Gd Practice in Prescribing and Medicines Management fr Pdiatrists
INTRODUCTION This cnsultatin dcument n Medicines Practice Guidance has been prepared by the Cllege f Pdiatry (CP) alng with input frm clleagues frm the Institute f Chirpdists and Pdiatrists (ICP). The advice herein is fr all thse with anntatin n the Health and Care Prfessins Cuncil (HCPC) Register as Supplementary r Independent prescribers, whether a member f the CP r the ICP, n the cnduct that is expected f all pdiatrist prescribers. There is a clear expectatin that pdiatrist prescribers frm bth prfessinal bdies will adhere t this guidance, and ensure that they are accuntable fr their actins. Whilst this dcument remains the prperty f the CP, the ICP fully expects its members t adhere t the guidance therein. Heather Bailey President Institute f Chirpdists & Pdiatrists Janna Brwn Chief Executive The Cllege f Pdiatry and The Sciety f Chirpdists & Pdiatrists 2 P a g e
Table f Cntents Page Frewrd 6 Intrductin 6 Key Legislatin & Terminlgy 7 Categries f Medicines 8 Ethical Requirements 9 Type f Pdiatrists Prescribing 9 Standards fr Prescribing 10 The Scpe f Pdiatry Prescribing 10 Scpe f Practice 10 Registratin & Prfessinal Liability Insurance 11 Sectin 1 Guidance n Prescribing Practice 12 Practice Guidance 1: Licence t prescribe 12 Practice Guidance 2: Accuntability 12 Practice Guidance 3: Assessment 12 Practice Guidance 4: Need 13 Practice Guidance 5: Cnsent 13 Practice Guidance 6: Cmmunicatin 14 Practice Guidance 7: Recrd-keeping 14 Practice Guidance 8: Evidence based prescribing 14 Practice Guidance 9: Delegatin 15 Practice Guidance 10: Infrmatin given t patients 15 Practice Guidance 11: Clinical Management Plans (supplementary prescribing) 16 Practice Guidance 12: Transcribing 16 3 P a g e
Table f Cntents cntinued Page Practice Guidance 13: Electrnic prescribing 17 Practice Guidance 14: Writing NHS prescriptins 17 Practice Guidance 15: Writing private prescriptins 18 Practice Guidance 16: Reviewing prescriptins 18 Practice Guidance 17: Repeat prescriptins 18 Sectin 2 Special prescribing circumstances 19 Practice Guidance 18: Family, Friends & Clleagues 19 Practice Guidance 19: Practice Guidance 20: Practice Guidance 21: Prescribing fr Special Classes f Patient: Children 19 Prescribing unlicensed medicines 20 Prescribing medicines fr use utside the terms f the licence/ marketing authrisatin ( ff-label use) 20 Practice Guidance 22: Cntrlled Drugs 21 Practice Guidance 23: Remte prescribing via telephne, email, fax, vide, link r website 22 Practice Guidance 24: Travelling with Sprts teams 23 Practice Guidance 25: Mixing 24 Practice Guidance 26: Practice Guidance 27: Prescribing n the recmmendatins f thers 24 Simultaneus prescribing and Dispensing 24 Sectin 3 Medicine Gvernance 25 Practice Guidance 28: Prescribing & administratin/ Supply 25 4 P a g e
Table f Cntents cntinued Page Practice Guidance 29: Prescribing and dispensing Drugs 25 Practice Guidance 30: Dispensing 25 Practice Guidance 31: Strage 26 Practice Guidance 32: Transprtatin 26 Practice Guidance 33: Dispsal 26 Practice Guidance 34: Errr Reprting 26 Practice Guidance 35: Practice Guidance 36: Reprting Unexpected Effects and Adverse Reactins 26 Cmplementary Medicinal Prducts 27 Sectin 4 Clinical Gvernance 27 Practice Guidance 37: Clinical Audit 28 Practice Guidance 38: Prescribing analysis & evidence based practice 28 Practice Guidance 39: Risk Management 29 Practice Guidance 40: Cntinuing Prfessinal Develpment 29 Practice Guidance 41: Pr Perfrmance 29 Practice Guidance 42: NHS Prescriptin Pads 29 Practice Guidance 43: Gifts and Benefits 30 Practice Guidance 44: Practice Guidance 45: Links with Pharmaceutical Cmpanies/Cnflict f Interest 30 NHS/Private Practice Prescribing Bundaries 31 Glssary f Terms 31 Legal Classificatin f Licensed Medicines Resurces 34 Resurces 35 5 P a g e
Frewrd I am delighted t intrduce this dcument, which prvides a clear and authritative framewrk fr pdiatrists wh extend their prfessinal practice by becming prescribers. It sets ut the standards fr excellence which will guide practitiners and ensure patient safety. The scpe f clinical practice in pdiatry has extended cnsiderably recently t include many prcedures such as surgery which were previusly nly undertaken by dctrs. At the same time research and new technlgies have prvided evidence fr mre effective treatment f many ft cnditins. These advances cntribute significantly t the wellbeing f many peple and are especially imprtant as we seek t supprt an ageing ppulatin. Gd ft care, the avidance f cmplicatins f chrnic cnditins such as diabetes, and the maintenance f mbility are crucial fr independence and the preventin f scial islatin, thus prmting bth physical and mental health. The authrity t prescribe, either as independent r supplementary prescribers, further extends the capacity f pdiatrists t cntribute t the health f the natin. As the arrangements fr the delivery f care within and utside the Natinal Health Service, becme mre diverse, pdiatrist prescribers will be well placed t ffer cnvenient and timely care t all their patients. This dcument will be an invaluable surce f guidance as the prfessin cntinues t extend its scpe f practice. It gives me great pleasure t cmmend it t pdiatrists, ther clinical prfessins engaged in prescribing and t patients. Dr. June Crwn CBE Intrductin This Medicines Practice Guidance bklet prvides advice n the cnduct that is expected f pdiatrists wh are independent and / r supplementary prescribers and wh are therefre anntated accrdingly n the register f the Health and Care Prfessins Cuncil (HCPC). This dcument is guidance. Guidance is infrmatin which a pdiatrist has a duty t cnsider and is expected t take int accunt as part f their decisin making prcess 1. If a pdiatrist prescriber deviates frm the advice given in this dcument, the reasn fr this shuld be carefully recrded. If a cmplaint is made against yu, the Health and Care Prfessins Cuncil s Fitness t Practise Cmmittee may take accunt f this dcument and thse t which it makes reference. A pdiatrist prescriber will be expected t justify any decisin t act utside the terms f this guidance. This Guidance dcument shuld be read in cnjunctin with the Health and Care Prfessins Cuncil Standards, including the Standards f cnduct, perfrmance and ethics, the Standards f prficiency fr Chirpdists / Pdiatrists and standards fr supplementary and independent prescribing. The advice in this dcument applies t all sectrs f health and scial care prvisin in the United Kingdm where prescribing activities ccur, as permitted by the prescribing legislatin in each f the Hme Cuntries separately. The law relating t prescribing in the NHS may nt be cmparable acrss England, Sctland, Wales and Nrthern Ireland. It is up t the individual t satisfy themselves f the law in the UK cuntry in which they wrk and that gd gvernance prcedures are in place in their wrkplace setting. 1 [2009] EWHC 281 Servier Labratries Ltd v NICE and thers. 6 P a g e
