Draft Guidelines on Traceability of Medicines in Hospital Settings

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DRAFT Traceability of Medicines in Hospital Settings
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Traceability of Medicines in Hospital Settings
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Background
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The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the
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Council of Europe, an intergovernmental organisation based in Strasbourg, France, set up to promote
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democracy and protect human rights and the rule of law in Europe. The EDQM is in charge of ensuring
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the basic human right of access to good quality medicines and healthcare in Europe.
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This mission and the development of common policy instruments and legal standards is ensured
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through intergovernmental structures such as the European Committee on Pharmaceuticals and
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Pharmaceutical Care (CD-P-PH) and its subordinate bodies, the Committee of Experts on Minimising
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Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED)
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and the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and
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Pharmaceutical Care (CD-P-PH/PC). These committees are composed of representatives from all the
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member states of the Council of Europe having acceded to the Partial Agreement on the European
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Pharmacopoeia (Ph. Eur. member states), and support these member states by anticipating and
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addressing challenges in their respective fields of expertise.
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In September 2019, the CD-P-PH approved a project proposal to develop guidance on the traceability
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of medicines in hospitals. The project was included in the committee’s Terms of Reference for 2020-21;
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however, work could not start immediately due to resource and prioritisation issues. Following the
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establishment of a working group, the drafting process started in 2022 as a joint initiative of the
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Committees of Experts CD-P-PH/PC and CD-P-PH/CMED to develop best practices for the traceability
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of medicines in hospital settings to minimise the incidence of medication administration errors and
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ensure patient safety.
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The aim is to propose harmonised approaches to traceability practices in Ph. Eur. member states
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through a guidance document to be further disseminated and promoted by the EDQM and member
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states. Its implementation in the member states’ regulations will need to be monitored and evaluated.
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Acknowledgments (to be added to the next version)
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Traceability of Medicines in
Hospital Settings
EDQM, Council of Europe
27 March 2024
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1. Executive summary
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Patient safety is an important and internationally recognised issue in healthcare. Safemedication
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processes are one of the drivers for improving patient safety. The medication process in healthcare
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institutions comprises multiple steps, all of which must be addressed to enhance medication safety.
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This document focuses on achieving full traceability of medicines in a hospital setting, which is key to
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improving medication safety. The overarching goal is clear, but important conditions and potential
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barriers affect the speed at which this goal can be achieved. The concept may seem simple, but the
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execution has proved complex. However, practices in some leading hospitals in Europe indicate that
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the principles of in-hospital medication traceability are applied. Sharing details of these cases and their
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outcome can facilitate the process in other hospitals and countries.
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In a hospital setting, traceability of medicines benefits patient safety. Medication administration errors in
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a hospital will be minimised if individual units of a medicine can be traced backto the point of
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administration. This traceability consists of the seven “rights”of medication administration: right patient,
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right medicinal product, right dose, right time, right administration route, right information and right
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documentation. In the event ofa recall, it is also easier to identify properly traced medicines and the
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patients who are at risk, preventing administration of recalled medicinal products.
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Traceability is contingent on several conditions and process steps: traditionally, medication
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administered to a patient is checked against the prescription and is recorded in a section of the patient
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medical record. If paper files are used, these are manual procedures, and any check will be a manual
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check in the individual patient files. If this is the case, only the medication name, dosage and
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administration route will be recorded inthe patient file. With manual medication administration
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registration, at peak times there are risks of missed recording. Audits are performed at the individual
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patient level, but in these circumstances these audits are manual, time-consuming and very limited in
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their ability to prevent errors. Manual recalls are time-consuming and may focus on containing
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potentially affected stock, as manual tracing of potentially affected patients would require reviewing
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many paper patient records. As manual procedures tend to be incomplete, it is obvious that they do not
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fully comply with and achieve the goal of traceability.
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Procedures based on barcode scanning are standardised, faster and more secure. In addition, these
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procedures facilitate (fast and secure) registration of data/information and monitoring. Although barcode
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scanning may be omitted at hectic times, it supports a standardised way of working and is faster and
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safer. The scanned data contain more information than a manual record, and the information is
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recorded automatically, allowingfor secure (and even automated) checks.
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Information technology (IT), digitalisation and electronic documentation are increasingly finding their
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wayinto healthcare and in hospitals. Digitalisation facilitates traceability. Digitalisation also benefitsfrom
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the standardisation of procedures (administrative, logistic and clinical), the use of IT standards, etc.
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Electronic documentation is clear and can be immediately available to all healthcare providers, reducing
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communication errors.
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However, investments in IT are costly and hospital budgets limited. Healthcare systems vary from
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country to country, with governance falling into two main categories: public hospitals (under
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local/regional/national governance) and privately-owned hospitals in a more market-oriented economy.
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When it comes to promoting and supporting technological developments in healthcare, national
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regulation or government sponsorship may vary. The implementation of IT varies between hospitals –
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even within the same country. As hospitals are complex organisations with many processes supporting
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the care process, hospitals often require multiple IT systems on their journey tofull digitalisation.
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Solution providers responsible for IT systems may vary, as few provide servicesboth regionally and
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globally. (International) certification and accreditation enhances the visibility of IT status.
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Digitalisation requires new ways of thinking and designing, ‘new pathways’, cultural changes, process
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changes and in fact – to be successful – major change management. It also brings a whole new group
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of professionals to the forefront of the hospital, IT experts who design the IT architecture, support the
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technology, maintain the new IT systems and support the clinical professionals. In addition, digitalisation
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also results in a major change for existing healthcare professionals, who should view digitalisation as a
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means to optimise care and use new technologies to facilitate their current workflow and thereby
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improve patient care. As a result of digitalisation, specific new roles have developed in hospitals (Chief
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Medical Information Officer (CMIO), Chief Pharmacy Informatics Officer (CPIO) and the Chief Nursing
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Information Officer (CNIO)).
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Given the diversity of hospitals and available IT systems, it is impossible to write a ‘blueprint’ for in-
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hospital traceability thatcovers the topic for all countries in Europe. This document is intended to serve
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as a guide to understand the importance of the issue, share experiences and best practices, and
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encourage organisations to take the next step in improving traceability and patient safety.
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2. Context
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Medication is an important component in the treatment of diseases. The purpose of medication can be
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curative, preventive, alleviation of symptoms and self-treatment of ailments. In hospital care, the
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prescription and administration of medication by hospital staff are common practice and ideally the
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processes are well controlled. In recent years, the increased focus on patient safety has also meant that
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additional attention is being paid to medication errors. In 2007 the ‘Preventing Medication Errors’ report
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found that patient harm caused by medication errors is common, costly and, to a large extent,
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preventable. An intervention such as barcoded medication administration increases administration
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accuracy and supports medication traceability up to the patient, preventing harm and even unnecessary
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deaths.
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Reducing medication errors is one strategy to enhance patient safety. In EU member states, the
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Falsified Medicines Directive (Directive 2011/62/EU, FMD) was implemented in 2019 to prevent the
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entry of falsified medicinal products into the healthcare supply chain. Preventing this entry has a
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positive effect on patient safety. However, in some hospitals, pharmacists still consider the
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implementation of the FMD as an additional administrative burden with limited added value for patient
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safety. As a result of this legislation, every unit of secondary packaging of prescription-only medicines in
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the EU has a unique barcode, allowing the pharmacy to check the legitimacy of the medication before
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dispensing. Each secondary package holds several individually packed medicines (units). However, the
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FMD does not provide for barcoding at the primary level and decommissioning of the secondary
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packaging barcode number is performed when the pharmacy receives the medicine.
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EU FMD refers to the legal distribution chain in EU member states. In-hospital traceability is not a goal
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of the EU FMD. This implies that the FMD in itself does not support full traceability from the moment an
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individual unit of a medicine leaves the pharmacy to the point of administration to the individual patient.
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However, since the implementation of the FMD, experience has been gained on traceability and on the
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added value and some of the limitations of barcoding/barcode scanning, as will be explained in this
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document.
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Developments and (national) guidelines supporting in-hospital medication safety, such as electronic
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prescribing, are a building block to achieving full traceability.
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3. Scope of the document
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a. Scope: in-hospital full traceability of medicines (individual units of a medicine) up to the point of
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administration to minimise the occurrence of medication administration errors and ensure patient
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safety (consisting of seven rights of medication administration: right patient, right medicinal product
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(right indication or approved indication), right dose, right time, and right administration route, right
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information and right documentation1).
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b. Setting: Hospitals
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The focus of this guidance document is on hospitals. However, traceability is valuable in all settings
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where medication is administered by care personnel in institutional care. In the not-too-distant future
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it is expected that traceability can be implemented in home care or in a ‘virtual ward’ (patients
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receiving hospital care in their home).
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c. Disclaimer: most medication in a hospital will be prescribed by the physician (or other authorised
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prescriber) for a given time, dosage and route.
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Some other medications, like ointments or drops (eye, ear, nose), may be given to the patient to
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self-administer. These types of medication administration may be excluded from the scope of this
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document.
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d. Out of scope:
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– Verification of authenticity of medicinal products entering the supply chain addressed by the FMD
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and Commission Delegated Regulation (EU) 2016/161.
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1 See for example Section 5.1 of EAHP’s European Statements of Hospital Pharmacy –
https://statements.eahp.eu/statements/final-statements
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– Prevention of the entry into the legal supply chain of falsified medicinal products.
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– Impact of repackaging/relabelling medicinal products at hospitals.
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– Diagnosis and prescription of medicines.
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4. Target audience
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Policy-makers, national competent authorities, healthcare payment bodies (including insurance
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companies), hospital managers, healthcare professionals involved in the medication process (such as
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physicians, hospital pharmacists and nurses), IT staff (in-hospitaland working in organisations
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supporting hospital IT) and patient associations.
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5. In-hospital traceability system
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This section focuses on track-and-trace in hospitals in terms of components/features of a complete
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track-and-trace system, development of such a system and systems that are already available.
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A medication cycle (prescribing, processing, dispensing and administering) that is electronic and
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automated as far as possible is also called a closed-loop medication process, a term commonly used in
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the UK.
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Identification of (medicinal) products, for instance by labelling, increases their safe use. An identification
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label is designed to list several characteristics of the product, such as the name of the substance,
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strength, batch or lot number and expiry date. The overall purpose of labelling medication packages is
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to ensure their unambiguous identification and safe use, and to improve logistics and supply chain
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efficiency. The implementation of a system of harmonised standards supports efficiency and cost-
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effectiveness for manufacturers, suppliers and transporters. Traceability is improved through
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standardised procedures and standardised data. A national medicines data repository (such as the G-
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Standaard in the Netherlands)2 makes it easier for all relevanthealthcare stakeholders (including the
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prescriber and the hospital pharmacist) to access and use the same medication information.
