Y GWASANAETH IECHYD GWLADOL, CYMRU Enwi, cychwyn, effaith a chymhwyso 1 1 Enw'r Rheoliadau hyn yw Rheoliadau'r Gwasanaeth Iechyd Gwladol (Gwasanaethau Fferyllol etc) (Presgripsiynau Amlroddadwy) (Diwygio) (Cymru) 2004. 2 Daw'r Rheoliadau hyn i rym ar 1 Ebrill 2004. 3 Diwygir Rheoliadau'r Gwasanaeth Iechyd Gwladol (Gwasanaethau Fferyllol) 1992 yn unol â Rhan 1 o'r Rheoliadau hyn. 4 Diwygir Rheoliadau'r Gwasanaeth Iechyd Gwladol (Ffioedd am Gyffuriau a Chyfarpar) 2001 yn unol â Rhan 2 o'r Rheoliadau hyn. 5 Mae'r Rheoliadau hyn yn gymwys i Gymru yn unig. RHAN 1 DIWYGIO RHEOLIADAU'R GWASANAETH IECHYD GWLADOL (GWASANAETHAU FFERYLLOL) 1992 Diwygio rheoliad 2 2 Yn rheoliad 2 (dehongli), ym mharagraff (1) — a yn lle'r diffiniad o “appropriate non-proprietary name” rhowch y diffiniad canlynol— “appropriate non-proprietary name” means a non-proprietary name which is not mentioned in Schedule 1 to the National Health Service (General Medical Services Contract) (Prescription of Drugs etc. ) (Wales) Regulations 2004 , or except where the conditions in regulation 3 of those Regulations are satisfied, in Schedule 2 to those Regulations; ; b ar ôl y diffiniad o “preliminary consent”, mewnosodwch y diffiniad canlynol— “prescriber” means— a doctor, an independent nurse prescriber, and a supplementary prescriber; ; c yn y diffiniad o “prescription form”, ar y diwedd mewnosodwch “and does not include a repeatable prescription;”; ac ch ar ôl y diffiniad o “Remission of Charges Regulations”, mewnosodwch y diffiniadau canlynol— “repeat dispensing chemist” is to be construed in accordance with regulation 16B(1); “repeat dispensing services” means pharmaceutical services which involve the provision of drugs or appliances by a chemist in accordance with a repeatable prescription; “repeatable prescription” means a prescription contained in a form provided by a Local Health Board and issued by a prescriber to enable a person to obtain pharmaceutical services which is in the format specified in Part I of Schedule 1 to the NHS (General Medical Services Contracts) (Wales) Regulations 2004 , and which — is generated by a computer but signed by a prescriber; and indicates that the drugs or appliances ordered on that form may be provided more than once, and specifies the number of occasions on which they may be provided; ; a d yn lle'r diffiniad o “Scheduled drug”, rhowch y diffiniad canlynol— “Scheduled drug” means a drug or other substance specified in Schedule 1 to the National Health Service (General Medical Services Contracts)(Prescription of Drugs etc.) (Wales) Regulations 2004, or except where the conditions in regulation 3 of those Regulations are satisfied, in Schedule 2 to those Regulations; . Diwygio rheoliad 4 3 Yn rheoliad 4 (rhestrau fferyllol)— a ym mharagraff (1), yn lle “supplemental services under regulation 16” rhowch “additional professional services under regulation 16A or repeat dispensing services under regulation 16B”; a b ym mharagraff (2)(b)(iii), ar ôl “pharmaceutical services” mewnosodwch “(other than repeat dispensing services)”. Mewnosod rheoliad 16B 4 1 Ar ôl rheoliad 16A mewnosodwch y rheoliad canlynol— Repeat dispensing services 16B 1 A chemist may provide repeat dispensing services if— a he or she satisfies the condition in paragraph (2); and b he or she has undertaken, in accordance with paragraphs (3) and (4), to provide repeat dispensing services, and a chemist who satisfies the requirements of sub-paragraphs (a) and (b) is referred to in these Regulations as a repeat dispensing chemist 2 The condition referred to in paragraph (1)(a) is that the chemist is not a supplier of appliances only. 3 A chemist who wishes to provide repeat dispensing services must notify the Local Health Board in whose pharmaceutical list he or she is included, in writing, undertaking to provide those services and specifying the date upon which he or she will begin to provide them. 4 The date specified by a chemist pursuant to paragraph (3) must be— a the first day of any specified month; and b at least one week after the date on which the notification specified in paragraph (3) is given to the Local Health Board. 