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Litigation.nhs.uk

4 March 2014

REF: SHA/17452

1 Trevelyan Square APPEAL AGAINST SURREY & SUSSEX AREA TEAM,
NHS COMMISSIONING BOARD ("NHS ENGLAND")
DECISION
MEDICATION
DELIVERY
SERVICES LTD WITH A REMEDIAL NOTICE AT UNIT
6C MERIDIAN INDUSTRIAL ESTATE, HOYLE ROAD,
PEACEHAVEN, EAST SUSSEX, BN10 8LN
The Decision
The decision letter from NHS England (Surrey & Sussex Area Team) dated 31st October 2013 states: This is a remedial notice issued under regulation 70 of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. Nature of the breach The repeat prescription ordering process used by the pharmacy has led to
medication being ordered from a patient's GP which had not previously been
prescribed for the patient.

The repeat prescription ordering process used by the pharmacy has resulted in
some items to be switched from a branded product to generic product (or vice
versa)

The repeat prescription ordering process used by the pharmacy relied on a
number of transcribing processes rather than the GP generated repeat slips,
thus increasing the likelihood of errors.

The regulations that apply to these issues are as follows: NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, Schedule 4, Part 2, (4) dispensing services An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting prescriptions for drugs or appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service Professional Standards 29. An NHS pharmacist must provide pharmaceutical services and exercise any
professional judgement in connection with the provision of such services in conformity
with the standards generally accepted in the pharmaceutical profession

The Surrey and Sussex area team has not received, on a regular basis, any
certificates of conformity (COC) or certificates of analysis (COA) for non-

licensed medicines that have been supplied on an NHS prescription; as is
required by the terms of service described in the drug tariff.

For specials not listed in the drug tariff Part VIIIB, the contractor or his representative must stamp, date, initial and endorse the Certificate of Analysis (COA)/Certificate of Conformity (COC) with the invoice price less discount and prescriber's details. At the end of each month, the contractor shall send a copy of the appropriately endorsed COA/COC to the NHSCB of the prescriber, allowing the NHSCB to match expenditure to the special supplied. A patient was not provided with medication that had been prescribed by the
patients GP as a result of market shortage of the medicine. The pharmacist
should ensure that in the event of a shortage of medication for any reason, the
prescriber is contacted so that alternative arrangements or medication can be
made to ensure that the patient always receives appropriate treatment of their
condition.

Schedule 4, Part 2, (4) dispensing services An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting prescriptions for drugs or appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service Professional Standards 29. An NHS pharmacist must provide pharmaceutical services and exercise any
professional judgement in connection with the provision of such services in conformity
with the standards generally accepted in the pharmaceutical profession for example
the General Pharmaceutical Councils principles and standards listed below:

Principle 1, make patients your first concern Principle 2, use professional judgment in the interests of patients and the public Standards on conduct, ethics and performance, Standard 1.2 take action to protect the well-being of patients and the public and Standard 2 use professional judgment in the interests of the patients and public and Standard 2.1, consider and act in the best interests of individual patients and the public Non-compliance with GPhC best practice regarding the maintenance of
controlled drugs registers' rolling balances

29. An NHS pharmacist must provide pharmaceutical services and exercise any
professional judgement in connection with the provision of such services in conformity
with the standards generally accepted in the pharmaceutical profession, for example
compliance with guidance regarding the safe management of controlled drugs.

Steps you are required to take, to the satisfaction of NHS England, in order to
remedy the breaches:

The repeat prescription reordering process must be fully reviewed by 30th November 2013 and modified to ensure that: 1.13.1 Only items that have been previously prescribed by the patient's GP on a repeatable basis are to be requested from the GP Practice. Any other prescribed items should be queried with the appropriate healthcare professional or GP surgery before ordering. 1.13.2 Systems must be put in place to ensure that all items ordered and provided are dispensed exactly as prescribed. There should be no generic substitution without specific permission of the prescriber. 1.13.3 The process for ordering prescriptions, Standard Operating Procedure, should be modified to only use GP generated prescription repeat requests slips to ensure that only medication that has been prescribed is ordered. This will ensure that unnecessary transcribing of prescription detail that is used in the reordering process is eliminated so reducing the likelihood of errors. 1.13.4 All certificates of conformity / certificates of analysis must be correctly endorsed and sent to the NHS England Surrey and Sussex Area Team Office in Horley every month without delay. 1.13.5 Procedures should be put in place to ensure that in the event of a shortage of a medicine for any patient, the prescriber should be contacted immediately to make appropriate arrangements to ensure that the patient continues to receive appropriate medication to treat their condition. 1.13.6 The controlled drug register rolling balance /stock balance audit must be completed at least at weekly intervals and after every dispensing event involving a controlled drug, where applicable. All of the above required steps must be completed by 30th November 2013. The Appeal
In a letter to the Family Health Services Appeal Unit of the NHS Litigation Authority ("the Appeal Unit"), dated 27th November 2013, Charles Russell LLP, on behalf of Medication Delivery Services Ltd ("the Appellant") appealed against NHS England's decision. The grounds of appeal are: NHS ENGLAND HAS FAILED TO COMPLY WITH REGULATION 69
Prior to issuing a Remedial Notice, NHS England has a statutory duty in accordance with regulation 69 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 "to communicate and co-operate with an NHS chemist . with a view to resolving any dispute between [the chemist] and the NHSCB relating to [the chemist's] compliance with [the chemist's] terms of service". NHS England has failed to comply with that statutory duty. Whilst there has been some correspondence between NHS England and the Appellant, NHS England has failed to have regard to the information provided by the Appellant. NHS England has consequently failed to communicate and co-operate reasonably with the Appellant in relation to this matter. NHS ENGLAND HAS FAILED PROPERLY TO PARTICULARISE THE ALLEGED
BREACHES

In accordance with regulation 70(2)(a) and the principles of natural justice, it is incumbent upon NHS England properly to particularise the nature of the breaches which are alleged to have been made by the Appellant. NHS England has failed to comply with its legal obligations. Taking each allegation in turn:- The repeat prescription ordering process used by the pharmacy has led to
medication being
ordered from a patient's GP which had not previously been
prescribed for the patient.

NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- What NHS England considers the "repeat prescription ordering process" used by the Appellant's pharmacy is; Which medication it is said was ordered by the Appellant's pharmacy; When it is said that medication was ordered by the Appellant's pharmacy; The identity of the patient for whom it is said medication was ordered; The identity of the patient's GP by whom it is said a prescription was issued; Details of the GP's systems for prescribing medication; The circumstances in which it is alleged the Appellant ordered such medication; Details of the patient's previous prescribing history; Details of any action taken against the GP who, it would appear, prescribed medication which he had not previously prescribed; 2.6.10 Why it is alleged the Appellant's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. The repeat prescription ordering process used by the pharmacy has resulted in
some items
to be switched from a branded product to generic product (or vice
versa)

NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- What NHS England considers was "the repeat prescription ordering process" that was used by the Appellant's pharmacy at the material time; Which items it is said have been switched from a branded product to generic product; Which items it is said have been switched from a generic product to a branded product; Which patients have received the "switched" products; When were those products prescribed; When were those products supplied; Details of any action taken against the GP who, it would appear, prescribed "switched" medication; Why it is alleged the Appellant's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. The repeat prescription ordering process used by the pharmacy relied on a
number of transcribing processes rather than the GP generated repeat slips,
thus increasing the likelihood areas

NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- What NHS England considers was "the repeat prescription ordering process" used by the Appellant's pharmacy; What NHS England considers were the "transcribing processes" used by the Appellant's pharmacy; What NHS England considers were the "GP generated repeat slips"; The evidence it relies upon to demonstrate that there of an increase in "the likelihood of errors"; What NHS England considers are the legal and ethical obligations upon a pharmacist in relation to repeat prescription requests; What evidence NHS England relies upon in relation to a pharmacist's legal and ethical obligations regarding repeat prescription requests; Why it is alleged the Appellant's procedures amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. The Surrey and Sussex Area Team has not received, on a regular basis, any
Certificates of Conformity (COC) or Certificates of Analysis (COA) for non-
licensed medicines that have been supplied on an NHS prescription; as is
required by the terms of service described in the Drug Tariff

NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- What COC and COA have been received from the pharmacy; For which supplies it is alleged a COC or COA have not been received. This should include details of the name of the patient, the date of the prescription, the nature of the product prescribed, the date it is said the product was supplied; Why it is alleged the Appellant's actions amount to a breach of the terms of
service in relation to which it is necessary for NHS England to issue a
remedial notice.
A patient was not provided with medication that had been prescribed by the
patient's GP as a result of market shortage of the medicine. The pharmacist
should ensure that in the event of a shortage of medication for any reason, the
prescriber is contacted so that alternative arrangements or medication can be
made to ensure that the patient always receives appropriate treatment of their
condition

NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- 2.10.1 Which patient was not provided with medication; 2.10.2 What was the medication prescribed; 2.10.3 What action it is alleged the Appellant failed to take in relation to that particular patient; 2.10.4 When was the medication supplied; 2.10.5 Has a complaint been made by the patient; 2.10.6 Has that complaint been resolved; 2.10.7 The pharmacist's legal obligations in relation to the supply of medication; 2.10.8 Why it is alleged the Appellant's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a
remedial notice.
Non-compliance with GPhC best practice regarding the maintenance of
controlled drugs registered rolling balances

NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- 2.11.1 What it is said is the GPhC's best practice regarding the maintenance of controlled drugs registers rolling balances; 2.11.2 What NHS considers were the records which were maintained by the 2.11.3 What is the Appellant's legal obligation in relation to the maintenance of running balances; 2.11.4 In what way did the Appellant not comply with the legal obligation; 2.11.5 If, as it appears, NHS England relies on "best practice", on what basis does NHS England allege that it the Appellant has a legal obligation to comply with "best practice". In the absence of the above full and proper particulars, NHS England has failed to comply with its statutory obligations contained within regulation 70(2)(a) of the Regulations. NHS ENGLAND HAS FAILED TO PROVIDE EVIDENCE OF THE ALLEGATIONS
CONTAINED WITHIN THE REMEDIAL NOTICE

