Reducing waste and errors

By Nathalie Wardé Dunoyer, D4Ppharma

Unit dose dispensing is a potential answer to demands for less waste and a means to avoid medication errors.

he healthcare sector is at risk with significant losses caused by avoidable errors. An alarming report published by McKinsey records US$ 50–100 billion lost due to improper administration of drugs in hospitals only, US$ 18–115 billion lost because of follow-up of medication errors, such as longer stay hospitals, disabilities, deaths, and more than 100,000 deaths annually, meaning that patients could be at risk of suffering avoidable harm from healthcare.

On the top of this, in our globalised world, medicinal products are manufactured and distributed in complex supply chains. Effective oversight of the supply chain is weakened, raising the risk of falsified medicines entering the market and increasing inefficiencies such as stockouts or expired products. This can lead to a loss of public confidence, which eventually results in reduced adherence to treatment. Supply chain risks and errors are inevitable, so the challenge is to reduce the frequency and impact of such events.. Regulatory guidance Regulators, such as the WHO, EDQM and national agencies all around the world, provide guidance to develop and implement tools to reduce risk and improve safety. More than 80% of countries have implemented regulations on the traceability of medical products in an attempt to fight falsification.

The fight against waste and the circular economy could also lead to another positive impact in reducing the risk of medication errors. In the context of making Europe climate neutral in 2050, the European Commission published a set of policies, known as The European Green Deal. This impacts the healthcare sector in many ways; reviewing measures to address pollution from large industrial installations, involving all healthcare professionals to educate patients on ways to reduce waste, and lowering the risk of accumulation of unused medicines. In this context in France, a law dated February 10, 2020, indicates that the dispensing of certain drugs at the pharmacy could be done by unit as of January 2022.

A recent report published by the French Academy of Pharmacy describes the current dispensing methods in hospitals or in pharmacies within the framework of Multi Dose Dispensing (MDD), mainly for establishment for dependent elderly persons. The report aims to be objective and does not really take a position. However, it recalls the regulatory framework in force in France for dispensing and underlines

the risks that the necessary adaptations to this type of practice will generate for all actors in the drug distribution chain, including manufacturers. Two other European countries (the Netherlands and Norway) mentioned in this report have moved towards this model.

Two cantons in Switzerland have also recently organised trials of delivery by unit and a report on the latest trial in Neuchâtel canton is due to be published soon. It should be noted that, contrary to France where MDD, although more and more practiced by pharmacists, still has no regulatory framework, the regulation in Switzerland covers the activities of preparation of unit doses: (1) on the one hand by the Swiss Pharmacopoeia and its monograph on the manufacture of small quantities of medicines. This regulation constitutes the basic reference for inspections by cantonal pharmacists; (2) on the other hand, by the GMP (Good Manufacturing Practices) for automated manufacturing. This activity can be subcontracted to manufacturers with an operating licence for the manufacture of medicinal products, and therefore under the responsibility of a Qualified Person (QP).

The European Pharmacopoeia reference for the manufacture of Automated Dose Dispensing (ADD) completes this regulatory picture. This particular distribution method will remain under pharmaceutical responsibility.

Waste and traceability gains Unit dose dispensing can also reduce the risk of errors in the administration of medicines and at in-take by the patients, which contributes to better therapeutic adherence, particularly in the case of complex treatments.

It is therefore highly likely that, in the context of waste prevention, but also in the context of treatment monitoring to improve compliance, the distribution of individual drugs will be facilitated in the coming years, particularly for certain treatments (especially the most expensive and the most sensitive to therapeutic monitoring).

Thus, the identification and traceability of these doses becomes imperative. Traceability technologies, such as the use of 2D barcodes, are available today offering the possibility to trace medical products along the supply chain from final stage manufacture until its administration or even until patient intake.

All the players in the chain – drug manufacturers, suppliers of automated dose manufacturing equipment and manual dose preparers – will have to agree to identify these unit doses in a simple and standardised way, in order to help dispensing pharmacists to exercise their pharmaceutical responsibility towards patients and to help better manage them.

Definitely, the European Green Deal principle of “do no harm” will continue to resonate strongly with healthcare professionals everywhere.