At the current time, prescribing is nt permitted by pdiatrists utside f the UK. Therefre a pdiatrist permitted t independently prescribe in the UK cannt perfrm this activity utside f UK jurisdictin. Each sectin f this guidance carries equal weight and the dcument is nt rdered in any pririty rder. Thrughut this dcument the use f the wrd must indicates a legal r regulatry requirement, and the use f the wrd shuld indicates what shuld fllw in all nrmal circumstances. Key Legislatin & Terminlgy Medicines use in the UK is cntrlled by a very clear framewrk gverned by the terms f the Human Medicines Regulatins 2012. Pdiatrists must be abslutely clear that they understand this framewrk and the distinctins between the five cre framewrks fr medicines use. Patient Specific Directins (PSD): A Patient Specific Directin is a written instructin frm an independent prescriber fr a medicine t be supplied and/r administered t a named patient (see glssary). A PSD is a direct instructin and des nt require an assessment f the patient by the healthcare prfessinal instructed t supply and/r administer. A PSD is nt a frm f prescribing. An independent prescriber (a dctr, dentist r ther independent prescriber) may instruct the pdiatrist t supply and/r administer a named medicine t a named patient. The pdiatrist must nly supply and administer the medicine in accrdance with the instructins that are written by the independent prescriber. It is nt gd practice fr ral instructins t be acted upn except in emergencies. A written recrd f instructins given under a PSD must be maintained. Patient Grup Directins (PGD): Patient Grup Directins enable specified registered healthcare prfessinals t supply and/r administer medicines directly t patients that fit the criteria laid ut in the PGD. PGDs are nt a frm f prescribing. A dctr and a pharmacist, in cnjunctin with the nn-medical prescriber will define in writing the named medicines that may be supplied and/r administered under the PGD. The PGD must be drawn up in a specific way and cntain certain infrmatin in rder t be legally valid. The pdiatrist must supply and administer the medicine in accrdance with the instructins that are written within the PGD. PGDs are nt valid in all healthcare delivery settings. The applicatin f PGDs in clinical practice varies between the Hme Cuntries. Individual pdiatrists identified by PGD are eligible t supply and/r administer specified medicines, and must satisfy specific educatinal and ther criteria laid dwn within the PGD. This criteria is apprved by a senir dctr and pharmacist. Statutry Exemptins: Prfessin specific exemptins (established via Statutry Instrument) allw certain listed medicines t be sld/supplied and/r administered t patients by pdiatrists wh have attained the required qualificatins and are recgnised by the Health and Care Prfessins Cuncil as cmpetent t d s (as indicated by specific anntatins t the HCPC register). Exemptins are nt a frm f prescribing. In additin t, but separate frm, the supplementary and/r independent prescribing anntatins, apprpriately qualified pdiatrists wh are registered with the Health and Care Prfessins Cuncil may pssess the fllwing anntatins permitting certain sale/supply and administratin rights t the medicines listed in the exemptins: Lcal Anaesthesia Prescriptin Only Medicines 7 P a g e
The Lcal Anaesthesia anntatin permits pdiatrists registered with the Health and Care Prfessins Cuncil (HCPC) t access and administer a specific range f parenterally administered lcal anaesthetic and ther prescriptin nly medicines. These are listed under the Human Medicines Regulatins 2012. Only thse wh have attained the certificate f cmpetence in lcal anaesthesia recgnised by the Health and Care Prfessins Cuncil may be s anntated. The Prescriptin Only Medicines anntatin permits pdiatrists registered with the Health and Care Prfessins Cuncil t sell and supply certain prescriptin nly medicines. This list f medicines is identified in the Human Medicines Regulatins 2012. Only thse wh have attained the certificate f cmpetence in the use f these medicines, recgnised by the Health and Care Prfessins Cuncil, may be s anntated. Supplementary Prescribing: Supplementary prescribing is a vluntary partnership between an independent prescriber and a supplementary prescriber, t implement a patient-specific clinical management plan, with the patient s agreement. It enables a pdiatrist t prescribe medicines t individual, named patients thse medicines that have been defined in writing within a clinical management plan as apprpriate t the needs f the named patient. The terms f use and definitin f clinical management plan are defined in law. Pssessin f this anntatin permits pdiatrists registered with the Health and Care Prfessins Cuncil t prescribe medicines as pdiatrist supplementary prescribers acting within the terms f a clinical management plan, as identified in the Human Medicines Regulatins 2012 Independent Prescribing: Independent Prescribing enables a pdiatrist t autnmusly prescribe medicines t individual, named patients apprpriate t the needs f the patient. Pssessin f this anntatin permit pdiatrists registered with the Health and Care Prfessins Cuncil t prescribe medicines as pdiatrist independent prescribers. Hwever, please nte that this guidance des nt cver: Supply and administratin f medicines via a Patient Grup Directin Sale supply r administratin f medicines via exemptin rders, as these are nt frms f prescribing (sale/supply and administratin f medicines n the exemptin lists are addressed in the HCPC s Standards f Prficiency which relate t existing undergraduate pharmaclgy training requirements) Ethical advice n generic issues arund the use and supply f drugs and medicines in pdiatric practice, which is cvered in the Cllege f Pdiatrists Cde f Cnduct 2 Thrughut this dcument, where the phrase independent prescriber is used, it will refer t a medical dctr r dentist. Use f the title pdiatrist independent prescriber will be used t refer t an independent prescribing pdiatrist. Categries f Medicines There are three legal categries f medicines, identified accrding t their ptency and risk f adverse side effects and the need fr the supply t be prfessinally supervised 2. Fr easy reference these definitins are als included in the glssary. 1. Prescriptin Only Medicines (POMs). These medicines may nrmally nly be sld r supplied against the signed prescriptin f an apprpriate practitiner ie a dctr, dentist, nurse prescriber, ptmetrist prescriber, pharmacist prescriber, radigrapher prescriber (supplementary nly), physitherapist prescriber r pdiatrist prescriber. 2 Cllege f Pdiatrists: Cde f Cnduct (First Published 2001) Revised 2010 8 P a g e