The burden of proving that the Appellant has breached its terms of service rests with NHS England. NHS England has failed to provide any evidence in support of the allegations made within the Remedial Notice. In the absence of such evidence, NHS England has failed to discharge the burden of proving the allegations made. For the avoidance of doubt, the Appellant does not accept the allegations made against it. NHS England is required to provide all the evidence that it has obtained as part of its investigation of the Appellant. This obligation in relation to disclosure includes an obligation to provide not only evidence which supports its allegations but also evidence which does not support its allegations and/or which may assist the Appellant in the defence of these allegations. NHS England should also provide a schedule of unused documents. NHS ENGLAND'S DECISION TO ISSUE A REMEDIAL NOTICE IS DISPROPORTIONATE
NHS England has an obligation to act fairly and proportionately in relation to the Appellant. In all the circumstances, NHS England's decision to issue a Remedial Notice is disproportionate in the circumstances of this case. For the reasons given above, the Appellant requests the Authority to uphold their appeal and dismiss the Remedial Notice. Summary of Representations
This is a summary of representations received on the appeal. NHS ENGLAND (SURREY & SUSSEX AREA TEAM) NHS England has failed to comply with Regulation 69 Prior to issuing a Remedial Notice, NHS England has a statutory duty in accordance with regulation 69 of the National Health Service {Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 "to communicate and co-operate with an NHS chemist . with a view to resolving any dispute between [the chemist] and the NHSCB relating to [the chemist's] compliance with [the chemist's] terms of service". NHS England has failed to comply with that statutory duty. Whilst there has been some correspondence between NHS England and our client, NHS England has failed to have regard to the information provided by our client. NHS England has consequently failed to communicate and co-operate reasonably with our client in relation to this matter. The Area Team's contract manager with lead responsibility for pharmacy issues has endeavoured to communicate with the responsible pharmacist of MDS Ltd, Ms Jane Wenyon, on numerous occasions by phone between 9th September 2013 and 7th October 2013 to discuss some of the many complaints regarding the pharmacy from numerous GP Practices, however he was told that she was not been available to speak to him. He then attempted to contact her by email using both her named and general business email accounts and, in addition, copied these to Mr Ian Pilsbury, the Managing Director of MDS Ltd. He also discussed some of the complaints directly following a contract monitoring visit on 6th June 2013 (this was the second appointment made to discuss concerns, he had been turned away on the first attempt a week previously even though an appointment had been made). During this discussion he raised some of the many concerns that had been raised with the Area Team from various GP Practices. During this discussion Ms Wenyon and Mr Pilsbury both indicated that their prescription re-ordering process was not at fault and that it must be the GP Practices at fault. He provided advice and asked that they consider revising their system at that stage, pointing out how errors could easily be "transcribed" without detection from the pharmacy staff. Subsequently, an email was sent to Ms Wenyon and Mr Pilsbury on 28th August 2013 with details of specific complaints received from Arlington Road Practice, Eastbourne (a copy of this email is attached as Appendix 1). Mr Pilsbury responded by email on 9th September 2013 (a copy of this email is attached as Appendix 2) but it was felt that he was misunderstanding the concerns that the Contract Manager was trying to pass on to him so the Manager telephoned and spoke with him and tried to explain why he was concerned. Mr Pilsbury appeared very defensive and eventually terminated the call. The Contract Manager then emailed them again on 11th September 2013 (a copy of this email is attached as Appendix 3) but he has had no response to this email and his phone calls have never been put through to either Ms Wenyon or Mr Pilsbury. NHS ENGLAND HAS FAILED PROPERLY TO PARTICULARISE THE ALLEGED BREACHES In accordance with regulation 70(2)(a) and the principles of natural justice, it is incumbent upon NHS England properly to particularise the nature of the breaches which are alleged to have been made by our client. NHS England has failed to comply with its legal obligations. Taking each allegation in turn:- 2.1 The repeat prescription ordering process used by the pharmacy has led to medication being ordered from a patient's GP which had not previously been prescribed for the patient. NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- (i) What NHS England considers the "repeat prescription ordering process" used by our client's pharmacy is; The Area Team is quite clear on what it "considers" the repeat prescription ordering process to be. It is as set out in an email dated 9th September 2013 from Mr Ian Pilsbury, (a copy of this email is attached as Appendix 2). This unequivocally shows that a member of the care home generates a repeat request using the home's own form, which would require items to be transcribed from another unidentifiable source e.g. a Medication Administration Record Chart. The completed form would then be then faxed to the pharmacy. The pharmacy staff would then, in turn, transcribe the information from the care home form they had received onto the pharmacy's computer system. The pharmacy suggest they correct any errors at this stage, however without a completely accurate source of information any errors in the first transcription process in the care home will continue to persist. The pharmacy would then generate their repeat request form from their computer and this is either taken or sent to the GP Practice. The Area Team is of the firm view that, if the GP generated repeat request slip that was issued when the item(s) were first prescribed was used there would be no need to transcribe as that repeat request that could be sent to the GP Practice as an original, verifiably correct source of information. (ii) Which medication it is said was ordered by our client's pharmacy; The medication that was requested by the pharmacy as a generic medicine are as follows:- Metformin MR 500mg, Donepezil, Memantine, Entacapone 200mg, Levodopa 150mg & Carbidopa 37.5mg, The medicines had originally been ordered as branded products by the prescriber (iii) When it is said that medication was ordered by our client's pharmacy; The concern was reported to Eastbourne, Hailsham and Seaford Clinical Commissioning Group's prescribing advisor by the Practice Manager at Arlington Road Practice 1 Arlington Road, Eastbourne East Sussex BN21 on 28th August 2013 and relayed to the Pharmacy Contract Manager on the same day (iv) The identity of the patient for whom it is said medication was ordered; Data Protection Act obligations precludes their full details being entered in this letter but their initials and date of birth are ES 8/2/30, PN 23/5/28, SB 13/2/33, PH 27/10/31. This, together with the fact that they are a residents of Shire Care Home should be sufficient for MDS Ltd to identify them) reasons. The email from Mr Pilsbury attached as Appendix 2 confirms this to be so. (v) The identity of the patient's GP by whom it is said a prescription was issued; 3.1.10 The GPs are Dr Mark Jones and Dr Jane Lofts from the Arlington Road (vi) Details of the GP's systems for prescribing medication; 3.1.11 There are numerous GP computer systems available and NHS England am unaware of the precise system in use in the Arlington Road Practice. But all will generate the standard paper FP10 prescription form on NHS supplied stationery with the order appearing on the green, left hand side section with a white "repeat request" form on the right hand side. This is a nationally used, standard format. (vii) The circumstances in which it is alleged our client ordered such medication; 3.1.12 The pharmacy supplies medication to patients who are residents of Shire Care Home, and this should occur in a normal 28 day cycle. The pharmacy then submitted the request form produced by their using their own computer rather than the use the standard, GP generated, repeat request form. (Viii) Details of the patient's previous prescribing history; I assume that the Appellant is asking about the patient's previous medication history. 3.1.13 This is shown in appendix 4. (ix) Details of any action taken against the GP who, it would appear, prescribed medication which he had not previously prescribed; 3.1.14 There is no suggestion that the GP "switched" the medication. In any case this is not relevant as a GP is able to prescribe any medication that s deemed necessary for a patient's condition by using a form FP 10. (x) Why it is alleged our client's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. 3.1.15 The pharmacy has requested a repeat prescription for medication specifying generic products. The medication was originally ordered by the patients GP who has specified branded products. The GP has not prescribed generically. 3.1.16 Medication ordered on a NHS prescription should be supplied as ordered unless specific permission to change any details is obtained from the prescriber (the GP) which includes switching from a branded product to a generic product. This would be a concern for patient safety; if the GP wants medication with consistent bio availability they would order a specific branded product for example. In addition, if the pharmacy is supplying generic medication against a prescription ordering branded product, but submitting a claim for a branded product, they could be paid (by NHS Business Services Authority Prescription Pricing Division) for the branded product. This is often more expensive than the generic equivalent. 3.1.17 The pharmacy's prescription ordering system relies on care home staff (who are unlikely to be trained in transcribing procedures) creating a re-order list for their patient's medication, using whatever information they have to hand and on their own stationery, which is then faxed then to the pharmacy. The pharmacy staff will then transcribe the re-order list to their computer system, prior to generating a further prescription reorder sheet which is sent to the GP Practice. 3.1.18 There have been numerous studies looking at the risks in using transcribing processes and link shows just one example, there is a ways a risk - for example if there is an error on the MAR chart· that this could be perpetuated by inaccurate transcribing. 3.1.19 East & South East England Specialist Pharmacy Services East of England, London, South Central & South East Coast Medicines Use and Safety Division Community Health Services "Transcribing" Transcribing Guidance Vs.1 Feb 25th 2011 (DG) 4 - S P S "Implementing transcribing in practice
The appendix lists a variety of situations where transcribing may be necessary. Wherever this happens the organisation should have a standard operating procedure which covers the following. When; What triggers the need for a record to be transcribed Who; Which member of staff can transcribe How; Details of the process including which MAR chart, what evidence is required, who should double check etc What The details required for administration to continue in a safe manner Further action; who needs to kept informed, how long is transcribed copy valid for etc." 3.1.20 The GPhC Standards conduct ethics and performance 2012 "The Responsible Pharmacist would have a duty to ensure that under the GPhC Standard 1 Make patients your first concern (1.1 Make sure the services you provide are safe and of acceptable quality, 1.5 If you need to, refer patients to other health or social-care professionals, or to other relevant organisations, 1.6 Do your best to provide medicines and other professional services safely and when patients need them) they provide a safe and acceptable service". Responsibility for meeting GPhC Standards for registered pharmacies lies with the pharmacy owner. If the registered pharmacy is owned by a 'body corporate' (for example a company or NHS organisation) responsibility. Under Principle 1(The governance arrangements safeguard the health, safety and wellbeing of patients and the public) the Superintendent must ensure that patients are not put at risk. Furthermore, the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 are quite clear when they say In Schedule 4 "Terms of service for NHS pharmacists":- 3.1.21 "Dispensing services 4. An NHS pharmacist must, to the extent that paragraphs 5 to 9 require and in the manner described in those paragraphs, provide proper and sufficient drugs and appliances to persons presenting prescriptions for drugs or appliances ordered by health care professionals in pursuance of their functions in the health service, the Scottish health service or the Northern Ireland health service" (Schedule 4, Part 2, paragraph 4 refers) 3.1.22 "Professional Standards 29. An NHS pharmacist must provide pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession. " (Schedule 4, Part 4, paragraph 29 refers) 2.2 The repeat prescription ordering process used by the pharmacy has resulted in some items to be switched from a branded product to generic product (or vice versa) NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- (i) What NHS England considers was "the repeat prescription ordering process" that was used by our client's pharmacy at the material time; 3.1.23 Please refer to the answer given at 2.1 (i) above (ii) Which items it is said have been switched from a branded product to generic product; 3.1.24 Please refer to the answer given at 2.1 (ii) above (iii) Which items it is said have been switched from a generic product to a branded product:; 3.1.25 There is no suggestion that this has occurred and it has never formed part of the Area Team's concerns (iv) Which patients have received the "switched" products; 3.1.26 Please refer to the answer given at 2.1 (iv) above (v) When were those products prescribed; 3.1.27 14th August 2013 (vi) When were those products supplied; 3.1.28 This is not known as the pharmacy would require time to dispense the medication after receiving the prescriptions from the GP practice. (vii) Details of any action taken against the GP who, it would appear, prescribed "switched" medication; 3.1.29 This has been misunderstood; the medication was switched by the pharmacy, not by the GP. It was the GP prescription clerk staff who identified these changes from the request sheets submitted by MDS in comparison of the records kept on the GP patient records. There is no suggestion that the GP "switched" the medication. In any case this is not relevant as a GP 's able to prescribe any medication that is deemed necessary for a patient's condition by using a form FP 10. (viii) Why it is alleged our client's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. 3.1.30 Medication ordered on a NHS prescription should be supplied as ordered unless specific permission to change any details is obtained from the prescriber (the GP) which includes switching from a branded product to a generic product. This would be a concern for patient safety; if the GP wants medication with consistent bio availability they would order a specific branded product for example. In addition, if the pharmacy is supplying generic medication against a prescription ordering branded product, but submitting a claim for a branded product, they could be paid (by NHS Business Services Authority Prescription Pricing Division) for the branded product. This is often more expensive than the generic equivalent. 