English version. Criteria, methodology and procedures for creating an E- codification concerning substances used in Pharmaceutical compounding

Transcription

1 CEN WORKSHOP CWA January 2009 AGREEMENT ICS English version Criteria, methodology and procedures for creating an E- codification concerning substances used in Pharmaceutical compounding This CEN Workshop Agreement has been drafted and approved by a Workshop of representatives of interested parties, the constitution of which is indicated in the foreword of this Workshop Agreement. The formal process followed by the Workshop in the development of this Workshop Agreement has been endorsed by the National Members of CEN but neither the National Members of CEN nor the CEN Management Centre can be held accountable for the technical content of this CEN Workshop Agreement or possible conflicts with standards or legislation. This CEN Workshop Agreement can in no way be held as being an official standard developed by CEN and its Members. This CEN Workshop Agreement is publicly available as a reference document from the CEN Members National Standard Bodies. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No.:CWA :2009 D/E/F

2 Contents Contents... 2 Foreword Scope Normative References Definitions and abbreviations Definitions Abbreviations The source of data Supplier of substances Pharmacopoeia Reference books and reviews Scientific committee Maintenance The Criteria of E-codification Criteria of identicalness Criteria of therapeutic similarity Criteria of pharmacological properties The structure of the database The E-codification The first key The second key The third key Data structure of the basic pharmaceutical information on the substance Preferred Name Notes CAS number Group Density Melting point Doping code Substance and Supplier evaluation olecurar weight Substance record Data structure of the Synonyms Synonyms first key Synonyms Reference country code Reference source Language Synonyms record Data structure of the essential pharmacological information on the substance Dose first key ATC code DDD Average daily dose Maximun daily dose Minimum daily dose Unit of measurement Route of administration code / Application type Route of administration description / Application type description Patient target Source of information Note MedDRA code MedDRA description Dose record Data structure of the national information National information first key

3 6.8.2 National notes Reference country code Country name Language Any field needs for specific national information National information record Data structure of the Supplier record Supplier first key Company name Reference country code Country name Address of the registered office Postal code of the registered office City of the registered office Province of the registered office Address of operative seat Postal code of the operative seat City of operative seat Province of operative seat Tax number Telephone number for orders Fax number for orders address for orders Sales officer s name Sales officer s telephone number Sales officer s Telephone number Fax number Supplier record Chart of data structure Annex A : Part of plants Annex B : Production processes and general treatments for herbal preparations Annex C : Solvents for herbal, animal and mineral preparations Annex D : Physical form for substances with herbal and animal origin Annex E : Part of the animal

4 Foreword The present CWA sets forth criteria and methodologies, addressed to scientific editors, to be followed for the implementation of a databank concerning substances used by compounding pharmacists for preparing Magistral Formula and Formula Officinalis, as endorsed by the CEN/ISSS Workshop on Pharmaceutical Compounding E-codification Methodology (WS/PCEC), which was established on Oct 15 th 2007 A list of the individuals and organizations which supported the technical consensus represented by this CEN Workshop Agreement is available to purchasers from the CEN/ISSS. The present CWA (CEN Workshop Agreement) has received the support of representatives of a variety of backgrounds: pharmacists, physicians, pharmacologists, representatives of European institutions in the pharmaceutical field, health informatics experts. These specifications represent a first step into technical specifications concerning pharmaceutical compounding. The present CWA is a reference document for the competent working groups within the Joint Initiative ISO/CEN/HL7, for E-health and for regulatory agencies. Within ISO TC 215 (Health Informatics) WG 6 work is ongoing on Identification of Medicinal Products - Product Information for Drug Dictionaries (MPID). ISO(-EN) standards is planned for the year This CWA might need to be revised after the publication of the ISO(-EN) standard. The ISO/EN standard does not specifically address compounding pharmacy, the field of 'magistral formula' and formula officinalis as defined by Council Directive 83/2001, which is instead the focus of this CWA. This CEN Workshop Agreement was endorsed electronically; the endorsement process ended on 20 September The Workshop was chaired by Alessandra Pastorino, consultant. The following organizations have expressed support to the publication of the CWA International Society of Pharmaceutical Compounding Italian Society for Pharmacology Pharmacy On Line Trade Sr. SACCHI Studio di Consulenza Società Italiana Farmacisti Preparatori (SIFAP) This CEN Workshop Agreement is publicly available as a reference document from the National Members of CEN : AENOR, AFNOR, ASRO, BDS, BSI, CSNI, CYS, DIN, DS, ELOT, EVS, IBN, IPQ, IST, LVS, LST, MSA, MSZT, NEN, NSAI, ON, PKN, SEE, SIS, SIST, SFS, SN, SNV, SUTN and UNI. Comments or suggestions from the users of the CEN Workshop Agreement are welcome and should be addressed to the CEN Management Centre. 4

