ANNEX B

SUMMARY OF REPLIES TO CONSULTATION MLX 284 – SUPPLEMENTARYPRESCRIBING (SP)

Key: IP = independent prescribing IP-er = independent prescriberSP = supplementary prescribing SP-er = supplementary prescriber

REPLIES FROM MEDICAL COLLEGES/BODIES/INTERESTS

The Royal College of Paediatrics and Child Health were supportive of proposal that range of drugsshould not be limited - particularly inclusion of unlicensed medicines for paediatric care - althoughthey felt strongly there must be paediatric input to the training programme if SP-ers are prescribing inthis area. They were disappointed with the exclusion of CDs as those included medicinescommonly used in analgesia (eg rectal diazepam which is used to terminate convulsions). Collegecan't form a view on the information provided whether proposed training would meet the needs ofindependent and SP-ers. Voiced various concerns about whether training is generic or within adiscipline, if nurses will be taught diagnostic skills in relation to the independent prescribing elementof training and who will assess their competency to prescribe in a particular area. Wondered if anythought had been given to specialist input to drafting of “exemplar care pathways” to form thepartnership between independent and SP-ers. Assume that a clinical management plan won't bewritten each time there is a new partnership for a condition but it is more likely there will be a singledocument photocopied and signed with the patient's details included. In that case would make senseto draft plans in consultation with a relevant expert to ensure consistency.

The Royal College of Physicians – Edinburgh- considers that proposed timescale for introductionof SP seems remarkably hasty. To maintain patient safety, substantial training would be required toimplement this initiative and this resource is not currently in place. Need to recognise costs of locumcover and the time spent on development of the agreed clinical management plan. Other issues aboutwhich there is uncertainty is the level of experience required for SP-ers and professional indemnitycover for extra responsibilities. SP characteristics should be enshrined in the clinical managementplan. Considers the range of medicines should be broad. Although supporting the exclusion ofunlicensed medicines (outside paediatric care) and controlled drugs, they comment that this maycause difficulties where powerful analgesia may be required and eg dermatology where SP would besuitable. Clear that relationship between the independent/SP-er will be extremely important to thesuccess of the arrangement. The clinical management plan will be key to success but impractical totailor to individuals and think a better model would be an arrangement similar to a PGD but withmore freedom for the actions that can be taken under it. For arrangements for teams, the Collegeargue that it might be safer if more than one IP-er had helped frame the plan. In hospital, applicationof this development should be relatively easier than in general practice. Changes of IP-er should notbe a problem if there is a clear robust clinical treatment plan - the new IP-er would be free to decidewhether or not to sign up to it. Any system introduced should, with suitable safeguards, be applicableto all health care establishments whether in the private or public sectors.

Proposals cause some anxiety for the Royal College of Physicians ( London ) about need for co-ordination with nurses and pharmacists over extension of prescribing rights. Practice should bereviewed periodically. Norms will develop as to how often the IP-er should review depending on thecondition. Feel these reviews are important and not provided for in the MLX.

The Royal College of Pathologists consider that, if implemented as proposed, SP should not lead tounnecessary prescribing of drugs, such as antimicrobials although this remains a concern. Theimpact of SP-ers needing advice and support outside the prescribing partnership must be assessed andcatered for. Excluding use of drugs for unlicensed indications is a problem in Haematology -particularly in relation to paediatrics. Few of the drugs used to treat leukaemia have gone through

the approval process but are now widely used and accepted. Would accept nurses who are part of theteam caring for these patients to prescribe these drugs. Could be useful for CDs to be included -examples of where they may be used include sickle cell disease, aspects of haemoplilia care andpalliative practice.

The Royal College of General Practitioners considers there should have been pilot sites where SPcould have been monitored and any potential problems dealt with before wider rollout. Feels thattake-up of SP will be handicapped by initial time and effort needed to draw up management plansand model plans might be helpful. Have anxieties about inclusion of unlicensed medicines, even forpaediatrics. But would welcome inclusion of CDs for palliative care nurses and pharmacists involvedin drug addiction therapy under a three way agreement (GP, community drug team and pharmacist).Will there be guidance on when SP is appropriate and in what settings? How will arrangements bepoliced? Concerns about SP-er altering or stopping medication and whether they are likely toholistically review prescribing. No detail given of their role in monitoring or review of long termmedication. Not clear from MLX who carries responsibility for prescribing - SP-ers should havesuitable indemnity arrangements in place. Lack of detail in the MLX surrounding training forpharmacists and preparation for IP-ers. Arrangements for teams should be on a named basis only toensure the patient is known to those professionals involved.

From the family planning perspective, the Royal College of Obstetricians & Gynaecologistsconsiders SP will be unworkable if new agreement must be reached when responsibility for thepatient moves to another IP-er. Family Planning clinics, especially in outreach settings, rely heavilyon PGDs and it is essential that this mode of dispensing contraceptives is allowed to continue.

In their reply the Public Health Laboratory Service Board have assumed that the proposals will notgenerally apply to antibiotics as they are used in the short term. Longer courses are unusual except inconditions such as TB which is managed under careful supervision. On this basis, they do not viewSP as impacting on the area of work with which they are concerned.

Concerns of the Specialist Advisory Committee on Antimicrobial Resistance centre around thepotential for both long term and unnecessary prescribing of antibiotics which might occur if theproposals are adopted as they stand. SACAR initially believed there are few instances where SP isappropriate for antibiotics. Subsequent to that reply, the Chairman of SACAR met the Chief NursingOfficer to discuss nurse prescribing. The Chairman confirmed that he has fewer concerns aboutsupplementary prescribing, as opposed to independent nurse prescribing, since antibiotic therapy isusually short term, but understandably wishes to reduce prescribing of antibiotics - particularly inprimary care.

The British Medical Association is generally supportive of extending prescribing rights to nursesand pharmacists but consider the proposals have serious drawbacks which could discourage manydoctors from taking part. The requirement to produce individual clinical management plans andconduct joint clinical reviews would substantially increase a doctor’s workload. This would be seenas a retrograde step at a time when many practices have devolved regular reviews of patients (with egasthma or hypertension) to practice nurses. Issues of accountability need to be considered in moredetail as there is enormous potential for conflict if things go wrong. Suggestion that more than oneIP-er might be involved will increase the risk of accountabilities being confused. Accessing andupdating records will be difficult until electronic systems are in use. Training proposals have seriousfunding and workload implications but, assuming content is appropriate, it is logical for nurses toqualify as both independent and SP-ers. MLX raises question of the extent SP-ers will take onbudgetary responsibility for prescribing and how budgets between them and IP-ers will be allocated.The BMA do not support principle of keeping prescribing and dispensing separate – dispensingdoctors have shown it is feasible to combine both roles. The BMA believe nurses with specialisedskills (eg palliative care, family planning) should be recognised and could include independentprescribing rights or to a higher level within a general protocol within their specialisation. This

would be preferable to developing individual management plans. The BMA accept the proposals onrange of medicines. They believe one of the main objectives of the proposal is to reduce GPs’ routineworkload associated with repeat dispensing and feel this could be achieved in a more straightforwardway by allowing repeat dispensing for specified periods of authorisation.

The Dispensing Doctors' Association have numerous concerns about the proposals. Consider therequirement to produce individual clinical management plans is an awesome task and can't see howthis will save time for the IP-er. Requirement for good communication channels only practicable forhealth professionals working from the same premises. Sharing and updating the patient record willbe problematical. There are also accountability issues and profound budgetary implications.Consider delegation of repeat dispensing to be a more attractive solution to the workload issue.

The Faculty of Pharmaceutical Medicine agree that SP should apply to non-NHS healthcareproviders. Consider that management plans would be facilitated by computerisation of nurse records,and that patients should need to give good reasons for refusal to participate in SP arrangements.Agree proposed categories of medicines and supports nurse reporting of ADRs, but feel it should bemade clearer if CDs are going to be included or not at a later stage. With regard to prescribing inteams, since continuity of care cannot be guaranteed, essential to define agreements between namedindependent and SP-ers within an agreed management document for any given patient. Endorseimportance of training and the importance of involving individuals with expertise in evidence basedmedicine and/or clinical pharmacology in this process.

The Faculty of Dental Surgery view the success of the proposal as highly dependent uponimplementation of a common electronic patient record. In addition, it will be significantly influencedby the access that the SP-er will have to that electronic record. In relation to the input of patient datathere is a potential problem regarding entry from multiple sites where a patient may be prescribedpreparations by several different individuals. Currently the dental practitioner is not part of anational electronic network and there is, therefore, a danger that the patients record will be deficientin this respect. It is essential that there is a robust mechanism for reporting of any adverse incident inrelation to the amended arrangements for prescribing. There is a general concern within the Facultyabout the overall responsibility for the patient and the prescribing process. It is essential that theprime responsibility of the clinician responsible for the patient is clearly defined.