2.3 The repeat prescription ordering process used by the pharmacy relied on a number of transcribing processes rather than the GP generated repeat slips, thus increasing the likelihood areas NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- (i) What NHS England considers was "the repeat prescription ordering process" used by our client's pharmacy; 3.1.31 Please refer to the answer given at 2.1 (i) above (ii) What NHS England considers were the "transcribing processes" used by our client's pharmacy; 3.1.32 Please refer to the answer given at 2.1 (i) above. (iii) What NHS England considers were the "GP generated repeat slips" 3.1.33 All GP practice computer systems will generate the standard paper FP10 prescription form on NHS supplied stationery with the order appearing on the green, left hand side section with a white "repeat request" form on the right hand side. This is a nationally used, standard format. These are the "GP generated repeat slips". (iv) The evidence it relies upon to demonstrate that there of an increase in "the likelihood of errors"; 3.1.34 Please refer to the answer given at 2.1 (ix) above (v) What NHS England considers are the legal and ethical obligations upon a pharmacist in relation to repeat prescription requests; 3.1.35 The Responsible Pharmacist would have a duty to ensure that under the GPhC Standard (General Pharmaceutical Council's Standards of conduct, ethics and performance; Principle 1 (1.1, 1.5 and 1.6) 3.1.35.1Make patients your first concern (1.1 Make sure the services you provide are safe and of acceptable quality, 1.5 If you need to, refer patients to other health or social-care professionals, or to other relevant organisations, 1.6 Do your best to provide medicines and other professional services safely and when patients need them) they provide a safe and acceptable service and 3.1.35.2Schedule 4, Part 2, (4) Dispensing services of NHS Pharmacy Services and Local Pharmaceutical services Regulations 2013. (vi) What evidence NHS England relies upon in relation to a pharmacist's legal and ethical obligations regarding repeat prescription requests; 3.1.36 Such requests emanate from either the patient or, as in the example under consideration, their representative. They would normally involve the GP being requested, by the use of the GP generated white "repeat request" form, for a prescription on Form FP10 ordering the relevant medication. That form is then presented to (or collected by) a pharmacy and dispensed as required by the pharmacists "terms of service" as detailed above. There are no different requirements regarding the dispensing of repeat prescriptions NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 are quite clear when they say in Schedule 4 "Terms of service for NHS pharmacists" 3.1.37 Please also refer to the answer given at 2.1(x) above. (vii) Why it is alleged our client's procedures amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. 3.1.38 The systems used by the pharmacy have resulted in a potential patient safety issue being identified by the GP Practice when processing the request for repeat prescriptions received on behalf of patients of the Shire Care home. 3.1.39 The switching of branded to generic medication is wrong from two points of 3.1.39.1The way that the active drug is released from a branded product in the body is likely to be different to that of a generic product (due to the differences in the manufacturing processes used) which could adversely affect the control of the condition for which the medicine has been prescribed. 3.1.39.2In most cases a branded product is more expensive, thus as the NHS Business Services Authority Prescription Pricing Division would pay for the medication listed on the Prescription form (FP10) the pharmacy would receive more money than the cost of the generic medicine if that was supplied to the patient. 2.4 The Surrey and Sussex Area Team has not received, on a regular basis, any Certificates of Conformity (COC) or Certificates of Analysis (COA) for non-licensed medicines that have been supplied on an NHS prescription; as is required by the terms of service described in the Drug Tariff NHS England has failed properly to particularise this allegation. This includes, but is not limited to, a failure to particularise the following:- (i) What COC and COA have been received from the pharmacy; 3.1.40 The Surrey and Sussex Area Team have not received any COC (certificate of conformity) or COA Certificate of Analysis) for this year since January 2013 (ii) For which supplies it is alleged a COC or COA have not been received. This should include details of the name of the patient, the date of the prescription, the nature of the product prescribed, the date it is said the product was supplied; 3.1.41 Please see appendix 5 which is epact data from NHS Business Services Authority showing specials medication supplied by MDS from January 2013 to September 2013. (iii) Why it is alleged our client's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. 3.1.42 The Drug Tariff specifically states that for "specials" not listed in part VIIIB the contractor should stamp, date, initial and endorse the COC or COA with the invoice price less discount and the prescriber's details. At the end of each month the contractor shall send a copy of the appropriately endorsed COC/COA to the NHS Commissioning Board (NHS England) Drug Tariff Dec 2013 Page 171. 2.5 A patient was not provided with medication that had been prescribed by the patient's GP as a result of market shortage of the medicine. The pharmacist should ensure that in the event of a shortage of medication for any reason, the prescriber is contacted so that alternative arrangements or medication can be made to ensure that the patient always receives appropriate treatment of their condition NHS England has failed properly to particularise this allegation. This includes. but is not limited to, a failure to particularise the following:- (i) Which patient was not provided with medication; 3.1.43 The patient was not identified but was a patient of Springfields Nursing Home in Brighton; this information was extracted from a report completed on behalf of the Brighton and Have City Primary Care Trust in August 2013 (Ii) What was the medication prescribed; 3.1.44 Lansoprazole Orodispersible Tablets (iii) What action it is alleged our client failed to take in relation to that particular patient; 3.1.45 Springfields Nursing Home had been told by MDS Ltd that there was a supply issue. The pharmacy should have notified the GP so that an alternative medicine could be supplied and the report indicated that the patient had not received any medication for at least one week. (iv) When was the medication supplied; 3.1.46 During the month of August 2012 (v) Has a complaint been made by the patient; (vi) Has that complaint been resolved; (vii) The pharmacist's legal obligations in relation to the supply of medication; 3.1.49 NHS Pharmaceutical Services and local Pharmaceutical Services Regulations 2013, Part 2, paragraph 5 Dispensing of drugs and appliances says, in the final sentence of that paragraph:- "P must, with reasonable promptness, provide drugs so ordered .as P supplies in the normal course of business." 3.1.50 In addition the pharmacist should have regard for the General Pharmaceutical Councils Standards of conduct, ethics and performance 3.1.51 Principle 1; "Make patients your first concern" "1.2 Take actions to protect the well-being of patients and the public" 3.1.52 Principle 2; "Use your professional judgement in the interests of patients and 3.1.53 Principle "2.1 Consider and act in the best interests of individual patients and the public." (viii) Why it is alleged our client's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. 3.1.54 NHS Pharmaceutical Services and Local Pharmaceutical Services Regulations 2013 state "Professional Standards" 29. An NHS pharmacist must provide pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession." (Schedule 4, Part 4, paragraph 29 refers) 3.1.55 MDS Ltd failed to contact the patient's GP to notify them of the manufacturing shortage of the patient's medication, resulting in the patient not having access to the prescribed medication for at least one week. 2.5 Non-compliance with GPhC best practice regarding the maintenance of controlled drugs registered rolling balances NHS England has failed properly to particularise this allegation. his includes, but is not limited to, a failure to particularise the following:- (i) What it is said is the GPhC's best practice regarding the maintenance of controlled drugs registers rolling balances; 3.1.56 CD running balance in the CD register of drugs remaining should be calculated and recorded after each transaction in line with GPhC guidance although this is not a legal requirement. The GPhC guidance is quite clear when it says (Principle 6 Be honest and trustworthy) 6.6 "Comply with legal and professional requirements and accepted guidance on professional practice". Ms Wenyon admitted during an interview last year with NHS Sussex that she did not comply with this guidance and had also been advised to do so by the GPhC Standards inspector (ii) What NHS considers were the records which were maintained by our client; The running balances were checked every 10 to 12 weeks so indicated by Ms Wenyon (iii) What is our client's legal obligation in relation to the maintenance of running balances; 3.1.57 There is no legal obligation, however it is a professional requirement and accepted guidance on professional practice issued by the GPhC. (iv) In what way did our client not comply with the legal obligation; 3.1.58 Not applicable (v) If, as it appears, NHS England relies on "best practice", on what basis does NHS England allege that it our client has a legal obligation to comply with "best practice". 3.1.59 There is no legal obligation, however it is a professional requirement and accepted guidance on professional practice issued by the GPhC. In the absence of the above full and proper particulars, NHS England has failed to comply with its statutory obligations contained within regulation 70(2)(a) of the Regulations. 3.1.60 Contrary to the assertion in the letter of appeal, the Surrey and Sussex Area Team of NHS England, has attempted to communicate with the contractor on numerous occasions with limited success. The contractor's responsible pharmacist has repeatedly refused to speak to the relevant Contract Manager and email correspondence has gone unanswered. Given that situation, and its concerns over the practices being followed in MDS with particular regard to the requesting of repeat prescriptions and the adherence to good practices regarding the procedures relating to Controlled Drugs it was felt, with reluctance, that a remedial notice was the only means remaining open to NHS England Surrey and Sussex Area Team to ensure patient safety. Summary of Observations
This is a summary of observations received. CHARLES RUSSELL LLP (ON BEHALF OF THE APPELLANT) The Appellant's letter of appeal raised 4 grounds: that NHS England had failed to comply with its statutory obligations; NHS England had failed properly to particularise the alleged breaches; NHS England had failed to provide any, or any sufficient evidence, in support of the alleged breaches; the issuing of a remedial notice was disproportionate in all the circumstances. NHS England has been given the opportunity to respond to each of those grounds of appeal, and its response is contained within its letter of 23rd December 2013. Whilst Charles Russell's client is the Appellant for the purposes of this appeal, the Authority must consider the matter de novo. It is therefore not for the Appellant to satisfy the Authority, on balance, that the remedial notice should be rescinded, but for NHS England to satisfy the Authority, on balance that: 4.1.3.1 The facts alleged are true; 4.1.3.2 The facts proved true support the allegations made; 4.1.3.3 Those allegations amount to a failure by the Appellant to comply with its terms of service; 4.1.3.4 That failure is ongoing and has not been remediated; 4.1.3.5 In all the circumstances it is necessary and proportionate to issue a remedial notice. Since the Appellant does not accept the facts alleged by NHS England; does not accept that those facts, even if found proved, amount to a failure by the Appellant to comply with its terms of service; does not accept that any such failure is ongoing; and does not accept that it was necessary for NHS England to issue a remedial notice, it is incumbent upon NHS England to provide sufficient, cogent, evidence to support each of its allegations. In fact, NHS England has not provided any, or any sufficient, evidence in support of its allegations. Whilst NHS England wrote to the Authority on 23rd December, that letter is not "evidence" of a sufficiently probative standard necessary to support a finding by the Authority that the remedial notice should be upheld. The lack of any clear or cogent evidence from NHS England demonstrates that NHS England has failed to deal with this matter appropriately and does not have in place appropriate systems for the investigation of allegations. Taking each of the grounds of appeal in turn and responding to NHS England's letter of 23rd December 2013, Charles Russell LLP comment as follows: NHS ENGLAND HAS FAILED TO COMPLY WITH REGULATION 69
NHS England states that the "Area Team's contract manager" has attempted to contact the Appellant by telephone and email but has had no response. However, no details are given regarding the dates and times of any attempted phone calls, nor has NHS England provided copies of the emails referred to. NHS England has not produced a witness statement from the relevant "contract manager". In the absence of this information, the Authority cannot be satisfied that NHS England has attempted to comply with regulation 69. For the avoidance of doubt, the Appellant has a system of recording all incoming messages digitally and, if necessary, manually. Its phone records show no calls at all from Mr Hedley's landline number or either of his mobile numbers during the period to which NHS England refers. The Appellant is not aware of any emails from Mr Hedley to which a response has not been made. It is disingenuous for NHS England to state that Mr Hedley "had been turned away" from the pharmacy during a contract monitoring visit. A contract monitoring visit was scheduled, but the Appellant had recorded the wrong date in his diary. When Mr Hedley arrived, it was not convenient for the contract monitoring visit to go ahead since no locum had been booked. A further visit was therefore arranged and took place. 4.1.10 The Appellant does not accept that the letter from NHS England accurately records the outcome of the contract monitoring visit. Unfortunately NHS England has failed to provide any evidence of the outcome of that visit. 4.1.11 In relation to the email of 28th August 2013 referred to by NHS England, it is unfortunate that NHS England has failed to disclose the full chain of emails that passed between the Appellant and NHS England. The Appellant had to make repeated requests to NHS England for further details to allow it to investigate. Following that chain of emails it was clear that the "specific complaints" referred to by NHS England (but again not properly particularised) related to a single GP at a single surgery. 4.1.12 NHS England refer to an email of 11th September 2013 at appendix 3, but that email is not included with the bundle of papers provided by the Authority. It is not accepted that "Mr Pilsbury appeared very defensive and eventually terminated the call" and no evidence is provided by NHS England to support this statement. NHS ENGLAND HAS FAILED PROPERLY TO PARTICULARISE THE ALLEGED
BREACHES