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From a clinical perspective, the aim of good medicine identification and labelling is to ensure that the
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appropriate medicine is selected for administration, leaving no room for doubt or error. At the point of
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administration, the identification (and recording) of the medication closes the loop to full traceability to
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the patient. In addition to thecorrect description of the medicinal product, this requires clear product
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identification and a robust recording system. This also supports the provision of information to ensure
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appropriate and safe storage, preparation, dispensing and administration. In the event of problems
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during the manufacturing, prescribing or dispensing process, the well-labelled and identified product can
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be tracked.
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The importance of correctly recording both prescribed and administered medications is clear, and not
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just for patient safety. The registration of administered/used materials (used for a specific patient) can
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also be used for specific billing purposes. In addition, reimbursement policies may differ between public
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and private hospitals and are facilitated by correct recording.
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Prescribing and administering are separate processes, each requiring its own registration process.At
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the level of the individual patient, the authorised prescriber prescribes the medication and registers this
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inthe patient file and on an order form (or prescription). In a hospital, all prescriptions are checked by
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the pharmacistand then authorised (verification). Medication is stored in the pharmacy and, depending
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on the policy and organisation of the pharmacy, in decentralised medication storerooms in the hospital
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(under the responsibility of the pharmacist), where they are prepared for dispensing.
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When the nurse prepares the medication for a specific patient, this will be registered in a specific
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system (such as a medication cardex). If procedures and systems are manual, full traceability cannot be
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achieved, as it would involve too many extra manual activities. For instance, individual patientrecords
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would need to be checked, the content of packages of medication in a ward or department would need
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to be counted and checked, etc. In addition, it is not technically feasible to record the specific
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identification details, such as lot number and expiry date for each individual medication administered.
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Digitised recording systems facilitate traceability and verification.
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This guidance document recommends that full traceability can only be achieved in a digitisedworking
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environment and when each individual dose is correctly identified (barcoded), with all essential
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identification keys.
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At present, only a small proportion of medicines entering a hospital are barcoded at the unit level. When
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a hospital implements point-of-care scanning, alternative procedures are required, such as relabelling at
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unit level in the pharmacy (e.g. through automated dose dispensing), a procedure that requires
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dedicated pharmacy personnel.
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However, even in a fully digitalised hospital ,traceability is not necessarily implemented for 100% of the
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medications. Based on risk and cost-benefit analyses, exemptions are defined, such as ointments (not
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barcoded at unit level and low risk) or inhalation medicines, drops (eye, ear and nose).
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As relabelling requires extra personnel and can be seen as a risky procedure, some hospitals do not
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relabel, but the nurse (or pharmacy assistant) scans the barcode on the secondary packaging (in the
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ward’s medication room) before dispensing, as this enables the lot and serial number to be traced to the
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2 https://www.z-index.nl/english
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individual patient. This step is followed by scanning the patient’s identificationat the time of
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administration. However, this is an indirect process and requires regular reconciliation of the contents of
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the pack with the amount administered to patients, which can be time-consuming and burdensome.
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Several systems have been developed to track medications:
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– Türkiye has a well-developed system (the Pharmaceutical Track&Trace system ITS)
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that is well established for the purchase of medicines, their sale, for the consumption centres (such
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as warehouses, pharmacies, hospitals), their declaration of consumption and their verification. The
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focus of this system is a safe medication supply chain. However, the system was not originally
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developed to track medication in the clinical setting through to administration to individual patients.
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– Multiple apps have been developed to support patients in managing medications, including
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remembering when and how to take them. These apps are consumer focused and have not been
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developed for use in a clinical setting.
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– In Ireland, a system has been developed specifically for the management of haemophilia patients in
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their own home, including medication management control. The patient uses an app, and the
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national centre manages control-at-a-distance. This system is well developed, efficient, increases
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the safety ofthe individual patients, and is mainly used to support out-patient care of haemophilia
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patients.
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A complete track-and-trace in-hospital system is not (yet) available on the market. Increasingly,
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electronic medical record (EMR) systems have built-in functionality to facilitate barcode scanning for
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verification, use a platform to store the barcoded data as master data, connect EMRs to other in-
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hospital IT systems, such as purchasing, pharmacy information or pharmaceutical warehouse
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management systems3. As the medicinal product and patient are reconciled with the prescription, this is
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also called a closed-loop system.
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Scanning medicinal products as they enter the hospital and again as they are administered to the
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patient – without scanning the steps in between – is an example of an end-to-end tracing system4. This
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type of implementation ensures traceability to the patient and is less costly to implement but misses out
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on the direct advantages of full visibility and efficiency in the in-hospital supply chain (as mentioned
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above), which could lead to additional costs to expand the system in the future.
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The implementation of the EU FMD is seen as supportive of in-hospital traceability, as theFMD results
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(for prescription medication) in package-level labelling with a scannable lot and expiry date.These are
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essential for traceability and patient safety.
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Ideally, the standardised product information encoded in the barcode should be uploaded into the
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hospital’s system by the hospital (or the hospital organisation). A standardised and harmonised system
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of barcoding and labelling that is applicable at all levels in a hospital is essential for traceability.
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Such a system should be compatible with the requirements of the General Data Protection Regulation
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(GDPR). Data should only be used for traceability and not in any other way by stakeholders that are not
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directly involved in the process of dispensing/administering medicines.
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6. Barcode Medication Administration (BCMA)
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As explained in this guidance document, full traceability of medication in a hospital is best achieved
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through barcode scanning (at all levels of the medication process). The medication process is complex
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and can be designed in well-described steps with clear expectations of costs and benefits.
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Barcode scanning of medication at the point of care can be achieved with BCMA. This section describes
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BCMA, including the specifics for success.
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Originally developed for retail and supply chain purposes, barcode technologies are increasingly being
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used in other sectors, including healthcare. Barcodes are electronically readable identifiers that identify
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specifics of the product, such as the product itself,numbers (lot, batch and/or serial), date (expiry date).
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In Europe, regulation drives the identification of medicinal products with identifiers that are encoded in
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barcodes. For instance, from February 2019, as a result of the FMD, medicinal products entering a
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hospital will at minimum have an identifier on the secondary package consisting of at least a product
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code (allowing identification of at least the product name, the active substance, the pharmaceutical
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3 (translate into English): https://www.chipsoft.nl/oplossingen/139/HiX-voor-medicatie-en-apotheek
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(translate into English): https://www.uzleuven.be/nl/bedsidescanning
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form, the strength, the pack size and the pack type of the medicinal product), the serial number, the
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batch number and the expiry date.
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As well as supporting the medication supply chain, warehousing and stock-keeping, barcodes on
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medication can also be used effectively in direct patient care. When the nurse scans and thereby
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identifies the medication at the point of care (bedside), this process improves patient safety and reduces
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the risk of medication errors.
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As the regulation requires identification with barcodes on the secondary packaging, this can be seen as
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a first step in improving patient safety. However, in a hospital setting, medications to be administeredto
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an individual patient will not be taken from a secondary pack but will be administered in unit doses.
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Therefore, full digitised hospital traceability requires additional barcoding and labelling operations at the
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primary packaging and/or single unit-dose level. The consistent availability of medication barcoded at
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the unit level reduces risky relabelling activities and would significantly increase (patient) safety.
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Packaging/relabelling at hospital level requires much greater investment, as it must be done by every
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hospital and, because it involves considerable manual labour, has much higher running costs. At
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industry level it can be incorporated into the production process. Manufacturers will need to invest in
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their packaging and IT systems. It would be preferable for industry to adapt, acknowledging that patient
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safety is at the core of healthcare activities. Hospitals would also need to invest in hardware, software,
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training and infrastructure.
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This context, and the absence of mandatory regulation of barcoding on the primary packaging of
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medicines, is the main reason for the lack of implementation of barcode scanning (and track & trace of
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medication) in hospitals. On this aspect, as only a limited number of hospitals had fully implemented
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bedside scanning during the administration of medicines, the Dutch Ministry of Health, Welfare and
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Sport commissioned Cap Gemini Consulting to conducta cost-benefit analysison Barcoding on the
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primary packaging of medicines (Nov 2016: https://open.overheid.nl/documenten/ronl-archief-
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752101ad-99a9-444d-8d2c-af9e41491b9a/pdf).
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Some large hospitals have voluntarily implemented a system of medication labelling down to the
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primary packaging unit level. This is an elaborate, rather high-risk process, requiring technology and
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dedicated personnel. The risks of relabelling should be weighed against the risk of medication errors. In
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fact, this consideration is patient versus process. Patient risks are significant but often are not noted or
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recognised. The process risk, such as relabelling, can be controlled more easily.
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However, a barcode on the unit dose will allow the nurse to perform BCMA, confirming an appropriate
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check of identity, form of medication, dosage and time of administration. The technology should fit well
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with the work processes and be well implemented to support the safety of the medication administration
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processes. It is to be noted that BCMA cannot be implemented in a hospital that is still fully paper
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based.
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A preliminary step for BCMA is identification of the medication unit dose. A linear barcode holdslimited
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data/information; a barcode in Data Matrix format (2-dimensional) can hold more data, includinglot and
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batch numbers and expiry date. In the EU, Data Matrix is currently the leading format for medicinal
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products.
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BCMA requires the development of IT systems, such as the implementation of barcode scanning,
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barcode scanners that can process the identification data correctly, a portable or desktop computer with
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a wireless connection, a computer server, relevant software and interoperability of relevant IT systems,
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and a data warehouse.
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When a nurse who is identified in the system administers medication to a patient in a healthcare setting,
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the nurse can scan the barcode on the patient’s wristband to verify their identity. The nurse can then
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scan the barcode on the medication and use software to verify that he/she is administering the right
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medication to theright patient at the right dose, through the right route, and at the right time (the ‘rights’
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ofmedication administration). BCMA was designed as an additional check to aid nurses inadministering
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medication; however, it cannot replace the expertise and professional judgment of the nurse. The
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implementation of BCMA has been shown to significantly reduce medication administration errors in the
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healthcare setting5.
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https://pure.rug.nl/ws/portalfiles/portal/3668356/Helmons_thesis.pdf
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7. Processes
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Medication safety is an important issue in hospitals, involving several stakeholders and multiple
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processes. A medication management process is actually a complex set of processes, and ideally
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consists of several steps, simplified as:
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– defining the best treatment for the defined diagnosis and selecting the appropriate medication
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(physician);
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– ordering/prescribing (prescribing or attending physician or authorised prescriber);
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– verifying (pharmacist);
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– dispensing (pharmacy personnel or nurse);
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– distribution (pharmacy personnel or nurse);
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– administration (nurse);
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– monitoring of the individual patient (physician, clinical pharmacist, nurse, etc.), e.g. if the patient’s
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condition deteriorates, it is possible to trace which medications were administered (or possibly
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forgotten);
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– evaluating (pharmacist and physician).
