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1 BRITISH PHARMACOPOEIA COMMISSION Expert Advisory Group _EAG by dfsiopmhy6

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									               BRITISH PHARMACOPOEIA COMMISSION
             Expert Advisory Group (EAG): Nomenclature (NOM)
                           SUMMARY MINUTES

A meeting of the Expert Advisory Group on Nomenclature was held at Market
Towers, 1 Nine Elms Lane, London, SW8 5NQ on 9 February 2010.

Present: Dr J K Aronson (Chairman), Dr L Tsang (Vice-chairman), Dr M Ahmed, Dr
G P Moss and Miss C Preston.
In attendance: Dr P Holland, Mr A Evans, Miss L Schachar and Mrs M Barrett.
Apologies: Mr P W Golightly and Dr R Thorpe.

INTRODUCTORY REMARKS
Welcome The Chairman welcomed members to the meeting and congratulated Mrs
Schachar on her recent marriage.

I     MINUTES
76    The minutes of the meeting held on 16 February 2009 were accepted.

II    MATTERS ARISING FROM THE MINUTES
77    The following matters arising from the Minutes were noted.
      Minute 65 British Approved Names 2007 Supplement No. 3 This had been
      published in August 2009. Members confirmed receipt of copies, which had
      been distributed in September 2009.
      Minute 70 Biosimilars – Update The Biologicals Working Party would be
      preparing a supplementary chapter on Biosimilars. EAG NOM Experts would
      be invited to comment on the draft text at the earliest opportunity.

III   REPORTS AND CORRESPONDANCE
78    General Matters                                                    NOM(10)1
      Membership A list of current members of EAG NOM was provided for
      information. Members were invited to notify the Secretariat of any necessary
      amendments to their contact details.

      Nomenclature Experts The difficulty in identifying nomenclature experts
      who would be suitable candidates for participation in the work of EAG NOM
      was acknowledged. Dr Moss undertook to advise on suitable candidates in
      chemical nomenclature. It was suggested that the Secretariat should contact
      the Royal Pharmaceutical Society about identifying a person with expertise in
      Pharmacy practice and who ideally would have an interest in drug
      nomenclature.

      Contribution from the NPSA Since the departure of Dr Warner, the NPSA
      had been invited to nominate a person for consideration by the BP
      Commission to become a member of EAG NOM. A response was awaited
      from Professor Cousins. It was important to retain a working relationship
      between the BP Commission and the NPSA, in particular in working together
      to minimise medication errors due to names.




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     Resignation Dr McNaught had resigned as a full member of EAG NOM. He
     had expressed a willingness to participate in the work of EAG NOM as a
     corresponding member. This would be drawn to the attention of the BP
     Commission, and they would be invited to approve the change in designation.

     Relocation The MHRA London office would be relocating from Nine Elms
     Lane to Buckingham Palace Road, Victoria later in the year. Full occupancy
     by staff was expected to occur during September 2010.

79   Market Towers Fire Evacuation Assembly Point                         NOM(10)2
     Members noted the fire evacuation protocol in the event of a fire at Market
     Towers. Experts were invited to inform the Secretariat if they would require
     special assistance in the event of a fire.

80   Action and use statements
     Nicorandil Tablets BP; Ephedrine Injection BP                        NOM(10)3
     Nicorandil Tablets The action and use statements in the British Approved
     Names 2007 book were reviewed to achieve consistency; when practicable,
     the pharmacological action was given prominence in the statement. Attention
     was drawn to the BP General Notices, which alluded to the fact that the
     published action and use statements in the BP are intended only as information
     on the principal pharmacological actions or uses of the materials in medicine
     and pharmacy. The user was advised not to assume that the substances had no
     other actions or uses in addition to those published.

     Members discussed the need to expand the published action and use statement
     for nicorandil to include ‘vasodilator used in cardiac diseases’. The above
     statement had originated from the WHO ATC classification system. It was
     commented that the ATC classification system had different uses, for example
     for re-imbursement of cost of the drug to the dispenser by a national health
     authority. It also had legal connotations, as for instance it was used for
     competition clearance in the UK. It was accepted that nicorandil was a
     vasodilator used for vascular diseases that affected the heart. EAG NOM could
     not predict future approved licensed therapeutic indications of nicorandil. It
     was agreed to amend the published action and use statement from ‘Potassium
     channel opener’ to ‘Potassium channel opener; vasodilator’.

     Ephedrine Injection It was agreed to amend the published action and use
     statement to ‘Adrenoceptor; reversal of hypotension from spinal and epidural
     anaesthesia’. It was noted that it would be undesirable to administer ephedrine
     to all patients with hypotension.