4.1.13 Taking each allegation in turn:- The repeat prescription ordering process used by the pharmacy has led
to medication being ordered from a patient's GP which had not
previously been prescribed for the patient.

What NHS England considers the "repeat prescription ordering process" used by the Appellant's pharmacy is; 4.1.14 Charles Russell LLP have no doubt that the Authority will consider the emails attached to NHS England's letter. It will therefore be evident to the Authority that NHS England has incorrectly paraphrased the Appellant's response contained within its email of 9th September 2013. The Appellant's email does not "unequivocally show that a member of the care home generates a repeat request.". 4.1.15 NHS England has produced no evidence to support its view of the Appellant's alleged repeat ordering process. For the avoidance of doubt, the Appellant does not accept that the repeat ordering process that NHS England alleges the Appellant employs accurately describes their actual processes. Since NHS England makes this allegation against the Appellant, it is for NHS England to provide evidence to support its view of the nature of their systems. 4.1.16 The Appellant's processes for ordering repeat medication are clearly defined and managed through its own SOPs and through its Service Level Agreements with the relevant care homes. The process described by NHS England does not reflect the SOPs or SLAs, although NHS England has had the opportunity to review those. The homes do not generate their own paperwork at all, nor is it transcribed from some "unidentifiable source i.e. a MAR chart." The completed forms are not faxed to the pharmacy. No evidence is produced by NHS England to support these assertions. For example, NHS England does not appear to have spoken to staff at the relevant care homes, or taken statements from those staff. Which medication it is said was ordered by the Appellant's pharmacy; 4.1.17 Despite the generality of the allegation, it would appear that NHS England is only referring to a small number of medicines which, it is alleged, were ordered as generic versions of the previously prescribed branded products. 4.1.18 As NHS England is aware, the Appellant contacted the software developer responsible for the dispensing application. The developer corrected the GP request form to produce both the generic and brand name of the item being requested. This issue is historic since their software has now been altered. When it is said that medication was ordered by the Appellant's pharmacy; 4.1.19 NHS England has failed to respond to this - it appears to have answered a different question. NHS England has not properly particularised the dates when it is said the Appellant submitted a repeat prescription request for the generic medication in the place of the branded product. It would appear that this failure is a result of NHS England's failure properly to investigate this matter. 4.1.20 In order for this allegation to be found proved, NHS England must identify which requests it alleges were incorrectly made by the Appellant. The identity of the patient for whom it is said medication was ordered; 4.1.21 It is unfortunate that NHS England has failed to provide the full string of emails that passed between the Appellant and NHS England to obtain this information to allow the Appellant to investigate matters. 4.1.22 NHS England has failed in its basic duty to provide full disclosure of all relevant material in this case, both material which assists NHS England and material which assists the Appellant. 4.1.23 Now that NHS England has purported to identify the relevant patients, the Authority will note that this allegation appears to relate to a very small number of patients (3). This must be placed in the context of a pharmacy which provides pharmaceutical services to many thousands of patients a year. The identity of the patient's GP by whom it is said a prescription was issued; 4.1.24 It is unfortunate that the Arlington Road Practice failed to contact the Appellant directly regarding its concerns. They have had no complaints from any other practice or the care homes that it serves. Again, it is necessary for the Authority to put this matter into the proper context. Details of the GP's systems for prescribing medication; 4.1.25 As the Authority will no doubt be aware, the statement that all GP prescribing systems produce a standard repeat slip is incorrect. There is no "standard" repeat prescribing system. 4.1.26 NHS England's inability to answer this question suggests that NHS England has failed to identify what software the GP operates. This is evidence of NHS England's failure properly to investigate this matter. The Authority cannot conceivably conclude that the system that the Appellant operates is less safe than the GP's system without knowing what system the GP currently operates. The circumstances in which it is alleged the Appellant ordered such medication; Details of the patient's previous prescribing history; Details of any action taken against the GP who, it would appear, prescribed medication which he had not previously prescribed; Why it is alleged the Appellant's actions amount to a breach of the terms of service in relation to which it is necessary for NHS England to issue a remedial notice. 4.1.27 Because NHS England has failed properly to particularise this allegation and has failed to provide any, or any sufficient, evidence in support of its allegation, it is still not clear exactly what the Appellant is alleged to have failed to do, why it is said that failure amounts to a breach of the terms of service and why it is said that breach is sufficiently serious (and continuing) that it is necessary or proportionate to issue a remedial notice. 4.1.28 For example, NHS England states "In addition, if the pharmacy is supplying generic medication against a prescription ordering branded product, but submitting a claim for a branded product, they could be paid . for the branded product. This is often more expensive than the generic product." Is NHS England alleging that the Appellant supplied a generic product against a prescription calling for a branded product? If so, which supplies and what is the evidence that the Appellant claimed for payment of the brand but supplied the generic version? If not, why has NHS England included this paragraph in its response? 4.1.29 As far as can be identified from the replies given, NHS England appears to suggest that the Appellant issued a repeat prescription request for a generic version of a branded medication at some unspecified time (perhaps the 23rd August 2013) for a very small number of patients (three) who are all registered with Dr Jones and live in one care home. Notwithstanding that request, it appears that Dr Jones prescribed a branded product, not the generic version. As far as the Appellant is aware (and there is no evidence to the contrary), the patients received a branded medicine. It would appear that Dr Jones did not contact the pharmacy, but raised a complaint with NHS England. NHS England investigated and, after numerous requests, provided sufficient information to allow the Appellant to investigate. Upon investigation, the Appellant identified a software issue which was resolved many months ago. No further concerns have been raised since. Even if those facts were found proved, they do not amount to a breach of the terms of service or, if they do, such breach is trivial in nature and does not justify the imposition of a remedial notice. Indeed, it does not appear that these facts are relied upon by NHS England to support its allegation, which relates to the repeat prescription ordering process itself, not requests for the three patients referred to by NHS England. 4.1.30 Whilst it is not properly particularised, NHS England's allegation in relation to the "repeat ordering process" appears to relate solely to the suggestion by NHS England that care home staff are required to "transcribe" the required medication. 4.1.31 This suggestion is both incorrect and is not supported by any evidence. For example, as far as the Appellant is aware, NHS England has not obtained statements from any employees at the care homes involved. At best, NHS England is hypothesising. NHS England includes quotes from "transcribing guidance", but it is not clear what this guidance is produced in respect of or why it is relevant to the Appellant's system. NHS England has failed to produce the guidance document itself. 4.1.32 Instead of the system used by the Appellant, NHS England suggests that the Appellant should use the "standard" repeat ordering request form, but no such "standard" form exists, nor can NHS England identify why it is said the Appellant's current system is in breach of the terms of service but using the "standard" form would not be. If it is suggested that using "standard" forms eliminates any scope for error, then this is clearly incorrect and is not supported by any evidence from NHS England. For example, a recent survey by the Appellant of a 12 bed home's repeat slips using the GP-produced request forms identified an extraordinarily high error rate, with repeat slips containing discontinued and expired items. 4.1.33 The Appellant has in place a system for reordering repeat prescriptions. This is set out in SOPs. Those SOPs have been produced in accordance with the Appellant's statutory and ethical obligations. No evidence has been produced by NHS England to the contrary. Even if NHS England had produced credible and cogent evidence regarding the nature of the Appellants "repeat ordering process", no evidence whatsoever is produced to prove, on balance, that their process is in breach of the terms of service. 4.1.34 NHS England is seeking to use the remedial notice procedure for an unlawful purpose namely to impose a system of operation the Appellant without any legal or ethical basis and without any evidence that their existing system is contrary to the terms of service. The repeat prescription ordering process used by the pharmacy has
resulted in some items to be switched from a branded product to
generic product (or vice versa)

