NHS TAYSIDE. Special Formulation and Unlicensed Products in Primary Care. A Guide for Pharmacists Working Within NHS Tayside

Transcription

1 NHS TAYSIDE Special Frmulatin and Unlicensed Prducts in Primary Care A Guide fr Pharmacists Wrking Within NHS Tayside Guideline Manager Diane Rbertsn, Principal Pharmacist, Cmmunity Pharmacy Develpment Cnsultatin Grup See Page 8 Apprved by Directr f Pharmacy, Frances Rney Guideline Established Octber 2013 Guideline Review Perid/Expiry Octber 2015 Last Updated December 2013 UNCONTROLLED WHEN PRINTED Identifier: NHST/Guid/Specials_

2 This cntrlled dcument shall nt be cpied in part r whle withut the express permissin f the authr r the authr s representative. Special Frmulatin and Unlicensed Prducts In Primary Care - A Guide Fr Pharmacists Wrking Within NHS Tayside Cntents Page N 1. Intrductin 3 2. Guidance And Further Reading 3 3. Definitin Of A Special 4 4. Prescribed Specials The Prescriber s Respnsibilities 4 5. Prescribed Specials The Pharmacist s Respnsibilities 5 6. Prcess Fr Checking, Authrising And Ordering A Special Fr A 5 Prescriptin 7. Prduct Specificatin 7 8. Pre-Authrisatin Of Specified Prducts 7 9. Prducts Initiated In Hspital Payment Or Reimbursement By Practitiner Services Divisin 7 (PSD) 11. Summary Cnsultatin Grup 9 Appendix 1: Cntact Infrmatin 10 Appendix 2: Algrithm Of Supply Prcess Fr A Special 11 Appendix 3: Request Frm Fr Authrisatin T Order A Special 12 Acknwledgment This dcument was based n an riginal dcument cmmissined by the Scttish CAPO Grup in Octber It was updated by Dn Page, Technical Services Pharmacist, Infrmatin and Statistics Divisin and issued by the Assciatin f Scttish Trust Chief Pharmacists and was been adapted t meet NHS Grampian needs. NHS Tayside has further adapted the dcument t meet NHS Tayside requirements. Identifier: NHST/Guid/Specials_

3 Special Frmulatin And Unlicensed Prducts In Primary Care - A Guide Fr Pharmacists Wrking Within NHS Tayside 1. Intrductin This guidance cvers the rdering and supply f special frmulatins and unlicensed prducts (Specials) in Primary Care within NHS Tayside. It is recgnised that it is smetimes necessary that specials are prescribed in Primary Care but the patient, prescriber and supplying pharmacist shuld all be aware when a special is being used and the implicatins f that. This guidance aims t: Supprt the new Part 7S and Part 7U f the Scttish Drug Tariff. Supprt lcal implementatin f Medicines and Healthcare prducts Regulatry Authrity (MHRA), Ryal Pharmaceutical Sciety (RPS) and General Medical Cuncil (GMC) advice. Ensure that unlicensed, expensive specials are nt prescribed when apprpriate licensed r mre cst effective alternatives are available. Remind pharmacists and prescribers f their respnsibilities and liabilities with regard t the supply f specials. Outline the crrect prcess t ensure pharmacists/prescribers: fulfil their legal and prfessinal respnsibilities. knw under what circumstances authrisatin is a requirement fr a special. knw hw t btain authrisatin fr a special. knw hw t ensure full remuneratin fr the specials they supply. 2. Guidance And Further Reading Further guidance n specials can be fund at: SHOW at: MHRA at: dicinesthatdntneedalicence/index.htm. Ryal Pharmaceutical Sciety at: General Medical Cuncil at: Identifier: NHST/Guid/Specials_

