Good practice in prescribing and managing medicines and devices

Transcription

1 You n fin the ltest version of this guine on our wesite t Referenes to Goo meil prtie upte in Mrh 2013 Goo prtie in presriing n mnging meiines n evies 1 In Goo meil prtie (2013) 1 we sy: n 12 You must keep up to te with, n follow, the lw, our guine n other regultions relevnt to your work. n n 14 You must reognise n work within the limits of your ompetene. 16 In proviing linil re you must: presrie rugs or tretment, inluing repet presriptions, only when you hve equte knowlege of the ptient s helth, n re stisfie tht the rugs or tretment serve the ptient s nees. provie effetive tretments se on the est ville eviene f hek tht the re or tretment you provie for eh ptient is omptile with ny other tretments the ptient is reeiving, inluing (where possile) self-presrie over-the-ounter meitions n n n 18 You must mke goo use of the resoures ville to you. 19 Douments you mke (inluing linil reors) to formlly reor your work must e ler, urte n legile. You shoul mke reors t the sme time s the events you re reoring or s soon s possile fterwrs. 21 Clinil reors shoul inlue: relevnt linil finings the eisions me n tions gree, n who is mking the eisions n greeing the tions the informtion given to ptients ny rugs presrie or other investigtion or tretment e who is mking the reor n when. 1 Generl Meil Counil (2013) Goo meil prtie Lonon, GMC. 01

2 Goo prtie in presriing n mnging meiines n evies Aout this guine 2 This guine provies more etile vie on how to omply with these priniples when presriing n mnging meiines n meil evies, inluing pplines. 3 You re responsile for the presriptions you sign n for your eisions n tions when you supply n minister meiines n evies or uthorise or instrut others to o so. You must e prepre to explin n justify your eisions n tions when presriing, ministering n mnging meiines. 4 Presriing is use to esrie mny relte tivities, inluing supply of presription only meiines, presriing meiines, evies n ressings on the NHS n vising ptients on the purhse of over the ounter meiines n other remeies. It my lso e use to esrie written informtion provie for ptients (informtion presriptions) or vie given. While some of this guine is prtiulrly relevnt to presription only meiines, you shoul follow it in reltion to the other tivities you unertke, so fr s it is relevnt n pplile. This guine pplies to meil evies s well s to meiines. 5 Serious or persistent filure to follow this guine will put your registrtion t risk. Keeping up to te n presriing sfely 6 Goo meil prtie sys tht you must reognise n work within the limits of your ompetene n tht you must keep your knowlege n skills up to te. You must mintin n evelop the knowlege n skills in phrmology n therpeutis, s well s presriing n meiines mngement, relevnt to your role n presriing prtie. 7 You shoul mke use of eletroni n other systems tht n improve the sfety of your presriing, for exmple y highlighting intertions n llergies n y ensuring onsisteny n omptiility of meiines presrie, supplie n ministere. The Meiines n Helthre Prouts Regultory Ageny s (MHRA) Drug Sfety Upte n the NHS Centrl Alert System provie informtion n vie to support the sfer use of meiines relevnt to your prtie n lert you to sfety informtion out meiines you presrie. The Ntionl eletroni Lirry for Meiines hs extensive informtion on the sfe, effetive n effiient use of meiines. The Ntionl Presriing Centre (now prt of the Ntionl Institute for Helth n Clinil Exellene (NICE)) pulishes rnge of mterils to help you improve the sfety n linil n ost effetiveness of your presriing. The eletroni Meiines Compenium lists Summries of Prout Chrteristis n Ptient Informtion Leflets. 8 If you re unsure out intertions or other spets of presriing n meiines mngement you shoul seek vie from experiene ollegues, inluing phrmists, presriing visers n linil phrmologists. 9 You must e fmilir with the guine in the British Ntionl Formulry (BNF) n British Ntionl Formulry for Chilren (BNFC), whih ontin essentil informtion to help you presrie, monitor, supply, n minister meiines. 10 You shoul follow the vie in the BNF on presription writing n mke sure your presriptions n orers re ler, in orne with the relevnt sttutory requirements n inlue your nme legily. 2 You shoul lso onsier inluing linil initions 3 on your presriptions. 2 Eletroni presriing servies n lso e use. In Engln presriptions n e sent eletronilly to phrmy; in Wles n Sotln, informtion is hel in roe on pper presription. For more etils see: Get Strte with EPS Helth n n soil Cre informtion Centre; Presriptions eletronilly NHS Wles Informtis Servie; Eletroni Trnsfer of Presriptions (ETP) (pf) Sottish Government See