5 A chemist may not provide repeat dispensing services unless he or she is a repeat dispensing chemist. . Diwygio rheoliad 18 5 Yn rheoliad 18 (safonau cyffuriau a chyfarpar, a thaliadau amdanynt), ym mharagraff (1)(g), ar ôl “supply of drugs and appliances”, mewnosodwch “, repeat dispensing services”. Diwygio Atodlen 2 6 1 Diwygir Atodlen 2 fel a ganlyn— 2 Ym mharagraff 1 (dehongli) — a ailrifir darpariaethau paragraff 1 i fod yn is-baragraff (1); a b ar ôl is-baragraff (1) ychwanegwch — 2 In this Schedule — “associated batch issue” means, in relation to a repeatable prescription, one of the batch issues relating to that prescription and containing the same date as that prescription; “batch issue” means a form provided by a Local Health Board and issued by a prescriber at the same time as a repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services, which is in the format specified in Part I of Schedule 1 to the National Health Service (General Medical Services Contracts)(Wales) Regulations 2004, and which— is generated by a computer and not signed by a prescriber; relates to a particular repeatable prescription and contains the same date as that prescription; forms part of a sequence of batch issues, the number of batch issues being equal to the number of occasions on which the drugs or appliances ordered on the repeatable prescription may be provided; and specifies a number denoting its place in the sequence referred to paragraph (c). 3 In this Schedule, drugs or appliances will be taken to be requested or provided in accordance with a repeatable prescription even if the person who wishes to obtain pharmaceutical services does not present that prescription, as long as— a the chemist has that prescription in his or her possession; and b that person presents, or the chemist has in his or her possession, an associated batch issue. . 3 Ym mharagraff 3 (darparu gwasanaethau fferyllol) — a yn is-baragraff (1)(b), yn lle “Schedule 11 to the Medical Regulations” rhowch “Schedule 2 to the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) (Wales) Regulations 2004”; b yn is-baragraff (1)(bb), ar ôl “doctor” mewnosodwch “or a supplementary prescriber”; c ar ôl is-baragraff (1) mewnosodwch — 1ZA Subject to sub-paragraph (1B) and paragraph 3A(4), (7), (8) and (9), where any person— a presents a 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, other than a drug which is for the time being specified in Schedule 4 or 5 of the Misuse of Drugs Regulations 2001, signed by a prescriber, ii an order for a drug specified in Schedule 2 to the National Health Service (General Medical Services Contracts)(Prescription of Drugs etc) (Wales) Regulations 2004, 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 Schedules 4 or 5 of the Misuse of Drugs Regulations 2001, signed by, and endorsed on its face with the reference “SLS”, by a prescriber, iii an order for appliances, not being restricted availability appliances, signed by a prescriber, or iv an order for a restricted availability appliance, signed by, and endorsed on its face with the reference “SLS” by, a prescriber, and also presents an associated batch issue; or b requests the provision of drugs or appliances in accordance with a repeatable prescription of a kind specified in paragraph (a), a repeat dispensing chemist must, with reasonable promptness, provide the drugs so ordered and such of the appliances so ordered as he or she supplies in the normal course or his or her business, in accordance with the directions contained in that repeatable prescription. ; ch yn is-baragraff (1A), ar ôl “prescription form” mewnosodwch “or repeatable prescription, or requesting the provision of drugs or appliances in accordance with a repeatable prescription,”; d yn is-baragraff (1B)— i ar ôl “prescription form” mewnosodwch “or repeatable prescription”, ac ii ar ôl “paragraph 3(1)” mewnosodwch “or paragraph 3(1ZA)”; dd yn lle is-baragraff (1C) rhowch— 1C Before providing any drugs or appliances in accordance with a prescription form or a repeatable prescription— a the chemist 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— i entitlement to exemption under regulation 8(1) of the Charges Regulations, or ii entitlement to remission of such charges under regulation 3 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 regulation 8(1) of the Charges Regulations or in respect of entitlement to remission by virtue of regulation 4(2)(e), (j) or (k) of the Remission of Charges