The British Pharmacological Society agrees proposed legislative arrangements and characteristicsof SP but questions if it will be possible to provide patient specific plans and whether it is necessaryto obtain the patient's written agreement to management by the SP-er? Considers the range ofmedicines should be broad. Although supporting the exclusion of unlicensed medicines (outsidepaediatric care) and controlled drugs, they comment that this may cause difficulties where powerfulanalgesia may be required and eg dermatology where SP would be suitable. Clear that relationshipbetween the independent/SP-er will be extremely important to the success of the arrangement. Theclinical management plan will be key to success but impractical to tailor to individuals and think abetter model would be an arrangement similar to a PGD but with more freedom for the actions thatcan be taken under it. [NB: same comments as RCP– Edinburgh] Considers it more efficient toinclude nurses and pharmacists on the same course and recommends SP-ers should have theircompetency recorded on the relevant professional register.

The British Association of Dermatologists is unclear if the clinical management plan will be ageneric plan or unique to an individual patient but should include a specific section on potential druginteractions. Agree the proposals for restricting unlicensed medicines to paediatric use. Guidanceshould point out that BNF "less suitable" products are listed as such because evidence of efficacy ispoor or absent and the issue should be kept under review. On prescribing partnerships, suggest thatthe supervising consultant/GP etc is named with the addition of something like " any appropriatelytrained doctor deputising for him or her". The statement that the IP-er is responsible for keeping theclinical management plan up to date may be unrealistic in many circumstances. If a failsafe system is

envisaged, it should be described together with the IT and manpower requirements needed to make itwork. IP-er should resume responsibility for the patient at their request or that of their carer. SP-ersshould only prescribe within their area of competence. Asks who will train the SP-ers and what willthe training comprise - would it allow prescribing in all areas or only in those where appropriatetraining can be demonstrated? Feel strongly that completion of the programme for SP should notallow nurses and pharmacists to become IP-ers.

Task Force on Medicines Partnership [NB: organisation supported by the DH]The arrangements must recognise the centrality of the patient as a partner in agreeing and owning theclinical plan. Patient (or carer, parent) should sign and hold a copy of it. The plan should be writtenin language that the patient can understand. The introduction of shared electronic patient recordsshould be accelerated but in the meantime paper-based patient held solutions must be deployed.Need to increase the flexibility of the arrangements so that so that patients' access to prescribingconditions is not restricted to the individual signatories to the plan, ie proposals should reflect realityof clinical practice in that care is increasingly based on a number of clinical team members. Seeproposals as an opportunity to provide training and support for new prescribers to implementmedicines concordance. Concordance being a new approach to putting patients' views at the centre,involving them as partners in prescribing decisions and supporting medicines taking.

The Royal College of Ophthalmologists and the Medical Protection Society supported theproposals without further comment.

Note: two further replies were received on a confidential basis.

REPLIES FROM PHARMACY COLLEGES/BODIES/INTERESTS

The Royal Pharmaceutical Society of GB believes there is considerable enthusiasm for SP and thatthe Health Departments should ensure that SP is taken forward and adequately resourced in anintegrated way within the wider context of NHS development in relation to, for example, shared andelectronic records. Considers word ‘responsible’, in MLX definition of an IP-er is unnecessary in thecontext of a professional partnership in which both participants accept responsibility for patient care.Also, the definition does not need to include possible clinical situations, as this could imply that otherappropriate service developments should be excluded. The RPSGB disagree with the principle thatprescribing and dispensing of medicines should be kept separate. All prescribers must have access tothe patient’s clinical and medication records and the use of patient-held records would ensure that thepatient consented to the transfer of information between prescribers. Patients who do not wishinformation about their medical state to be accessible to SP-ers may prefer to remain under the solecare of the IP-er. Individual patients must agree to prescribing arrangements. The Society supportproposals relating to range of medicines and also wish to see CDs included. They agree summary ofresponsibilities but view the restriction of SP to partnerships of one named IP-er and one named SP-er as incompatible with continuing patient care and would severely limit the usefulness of SP topatients, professionals and the health service. The Society is pleased to note that the Department ofHealth has commissioned the National Prescribing Centre to develop a competence framework forpharmacists based on the current nurse prescribing competence framework. Envisages that theprofessional partnership between independent and SP-ers will be mutually supportive and thattraining for this role will be undertaken jointly. Likely that the same core training will be needed forindependent and SP and that the introduction of extended prescribing offers exciting opportunities formultidisciplinary education and training in the core modules. Assume that pharmacists willultimately undertake independent as well as SP - in response to that extension of practice ofpharmacists, the undergraduate course and pre-registration programme will incorporate the necessaryadditional knowledge and skills required.

The Paediatric Chief Pharmacists Group consider the proposals should include discontinuation ofmedicines by SP-ers and should clarify the need for regular review of the management plan. Theyagree there should be no restriction on the range of clinical conditions provided all parties are agreed.Consider it important to include unlicensed medicines for paediatrics but mention there are also otherpatient groups [NB: unspecified] for which this important. Believe changes to Misuse of DrugsRegulations should be pursued to allow inclusion of CDs. Training for SP-ers will need to be morecomprehensive as the range of medicines involved is wider than those available for independentnurse prescribers.

The UK Psychiatric Pharmacy Group agree that in many care environments prescribingresponsibilities are shared amongst teams and it would be restrictive to limit the relationship to oneindependent and one SP-er. Consideration should be given to permitting SP-ers to order specifiedmonitoring tests for ensuring patient safety. Access to patient notes by SP-ers is of paramountimportance. Support inclusion of unlicensed medicines. Definition of SP should reflect that bothtypes of prescriber are responsible for their professional activities. Prescribing and dispensing shouldbe kept separate but this may not always be possible in the hospital environment. Also, in samesetting, the Group believe the written clinical management plan is contained in the patient's casenotes and prescription. Suggest that training for independent/SP-ers takes place together to faciliateearly co-operation and support.

The Pharmaceutical Services Negotiating Committee supports the proposals. They believe theprinciple that prescribing and dispensing responsibilities should be separate is flawed. Fully agreethat patient safety and governance are vital but, in PSNC’s view, there are no principles of patientsafety and governance that are met only by separation of prescribing and dispensing responsibilities,in respect of SP. Suggest the clinical management plan refers to the patient’s specific condition, or

conditions, to ensure that a single clinical management plan could apply for a patient with forexample, asthma and hypertension, if this was considered wise by the independent and SP-er. Alsobelieve it would be wise to ensure that a clinical plan can provide for SP-ers to prescribe non-medicinal items, such as support hose. Accepts that Community pharmacy businesses are of coursetreated as businesses for the purposes of the RIA, but see no ground for treating the pharmacist assuch, distinguishing him or her from other health professionals. The business operation within whicha professional practises must be distinguished from the professional’s practice.

The UK Clinical Pharmacy Association queries who takes responsibility for using a medicineoutside its SPC (especially if treatment fails). Is this the IP-er for choosing it or the SP-er forcontinuing supply or is it joint responsibility? Agreement between independent and SP-ers must bebased on the acceptance of equal ‘standing’ of both health professionals involved in the decisionmaking. MLX implies the IP-er would inform the SP-er of the limits of their responsibility shouldthis not be a discussed agreement? Responsibility for clinical management could pass to anotherhealth professional and how would lines of responsibility be established? Professional responsibilitywould be taken for your personal decisions but defining the line may be difficult. Access to patienthealth record is essential and must allow chronologically accurate data entry by SP-er. Queries howthe principle of separating prescribing and dispensing responsibilities will impact on the manpowershortages already in health care. From a risk management point of view if the pharmacist prescribes,who will do the clinical check? Suggest management plan could follow “care pathways” for specificconditions rather than centre on individual patients unless patients fall outside these pathways. Couldthe undergraduate degree or clinical diploma already count towards some of the training programme?Asks if the Centre for Pharmacy Postgraduate Education (and equivalents in Wales and Scotland) orthe College of Pharmacy Practice are going to have any role. UKCPA would be interested in beingpart of the training. Also, if a 25-day training course is sufficient to train a nurse to become a SP-erwhat about hours already undertaken by pharmacists in training?

The College of Pharmacy Practice [cross refers to replies from Neonatal and Paediatric PharmacistsGroup (NPPG) and The Board of the Faculty of Prescribing and Medicines Management] endorsesNPPG’s view that use of unlicensed medicines in paediatrics is necessary if there is no suitablealternative. Emphasises that it is essential for community pharmacists involved in prescribing to haveaccess to the patient record. Queries proposals to facilitate this shared access as continued failure toaddress the exclusion of community pharmacy from NHSNet means the exclusion of significantresource to carry through the objectives of SP. Unless startlingly rapid progress is made here throughthe NHS, this sector will presumably have to bear the large costs of electronic links and equipment totake part in this advance. Considers circumstances and range of medicines available to independentnurse prescribers is significantly narrower than those same aspects of SP. Notwithstanding that SP is“dependent” on initial prescribing by a doctor or dentist, believe there will have to be a substantialexpansion of the clinical pharmacology component of SP-er training for nurses to ensure patientsafety. Far too early to judge whether extended formulary training would support both independentand SP for nurses. Considerably more awareness of the legal framework for medicines supply shouldbe included in the basic training of nurses if they are to anticipate a major prescribing role in thefuture. Conversely, areas of patient advocacy, psychology of prescribing and working in a teamcontext may need to be emphasised for the training of pharmacist SP. Training must be properlyfunded and available to community pharmacists. The College has experience in accreditation oftraining and would be happy to get involved in this for SP-ers. The College would welcomeassurance that the MCA will be collaborating with inspectors of the Royal Pharmaceutical Societyand that their monitoring, etc will extend to hospitals, clinics and GP surgeries to support and achieveSP compliance.