2. Pharmacy Only Medicines (P) must be supplied r sld by a pharmacist r under the supervisin f a pharmacist in registered pharmacy premises (unless specified therwise in a statutry exemptin). 3. General Sales List Medicines (GSL) can be supplied direct t the public in an unpened manufacturer s pack at any lckable business premises. In additin, Cntrlled Drugs (CD) are prescriptin nly medicines restricted under the Misuse f Drugs Act (1971), and the classes f persns wh are authrised t supply such medicines are defined under the Misuse f Drugs Regulatins (2001), which als identifies 5 schedules gverning such activities as imprt, exprt, prductin, supply, pssessin, prescribing and recrd keeping 3. Ethical requirements In line with the brader plicy agenda cncerned with equality, diversity and inclusin, the Equality Act (2010) public sectr equality duty relating t all rganisatins in receipt f public funding extends t areas such as emplyment, the prvisin f services and educatin (as well as the accessibility f buildings, websites and transprt). As a result, it is necessary t ensure that the requirements f the Equality Act (2010) are satisfactrily addressed in the prvisin f educatinal prgrammes in supplementary and independent prescribing. The Act defines a number f prtected characteristics (fr eg. race, age, disability, gender). These may be used t infrm relevant plicies designed t prevent r deal with discriminatin, harassment r victimisatin f a persn, r grup f peple, wh identify with any f these prtected characteristics, including institutinal discriminatin and failure t prvide fair access. In particular, the general duty f the Act states that public authrities, in the exercise f their duties, must have due regard t the need t: Eliminate discriminatin, harassment and victimisatin; Advance equality f pprtunity (remving r minimising disadvantage, meeting the needs f peple wh share a relevant prtected characteristic r thse wh d nt share it, and encuraging participatin in public life r any activity in which participatin is lw); Fster gd relatins between peple wh share a prtected characteristic and thse wh d nt share it Type f Pdiatrist Prescribing There are tw types f prescribing which may be undertaken as a pdiatrist prescriber: supplementary and independent prescribing. Sme pdiatrists will be qualified as bth, thers nly as supplementary prescribers. The anntatin n the register f the Health and Care Prfessins Cuncil, will if a pdiatrist is independent prescriber list them as such and/r a pdiatrist supplementary prescriber. The mde f prescribing practice will depend upn the needs f the patient at the pint f treatment. A supplementary prescriber can nly prescribe in accrdance with a clinical management plan. The guidance in this dcument applies t bth Natinal Health Service (NHS) and private practice. It is up t the individual t ensure that arrangements fr gd gvernance are in place. 3 Department f Health, Review f Prescribing, Supply and Administratin f Medicines Final Reprt, Lndn: DH, 1999. 9 P a g e
Standards fr Prescribing The HCPC define the standards f prficiency that will be required by pdiatrists wh wish t use Supplementary and/r Independent Prescribing. The HCPC already prduce standards fr Supplementary Prescribing and will publish the standards required fr Independent Prescribing in late Spring 2013. The standards will include the prficiencies required t prescribe safely and effectively. These prficiencies are in additin t the prficiencies that apply t nn-prescribing pdiatry practise. The Scpe f Pdiatry Prescribing Pdiatrist prescribers shuld nt be asked t prescribe fr patients t make up fr shrtfalls in ther prfessinal prescribing grups. The purpse f pdiatrist-prescribing is t supprt and enhance the delivery f pdiatry t patients. As such, pdiatrists will use prescribing t supprt and enhance the delivery f pdiatry based therapeutic interventins that are aimed at addressing health and wellbeing needs f individuals and grups related t mvement, physical perfrmance and human functining in their widest sense. Scpe f Practice The educatin and training prgramme in prescribing ensures pdiatrists are equipped with the principles f prescribing, t enable them t be safe, effective and cst-effective prescribers. Pdiatrist prescribers shuld ensure that they are able t apply the prescribing principles t their wn area f practice, bearing in mind that this may be a requirement fr cntinuing registratin. Pdiatrist prescribers must nly prescribe within their scpe f practice and understand that if they change clinical areas they will require a perid f training befre they are cmpetent t prescribe in a new area. An individual s scpe f pdiatry practice must fall within the verall scpe f the prfessin, and thus an individual s pdiatrist-prescribing practice must fall within the verall prescribing scpe f the prfessin. At the current time, prescribing is nt permitted by pdiatrists utside f the UK and therefre a pdiatrist wh wuld be permitted t independently and/r supplementary prescribe in the UK wuld nt be permitted t perfrm this activity utside UK jurisdictin. Prescribers must have sufficient educatin, training and cmpetence t: Assess a patient s clinical cnditin Undertake a thrugh histry, including medical histry and medicatin histry (including ver-the-cunter medicines and cmplementary therapies) Diagnse where necessary Decide n management f the presenting cnditin and whether r nt t prescribe and/r refer Identify apprpriate prducts f medicatin as required Advise the patient n risks, benefit and utcmes f the medicatin Prescribe if the patient agrees Mnitr the patient s cnditin, including any respnse t the medicatin prescribed Give lifestyle advice as apprpriate Refer t ther prfessinals if necessary 10 P a g e