Regulations, and at the time of the declaration, the chemist already has such evidence available to him or her; and b if no satisfactory evidence is produced to the chemist (and, where it is relevant, none is readily available to him or her as mentioned in paragraph (a)) the chemist must endorse the form on which the declaration is made to that effect. ; e yn is-baragraff (3), yn lle “prescription form, signed as a specified in sub-paragraph (1)” rhowch “prescription form or a repeatable prescription, signed as specified in sub-paragraph (1) or (1ZA)”; f yn is-baragraff (4), ar ôl “prescription form” mewnosodwch “or repeatable prescription”; ff yn is-baragraff (6), ar ôl “prescription form” mewnosodwch “or repeatable prescription”; g yn is-baragraff (9), ar ôl “prescription form”, yn y ddau le, mewnosodwch “or repeatable prescription”; ng yn is-baragraff (10), ar ôl “prescription form” mewnosodwch “or repeatable prescription”; h yn is-baragraff (11), ar ôl “prescription form” mewnosodwch “or repeatable prescription”; i yn is-baragraff (14), ar ôl “prescription form” mewnosodwch “or repeatable prescription”; j ar ôl is-baragraff (14) ychwanegwch — 15 If a person presents a repeatable prescription to a chemist who is not a repeat dispensing chemist, that chemist must provide the person with the names and addresses of at least two pharmacies where the person may obtain repeat dispensing services. 16 If a person wishes to obtain repeat dispensing services from a chemist (chemist A), but the person’s repeatable prescription is held by a different chemist (chemist B), chemist A must inform the person that he or she must return to chemist B to obtain repeat dispensing services. 17 A chemist must secure that any pharmacist employed by him or her in connection with the provision of pharmaceutical services complies with the requirements set out in this paragraph. . 4 Ar ôl paragraff 3 (darparu gwasanaethau fferyllol), mewnosodwch — Provision of repeat dispensing services 3A 1 A repeat dispensing chemist who is a pharmacist may personally dispense drugs or appliances in accordance with a repeatable prescription only if he or she has received training appropriate to the provision of repeat dispensing services. 2 When a repeat dispensing chemist provides drugs or appliances in accordance with a repeatable prescription, he or she must endorse the repeatable prescription to show— a the quantity of the drug provided or the number of appliances provided; and b the date on which the drug or appliance is provided, and, on the first occasion upon which he or she provides drugs or appliances in accordance with a particular repeatable prescription, must stamp that prescription with the chemist’s stamp. 3 A repeat dispensing chemist must store securely at the premises from which he or she provides pharmaceutical services— a repeatable prescriptions; b batch issues relating to drugs or appliances which have been provided; and c if requested to do so, batch issues relating to drugs or appliances which have not yet been provided, until such time as he or she is required, in accordance with the requirements set out in the Drug Tariff, to send the repeatable prescription or batch issue to Health Solutions Wales. 4 A repeat dispensing chemist must not provide any drugs or appliances in accordance with a repeatable prescription— a after the period of one year has elapsed since the date of the repeatable prescription; or b where the presciber who issued the repeatable prescription has marked on it an earlier expiry date, after that date. 5 A repeat dispensing chemist must destroy any batch issues relating to drugs or appliances which— a are not required; or b should not be provided because — i the chemist has been notified to that effect by the prescriber who issued those batch issues, or ii the repeatable prescription to which those batch issues relate has expired. 6 Before providing any drugs or appliances in accordance with a repeatable prescription, a repeat dispensing chemist must refer to that prescription and must make inquiries in order to satisfy himself or herself— a that the person named on the repeatable prescription— i is taking or using, and is likely to continue to take or use, the drugs or appliances appropriately, and ii is not suffering any side effects which lead the repeat dispensing chemist to conclude that the repeatable prescription ought to be reviewed; and b that there are no other reasons why the drugs or appliances should not be provided. 