3 Goo prtie in presriing n mnging meiines n evies 11 You shoul tke ount of the linil guielines pulishe y the: 15 In Consent: ptients n otors mking eisions together, 5 we sy: e NICE (Engln) Sottish Meiines Consortium n Helth Improvement Sotln (inluing the Sottish Interollegite Guielines Network) (Sotln) Deprtment for Helth, Soil Servies n Puli Sfety (Northern Ireln) All-Wles Meiines Strtegy Group (Wles) meil royl olleges n other uthorittive soures of speilty speifi linil guielines. 5 If ptient sks for tretment tht the otor onsiers woul not e of overll enefit to them, the otor shoul isuss the issues with the ptient n explore the resons for their request. If, fter isussion, the otor still onsiers tht the tretment woul not e of overll enefit to the ptient, they o not hve to provie the tretment. But they shoul explin their resons to the ptient, n explin ny other options tht re ville, inluing the option to seek seon opinion. 12 You shoul mke sure tht nyone to whom you elegte responsiility for ispensing meiines in your own prtie is ompetent to o wht you sk of them. Avie on trining for ispensing support stff n e otine from the Generl Phrmeutil Counil. 13 You shoul mke sure tht nyone to whom you elegte responsiility for ministering meiines is ompetent to o wht you sk of them. 4 Nee n ojetivity 14 You shoul presrie meiines only if you hve equte knowlege of the ptient s helth n you re stisfie tht they serve the ptient s nees. 16 You must not presrie meiines for your own onveniene or the onveniene of other helth or soil re professionls (for exmple, those ring for ptients with ementi in re homes 6 ). Presriing for yourself or those lose to you 17 Wherever possile you must voi presriing for yourself or nyone with whom you hve lose personl reltionship. 18 Controlle meiines present prtiulr ngers, osionlly ssoite with rug misuse, ition n misonut. You must not presrie ontrolle meiine for yourself or someone lose to you unless: no other person with the legl right to presrie is ville to ssess n presrie without ely whih woul put your, or the ptient s, life or helth t risk or use uneptle pin or istress, n 4 See explntory guine on Delgtion n referrl (2013). 5 Generl Meil Counil (2008) Consent Lonon, GMC. 6 See The use of ntipsyhoti meition for people with ementi: Time for tion (Deprtment of Helth, 2009), whih reporte tht roun 180,000 people with ementi re trete with ntipsyhoti meition ross the ountry per yer use t this level equtes to n itionl 1,800 eths, n n itionl 1,620 ererovsulr verse events, roun hlf of whih my e severe, per yer, n NICE linil guieline 42: Dementi. The Ntionl Presriing Centre wesite ( n the joint NHS Institute n Dementi Ation Alline s Cll to tion: the use of ntipsyhoti rugs for people with ementi lso ontins guies, se stuies n other mterils to support goo presriing prtie n lterntive re strtegies for ptients with ementi. 03

4 Goo prtie in presriing n mnging meiines n evies the tretment is immeitely neessry to: ny previous verse retions to meiines i ii sve life voi serious eteriortion in helth, or iii llevite otherwise unontrollle pin or istress. reent use of other meiines, inluing non-presription n herl meiines, illegl rugs n meiines purhse online, n other meil onitions. 19 If you presrie for yourself or someone lose to you, you must: Consent mke ler reor t the sme time or s soon s possile fterwrs. The reor shoul inlue your reltionship to the ptient (where relevnt) n the reson it ws neessry for you to presrie. tell your own or the ptient s generl prtitioner (n others treting you or the ptient, where relevnt) wht meiines you hve presrie n ny other informtion neessry for ontinuing re, unless (in the se of presriing for someoy lose to you) they ojet. 20 In Consent: ptients n otors mking eisions together, we sy: 3 For reltionship etween otor n ptient to e effetive, it shoul e prtnership se on openness, trust n goo ommunition. Eh person hs role to ply in mking eisions out tretment or re. 21 Together with the ptient, 7 you shoul mke n ssessment of their onition efore eiing to presrie meiine. You must hve or tke n equte history, inluing: 22 You shoul enourge your ptients to e open with you out their use of lterntive remeies, illegl sustnes n meiines otine online, s well s whether in the pst they hve tken presrie meiines s irete. 