This Guidance underpins the principles f prescribing practice within the cntext f the full scpe f pdiatry practice. Single Cmpetency Framewrk published by the Natinal Prescribing Centre prvides further prescribing infrmatin gruped int the fllwing dmains: Clinical and pharmaceutical knwledge Establishing ptins Cmmunicating with patients Prescribing safely Prescribing prfessinally Imprving prescribing practice Infrmatin in cntext The NHS in cntext The team and individual cntext (http://www.npc.c.uk/imprving_safety/imprving_quality/resurces/single_cm p_framewrk.pdf) Registratin and Prfessinal Liability Insurance (PLI) Pdiatrists wh are member f the Cllege f Pdiatrists (CP) r the Institute f Chirpdists & Pdiatrists (ICP) benefit frm Prfessinal Liability Insurance (PLI) as part f their membership. In rder fr their PLI t be in frce (subject t the terms f the plicy) members (pdiatrists) must: Hld current registratin with the HCPC Hld a current CP/ICP membership in a categry that prvides PLI cver at the time that treatment r advice is given Be practising lawfully Be practising within the verall scpe f the prfessin f pdiatry Prescribing is accepted within the verall scpe f the pdiatric prfessin and due t the requirement fr a pdiatrist t be practising lawfully fr PLI t be in frce, fr prescribing t be cvered as part f an individual s PLI the member must: Have an HCPC anntatin shwing his/her prescribing status as either an independent r supplementary prescriber Ensure that his/her cntinuing prfessinal develpment is in line with his/her current r future practice, including prescribing CP/ICP members d nt need t infrm their prfessinal bdy f their prescribing status, but they must nt prescribe until they are satisfied that their HCPC entry has been updated. Pdiatrists wh are nt members f the CP/ICP will need t ensure they have adequate insurance in place fr their practice. They may be persnally liable fr any csts if they are nt adequately r apprpriately insured. Many emplyers nw expect individual health prfessinals t hld their wn persnal insurance in additin t any emplyer vicarius liability insurance that may be in frce. 11 P a g e
Sectin 1 Guidance n Prescribing Practice This sectin prvides advice and guidance n prescribing practice. Having achieved the cmpetencies fr prescribing, pdiatrists are expected t fllw this advice in their practice. The advice and guidance prvided in this dcument applies t all settings in which a pdiatrist may prescribe within the NHS, private practice, prisn service, armed frces r any ther prvisin. Practice Guidance 1: Licence t prescribe 1.1 Yu must nly prescribe nce yu have successfully cmpleted an apprved prgramme, and been anntated n the register f the Health and Care Prfessins Cuncil as a recgnised prescriber (which specifies either supplementary r independent prescribing). 1.2 Pdiatrists shuld cmply with this and ther guidance issued by the Cllege f Pdiatrists, and with any statutry requirements applicable t their prescribing practice. Failure t d s may put their registratin at risk. 1.3 The ability t prescribe is a privilege granted t yu by legislatin and yur emplyer (if applicable) and shuld be seen in this light. Practice Guidance 2: Accuntability 2.1 As an Independent Prescriber yu are prfessinally accuntable fr yur prescribing decisins, including actins and missins, and cannt delegate this accuntability t any ther persn. As a supplementary prescriber yu are whlly respnsible fr yur prescribing decisins fr the medicines listed within the CMP. The decisin, hwever, t include medicines in a CMP may be shared between yu and the registered medical prescriber. 2.2 Yu must nly ever prescribe within yur level f experience and cmpetence, acting in accrdance with the Cllege f Pdiatrists Cde f Cnduct and Standards fr Clinical Practice. 2.3 If yu mve t anther area f practice yu must cnsider the requirement f yur new rle and nly ever prescribe within yur level f experience and cmpetence. 2.4 Yu must infrm anyne wh needs t knw abut any restrictins placed n yur prescribing practice. In particular, ther practitiners with dispensing respnsibilities need t knw abut this. Fr example, yur emplyer may perate a specific prescribing frmulary and may nt allw yu t prescribe utside f this frmulary. Yu must als infrm the relevant authrities if yu have any frmal regulatry restrictins placed n yur prescribing activity. 2.5 An example f a restrictin that culd be placed n yur prescribing practice might be a lcal NHS plicy that limited yu t prescribing certain drugs. This restrictin wuld nly apply t yur NHS practice fr that emplyer, and wuld nt prevent yu frm prescribing these medicines in the cntext f private practice. Practice Guidance 3: Assessment 3.1 In rder t prescribe fr a patient yu must satisfy yurself that yu have undertaken a full assessment f the patient, including a thrugh histry and, where pssible, accessing a full clinical recrd. 3.2 Yu are accuntable fr yur decisin t prescribe and must prescribe nly where yu have relevant knwledge f the patient s health and medical histry. 3.3 Yu must ensure a risk assessment has been undertaken in respect f the patient s current medicatin and any ptential interactin with ther medicines. 3.4 Yu must refer t an apprpriate prescriber if yu d nt fully understand the implicatins f yur prescribing practice in terms f the physilgy r pharmac- 12 P a g e