The Faculty of Prescribing and Medicines Management consider that the definition of SP shouldinclude a stronger reference to the patient as a true partner in any agreement about the care providedto them. Essential there is a clearer definition of what constitutes an agreed management plan as wellas a way of ensuring the quality and consistency of plans at local level. Clinical management plan

should be drawn up with the patient’s full involvement and written agreement. Joint clinical review isessential and if this does not take place then the arrangement for SP should cease. Patient safety andthe quality of care provided may well be compromised if prescribing continues without anappropriate review. Difficulties in defining and implementing medication reviews in older peoplefollowing the publication of the NSF suggests that guidance on the content of the agreed managementplan might prove helpful to avoid inappropriate variations. The updating of records, transfer ofpatient-sensitive materials and confidentiality of information must be an essential part of the SPagreement. Any plan must include an unequivocal statement of whose responsibility this is and whowill be accountable for its implementation. The Faculty is concerned at separating prescribing anddispensing because this may run counter to intention to provide quicker and efficient access toservices. Might also mean that opportunities for community pharmacists to enter into SPrelationships are restricted. Instead suggest appropriate quality control and monitoring systemsshould be in place. SP should provide the widest range of services for patients and eg medicatedwound dressings and antifungal mouthwashes are an example of POMs where it would be entirelyappropriate for a pharmacist to be a SP-er. The need for a new management plan if the patientdecided to use a different pharmacy/pharmacists as part of any SP relationship raises questions re:access to records and confidentiality; also are arrangements needed to prevent a patient entering intoparallel arrangements with different IP-ers and SP-ers? Where unlicensed medicines are to be used,the patient should be clearly informed and the SP-er appropriately indemnified. For paediatric care itis essential that in the management plan there is the facility for consultation with specialists andinformation on what to do if there are supply issues with unlicensed medicines in paediatric cases[NB: under the Marketing Authorisation Regulations, unlicensed medicines must be ordered by adoctor or dentist and for use by his individual patients on his direct personal responsibility and aresubject to certain conditions]. Supports use of BNF “less suitable” if justified and also supports nurseprescribing of ADRs. Asks if hospital physicians can have an arrangement for SP with pharmacists ornurses in the community? Some long-term medicines, such as anti-rejection agents, those requiringspecial monitoring or where other shared care agreements are already in place are prescribedexclusively by hospital physicians. This needs to be recognised. Competency to prescribe must beheld on a relevant register and regularly updated. There may need to be additional requirements forthe SP-er to be registered with the host Primary Care Trust (to cover such issues as stolenprescription pads, drug recalls, clinical governance arrangements etc)? Faculty considers there areseveral issues still to resolve such as who arbitrate if there is an ethical conflict between theprescribers, the use of antibiotics and whether any issues exist in respect of appliance contractors oroxygen therapy services [NB: latter comment not expanded]

The Guild of Healthcare Pharmacists supports principles of SP and in particular, think it right thatprescribing and dispensing responsibilities are kept separate. Keen that proposals workable inpractice eg a legal requirement for a pharmacist to check there is a prescribing partnership couldresult in considerable difficulties in dispensing prescriptions from SP-ers. Possible solution is toinclude requirement for the SP-er to be registered. Level of competence should be the same for allprofessions. Suggests patient held records might be a solution where there are difficulties inaccessing a common patient record and believes where access is inadequate, SP should not beintroduced. A risk assessment for SP should be undertaken where patients have multiple conditions toensure SP has sufficient background knowledge of various presenting pathologies to prescribe safely.Quotes other areas where SP could be appropriate - eg hospital pharmacists adjusting doses wheredrugs have a narrow therapeutic index. Consider there should be some use of Black Triangle drugs inthe organisation before allowing use by a SP-er. Consider there may be probity issues for communitypharmacists which might be difficult to control eg prescribing drugs that are not strictly necessary(similar to dispensing doctors). Consider CDs should be included – particularly Schedules 4 and 5. Inhospital setting clinical management plan might be the “care pathway” contained in the patient’snotes or an adapted protocol. DH guidance might include what is deemed to constitute such a planas well as a best practice document. In hospital setting might not be feasible for the plan to be signedby two individuals but it should be clear who is responsible for the patient at any given time.Concerns that the time spent by IP-er in meeting SP requirements may exceed the time that person

would have spent on prescribing. Considers there should be a standard competence framework fornurses, pharmacists and eventually other professions.

The British Oncology Pharmacy Association agree that prescribing and dispensing should be keptseparate. Agree proposals for range of medicines but feel unlicensed medicines should be includedfor cancer and palliative care patients and would also support inclusion of CDs. Thinks it should bepossible to have a prescribing partnership with more than one IP-er in the same way that thepartnership now exists within a medical prescribing team. Believes training should be the same forall potential prescribers. Arguably, SP should become the first step towards independent prescribingas it requires relatively close supervision of one prescriber by the other.

The Co-operative Pharmacy Technical Panel views all pharmacists as potential SP-ers and wouldlike to see training incorporated in the degree course. Concerned with the principle of keepingprescribing and dispensing separate and wish to ensure that this is not a barrier to communitypharmacists becoming SP-ers. Believe separation is easily achieved in community pharmacies.Agree with other principles set out in the MLX. There is a role for a prototype plan to ensure allrelevant information is included and presented in a common format. Has concerns about ensuringaccess to patient notes and need to find a way of achieving this as well as means of updating notes assoon as possible after consultation with the patient. One suggestion would be use of patient heldrecords. Agrees proposals for range of drugs. Believe instances of BNF “less suitable” drugs beingincluded will be small as the management plan will be drawn up with regard to the principles ofevidence based medicine. Agree roles/responsibilities but would like to see some emphasis on themutually supportive role of both parties. Panel would welcome training programme to includevarious other training media, eg distance learning and computer based training as well as face to faceinteractions.

The Pharmacy Community Care Liaison Group considers that the legal requirements needthought to ensure community pharmacists are able to dispense prescriptions without too muchbureaucracy, eg difficult for them to check if a partnership existed between the independent and SP-ers. Agree that prescribing and dispensing responsibilities should, where possible, be separate, butthis is likely to exclude the majority of community pharmacists. SP could facilitate repeat dispensingby community pharmacists for patients with chronic conditions within agreed management plans butthis cannot occur if the pharmacist prescribes as a SP-er and then dispenses for the same patient. It isessential that independent and SP-ers must share access to, consult and use the same common patientrecord, but how will this come about as community pharmacists appear not to be included in plans toaccess electronic records via NHSnet. Supports the view that SP should not be restricted to specificclinical conditions, but consider that guidance will be needed as to what is more suitable for thearrangement, and to cover various conditions where patients have multiple pathologies. Supports theproposal not to restrict the range of medicines provided the SP-er is fully knowledgeable andunderstands the implications of prescribing outside licensed arrangements. Suggest that the reasonfor prescribing unlicensed medicines for paediatric care, black triangle drugs and “less suitable” BNFproducts should be discussed with the patient/carer and documented in the clinical management plan.Wish to see inclusion of CDs. There is concern about the potential for fraud, e.g. with care homeswhere both nurses and pharmacists may be involved, for example, with prescribing, ordering,receiving and administering medicines. In hospitals, suggest that clear accountability at consultantlevel will be necessary with documented transfer between specialties. The situation also needs toreflect arrangements in general practice where several IP-ers may be responsible for the patient’s carewithin the duration of the management plan. The level of competence in how to prescribe should bethe same for all prescribers as well as the level of knowledge of the pharmacology of the area, egdiabetes, in which a professional is to prescribe. This means that training requirements will differconsiderably between professions.

The Neonatal & Paediatric Pharmacists Group [cross reference to this reply by College ofPharmacy Practice] stress that the mechanism for recording clinical management plans are defined

more precisely and that there should be some way of defining and using established “pathways”agreed at local or national level . The Group (as per the Royal College) accept informed use ofunlicensed and off-label medicines is necessary in paediatric practice when there is no suitablealternative. The national paediatric formulary ‘Medicines for Children’ provides accessible soundinformation and guidance and is an authoritative statement of paediatric therapeutic practice in thiscountry. It should be recommended in any new legislation [NB: better placed in guidance?] as anessential source of information when prescribing for children. The group see no reason to excludeblack triangle medication and recommend that nurses should be able to formally report adversereactions in the same way as pharmacists and doctors. In hospital setting, consider an individualpatient should have one lead consultant under whom they were admitted and it should be that IP-eronly that is able to implement the clinical management plan. With regard to training it is importantthat the training of all professionals is multidisciplinary. The nurses training should be the same forindependent and SP. SP should ideally be carried out by "specialists" in an area. This is particularlytrue of paediatric prescribing which is understood to be a specialist area and an area of high risk.Suggests that the Faculty of Neonatal and Paediatric Pharmacy (FNPP), part of the College ofPharmacy Practice would be the appropriate body for training pharmacists for SP for children. Ifcourses are to be general then they must contain adequate paediatric content if they are intended to fitnurses and pharmacists for SP for children. It may certainly be appropriate to have specialistpaediatric training courses when SP for children is to form the major part of the work of a SP-er.