4.1.35 Since it would now appear from NHS England's response that this allegation is a repeat of the previous one, Charles Russell LLP will not repeat the information given above. 4.1.36 However, in addition to the above, the Authority will be aware that NHS England has produced no evidence to support a finding that any patient's medication has been "switched". Indeed, NHS England confirms that the patients were prescribed the branded version notwithstanding the information provided in the repeat request, so no items were "switched" from branded to generic. This is confirmed in NHS England's reply to 2.2(vii) where it is stated that the GP prescription clerk identified that a generic had been requested but a branded medication previously supplied and a prescription for the branded version was written. 4.1.37 In its remedial notice, NHS England alleged that 'The repeat ordering process used by the pharmacy has resulted in some items to be switched from a branded product to generic product (or vice versa)". (emphasis added). However, it is clear from NHS England's response to paragraph 2.2(ii) of the Appellant's letter of appeal (which referred to this alleged breach) that, contrary to the original allegation made, no items have been switched from a generic product to a branded product (i.e., there is no "vice versa"). The repeat prescription ordering process used by the pharmacy relied
on a number of transcribing processes rather than the GP generated
repeat slips, thus increasing the likelihood of errors

4.1.38 Again since it would now appear from NHS England's response that this allegation is a repeat of the first allegation, Charles Russell LLP will not repeat the information given in relation to paragraphs 2.1 and 2.2 above. 4.1.39 NHS England has produced no evidence whatsoever that the Appellant's system for ordering repeat medication "increases the likelihood of errors". The Appellant asserts that its system is no more likely to cause errors than using "GP generated repeat slips" and, indeed, they considers that its system is less likely to lead to errors. 4.1.40 There is no evidence that the Responsible Pharmacist has failed in either his legal or ethical obligations. NHS England is unable to identify any legal or ethical obligation on the Responsible Pharmacist to use "GP generated repeat slips". The Appellant asserts that this is because no such obligation exists. The Surrey and Sussex Area Team has not received, on a regular basis,
any Certificates of Conformity (COC) or Certificates of Analysis (COA)
for non-licensed medicines that have been supplied on an NHS
prescription; as is required by the terms of service described in the
Drug Tariff

4.1.41 The Appellant has complied with the requirements of the Drug Tariff. Copies of the documents referred to for the items contained within appendix 5 were sent by post to the NHS South East Coast Strategic Health Authority following the Contract Monitoring visit by Mr Hedley. 4.1.42 It is not clear from the information provided by NHS England whether it accepts that this information has been received. If it does, then the Appellant is not in breach of its terms of service and it is neither necessary nor proportionate for NHS England to issue a remedial notice. It is does not, then further copies can be sent, but it is neither necessary nor proportionate for NHS England to issue a remedial notice to obtain this information. A patient was not provided with medication that had been prescribed by
the patient's GP as a result of market shortage of the medicine. The
pharmacist should ensure that in the event of a shortage of medication
for any reason, the prescriber is contacted so that alternative
arrangements or medication can be made to ensure that the patient
always receives appropriate treatment of their condition

4.1.43 It is evident from the response given by NHS England that there has never been any complaint made in relation to this allegation. It would appear that NHS England has stumbled upon this after reading a report completed on behalf of a former PCT. NHS England has then added it as an allegation in its remedial notice without even being in a position to identify the patient. NHS England has no first hand knowledge of this matter, nor, it would appear, has it sought to investigate it. NHS England has not even produced a copy of the report to which it refers. This allegation has not been properly particularised, nor has NHS England produced any evidence in support of it. NHS England is a statutory body. It has public law duties, including duties to act fairly, openly and transparently. Including this allegation against the Appellant breaches each one of those public law duties. It also goes against all accepted tenets of natural justice, since it denies the Appellant the opportunity to investigate and/or question the person making the allegation. 4.1.44 Charles Russell LLP have no doubt that the Authority will approach this allegation with the utmost caution, and will be extremely concerned with its inclusion in the remedial notice. 4.1.45 The Authority will also no doubt have in mind the ongoing issue in relation to stock shortages of particular branded medicines in the UK. There is no evidence whatsoever that the Appellant has acted unlawfully or unethically, nor that its actions are in breach of the terms of service which require all pharmacists to provide medicines with reasonable promptness (emphasis added). Non-compliance with GPhC best practice regarding the maintenance of
controlled drugs registered rolling balances

4.1.46 It appears to be accepted by NHS England that there is no legal requirement to keep and maintain controlled drugs register running balances. There is also no ethical obligation upon a pharmacist to do so. Whilst the GPhC has issued "guidance", this is neither legally nor ethically binding. Even if a pharmacist were not to maintain running balances, this would not be a breach of the NHS terms of service since the terms of service do not include an obligation to maintain running balances. 4.1.47 NHS England seeks to use the remedial notice procedure for an improper purpose, namely to impose an obligation upon the Appellant which is neither a legal nor ethical obligation contained within the terms of service. 4.1.48 For the avoidance of doubt, the Appellant complies with its legal obligations in relation to the keeping and maintenance of controlled drugs registers, including weekly stock checks where appropriate. 4.1.49 In conclusion, for each of the allegations made by NHS England, the Authority is invited to consider: 4.1.49.1what facts NHS England purports to rely upon in support of its 4.1.49.2whether any, or any sufficient, evidence has been produced by NHS England to satisfy the Authority, on balance, that the facts alleged are true. 4.1.49.3whether any facts found true support the allegations made in the remedial notice. 4.1.49.4whether those allegations amount to a breach of the terms of service. 4.1.49.5whether any such breaches had been remediated prior to the remedial notice being issued. If they had, a remedial notice is inappropriate. 4.1.49.6where any breaches had not been remediated prior to the remedial notice being issued, whether it is necessary and proportionate in all the circumstances to issue a remedial notice. 4.1.50 The Authority must be satisfied in relation to each of the paragraphs (1) to (6) above for each of the allegations. If the Authority is not satisfied in relation to each of the paragraphs (1) to (6) above for each of the allegations then the Authority must uphold the appeal for that allegation. 4.1.51 If the Authority considers that one or more of the allegations has been found proved, the Authority should then "step back" and consider whether, having regard to the matter(s) found proved, it is necessary and proportionate to issue a remedial notice. If the Authority is not satisfied that it is necessary and proportionate then the appeal should be upheld. Head of Appeal 1: Alleged failure of NHS England to comply with Regulation 69
Under Regulation 69(1) of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 ("the Regulations"), before issuing a remedial notice, NHS England must: "make every reasonable effort to communicate and co-operate with an NHS chemist (C) with a view to resolving any dispute between [the chemist] and the NHSCB relating to [the chemist's] compliance with [the chemist's] terms of service". The Regulations contain no definition of what constitutes "reasonable effort to communicate and co-operate". The Appellant alleges that NHS England has failed to comply with the above duty. From the information provided, there appears to be some disagreement as to the content of discussions, as to NHS England's attempts to contact the Appellant prior to issuing the remedial notice, and as to whether the discussions that did take place amounted to a reasonable effort to communicate and co-operate. NHS England states that a number of complaints were addressed directly with the Appellant following a contract monitoring visit on 6 June 2013. It comments that this visit had been attempted the previous week. The Appellant concedes that that proposed earlier visit did not take place because the visit date had been incorrectly recorded by the Appellant and the actual proposed date was then not convenient for the Appellant. NHS England submits that during the 6 June visit, the Area Team Contract Manager (Mr Mike Hedley) raised some of the concerns which had been directed to the Area Team. It states that Ms Wenyon (the responsible pharmacist) and Mr Pilsbury (the Managing Director) indicated that the Appellant's prescription re-ordering process was not at fault and that the blame lay with the GP practices: advice was given and Mr Hedley asked that the Appellant consider revising its system. The Appellant does not agree that the above is an accurate reflection of the outcome of the visit. An email was subsequently sent to Ms Wenyon (cc'd to Mr Pilsbury) on 28 August 2013 with details of further complaints received by NHS England. This email, which appears as Appendix 1 to the NHS England letter dated 23 December 2013, states that the same type of issues had been discussed during the contract monitoring visit that took place earlier that year. The subsequent email from the Appellant does not dispute this fact, suggesting that, in accordance with NHS England's position, concerns were in fact raised at the contract monitoring visit. NHS England argues that the Appellant's reply (to the NHS England email of 28 August) dated 9 September 2013, demonstrates that Mr Pilsbury misunderstood the concerns raised, leading to the Area Team Contract Manager seeking to speak to him via phone. NHS England records that Mr Pilsbury was very defensive during this call. NHS England indicates that it emailed Mr Pilsbury on 11 September 2013. A copy of that email is referred to, but has not been included among the appendices to the 23 December 2013 letter. I have received no explanation of the purpose or content of the email. I know only that NHS England says that no reply has been received in response to it. NHS England submits that the Area Team Contract Manager, Mr Hedley, attempted to contact the Appellant's responsible pharmacist, Ms Wenyon, by phone on numerous occasions between 9 September 2013 and 7 October 2013 to discuss the complaints received, and he was informed that she was unavailable. He subsequently attempted to contact her via email using her named and general business accounts, copying these to Mr Pilsbury. NHS England have not provided evidence of the calls (including the telephone number or location from which the calls are said to have been made) but nor do I have evidence in support of the Appellant's suggestion that the calls were not made. I consider, however, that the circumstances of this case fall within Regulation 69(3)(b)(ii). This entitled NHS England to issue (and effectively entitles the Authority to 're-issue') a remedial notice immediately without reference to the requirement to make every reasonable effort in order to protect the safety of any persons to whom the Appellant may provide pharmaceutical services. It is apparent from the evidence provided that NHS England has received a number of complaints regarding the Appellant's provision of pharmaceutical services to members of the public. It is also clear that NHS England has concerns regarding the provision of these services, including in relation to the Appellant's repeat ordering process. This is clear from NHS England's email of 28 August 2013, in which they expressly state that the issues raise concerns for patient safety. Whilst the Appellant states that NHS England's understanding of their repeat prescription ordering process is incorrect, nevertheless it appears from the evidence provided, which I consider in more detail below, that there have been issues regarding the provision of medication to those in receipt of the Appellant's pharmaceutical services, such that patient safety may have been compromised. Heads of Appeal 2 and 3: Alleged failure properly to particularise the alleged breaches /
to provide evidence, and alleged disproportionate action