7 If a repeat dispensing chemist is not satisfied as mentioned in sub-paragraph (6), or at any other time has reason to be concerned about the safety or appropriateness of a person receiving drugs or appliances ordered on a repeatable prescription — a the repeat dispensing chemist must, if he or she considers it appropriate, do one or both of the following— i inform the person that he or she should make an appointment to see that person’s doctor, and ii contact the doctor who issued the prescription as soon as is practicable; and b the repeat dispensing chemist may refuse to provide the drugs or appliances so ordered until he or she is so satisfied, and if that chemist has refused to provide the drugs or appliances, he or she must inform the prescriber who issued that prescription of that fact as soon as is practicable. 8 A repeat dispensing chemist must provide drugs and appliances in accordance with a repeatable prescription only at the intervals specified in that prescription, and if the repeatable prescription does not specify intervals, the repeat dispensing chemist must use his or her professional expertise to determine the intervals at which the drugs or appliances should be provided. 9 Where a person — a requests the provision of drugs or appliances in accordance with a repeatable prescription, which he or she believes to be held by a repeat dispensing chemist, but that chemist has no record of that prescription; b requests the provision of drugs or appliances in accordance with a repeatable prescription, but does not present (and the chemist does not have in his or her possession) any associated batch issues; c presents a repeatable prescription which is not signed by a prescriber; or d requests the provision of drugs or appliances in accordance with a batch issue which contains an irregularity (for example, the drug or dosage specified in the batch issue differs from that specified in the repeatable prescription to which that batch issue relates), the repeat dispensing chemist must refuse to provide the drugs or appliances in question, and must advise the person to contact the prescriber who issued the prescription or batch issue as soon as possible. 10 A repeat dispensing chemist must secure that any pharmacist employed by him or her in connection with the provision of repeat dispensing services complies with the requirements of this paragraph. . 5 Ym mharagraff 5 (darparu cyffuriau a ffitio cyfarpar), yn is-baragraff (2) — a ar ôl “paragraph 3(1)” mewnosodwch “or paragraph 3(1ZA)”; a b ar ôl “prescription form” mewnosodwch “or repeatable prescription”. 6 Ym mharagraff 8 (tâl fferyllwyr), ar ôl is-baragraff (2A) mewnosodwch— 2B The Local Health Board shall make such payments, if any, as are provided for by the Drug Tariff (or by any determination made by virtue of regulation 18(1A)) to chemists who provide repeat dispensing services. . 7 Ym mharagraff 11B, yn is-baragraff (a) — a yn lle “regulation 3(1)” rhowch “regulation 4(1)”; b hepgorwch “sub-paragraph (a), (b), (c), (d) or (e) of”; c ar ôl “regulation 8(1) of the Charges Regulations” mewnosodwch “or in respect of entitlement to remission by virtue of regulation 4(2)(e), (j) or (k) or the Remission of Charges Regulations”. RHAN 2 DIWYGIO RHEOLIADAU'R GWASANAETH IECHYD GWLADOL (FFIOEDD AM GYFFURIAU A CHYFARPAR) (CYMRU) 2001 Diwygio rheoliad 2 7 Yn rheoliad 2 (dehongli)— a ym mharagraff (1)— i yn lle'r diffiniad o “ffurflen bresgripsiwn” rhowch y diffiniad canlynol— ystyr “ffurflen bresgripsiwn” (“ prescription form ”) yw ffurflen sy'n cael ei darparu gan Fwrdd Iechyd Lleol neu Ymddiriedolaeth GIG a'i dyroddi gan feddyg, deintydd, rhagnodydd atodol neu neu nyrs annibynnol sy'n rhagnodi i alluogi person i gael gwasanaethau fferyllol ac— mae'n cynnwys ffurflen bresgripsiwn sy'n cael ei darparu a'i dyroddi o dan drefniadau cyfatebol sy'n cael effaith yn Lloegr, yr Alban, neu Ogledd Iwerddon; a nid yw'n cynnwys presgripsiwn amlroddadwy; , a ii ar ôl y diffiniad o “ffurflen bresgripsiwn” mewnosodwch y diffiniad canlynol— “ystyr “gwasanaethau amlweinyddu” (“ repeat dispensing services ”) yw gwasanaethau fferyllol