Although the Pharmacy Substance Misuse Advisory Group see the exclusion of schedule 5 CDs asa positive step towards preventing substance misuse, the exclusion of these products also means thatpharmacists and nurses will be prevented from prescribing pain killers. Also, the SP proposals wouldmean that pharmacists are able to legally supply Schedule 5 CDs to paying customers yet notprescribe them as SP-ers to those unable to pay. We would support discussions with the Home Officeand the Advisory Council on the Misuse of Drugs to clarify this situation. In addition, we recognisethat SP could have a major role in areas such as palliative care, drug dependency and pain controlwhere Schedule 2 to 4 drugs are commonly used. An early review of Schedule 2 to 4 drugs istherefore necessary otherwise a vital opportunity may be lost. If restrictions on CDs under SP applyto all Schedules [NB: yes, they do], this would obviously exclude too many drugs (eg. co-proxamol,codeine, temazepam) which would be very unhelpful indeed. PharMAG supports exclusion ofunlicensed medicines (outside paediatric care) but recognise that, in practice, it may well beunworkable to exclude unlicensed drugs or drugs for unlicensed indications. Identifying such drugs atthe point of prescribing is very difficult and they are used far too widely to restrict them in practice.Important to inform patient if an unlicensed drug is being given. In such cases, and includingprescribing unlicensed medicines in paediatric care, the clinical management plan should clearly statethe liability of the SP-er and others in such situations. Asks if the SP-er is responsible for acceptingclinical responsibility and professional accountability for their prescribing decisions and practice inrelation to unlicensed medicines. Recommends SP-er’s responsibilities includes changing frequencyand dose of medication as in practice, this is more likely to occur than a change to actual drug,especially in the field of drug dependency. Supports proposal that all SP-ers should report ADRs, notonly those arising from black triangle drugs. Concerned that products currently suggested by theBNF to be “less suitable for prescribing” may be included in SP - if a product is less suitable forprescribing then surely it must be so for both independent and SP? Recognises that the relationshipbetween individual independent and SP-ers will be key to safe and effective SP. Greater involvementof clinical pharmacists could assist the effective introduction of such partnerships into hospitals.Guidance required on the format for the clinical management plans to avoid duplication and ensuresome consistency.

The Pharmaceutical Advisers Group consider that SP could be extended to other professionals butthat the range of drugs may need to be limited to those appropriate for a particular profession.Communication would be enhanced by electronic records or, for now, patient-held records. Supportsthe separation of prescribing and dispensing wherever possible. Agree with proposals relating torange of medicines - apart from unlicensed products which should be avoided wherever possible.

Helpful to move towards inclusion of CDs. Good practice to exclude BNF less suitable drugs. Theclinical management plan should allow adherence to more general care pathways and could becreated from existing documents adapted to include individual patient factors. Ideally, should be asingle patient record. Potential for a patient to have more than one SP-er should be avoided. Thereshould be agreement among teams so there is no confusion for a SP-er working for more than one IP-er. Division of responsibilities between the two prescribers seems appropriate provided there isclarity over frequency of review. Partnerships should be voluntary. Important that patient recognisesall as prescribers - the supplementary/independent tags may not be helpful in the long run.On training, essential for this to include input from doctors and pharmacists. Makes sense for nursesto qualify as both independent and SP-ers. Conflicting concerns about whether extended nurseprescribing and SP require the same level of training. It would be valuable for nurses andpharmacists to train together as soon as possible. Regulatory Impact Assessment suggests thatcommunity pharmacies would have to bear the costs of training etc, rather than the NHS, and thiswill be a limiting factor to the expansion of SP to community pharmacists. Also, thinks it likely thatlocum costs are underestimated.

The National Pharmaceutical Association believe that the proposals are likely to be applicable toall other healthcare professionals. They are concerned that the definition of SP is too detailed andmay prove unnecessarily restrictive in practice. Consider that all registered pharmacists should beconsidered as potential SP-ers from the outset and proposals should be implemented at the same timeas nurses. Endorses principles of SP, apart from separation of prescribing/dispensing which willinhibit the SP role for pharmacists. Does not think the principle of the independent and SP-er needingpreparation before entering a prescribing partnership is a true ‘principle’ that should underpin SP.Points to difficulties in accessing GP records and consider the ideal solution would be for patients tocarry smart cards. However, as this is not likely to happen in the near future suggest that currentmodel of patient-held notes should be introduced for those patients who elect to have their caremanaged by a SP-er. Agrees with the recommendation that SP should not be restricted to a specificlist of clinical conditions. Similarly, the NPA supports the proposal that the range of medicinessuitable for SP should not be restricted. Providing both the independent and SP-ers agree the use ofan unlicensed medicine, or of a medicine outside its licensed indications or dosage, then this shouldbe acceptable practice. CDs should be eventually be included as medicines suitable for SP. Variousquestions about what will constitute a clinical management plan and advises that SP partnershipsmust have some flexibility built in to allow for absences such as holiday, sickness, professionaldevelopment and so on.

The Association of British Pharmaceutical Industry consider that only competent health careprofessionals should undertake SP, having been educated to an appropriate level followed by regularperiods of assessment to evaluate their effectiveness and efficiency in these new roles. Concerns thatthere may be a potential conflict of interest, for community pharmacists in particular, indemonstrating probity and transparency. Community pharmacists generate revenue by trading inmedicines and they have to balance both professional and commercial responsibilities. This potentialconflict of interest must be both recognised and addressed. There is a practical problem where thesharing of records and other relevant information is not currently possible within the primary careenvironment. It is easier to envisage the proposals for SP being implemented in certain hospitalclinical environments than in primary care as organised today. It will be essential that patient recordinformation is shared with relevant parties, with mechanisms in place to keep that information up todate and accessible. There are no proposals in the MLX as to how this will be accomplished in theabsence of electronic patient records. It is vital that the principles of partnership with patients inprescribing decisions are recognised from the outset and that when defining the detailed roles ofindependent and SP-ers the central role of patient is not overlooked. It is perhaps of concern thatMLX 284 does not offer any proposals as to how patient involvement and engagement will beensured. Questions how health care professionals are to know when they reach, and risk exceeding,their level of competence. In areas of chronic treatment, GP contact with patients is likely to lessen asnurses and pharmacists take on SP. Systems must be in place to ensure that an appropriate standard

of GP-patient contact and review are maintained for chronically ill patients. ABPI considerstherefore that SP should be introduced once these difficulties have been resolved and agrees that SPshould not be extended to other health professionals until experience is gained with nurses andpharmacists. Important to define ‘clinical management plan’, otherwise will lead to wideinterpretation, even allowing for tailoring for individual patient. Supports proposals for range ofdrugs (ie exclusion of CDs, unlicensed medicines apart from paediatrics, inclusion of BNF lesssuitable products) and supports nurses reporting of ADRs. Important that there are clear lines ofprofessional accountability and that protocols are developed to deal with any incidents that mayoccur. Possible perception that SP is being performed by professionals that are less well qualifiedthan are doctors. In an increasingly litigious environment it will be essential for SP-ers (and IP-ersinvolved with SP) to have legal opinion on the appropriate professional indemnity cover. Trainingmay be best tackled under specific chronic diseases and prescribing limited to those medicines usedin the disease in question.

The Proprietary Association of Great Britain’s comments are mostly related to the NHS Planrather than the proposals in the MLX; they support inclusion of BNF “less suitable” products.. Thereply from the Prescription Pricing Authority covered issues outside the scope of the consultation.