23 You shoul ientify the likely use of the ptient s onition n whih tretments re likely to e of overll enefit to them. 24 You shoul reh greement with the ptient on the tretment propose, 8 explining: e the likely enefits, risks n urens, inluing serious n ommon sie effets wht to o in the event of sie effet or reurrene of the onition how n when to tke the meiine n how to just the ose if neessry, or how to use meil evie the likely urtion of tretment rrngements for monitoring, follow-up n review, inluing further onsulttion, loo tests or other investigtions, proesses for justing the type or ose of meiine, n for issuing repet presriptions. 25 The mount of informtion you give to eh ptient will vry oring to the nture of their onition, the potentil risks n sie effets n the ptient s nees n wishes. You shoul hek tht the ptient hs unerstoo the informtion, n enourge them to sk questions to lrify 7 or, where pproprite, prents or rers with uthority to mke eision on ehlf of ptients. Meiines my e presrie without onsent if it is likely to e of overll enefit to ults who lk pity, or in orne with mentl helth legisltion. 8 A numer of ptient eision is re ville on the Ntionl Presriing Centre wesite ( ). 04

5 Goo prtie in presriing n mnging meiines n evies ny onerns or unertinty. You shoul onsier the enefits of written informtion, informtion in other lnguges n other is for ptients with isilities to help them unerstn n onsier informtion t their own spee n to retin the informtion you give them. 26 You shoul lso provie ptients rers with informtion out the meiines you presrie, either with the ptient s onsent or, if the ptient lks pity to onsent, if it is in their est interests. 27 It is sometimes iffiult, euse of time pressures, to give ptients s muh informtion s you or they woul like. To help with this, you shoul onsier the role tht other memers of the helthre tem, inluing phrmists, might ply. Phrmists n unertke meiines reviews, explin how to tke meiines n offer vie on intertions n sie effets. You shoul work with phrmists in your orgnistion n/or lolity to voi the risks of overurening or onfusing ptients with exessive or inonsistent informtion. 28 You shoul lso refer ptients to the informtion in ptient informtion leflets (PILs) n other relile soures of relevnt informtion. 9 PILs re useful supplements to the informtion you give ptients out their meiines, ut they re not sustitute for tht informtion. Shring informtion with ollegues 30 You must ontriute to the sfe trnsfer of ptients etween helthre proviers n etween helth n soil re proviers. This mens you must shre ll relevnt informtion with ollegues involve in your ptient s re within n outsie the tem, inluing when you hn over re s you go off uty, when you elegte re or refer ptients to other helth or soil re proviers. This shoul inlue ll relevnt informtion out their urrent n reent use of other meiines, other onitions, llergies n previous verse retions to meiines. 31 It is essentil for sfe re tht informtion out meiines ompnies ptients (or quikly follows them, for exmple on emergeny mission to hospitl) when they trnsfer etween re settings If you presrie for ptient, ut re not their generl prtitioner, you shoul hek the ompleteness n ury of the informtion ompnying referrl. When n episoe of re is omplete, you must tell the ptient s generl prtitioner out: hnges to the ptient s meiines (existing meiines hnge or stoppe n new meiines strte, with resons) 29 Some ptients o not tke meiines presrie for them, or o not follow the instrutions on the ose to tke or the time meiines shoul e tken. You shoul try to unerstn the resons for this n ress them y proviing ressurne n informtion, n y negotiting with the ptient to reh greement on n pproprite ourse of tretment tht they re le n willing to here to. 10 length of intene tretment monitoring requirements ny new llergies or verse retions ientifie, 12 unless the ptient ojets or if privy onerns overrie the uty, for exmple in sexul helth linis. 9 NHS Choies n informtion ering The Informtion Stnr qulity mrk, for exmple. 10 The Ntionl Presriing Centre wesite ( inlues informtion, guine n tools for unerstning n improving herene. See lso NICE s Clinil guielines CG76 on meiines herene. 11 See Keeping ptients sfe when they trnsfer etween re proviers getting the meiines right (Royl Phrmeutil Soiety, July 2011). 12 See the Cre Qulity Commission s 2009 ntionl stuy, Mnging ptients meiines fter ishrge from hospitl n the EQUIP (Errors Questioning Unergrute Impt on Presriing) stuy regring inpproprite elegtion of responsiility for writing up ishrge summries to junior stff with insuffiient phrmology trining or knowlege of ptients. 05

