Packaging Read the L


abels on investigational drug packaging represent one of the key elements of effective preparation for clinical trials. Without accurate and essential information, the labels can become a weak link in the chain that ideally leads to successful trials for new medication. The consequences of poor labelling could be severe for the patient, who may suffer adverse effects from the wrong dose or application. If patients are participating remotely, it might be


small print


The labels on drug packaging are one of the main drug/patient interfaces in a clinical trial, especially one that is conducted remotely. Despite this, confusion involving packaging and labelling on investigational drugs is frequently implicated in medication errors. David Callaghan speaks to


pharmacy research coordinator at the Centre Hospitalier Universitaire (CHU) Sainte-Justine, Cynthia Tanguay and Matthew Grissinger, director of education at the Institute for Safe Medical Practices (ISMP) in the US, to find out how organisers can reduce the incidence of medication error in trials.


difficult to reach a health professional to ask their advice. These issues can be especially complicated in blinded trials, where patients are given minimal information about the drug they are taking. Inaccurate labelling can also have a knock-on effect on clinical trial sponsors, for whom mistakes could cause the results of a trial to be inaccurate, meaning they lose the resources they have invested for very little gain. It always takes a significant financial commitment to set up a trial, and to see it through


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Clinical Trials Insight / www.worldpharmaceuticals.net


Modvector; 4zevar/Shutterstock.com


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