REPLIES FROM NURSING COLLEGES/BODIES/INTERESTS

The Royal College of Nursing’s long held policy is that nurses with specialist competencies, havingbeen adequately prepared through a specific educational programme, should be able to prescribe anyproduct required to meet the care needs of their patients. They believe that if any nurse who neededto prescribe was educated to do so and given access to a wider formulary – akin to the BNF – then SPwould be of far less significance. As such, the College’s response to MLX 284 is in the spirit ofmaking the best of a situation deemed appropriate by the DH and which they are keen to develop tomaximum effect for the benefit of patients, rather than what would they consider to be the ideal.Emphasises that their response deals primarily with implications for nurses but supports fullimplementation of SP in all sectors of the health care system throughout the UK. The RCN agrees theproposed definition, principles and criteria but would want independent nurse prescribers to beregarded as IP-ers under SP. Also, the College considers the mechanism for SP to be cumbersome,relating as it does to individual patients. Suggest that as evaluation of SP takes place the possibility ofextending the model to groups of patients with similar presentation and health care needs (as is thecase with PGD) is considered. The RCN welcomes proposal not to restrict the range of conditions.Would wish range of medicines available to SP to be a matter for agreement between independentand SP-er and not restricted in any other way; this principle should also extend to CDs. Agreeunderlying rationale for prescribing partnerships. The proposed responsibilities for IP-ers seemreasonable but RCN questions who the SP-er partnership when patients are transferred from ahospital based clinic to primary care - ie is this with the hospital consultant who made the diagnosisor the GP?. Makes more sense to have the nurse in partnership with the GP who takes overresponsibility for the care of the patient, yet this does not fit with the assumption that the IP-er isresponsible for ‘the initial clinical assessment of the patient and the formulation of the diagnosis”.Propose that the IP-er in the partnership is defined as the clinician having ongoing responsibility forthe assessment and care of any given patient, but need not be the initial diagnostician. RCN agree inprinciple with the need to ensure nurses are specifically prepared as both supplementary and IP-ers.Advocate a model of common training for both subject to their comments on the existing independentnurse prescribing training programme Want to see a much more open attitude to AP(E)Larrangements, particularly as many nurses wishing to engage in SP partnerships will have attendedspecific courses concerning chronic disease management. Essential that IP-ers are fully prepared fornurses’ role in SP partnerships. This preparation should include information about the skills andcompetencies of nurses, and how nurses operate within a professional code of conduct and determinethe scope of their practice. Whilst the RCN would wish to see a more extensive introduction ofindependent nurse prescribing with access to a much wider formulary, they acknowledge SPpartnerships as a step in the right direction. RCN hope that SP is extensively reviewed and evaluatedand that those medicines which come to be used frequently within this model are added to the INPformulary.

Royal College of Nursing - Sexual Health Forum consider the concept of individual managementplans to be too cumbersome and therefore unworkable. Would be more efficient to approve SP-ers towork within a particular speciality with individual contracts specifying which patients and in whichsituations nurses could treat. Outline clinical contracts agreed at national level and fine tuned locallywould lead to standardisation throughout the UK. Welcome extending to other professions butconcerned that this will lead to an overburdened regulatory system. Agrees definition of SP, criteriafor SP, proposals that there are no restrictions on clinical conditions and range of medicines (allmedicines listed in BNF should be included). Do not welcome exclusion of CDs and unlicensedmedicines. Vital that independent and SP-ers can report ADRs on own authority. Foresee problemswith proposal that, if clinician responsible for the patient changes, a new prescribing partnership willneed to be agreed. Finally, consider there should be one training programme to enable nurses tobecome independent and SP-ers.

The Community and District Nursing Association objects to independent nurse prescribers beingexcluded as IPs under SP. Would strongly support inclusion of CDs, particularly for palliative care.

Explains that as district nursing teams function all week there will be different SPs responsible forpatient during that time. Therefore IP may need to be at group practice level and SP held at districtteam level. More efficient if training programmes were closely linked and automatic progressionbuilt into programmes.

In the main the Association for Nurse Prescribing (ANP) feels that SP offers a valuable new optionfor patients. However, they fear a risk of low uptake among clinicians because of eg potentialbureaucracy, too much paperwork or unrecompensed time input for many IP-ers. There must be areal and perceived advantage in bringing in SP where patient group directions, independent nurseprescribing or other informal systems are already in use. Clinical management plans require a levelof support from information technology which is not available to nurses or pharmacists at themoment. On balance the ANP feels that the definition and principles for SP are satisfactory but thinkin the future that others could become IP-ers, such as nurse consultants. On the point aboutprescribing and dispensing responsibilities being separate, the ANP can envisage this conflicting withthe patient's desire for convenience. Consider the clinical management plan should perhaps specifythe names of drugs, or groups of drugs concerned. ANP welcome the proposal that SP should not berestricted to specific clinical conditions. Recognise that unlicensed medicines are widely used inpaediatric care and that good practice may require their use by SP-ers if they are to manage chronicdisease effectively. Would like CDs to be included. Ultimately the principle which underpins allprescribing practice is that the professional should only do it if clinically competent to do so.Essential that there is good communication between the independent and SP-er, which takes accountof the expertise and role of both. All partners should be aware of each other's skills and abilities, andthis includes the patient. Patient-held records would be advantageous and would clearly involve thepatient in the process. Clear referral criteria also need to be agreed and documented. ANP concernedthat there could be confusion if there is more than one named IP-er and if there is disagreement abouttreatment options. Feels that that responsibility should be referred back to the IP-er only inexceptional circumstances. In the normal course of events the SP-er should take full clinicalresponsibility for the agreed plan. There are three important issues to be dealt with under training andpreparation - the level of training, the practicalities of training, and how training for pharmacists andnurses, and for independent and SP-ers will fit together. There should be different elements to theeducational preparation although independent and SP should achieve a similar level of training. IP-er training needs to focus on diagnosis and consultation, but SP-er training needs to focus on issuessuch as: care pathways and chronic disease, clinical responsibility and accountability. The ANP feelsthat SP-er training could provide a good level of background necessary for IP-er course. Ultimatelythere would be huge benefits if prescribing courses included both pharmacists and nurses, and - intime - doctors. This would enrich working relationships and lead to better care. Other points includethe question of whether there will be training for doctors and dentists becoming IP-ers, possibility ofconfusion and mistakes if a nurse is both an IP-er and a SP-er and also administering medicationunder patient group directions [NB: latter point not expanded].

The British Dermatological Nursing Group support extension of prescribing rights to otherprofessions, although identifying an IP-er may not be clear cut for some professions. Consider thatSP-er should only prescribe within identified area of specialist practice. Some concerns that clinicalmanagement plan will have significant time implications for those involved. The plan is similar toPGDs and to avoid confusion feel that the two documents should be made distinctly different. Alsofeel that the plan is too prescriptive and a local agreed formulary would be a more workable, flexibleapproach. Welcome proposal that there are no restrictions on the range of conditions. Wish tohighlight the fact that SP-ers treating dermatological conditions are likely to be regularly required toprescribe unlicensed treatments. Exclusion of CDs hinders work of specialist pain and palliative carenurses. Believe nurses should be able to report ADRs. Essential that the patient understands the planand/or SP and consents to treatment by the SP-er. Patients may not need to be brought back forreview if condition is stable and they ask if the review could be a casenote discussion. Someconcern about relying on close relationship between independent and SP-er because development ofSP will only be achieved if the IP-er is motivated. Need a backup system if a problem arises when

the independent subscriber is absent. Support roles/responsibilities but think development andupdating of the clinical plan should be a joint responsibility. Consider it more cost effective to haveone prescribing course for both independent and dependent prescribers which is standardised andrecordable. Efforts should be made to harmonise training across the devolved administrations.

While the RCN - Diabetes Forum – consider this consultation is another step in the right direction,it fails to recognise that, in many cases, the specialist nurse is already the prescribing expert and notthe doctor. Would like to see firm proposals in place for a prescribing skills escalator leading to twotiers of SP for nurses with appropriate training and experience. Although SP, as proposed in theconsultation, would probably be workable in specialist clinics, where the team is led by a consultantdiabetologist, there may be a shortage of doctors in Primary Care with the expertise required toformulate individual clinical management plans for people with diabetes. Given that the treatmentplan must be agreed in partnership with a doctor, the traditional medical power base will remainunchanged, stifling the full potential of the nursing workforce. There is therefore a real danger thatthe current SP proposal may arrest the progression of the wider prescribing agenda, as there will belittle or no motivation for further change. Nurses would continue to undertake day-to-day prescribingfor chronic diseases, without full recognition of their abilities. Nurses trained as SP-ers could findthemselves in a position where they are required to prescribe, but are unable to develop and agree atreatment plan with their medical colleagues. This would leave them in a very similar position to thecurrent legally precarious situation. The introduction of two tier SP could provide a solution. Once adoctor has made a diagnosis, the higher tier SP-er could devise a management plan independentlywith the patient, and review it as required, only consulting the doctor again if necessary. First tier SP-ers could assist in drawing up the clinical management plan, and prescribe within it, as theconsultation suggests. Believe this alternative proposal would also facilitate the implementation ofthe National Service Framework for diabetes, and enhance patient care.

The Preston Practice Nurse Forum (representing 60 practice nurse) consider the exclusion ofindependent nurse prescribers as IP-ers under SP might limit patient choice and care (eg INP maydiagnose leg ulcer and initiate treatment - no reason why she could not then develop SP managementplan with patient and, say, practice nurse as SP]. Should be standard format for management plans.Range of medicines should be wide. Might be unrealistic for IPs to review annually [eg stable asthmareviewed annually by practice nurse]. Support inclusion of BNF “less suitable” and supports nurseADR reporting. Agrees common training for INPs and SPs but latter needs to be delivered in flexibleway as many GPs will not release nurse for 25 days in one go. Also promotes central funding asmany practices/PCTs will not be able to fund costs of SP.