6 Goo prtie in presriing n mnging meiines n evies 33 If ptient hs not een referre to you y their generl prtitioner, you shoul lso: onsier whether the informtion you hve is suffiient n relile enough to enle you to presrie sfely; for exmple, whether: i ii you hve ess to their meil reors or other relile informtion out the ptient s helth n other tretments they re reeiving you n verify other importnt informtion y exmintion or testing sk for the ptient s onsent to ontt their generl prtitioner if you nee more informtion or onfirmtion of the informtion you hve efore presriing. If the ptient ojets, you shoul explin tht you nnot presrie for them n wht their options re. 34 If you re the ptient s generl prtitioner, you shoul mke sure tht hnges to the ptient s meiines (following hospitl tretment, for exmple) re reviewe n quikly inorporte into the ptient s reor. This will help to voi ptients reeiving inpproprite repet presriptions n reue the risk of verse intertion. 13 Shre re 35 Deisions out who shoul tke responsiility for ontinuing re or tretment fter initil ignosis or ssessment shoul e se on the ptient s est interests, rther thn on your onveniene or the ost of the meiine n ssoite monitoring or follow-up. 36 Shre re requires the greement of ll prties, inluing the ptient. Effetive ommunition n ontinuing liison etween ll prties to shre re greement re essentil. Presriing t the reommention of professionl ollegue 37 If you presrie t the reommention of nother otor, nurse or other helthre professionl, you must stisfy yourself tht the presription is neee, pproprite for the ptient n within the limits of your ompetene. 38 If you elegte ssessment of ptients suitility for meiine, you must e stisfie tht the person to whom you elegte hs the qulifitions, experiene, knowlege n skills to mke the ssessment. You must give them enough informtion out the ptient to rry out the ssessment require. You must lso mke sure tht they follow the guine in prgrphs on onsent. 39 In oth ses, you will e responsile for ny presription you sign. Reommening meiines for presription y ollegues 40 If you reommen tht ollegue, for exmple junior otor or generl prtitioner, presries prtiulr meiine for ptient, you must onsier their ompetene to o so. You must stisfy yourself tht they hve suffiient knowlege of the ptient n the meiine, experiene (espeilly in the se of junior otors) n informtion to presrie. You shoul e willing to nswer their questions n otherwise ssist them in ring for the ptient, s require. 13 See Meiines Reonilition: A guie to implementtion (Ntionl Presriing Centre, 2008). 06

7 Goo prtie in presriing n mnging meiines n evies Shre re presriing 41 If you shre responsiility for ptient s re with ollegue, you must e ompetent to exerise your shre of linil responsiility. You shoul: re is shre or from nother experiene ollegue. If you re still not stisfie, you shoul explin this to the other liniin n to the ptient, n mke pproprite rrngements for their ontinuing re. keep yourself informe out the meiines tht re presrie for the ptient Rising onerns e le to reognise serious n frequently ourring verse sie effets mke sure pproprite linil monitoring rrngements re in ple n tht the ptient n helthre professionls involve unerstn them keep up to te with relevnt guine on the use of the meiines n on the mngement of the ptient s onition. 42 In proposing shre re rrngement, speilists my vise the ptient s generl prtitioner whih meiine to presrie. If you re reommening new, or rrely presrie, meiine, you shoul speify the osge n mens of ministrtion, n gree protool for tretment. You shoul explin the use of unliense meiines, n eprtures from uthorittive guine or reommene tretments n provie oth the generl prtitioner n the ptient with suffiient informtion to permit the sfe mngement of the ptient s onition Presriing n ministrtion errors y otors re ommon, 15 ut hrm is usully voie y professionl ollegues intervening efore the errors n ffet ptients. 45 You must protet ptients from risks of hrm pose y ollegues presriing, ministrtion n other meiines-relte errors. You shoul question ny eision or tion tht you onsier might e unsfe. 16 You shoul lso respon onstrutively to onerns rise y ollegues, ptients n rers out your own prtie. Reporting verse rug retions, meil evie verse inients n other ptient sfety inients 46 Erly, routine reporting of verse retions, inients n ner misses involving meiines n evies n llow performne n systems issues to e investigte, prolems retifie n lessons lerne. 