The Appellant states that NHS England has failed to properly particularise the allegations, contrary to Regulation 70(2)(a). This regulation states that a remedial notice must include "the nature of the breach." The Department of Health guidance "Performance sanctions including market exit for contractors providing pharmaceutical services" (published in August 2012 and revised in November 2013) to which NHS England is to have regard, states that, with regards to remedial notices, the nature of the breach should include: "…what the contractor has or has not done and which term of service this breaches". I have considered the allegations made by NHS England and am of the view that – in relation to some of the matters raised in the notice – the notice sets out sufficiently the nature of the breaches in question. I therefore consider that the above regulation has been met to the extent set out below. The Appellant also suggests that NHS England has failed to provide evidence of the allegations contained within the remedial notice. Where necessary, we have addressed this below. The Appellant also suggests that the decision to issue a remedial notice is disproportionate. The service of a remedial notice is discretionary and this is therefore a relevant consideration. This too is addressed below. Alleged breach 1: The repeat prescription ordering process used by the
pharmacy has led to medication being ordered from a patient's GP which had
not previously been prescribed for the patient.

Repeat ordering process
I have considered the conflicting views regarding the Appellant's re-ordering process. It is apparent from the evidence provided that NHS England has received a number of complaints regarding the Appellant's provision of pharmaceutical services to members of the public. It is also clear that NHS England has concerns regarding the Appellant's provision of these services, such as processes for dealing with repeat prescriptions. The Appellant states that NHS England's understanding of their repeat prescription ordering process is incorrect and has provided some partial information about some aspects of its systems of operation. I am not in a position to set out exactly the full nature of the Appellant's processes and I have treated the reference to the "repeat ordering process" as a general term for the actions of the Appellant in connection with the provision of medication. It is apparent from the evidence provided by NHS England, and acknowledged by the Appellant, that there have been issues of concern with the provision of medication. Medication ordered by the Appellant
The alleged breach relates to the Appellant requesting medicines for patients who have never previously been prescribed them. In particular, it appears that the generic products  Metformin MR (500mg)  Donepezil  Memantine  Entacapone (200mg)  Levodopa (150mg)  Carbidopa (37.5mg) were ordered for the patients in question, when branded products had been specified by the prescriber. The Appellant raises concerns that the dates on which these items are said to have been requested are not specified, and therefore this allegation cannot be proved. I consider that sufficient information has been provided by NHS England to evidence a breach. NHS England states that concerns were raised by the relevant GP Practice on 28 August 2013 and has provided a subsequent email received from the relevant GP practice. The emails sent by the Appellant to NHS England (in response to NHS England's concerns) do not deny that requests were made but rather offer an explanation as to why they may have occurred. It appears that the issues are therefore sufficiently well known to the parties. In any event, NHS England has provided further information in relation to this alleged breach such as the medication history of the patients in question. This demonstrates that the patients have not previously been prescribed the medication requested by the Appellant. NHS England therefore had cause to consider issuing a remedial notice. In assessing whether it was proportionate for NHS England to issue such a notice, I have examined each medicine request in turn. Donepezil and Memantine requests
As explained above, I am satisfied that the two above medications were requested by the Appellant despite the patient in question not having previously been prescribed them. However, I am not satisfied that it was proportionate to issue a remedial notice in respect of these breaches. The Appellants explain in their email (Appendix 2 to NHS England's letter dated 23 December 2013) that the reason for any error was due to limitations with their dispensing software. The Appellant states that this issue has now been addressed. NHS England has not provided any evidence to the contrary. It appears that the Appellant has rectified this issue. This issue has therefore been remediated and it is not appropriate to issue a remedial notice with regards to the alleged ordering of these two medications. Metformin MR (500mg), Entacapone (200mg), Levodopa (150mg), Carbidopa
(37.5mg) requests

In relation to the remaining generic products requested, I am satisfied that it is proportionate to issue a remedial notice in the terms outlined by NHS England. The explanation given by the Appellant in relation to these medicines is that they have been part of the patient's treatment previously, and are listed on the prescription by a brand name. As explained above, having reviewed the patient's medication history I am satisfied that only the branded medication has been prescribed. I consider that no satisfactory explanation has been provided in relation to this issue. Although the number of known patients is small, I do not consider that a remedial notice would therefore be disproportionate A remedial notice may be issued when a pharmacist breaches a term of service. In this case, the relevant term of service is that set out in Schedule 4, paragraph 4 (read together with paragraphs 5 and 8). Regardless of how many patients are known to have been affected, this represents a genuine and potentially ongoing concern and I consider a remedial notice to be proportionate and justified. The information available to me indicates that the situations described should have been prevented. The remedial step is therefore appropriate in general terms although it should take proper account of the overall provisions of Part 2 of Schedule 4. Given the interconnection of these matters with those set out in alleged breach 2, a single revised remedial step is set out below under that heading. Alleged breach 2: The repeat prescription ordering process used by the
pharmacy has resulted in some items to be switched from a branded product to
generic product (or vice versa)

This alleged breach appears to be based on the same facts and circumstances as detailed above. For the reasons explained above, I am satisfied that the available information demonstrates a breach of the Appellant's terms of service in that generic products were requested when the branded product was prescribed. For the reasons explained above, I am of the view that the decision to issue a remedial notice was proportionate and justified. However, the terms of the breach alleged by NHS England are set out as follows: "The repeat prescription ordering process used by the pharmacy has resulted
in some items to be switched from a branded product to generic product (or
vice versa)"
(emphasis added)
While there is evidence to suggest that generic items were provided rather than prescribed branded items, there is no evidence to demonstrate that branded items have been provided rather that prescribed generic items. NHS England has confirmed that this latter situation has never been part of their concerns. I am satisfied that the remaining generic products were requested (when a corresponding branded product had been prescribed) and that the issue of a remedial notice - in the terms outlined with the final three words which appear in brackets - is proportionate and justified. The information available to me indicates that the situations described should have been prevented. The remedial step is therefore appropriate in general terms although it should take proper account of the overall provisions of Part 2 of Schedule 4 in a single revised remedial step, covering the matters in alleged breaches 1 and 2, which reads: "The Appellant must, within 28 days, review and modify its systems to ensure that (subject to provisions of Part 2 of Schedule 4 to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulation 2013 which may allow otherwise) only items that have previously been prescribed by the patient's GP on a repeatable basis may be the subject of a request to the GP practice for approval of dispensing by the Appellant. Where the item prescribed is a branded item, such requests must be for that branded item." Alleged breach 3: The repeat prescription ordering process used by the
pharmacy relied on a number of transcribing processes rather than the GP
generated repeat slips, thus increasing the likelihood of errors

