05/04/2007
Council of Europe recommends bar codes on medicines
Source : Council of Europe
On 19 March 2007 the Council of Europe Expert Group on Safe Medication Practices published its report “Creation of a better medication safety culture in Europe: Building up safe medication practices”.
On 19 March 2007 the Council of Europe Expert Group on Safe Medication Practices published its report “Creation of a better medication safety culture in Europe: Building up safe medication practices”.
It primarily concentrates on preventable harm from medicines and represents the first international report on this topic with a special focus on Europe. In particular, this work charts how harm can be prevented by improvements in culture, systems and products. Human factors, bar codes and labelling, EU and national medicines regulations, good medicine information practices as well as the role of patients, their families and health care professionals are the keys to minimise harm from medicines.
The report analyses causes of medication errors from the perspectives of patients, carers, prescribing doctors, dispensing pharmacists and nurses. It gives recommendations on how to improve the safety of medicines labelling in day-to-day use and foster safer medicine information practices.
The EAHP is very pleased to see that this report is supportive and recommends bar-coding and single doses.
In particular, the report states:
“Barcode-based scanning of medicines offers significant benefit for the identification of medicines during their procurement, inventory, storage, preparation, dispensing and administration. Medication safety is supported by the above technology through a close association of information with the medicinal product. Barcodes are printed on the packaging or more sophisticated electronic devices such as radiofrequency tags (RFID) are attached to packaging. Machine-readable codes on medicinal products enable accurate identification throughout the supply chain and at the stages of dispensing, preparing and administration.
The use of the above technology may not only improve the efficiency of the medication use system, reduce delays and lower costs, but also assist in the dispensing of patient packs and, where appropriate, unit dose medicines distribution systems. This technology makes it possible to confirm the origin of a medicine before it is dispensed and to identify counterfeit medicines.
Particularly in acute care settings, the use of barcode scanning of the health care provider, the medicine, the patient's medical record and of the patient himself helps ensure safety in the administration of medicines. Patient safety is improved because this technology allows real-time confirmation of patient identification, medication, dose, time and route of administration, thus offering a unique opportunity for safety checks before administration of the medicine.
By “closing the loop” the continuous identification of medicines during the medication use system reduces medication errors, prevents costs being incurred by damage to the health due to medication errors and provides other benefits for a healthcare site such as traceability and better identification of medicine-related costs.
In order for this technology to fully benefit patient safety, it is recommended that the following changes be made to European medicines regulations: all medicinal products marketed in Europe should:
In addition, the report supplies certain tools:
The report
The report analyses causes of medication errors from the perspectives of patients, carers, prescribing doctors, dispensing pharmacists and nurses. It gives recommendations on how to improve the safety of medicines labelling in day-to-day use and foster safer medicine information practices.
The EAHP is very pleased to see that this report is supportive and recommends bar-coding and single doses.
In particular, the report states:
“Barcode-based scanning of medicines offers significant benefit for the identification of medicines during their procurement, inventory, storage, preparation, dispensing and administration. Medication safety is supported by the above technology through a close association of information with the medicinal product. Barcodes are printed on the packaging or more sophisticated electronic devices such as radiofrequency tags (RFID) are attached to packaging. Machine-readable codes on medicinal products enable accurate identification throughout the supply chain and at the stages of dispensing, preparing and administration.
The use of the above technology may not only improve the efficiency of the medication use system, reduce delays and lower costs, but also assist in the dispensing of patient packs and, where appropriate, unit dose medicines distribution systems. This technology makes it possible to confirm the origin of a medicine before it is dispensed and to identify counterfeit medicines.
Particularly in acute care settings, the use of barcode scanning of the health care provider, the medicine, the patient's medical record and of the patient himself helps ensure safety in the administration of medicines. Patient safety is improved because this technology allows real-time confirmation of patient identification, medication, dose, time and route of administration, thus offering a unique opportunity for safety checks before administration of the medicine.
By “closing the loop” the continuous identification of medicines during the medication use system reduces medication errors, prevents costs being incurred by damage to the health due to medication errors and provides other benefits for a healthcare site such as traceability and better identification of medicine-related costs.
In order for this technology to fully benefit patient safety, it is recommended that the following changes be made to European medicines regulations: all medicinal products marketed in Europe should:
- have an EAN-13 barcode containing the GTIN (Global Trade Item Number) on the primary medicine container as a minimum requirement with an implementation period of two years
- have a data matrix barcode or RFID chip on both the primary container and unit dose with an implementation period of five years. The GTIN, batch number and expiry date should be encoded
- include a unique serial number for each package or container in addition to the data matrix and an RFID chip with an implementation period of five years, if the medicine is at risk of being counterfeit.
In addition, the report supplies certain tools:
- a glossary of terms related to patient and medication safety for reporting systems for which currently no harmonised approach exists. This facilitates reporting across borders;
- an assessment tool to assist regulators, industry and health professionals in evaluating whether labels and packaging of medicines may cause medication errors
- statements of best practice for the prevention of medication errors for promotion and training purposes.
The report
eu_monitor_march07eahp2.pdf 243.23 kB
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