17 You must mke reports in orne with your employer or ontrting oy s lol linil governne proeures If you re unertin out your ompetene to tke responsiility for the ptient s ontinuing re, you shoul seek further informtion or vie from the liniin with whom the ptient s 14 Shre re resoures re ville from the Ntionl Presriing Centre; Milns Therpeutis Review & Avisory Committee, whih hs proue 16 Effetive Shre Cre Agreements overing vriety of meiines/initions; UK Meiines Informtion, whih hs pulishes mny shre re protools/greements; n Keele Shool of Phrmy pulishes n Effetive Shre Cre Agreement Toolkit to ssist helthre professionls in the evelopment of their own shre re greements to support lolly gree presriing. 15 See the EQUIP (Errors Questioning Unergrute Impt on Presriing) stuy n Investigting the prevlene n uses of presriing errors in generl prtie: The PRACTICe stuy. 16 See Rising n ting on onerns out ptient sfety (2012). 17 You shoul nonymise or oe the informtion or seek onsent, if prtile, or see our onfientility guine for more vie. 18 You must lso mke sure ngerous ourrenes n ients re reporte to the Helth n Sfety Exeutive in orne with the Reporting of Injuries, Diseses n Dngerous Ourrenes Regultions 1995, n tht lol proeures for reporting n lerning from similr issues re followe. 07

8 Goo prtie in presriing n mnging meiines n evies 47 You must inform the MHRA out: serious suspete verse retions to ll meiines n ll retions to prouts mrke with Blk Tringle in the BNF n elsewhere using the Yellow Cr Sheme. 19 verse inients involving meil evies, inluing those use y humn error tht put, or hve the potentil to put, the sfety of ptients, helthre professionls or others t risk. 20 These inients shoul lso e reporte to the meil evie liison offier within your orgnistion. 48 You shoul provie ptients with informtion out how they n report suspete sie effets iretly to the MHRA. 49 You shoul lso: hek tht ll serious ptient sfety inients re reporte to the Ntionl Reporting n Lerning System (in Engln n Wles), espeilly if suh inients re not utomtilly reporte through linil governne rrngements where you work where pproprite, inform the ptient s generl prtitioner, the phrmy tht supplie the meiine, the lol ontrolle rugs ountle offier n the meiines mnufturers of relevnt verse rug retions n ptient sfety inients. 50 You shoul respon to requests from the Drug Sfety Reserh Unit for presription-event monitoring t n informtion for stuies on speifi sfety or phrmovigilne issues. Reviewing meiines 51 Whether you presrie with repets or on oneoff sis, you must mke sure tht suitle rrngements re in ple for monitoring, followup n review, tking ount of the ptients nees n ny risks rising from the meiines. 52 When you review ptient s meiines, you shoul re-ssess the ptient s nee for unliense meiines (see prgrphs 67 70), for exmple ntipsyhotis use for the tretment of ehviourl n psyhologil symptoms in ementi Reviewing meiines will e prtiulrly importnt where: ptients my e t risk, for exmple, ptients who re fril or hve multiple illnesses. meiines hve potentilly serious or ommon sie effets the ptient is presrie ontrolle or other meiine tht is ommonly use or misuse the BNF or other uthorittive linil guine 22 reommens loo tests or other monitoring t regulr intervls. 54 Phrmists n help improve sfety, effiy n herene in meiines use, for exmple y vising ptients out their meiines n rrying out meiines reviews. This oes not relieve you of your uty to ensure tht your presriing n meiines mngement is pproprite. You shoul onsier n tke pproprite tion on informtion n vie from phrmists n other helthre professionls who hve reviewe ptients use of meiines, espeilly following hnges to their meiines or if they report prolems with tolerne, sie effets or with tking meiines s irete. 19 The MHRA ollets t on liense n unliense presription-only, phrmy n over-the-ounter meiines. 20 Further guine on reporting is ville from the MHRA: Reporting Averse Inients. Inients involving meil evies in Engln n Wles shoul e reporte to MHRA (reporting verse inients). In Northern Ireln they shoul e reporte to Northern Ireln Averse Inient Centre; n in Sotln to Helth Filities Sotln online inient reporting. 21 See footnote on pge See 10 Top Tips for GPs Strtegies for sfer presriing (Ntionl Presriing Centre, 2011). 08