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The hospital formulary contains a selection of medications most commonly prescribed in the hospital
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and serves as a guidance document for prescribers. The hospital pharmacist is an important member of
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the hospital’s Drugs and Therapeutics Committee (the name may vary), a multidisciplinary team in
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charge of selecting, discussing and deciding on the final hospital formulary. Important considerations
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include existing national formularies/lists of medicines, characteristics and needs of specific patient
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populations, state-of-the-art treatments, interactions, and a pharmaco-economic analysis.
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This process requires a formulary management system with continuous updating and attention to
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formulary compliance (by both hospital pharmacists and prescribers).
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Hospitals have a (central) main medication storage facility in the hospital pharmacy and smaller
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decentralised medication facilities near the point of care, such as departmental/wardmedication rooms.
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The range of medications in decentralised locations is often ‘general stock’, not yet labelled for
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individual patients, and is limited to the specific medication for the type of patients expectedin each
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particular department. For instance, a ward for neurological patients will have different medicationsin
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stock than a ward for surgical patients. In the event of an acute need for additional prescriptions (of
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medication not in stock on the particular ward), the medication could be ordered fromthe hospital
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pharmacy and delivered directly to the ward in the patient’s name. Before administering medications,
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either a pharmacy technician or one of the nurses prepares the patient-specific medication according to
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the prescription (dispensing) in the medication room. In some countries, routine practice involves
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another nurse checking and then administering the medication to the patient. Any high-risk medication
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will officially require adouble check and documenting of this double-check procedure. This is the case
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for oncolytic medication or opiates, for example.
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Robots can be used in the in-hospital medication supply system, both in the pharmacy and in robotic
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dispensing cabinets on the wards. It is expected that more hospitals will use these robots in the future,
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as implementation is part of a positive business case, reducing pharmaceutical staff, reducing stock
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levels, reducing space requirements and reducing waste. Robots are not discussed further in this
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document.
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Medication reconciliation is important when a patient is admitted to hospital. In many instances the
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processes of medication verification on admission, transfer and discharge are done by pharmacy staff,
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sometimes by nurses. The authorisation of these medications is regularly done by doctors. Eventually
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the doctor will write new medication orders (including continuation and, if needed, new prescriptions),
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starting the in-hospital medication process. As a rule, hospitalised patientsare not responsible for
467
storing/keeping their own medication supplies, nor are they responsible for the administration of
468
medications.
469
470
Medications in a hospital setting are prescribed by the authorised prescriber, either in handwritten form
471
or – preferably – as an electronic prescription. The hospital pharmacist checks all prescriptions in the
472
pharmacy. Eventually, on the ward (or department) the nurse administers the medication according to
473
the prescription, at the indicated time, in the correct dose, in the correct form and via the correct route to
474
the correct patient. Administered medication is registered in the individual patient’s record and in a
475
specific medication system that can be reconciled to the required stock levels.
476
477
Hospitals that use paper files have manual procedures to register administration and for stock keeping.
478
Hospitals using electronic files may have a completely electronic process, or mixedpaper/electronic
479
processes.
480
481
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A digitised hospital will have interfaces between the different systems supporting themedication
482
processes. Examples of such systems are:
483
– digital pharmacy systems (interfaced with lab systems, for verification purposes, for stock-keeping,
484
etc);
485
– a digital formulary management system;
486
– a digital formulary that is connected to a clinical decision support system, connected to the
487
computerised physician order entry (CPOE), connected or integrated in the EMR, connected to the
488
Medication Administration System and to the BCMA;
489
– fully integrated systems covering all the above functions.
490
491
492
8. Phased implementation
493
494
In a voluntary implementation scenario, no hospital will be able to implement all the requirements of a
495
medication traceabilitysystem immediately. Implementation cases show a mix of top-down and bottom-
496
up approach.
497
498
Vision and strategy are as important as the commitment and understanding of medical professionals. In
499
every hospital, the investment in an IT implementation must be balanced against other priorities.
500
501
Assuming the prerequisites are in place, such as a (to some extent) IT-developed hospital, the
502
necessary hardware and software and trained staff, a well-defined phased approach will facilitate the
503
implementation of a track-and-trace system and procedure. In practice, some patient care areas will
504
benefit more from scanning barcodes than others. Several years ago, literature reviews already showed
505
that BCMA results in a medication administration error reduction of 50%6. Sharing best practice
506
information,including site visits to hospitals that have implemented BCMA, is a great way to learn and
507
design theoptimal implementation strategy for an individual hospital or even all national hospitals.
508
509
Priorities can be set using the cost-benefit ratio, with the benefit of implementing barcoding at unit-dose
510
level exceeding the cost for expensive medications. Administration of oncolytic medication is an
511
example of a process that is well controlled in hospitals (specific procedures in the pharmacy,
512
guidelines to deal with waste, specific procedures for any related emergency, training of nurses) and is
513
costly. The cost of oncolytic medication is high, the process is well controlled, and the pharmacy has a
514
central role in almost the entire process. Spillage reduction and waste reduction will directly yield
515
financial savings that can be better used to maintain and strengthen the quality of the healthcare
516
services delivered by the hospital. For intravenous oncolytic medication, the final preparation is ‘mixed’
517
shortly before administration. Barcode scanning throughout the process from pharmacy through
518
preparation and dispensing to administration at the point of care ultimately enables full traceability and
519
increases patient safety. However, this describes a process that is already well controlled, and it entails
520
only specific high-risk medication.
521
522
Priorities can also be set on a (known) risk ratio. Similar procedures can be designed for high-risk
523
medication that is commonly used (and well known for patient safety incidents) like digoxin or
524
methotrexate.
525
526
Another approach to consider is to select a specific ward as a pilot and design an implementation that
527
will work for all medication that is used in this specific ward. If implemented well, this will greatly
528
enhance safety for staff and patients and reduce the risk of workarounds. After evaluation, this
529
implementation can be rolled out to other wards.
530
531
Preparation of medication and administration are steps that should be well distinguished. Both steps
532
can benefit from identification and scanning.
533
534
Steps to be followed in a hospital to track-and-trace single unit doses until the point ofadministration
535
include the following:
536
– business plan: make a plan to consider funding the implementation of hospital traceability;
537
– write a project plan for the specific implementation;
538
– important to note: not all hospitals or healthcare systems will be able to generate or allocate
539
6
For instance: https://www.rug.nl/about-ug/latest-news/news/archief2014/promoties/promotie-p.j.-
helmons_medication-safety-through-information-technology.-a-focus-on-medication-pr or
https://research.rug.nl/files/3668356/Helmons_thesis.pdf
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sufficient funds. Sometimes, there is a need for funding from sources other than hospital
540
management, such as from national or EU funds;
541
– project ownership for implementation: hospital board in accordance with governing organisation;
542
– process ownership: the medication process involves practically all disciplines in the hospital.
543
544
Several actors can be identified for the overall processes and the separate steps. Defining clear
545
responsibilities and addressing the correct actor is essential.
546
547
Action Actor(s)
Being an ambassador of safe medication
practices in the institution (including proactive
pharmacovigilance)
Hospital pharmacists
Sharing the vision and benefits of safe
medication practices
Allocation of adequate budget. Actor: hospital
board and finance department.
Identify the ‘early adopters’ within the profession
and within the hospital.
Engaging and involving hospital management (at
all levels).
Hospital board and higher management
Prioritising IT investments Hospital board and IT department.
Involving IT department Hospital board, head of IT, finance department.
If present:CPIO
Define the required IT strategy, including
selection of system(s), software and hardware
Head of IT department together with hospital
pharmacist. Involve the procurement
department.
Perform a gap-analysis to identify gaps and
define scenarios to resolve gaps
Will depend on the local situation, in any case
the IT department, the hospital pharmacist and
the nurses
On arrival at the hospital pharmacy, only
barcoded medication is received
Pharmaceutical manufacturer and supplier.
In-hospital actor: hospital pharmacist (selection
procurement and process design) and IT
department (for hardware and software).
Engaging pharmaceutical staff Hospital pharmacist.
Decision on level of identification and barcoding
with relabelling to unit dose
Hospital pharmacist and hospital board
Engaging physicians Hospital pharmacist and medical board
Engaging nurses Hospital pharmacist, chief nursing officer,
training department
Engaging other staff, such as logistics staff.
Support the necessary change management
Human resources department and training
department
Share the message and share the results to
support commitment
Communication department
548
549
In addition to regular out-patient clinics and the treatment of these outpatients, in-patient stays are
550
increasingly being shortened, while treatments are still ongoing. This leads to what are sometimes
551
called ‘virtual wards’. These offer future opportunities to extend point-of-care administration and full
552
traceability of medicinal products to patients who are still under the full responsibility of the hospital, but
553
are receiving their care at home or in another non-hospital setting.
554
555
556
9. Available systems
557
558
As in other sectors, in recent years digitalisation has progressed in healthcare, gradually replacing
559
paper files and manual procedures. Any move forward in digitalisation involves risk assessment and
560
change management. Hospitals are risk-prone environments; process changes need to be carefully
561
designed to reduce risks. Resistance to change will have several causes: implementations that are
562
perceived as beneficial for the nurse or the patient and do not add to the workload will be implemented
563
more easily. In addition, technological implementations require safe and reliable technology and well-
564
designed processes, or nurses (and physicians) will continue to use work-around processes, that have
565
proven workable solutions in the past. A technological implementation, such as IT support,
566
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implementing an EMR and barcode scanning require close observation of the original processes and
567
supporting the advancement and improvement or redesign of these processes. It takes time to get
568
medical personnel to understand the background and early stages of an implementation. However,
569
changes and improvements that align well with the care processes will not only result in commitment,
570
but also in safer processes and more time available for patient care7.
571
572
As multiple entry points serve to facilitate and support digitalisation in a hospital, multiplesystems are
573
developed, each serving a specific need. Even within a hospital, multiple stakeholders may own a
574
system such as ‘the hospital, the pharmacy, or a specific department. As a result, IT in a hospital setting
575
has evolved into a complex system of solutions, sometimes stand-alone, sometimes in a network
576
(multiple systems from the same developer), and sometimes requiring interfaces for interoperability.
577
This, of course, not only adds complexity, it also adds cost.
578
579
National guidance on the form of digitalisation varies between countries, adding to the diversity and
580
overall complexity of achieving the goal of full in-hospital traceability. The aim of this European guidance
581
document is to provide a summary of best practice and advice on how to implement it at operational,
582
professional, standardisation and regulatory levels.
583
584
Concerning in-hospital medication, the hospital pharmacy is the starting point, as the centralentry-point
585
for medication. A pharmaceutical warehouse management system facilitates stock-keeping and
586
procurement, for example. The barcode required by the EU FMD allows for better checking of the expiry
587
date, contributing to patient safety.