4 NELM at: QA294Therapeutic ptins fr patients unable t take slid dsage frms - Ryal Cllege f Paediatrics and Child Health at: The use f unlicensed medicines r licensed medicines fr unlicensed applicatins in paediatric practice - nt%20n%20unlicensed%20medicines%20octber%202010%20final.pdf 3. Definitin Of A Special The term special can be applied t any Medicinal Prduct, as defined by the Medicines Act 1968, that des nt hld a full Marketing Authrisatin (MA) r Prduct Licence (PL) r Eurpean Medicines Evaluatin Authrity Licence (EMEA). Fr the purpses f this guideline, the prducts may include: Nn-standard and therefre unlicensed strengths f existing licensed medicines. Nn-standard presentatins f existing active ingredients. Nn Eurpean Medicines Evaluatin Agency (EMEA) apprved imprted prducts (nt therwise available in the United Kingdm). Other prducts nt therwise cmmercially available. Please nte that the MHRA guidance n specials des nt apply t a prduct made up directly by the pharmacist, n the direct rder f a dctr r a dentist, fr a specific patient, if the prescriptin frm is within the building where the cmpunding is ccurring (i.e. extempraneus dispensing f a prescriptin by the pharmacist in their pharmacy). 4. Prescribed Specials The Prescriber s Respnsibilities A prduct hlding a Marketing Authrisatin (MA) will d s fllwing evaluatin by the MHRA r EMEA f all data regarding the prduct frm Indicatins and Dses thrugh t the surce f raw materials, precise methd and lcatin f manufacture and Quality Checks prvided thrugh the whle manufacturing prcess. The MA Hlder is bliged t ensure that full Prduct Infrmatin is supplied t bth the prescriber and dispenser f the prduct. The marketing Authrisatin cnfers liability upn the Hlder fr the prduct in use when the terms f the license are cmplied with. This means that in the extremely rare event f misadventure where the cause can be slely attributed t the prduct, and it can be prved that the prduct was prescribed and used in accrdance with the terms f the Marketing Authrisatin the Hlder is liable fr any claim that may be entertained. Fr an unlicensed prduct, n such liability exists. The prescriber bears clinical respnsibility fr prescribing the prduct. The prescriber shuld fully understand that prescribers f unlicensed medicines, r medicines prescribed ut with their marketing authrisatin (ff-label), have a persnal liability fr their prescriptin that cannt be transferred t the manufacturer r imprter f the medicine. (The prescriber shuld ask themselves whether an Identifier: NHST/Guid/Specials_

5 acceptable licensed prduct might be suitable instead.) 5. Prescribed Specials Pharmacist s Respnsibilities The pharmacist directly supplying a special bears shared clinical respnsibility with the prescriber as t the suitability and safety f the prduct fr use by the individual patient. The pharmacist is als cnsidered the prducer f the prduct (under the Medicines Act) and bears direct respnsibility fr the frmulatin, quality, presentatin and labelling f the prduct and that it meets dispensing standards. It shuld be nted that a specials manufacturer license is specific t bth the premises and the prduct. Sme manufacturers may make prducts that are nt cvered by their license and it is up t the pharmacist rdering the prduct t ensure that the item rdered is cvered by the specials license. Supply f a special shuld nt be entered int withut due cnsideratin f the needs f the patient and suitability f the special and must nly be cnsidered if there is n suitable licensed prduct available. When presented with a prescriptin fr a special r unlicensed prduct fr a patient, the pharmacist as purchaser f the item has clear prfessinal duties t discuss the apprpriateness f the medicatin with the prescriber in terms f: availability f any licensed prduct that is therapeutically equivalent. Infrming/reminding the prescriber f their respnsibilities in prescribing a special including: that they (the prescriber) will bear clinical respnsibility fr prescribing an unlicensed prduct. that full prescribing infrmatin abut the prduct is nt always available. the cst invlved in btaining the prduct. the timescale fr btaining the prduct. The pharmacist must infrm/remind the patient that the prduct being dispensed is an unlicensed r special prduct and the implicatins f this, e.g. unlicensed, time delay etc. 6. Prcess Fr Checking, Authrising And Ordering A Special Fr A Prescriptin When a prescriptin fr a special is received in the pharmacy the fllwing steps and checks shuld be undertaken in every case. (1) Check if the patient has had the item dispensed befre. (2) Check if the special is clinically suitable fr the patient. (3) Check the BNF t see if a licensed alternative is available either in a different frm r as an alternative prprietary prduct in the same class. (4) Check if any licensed prducts culd be used in an unlicensed way, e.g. tablets crushed r dispersed, r capsules pened. Is using a prduct in this way biequivalent t the riginal? The UKMI dcument Therapeutic ptins fr patients unable t take slid ral dsage frms may be a useful Identifier: NHST/Guid/Specials_

