who medicines strategy - libdoc.who.int - World Health Organization
who medicines strategy - libdoc.who.int - World Health Organization who medicines strategy - libdoc.who.int - World Health Organization
WHO MEDICINES STRATEGY 2004-2007 | 88EO 5.2Medicines nomenclature andclassification efforts continuedthrough assignment, promotion,and protection of internationalnonproprietary names, and thepromotion and development ofATC/DDD systemRationaleInternational Nonproprietary Names (INN)identify pharmaceutical substances or activepharmaceutical ingredients. Each INN (oftenreferred to as a “generic” name) is a unique namethat is globally recognized and is public property.The existence of an international nomenclaturefor pharmaceutical substances, in the form ofINN, is important for the clear identification andsafe prescription and dispensing of medicinesto patients, as well as for communicationand exchange of information among healthprofessionals and scientists, businesses, andgovernments worldwide. Providing INN is one ofthe oldest services that WHO provides to MemberStates. INN are made available in all six WHOlanguages (Arabic, Chinese, English, French,Russian, and Spanish) as well as in Latin. Thework of the INN Programme and the assignmentof INN are both guided by International INNExpert Group.An additional classification system has beendeveloped to serve primarily as a tool for drugutilization research. The Anatomical TherapeuticChemical (ATC) classification system togetherwith the Daily Defined Dose (DDD) continuesto be developed and maintained by theWHO Collaborating Centre for Drug StatisticsMethodology in Oslo, Norway, under thesupervision of the WHO International WorkingGroup for Drug Statistics and Methodology.The Working Group, comprised of experts inclinical pharmacology and medicines utilizationrepresenting the six WHO Regions, meets twicea year and oversees the work of the CollaboratingCentre for Drug Statistics Methodology. The ATCclassification system with its hierarchical codesdivides drugs into different groups according tothe organ system on which they act and theirchemical, pharmacological, and therapeuticproperties. In the ATC system, one drug can haveseveral ATC codes due to different therapeutic useand local application formulations. The DDD isa unit of measurement in drug utilization studiesreflecting average daily maintenance dose of thedrug when used for its main indication. AlthoughATC codes are increasingly used for classificationpurposes (i.e. in drug formularies), the main utilityof ATC codes is in conjunction with DDD for drugutilization research worldwide.ProgressThe use of the INN system is expanding withthe increase in the number of names. Its wideapplication and global recognition are also dueto close collaboration with numerous nationalmedicines nomenclature bodies in the processof INN selection. As a result, most of thepharmaceutical substances used today in medicalpractice are designated by an INN. The use ofINN is common in scientific literature, regulatoryaffairs, research, and clinical documentation. Theyare also used for administrative purposes. Theirimportance is increasing due to expanding use ofgeneric names for pharmaceutical products.Nonproprietary names are widely used in
COMPONENTS OF THE STRATEGY | 89pharmacopoeias, product labelling andinformation, advertising and other promotionalmaterials, medicines regulation, and scientificliterature, and as a basis for product names in thecase of generic medicines. The INN Programme iscollaborating closely with the WHO CollaboratingCentre for Drug Statistics Methodolology in Oslo,Norway, and the INN and ATC databases havebeen cross-linked — providing a unique source ofinformation for medicines regulatory authorities,scientists, and others in the pharmaceutical field.Information technology tools to facilitate accessto the information are being developed (e.g. webbasedaccess through MedNet, Cumulative List ofINN with additional information on CD). Activecollaboration with medicine regulatory authorities(e.g. the European Medicines EvaluationAgency (EMEA)), pharmacopoeias (e.g. JapanesePharmacopoeia), nomenclature bodies (e.g.United States Adopted Names Council), and otherinterested parties is becoming part of the mainINN Programme activities.The use of the ATC/DDD system is wideningglobally. Many regulatory authorities todayuse ATC codes for drug registration and otheradministrative purposes. ATC codes are alsoincreasingly referred to in drug formularies andother information sources. Recent publicationsby the Centre include: Guidelines for ATCclassification and DDD assignment and an Indexwith all the assigned ATC/DDDs (both issuedannually, the latest 2003). A recent publication,An Introduction to Drug Utilization Research(WHO, 2003), has broken new ground inpromoting drug utilization research by givingsimple and robust advice on how best to carry outand benefit from drug utilization research with theaim of promoting rational use of drugs.Challenges remainingThere is a continuing need to promote theimportance and use of unified classificationsystems for medicines so as to avoid confusionand facilitate the exchange of informationand research into the therapeutic use ofmedicines. The health and financial benefitsfrom methodologically sound drug utilizationresearch remain underestimated, whereas thecosts are overestimated. There is a growing needfor problem-oriented training activities that areintegrated with public health programmes.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to support and promote thecollaborative programmes in nomenclatureand classification of medicines.> increase capacity to deliver training in drugutilization research in collaboration with otherinterested partiesOUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries using INNs in medicines registration na na na 108/131 82% 90%
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COMPONENTS OF THE STRATEGY | 89pharmacopoeias, product labelling andinformation, advertising and other promotionalmaterials, <strong>medicines</strong> regulation, and scientificliterature, and as a basis for product names in thecase of generic <strong>medicines</strong>. The INN Programme iscollaborating closely with the WHO CollaboratingCentre for Drug Statistics Methodolology in Oslo,Norway, and the INN and ATC databases havebeen cross-linked — providing a unique source ofinformation for <strong>medicines</strong> regulatory authorities,scientists, and others in the pharmaceutical field.Information technology tools to facilitate accessto the information are being developed (e.g. webbasedaccess through MedNet, Cumulative List ofINN with additional information on CD). Activecollaboration with medicine regulatory authorities(e.g. the European Medicines EvaluationAgency (EMEA)), pharmacopoeias (e.g. JapanesePharmacopoeia), nomenclature bodies (e.g.United States Adopted Names Council), and other<strong>int</strong>erested parties is becoming part of the mainINN Programme activities.The use of the ATC/DDD system is wideningglobally. Many regulatory authorities todayuse ATC codes for drug registration and otheradministrative purposes. ATC codes are alsoincreasingly referred to in drug formularies andother information sources. Recent publicationsby the Centre include: Guidelines for ATCclassification and DDD assignment and an Indexwith all the assigned ATC/DDDs (both issuedannually, the latest 2003). A recent publication,An Introduction to Drug Utilization Research(WHO, 2003), has broken new ground inpromoting drug utilization research by givingsimple and robust advice on how best to carry outand benefit from drug utilization research with theaim of promoting rational use of drugs.Challenges remainingThere is a continuing need to promote theimportance and use of unified classificationsystems for <strong>medicines</strong> so as to avoid confusionand facilitate the exchange of informationand research <strong>int</strong>o the therapeutic use of<strong>medicines</strong>. The health and financial benefitsfrom methodologically sound drug utilizationresearch remain underestimated, whereas thecosts are overestimated. There is a growing needfor problem-oriented training activities that are<strong>int</strong>egrated with public health programmes.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to support and promote thecollaborative programmes in nomenclatureand classification of <strong>medicines</strong>.> increase capacity to deliver training in drugutilization research in collaboration with other<strong>int</strong>erested partiesOUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries using INNs in <strong>medicines</strong> registration na na na 108/131 82% 90%