588
589
Prescription orders should no longer be handwritten, but should preferably be issued electronicallyvia
590
the CPOE. A Clinical Decision Support System (CDSS) supportsthe physician in prescribing, via
591
advice, alerts and reminders. Point-of-care referenceinformation can be accessed via the internet, but
592
ideally such a system is connected to or integrated with the hospital pharmacy system, enabling and
593
facilitating the advisory role of the hospital pharmacist. The advisory role of the pharmacist can be
594
enhanced by system links with direct patient-related parameters, such as laboratory results.
595
596
Any patient-related information (including prescription information) should be recorded manually in the
597
patient file, or, in a digitised hospital, in the electronic medical record (EMR). Paper patient files often
598
consist of multiple parts, a medical file for physicians’ notes, a nursing file for nurses’ notes and a
599
medication card specifically to register administered medications. In a digitised hospital themedication
600
card will be replaced by a medication administration system. The EMR should contain all of the
601
informationfrom these formerly paper files, facilitating multidisciplinary care and enhancing patient
602
safety.
603
604
Interoperability is required with the CPOE, the medication administration system and withthe pharmacy
605
systems. The best option is to have CPOE, CDSS and pharmacy systems integrated with the EMR.
606
Separate functions, but not separate systems. This hospital best practice requires some form of
607
hospital-digitalisation.
608
609
610
10. Personnel and training
611
612
Digitalisation of a hospital requires a completely new section/department of IT professionals. If a
613
hospital decides to have an in-house-developed EMR, the number of professionals will be large,
614
including developers. If the hospital opts for an off-the-shelf EMR, fewer developers will be needed, but
615
expertise to integrate the EMR with the in-hospital workflows will still berequired. Next to technical IT
616
expertise, support expertise is needed and experts such as data-analysts.
617
618
Practice shows that to achieve full traceability of medications up to final administration to patients
619
requires changes to systemsand workflows, and involves several types of healthcare professionals.
620
This requires an understanding of responsibilities, workflows, risk analysis – including connecting
621
(exchange) moments – and ultimately full alignment. In effect, this is major change management. Any
622
implementation will therefore benefit from the (orderly) involvement and commitment of representatives
623
of all affected staff, both in the design phase and in the implementation.
624
625
The expertise of healthcare professionals is primarily in ‘caring and curing’, and their focus is not
626
necessarily on processes or interactions. The working conditions for medical professionals, and thereby
627
the basic conditions for a patient-centred environment, should be ensured by appropriate IT and
628
technical as well as construction/building capacity infrastructure.
629
7 https://pure.rug.nl/ws/portalfiles/portal/3668356/Helmons_thesis.pdf
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630
Moving to a more digitised working environment requires not only adapted procedures, but also a
631
cultural change. A “scanning culture” should be developed, to discourage workarounds as much as
632
possible, since workarounds add risk to the processes and potentially to the patients. Redesign of
633
processes and design of the system should lead to scanning as the easiest pathway. In a scanning
634
culture the goals of traceability and scanning should be clearly communicated, and scanning
635
compliance should be monitored on a regular basis. Analysis of warning overrides should be performed
636
on, e.g. a weekly basis, systems/processes should be evaluated, fine-tuned and, where necessary,
637
feedback provided to staff involved in the process. Since processes interact constantly with each other,
638
monitoring and fine-tuning is a continuous effort to establish a safe and workable situation.
639
640
In a hospital, medication safety is the responsibility of several stakeholders and professionals, so the
641
sequential flow of medication through the hospital needs to be central to the decision process, and the
642
training process. Each stakeholder needs to be fully confident that all responsibilities are performed
643
correctly through a chain of trust, so that they can rely on safe systems and on the previous
644
professional in line, and feel trusted by the next professional in line.
645
646
Whether a hospital is a ‘paper world’ or fully digitised (and all possible variations in between) a good
647
overviewof the workflow processes and the stakeholders is paramount. In practice, even if the high-
648
level processes are similar, each hospital will have its own workflows and processes. Understanding
649
these is essential for successful change management processes.
650
651
Implementing traceability requires change management and understanding the effect of changes on the
652
medical professionals and other hospital staff. This can be addressed in training, which (in part) needs
653
to be tailor-made for the specific target groups. To achieve the necessary change management in a
654
hospital, this type of training should not be voluntary, but compulsory.
655
656
Training is not just required for prescribers and nurses, but also for pharmaceutical staff, as they have
657
an essential role in ensuring the correct medication is available, checking prescriptions and uploading
658
safety warnings into the system. Training should also include staff in logistics, in IT, physicians and staff
659
in administration and management. Training should preferably also include purchasing staff, warehouse
660
staff and logistics management.
661
662
In order to ensure the long-term implementation of full hospital traceability, training must be extended to
663
educational organisations and universities. Future generations of healthcare professionals (such as
664
clinical support staff, hospital pharmacists, quality assurance professionals, nurses and physicians)
665
should be suitably trained in the understanding and use of IT tools and ontraceability in order to ensure
666
successful implementations and to lay a foundation for continuous innovation.
667
668
Training in a healthcare environment will always require continuous attention and is an ongoing
669
process.
670
671
672
11. Premises and equipment
673
674
Equipment needed for the implementation of full hospital traceability includes barcode readers and
675
interoperable IT systems that can process the scanned data. Their efficient use requires the use of
676
ubiquitous standards, e.g. for the generation of identifiers and barcodes. The advantage of a global
677
system of standards (such as GS1) is the applicability throughout the hospital and the healthcare supply
678
chain.
679
680
With the GS1 standards, identification keys are converted to machine-readable datacarriers (barcodes)
681
so the encrypted information can be read automatically. These standards are system agnostic and can
682
be built into IT systems. This system has developed (global) standards for, among others, product
683
identification, asset identification, locations, transactions, processes, relations and all required
684
identification keys (such as expiry date, lot and batch numbers). A linear barcode has limited data
685
capacity; increasing demands for data capacity may result in multiple linear barcodes on a pack, which
686
can be confusing as to which should be scanned for what purpose. Innovations of the original linear
687
barcode as a data carrier and adjustments to match the (increasing) data requirements of a specific
688
sector have led to the development and implementation of 2D data carriers (such as DataMatrix). The
689
DataMatrix contains much more information in one scannable symbol, making it easier to capture
690
information and simplify the scanning process.
691
692
Throughout this guidance document, reference is made to necessary steps, equipment, etc. This
693
section summarises the essentials. No further details are added, as the details depend on the specific
694
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conditions and situation in a given country and/or hospital.
695
696
To achieve traceability of medicinal products in a hospital, at least the following are required:
697
– Understanding the need to standardise and that standardisation facilitates IT
698
implementation in hospitals.
699
– Barcoded medications (from the manufacturer) with harmonised details included in the barcode at
700
unit-dose level (product details, lot or batch number, expiry date).
701
– Identification at correct product/package level (to prevent relabelling).
702
– Development of IT, including necessary interfaces.
703
– Implementation of a patient identifier (and preferably a staff identifier).
704
– Desktop computers and mobile devices (laptops, tablets and mobile phones) in sufficient numbers.
705
– Including medication trolleys for the nurse to use during the medication round.
706
– In-hospital computerised systems, that have interfaces and are interoperable.
707
– Data warehouse for storing data.
708
– Allowing/building IT interfaces and exchange of data and translating data into information.
709
– Secure Wi-Fi environment.
710
– Barcode scanners with the correct capabilities and configuration.
711
– Printers (document printers as well as label printers).
712
– For any IT-related system, redundancy/back-up is an important necessary aspect.
713
714
715
12. Potential obstacles to development/implementation of full traceability
716
717
As described in the previous sections, digitalisation and barcode scanning can be considered important
718
innovations in hospitals and are also needed for the purpose of medication traceability. Processes are
719
similar in all hospitals. However, as circumstances vary from country to country and hospital to hospital,
720
the perceived challenges and barriers may vary. This section gives an overview of potential obstacles.
721
722
A lack of regulation on barcoding at the primary packaging level poses an important threat to the goal
723
of full in-hospital traceability. Stakeholders, such as manufacturers, can decide to simply comply with
724
barcoding/identification at the secondary level (as regulated by the FMD) or go beyond to barcode the
725
medications at the primary packaging level. Hospitals can opt to scan at the bedside only those
726
medications that are barcoded at the correct level and register the rest manually or invest in the
727
relabelling of all medications. Obviously, in practice, either of these situations allows for permanent
728
gaps, implying incomplete traceability.
729
730
The availability of the correct IT infrastructure and the necessary peripheral equipment is an important
731
precondition for any traceability programme. Experience shows that before starting a traceability
732
programme in a hospital, some practical issues need to be addressed. This guidance document
733
addresses some of these. This section lists some of the practical issues collected by the drafting group
734
that are identified as weaknesses:
735
– Identification/barcoding at the pack level, requiring alternative ways to scan the correct barcode at
736
the point of care, such as relabelling, scanning packages from which a single unit is taken (‘indirect
737
scanning’) to be administered to the patient, or entering the administered dose manually.
738
– Unscannable barcodes (damaged or misplaced).
739
– Hybrid situations in hospitals, partly handwritten records and partly digitisedprocedures.
740
– Lack of knowledge among the medical and nursing staff of ‘practical automation’, such as the use of
741
electronic records.
742
– The assumption that medical personnel can automatically change their way of working without
743
proper training.
744
– The assumption that medical staff automatically understand which barcode on a pack should
745
to be scanned and why.
746
– Pharmaceutical products with incomplete barcodes: identifiers that lack a lot/batch number and/or
747
lack the expiry date.
748
– Processes that allow workarounds, resulting in incomplete registration, an increase in patient safety
749
risks and the prevention of full registration, which hinders traceability. This can happen in acute care
750
situations, for example.
751
– Mixed processes, more specific procedures that are partly manual and partly use scanning. This is
752
especially risky if these processes also allow workarounds.
753
– Mistakes in the process redesign leading to workflows disrupting processes.
754
– In some hospitals “over-alerting” (interactions/dose checker/contraindications) is an issue. This can
755
cause additional ‘digitalisation fatigue’ among healthcare personnel and should be addressed and
756
avoided throughout the process of using decision support systems and EMRs.
757
758
Costs (high-level considerations):
759
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760
Digitalisation has benefits and costs. Time is needed to transform all aspects of healthcare from a paper
761
reality to a fully automated digital reality. This involves changes for each stakeholder.As healthcare is a
762
‘chain’, ideally each stakeholder understands the effect the changes will have on the processes of the
763
next stakeholder in the chain. For instance, a barcode on a product should be labelled in such a manner
764
that barcode scanning can be done easily, and the barcode should hold all necessary identification
765
keys. An EMR in itself is not enough to allow for barcode scanning at the bedside, barcode scanners
766
that can process the data are needed as well as the previously mentioned IT systems.
