ISO/TS TECHNICAL SPECIFICATION 19293 First edition 2018-04 Health informaticsRequirements fora record of a dispense of a medicinal product Informatiquede sante-Exigences relatives a un enregistrementde la delivrance d'un medicament Referencenumber ISO/TS19293:2018(E) ISO IS02018 IS0/TS19293:2018(E) COPYRIGHTPROTECTEDDOCUMENT IS02018 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in anyform or byany means,electronic or mechanical, including photocopying,or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IO at the address beloworIso'smemberbodyinthecountryoftherequester ISO copyright office CP 40i.Ch.de Blandonnet 8 CH-1214 Vernier, Geneva Phone:+41227490111 Fax: +4122749 09 47 Email: copyright@iso.org Website:www.iso.org Published in Switzerland ii @IS0 2018-All rights reserved IS0/TS19293:2018(E) Contents Page Foreword ..V Introduction ..i. 1 Scope. 2 Normative references .... 3 Terms,definitionsandabbreviatedterms 3.1 Terms and definitions. .1 3.2 Symbols and abbreviated terms Dispenseprocessanddispenseevent 4 4.1 General. .4 4.2 Dispenserecordindiversedispenseprocesses ..4 4.3 Dispenserecord information purposes. ..5 5 Requirements .5 5.1 General considerations 5.2 Issuance of the dispense record .6 5.2.1 General .6 5.2.2 Dispense record scenarios 6 5.2.3 Dispense record uniqueness. ..6 5.2.4 Dispenseprocess unambiguity. 7 5.2.5 Dispenserecord unequivocalidentification 7 5.2.6 Dispenseactdate/time 7 5.2.7 Dispenselocation—Institution/department 7 5.2.8 Confirmations,authorizations,oradvice .8 5.2.9 Additional information to support the adequateand legal dispensing .8 5.2.10 Relevantfindingselicitedduringtheclinicalreview .8 5.2.11 Decisionnotto dispense 8 5.3 Prescription-related .8 5.3.1 General. .8 5.3.2 Linktoprescription. 9 5.3.3 Additional prescription linking data 9 5.3.4 Previousprescriptionchanges/advice 9 5.3.5 Outcomeofclinicalreviewoftheprescription 9 5.4 Dispenser identification. ..11 5.4.1 Dispensing professional ..11 5.4.2 Dispensing organization. ..11 5.4.3 Automatedandsemi-automateddispensingsystems 5.5 Patientidentification ..11 5.5.1 General. 5.5.2 Patientidentificationverification .11 5.6 Dispensedproduct ..12 5.6.1 General ..12 5.6.2 Dispensed producttype. ..12 5.6.3 Dispensed physical item 5.7 Quantity. ..14 5.7.1 Dispensedproductquantity ..14 5.7.2 Retrieved product quantity ..14 5.8 Dispenserepeat number. ..14 5.9 Fulfilmentnotes ..14 5.10 Patient instructions. ..14 5.10.1 General. ..14 5.10.2 Reimbursement ..15 5.10.3 Transport.. ..15 AnnexA(informative)Examplesofusecases(fromNVN-ENV13607) ..16 IS0 2018-All rights reserved ili