6 reference: (5) Determine the specific frmulatin that is required fr the special. (6) Determine if the prduct can be extempraneusly prepared. (7) Use the frmulatin and additinal infrmatin n packaging, labelling, strage, and expiry t frm a specificatin fr the prduct. (8) Where the prduct is nt exempt frm authrisatin as detailed in para 11 belw the pharmacist shuld request csting infrmatin frm at least tw specials cmpanies r whlesalers based n this specificatin (including pstage and packing, delivery r handling charges). Nte: At this pint it may als be useful t check with these suppliers if alternative frms r strengths f the preparatin requested are available mre readily (e.g. a higher strength liquid which wuld enable the prescribed dse t be easily given via an ral syringe). Als check the mst cst effective quantity t purchase, e.g. 100 tablets may cst less than the 56 required. (9) Cntact the prescriber t prvide infrmatin n alternative prducts, csts, time scales and t discuss the prduct ptins fr the patient (strength, frmulatin, frm, presentatin). (10) Agree the mst apprpriate ptin fr the patient. (11) If the prescriber cnfirms that the special is the mst apprpriate prduct fr the patient then NHS Tayside authrisatin must be btained prir t rdering the special unless the prduct: is listed in Part 7S r Part 7U f the Drug Tariff. can be prepared extempraneusly in the pharmacy is available frm Tayside Pharmaceuticals r Glasgw Western Infirmary Pharmaceutical Prductin Unit. is a repeat prescriptin fr a specific patient and prduct where an authrisatin number has previusly been granted fr either 6 r 12 mnths, prvided the cst has nt increased since the last dispensing and the authrisatin is still valid. (12) NHS Tayside authrisatin can be requested fllwing submissin f the fully cmpleted Request Frm fr Authrisatin t Order Specials. Requests must be ed t pharmacyspecials.tayside@nhs.net. (13) A 6 r 12 mnth authrisatin may in sme cases be granted fr individual patients n a lng term unlicensed medicine. If this is required this shuld be specified n the individual request. This is at the discretin f the authrising fficer. (14) An authrisatin cde will be ed back t the senders address r failing that, further investigatin r alternative supply arrangements suggested. (15) An reply will be sent within 24 hurs Mnday t Friday. If an reply has nt been received with 24 hurs r the request is urgent the pharmacist shuld call (16) When authrisatin is given, pharmacists will be prvided with an authrisatin cde, which they shuld then add int the bx prvided in their cpy f the request frm if the frm has nt been sent back with this incrprated. (17) Order the prduct frm the agreed surce. (18) When rdering a special, the pharmacist must als btain a Certificate f Analysis (COA) r Certificate f Cnfrmity (COC) frm the supplier. Identifier: NHST/Guid/Specials_

7 (19) Each mnth the pharmacist will submit t Diane Rbertsn, (Cmmunity Pharmacy Develpment, Pharmacy Department, East Day Hme, Kings Crss Hspital, Clepingtn Rad, Dundee DD3 8EA), a cpy f all COA/ COCs fr specials received in that mnth, each apprpriately endrsed (see PCA(P)(20013)4 pint 6 and Appendix 1 (cntact infrmatin)). (20) Apprpriate recrds f the supply must be kept fr 5 years. (21) Fr queries regarding specials (nt authrisatin) pharmacists shuld either as per the authrisatin address (if nt urgent) r call and ask t speak t Diane Rbertsn, David Gill r David Culsn with a specials query. A flw chart Algrithm f Supply Prcess fr a Special f the steps required in rder t make a supply is available in Appendix Prduct Specificatin It is the respnsibility f the pharmacist supplying a special t understand and define the specificatin and frmulatin f the prduct that they require frm the specials manufacturer. As part f this, it is necessary fr the pharmacist t fully understand the intended use f the medicine. The specificatin will include infrmatin n frmula, labelling and the strage requirements f the prduct and any ther apprpriate details, e.g. any patient infrmatin. 8. Pre-Authrisatin Of Specified Prducts NHS Tayside has pre-authrised all specials prducts available and surced frm either Tayside Pharmaceuticals r Glasgw Western General Pharmaceutical Prductin Unit i.e. n request fr authrisatin frm is required. 9. Prducts Initiated In Hspital If a patient has been discharged frm hspital n a special, the hspital pharmacist can be cntacted fr advice and the Ninewells Area Pharmacy Office fr the specificatin and frmulatin that was used and the surce f supply. Where difficulty f supply is an issue, the hspital cncerned may be willing t supply the prduct r prvide a suitable frmula fr extempraneus preparatin in the pharmacy. This wuld be at the discretin f the hspital pharmacy, and wuld take accunt f clinical respnsibility fr the patient, where this has been retained by the hspital specialist. Where the prduct is supplied in this way, the pharmacy will be inviced by the hspital fr the prduct, and this invice can be sent with the prescriptin (suitably endrsed) when it is submitted fr payment t PSD. 10. Payment Or Reimbursement By Practitiner Services Divisin (PSD) Infrmatin n payment fr specials is given in the Scttish Drug Tariff, Part 7S at: Tariff/Dcs/SDT_Part7S_Preface.pdf. Part 7U at: Tariff/Drugs-and-Preparatins-with-Tariff-Prices.asp Identifier: NHST/Guid/Specials_