767
768
Given the variety of hospital systems, the variety of digitalisation and the complex IT market, it is
769
difficult, if not impossible, to estimate the investment required to reach the goal of full medication
770
traceabilityin hospitals. In some countries, software providers are increasingly offering scan capability
771
embedded in their software. This is an important development that will help to ensure that only hospital
772
IT systems that support barcode scanning and traceability will be used in the future.
773
774
EMR systems that are available on the market are costly (millions of euros for purchaseand
775
implementation), excluding the training of staff and other internal costs. Interfaces with other IT systems
776
are essential and, depending on the solution provider, these are sometimes costly. In addition, all
777
systems require an adequate budget for maintenance and updates.
778
An in-house built EMR system might seem less expensive, but requires a great number of dedicated in-
779
house IT staff, and also requires maintenance, updating and interfaces. For hospitals already equipped
780
with an EMR, the additional costs (scanners, training, etc.) to achieve full traceability are much more
781
limited.
782
783
Any cost-benefit analysis must include direct costs (such as hardware, software and data storage) and
784
indirect costs(including manpower, training and maintenance). The same is true for benefits, such as
785
the potential gain in staff time by reducing manual procedures, and capitalising on improved patient
786
safety (e.g. reduction in hospital in-patient days, reduction in medication errors). Any cost-benefit ratio
787
will depend on the (quality of) care issues that are to be improved.
788
789
A developed business case per country could provide a rough overview of the costs and benefits
790
involved, given the specific IT context of the country. Some countries have already outlined a policy on
791
digitalisation in healthcare, such as the UK’s National Health Service (NHS) digital8.
792
Some benefits are:
793
– improved patient safety, including reduction of medication errors,
794
– increased efficiency in several processes,
795
– efficiency in pharmaceutical supply chain management, including reduction of medication stock,
796
– better and real time information for national medicines monitoring systems, supporting rationalising
797
procurement,
798
– reduction of waste due to better stock management , e.g. for a better monitoring of expiry dates,
799
– nurses’ time given back to care,
800
– time given back to hospital pharmacists and their staff,
801
– better monitoring and evaluation of medical processes,
802
– possible increase in medical productivity.
803
804
In addition to the above-mentioned benefits, reductions in paper use, printer facilities and other long-
805
term benefits contribute to sustainability goals.
806
807
No hospital will be capable of immediately implementing everything required for a medication
808
traceabilitysystem. In part, the investments can be recouped through waste reduction and hours given
809
back to care. If each step in a designed process is well described, costs and benefits can be
810
compared/balanced per step.
811
812
Guidance, including sharing of good examples, is needed to understand both costs and benefits.
813
814
13. Quality assurance
815
816
For all stakeholders, an important aspect of healthcare is quality. Quality can also be considered an
817
important aspect of patient safety, or patient safety can be considered an aspect of quality. Healthcare
818
professionals work with professional guidelines in which quality is embedded. Hospitals will have a
819
quality department and dedicated quality staff in specific departments, such as the laboratory, the
820
8
https://digital.nhs.uk
https://digital.nhs.uk/services/digital-and-interoperable-medicines/resources-for-health-and-care-services/other-
resources/strategic-drivers
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pharmacy and wards.
821
822
Quality assurance and quality monitoring are two sides of the same coin. Quality assurance originates
823
from the manufacturing industry, establishing and maintaining set requirements for developing or
824
manufacturing reliable products. Quality monitoring supports the evaluation of processes, and checks
825
the desired outcome against the actual outcome, supporting continuous improvement. Quality
826
assurance and quality monitoring are widely used in healthcare and hospitals to improve work
827
processes and efficiency and to meet the needs, expectations and requirements of both clinicians and
828
patients.
829
830
The implementation of well-tested procedures, protocols and standards is part of continuous quality
831
improvement. In the field of medical work, implementing and maintaining a quality assurance
832
programme helps prevent errors before they happen.
833
834
In order to meet the requirements for a well-functioning implementation of bedside scanning, there are
835
some important conditions that are not only specific to bedside scanning, but to the proper functioning
836
of the hospital, e.g.:
837
838
– A good quality system needs to be implemented.
839
– Personnel must have an appropriate level of training and can only perform tasks for which they are
840
authorised.
841
– Automated systems must be secured with adequately functioning back-up systems.
842
– All areas where medicinal products are stored must be controlled and monitored for appropriate
843
climatic conditions and authorised access.
844
845
As hospitals move from manual processes to IT-supported processes and IT-supported administration
846
and registration, more and more data become available. Data are less meaningful if they cannot be
847
interpreted or shared (requiring interoperability of systems and a well-functioning data warehouse).
848
Standardisation of what is incorporated in data, and how data are obtained and shared/exchanged are
849
examples of quality assurance of IT systems.
850
851
The implementation of global standards facilitates the exchange of unique data in a uniform way, using
852
the same definitions and descriptions.
853
854
Although each patient’s situation is unique,, healthcare delivery benefits from standardisation, as this
855
increases the reliability of processes and procedures and supports state-of-the art clinical pathways.
856
Bedside scanning requires standardisation and is IT-supported. For the success of digitalisation and IT,
857
standardisation of procedures and processes is essential. Digitalisation facilitates the transformation of
858
data into useful information, supporting severalprocesses, logistic, administrative as well as clinical.
859
Data use and transformation also requires standardisation of definitions, reduction of ‘free text’ in
860
patient records, and good data processing. Good implementation of standards is essential to enable
861
data processing and, for example, interoperability of systems and data exchange. Hospitals benefit from
862
the digital exchange of product data with the manufacturers and suppliers for purchasing purposes. For
863
drug information, national and international databases form an indispensable source. However, patient-
864
related data (traceable to the individual patient) must be protected in the hospital environment and
865
safeguarded from unauthorised access by external stakeholders.
866
867
The hospital must add/embed the above-mentioned processes and procedures in their quality system.
868
Hospitals are responsible for creating a “scanning culture” in which workarounds should be discouraged
869
as much as possible. Some components of a scanning culture include:
870
– processes are designed so that they encourage scanning;
871
– the goals of traceability and scanning are clearly communicated;
872
– scanning compliance is checked on a regular basis;
873
– analysis of ‘warning overrides’ is performed on, e.g. a weekly basis;
874
– records and Analysis of non-compliance;
875
– system/process is evaluated, fine-tuned and developed;
876
– when needed, feedback is provided to staff involved in the process.
877
878
Regular reports to management and the board ensure that quality and safety receive the required
879
attention at all levels. Internal audit systems add to quality assurance. These audits can be
880
administrative (or on separate parts of the administrative processes), on logistics (including the
881
mandatory control at reception and the labelling control after unpacking), and on patient pathways or
882
even on patient-related outcomes.
883
884
External accreditation or certification of a hospital is increasingly seen as a guarantee of publicquality
885
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assurance. Accreditation organisations are active in several countries. In recent years, some global
886
accreditation organisations (such as Joint Commission International (JCI), Accreditation Canada) have
887
taken a large share of the market. In some countries a successful accreditation procedure has been
888
made mandatory by regulation for hospitals. A positive accreditation result is usually valid for several
889
years. These procedures involve costs for the accreditation process itself and internal costs, e.g. for
890
staff.
891
892
One such accreditation organisation is the Healthcare Information and Management Systems Society
893
(HIMSS). HIMSS has developed several maturity models, one of which, the Electronic Medical Record
894
Adoption Model (EMRAM) specifically focuses on electronic medical records. EMRAM is designed to
895
measureclinical outcomes, patient engagement and clinician use. Stage 7 is the top level of this
896
maturity model. The audit procedure for stage 7 checks whether the hospital has implemented barcode
897
scanning in their procedures. As described, ‘EMRAM ensures the workflow and content in the digital
898
tool meets the needs of the clinical teams while monitoring compliance with approved standards.’
899
900
To become a ‘stage 7 HIMSS hospital’ electronic traceability of medications is a requirement, illustrating
901
that institution-wide traceability is very much possible. In 2022, several European hospitals reached this
902
level of validation/accreditation9.
903
904
905
14. Regulation
906
907
The safety of patients, healthcare professionals and products used in healthcare (such as medicinal
908
products, medical devices and health IT) is subject to regulation. In principle this governs actions or
909
procedures and requires an authority to oversee the organisation or system. Healthcare, of which
910
hospital care is a specific part, is subject to several levels of regulation.
911
912
In the absence of regulation, professional standards are set by scientific associations of medical
913
professionals (increasingly aligned internationally), which promotes equal quality of care for all patients.
914
915
National governments establish and enforce national regulations and legislation, for example,
916
requirements for the recognition of professional qualifications in their healthcare system.
917
918
International and national healthcare regulations are important drivers to ensure adequate qualification
919
and training of healthcare professionals and quality of care, healthcare products and healthcare IT
920
systems.
921
922
Through their governmental enforcement role, healthcare inspectorates support public health by
923
ensuring a high level of quality assurance in healthcare establishments. This also gives governments
924
access to data useful for establishing and maintaining healthcare policies and, to some extent, cost
925
control.
926
927
For EU member states, national legislation is supplemented by EU directives, which must be
928
transposed into national law, and EU regulations, which are directly applicable in all member states.
929
There is currently no requirement covering full traceability of medicinal products in EU directives or
930
regulations.
931
932
The implementation of the EU FMD has created a focus on the logistics chain. Although the purpose of
933
the FMD is to prevent falsified medicinal products from entering the supply chain, the FMD has in fact
934
raised awareness of the issue of traceability of medicinal products and the possibility of achieving
935
traceability to the patient. All stakeholders – including manufacturers – are faced with the costs of
936
implementing barcoding and adapting procedures. The benefits lie in patient safety, but also in
937
efficiency.
938
939
However, the FMD has mandated coding of medicinal products at the secondary packaging level and
940
will not mandate coding at the primary packaging level. It is important for all stakeholders to understand
941
this ‘missing link’ to reaching full traceability and to work together towards a harmonised solution.
942
943
A national example of a next step can be seen in the UK. A recent consultation on ‘point-of-care
944
manufacturing’10 is a preparatory step towards new legislation that is aimed at supporting increased
945
manufacture of point-of-care products while ensuring that these products achieve the same assurance
946
of safety, quality and efficacy that currently exists for more conventional medicinal products. A new
947
9 https://www.himss.org/news/himss22-europe-celebrates-healthcare-systems-validated-emram-stages-6-and-7
10 https://www.gov.uk/government/consultations/point-of-care-consultation/consultation-on-point-of-care-manufacturing
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regulatory framework has been proposed, based on and linking with current regulatory systems for
948
medicines approvals, clinical trials, evaluation of regulatory compliance at manufacturing sites and
949
safety monitoring11.