therapeutic actin f medicatin prescribed even thugh yu may be able t take a thrugh and apprpriate histry, which leads t a diagnsis. 3.5 Yu shuld ensure yu cnsider the effects f yur patient s lifestyle which may affect the safety f the medicines yu prescribe. This will include: The effects f smking, caffeine, alchl The effects f recreatinal r street drugs r thse used t enhance physical r sprting perfrmance The effects f ver-the-cunter medicines including herbal preparatins 3.6 Where necessary yu shuld request additinal apprpriate tests, relevant t the presenting cnditin and/r apprpriate t the prescribing decisins t be made in rder t assist yur prescribing decisins. Apprpriate bichemical and histpathlgical assessments shuld be undertaken where necessary and these may include: Liver functin tests Thyrid functin tests Kidney functin tests Bld bichemistry tests Practice Guidance 4: Need 4.1 Yu must nly prescribe where yu have assessed the patient and there is a genuine clinical need fr treatment. 4.2 Yu must als cnsider the circumstances in which yu may decide t withdraw medicatin, cease t cntinue prescribing a named medicatin r alter the prescribed dse f a medicatin. Patients may als wish t discuss with yu withdrawal frm medicatin at their chice. Any withdrawal frm medicines needs t be planned in partnership with the patient and take place ver an agreed time perid 4.3 Yu shuld never prescribe fr yur wn cnvenience r simply because a patient demands that yu d. 4.4 Yu shuld prescribe in the patient s best interests and achieve this by reaching agreement with the patient n the use f any prpsed medicine. The amunt f infrmatin yu discuss with yur patient will vary accrding t the nature f the patient s cnditin, the risks and benefits f the medicine and the patient s wishes. In all circumstances this will include the prvisin f sufficient infrmatin t allw the patient t make an infrmed chice i.e. t give their infrmed cnsent. Yu shuld aim t: Establish the patients pririties, preferences and cncerns Discuss ther treatment ptins available t the patient Satisfy yurself that yu have enugh relevant infrmatin t make a prescribing decisin Satisfy yurself that the patient understands hw t take the medicine as prescribed 4.5 Yu must nly prescribe fr patients wh are part f yur wn caselad r under yur wn care, yu must nt write up prescriptins fr patients simply because yu are the nly prescriber arund. Practice Guidance 5: Cnsent 5.1 Yu must explain yur rle as a nn-medical prescriber t the patient r their representative. 5.2 Yu must be aware f cultural and religius differences insfar as they apply t prescribing. 13 P a g e
5.3 As a pdiatrist prescriber yu must act in accrdance with the Cllege f Pdiatrists Cde f Cnduct (sectin 3), the Standards f Clinical Pdiatric Practice in Primary Care (sectin 2) and the CP Guidelines n Patient Cnsent. This must als be dne in line with lcal Trust guidance frm the PCT (fr NHS emplyees). 5.4 Yu must make it clear t the patient that prescribing activity cannt be undertaken in islatin. Yu shuld infrm anyne else wh may be in a psitin t prescribe fr that patient f yur actins in rder t avid prescribing errrs. This is mst likely t be the patient s general medical practitiner, but may als include ther medical r nn-medical prescribers. If the patient refuses t cnsent t yu sharing infrmatin yu must ffer an explanatin f the risks f nt ding s. If the patient cntinues t refuse t give cnsent, yu must cnsider which curse f actin wuld be in the best interests f the patient. This may include nt prescribing in this case. This must be dcumented in their recrds. Practice Guidance 6: Cmmunicatin 6.1 Yu have a respnsibility t cmmunicate effectively with ther practitiners invlved in the care f the patient. Yu must refer the patient t anther prescriber when it is necessary t d s. 6.2 When prescribing, yu must take the views f the patient int accunt in rder t create an envirnment where shared-decisin making is the nrm. This will include taking int accunt the patient s persnal views and beliefs and discussing treatments in relatin t these. 6.3 Prescribing is nt an activity that ccurs in islatin. Prescribing infrmatin must be shared with ther health prfessinals wh need t knw the infrmatin fr the benefit f the patient and this will include the patient s GP. Yu shuld decide the best methds f sharing this infrmatin. Yu shuld have access t ther prfessinals prescribing decisins. This will include cmmunicatin acrss NHSprivate practice bundaries where it is necessary t ensure that clinicians have apprpriate infrmatin t infrm their prescribing practice. 6.4 Yu must knw what medicatin the patient is currently taking (including OTC and herbal preparatins) befre prescribing new medicatins and yu must take steps t ensure yu have access t the primary surce f prescribing infrmatin which is likely t be the GP recrd. 6.5 Dcumentatin f yur prescribing cmmunicatins shuld be recrded as described in sectin 7 (Recrd keeping). Practice Guidance 7: Recrd keeping 7.1 The Cllege f Pdiatrists Cde f Cnduct, Standards f Clinical Pdiatric Practice in Primary Care and the CP Guidelines n Patients Recrds prvide the underlying principles. 7.2 Yu shuld ensure recrds are accurate, cmprehensive, cntempraneus and accessible by all members f a prescribing team (effective plicies must be in place lcally t enable this t happen). 7.3 In supplementary prescribing, the dctr/dentist and supplementary prescribers must share access t, cnsult and, wherever pssible, use the same cmmn patient recrd. Practice Guidance 8: Evidence based Prescribing 8.1 Pdiatrists shuld prescribe accrding t the available evidence base. Evidencebased prescribing invlves the applicatin f best available evidence when making prescriptin decisins. Reference t the evidence base can minimise the risk f adverse drug reactins, and ensure effectiveness. An evidence based apprach is being devised as part f the develpment f The Cllege f Pdiatrists Clinical Management Guidelines fr prescribers, which will becme available nline n the website f the Cllege f Pdiatrists, under the sectin Medicines. Wherever 14 P a g e
pssible, evidence based interventins will be recmmended. Where the evidence base is minimal, recmmendatins are included where there is a clinical cnsensus fr their effectiveness. 8.2 The clinical management guidelines will be prduced by the Cllege f Pdiatrists, but it will be a freely available nline resurce t all supplementary and independent prescriber pdiatrists when it is available. Practice Guidance 9: Delegatin 9.1 Yu may delegate the administratin f a medicine that yu have prescribed. Yu remain accuntable fr yur prescribing decisin and yu are als accuntable fr yur decisin t delegate the task f administratin t smene else. This includes yur assessment that the persn is cmpetent t carry ut the task and has received sufficient training t administer the prescribed medicatin. Yu are nt accuntable fr the utcme f an actin perfrmed by anther persn. 