While the Joint Professional Committee for Nursing, Midwifery and Health VisitingAssociations (England) accepts necessity for clinical management plan, the proposal is proscriptiveand has significant time implications for all involved. No single opinion on including unlicensedmedicines. Supports inclusion of Black Triangle medicines and nurse reporting of ADRs. CDsshould also be included. Some concern that development of SP may only be achieved if there is asupportive IP-er. Need a system to cover absence of the IP-er if only one is identified. Where teamsare involved, suggest a collective of IP-ers could agree a local formulary for the SP-er. To sharepatient records, the patient would need to be reviewed in the same practice/hospital which may berestrictive. On responsibilities of the prescribers, they note that the SP-er should monitor thepatient's progress and are concerned that pharmacists may not have knowledge, experience andresources to make this type of assessment. Support one prescribing course for independent and SP-ersbut raise concerns over time commitment and employees support for such courses. Believe that SP-ers should be able to demonstrate specialist knowledge and skill before prescribing in a specialistarea. Training and practice standards should be harmonised across the UK.

The Royal College of Midwives consider the principles for SP as clear and comprehensive. Theywelcome the proposal not to restrict the range of medicines to specific clinical conditions. Althoughthe consultation does nor relate directly to midwives there is some concern that there could be

restriction to midwifery practice for those midwives working in the secondary care setting because ofthe exclusion of unlicensed and CDs. If CDs are restricted, women’s choice of pain relief in labourmay be restricted. Supports ADR reporting in principle and the early introduction of nurse reporting.Welcomes the proposal of more than one named prescriber. It is envisaged that local arrangementswill be such that there is good partnership working for the safety and protection of the patients. TheCollege would like to see criteria include the need to refer women back to the IP-er when pregnancyis suspected or confirmed.

The Community Practitioners and Health Visitors Association agree the IP-er should be a doctoror a dentist in the first instance. Also agree that independent nurse prescribers should be able tobecome SP-ers. CPHVA envisage that in GP practices and clinics the IP-er would be the GP or clinicdoctor with the SP-er being the clinic nurse or practice nurse. These professionals would have a closeworking relationship and regular communication though the clinical management plan. This may bemore difficult with the pharmacists who do not at present have access to patient records andconfidential information. There are issues of improved information technology to make this happen.Consider that training and preparation, plus locum costs, raise huge financial cost implications.Although agreeing with the principles laid out in the document on SP, consider that in practice thesemay not be workable. Given the ever increasing workload in general practice, will GP's will bewilling to give SP the time it will require?

The RCN Nurse Practitioner Steering Group welcome the advances proposed for SP but feel, inpractical terms, it is fraught with difficulties. Nurses working in General Practice have developed arange of skills both in acute and chronic disease management. More specifically since the GPcontract in 1989 both Practice Nurses and Nurse Practitioners have and continue to take on advancedtraining in the management of Asthma, COPD, Diabetes, Breast and cervical screening, familyplanning and Cardiovascular disease. This training allows Nurses to work with patientsindependently and without recourse to a General practitioner. MLX assumes that nurses areincapable of making a clinical diagnosis. While all are concerned with patient safety, consider it aretrograde step, given the scale of Nurse led clinics, to have to draw up management plans forindividual patients to be signed by the GP. Nurses will prefer to carry on working under PatientGroup Directions or under the current system of getting a script signed as per usual. It would becomeextraordinarily bureaucratic and a legal minefield in terms of the paperwork needed to make itoperational. Many GPs will view it as extra work for which they are not paid and tensions will occurbetween both nurse and doctor. It is inconceivable that when a patient comes to the nurse for acervical smear and requires a prescription for an infected toe that the nurse is required to get thepatient to see a doctor. Similarly if a patient is diagnosed as having asthma by the nurse it isinconceivable that she asks the doctor to make a second diagnosis and then to draw up a managementplan. In essence it would only work for a small group of nurses with no autonomy and who saw veryfew patients. Many nurses are monitoring anticoagulation treatment and make use computer assistedprogrammes to do so (which also highlight drug interactions and contraindications). If IT is used inthis way for a range of conditions there would be no need for management plans. It would be morecost effective for someone to produce a series of programmes incorporating clinical guidelines . Independent Nurse Prescribing is restricted to a limited formulary yet there is little restriction by andlarge on SP. Those nurses who already have undertaken approved courses at University inPharmacology will be somewhat frustrated by this. In relation to prescribing partnerships, it isinconceivable that the medical or nursing professions would have time to subscribe to this. Howeverdo agree with some of the points relating to SP-ers responsibilities. There are circumstances wherethey could see this working - for example Hypertension Monitoring in isolation without otherpathology. This would depend again on the relationship between the IP-er and the SP-er. There is norelationship between dentists and the professional nurse in terms of prescribing and assume thisrefers to a relationship between the dentist and the pharmacist. Anticoagulant monitoring has beenfraught with difficulties because dentists often do not understand the monitoring system. We aresending mixed messages out to patients and there is an assumption because you hold a medical ordental Degree that you are safe to practice.

The Nursing and Midwifery Council have some concerns around resources for the implementationof SP. Wish to see preparation for medical staff role clearly articulated as they are not prepared totrain/supervise other practitioners. Wish to see midwives specified as eligible to be SP-ers. Supportneed to register the prescribing qualification and have decided to make a charge for this from a dateto be agreed. Would like to see guidance indicating implementation dates for England and thedevolved administrations. NMC look forward to working with each of the administrations onagreeing standards for preparation and training. Guidance should specify that the SP-er is a firstlevel registered nurse. Need to consider how to simplify the process of obtaining prescription padswhich may become onerous although practicalities involved in issuing these are for the employingauthority. Welcome the emphasis on patient specific management plans. Support the proposalsrelating to the range of drugs and intention not to restrict SP to particular conditions. Also welcomethe notion of more than one IP-er. NMC sees some advantages to preparing nurses to be bothindependent and SP-ers, enabling them to be deployed in appropriately designated posts.

Sexual Health Working Group of the London Standing Conference for Nurses, Midwives andHealth Visitors feel strongly that Patient Group Directions should remain an option for supply ofmedicines. Proposed principle of keeping prescribing and dispensing separate would be a barrier tonurses as SP-ers. GUM and contraception services are unique in that to protect patientconfidentiality, prescribing and dispensing often occur on-site usually by the same person.Disappointed with the proposal to restrict prescribing of CDs but otherwise agree range of medicines.Believe there should be one training course for independent/supplementary nurse prescribers.

REPLIES FROM PROFESSIONAL COLLEGES/BODIES/INTERESTS OTHER THANMEDICAL, PHARMACEUTICAL OR NURSING

The replies from the General Optical Council and the College of Optometrists explain thatoptometrists are not envisaged as SP-ers unless they are part of a co-management scheme. Bothpress for early introduction of independent prescribing rights for optometrists in line with therecommendations of the Crown report.

The British Dietetic Association is concerned that MLX only relates to nurses and pharmacists. SPfor dietitians would be another quality measure ensuring patient safety when intregrating dietmedication and exercise management. Dietitians and other allied health professionals need to betrained to the appropriate level of competency to undertake their role effectively and efficiently forthe benefit of the patient. No definite views about whether dietitians see themselves routinely assupplementary or IP-ers but some might need to become the latter. Also concerned about uniformityacross the UK as it is imperative that proper standards are maintained. Dietetics is a small, highlymobile regulated profession. There will be a requirement for consistency and uniformity if patientcare is not to be compromised. On principles, need clarification of what is meant by preparationbefore entering into a prescribing partnership and, for dietitians, clarity between prescribing anddispensing. Support all the proposals relating to the range of medicines. Would like to see core careplans set up with scope for individualisation, limits to responsibility agreed and signed, and reviewsconfirmed by the IP-er. Also build in time for multi-disciplinary team discussions for complexpatients and channels of communication to pharmacists. Feel that for doctors, there will be asignificant impact on their workload. Agree with all proposed responsibilities of the SP-er. Trainingmust be accredited.

The Society of Radiographers are disappointed that the proposals only relate to pharmacists andnurses and do not answer the question of how this will impact on the ability of radiographers toprescribe in the future. Consider that appropriate training is available to allow radiographers tobecome both independent and SP-ers. However, letter goes on to imply that radiographers might bebetter suited to an independent prescribing role.

The Society of Homeopaths point out the possibilty that SP-ers might have to prescribehomoeopathic medicines and recommend that, whatever professional is involved, they should betrained and competent to National Occupational Standards in Homoeopathy. The Society take theview that each prescription of a homoeopathic medicine should be decided by a properly qualifiedhomoeopath.

The Society of Chiropodists and Podiatrists and a reply from an individual podiatrist welcomesthe concept of SP, particularly where completion of training might enable healthcare professionals toqualify as both independent and SP-ers. However, SP per se for podiatrists will have no more than amarginal impact on flexibility and effectiveness for patients requiring certain POMs as part ofpodiatric management. Both look forward to introduction of independent prescribing rights andconsider appropriate training is already available.