950
951
This can be seen as the first framework of its kind to facilitate the manufacture of innovative medicines
952
at the point of care, which will facilitate point-of-care (bedside) scanning.
953
954
955
15. Data protection and data sharing
956
957
The EU GDPR has been in force since May 2018. For national authorities, the GDPRis fundamental to
958
the development and implementation of national privacy regulation. Protection of data is an important
959
focus of the GDPR. This regulation applies to a ‘paper world’ as well as to the ‘digital world’. Principles
960
that were already part of good practice are now regulated in the GDPR.
961
962
Some of these principles align well with the requirements for a full medication traceability system.Some
963
require extra attention. For example, when processing personal data, one of the principles is data
964
minimisation, in other words, the processing of data must be ‘adequate, relevant and limited to what is
965
necessary in relationto the purposes for which they are processed’.
966
967
Any healthcare-related system that uses data, generates data or holds data must be compatible with
968
the requirements of the GDPR. Personal patient-related data must always be protected, so that it is only
969
accessible to the treating healthcare professionals. In terms of traceability, healthcare-related data
970
should only be used for (product) traceability purposes (such as in-hospital reconciliation of the
971
prescribed drug versus the administered drug) and not in any other way by stakeholders that are not
972
directly involved in the process of dispensing/administering medicines or treating the specific patient.
973
974
If this is transposed to a hospital setting, personal patient data must be accessible to the relevant (and
975
authorised) caregivers. The hospital is obliged to construct safe systems of access to patient data, and
976
audit and monitor these. This requires both paper and digital systems. Consent of patients is needed for
977
any exchange of personal data with third parties. In line with this principle, medical professionals who
978
are not involved in care processes for any given patient are considered as third parties, and therefore
979
have no right to access and process data from this patient.
980
981
Another important principle is integrity and confidentiality: data must be ‘processed in a manner that
982
ensures appropriate security of the personal data, including protection against unauthorised or unlawful
983
processing and against accidental loss, destruction or damage, using appropriate technical or
984
organisational measures.’ Hospitals must comply with this principle.
985
986
Aggregated healthcare data can be used and shared, for example, for research, treatment evaluation,
987
national or international medical related registries and healthcare policies. These opportunities leverage
988
great benefits. However, these aggregated datamust be anonymised in a format that cannot be traced
989
back to individual patients.
990
991
In cases where traceability to specific patients would be necessary (e.g. in the case of serious and
992
harmful side-effects of a treatment), the hospital must trace the individual patients without disclosing
993
their personal data elsewhere.
994
995
When designing and implementing barcode scanning and bedside scanning, the GDPR guidance must
996
be respected by all stakeholders.
997
998
999
000
001
11 https://www.gov.uk/government/news/uk-to-introduce-first-of-its-kind-framework-to-make-it-easier-to-manufacture-
innovative-medicines-at-the-point-of-care
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16. Recommendations
002
003
Background to the recommendations
004
– Developments and (national) guidelines supporting in-hospital medication safety, such as electronic
005
prescribing, are building blocks for achieving full traceability.
006
– Ensuring full in-hospital traceability raises concerns about the demands on the hospital’s
007
infrastructure. Elements such as scanning points, medication trolleys, barcoded products, patient
008
identifiers and on-screen alerts are not always in place, depending on the hospital. Introducing and
009
implementing traceability of medicinal products in a hospital is a complex and costly process.
010
Overall, the costs of this process are expected to initially outweigh the immediate benefits.
011
Capitalising on the expected medium- and long-term benefits will help to build a strong business
012
case. For the healthcare supply chain, the benefits are quite well documented. More research and
013
publications on this topic in the hospital environment will be helpful12.
014
– All stakeholders should be aware of the investment cost for the implementation of full in-hospital
015
traceability with barcoding of medicinal products at the primary level, to be balanced by benefits at
016
other levels of the healthcare systems. This will be made possible through co-operation on
017
harmonised solutions, such as agreeing upon a universal standard.
018
– Hospital processes tend to have risky moments and gain quality through routine and
019
standardisation. Any process change needs to be ‘thought through’, and designed to be as non-
020
disruptive as possible. To introduce traceability in the medication process from pharmacy to
021
administration to the patient requires process redesign. Describing the various steps in the
022
medication processes, and deciding on which IT support/system is needed for which step, requires
023
both IT expertise and insight/expertise in the actual work processes. Depending on previous related
024
IT decisions (such as which EMR is selected) each step requires a decision about interoperability,
025
immediate benefits and expected future benefits. If the medication processes are well designed
026
with IT support, the actual bedside scanning is the final step and probably the least costly. In a
027
business case, the direct and indirect financial implications must be capitalised.
028
029
030
Recommendations for specific stakeholders:
031
032
Policy-makers and regulators (medicines and hospitals), at EU and national levels
033
– Being aware that digitalisation in healthcare is greatly enforced by regulation,
034
– Being aware that the financial margins of healthcare providers (especially the public ones) are small
035
and implementation may need to be facilitated or supported,
036
it is recommended that policy-makers
037
– establish a regulatory framework for digitalisation, including interoperability of systems and safe
038
back-up systems,
039
– take harmonised measures across Europe to avoid multiple systems with issues of interoperability,
040
– based on the evidence of the impact of regulations on in-hospital traceability on patient safety and
041
of the accompanying cost-benefit, establish regulation for unit-dose barcoding of all authorised
042
medicinal products. It is acknowledged that in the absence of regulation, only equipped and
043
resourced hospitals would be able perform unit-dose relabelling with barcoding allowing in-hospital
044
traceability.
045
046
Industry (pharmaceutical manufacturers, solution providers, industrial third parties)
047
– Recognising the efforts made by stakeholders from industry to support patient safety and the need
048
for these efforts to be continued,
049
it is recommended that pharmaceutical manufacturers, with the support of their solution providers and
050
other industry third parties:
051
– implement the regulatory requirements for barcoding unit doses, facilitating full in-hospital
052
traceability,
053
– ensure that their monitoring systems in packaging lines and in quality control guarantee that
054
barcodes are scannable at the next level (hospital) and placed at the correct scannable location,
055
– ensure that the barcodes include all relevant data, such as product code, batch number and expiry
056
date, as these need to be included in the in-hospital traceability systems.
057
058
Hospital boards
059
– Considering the awareness of hospital boards of the topic of full in-hospital traceability, specifically
060
12
Implementation of barcode medication administration. (BMCA) technology on infusion pumps in the
operating rooms. BMJ Open Quality 2023;12:e002023. doi:10.1136/bmjoq-2022-002023.
IJQHC Communications, 2021, 1(1), 1–3; DOI: https://doi.org/10.1093/ijcoms/lyab014. Use of barcode
technology can make a difference to patient safety in the post-COVID era
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of its benefits (on top of efficiency) for patient safety,
061
it is recommended that hospital boards:
062
– share (and facilitate the sharing of) best practices and use cases,
063
– define their needs with policy-makers and payment bodies in order to generate funding for the
064
investments to be made (infrastructure, human resources, training, etc.),
065
– ensure a quality culture is in place (including quality departments and quality systems) to support
066
the implementation of in-hospital traceability,
067
– consider the training required to design and implement a secure system of full traceability.
068
–
069
–
070
IT managers/IT service providers
071
– Acknowledging the responsibility of IT managers for the redesign of the IT system supporting the
072
implementation of in-hospital traceability and involve healthcare professionals to establish safe and
073
lean workflow processes,
074
it is recommended that IT managers:
075
– facilitate and create interoperability between the various IT systems (current and future),
076
– ensure proper data management with respect to GDPR.
077
It is recommended that IT service providers:
078
– ensure that each IT system developed supports both barcode scanning and the processing of
079
scanned data such as product code, batch number and expiry date, as these are required for
080
inclusion in the in-hospital traceability systems,
081
– ensure interoperability of systems and data warehouses and prevent (or at a minimum reduce)
082
vendor lock-in.
083
084
Hospital quality management departments
085
It is recommended that quality management departments:
086
– support the hospital board in understanding the need for the capability and capacity of the
087
development of the traceability function,
088
– support hospital management and departments through the development of quality procedures for
089
the implementation of in-hospital traceability,
090
– inform and train hospital staff on developments to implement identification of medicines in these IT
091
systems and on the alignment with national and international accreditation systems and with
092
hospital and pharmaceutical regulations,
093
– ensure the quality of the traceability function/system through auditing, failure analysis, evaluation
094
and support for accreditation.
095
096
Hospital pharmacists
097
– Recognising the important role played by hospital pharmacists and their professional associations,
098
both nationally and internationally, in raising awareness and sharing good practices for the
099
business case for implementation of full in-hospital traceability,
100
it is recommended that hospital pharmacists:
101
– take an active part along with other healthcare professionals in providing hospital boards with
102
evidence about the benefit of in-hospital traceability for patient safety,
103
– are involved and combine efforts with other healthcare professionals in the redesign of the
104
processes ensuring implementation of full in-hospital traceability, including for the reception of
105
medicines,
106
– ensure in their hospitals that conditions are met to allow bedside scanning.
107
108
Other healthcare professionals in the hospital (such as physicians, nurses)
109
– Recognising the role played by all healthcare professionals in raising awareness of the importance
110
of full medication traceability,
111
it is recommended that other healthcare professionals:
112
– take an active part in providing hospital boards with evidence of the benefit of in-hospital traceability
113
for patient safety,
114
– combine efforts to develop and implement process redesign to ensure the implementation of in-
115
hospital traceability, e.g. for the roll-out of a pilot in their own hospital.
116
117
Healthcare payment bodies (NHS, insurance companies, etc.)
118
– Considering the awareness of healthcare payers that achieving benefits from any change requires
119
investment, for which not all healthcare providers and hospitals will have financial resources,
120
– Recognising that healthcare payers have to inform themselves about the benefits of full in-hospital
121
traceability and must be involved in its establishment by providing them with examples and
122
business cases,
123
it is recommended that healthcare payment bodies:
124
– ensure the investments necessary are made in piloting, developing and rolling out full in-hospital
125
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traceability,
126
– take up a leading role in facilitating the sharing of good practice cases, knowledge and expertise,
127
– encourage hospitals to implement full in-hospital traceability.
128
129
Patients
130
– Considering that patient organisations, both nationally and internationally, need to be aware of the
131
benefits of barcode scanning for patient safety,
132
it is recommended that patient organisations:
133
– strongly advocate for in-hospital traceability by stressing the importance of the topic at all levels in
134
which they are involved.
135
136
137
Note for Committees’ review: standardisation bodies (e.g. HIMSS, JCI) have not been considered as
138
suitable targets for recommendations in this guideline document, at least at this stage, as accreditation
139
of in-hospital traceability could significantly add to investment costs. However, they could be involved in
140
the public consultation.