9 Goo prtie in presriing n mnging meiines n evies Repet presriing n presriing with repets 55 You re responsile for ny presription you sign, inluing repet presriptions for meiines initite y ollegues, so you must mke sure tht ny repet presription you sign is sfe n pproprite. You shoul onsier the enefits of presriing with repets to reue the nee for repet presriing. 56 As with ny presription, you shoul gree with the ptient wht meiines re pproprite n how their onition will e mnge, inluing te for review. You shoul mke ler why regulr reviews re importnt n explin to the ptient wht they shoul o if they: suffer sie effets or verse retions, or stop tking the meiines efore the gree review te (or set numer of repets hve een issue), You must mke ler reors of these isussions n your resons for repet presriing You must e stisfie tht proeures for presriing with repets n for generting repet presriptions re seure n tht: e f ptients who nee further exmintion or ssessment re reviewe y n pproprite helthre professionl ny hnges to the ptient s meiines re ritilly reviewe n quikly inorporte into their reor. 58 At eh review, you shoul onfirm tht the ptient is tking their meiines s irete, n hek tht the meiines re still neee, effetive n tolerte. This my e prtiulrly importnt following hospitl sty, or hnges to meiines following hospitl or home visit. You shoul lso onsier whether requests for repet presriptions reeive erlier or lter thn expete my inite poor herene, leing to inequte therpy or verse effets. 59 When you issue repet presriptions or presrie with repets, you shoul mke sure tht proeures re in ple to monitor whether the meiine is still sfe n neessry for the ptient. You shoul keep reor of ispensers who hol originl repet ispensing presriptions so tht you n ontt them if neessry. Remote presriing vi telephone, vieo-link or online the right ptient is issue with the orret presription the orret ose is presrie, prtiulrly for ptients whose ose vries uring the ourse of tretment the ptient s onition is monitore, tking ount of meiine usge n effets only stff who re ompetent to o so prepre repet presriptions for uthoristion 60 Before you presrie for ptient vi telephone, vieo-link or online, you must stisfy yourself tht you n mke n equte ssessment, estlish ilogue n otin the ptient s onsent in orne with the guine t prgrphs You my presrie only when you hve equte knowlege of the ptient s helth, n re stisfie tht the meiines serve the ptient s nees. You must onsier: the limittions of the meium through whih you re ommuniting with the ptient 23 See Sving time, helping ptients: A goo prtie guie to qulity repet presriing (2004), Dispensing with repets: prtil guie to repet ispensing (2008) n servie improvement guies n other resoures ville t 09

10 Goo prtie in presriing n mnging meiines n evies the nee for physil exmintion or other ssessments whether you hve ess to the ptient s meil reors. 62 You must unertke physil exmintion of ptients efore presriing non-surgil osmeti meiinl prouts suh s Botox, Dysport or Vistel or other injetle osmeti meiines. You must not therefore presrie these meiines y telephone, vieo-link, or online. 63 If you re presriing for ptient in re or nursing home or hospie, you shoul ommunite with the ptient (or, if tht is not prtile, the person ring for them) to mke your ssessment n to provie the neessry informtion n vie. You shoul mke sure tht ny instrutions, for exmple for ministrtion or monitoring the ptient s onition, re unerstoo n sen written onfirmtion s soon s possile. 64 If the ptient hs not een referre to you y their generl prtitioner, you o not hve ess to their meil reors, n you hve not previously provie them with fe-to-fe re, you must lso: 66 If you presrie for ptients who re overses, you shoul onsier how you or lol helthre professionls will monitor their onition. You shoul lso hve regr to ifferenes in prout s liense nme, initions n reommene osge regimen. You my lso nee to onsier: MHRA guine on import/export requirements n sfety of elivery, whether you will nee itionl inemnity over whether you will nee to e registere with regultory oy in the ountry in whih the presrie meiines re to e ispense. Presriing unliense meiines 67 The term unliense meiine is use to esrie meiines tht re use outsie the terms of their UK liene or whih hve no liene for use in the UK. 25 Unliense meiines re ommonly use in some res of meiine suh s in peitris, psyhitry n pllitive re. They re lso use, less frequently, in other res of meiine. give your nme n, if you re presriing online, your GMC numer explin how the remote onsulttion will work n wht to o if they hve ny onerns or questions 68 You shoul usully presrie liense meiines in orne with the terms of their liene. However, you my presrie unliense meiines where, on the sis of n ssessment of the iniviul ptient, you onlue, for meil resons, tht it is neessry to o so to meet the speifi nees of the ptient. follow the vie in prgrphs on Shring informtion with ollegues. 