sy'n cynnwys darparu cyffuriau neu gyfarpar gan fferyllydd yn unol â phresgripsiwn amlroddadwy; ar ôl y diffiniad o “nyrs sy'n rhagnodi” mewnosodwch y diffiniadau canlynol— ystyr “presgripsiwn amlroddadwy” (“ repeatable prescription ”) yw presgripsiwn sydd wedi'i gynnwys mewn ffurflen sy'n cael ei darparu gan Fwrdd Iechyd Lleol a'i dyroddi gan ragnodydd, i alluogi person i gael gwasanaethau fferyllol ac sydd yn y fformat a bennir yn Rhan I o Atodlen 1 i Reoliadau'r Gwasanaeth Iechyd Gwladol (Contractau Gwasanaethau Meddygol Cyffredinol) (Cymru) 2004, ac sydd— yn cael ei gynhyrchu gan gyfrifiadur ond yn cael ei lofnodi gan ragnodydd; a yn dangos y caniateir darparu'r cyffuriau neu'r cyfarpar a archebwyd ar y ffurflen honno fwy nag unwaith, ac yn pennu'r nifer o weithiau y caniateir eu darparu; ; ystyr “rhagnodydd” (“prescriber”) yw— meddyg, nyrs annibynnol sy'n rhagnodi, ac rhagnodydd atodol;” ar ôl y diffiniad o “rhestr feddygol”, mewnosodwch y diffiniad canlynol— ystyr “swp-ddyroddiad” (“ batch issue ”) yw ffurflen sy'n cael ei darparu gan Fwrdd Iechyd Lleol a'i dyroddi gan ragnodydd yr un pryd â phresgripsiwn amlroddadwy i alluogi fferyllydd i gael taliad am ddarparu gwasanaethau amlweinyddu, ac sydd yn y fformat a bennir yn Rhan I o Atodlen 1 i Reoliadau'r Gwasanaeth Iechyd Gwladol (Contractau Gwasanaethau Meddygol Cyffredinol) (Cymru) 2004 , ac sydd— yn cael ei gynhyrchu gan gyfrifiadur ac nad yw'n cael ei lofnodi gan ragnodydd; yn ymwneud â phresgripsiwn amlroddadwy penodol ac yn cynnwys yr un dyddiad â'r presgripsiwn hwnnw; yn ffurfio rhan o ddilyniant o swp-ddyroddiadau, lle mae'r nifer o swp-ddyroddiadau, yn gyfartal â nifer yr adegau y caniateir darparu'r cyffuriau neu'r cyfarpar a archebwyd ar y presgripsiwn amlroddadwy; ac yn pennu Rhif i ddynodi ei le yn y dilyniant y cyfeiriwyd ato ym mharagraff (c); a ym mharagraff (3), ar ôl “un ffurflen bresgripsiwn” mewnosodwch “, neu ar un presgripsiwn amlroddadwy (ond dim ond pan fo'r cyflenwad gyferbyn ag un swp-ddyroddiad sy'n ymwneud â'r presgripsiwn amlroddadwy hwnnw)”. Diwygio rheoliad 3 8 1 Diwygir rheoliad 3 (cyflenwi cyffuriau a chyfarpar gan fferyllwyr) fel a ganlyn. 2 Ym mharagraff (1), yn lle “Yn ddarostyngedig i baragraff (3),” rhowch “Ac eithrio fel a ddarperir ym mharagraff (1A) ac yn ddarostyngedig i baragraff (3),”. 3 Ar ôl paragraff (1) mewnosodwch— 1A Yn ddarostyngedig i baragraff (3), rhaid i fferyllydd sy'n darparu gwasanaethau amlweinyddu i glaf, godi ar y claf hwnnw a chasglu ohono, ar gyfer pob aml-ddyroddiad— a ffi o £6.00 am eitem hosan elastig, hynny yw, ffi o £12.00 y pâr; b ffi o £6.00 am gyflenwi pob cyfarpar arall ac am bob swm o gyffur. 1B Os yw ffi yn cael ei thalu o dan baragraff (1A), wrth wneud y taliad rhaid i'r person sy'n talu lofnodi datganiad ysgrifenedig ar y swp-ddyroddiad fod y ffi berthnasol wedi'i thalu. . 4 Yn lle paragraph (3) rhowch— 3 Rhaid peidio â chodi na chasglu unrhyw ffi o dan baragraff (1) neu (1A) — a os oes esemptiad o dan reoliad 8 a bod datganiad o hawl i gael esemptiad wedi'i gwblhau'n briodol gan y claf neu ar ei ran— i mewn achosion sy'n dod o dan baragraff (1A), ar y swp-ddyroddiad adeg cyflenwi'r cyffur neu'r cyfarpar, ii ym mhob achos arall, ar y ffurflen bresgripsiwn; b os oes hawl i beidio â thalu'r ffi o dan reoliad 3 o'r Rheoliadau Treuliau Teithio a Pheidio â Chodi Tâl a bod datganiad o hawl i beidio â thalu wedi'i gwblhau'n briodol gan y claf neu ar ei ran— i mewn achosion sy'n dod o dan baragraff (1A), ar y swp-ddyroddiad adeg cyflenwi'r cyffur neu'r cyfarpar, ii ym mhob achos arall, ar y ffurflen bresgripsiwn; neu c os yw'r claf yn preswylio mewn ysgol y mae ei henw wedi'i mewnosod neu neu sefydliad y mae ei enw wedi'i fewnosod ar y ffurflen bresgripsiwn gan feddyg yn unol â pharagraff 44 o Atodlen 6 i Reoliadau'r Gwasanaeth Iechyd Gwladol (Contractau Gwasanaethau Meddygol Cyffredinol) (Cymru) 2004. 5 Ym mharagraff (5)— a ar ôl “ffurflen bresgripsiwn” mewnosodwch “neu bresgripsiwn amlroddadwy”; a b ar ôl “baragraff (1)” mewnosodwch “neu baragraff (1A)”. 6 Ym mharagraff (6)— a ar ôl “paragraff (1)” mewnosodwch “neu baragraff (1A)” ; a b yn y testun Saesneg, hepgorwch “[dmb1/”. Llofnodwyd ar ran Cynulliad Cnedlaethol Cymru o dan adran 66(1) o Ddeddf Llywodraeth Cymru 1998 D. Elis-Thomas Llywydd y Cynulliad Cenedlaethol 31 Mawrth 2004