141
142
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17. Definitions
143
144
This section provides definitions specifically for the purpose of this guidance document.
145
146
Adverse drug event (ADE): any injury secondary to medication use.
147
148
Administering medication: point-of-care process involving the direct application of aprescribed
149
medication – whether by injection, inhalation, ingestion or other means – to an individual patient by an
150
individual person legally authorised to do so.
151
152
Barcode: a symbol that can be scanned electronically using laser or image-based technology. Barcodes
153
are used to encode information such as key identifiers (product, shipment, location, etc.) and key
154
attributes (serial numbers, batch/lot numbers, dates, etc.). The most commonly used standard for
155
barcoding identification in Europe is GS1, using GS1 syntaxes (plain, GS1 element string and GS1
156
Digital Link URI)13. Linear barcodes(one-dimensional) and increasingly two-dimensional (2D) barcodes
157
(such as the Data Matrix) are used in healthcare.
158
159
Referring to medicines entering the hospital in accordance with the FMD: “The barcode shall be a
160
machine-readable Data Matrix and have error detection and correction equivalent to or higher than
161
those of the Data Matrix ECC200. Barcodes conforming to the International Organization for
162
Standardisation/International Electrotechnical Commission standard (‘ISO/IEC’) 16022:2006 shall be
163
presumed to fulfil the requirements”.
164
165
Barcode Medication Administration (BCMA): identification of medication at the bedside/point of care
166
using barcode scanning.
167
168
Cardex: originally the proprietary name for a filing system for nursing records and orders that was held
169
centrally on the ward and contained all the nursing details and observations on patients that had been
170
acquired during their stay in hospital.
171
172
Clinical Decision Support System (CDSS): health IT, primarily used atthe point of care, intended to
173
improve healthcare delivery by enhancing medical decisions withtargeted clinical knowledge, patient
174
information and other health information. CDSS encompasses a varietyof tools to enhance decision-
175
making in the clinical workflow.
176
177
Computerised Physician Order Entry (CPOE): the process of a medicalprofessional entering and
178
sending medication orders and treatment instructions electronically via a computer application instead
179
of on paper charts. This advantageous format reduces errors related to the ambiguity of handwriting or
180
transcription of medication orders.
181
182
Dispensing medication: preparing medication for administration to the patient according to the
183
prescription.
184
185
Double check (verification in a double procedure): making certain that an item or a process is correct or
186
safe, usually by examining it again (four eyes principle). In the specific case of medication, checking if
187
the prepared medication is correct according to the prescription before administering to the patient.
188
Double check can be performed by another healthcare professional or by a safe system-check, such as
189
an IT solution to support verification, like barcode scanning.
190
191
Electronic Medical Record (EMR): technology that enables the storage, retrieval and modification of
192
health data using digital means instead of paper-based recording systems within one healthcare
193
organisation or hospital. An EMR is a software application/system that replaces paper patient records,
194
stores patient information digitallyand makes this information available to authorised users in real time.
195
Its purpose isto securely support care processes.
196
197
The EMR should interface with other IT systems, such as the laboratory information system, thehospital
198
pharmacy information system, the electronic prescription system, the CPOE, with data back-up
199
provided, etc.
200
201
EMRs can be either in-house developed or purchased from specialised EMR developers (who provide
202
maintenance). Since clinical workflows and working habits vary from hospital to hospital, EMRs need to
203
be customised to reduce the risks to patients from the handling of records by healthcare professionals
204
(physicians, hospital pharmacists and nurses).
205
13 https://www.gs1.org/standards/barcodes
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Electronic Prescription System: computer-based electronicgeneration, transmission and filling of a
207
medical prescription (including authorised access), replacing paper and faxedprescriptions.
208
209
Electronic Medical Record Adoption Model (EMRAM): the HIMSS EMRAM measures clinical outcomes,
210
patient engagement and clinician use of EMR technology to strengthen organisational performance and
211
health outcomes across patient populations. The internationally applicable EMRAM incorporates
212
methodology and algorithms to score a whole hospital, including in-patient, out-patient and day care
213
services provided on the hospital campus. EMRAM scores hospitals around the world relative to their
214
digital maturity, providing a detailed road map to ease adoption and begin a digital transformation
215
journey towards aspirational outcomes. Measuring evidence-based data at each stage, organisations
216
use EMRAM to optimise digital work environments, improve performance and financial sustainability,
217
build a sustainable workforce, and support an exceptional patient experience. Leveraging information
218
digitally improves patient safety and clinician satisfaction by reducing errors in care, length of stay for
219
patients and duplicated care orders, and streamlining the access and use of data to inform care
220
delivery.
221
222
Falsified Medicines Directive (Directive 2011/62/EU, FMD) and Commission Delegated Regulation(EU)
223
2016/161: EU rules for the prevention of the entry into the legal supply chain of falsified medicinal
224
products. The FMD is implemented in EU member states.
225
226
Formulary: a hospital-specific selection of drugs/medications (covering all required therapeutic areas)
227
that can be used in the hospital to assist in the selection of the correct medication. A formulary may be
228
in printed or digital form.
229
In a hospital, the selection of pharmaceutical products, among which medications, is theresponsibility of
230
Drugs and Therapeutics Committees, that are multidisciplinary teams in charge of selection and of
231
which the hospital pharmacist is an important member. Physicians take part in these committees to
232
discuss and decide on the final hospital formulary. Important considerations include existing national
233
formularies/list of medicines, characteristics and needs of specific patient populations, state-of-the-art
234
treatment, interactions, and the pharmaco-economic analysis.The in-hospital selected pharmaceuticals
235
are basis of the hospital formulary, that contains a listof medications most prescribed in the hospital
236
and serves as a guidance document for the prescribers.
237
238
This requires a formulary management system, continuous updating and attention to formulary
239
compliance (by the prescribers and the hospital pharmacists).
240
241
General Data Protection Regulation (GDPR): regulation in force from 25 May 2018 in all member states
242
to harmonise data privacy laws across Europe14.
243
244
Hospital Information Management System (HIMS): a unique system that tracks all operations in a
245
hospital and often comprises a combination of software used for administrative purposes and software
246
used for clinical purposes by different professionals. Patient-related identification details, investigations,
247
laboratory and pathology results, operating room processes, hospital pharmacy operations and human
248
resources processes are included. Electronic medical records (EMRs) containing the medical and
249
nursing history of individual patients, can be part of the HIMS or can be connected via interfaces.
250
251
Healthcare professional: a trained and licensed professional, such as a Doctor of Medicine, a nurse
252
responsible for general care, a dental practitioner, a midwife or a pharmacist, or another professional
253
exercising activities in the healthcare sector.
254
255
Healthcare provider: often used interchangeably to refer to either an individual healthcare professional
256
or an organisation that offers healthcare services.
257
258
Healthcare Information and Management Systems Society (HIMSS)15: not-for-profit organisation that
259
develops IT standards16 to help reform the global health ecosystem. Among others, HIMSS drives the
260
adoptionof standard-based interoperability to improve the way healthcare systems share information for
261
optimal care; and provides educational and professional opportunities to prepare the next generation of
262
14 https://gdpr-info.eu
15
(www.himss.org/who-we-are
16
Clinical Supply Chain Outcome Model (CISOM):https://www.himss.org/what-we-do-solutions/digital-health-
transformation/maturity-models/clinically-integrated-supply-outcomes-model-cisom
Electronic Medical Record Adoption Model (EMRAM):https://www.himss.org/what-we-do-solutions/digital-health-
transformation/maturity-models/electronic-medical-record-adoption-model-emram
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health information and technology leaders for the digital health workforce.
263
264
Identifier: a character or group of characters used to identify or name a series of associated data.
265
Digitalisation facilitates the readability, storage and exchange of the data in an identifier. A barcode is a
266
data carrier for identifiers.
267
268
Information technology (IT): a broad (still evolving) concept that covers any product that will store,
269
retrieve, manipulate, transmit or receive information electronically in a digital form (e.g. personal
270
computers, including smartphones, digital television, email and robots).
271
272
Integrating the Healthcare Enterprise (IHE): international not-for-profit organisation that has published
273
several documents on traceability of medicines in hospitals17.
274
275
Joint Commission International (JCI): US-based international organisation in healthcare/hospital
276
accreditation18 .
277
278
279
Labelling: information on the immediate or outer packaging.
280
281
Medication error: any mistake in ordering, prescribing, dispensing, administering or monitoring (the
282
effect of) a medication.
283
284
Medication Ordering System: the system whereby a medical professional hand-writes prescriptions that
285
are sent to, transcribed by and checked by the hospitalpharmacist.
286
287
Medical record: set of documents to register and store the health data of an individual patient. This will
288
consist of physicians’ notes, nurses’ notes, prescriptions, orders, laboratory and other test results, and
289
reports of interventions.
290
291
Medicinal product: any substance or combination of substances presented for treating or preventing
292
disease in human beings.
293
294
Patient safety: the prevention of errors and adverse effects to patients associated with healthcare.
295
While healthcare has become more effective over the years, it has also become more complex, with
296
greater use of new technologies, medicines and treatments. While these bring benefits, they can also
297
increase risks to patient safety.
298
299
Prescriber: a healthcare professional authorised (and often licensed) to prescribe a treatment and/or
300
medication, such as a physician, a midwife, a physician assistant and, in specific situations, a nurse.
301
302
Prescription19: instruction issued by a professional person qualified to do so (written or electronic) that
303
authorises a patient to be issued with a medicinal product or treatment. National policies on over-the-
304
counter and prescription-only medications may differ. In a hospital setting, the physician will prescribe
305
medication for the individual patient and the pharmacist will verify and support the dispensing process.
306
307
Primary packaging: the first layer containing the finished product, or the packaging that is in direct
308
contact with the product. In this document, it refers to the packaging of the medicinal product which is in
309
direct contact with the product and is marked with a data carrier either on the packaging or on a label
310
affixed to the packaging.
311
312
Single unit dose: (a package that contains) one unit of medication. A single unit dose can also be a
313
single vial or a medicine unit out of its blister pack.
314
315
Secondary packaging: the level of packaging that may contain one or more primary packages or a
316
group of primary packages containing a single item. Secondary packaging is the packaging that holds
317
together the individual units of a product. This type of packaging is used to group a certain number of
318
products to create a stock-keeping unit. It facilitates the handling of smaller products by collating them
319
into one pack.
320
321
Standards: rules that govern technology, behaviour and interaction. They are an agreed way of doing
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17

Integrating the Healthcare Enterprise (IHE)

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https://www.jointcommissioninternational.org.
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things, giving organisations a set of tools with the potential to help them perform better. Standards are
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different from regulation. Regulation is a rule or directive made and maintained by an authority.