The British Healthcare Trades Association are anxious to be reassured that DispensingCompliance Contractors will not be compromised by the proposals in relation to supply ofappliances, continence products and stoma care products.

The Chartered Society of Physiotherapy expresses extreme concern that, despite legislation toextend prescribing to a range of professions including physiotherapy, there has been no workundertaken to take this forward. Benefit to patients of physiotherapists prescribing has been wellrehearsed. Aware that the profession use PGDs and are delivering good results. However, for longterm patient with infrequent contact with a GP or consultant, a SP physiotherapist would facilitatetheir long term care. These groups of patients are outside those populations seen by nurses or

pharmacists on a regular basis. Would welcome discussions as to why this extension has not occurredand when it is likely to happen. The Society think there is a reluctance to discuss these issues withthem.

The Joint Royal Colleges Ambulance Liaison Committee supported the proposals without furthercomment.

SUMMARY OF SELECTED ADDITIONAL REPLIES

The Prison Health Policy Unit & Task Force would in principle support the development of SP inthe prison health care environment, in partnership with local NHS colleagues. Registered nurses whodemonstrate specialist competencies and who are adequately prepared and trained to an agreednational standard would be in a position to carry out this role. Examples within the prison health careenvironment where there are established nurse led clinics include asthma, diabetes, well-man or well-woman clinics. Practice nurses in particular will be very keen to expand their role in this area.Simple over the counter medication that is not easily available to the prisoner/ patient could be morereadily accessed from the competent nurse through SP.

The Ministry of Defence stress the importance of SP applying in the DMS as well as within the NHSand the independent healthcare sector. Supports use of Black Triangle drugs and unlicensed and offlabel use for all DMS patients, as well as CDs for palliative care. Hopes extension of SP to eg,physios and military combat medical technicians will be possible. Would welcome greater definitionof the content and structure of the clinical management plan. In large DMS establishments, will be aneed for teams of independent and SP-ers. Suggest there should be provision for a named individual(lead consultant or GP in larger establishments (hospitals or large medical practice)) to authorise SPwith the agreement of the clinician responsible for the patient's care.

The National Patient Safety Agency’s response focuses on ensuring safe medication practice tominimise the risk of medication errors as a result of the new proposals. They regard as a vital issuethat SP should be overseen by a Medicines Management Committee in each Trust in the same way asPatient Group Directions. Without this oversight, the resulting SP could be unsafe and causeadditional cause medication errors. The Agency consider it unnecessary to always have an individualwritten clinical management plan. In the majority of cases a clinical management plan can be agreedfor a group of patients requiring treatment for the same condition, possibly by teams of independentand SP-ers (i.e. within a clinical directorate team in a hospital or team of general practitioners withina group practice). Individual IP-ers can then provide a written referral to the appropriate team for SP,indicating the pre-arranged clinical management plan to follow, and any patient specific issues suchas drug allergy. This procedure would be easier to administer operationally. Very important that theTrust/Organisation is made aware and is able to authorise any SP arrangements for which practice itwill be held legally accountable. Must also be able to oversee the arrangements. Unlike extendednurse prescribing, SP includes a comprehensive range of conditions and medicines. It is importantthat general arrangements between independent and SP-ers are subject to multidisciplinary review byrepresentatives of the Trust prior to implementation. Need to determine the responsibilities ofpharmacists responsible for supervising the supplies of medicines on the prescription of SP-ers. Willcommunity pharmacists have any responsibility for ensuring that SP-ers only prescribe medicines forwhich they have agreed clinical management plans? Will the community pharmacist be informed ofthe clinical management plan in place? In hospital trusts how will other hospital staff know of theauthorised status of SP-ers or what has been prescribed is part of an agreed clinical managementplan? Many of these issues could be resolved by the requirement for SP arrangements to agreed by aTrust multidisciplinary group e.g. Drugs and Therapeutics or Medicines Management Committeeprior to implementation. The Agency does not support exclusion of unlicensed drugs or productsused outside their licensed indications. Current training for independent nurse prescribing whileproviding a prescribing overview, does not adequately prepare nurses for SP of every POM medicinelisted in the BNF. A similar course for pharmacists would be helpful, with less informationconcerning clinical pharmacology and a greater emphasis on physical and clinical examination toenable pharmacists to better monitor the patient’s clinical condition while undertaking SPresponsibilities. Specific in-depth knowledge is required of the medicines to be prescribed by SP-ersand it is impractical to cover all the medicines which may be prescribed on any general course, as themajority will never be prescribed or be of interest to individual SP-ers.

While acknowledging the requirements of the Misuse of Drugs Act and Regulations, theIndependent Heathcare Association view it as an anomaly that a supplementary pharmacistprescriber could sell a Schedule 5 P-status product but will not be able to prescribe them. IHAbelieves that independent hospitals already provide quick and efficient access to healthcare, and thatSP may not significantly increase speed, efficiency or quality of service. It would however provide anopportunity to maximise the application of the skills and knowledge of nurses and pharmacists. TheIHA are disappointed that SP will be excluded in the nursing home setting as a significant proportionof residents suffer from chronic conditions that could be managed through the proposed SParrangements, thus helping the GP. [NB: for clarification, SP will apply wherever healthcare isprovided and will include nursing homes]. The proposal to extend SP to other professions must onlybe considered once safe practice has been established with registered nurses and pharmacists. Thereare opportunities to broaden the definition of SP to encompass the more acute conditions found inmany hospitals where the patient is not always identified in advance, but where treatment follows apredefined treatment plan that is discussed and agreed with the patient at the time of treatment. Inmany ways this would combine elements of the Patient Group Directions legislation and practicewith SP. IHA would like clarity on whether separate prescribing budgets will exist for independentand SP-ers. From a risk management perspective IHA believes that the prescribing and dispensingmust always be separate. IHA point out that there is no unified patient record and urgentconsideration needs to be given to this point also to where it will be kept. Do not support inclusion ofunlicensed medicines for paediatrics, Black Triangle or BNF “less suitable” products. Would supportamendment of the Misuse of Drugs Act and Regulations to allow schedule 5 drugs to be prescribedby SP-ers. IHA argue that discussion and agreement with the patient is imperative, and observe thatsurely a patient has the right not to accept a SP-er. In the care of older people and in the mentalhealth setting, safeguards must be built in to ensure that vulnerable adults are protected as per currentlegislation. Requirement for regular [italics theirs] communication needs to be defined in the contextof the individual patient and built into the clinical management plan. Patient consent is vital. Reviewof patient’s progress should be earlier than one year from the initial assessment, especially whenprescribing to vulnerable adults. Mechanism needs to be developed so that when an anticipated movefrom one IP-er to another occurs, preparations that meet the patient’s needs are made in advance.Treatment plans should allow endorsement by a team of IP-ers and SP-ers, any of whom may fulfilthe requirements of the plan. Biggest issue for training and preparation will be cost of training,releasing the expertise for the course and financing appropriate cover - will any funding be madeavailable to independent sector providers? If registered nurses cannot be released or funded to attendthe course, the benefits that the government is hoping to see will not be achieved. Stance on whetherthe proposed training for nurses could enable them to qualify as both independent and SP-ers isunclear. The IHA chairs an independent sector wide Education and Training Advisory Group whichwould be pleased to enter into dialogue, in particular on training issues. Very similar points made inthe reply from BUPA.

The Professional Standing Committee of Boots Pharmacists Association regard the proposedworking definition of SP as s cumbersome. Their vision is that the process will need to bedrug/disease specific, rather than patient specific. Believe that SP should exclude "black triangle"products, BNF “less suitable”, unlicensed products and those used outside licenced indications. Feelprecise definitions of "patient's record" and "common patient record" are required. Consider theseparation of prescribing and dispensing will be difficult to achieve in a community pharmacy ifconvenience for the patient is to be maintained, but should not be seen as an insurmountableobstacle. Ideally a consulting room or other suitable accommodation should be available but manycommunity pharmacy premises will not have appropriate space available for conversion.Additionally there is a need to identify sources of finance to fund the necessary modifications topremises. There is a place for Government grants to assist. Mechanisms will be needed to enablepharmacists to record their SP competency on the Register of Pharmaceutical Chemists. Theproposal that pharmacists should agree with their employer that SP should be included in their jobdescription needs careful consideration. There are important implications for terms, conditions andremuneration. It is possible that employers of community pharmacists will be reluctant to remunerate

a SP "skill" if that "skill" is only used for part of the contracted employment periods. The proposalscan be viewed as being no more than a medicines management scheme in a new guise. However,agree that SP, as outlined, is a role that could be embraced by community pharmacists although notconfident that costs to business will be insignificant.

The Royal Society for the Promotion of Health view as essential that SP-ers demonstrate necessaryknowledge of anatomy, physiology and pathology needed to make initial diagnosis as well as furtherdiagnosis during the course of the disease. Prescribing should not be seen in isolation as it is a skilland not a privilege. Prescribers must have full medical defence agency cover and symptoms/signsthat led to the diagnosis should be clearly recorded in patients' notes.