5 1. Scope The domain addressed by this CWA is the E-codification of substances used by compounding pharmacists in pharmaceutical compounding. The present document specifies the technical requirements for creating the record structure and E- codification of the various substances supplied by commercial suppliers and used by the pharmacist in the pharmacy for preparing Magistral Formula and Formula Officinalis as defined by the European Directive 2001/83, Article 3, Paragraph 1) and 2). The CWA includes a record of the supplier of substances. Magistral Formula and Formula Officinalis are not themselves part of the present CWA The users of the CWA are the editors of a databank. In this sense the CWA is not addressed to the final users of the databank but to the subjects which realize and implement the databank (the editors) The purpose of the CWA is to define certain criteria the editors have to comply with, in realizing a databank in order to: (i) allow an unique identification of the single substance in order to avoid any possible misunderstanding; (ii) provides pharmacists and physicians with the basic information on each single substance and its administration (see paragraph 6.2, 6.4, 6.6, 6.8); (iii) provides pharmacists and physicians with indication on the availability of the substance on the European and international market; The CWA aims at setting forth the basis for establishing a unique language for compounding pharmacists, physicians and providers to the pharmacy of substances. The CWA proposes to fill a gap, in terms of harmonization, that characterizes the pharmaceutical compounding. This shall allow: (i) an increase in the sharing of scientific information concerning substances used in pharmaceutical compounding and basic pharmacological and administration information among physicians and pharmacists; (ii) a development of the pharmacy compounding; (iii) An increased in ADR reporting concerning substances used in pharmaceutical compounding by physicians, pharmacists and consumers. Any authorized medicinal product is out of the scope of the present CWA. The groups of substances which fall under the scope of the present document are the followings: Synthetic substances Semi-synthetic substances Crude drug substances The above groups are listed with respect to origin. See definitions on substances and crude drug substances. 5

6 2. Normative References EN ISO : 2002 Codes for the representation of names of countries and their subdivision Part 1: Country codes (ISO :2006) Informative references pren ISO Health Informatics Pharmacovigilance Individual case safety Report (ICSR) 1 pren ISO Health informatics Identification of medicinal products Data elements and structures for the exchange of regulated product Information for drug dictionaries (MPID) 1 pren ISO Health informatics Identification of medicinal products Structures and controlled vocabularies for pharmaceutical product identifiers (PhPIDs) 1 pren ISO Health informatics Identification of Medicinal products Structures and controlled vocabularies for ingredients (substances) 1 pren ISO Health informatics Identification of medicinal products _ Structures and controlled vocabularies for pharmaceuticals dose forms, units of presentation and routes of qdministration 1 pren ISO Health informatics Identification of medicinal products Structures and controlled vocabularies for units of measurement 1 pren ISO Health informatics Pharmacovigilance Structures and controlled vocabularies for laboratory test units for the reporting of laboratory results 1 ICH M5 EWG Step2 Guideline Rev. 5.1 ISO 639-1:2002 Codes for the representation of names of languages -- Part 1: Alpha-2 code ISO/TS 17120:2004 Health Informatics Country identifier standards 1 URL: under heading Standards under development in ISO TC 215 6