Regulation 70 provides that a remedial notice may be issued where an NHS chemist breaches a term of service and the breach is capable of remedy. Having considered the evidence provided by the Appellant and NHS England, I am of the view that the alleged breach does not constitute the breach of a term of service. It is therefore not appropriate for a remedial notice to be issued in respect of this alleged breach. Although the process described may be inadvisable, no evidence is provided which shows that it amounts to a breach. Alleged breach 4: The Surrey and Sussex Area Team has not received, on a
regular basis, any Certificates of Conformity (COC) or Certificates of Analysis
(COA) for non-licensed medicines that have been supplied on an NHS
prescription; as is required by the terms of service described in the Drug Tariff

Regulation 11(1)(b) includes obligations set out in the Drug Tariff as a part of the Appellant's terms of service. That includes the following provision which appears in Part VIIIB: "For specials not listed in this Part, the contractor or his representative must stamp, date, initial and endorse the Certificate of Analysis (COA)/Certificate of Conformity (COC) with the invoice price less discount and prescriber's details. At the end of each month, the contractor shall send a copy of the appropriately endorsed COA/COC to the NHSCB of the prescriber, allowing the NHSCB to match expenditure to the special supplied." NHS England has provided a document setting out specials medication supplied by the Appellant from January 2013 to September 2013 for which a COA or COC should have been sent to NHS England, the name by which NHSCB is commonly known (or to its predecessor). A copy can be found at Appendix 5 to the NHS England letter dated 23 December 2013. NHS England indicates that it has not received any information pursuant to the paragraph of the Drug Tariff set out above since January 2013. The Appellant states that it has complied with the requirement to provide a COA or COC for non-licensed medicines that have been supplied on an NHS prescription. It submits that copies of the COA/COC for the items referred to within the document supplied by NHS England were sent by post to the NHS South East Coast Strategic Health Authority ("the SHA") following the contract monitoring visit by Mr Hedley on 6 June 2013. The Appellant states that if the information has not been received further copies can be sent. It therefore submits it is neither necessary nor proportionate to issue a remedial notice to obtain this information. Subject to any transitional arrangements, certificates relating to the period prior to 1 April 2013 should have been sent to NHS England's predecessor. Certificates relating to the period since 1 April 2013 should have been sent to NHS England. While there is no obligation to confirm receipt of information, in order to comply with the requirement to send the information to NHS England, the Appellant must send information which is complete and ensure that it is correctly addressed. In this case, there has clearly been a failure to comply with that latter requirement. For reasons which are not clear, the Appellant sent the information on or after 6 June 2013 to the SHA – an organisation which had ceased to exist on 31 March 2013. Copies of the documents should have been provided to NHS England (via the Surrey and Sussex Area Team) - as confirmed in the remedial notice dated 31 October 2013. The Appellant has therefore failed to comply with its terms of service. I consider that a remedial notice is justified and proportionate. The remedial notice dated 31 October 2013 states to whom the COA/COC should be sent. The Appellant admits that it sent copies of the documents to the now abolished SHA. This should have led the Appellant to realise that the documents had not been provided in accordance with their terms of service. NHS England's representations dated 23 December 2013 make clear that the COA/COC had still not been received from the Appellant since January 2013. Despite the issue being brought to the attention of the Appellant within the remedial notice of 31 October 2013, and referred to again in NHS England's representations of 23 December 2013, NHS England are yet to receive copies of the COA/COC. Even if it had failed to understand its obligations previously, the Appellant has known since receipt of the 31 October remedial notice that the information had not been sent to the correct addressee and yet has failed to provide the required information. It is therefore reasonable and proportionate to require the Appellant to provide the information by way of remedial notice. The information available to me indicates that the failure described should have been prevented and is ongoing. Although part of the period relates to a time when NHS England had not yet assumed responsibility for receipt of the certificates, NHS England appears to be the appropriate body to receive historic data. The following remedial step is therefore appropriate: "The Appellant must, within 28 days, send correctly endorsed certificates of analysis/conformity relating to the period from January 2013 to date to NHS England Surrey and Sussex Team in Horley and send future certificates on a monthly basis without delay." Alleged breach 5: A patient was not provided with medication that had been
prescribed by the patient's GP as a result of market shortage of the medicine.
The pharmacist should ensure that in the event of a shortage of medication for
any reason, the prescriber is contacted so that alternative arrangements or
medication can be made to ensure that the patient always receives appropriate
treatment of their condition

I note the Appellant's comment that no complaint appears to have been made in relation to this allegation, and that the concern arises instead out of a report brought to the attention of NHS England. I consider it irrelevant how an alleged breach of the Appellant's terms of service comes to the attention of NHS England but acknowledge that there must be sufficient evidence to demonstrate that a breach has occurred. I do not consider that I have sufficient evidence in this case. NHS England has stated that this medication was supplied in August 2012 and that the information was extracted from a report completed on behalf of the Brighton and Hove PCT in August 2013. (This latter would appear to be inaccurate as the PCT had by that date ceased to exist.) No details have been provided as to the patient or the circumstances surrounding this allegation. I note NHS England's representation that Springfields Nursing Home was informed by the Appellant that there were "supply issues" concerning the medication in question (although the basis for that representation is unclear). It is a requirement under the Appellant's terms of service that any drugs ordered should be supplied promptly. On the little information provided, I am unable to form a view on whether drugs were provided promptly in this case. I have received no direct evidence (if there is any) which would be supportive of the facts as presented by NHS England. Accordingly, I am not satisfied that there has been a breach of the terms of service. Alleged breach 6: Non-compliance with General Pharmaceutical Council
("GPhC") best practice regarding the maintenance of controlled drugs
registered rolling balances

There is disagreement as to whether non-compliance with GPhC "best practice" constitutes a breach of its terms of service. Paragraph 29 of Schedule 4 to the Regulations states that an NHS pharmacist must: "provide pharmaceutical services and exercise any professional judgement in connection with the provision of such services in conformity with the standards generally accepted in the pharmaceutical profession." NHS England seeks to rely on Principle 6 of the GPhC's Standards of conduct, ethics and performance ("the Standards"), headed "Be honest and trustworthy", which provides that pharmacists must "comply with legal and professional requirements and accepted guidance on professional practice." NHS England submits that not following GPhC guidance regarding the maintenance of controlled drugs registers rolling balances would be a breach of Principle 6 of the Standards, which in turn is a breach of the Appellant's terms of service. The Appellant is of the view that the GPhC guidance is neither legally nor ethically binding, and that it would not be a foundation for any claim of a breach of the terms of service. It considers that NHS England has made use of the remedial notice for an improper purpose. I have not been provided with any guidance published by the GPhC, with the title of any such guidance or referred to any such guidance. I am therefore unable to determine the status of any such guidance and whether the Appellant has followed it. In these circumstances I am of the view that it is not appropriate for a remedial notice in relation to this issue. Decision
I am satisfied that the issue of a remedial notice immediately pursuant to Regulation 69(3)(b)(ii) was and is justified in order to protect the safety of any persons to whom the Appellant may provide pharmaceutical services. For the reasons outlined, the Authority substitutes the following as the terms of a remedial notice pursuant to Regulation 70: in place of the matters set out in relation to the first and second alleged breaches in the original remedial notice- the first breach as set out in the original notice, the second breach as set out in the original notice, but with the removal of the final words "(or vice versa)" the following remedial action - The Appellant must, within 28 days, review and modify its systems to ensure that (subject to provisions of Part 2 of Schedule 4 to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulation 2013 which may allow otherwise) only items that have previously been prescribed by the patient's GP on a repeatable basis may be the subject of a request to the GP practice for approval of dispensing by the Appellant. Where the item prescribed is a branded item, such requests must be for that branded item. in place of the matters set out in relation to the fourth alleged breach in the original remedial notice - the breach as set out in the original notice, the following remedial action - The Appellant must, within 28 days, send correctly endorsed certificates of analysis/conformity relating to the period from January 2013 to date to NHS England Surrey and Sussex Team in Horley and send future certificates on a monthly basis without delay.
Lisa Hughes
Head of FHS Appeal Unit

A copy of this decision is being sent to:
Charles Russell LLP, on behalf of Medication Delivery Services Ltd
NHS England - Surrey & Sussex Area Team

Source: http://www.litigation.nhs.uk/fhsau/Documents/17452%20-%20Pharmaceutical%20Decisions%20(2013).pdf

Microsoft word - 0025_shmehr_excerpt 008-final.doc

Arch Iranian Med 2008; 11 (2): 238 – 241 Excerpts from Persian Medical Literature Pediatric Tumors of the Liver: A Ten-Year Study The aim of this study was to review the frequency, histopathology, and outcome of hepatic tumors in In this retrospective descriptive study, medical records of 30 children treated for liver tumors from 1996