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Track-and-trace of medications: a process used to determine a medicinal product’s current and past
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locations. When track-and-trace is correctly implemented, a drug can be tracked throughout the supply
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chain and traced back up the supply chain upon return or recall. A pharmaceutical track-and-trace
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system is a logistical technology that enables the tracking and localisation of a medicine throughout the
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supply chain. In the scope of this document, track-and-trace is limited to the in-hospital environment,
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from the pharmacy up to the point of administration to the patient.
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Unit dose: the ordered amount of a drug in a dosage form prepared for a one-time administration to an
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individual, indicating the name, strength, lot and/or batchnumber. A unit dose is the amount of a
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medication administered to a patient in a single dose.
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18. Further reading (to be finalised in next version)
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1. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse
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drug events. Implications for prevention. ADE Prevention Study Group. JAMA 1995; 274:29-34.
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2. CD-P-PH, pharmaceutical practices and pharmaceutical care (EDQM);
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https://www.edqm.eu/en/pharmaceutical-practices-and-pharmaceutical-
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care?p_l_back_url=%2Fen%2Fweb%2Fedqm%2Fsearch%3Fq%3DCDPPH%252FPC%2Bguidanc
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e%25E2%2580%2599s%2Bterminology
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3. CPOE: Megan Charles, Alex DelVecchio, Brian Eastwood. TechTarget; Health IT; Updated
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October 2018: https://www.techtarget.com/searchhealthit/definition/computerized-physician-
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order-entry-CPOE
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4. Cap Gemini Consulting: Report by order of Dutch Ministry of Health: ’Barcodering op de
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primaire verpakking van geneesmiddelen in ziekenhuizen; een kosten-baten analyse’, 2017:
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https://open.overheid.nl/documenten/ronl-archief-752101ad-99a9-444d-8d2c-af9e41491b9a/pdf
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5. Warren Connolly, Natasha Rafter, Ronan M Conroy, Cornelia Stuart, Anne Hickey, David J
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Williams: The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends inadverse
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event rates in the Irish healthcare system, 2020,
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https://qualitysafety.bmj.com/content/30/7/547
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6. Cummings J, Bush P, Smith D, Matuszewski K (15 December 2005). “Bar-coding medication
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administration overview and consensus recommendations”. American Journal of Health-
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System Pharmacy. 62(24): 2626–9.doi:10.2146/ajhp050222.PMID 16333061.
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7. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on
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the Community code relating to medicinal products for human use
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https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32001L0083
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8. EAHP on traceability for hospital pharmacist:
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https://statements.eahp.eu/statements/statement-511
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https://statements.eahp.eu/statements/final-statements
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9 EDQM: Resolution CM/Res(2020)3: on the implementation of pharmaceutical care for the
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benefit of patients and health services
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10. European Commission; Presentation Patrizia Tosetti, DG Sante: Medicines verification in
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Europe, what to expect in 2019; https://health.ec.europa.eu/system/files/2016-
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11/201602_stakeholders_workshop_final_0.pdf
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11. European Medicines Verification System (EMVS); European Pack Coding Guidelines, Version
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4.0 July 2017: https://emvo-medicines.eu/new/wp-content/uploads/European-Pack-Coding-
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Guideline-V4_0.pdf
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12. Expert Group on Safe Medication Practices. Creation of a better medication safety culture in
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Europe: Building up safe medication practices. 2006. http://optimiz-sih-circ-
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med.fr/Documents/Council_of_Europe_Medication_Safety_Report_19-03-2007.pdf
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13. Feargal McGroarty, St James’s Hospital, Dublin, Ireland, 2011-12: Barcoding on
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pharmaceutical packaging cuts costs and improves patient safety:
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https://www.gs1ie.org/download_files/healthcare_files/haemophilia_treatment_traceability_cas
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e_studyv2.pdf
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14. G-Standaard: the Dutch drug database which is used by all parties in healthcare in the
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Netherlands. The G-Standaard contains all the products that are dispensed by or used in the
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pharmacy. It enables an efficient exchange of information between healthcare parties.
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https://www.z-index.nl/english
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15. GS1 Healthcare:
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– Antonius Hospital makes safer medication a priority:
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https://www.gs1.org/industries/healthcare/reference-books-library
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– Hospital Israelita Albert Einstein continues its journey to full traceability ofpharmaceuticals
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– Webinars: https://www.gs1.org/industries/healthcare/hpac/webinars#tab-2018
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§ Richard Price, EAHP, 2014: Bar coding medicines to the single unit administered
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in hospitals: EAHP’s work towards a solution
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§ Thomas de Rijdt, UZ Leuven, Belgium, 2014: The missing link in hospital
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pharmacy
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§ Pieter Helmons: 2018: Yes we scan! Minimizing medication administration errors
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through successful change management, the Netherlands
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§ 2019: Bedside Scanning requires cultural change, Copenhagen, Denmark
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16. HealthManagement.org, 2015. Heidi Wimmers, Argentina: Why is Drug Traceability Important
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in a Hospital? https://healthmanagement.org/c/icu/issuearticle/why-is-drug-traceability-
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important-in-a-hospital
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17. HIMSS (Healthcare Information and Management Systems Society), EMRAM stage 7
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validation Europe 2022:
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https://www.himss.org/news/himss22-europe-celebrates-healthcare-systems-validated-emram-
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stages-6-and-7
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18. Hogerwaard M, Stolk M, Dijk L, et al. Implementation of barcode medication administration
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(BMCA) technology on infusion pumps in the operating rooms. BMJ Open Quality 2023;
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Implementation of barcode medication administration
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(BMCA) technology on infusion pumps in the operating rooms. BMJ Open Quality
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2023;12:e002023. doi:10.1136/bmjoq-2022-002023..
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19. ICT&Health: barcodes on medication enhances patient safety, 2017:
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Barcodes op medicijnverpakking vergroot patiëntveiligheid

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20. Institute of Medicine. Quality Chasm Series. Preventing Medication Errors. Washington DC:
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National Academy Press; 2007
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21. Integrating the Healthcare Enterprise (IHE):
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– Hospital Medication Workflow. 2019.
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https://wiki.ihe.net/index.php/Hospital_Medication_Workflow
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– IHE Pharmacy Profiles: https://www/ihe.net/ihe_domains/pharmacy
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– https://www.ihe.net/uploadedFiles/Documents/Pharmacy/IHE_Pharm_Suppl_MMA.pdf
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2019
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– Mobile Medication Administration:
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https://wiki.ihe.net/index.php/Mobile_Medication_Administration
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– Uniform Barcode Processing:https://wiki.ihe.net/index.php/Uniform_Barcode_Processing
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22. IHE/Nictiz article: interoperability:
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https://nictiz.nl/app/uploads/2022/10/ICThealth_nr5_2022_60-61.pdf
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23. Interoperability of track and trace systems: key to public health protection | European
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Medicines Agency; News 06/08/2021
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24. McKinsey&Company: Strength in Unity, the promise of global standards in healthcare, 2012,
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https://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/operations/pdfs/ops_%20
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%20mck%20white%20paper%20global%20standards%20vf.pdf
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25. National Health Service, NHS, UK: web based information:
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– NHS digital:
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– https://digital.nhs.uk
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– https://digital.nhs.uk/services/digital-and-interoperable-medicines/resources-for-health-
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and-care-services/other-resources/strategic-drivers
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– Scan4Safety: https://www.scan4safety.nhs.uk/index.html
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26 Nictiz article: medical data exchange EU-countries:
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https://nictiz.nl/app/uploads/2022/10/ICThealth_nr5_2022_62-63.pdf
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27. Nursing, 2011: Cardex-medication: https://www.nursing.nl/blog/medicatie-verstrekken-hoe-
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doe-je-dat-veilig-op-een-zuigelingenafdeling-nurs006669w/
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28. Official Journal of the European Union: COMMISSION DELEGATED REGULATION (EU)
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2016/161 of 2 October 2015; supplementing Directive 2001/83/EC of the European Parliament
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and of the Council by laying down detailed rules for the safety features appearing on the
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packaging of medicinal products for human use: https://health.ec.europa.eu/system/files/2016-
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11/reg_2016_161_en_0.pdf via https://health.ec.europa.eu/medicinal-products/falsified-
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medicines_en
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29. Peter Lachman, Els van der Wilden, IJQHC Communications, 2021, 1(1), 1–3; DOI:
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https://doi.org/10.1093/ijcoms/lyab014. Use of barcode technology can make a difference to
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patient safety in the post-COVID era
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30. Pieter Helmons: Medication safety through information technology: a focus on medication
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prescribing and administering. 2014. Dissertation. Rijksuniversiteit Groningen:
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https://www.rug.nl/about-ug/latest-news/news/archief2014/promoties/promotie-p.j.-
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helmons_medication-safety-through-information-technology.-a-focus-on-medication-pr or
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https://research.rug.nl/files/3668356/Helmons_thesis.pdf
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https://pure.rug.nl/ws/portalfiles/portal/3668356/Helmons_thesis.pdf
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31. Pharmaceutical Track&Trace system, Turkey: https://www.drugtrackandtrace.com/drug-track-
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and-trace-system/
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32. Website: GS1 Nederland:
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– Barcoding to uniquely identify medications: https://www.gs1.nl/nieuws-en-
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events/nieuws/2017/nvza-nu-doorpakken-met-uniforme-toedieningsregistratie/
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33. WHO: Policy paper on traceability of medical products. Geneva: World Health Organization;
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2021. Licence: CC BY-NC-SA 3.0 IGO.
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34. WHO: pharmaceutical track&trace system: https://www.drugtrackandtrace.com/drug-track-
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and-trace-system/concepts/
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34. WHO: Irish case on vaccine delivery: https://www.who.int/ireland/news/item/09-09-2022-
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ireland-tracks-its-way-to-covid-19-vaccine-delivery-success
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35. W. van der Veen, dissertation: Information technology and medication safety, Groningen
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Graduate School of Science and Engineering (GSSE), the University of Groningen, the
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Netherlands, 2018;
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https://www.gildeprint.nl/flippingbook/Information%20Technology%20and%20Medication%20Safety
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/20/index.html
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36. World Hospital and Health Services: International Hospital Federation Official Journal 2018
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Volume 54 Number 4: several articles on barcoding, medication safety and traceability:
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https://region1.healthresearch.ph/index.php/research-news/145-r1hrdc-international-hospital-
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federation-official-journal-2018-volume-54-number-4
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37. Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom: Consultation
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on point-of-care manufacturing: https://www.gov.uk/government/consultations/point-of-care-
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consultation/consultation-on-point-of-care-manufacturing
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38. Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom:
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https://www.gov.uk/government/news/uk-to-introduce-first-of-its-kind-framework-to-make-it-easier-
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to-manufacture-innovative-medicines-at-the-point-of-care
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