     Unlicensed Medicines The expert advisory group with responsibility for
     unlicensed medicines would be seeking advice from EAG NOM on
     consistency between published action and use statements for unlicensed
     medicines and those for licensed medicines. The necessary information would
     be distributed to EAG NOM Experts at the earliest opportunity.




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81   British Approved Names 2007                                      NOM(10)4
     Supplement No. 4
     A draft British Approved Names 2007 Supplement No. 4, with 17 new entries,
     was presented. The selection of names had been based on licensed products
     available in the UK. Most of these had published rINNs, which would be
     adopted as the BANs. Technical and editorial comments on the graphic
     formulae and the systematic names had been received from Dr Moss before
     the meeting. Comments made at the meeting are outlined below.

     Botulinum Toxin A Delete the draft entry.

     Rifaximin The action and use statement would be changed to ‘Antibacterial;
     treatment of infective diarrhoea’. An appropriate symbol showing that it is for
     veterinary use only would be added to the entry.

     Romiplostim The action and use statement would be changed to ‘ Fusion
     protein analogue of thrombopoietin; treatment of idiopathic thrombocytopenic
     purpura’.

     Botulinum Toxin A; Haemagglutinin Botulin Toxin A – Haemagglutinin
     complex was licensed in the UK for treatment for cervical dystonia and focal
     spasticity; some of the products were licensed for cosmetic purposes.
     Members discussed the need to adopt the name Botulinum Toxin A as a BAN.
     It was agreed that this was an established chemical name and that it was not
     necessary to include it in the list of BANs. Likewise, the name haemagglutinin
     was a well established name in the UK, and a published BAN was not
     required.

     Salicylic acid; Lactic acid The need to adopt both salicylic acid and lactic
     acid as BANs, as they were the two active constituents in the licensed product
     Salactol was discussed. Both lactic acid and salicylic acid were well
     established chemical names and it was not necessary to publish either as a
     BAN.

82   British Approved Names 2012                                           NOM(10)5
     It was intended to publish a new edition of the British Approved Names book,
     to come into effect in 2012. This would incorporate Supplements 1, 2, 3, and 4
     to the BAN 2007 and any new names of commercially available products in
     the United Kingdom for which there were published rINNs or which were
     included in the European Pharmacopoeia publications as monograph titles of
     the Ph Eur. Members were invited to comment on the suggested technical
     aspects listed below to be reviewed by means of BAN 2012. They were also
     invited to inform the Secretariat of areas in the publication that should also be
     reviewed.

     Radiopharmaceutical Preparations - Ph Eur Monograph Titles The
     current policy of the BP Commission was for Ph Eur monograph titles for
     which no BANs existed to be adopted as BANs. A list of Ph Eur monograph
     titles for Radiopharmaceutical Preparations that were not listed as BANs was
     received. Members discussed whether including names of all outstanding Ph


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     Eur monograph titles for radiopharmaceutical preparations in the BAN
     publication with a designated symbol would be beneficial to stakeholders. A
     clear consensus was not to include established chemical names, such as
     sodium fluoride, in the list of BANs, but to adopt those that were rINNs. In
     future, rINNs used in the naming of licensed radiopharmaceutical preparations
     that were commercially available on the UK market or adopted as Ph Eur
     monograph titles will be presented to the BP Commission for adoption as
     BANs.

     Co-names The list of co-names would be reviewed, to ensure that the correct
     spelling of rINNs had been used in the individual entries. For example,
     danthron would be replaced by dantron.

     Graphic Images The Secretariat would re-draw the images to make them
     compatible with the software being used for the publication. Members agreed
     to proof-read the re-drawn images to ensure accuracy.

     Pegfilgrastim The structure of the repeating units would be clarified,
     replacing ‘M’ by ‘Met’ to show that it is methionine. The re-drawn structures
     would be circulated to EAG NOM experts for comments.

     Cetirizine Add the name Cetirizine Dihydrochloride as a BANM.

     Post-translational modifications Dr Moss commented that more detailed
     information on post-translational modifications in biological substances would
     be helpful to users of the BAN publication. The need for more detailed
     information on linker pegols in the published list was noted. Dr Moss added
     that for conjugates in general, it would be beneficial if it was defined how the
     starting compounds were mixed. It was acknowledged that at the time of
     adoption of a non-proprietary name, detailed information, such as the number
     of sites pegylated, might not be well established. It was questioned whether
     there were clinical differences between commercially available epoetins. It
     was accepted that in general variation in post-translational modifications
     between two related compounds did not have a significant effect on efficacy,
     although occasionally there were adverse effects, such as red cell aplasia. It
     was agreed to harmonise any amendments in the BAN definitions of biological
     substances with those included in the list of INNs.