69 Presriing unliense meiines my e neessry where: 65 You shoul not ollue in the unlwful vertising of presription only or unliense meiines to the puli y presriing vi wesites tht reh vertising regultions. 24 There is no suitly liense meiine tht will meet the ptient s nee. Exmples inlue (ut re not limite to), for exmple, where: See The Meiines (Avertising) Regultions 1994 n The Meiines (Monitoring of Avertising) Regultions 1994, oth s mene, n The Blue Guie: Avertising n Promotion of Meiines in the UK (MHRA, 2005). 25 This efinition is se on informtion pulishe y the MHRA, whih is the liensing n regultory oy for the supply n use of meiines n meil evies. MHRA guine on the lwful supply n use of unliense meiines is set out in the MHRA pulition The supply of unliense meiinl prouts ( speils ), MHRA Guine Note 14 ville t groups/is-li/ouments/pulition/on pf. 26 We nnot foresee every irumstne in whih it my e neessry to presrie n unliense meiine to meet prtiulr ptient s ssesse nees. If in out, onsult the MHRA ( or seek legl vie. 10

11 Goo prtie in presriing n mnging meiines n evies i ii there is no liense meiine pplile to the prtiulr ptient. For exmple, if the ptient is hil n meiine liense only for ult ptients woul meet the nees of the hil; or meiine liense to tret onition or symptom in hilren woul nonetheless not meet the speifi ssesse nees of the prtiulr hil ptient, ut meiine liense for the sme onition or symptom in ults woul o so; or iii the osge speifie for liense meiine woul not meet the ptient s nee; or iv the ptient nees meiine in formultion tht is not speifie in n pplile liene. Or where suitly liense meiine tht woul meet the ptient s nee is not ville. This my rise where, for exmple, there is temporry shortge in supply; or mke ler, urte n legile reor of ll meiines presrie n, where you re not following ommon prtie, your resons for presriing n unliense meiine. Informtion for ptients out the liene for their meiines 71 You must give ptients (or their prents or rers) suffiient informtion out the meiines you propose to presrie to llow them to mke n informe eision. 72 Some meiines re routinely use outsie the terms of their liene, for exmple in treting hilren. In emergenies or where there is no relisti lterntive tretment n suh informtion is likely to use istress, it my not e prtil or neessry to rw ttention to the liene. In other ses, where presriing unliense meiines is supporte y uthorittive linil guine, it my e suffiient to esrie in generl terms why the meiine is not liense for the propose use or ptient popultion. 27 You must lwys nswer questions from ptients (or their prents or rers) out meiines fully n honestly. The presriing forms prt of properly pprove reserh projet. 70 When presriing n unliense meiine you must: e stisfie tht there is suffiient eviene or experiene of using the meiine to emonstrte its sfety n effiy tke responsiility for presriing the meiine n for overseeing the ptient s re, monitoring, n ny follow up tretment, or ensure tht rrngements re me for nother suitle otor to o so 27 The Meiines for Chilren leflets on unliense meiines proue y the Royl College of Peitris n Chil Helth/Neontl n Peitri Phrmists Group Stning Committee on Meiines my e helpful in explining to hilren n prents why suh prtie is ommon in ring for hilren. The British Pin Soiety pulishes Using meiines eyon liene: Informtion for ptients. 73 If you inten to presrie unliense meiines where tht is not routine or if there re suitly liense lterntives ville, you shoul explin this to the ptient, n your resons for oing so. 74 You shoul e reful out using meil evies for purposes for whih they were not intene. Sports meiine 75 You must not presrie or ollue in the provision of meiines or tretment with the intention of improperly enhning n iniviul s performne in sport. This oes not prelue the provision of ny re or tretment where your intention is to protet or improve the ptient s helth. Pulishe Jnury 2013 Cme into effet Ferury 2013 Upte Deemer Generl Meil Counil The GMC is hrity registere in Engln n Wles ( ) n Sotln (SC037750) Coe: GMC/GMPiP/