8 Full instructins fr required paperwrk and endrsements fr specials prescriptins are available in PCA(P)(2013)4 n the Scttish Health n the Web (SHOW) website and in the Scttish Drug Tariff. In line with MHRA Guidance, prescriptins fr special frmulatins that are deemed t be pharmaceutically equivalent t an existing licensed prduct wuld nt be paid at invice price unless it is prved that the licensed versins were genuinely unavailable r unsuitable fr the patient. PSD maintains a list f prducts that are frmally unbtainable, and this may be checked by cntacting ne f the pricing ffices r checking the Scttish Drug Tariff. Pharmacists are reminded that under the RPS guidance they have an bligatin t seek best value fr the NHS. It is expected that in discharging their bligatin pharmacies will btain qutatins fr a particular prduct frm different suppliers prir t requesting authrisatin t rder a special. 11. Summary There are ccasins when after discussin with the prescriber, the patient s needs dictate that there is n ther chice than t supply a special prduct. This NHS Tayside dcument describes the acceptable prcesses fr btaining a special which will guarantee full reimbursement f the cst f that special. Where pharmacies are surcing prducts frm ther suppliers, pharmacies require authrisatin frm NHS Tayside prir t rdering. Failure t fllw the prcesses in this guidance, and in particular failure t apply fr authrisatin where needed, will result in pharmacies nt being fully reimbursed fr the specials medicines they have supplied. The fllwing directins apply: The Scttish Drug Tariff cntains a list f specials that attract a set reimbursement payment and which may be rdered withut prir authrisatin (Part 7S and Part 7U) Extempraneus preparatin, within the pharmacy, shuld be cnsidered. Where either Tayside Pharmaceuticals r Glasgw Western Infirmary prductin units are used t btain specials, these specials may be rdered withut prir authrisatin. Authrisatin fr Specials must be btained prir t rdering except where the prducts are in Part 7S r Part 7U f the Drug tariff, r prepared extempraneusly, r available frm Tayside Pharmaceuticals r Glasgw Western Infirmary Pharmaceutical Prductin Unit. Authrisatin must be requested by submitting the request frm (Appendix 3) t pharmacyspecials.tayside@nhs.net. Pharmacy cntractrs must nt prceed with rdering r supply f the item unless authrisatin has been granted. Where authrisatin is nt granted further directin will be given. Pharmacy cntractrs must keep full recrds f prcurement and supply f specials. There is a further requirement t submit infrmatin n specials Identifier: NHST/Guid/Specials_

9 prducts supplied t NHS Tayside each mnth, in accrdance with PCA(P)(2013)4 item 6. The prescriptin shuld be endrsed as previusly with the additin f the authrisatin cde. 12. Cnsultatin Grup Frances Rney David Culsn David Gill Diane Rbertsn Directr f Pharmacy Acting Head f Medicines Gvernance Head f Pharmacy Angus CHP Cmmunity Pharmacy Develpment Area Pharmaceutical Cmmittee Chair and Vice Chair Area Pharmacy Cntractrs Cmmittee Identifier: NHST/Guid/Specials_