     Other comments A new edition of the IUPAC reference book on
     ‘Nomenclature of organic chemistry’ (the blue book) was currently being
     prepared. Dr Moss advised that once published, the systematic names in the
     BAN publications should be harmonised with the IUPAC preferred names.

83   Ph Eur Monographs Titles for Radiopharmaceuticals                    NOM(10)6
     Members discussed the request by the BP Commission Panel of Experts on
     Radioactive materials to advise on the use of parentheses and square brackets
     in the titles of Ph Eur monographs for radiopharmaceutical preparations.
     Monographs for radiopharmaceutical preparations included in BP publications
     were those of the European Pharmacopoeia Commission, reproduced for the
     convenience of the users of the BP. In cases of doubt or dispute, the user was


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     asked to make reference to the Council of Europe text.

     The monograph title is given according to the INN nomenclature. The
     radionuclide symbol follows the name of the entity that is or contains the
     element and is in parentheses. In the Ph Eur monographs for
     radiopharmaceutical preparations reproduced in the BP, the parentheses in the
     Ph Eur monograph titles had been replaced by square brackets.

     Use of parentheses and square brackets in isotopically modified
     compounds Members discussed the significance of the use of parentheses
     and square brackets in isotopically modified compounds. Following a detailed
     discussion, it was accepted that parentheses depicted complete radio-
     substitution of all the respective molecules by the radionuclide. The use of
     square brackets showed partial radio-labelling of the respective molecules by
     the radionuclide. It was commented that because of the nature of radioactivity,
     a compound in which all the molecules were radio-substituted would be highly
     unstable and was unlikely to exist.

     British Pharmacopoeia Publications
     It was agreed that taking into consideration the legal status of Ph Eur
     monographs in Member States and the information on ‘Isotopically Modified
     Compounds’ in IUPAC Nomenclature of Organic Chemistry (1979 edition),
     the Ph Eur monographs for Radiopharmaceutical preparations should be
     adopted in entirety for inclusion in the British Pharmacopoeia. No
     amendments were necessary for the entries in the BAN publications.

84   BP Monograph Titles - Review                                            NOM(10)7
     At the meeting of EAG NOM held in February 2009, it was noted that the
     Secretariat was investigating the feasibility of a project to rationalize the
     names of compounds in monograph titles. A desirable end result would be to
     harmonise the various naming conventions that had evolved over a long period
     of time. An extract from the minutes of EAG MC2 seeking advice on an
     appropriate monograph titles for Losartan Potassium Tablets and Etidronate
     Tablets was received.

     Members discussed the proposal to devise BP monograph titles based on how
     the strength of the active constituent was expressed in commercially available
     products. The committee reviewed how such an approach would affect current
     monograph titles, such as are described below. After discussion of the
     proposal and reflecting on the examples below, it was agreed in principle to
     base BP monograph titles on the strength of the active constituent of the
     formulation, subject to a demonstration of successful applicability to a large
     volume sample of published BP monograph titles.

     Enalapril Tablets BP In the published BP monograph for Enalapril Tablets,
     the tablets are defined as containing Enalapril Maleate. The strength of
     commercially available products is expressed in terms of Enalapril Maleate.
     Expressing the monograph title in terms of the expression of strength of the
     active substance in commercially available products, the revised monograph
     title would be Enalapril Maleate Tablets.


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     Chloroquine formulations There were published BP monographs for both
     Chloroquine Sulphate Tablets and Chloroquine Phosphate Tablets. The
     strength of commercially available tablets is expressed in the form of the salt
     together with the equivalent weight of the salt to the base. It was noted that in
     the BNF doses were expressed as Chloroquine base. There was a large
     difference in the dose given if the base or the salt was prescribed. This would
     be borne in mind in the review process.

     Etidronate Tablets For reasons of patient safety, it was agreed in principle
     that unless otherwise justified the name of the active constituent should come
     before the name of an associated counter ion, as for instance Etidronate
     Disodium and not disodium etidronate.

     Losartan Potassium Members’ attention was drawn to the extract of the
     minutes of EAG MC2, in which a member had commented that it was
     important to retain the counter-ion in the monograph title in the interest of
     transparency and to reduce confusion when the product was used. Following
     discussion by NOM experts, it was agreed that the clinical risk was very small.
     For instance, there had been very few published reports of hypernatraemia
     associated with the administration of sodium salt formulations. The need to
     retain names of counter-ions in BP monograph titles will be evaluated on a
     case by case basis and will form part of the wider review of BP monograph
     titles. The above discussion would be drawn to the attention of the BP
     Commission.

