A new delivery device should reduce the risk posed by the availability of high-dose insulin in Europe say regulators, but vigilance is still needed.
This month the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tresiba, an insulin used to treat Type II diabetes that was developed by Novo Nordisk.
If approved, the plan is to make the product available in two formats: a 100unit/ml version which is comparable to those currently on the market; and a 200 units/ml version which would be the strongest sold in Europe.
High dose insulin is required by the estimated 500,000 European diabetics who must receive multiple injections because need they more insulin than the 100 units/ml per day that can be delivered using existing pens.
However, the introduction of high dose insulin to the market in currently available pen formats could potentially have increased the risk of under- or overdose, as the Danish Health and Regulatory Agency explained.
“More than a generation ago the lower-strength insulin products were phased out to the benefit of the 100 unit/ml, and this did not take place without difficulties. The different insulin strengths caused confusion and led to dose errors.”
Mindful of this risk the CHMP reviewers looked at ways of minimising such confusion in a process that involved patietns, healthcare workers and device developers according to the EMA
“During the evaluation of Tresiba, the CHMP considered ways to minimise the possible risk of medication errors associated with a 200 units/ml formulation, which could lead to over- or underdosing.
“The main risk-minimisation activities to reduce the risk of medication errors between the 100 units/ml and 200 units/ml strengths are that the 200 units/ml strength is only presented in a pre-filled pen, that both strengths are dialled-in units, that the pack design of the two strengths has been clearly differentiated.”
The Danish regulators had a similar interpretation, commenting that: “It had great significance that the new strength is only presented in a pre-filled pen, where the display always shows the dialled-in dose. In other words, the patient is given the dose shown in the display – regardless of the strength used.
“The previous calculation of injection volume based on strength and dose required – and consequent risk of dose errors – is no longer necessary.
However, it also said that: "The marketing of a new insulin strength is a major change, which could imply risks of incorrect prescriptions and dispensing and perhaps even risks of dose errors.