10 Appendix 1 Cntact Infrmatin Practitiner Services Divisin (Ask fr a Grup Leader) Aberdeen Tel Edinburgh Tel Glasgw Tel SPGC Tel ISD Custmer Services Desk Tel Scttish Drug Tariff web link MRHA Website ISD Tpics/Prescribing-and-Medicines/Scttish-Drug- Tariff Tayside Pharmaceuticals Tel Fax Ninewells Area Pharmacy Tel Fax Office pharmacyffice.tayside@nhs.net Glasgw Western General Tel Fax Pharmaceutical Prductin Unit Medicines Infrmatin Department, Ninewells Pharmacy Medicines Gvernance Fr enquiries regarding specials Tel Tay-UHB.medinf@nhs.net Tel Fr authrisatin f specials requests All requests shuld be ed pharmacyspecials.tayside@nhs.net Authrisatin Officers Lead Officer Diane Rbertsn dianerbertsn3@nhs.net David Gill david.gill@nhs.net David Culsn david.culsn@nhs.net Identifier: NHST/Guid/Specials_

11 Algrithm Of Supply Prcess Fr A Special Appendix 2 The pharmacist shuld cntact the prescriber t discuss the need fr special and t cnsider if: a special is necessary a licensed prduct f a different strength r frm is available as an acceptable alternative tablet frmulatin can be crushed and disslved r dispersed r capsules pened the cst is acceptable. Fllwing this discussin, des the prescriber still wish t prescribe the special? N Yes Identify prduct specificatin Agree alternative arrangements as required Is the prduct listed in Part 7S r 7U f the Drug Tariff? Can yu apprpriately prepare the prduct extempraneusly? Is the prduct available frm Tayside Pharmaceuticals r Glasgw Western Infirmary? N Cmplete and submit authrisatin request t pharmacyspecials.tayside@nhs.net including apprpriate qute If the answer t all f these is N If the answer t any ne f these is Yes Has request been authrised? Yes Make a supply Make the apprpriate endrsements and submissins and keep secure recrds as required UNCONTROLLED WHEN PRINTED Review Date: September 2015 Special Frmulatin and Unlicensed Prducts in Primary care: A Guide fr Pharmacists Versin 1.1 Identifier: NHST/Guid/Specials_

12 Versin 1.1 Octber 2013 Appendix 3 NHS Tayside Request Frm fr Authrisatin t Order Specials This frm must be cmpleted if the prduct requested des nt fall int ne f the fllwing categries: Is listed in part 7S r part 7U f the Drug Tariff Can be prepared extempraneusly in the pharmacy Is available frm Tayside Pharmaceuticals r Glasgw Western Infirmary Pharmacy Prductin Unit pre-authrised. Is a repeat prescriptin fr a specific patient and prduct where an authrisatin number has previusly been granted fr either 6 r 12 mnths, prvided the cst has nt increased since the last dispensing and the authrisatin is valid. Patient must be reviewed each time as per plicy t ensure apprpriate. Please remember t lk at ther ptins and reasns fr prescribing befre autmatically prceeding t rder as a special in all cases. T be ed t pharmacyspecials.tayside@nhs.net Cntact Number fr enquiries Pharmacy Cntractr Cde Name and address f Cmmunity Pharmacy Telephne Number Cmmunity Pharmacists Name Prescribers Name and General Practice (r ther surce) Practice Cde CHI Prduct Details (Name, Frm, Strength, Dse, Quantity) Quted Cst (Excluding VAT) fr FULL quantity Cheapest f at least 2 qutes Additinal Csts (Pstage/Carriage) Supplier Details Cmments r Exceptinal Circumstances Please specify r request is fr this script nly r if it is a lng term patient request fr 6 mnths r 12 mnths. Authrisatin is fr this prescriptin nly 6 mnths (until) / / (insert date) 12 mnths (until) / / (insert date) Authrisatin Number Authrising Officer Date This prduct has nt been authrised (give alternate instructins) Recrds f all special prducts must be kept as detailed in part 6 f the circular ( A cpy f the endrsed COA/COC (r invice) as per pint 6 f the circular must be sent t the Pharmacy Department, East Day Hme at the end f each mnth. Please remember t endrse the authrisatin cde n prescriptin and paperwrk A cpy f the invice fr the prduct shuld be submitted with the prescriptin when it is sent fr pricing. UNCONTROLLED WHEN PRINTED Review Date: September 2015 Special Frmulatin and Unlicensed Prducts in Primary care: A Guide fr Pharmacists Versin 1.1 Identifier: NHSG/Guid/Specials_