85   World Health Organization’s
     International Nonproprietary Names
     48th and 49th Consultation Feedback                              NOM(10)8
     It was noted that Executive Summary of both the 48th and 49th Consultations
     would be made available on the INN website in due course.

     Updated stem book; Bio-review Links to an updated electronic copy of the
     “The use of stems in the selection of International Nonpropprietary Names
     (INN) for pharmaceutical substances” and the “Bio-review” on the WHO
     website were included in the papers for the meeting.

86   Invented Names                                                      NOM(10)10
     The Secretariat had assessed 1054 invented names in 2009. The Secretariat
     was assessing names received directly from UK manufacturers before
     submission of a product licence application, in order to rule out names that
     were considered to be unacceptable.

87   Invented Names of Vaccines                                          NOM(10)11
     The EMA’s Names Review group (NRG) was in the process of discussing the
     use of the suffixes ‘-vac’, ‘-vaq’, and ‘-vax’ in invented names. Concerns had
     been expressed on the use of such suffixes, because they could be confusing to
     patients when used for certain types of medicines, as for instance
     immunotherapeutic products. Member states had reviewed established
     invented names incorporating these suffixes. The NRG would decide on a case


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     by case basis the acceptability of applications of names incorporating the
     above suffixes.

88   MHRA Product Name Guideline                                         NOM(10)12
     Members’ attention was drawn to the publication of the “MHRA Guideline for
     the Naming of Medicinal Products and Braille requirements for Name on
     Label”. The extensive input of the Secretariat, and in particular Adrian Evans,
     into the drafting of the guideline was acknowledged. A link to the electronic
     version of the document was included in the papers of the meeting.

89   Date of Next Meeting Tuesday, 8 February 2011




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Acronym/Synonym   Name
ATC               Anatomical Therapeutic Classification
ANDPB             Advisory Non-Departmental Public Bodies
AOAC              Association of Analytical Chemists International
API               Active Pharmaceutical Ingredient
BAN               British Approved Name
BANM              British Approved Name Modified
BHomP             British Homoeopathic Pharmacopoeia
BNF               British National Formulary
BP                British Pharmacopoeia
BP (Vet)          British Pharmacopoeia (Veterinary)
BPC               British Pharmacopoeia Commission
BPCRS             British Pharmacopoeia Chemical Reference Substance
BPL               Blood Products Laboratory
BRP               Biological Reference Preparation
BS                British Standard
BSP               Biological Standardisation Programme
CEP               Certification Procedure for the European Directorate for the
                  Quality of Medicines
CHM               Commission on Human Medicines
CP                Pharmacopoeia of the People’s Republic of China
CRS               Chemical Reference Substance
EAG               Expert Advisory Group
EPBRP             European Pharmacopoeia Biological Reference Preparation
EPC               European Pharmacopoeia Commission
EPCRS             European Pharmacopoeia Chemical Reference Substance
EU                European Union
FIP               International Pharmaceutical Federation
FOI               Freedom of Information
GC                Gas chromatography
GSL               General Sale List
HAB               German Homoeopathic Pharmacopoeia
HKCMMS            Hong Kong Chinese Materia Medica Standards
ICH               International Conference on Harmonisation
INNM              International Nonproprietary Name Modified
NOM               Nomenclature
pINN              Proposed International Nonproprietary Name
rINN              Recommended International Nonproprietary Name
ISO               International Organisation for Standardisation
JP                Japanese Pharmacopoeia
LC                Liquid chromatography
LD                Licensing Division
LGC               Laboratory of the Government Chemist, Teddington
LR                BP Laboratory Report
MAIL              The MHRA updating service for medicines
MAH               Marketing Authorization Holder
MC2               Medicinal Chemicals 2


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MHRA       Medicines and Healthcare products Regulatory Agency
NIBSC      National Institute for Biological Standards and Control
NOAH       National Office of Animal Health
NPA        National Pharmacopoeial Authority
NPSA       National Patient Safety Agency
OMCL       Official Medicines Control Laboratory
OTC        Over the Counter
Ph. Eur.   European Pharmacopoeia
QA         Quality assurance
QC         Quality control
RS         Related substances
TGA        Therapeutic Goods Administration, Australia
TLC        Thin-layer chromatography
UK         United Kingdom
UKD        United Kingdom Delegation [to the European Pharmacopoeia]
USP        United States Pharmacopeia
WHO        World Health Organization




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