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EAHP & EFPIA publish joint guidance on single unit barcoding

Medication errors are a source of preventable harm in hospitals. Advances in technology can increase patient safety by allowing pharmacists to scan a barcode when dispensing medicines. This ensures the right patient receives the right doseof the right medication.

New guidance published today by The European Association of Hospital Pharmacists (EAHP) and the European Federation of Pharmaceutical Industries & Associations (EFPIA) supports the application of barcodes to each dose of medication. This will be a step forward from applying barcodes to multi-packs of medication.

The guidance was developed jointly by EAHP and EFPIA following studies by pharmacists showing that bedside scanning can significantly reduce medication errors by between 30% and 60%.  The document sets out a clear, ambitious and feasible implementation plan which will result in a better experience and outcomes for patients.

The new approach will be phased in over a 15-year period to minimise disruption for patients and hospitals while managing additional costs. It applies to all new medicines from 2031 and will extend to existing products over time. The initiative is the result of ongoing efforts by hospital pharmacists and industry to advance patient safety.

“EAHP welcomes the joint guidance on single unit barcoding as an important step forwards in reducing medication errors and adverse events. We thank EFPIA for their collaboration and commitment to the implementation of this important guidance.” Said Nenad Miljković, EAHP President. “EAHP is committed to ensure the effective and suitable use of single unit coding in healthcare systems to guarantee patient safety.

This joint guidance on single unit barcoding reflects our shared commitment to patient safety. I thank EAHP for their constructive collaboration and acknowledge the efforts of EFPIA member companies in preparing to implement the guidance,” said Nathalie Moll, EFPIA Director General. “Over the next five years, all new medicines will include a barcode on every dose. This will support better use of healthcare resources, including healthcare professionals’ time, and will deliver real advances in patient care.”

Read the joint guidance HERE.

Background: Better for patients, better for health services

Errors in dispensing medication in hospitals can lead to increases in illness and, in some cases, death. Administering the wrong dose or wrong medication also leads to longer hospital stays, avoidable readmissions and higher costs. However, the health and economic burden of medication errors can be reduced.

In hospitals, medication multi-packs can contain several doses of medication which are separated into individual doses and dispensed to several patients. At present, while the original pack may carry a barcode, the individual doses often do not. Printing barcodes on each individual vial, blister or pre-filled syringe can reduce error rates by up to 41%[1].

The barcode will contain information on the GTIN product code, batch/lot number, and expiry date. This information will allow pharmacists to check that the patient is receiving the right medicine.

From 2031, all new products will feature barcodes on each single unit dose of medication, while the new approach will be applied to existing medicines on a phased basis. 50% of hospitals in Europe will be able to perform bedside scanning of the code by 2032, increasing to 80% by 2036.

[1] Effect of Bar-Code Technology on the Safety of Medication Administration | New England Journal of Medicine

Efforts on European level

The European Association of Hospital Pharmacists (EAHP) therefore calls on decision makers, politicians and national administrations to implement bar coding of medicines to the single dose administered in hospitals in national and European regulations.

See EAHP statement here

See EAHP response to European Commission consultation on the Unique Identifier for Medicinal Products (April 2012) here.

Efforts on national level

The Netherlands is hoping to play a pioneering role in the introduction of a uniform system for registration of the administration of medication. In an interview with GS1 Netherland (English translation available HERE), the President of the Dutch Association of Hospital Pharmacists (NVZA), Tjalling van der Schors highlighted his hopes that the current Dutch cabinet will take the necessary steps for the compulsory introduction of uniform barcoding on primary medication. Improved patient safety and the minimisation of administration errors are benefits mentioned by Mr van der Schors. The implementation of the Delegated Regulation laying down detailed rules for the safety features appearing on the packaging of medical products for human use could have been an excellent opportunity to introduce the registration of the administration of medication. This chance was however missed.

His hopes now rest on the former Dutch Minister of Health Edith Schippers. She informed the Dutch Parliament in early February 2017 by means of a letter that all parties concerned needed to take steps to introduce barcoding on primary medication packaging as a matter of urgency. She based this viewpoint on the conclusions of the report ‘Barcodering op de primaire verpakking van geneesmiddelen in ziekenhuizen; een kosten-baten analyse’ (Barcoding on the primary packaging of medication in hospitals: a cost-benefit analysis) by Capgemini Consulting, which had been commissioned by the Ministry of Health, Welfare and Sport.

Image courtesty of Optel Vision