The Company Chemist Association suggest removing "responsible" from the working definition ofSP as all particiants need to accept responsibility for the patient. Recommend use of patient -heldrecords. Clinical management plan should incorporate confirmation of patient consent to participate.Supports inclusion of CDs, off-license drugs and BNF “less suitable” products if agreed by bothprescribers. Nurses should be included in the ADR process. Thinks the management plan couldinclude second independent/SP-ers to cover for holidays etc. Changes to the plan need to berecorded. Plan should also include limits to SP-er's responsibilities.

The Intensive Care Society view the SP proposals as making formal a process that occurs already inIntensive Care Units. However, the 35 day training requirement, plus presumably periodic refreshers,appears to be somewhat impractical. If the proposals are to be of practical use in a busy Unit, then allthe senior nurses would need to be trained. Suggests SP needs piloting in a number of centres. TheCentre for Study For Complimentary Medicine wants SP to also cover prescription ofhomoeopathic medicines, homoeopathic complexes, nutritional medicines and products (egprobiotics) – which are all unlicensed – to be regarded as an exception alongside that proposed forpaediatrics.

Eight (8) replies were received from organisations representing “condition specific” interests. The British Heart Foundation queried who retained overall responsibility for the patient and felt theneed for evaluation, monitoring and regular updating of information not covered in sufficient depthin the MLX. Felt clinical management plan must specify all co-morbid conditions regardless of theirrelevance to the condition being treated. Queried whether existing cardiovascular disease willincluded as one of the conditions benefiting from SP. Suggests special care needed in consideringrecently licensed drugs and that BNF “less suitable” should be excluded. Not clear if there isconsultation between independent/SP-ers when changing a drug regime - team approach is vital. IP-ers will need more than brief preparation for their role so they are aware of all the implications ofsharing prescribing responsibility. Diabetes UK see it as logical that a nurse, with specialistknowledge in diabetes, should be able to prescribe ongoing treatment for that condition and fordiabetes-related conditions eg wound dressings for ulcers and antibiotics. Especially whenindividuals are first commenced on insulin, dosages may need to be altered a few times before bloodglucose levels become stable. For the many individuals who may be concerned about starting insulintherapy, ease of access to necessary alterations may make them feel more supported through thisdifficult stage. A diabetic's care may involve a number of health care professionals and it would beadvisable to have more than one named IP-er to allow continuity of SP in a variety of settings. Withregards the costs of a training programme, long-term benefits of this should outweigh the costs interms of diabetes care. The Insulin Dependent Diabetes Trust approved the proposals withoutfurther comment. The National Asthma Campaign believe that SP would be of particular benefit topeople with asthma, particularly from the participation of community pharmacists. Nurses,particularly trained asthma nurses, play a central role in asthma management for many people withasthma. SP-ers will need adequate training, time and facilities to participate satisfactorily. Note that apharmacist acting as a Prescriber may not be able to act as the dispenser. This will prevent manycommunity pharmacists from participating. Pharmacists who do not have ready access to read andcontribute to notes will be constrained in their participation. It may be necessary to pilot a system

where people with some long term conditions carry their own notes. Adequate training and facilitiesmust be provided for SP-ers be they nurses or pharmacists. The Marie Curie Cancer Care considersthe principle of good communication will be challenging, particularly in primary and communitycare, and may only be solved with electronic records and remote access. Within cancer and palliativecare, team working is fairly well developed. In this context, proposals have potential to enhancemultidisciplinary care. Support principle of separating prescribing and dispensing, which may also berelevant to dispensing GPs. Agree proposed legislative requirements. Consider the adoption of astandard template for the clinical management plan may ensure a standard and clinically effectiveapproach. SP in palliative care will need use of products outside licensed indications and also CDs.See proposal for more than one IP-er as being most problematic. Within Marie Curie, there is theissue of being involved with patients from different GPs and the status of nurses employed byindependent sector hospices. Believe there is little difference on the face of it in the preparationrequired to undertake independent and SP roles. On regulatory impact, thinks there could be anadditional burden for the charitable sector which could limit potential adoption of proposals in thatsector. The nurse members of the Pain Society feel many nurses in this field would not training well-spent if they are unable to prescribe CDs and unlicensed medicines which they use on a daily basis.Support one course for nurses covering independent/SP. The National Eczema Society have someconcerns about whether pharmacists have the time, space and skills to assess patients. Electronicrecord systems need to be implemented. Do not support exclusion of unlicensed products, quotingthat many used within dermatology for adults and children [NB: see also reply from BritishAssociation of Dermatologists]. Supports CD prescribing by nurses but only for their specific area ofpractice. Support nurse reporting of ADRs. If training for independent and SP is to be similar,consider that successful completion of the independent course should qualify the nurse for both roles.Nurses should have a recognised number of years of experience in a relevant area of clinical practice.No mention in the MLX of maintaining competence. Need to resolve matters of GP reluctance tobecome mentors or send nurses on courses as otherwise some nurses won't be able to extend theirknowledge or skills. A further letter was received from a company – Nutricia – who manufactureand supply a wide range of foods and borderline substances. Response focused on the proposals asthey relate to prescribing of these products, and in particular highlight dieticians as the mostappropriate profession to prescribe these Drug Tariff items.

SUMMARY OF REPLIES WHICH OBJECTED TO SP IN PRINCIPLE

In summary, seventy-eight (78) replies objected in principle to SP:

The Dispensing Doctors Association had numerous concerns [NB: not detailed] and objected to theproposals in primary care settings. The Association felt the requirement to produce individualclinical management plans is an awesome task and can't see how this will save time for the IP-er.Requirement for good communication channels only practicable for health professionals workingfrom the same premises. Sharing and updating the patient record will be problematical. There arealso accountability issues and profound budgetary implications. Put forward their views ondelegation of repeat dispensing which they feel should be a more attractive solution to the workloadissue.

From within the NHS, eleven (out of a total of 280) replies objected in principle to the proposals.Three were from midwives who objected to midwives as SP-ers saying that they should haveindependent prescribing status. One is from a palliative care team within a Trust who have concernsabout the level of training proposed but who in any event consider SP inappropriate for patientswhose conditions can change rapidly in the palliative phase of their illness. They view any changes tomedication in such circumstances to best remain with doctors. Nurses working within a urology unitfelt SP was of no significant benefit to them or their patients and instead favoured prescribing from alimited formulary appropriate to specialism (not just urology). A Prescribing and MedicinesManagement Committee within a Trust had various concerns about the requirements for SP andrecommended that it be piloted. Separate replies from an NHS Walk In Centre, an NHS Trust, a GPpractice and a Drugs and Therapeutics Committee took the view that SP was too time-consumingwithout significant benefit and that Patient Group Directions were preferable. One reply objected tothe proposals without further comment.

A number of replies were received from individuals. Forty-two replies (of 102 in total) werereceived from doctors objecting to the proposals. Of those, six (6) considered that prescribing shouldremain with doctors (with possible delegation of simple (unspecified) prescribing) and that proposalswould disassociate doctors from patients. Six (6) felt the proposals were just a way of meetingmedical shortages “on the cheap”. Two (2) felt development of SP should follow pilot schemes.Three (3) objections centred on the IP retaining overall responsibility, saying objections would ceasewhen SPs took full responsibility for their actions. One felt patient safety would be compromised andanother could not see the need for another tier of prescriber in addition to an IP-er. Four (4) felt thetraining was inadequate and that the proposals would increase potential for prescribing errors. Onereply voiced concerns over prescribing and dispensing. One objected with no further comment andanother commented that concerns were “many and various” (but did not explain further). The largestsingle objection (16) was that the proposals were over-bureaucratic and too costly for their practiceswithout any matching benefits. Eight replies (of 91 in total) were received from nurses. Five (5)regarded the proposals as over complex, one was concerned that SP would detrimentally affect therelationship between nurse and patient, one was concerned about the adequacy of training indiagnosis and another objected in principle to SP as the aim should be INP. Six replies (from 124 intotal) were from Pharmacists. Of these, two (2) felt the proposals unworkable in terms ofpaperwork and cost of locum cover. One felt prescribing should remain with a doctor. Another feltSP should await evaluation of INP. One recommended pilots for selected patients and the last felt SPwas too complex when IP for pharmacists should be the aim. Ten replies (of 61 in total) were fromother individuals whose concerns range from the cost in time and effort in implementing SP (2replies), a wish (from a patient) to have one known prescriber, a view (from a nurse) that SPappeared to be more training, more work and more accountability without extra pay, theimpracticality (from a pharmacist) of him being able to afford cover for the 25 days training, a view(from a hospice) that SP was pointless without access to unlicensed drugs and CDs, a view that SPseemed more work for GPs, a view that a single source of prescribing was safest for patients, a view

that the proposed training was inadequate of training to prepare nurse for diagnosis and a view thatfor eg asthma patients, Patient Group Directions appeared more effective.