (iii) appropriate training for staff with regard to compliance with the Data Protection Act 1998 and patient confidentiality, and for the purposes of this sub-paragraph "approved" means approved by the National Assembly for Wales. Professional standards
(b) upon the coming into force of such regulations, comply with those regulations. Directed services 29.A chemist with whom a Local Health Board makes an arrangement for the provision of any directed services shall comply with the terms and conditions of the arrangement. Information to be supplied 30 - (1) A chemist shall give notice to the Local Health Board within 28 days (or if this is impracticable, as soon as practicable thereafter) of -
(b) in the case of a chemist who is an individual, any change of his private address; and (c) in the case of a chemist that is a body corporate, any change to the address of its registered office. (2) A chemist shall give the Local Health Board, if it so requests, the name of any pharmacist employed by him who is responsible for dispensing a particular prescription.
(b) particulars of the other NHS performers or providers list. (5) Subject to sub-paragraph (7), if a chemist or the director or superintendent of a chemist that is a body corporate has himself in the five years prior to 1 April 2005 been on, or has in the five years prior to 1 April 2005 been the director or superintendent of a corporate body that which was when he was a director on, another NHS performers or providers list (that is, on a list other than the pharmaceutical list referred to in sub-paragraph (1)), that person shall supply in writing to the Local Health Board -
(b) particulars of the NHS performers or providers list. unless that information has already been supplied pursuant to sub-paragraph (4).
(b) if he becomes a director or superintendent of a body corporate which is on any of another Local Health Board's NHS performers or providers list, or which applies to be included in such a list, and the outcome of any such application. (7) Where a chemist is a body corporate with a registered office in Wales, the information to be provided under sub-paragraphs (3) to (6) may be provided only to the Local Health Board in which that registered office is located, if the chemist also provides that Local Health Board with details of all the other Local Health Boards on whose pharmaceutical lists it is, and in these circumstances that Local Health Board shall pass the information on to any other Local Health Board -
(b) to whom the chemist makes an application to be on its pharmaceutical list, that requests it.
(b) any other list. Withdrawal from pharmaceutical lists
(b) from 1 July 2005, it is duly made on Form WP57 0405 within three months of the date on which the charge was paid. Inspections and access to information
(b) auditing, monitoring and analysing -
(ii) the management by the chemist of the pharmaceutical services he provides, where the conditions in sub-paragraph (2) are satisfied. (2) The conditions are that -
(b) the Local Pharmaceutical Committee for the area where the pharmacy is situated have been invited to be present at the inspection, where this is requested by the chemist; (c) the person authorised in writing carries written evidence of his authorisation, which he produces on request; and (d) he does not enter any part of the premises used solely as residential accommodation without the consent of the resident. (3) A chemist shall, at the request of the Local Health Board or of person authorised in writing mentioned in sub-paragraph (1), allow it or him access to any information which it or he reasonably requires -
(b) in the case of the Local Health Board, in connection with its functions that relate to pharmaceutical services.". Substitution of Part III of Schedule 2 to the principal Regulations Dispensing of drugs and appliances ordered by independent prescribers 34. - (1) Subject to the following provisions of this Part, where a patient presents on a prescription form -
(b) an order for drugs specified in Schedule 2 to the Prescription of Drugs Regulations, signed by, and endorsed on its face with the reference "SLS" by an independent prescriber; or (c) an order for restricted availability appliances, signed by and endorsed on its face with the reference "SLS" by an independent prescriber, to a doctor who is authorised or required by regulation 20 to provide the drugs or appliances to that patient, the doctor may provide to the patient such of the drugs or appliances so ordered as he supplies in the normal course of his practice.
(b) he shall provide those drugs and appliances in a suitable container; (c) he shall provide for the patient a drug specified in Schedule 2 to the Prescription of Drugs Regulations only where the conditions in paragraph 42(2) of Schedule 6 to the GMS Regulations are satisfied; (d) he shall provide for the patient a restricted availability appliance only if the patient is a person, or it is for a purpose, specified in the Drug Tariff. Preliminary matters before providing ordered drugs or appliances
(ii) entitlement to remission of such charges under regulation 4 of the Remission of Charges Regulations, to produce satisfactory evidence of such entitlement unless the declaration in respect of entitlement to exemption by virtue of regulation 8(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 4(2)(e) to (k) of the Remission of Charges Regulations, and at the time of the declaration the doctor already has such evidence available to him; and Provision of Scheduled drugs
(b) had the drug or appliance been provided by a contractor providing dispensing services under a GMS contract, the contractor would have been entitled to a payment in respect of the drug or appliance by virtue of directions given by the National Assembly for Wales under section 28T of the Act, the Local Health Board shall credit him with the payment. Amendment of Schedule 3 to the principal Regulations
ESSENTIAL SERVICES FROM THIS PHARMACY
ADVANCED SERVICES FROM THIS PHARMACY
(b) on appeal, by the National Assembly for Wales, in accordance with paragraph 4 concerning the days on which and the times at which a chemist is to provide pharmaceutical services that is in existence on 31 March 2005 will remain in existence until a subsequent determination or direction is made in accordance with the provisions substituted by regulation 8 of these Regulations.