9.2 Yu may nt delegate administratin f a medicine that yu supply r administer via a Patient Grup Directin (PGD) (see glssary fr a definitin f a Patient Grup Directin). Medicines listed within a PGD can nly be administered by the registered health prfessinals named n the PGD. 9.3 When delegating the administratin f a medicine t smene else yu shuld recrd in the apprpriate recrd: The name and prfessin f the persn t whm yu delegated the administratin What yu have asked them t administer Hw yu have asked them t administer it 9.4 Where this infrmatin is nt clearly identifiable frm yur written prescriptin then the infrmatin shuld be separately recrded in the patient recrd. 9.5 Yu may delegate the administratin f a medicatin t anther cmpetent persn. Yu must nly delegate administratin if yu are satisfied that the persn is educated, trained and cmpetent t administer the medicine safely. 9.6 Yu must prvide direct supervisin f any pst-registratin student pdiatrist wh is underging a perid f training in the safe use f medicines. Practice Guidance 10: Infrmatin given t patients 10.1 Patients, r thse authrising treatment n behalf f the patient, shuld be given as much infrmatin as they require in rder fr them t make an infrmed chice with regard t prescribing decisins. Yu shuld include: Diagnsis giving rise t prescribing need Any knwn serius r cmmn side effects f the prpsed medicine Hw the medicine wrks Hw lng t take it fr Hw t stp 10.2 Infrmatin prvided must be apprpriate t the patient s levels f understanding. 10.3 Where practicable yu shuld supprt infrmatin given t yur patients in writing. 10.4 Yu shuld tell the patient that their medicine will cme supplied with a manufacturer Patient Infrmatin Leaflet which will give them additinal infrmatin. 15 P a g e
10.5 Yu must infrm the patient if yu prpse t prescribe r use any medicine that is unlicensed r utside the terms f licence/marketing authrisatin (including the use f mixed medicines). This wuld include cases where there is little research r ther evidence f current practice t supprt such use, r where the use f the medicine is innvative. Practice Guidance 11: Clinical Management Plans (supplementary prescribing) 11.1 If yu are prescribing as a supplementary prescriber, yu must prescribe in accrdance with a patient s individual clinical management plan (CMP). 11.2 The independent prescriber must have made the initial diagnsis f the patient 11.3 Where standard CMPs are in place as a starting pint, yu must tailr them t reflect the individual patient s persnal, medical and medicines histry. The CMP must be agreed with yu by an independent prescriber and with the cnsent f the patient, befre supplementary prescribing begins. This culd be in the frm f a signature, r fr an electrnic recrd and a recrdable indicatin f agreement. 11.4 Within supplementary prescribing, yu must refer the patient back t the independent prescriber shuld the patient s clinical circumstances change. It may then be decided that a CMP is n lnger apprpriate r may need amending t reflect the change in circumstances. 11.5 Within supplementary prescribing yu must never prescribe medicatin in the absence f a written CMP which has been agreed with the independent prescriber and with the cnsent f the patient. The independent prescriber may agree verbally t a CMP prviding that it is cnfirmed by fax r secure email befre prescribing ccurs, and frmally recrded within tw wrking days. 11.6 The prescribing f a Prescriptin Only Medicine (POM) by a supplementary prescriber utside a CMP cnstitutes a criminal ffence under the terms f the Human Medicines Regulatins 2012, and it is als pssible that actin wuld be taken by the Health and Care Prfessins Cuncil under its Fitness t Practice prcedures. 11.7 If a pdiatrist wh is bth an independent and supplementary prescriber sees a patient as a supplementary prescriber they must adhere t the terms f the CMP when managing the patient s cnditin fr which the CMP has been agreed. This des nt preclude the pdiatrist frm prescribing medicatin fr the patient fr an unrelated cnditin, where the pdiatrist is acting as an independent prescriber and is cmpetent t treat the cnditin cncerned. The patient shuld be tld f the distinctin between the authrity t prescribe as an independent prescriber and that f a supplementary prescriber. They shuld be tld that the pdiatrist is acting as an independent prescriber in that instance. Practice Guidance 12: Transcribing 12.1 In sme circumstances, yu may be asked t transfer medicines infrmatin frm ne dcument t anther, a prcess knwn as transcribing. Transcribing shuld nt be a rutine r regular ccurrence. 12.2 If yu transcribe, yu are accuntable fr yur actins and missins and this will include any errrs yu make in transferring the infrmatin frm ne dcument t anther. 12.3 Yu shuld satisfy yurself that transcribing is a necessary activity that cannt be eliminated by reviewing and imprving the care pathway. If transcribing must 16 P a g e
ccur, yu shuld ensure that the activity meets lcal clinical gvernance requirements. 12.4 Any transcriptin must include the fllwing: Patient s full name Date f birth Name f medicine Drug dsage, strength, timing, frequency and rute f administratin Practice Guidance 13: Electrnic Prescribing Medicines and prescribing legislatin underpins the safe and effective use f medicines. By adapting t advances in healthcare delivery, medicines legislatin can enable clinicians t imprve the patient experience thrugh new rles, new ways f wrking, extended rles and service redesign, t enable flexible respnsive and practive services. One part f medicines management is 'e-prescribing'. Where it is used it will enable pdiatrists t access better mechanisms f prescribing, supplying and administering medicines. Fr 'eprescribing' t wrk effectively there is a clear indicatin that it be linked t a patient s electrnic recrd. This allws fr cntraindicatins and interactins t be clearly identified. Althugh nt currently accessible t many prescribers, it is expected that it will be implemented mre widely. 13.1 Yu may prescribe via cmputer-generated prescriptins prviding the necessary sftware is available t enable them t be signed with an advanced electrnic prescriptin. 13.2 A visible audit trail f yur prescribing actins must be maintained. 13.3 Prescriptins shuld always be signed immediately if nt electrnically apprved. 