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Individual Device Identification: Coding and Marking for the New Dimension in Patient Health and Safety

Counterfeit products and product piracy are serious issues for the pharmaceutical industry – but recent product marking requirements in developed economies, including the US and the European Union, have gone some way towards securing legitimate pharmaceutical supply chains. The WHO estimates that the share of falsified medicine in global marketplaces ranges from 10% in certain low- and middle-income economies to as little as 1% in developed countries.1

While there is still much to be done to increase the scope and reach of current legislation and improve safe access to pharmaceuticals in less developed economies, regions that have already implemented compulsory serialisation of pharmaceuticals should also prepare for change.

In economies governed by regulatory serialisation requirements, hospitals, pharmacies, and healthcare providers are realising the benefit of data in helping to protect patient safety. These key stakeholders are now placing pressure on pharmaceutical manufacturers to provide more granular information on pharmaceutical products to protect patients from the risk of unsafe medication practices and medication errors.

Medication errors are one of the leading causes of avoidable harm in healthcare worldwide. On a global level, it is estimated that the total annual cost for medication errors is USD 42 billion; some 5% of all patients admitted to hospital experience a medication error; and an average hospital will have one medication error every 23 hours or every 20 admissions.2

Stricter serialisation practices – requiring identification down to the individual dose of a pharmaceutical product – could help to mitigate unsafe medication practices and medication errors.

Tackling Medication Errors

Errors can occur at different stages of the medication use process – from preparation to patient monitoring – and may be due to inefficient in-house systems or human factors such as fatigue, poor environmental conditions, or staff shortages. A simple mistake can have potentially devastating effects, resulting in severe patient harm, disability, and even death.

Stricter serialisation measures – with individual identification down to the specific dose – can play a crucial role in helping to overcome the risk of medication errors in pharmacies and healthcare providers and ensure that the right patient gets the right dose of the right medication at the right time.

Adding more granular data to strips and blister packs of medicines, for example, can allow for better control within hospitals, care homes, and other healthcare facilities to improve medicine distribution. Scanning serialised 2D codes can allow for automatic electronic validation of medicines to ensure that patients receive the correct medicine and dose. This level of detail decreases dispensing errors and can improve inventory management and stock control.