(b) in accordance with the provisions of paragraph 4 -
(ii) a review or variation has been initiated by a Local Health Board, or (iii) an appeal has been made to the National Assembly for Wales, concerning the times at which a chemist is to provide pharmaceutical services, the provisions of these paragraphs shall (notwithstanding the coming into force of the substitution made by regulation 8 of these Regulations) continue to apply on and after that date to any investigation, consideration , application, approval, variation, review or appeal which, by virtue of these paragraphs, falls to be undertaken, held or made in relation to any such complaint, application, variation, review or appeal. (This note is not part of the Regulations) These Regulations further amend the National Health Service (Pharmaceutical Services) Regulations 1992 (S.I.1992/662) ("the principal Regulations") which govern the arrangements the provision of pharmaceutical services under the National Health Service Act 1977. The amendments made by these Regulations introduce a contractual framework for the provision of pharmaceutical services which will enable pharmacies to provide a greater range of services and to be rewarded for the range and quality of those services. Regulation 8 of these Regulations replaces Part II of the Terms of Service for Chemists which are contained within Schedule 2 to the principal Regulations with new terms of service for Chemists which are contained within Parts 2 to 5 of the substituted provision. The new terms of service introduce three tiers of pharmaceutical services: firstly, nationally set essential services, which include dispensing, repeat dispensing, clinical governance requirements and disposal of medication; secondly, advanced services, which are also nationally set and which currently comprise medicines use review and prescription intervention services; and finally, locally enhanced services, which can commissioned by Local Health Boards and the terms of which can be agreed locally. Regulation 9 substitutes a new Part 6 into Schedule 2 to the principal Regulations. This replaces, without change, the terms of services for doctors who provide pharmaceutical services. These Regulations make other amendments to the principal Regulations that are consequential upon the introduction of the new contractual framework for chemists. Regulations 11 and 12 contain transitional provisions. Notes: [1]1977 c.49; Section 41 was substituted by the Health and Social Care Act 2001 (c.15) ("the 2001 Act"), section 42(1); and amended by the National Health Service Reform and Healthcare Professions Act 2002 (c.17) ("the 2002 Act"), Schedule 2, paragraph 13 and by the Health and Social Care (Community Health and Standards) Act 2003 (c.43) ("the 2003 Act"). Section 42 was substituted by the National Health Service (Amendment) Act 1986 (c.66), section 3(1); extended by the Health and Medicines Act 1988 (c.49), section 17; and amended by SI 1987/2202, article 4; by the National Health Service and Community Care Act 1990 (c.19) ("the 1990 Act"), section 12(3) and by the Health Authorities 1995 (c.17) ("the 1995 Act"), Schedule 1, paragraph 30; by the 2001 Act, sections 20(6), 23(5), 40(3), 43(2), (3) and (4) and by Schedule 6, Part 1; and by the 2002 Act, Schedule 2, paragraph 16. Section 43 was amended by the Health Services Act 1980 (c.53), Schedule 9, paragraph 18(2); by the 1995 Act, Schedule 1, paragraph 31; by the Pharmacists (Fitness to Practise) Act 1997 (c.19), paragraph 6 of the Schedule; and by the National Health Service (Primary Care) Act 1997, section 29(1) and Schedule 2, paragraph 14; by the 1990 Act, Schedule 9, paragraph 18(2); by the 2001 Act, sections 20(7), 42(2) and 43(5); by the 2002 Act Schedule 2, paragraph 17; and by the 2003 Act, Schedule 11, paragraph 19. See section 128(1) as amended by the 1990 Act, section 26(2)(g) and (i), and by the Health Act 1999 (c.8) ("the 1999 Act), Schedule 4, paragraph 38(2)(b), for the definitions of "prescribed" and "regulations". Section 126(4) was amended by the 1990 Act, section 65(2) and the 1999 Act , Schedule 4, paragraph 37(6). The functions of the Secretary of State under sections 41, 42, 43, and 126(4) of the National Health Service Act 1977 were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999, S.I.1999/672, article 2 and Schedule 1, as amended by the 1999 Act, section 66(5), the Health and Social Care Act 2001 (c.15), section 68(1), National Health Service Reform and Health Care Professions Act 2002 (c.17), section 40(1) and the Health and Social Care (Community Health and Standards) Act 2003 (c.43), section 197(1).back [2]SI 1992/662back [3]c.61back [4]SI 1976/1213 (NI 22)back [5]The register is maintained by the Health Professions Council in accordance with Article 6 of the Health Professions Order 2002 (SI 2002/254)back [6]Sections 49I and 49J of the National Health Service Act 1977 (c.49) ("the Act") were inserted by the Health and Social Care Act 2001 (c.15) ("the 2001 Act), section 25; and amended by the National Health Service Reform and Healthcare Professions Act 2002 (c.17) ("the 2002 Act"), section 2(5) and Schedule 2. Section 49I was also amended by the 2003 Health and Social Care (Community Health and Standards) Act 2003 (c.43) ("the 2003 Act"), section 196 and Schedule 14.back [7]Section 28DA was inserted into the Act by the National Health Service (Primary Care) Act 1997, section 21(1); and was amended by the 2002 Act, section 42 and Schedule 3; and by the 2003 Act, section 184 and Schedule 11.back [8]Section 43D was inserted by section 24 of the 2001 Act; was amended by section 2(5 ) of and Schedule 2 to the 2002 Act and by section 196 of and Schedule 14 to the 2003 Act.back [9]Inserted by the 2001 Act, section 26(2), repealed in relation to personal medical services by the 2003 Act, sections 178, 196 and Schedule 14.back [10]SI 2002/1920back [11]SI 2001/3744back [12]S.I. 2004/905 (W.89)back [13]c.72back [14]c.50back [15]c.43back [16]c.38back ISBN0 11 091109 1 -- Back --
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