13.4 As an independent pdiatrist prescriber, yu shuld ensure yu are apprpriately trained t fllw lcal prtcl arund 'E-prescribing'. Practice Guidance 14: Writing NHS Prescriptins 14.1 Yur written prescriptin must cntain the infrmatin required by law: It must be signed in ink It must cntain yur name and wrkplace address The date n which the prescriptin was signed by yu and/r the date after which it can be dispensed Yur prfessin The name and address f the patient The age f the patient if under 12 years ld 14.2 The names f the medicines must be written clearly using apprved names nly. Yu must nt use abbreviatins in the name f the medicine. 14.3 A nn-repeat prescriptin is valid fr six mnths after the date f signing, hwever yu shuld ensure that the medicines prescribed are apprpriate fr the patient s needs as yu have assessed them, s the reasns fr any significant delay between assessment and prescriptin dispensing shuld be dcumented. 14.6 Yu must nly write prescriptins fr yur NHS patients n an FP10 r In-patient Drug Chart. When using FP10 s these must have been issued specifically t yu fr yur NHS practice and shw yur name and HCPC registratin number. 14.7 Yu must never tamper with an existing prescriber s details n a prescriptin frm r add yur wn prescribing details. 17 P a g e
14.8 Yu must sign yur prescriptins immediately they are prduced. If this is nt pssible (e.g. the prescriptin is printed in a dispensary away frm yur clinic rm), the unsigned prescriptins must be securely stred until yu can sign them. Yu must sign them within 24 hurs. 14.9 Yu must never sign a blank prescriptin frm in advance and then stre them fr future use. Practice Guidance 15: Writing Private Prescriptins 15.1 Pdiatrist independent prescribers may issue private prescriptins fr any licensed medicine prviding this falls within the recgnised scpe f practice and sphere f cmpetence f the pdiatrist. Supplementary prescribing may als perate in private practice, where any prescriptin must be in accrdance with what has been agreed with the independent prescriber and the patient within the terms f the CMP. 15.2 The apprpriate infrmatin as utlined in Practice Guidance 14 pertaining t prcess shuld be applied in this setting (in accrdance with lcal prtcls in private hspitals) t. Practice Guidance 16: Reviewing Prescriptins 16.1 Yu shuld review a patient s medicatin regularly and in particular when yu are staring a new medicatin, stpping a medicatin r changing a dse f a current medicatin. Practice Guidance 17: Repeat Prescriptins 17.1 The plurality f prvisin within health services in bth the NHS and in private practice will mean that repeat prescribing and the issue f repeatable prescriptins may becme a significant aspect f the rle f the pdiatrist prescriber. The Natinal Prescribing Centre in England has prduced gd practice guidelines: Saving time, helping patients: a gd practice guide t quality repeat prescribing, available at www.npc.c.uk. 17.2 Yu may issue a repeat r repeatable prescriptin, but yu shuld nly d s in the knwledge that yu are respnsible as the signatry f the prescriptin and are accuntable fr yur practice. 17.3 Befre signing a repeat r repeatable prescriptin, yu must be satisfied that it is safe and apprpriate t d s and that secure prcedures are in place t ensure that: a) The patient is issued with the crrect prescriptin. b) Each prescriptin is regularly reviewed and is nly re-issued t meet clinical need. c) A case review takes place after six mnths. d) Suitable prvisin is in place t ensure that patients wh need a further examinatin r assessment d nt receive a repeat prescriptin withut first being seen by an apprpriate prescriber. e) A recrd is made f the repeat prescriptin n the patient s recrd. 17.4 Repeat prescriptins are valid fr six mnths and, unless specified in writing n the prescriptin therwise, the medicine may be dispensed twice within the validity f the prescriptin (with the exceptin f cntraceptives, which may be dispensed six times). Yu shuld ensure that yu review yur patient s medicatin at regular intervals t ensure the prescriptin remains apprpriate fr yur patient s needs. 18 P a g e
17.5 If yu issue repeat prescriptins, yu must ensure that yu prescribe safely and respnsibly. Befre signing repeat prescriptins, yu must be satisfied that it is safe and apprpriate t d s. Yu shuld review repeat prescriptins regularly and d nt issue medicines fr lnger than is clinically required. If multiple medicines have been prescribed previusly, ensure that all are needed n repeat. Yu shuld ensure the crrect dse is prescribed fr medicines where the dse varies accrding t the curse f the treatment. Sectin (2) Special prescribing circumstances Practice Guidance 18: Family, Friends & Clleagues 18.1 Yu must nt prescribe medicatins t treat yurself. Yu shuld be registered with yur wn medical and/r health practitiner wh will be bjective in prviding yu with gd care. 18.2 Yu shuld wherever pssible avid prescribing fr thse clse t yu. Peple clse t yu include yur immediate family (fr example parents, grandparents, children, grandchildren, siblings, aunts, uncles and first cusins), smene with whm yu have an intimate persnal relatinship and yur friends r clleagues. 18.3 Yu shuld avid prescribing fr family and friends unless: N ther prescriber is available t assess the patient s clinical cnditin and t delay prescribing wuld put the patient s life r health at risk, r cause intlerable pain The treatment is immediately necessary t: - Save life - Avid serius deteriratin in the patient s health and well-being - Alleviate therwise uncntrllable pain 18.4 Yu must be able t justify yur decisins t prescribe fr family and friends. Yu must recrd the nature f yur relatinship and the special circumstances that necessitated yur actin f prescribing fr family and friends. 18.5 At all time yu must maintain an bjective view f yur patient s interests. See in particular Sectin 3, Cllege f Pdiatrists Cde f Cnduct. Practice Guidance 19: Prescribing fr Children, Pregnancy & Older Peple 19.1 Medicines are ptent treatments and prescribing them can present significant risk t patients. This is especially s fr children and lder peple, whse respnses may differ frm adults (See Practice Guidance 21.4). It is essential that registrants recgnise the unique implicatins fr children and yung peple. Cautin shuld als be taken when prescribing fr pregnant and lactating wmen. Only pdiatrists with relevant knwledge, cmpetence, skills and experience in treating children shuld prescribe fr children. Anyne prescribing fr a child must be able t demnstrate cmpetence t prescribe fr children and t refer t anther practitiner when wrking utside their area f expertise and level f cmpetence. 19.2 In all cases reference shuld be made t the fllwing dcuments that address medicines management issues in paediatrics: The BNF fr Children (England/Wales/Sctland) at www.bnfc.rg Medicines Standard: Natinal Service Framewrk fr Children, Yung Peple and Maternity Services at www.dh.gv.uk under Plicy and Guidance, Health and Scial Care Tpics, Children Services Medicines Standard: Natinal Service Framewrk fr Children, Yung Peple and Maternity Services (Wales) 19 P a g e
Ryal Cllege f Paediatrics and Child Health infrmatin n use f licensed and unlicensed medicines at www.rcpch.ac.uk/publicatins Scttish Executive - The Administratin f Medicines in Schls and The Right Medicine: A Strategy fr Pharmaceutical Care in Sctland SIGN Guidance at www.sign.ac.uk DHSSPS Medicines Management Standard DH Every Child Matters (2004) Practice Guidance 20: Prescribing unlicensed medicines 20.1 Yu must nt prescribe an unlicensed medicine as a pdiatrist independent prescriber 20.2 Yu may prescribe an unlicensed medicine as a supplementary prescriber as part f a CMP prviding: The independent prescriber has agreed with yu the clinical management plan with the patient s cnsent. Yu are satisfied that there is a sufficient evidence base and/r experience t demnstrate the medicatin s safety and efficacy fr that particular patient. Yu and the independent prescriber are prepared t take the respnsibility fr prescribing the unlicensed medicine and have agreed the patient s CMP t that effect. The patient agrees t a prescriptin in the knwledge that the drug is unlicensed and understands the implicatins theref. The medicatin chsen and the reasn fr its selectin is dcumented in the CMP. Practice Guidance 21: Prescribing medicines fr use utside the terms f the licence/marketing authrisatin ( ff-label use) 21.1 Off-label prescribing is where a licensed medicine is prescribed utside the terms f its prduct licence. There may be circumstances where pdiatrists may prescribe licensed medicines fr use utside the terms f the medicine s licence. 21.2 In rder t prescribe medicines fr ff-label use, yu must ensure the fllwing cnditins are met: Yu are satisfied that it wuld better serve the patient s needs than an apprpriately licensed alternative Yu are satisfied that there is a sufficient evidence base and/r experience f using the medicine t demnstrate its safety and efficacy. Where the manufacturer s infrmatin is insufficient r f limited help, the necessary infrmatin must be sught frm anther reliable surce. Yu shuld explain t the patient/carer, in brad terms, the reasns why medicines are nt licensed fr their prpsed use. If pdiatrists intend t prescribe ff label they are advised t btain the written cnsent f the patient. Yu make a clear, accurate and legible recrd f all medicines prescribed, and the reasns fr prescribing an ff label medicine. 21.3 Yu may als, as a supplementary prescriber, prescribe a medicine fr use utside the terms f its licence prviding: There is a CMP in place, agreed in cnjunctin with the independent prescriber and with the cnsent f the patient and/r carer. The use f the medicines utside the terms f its licence is dcumented. 20 P a g e
The independent prescriber and the pdiatrist supplementary prescriber take respnsibility fr prescribing the medicine and jintly versee and mnitr the patient s care, and arrange fr any fllw-up treatment required. 21.4 Pharmaceutical cmpanies d nt usually test their medicines n children and cnsequently cannt apply t licence their medicines fr use in the treatment f children. It is ften necessary in paediatric practice t use medicines that are licensed nly fr adults. See the British Natinal Frmulary fr Children. 21.5 It is gd practice t give as much infrmatin t patients, r thse authrising treatment f their behalf, as is required r which they may see as significant. This wuld include the prpsed curse f treatment, any knwn serius r cmmn side effects r adverse reactins. Infrmatin must be given that is apprpriate t the target audience (eg. children r thse with learning difficulties). 21.6 Any infrmatin prvided may be supprted by written infrmatin, fr example, the leaflet n unlicensed medicines prduced by the Ryal Cllege f Paediatrics and the Child Health/Nenatal and Paediatric Pharmacists Grup Standing Cmmittee n Medicines. Practice Guidance 22: Cntrlled Drugs 22.1 Yu may prescribe, supply and r administer Cntrlled Drugs by several mechanisms. A pdiatrist independent prescriber may issue a valid prescriptin fr thse cntrlled drugs listed n their frmulary. A pdiatrist supplementary prescriber may prescribe any cntrlled drug where it is listed n the valid written clinical management plan agreed by a dctr. Cntrlled Drugs frm Schedules 4 and/r 5 may be supplied and/r administered under the terms f a PGD, but must nt include anablic sterids r the management f drug addictin. 22.2 Yu may have a need t use cntrlled drugs in settings and circumstances where patients are cared fr as part f a medical Cnsultant-led team and/r where yu have regular and n-ging access t a Cnsultant. Examples include A&E and inpatient hspital settings fr management f acute and pre/pst-perative pain and ut-patient hspital settings fr chrnic pain management 4. 22.3 Yu must nt prescribe a cntrlled drug fr yurself. 22.4 Yu must nt prescribe cntrlled drugs fr smene clse t yu unless N ther prescriber is available t assess the patient s clinical cnditin and t delay prescribing wuld put the patient s life r health at risk, r cause intlerable pain. Yu must be able t justify yur decisins t prescribe cntrlled drugs fr thse clse t yu. Yu must recrd the nature f yur relatinship and the special circumstances that necessitated yur actin f prescribing cntrlled drugs t thse clse t yu. 22.5 Yu shuld knw wh yur lcal Accuntable Officer is and cmply with lcal mnitring and/r inspectin requests as necessary. Safer management f cntrlled drugs: (1) guidance n strengthened gvernance arrangements (January 2007) 22.6 Standard Operating Prcedures (SOPs) must be in place fr the prescriptin f Cntrlled Drugs (CDs) accrding t Regulatins, and shuld include prcedures fr: Prescribing CD s 4 In these settings the GP may be asked t prvide the cntrlled drug n the recmmendatin f the secndary care team. 21 P a g e