Problem Or Issue:
In July 2018, the HPRA informed patients, carers and healthcare professionals of a potential quality defect issue with a small percentage of products from the Emerade range of treatments. The issue concerned the potential for the needle in a small percentage of the auto-injector pens to become blocked and thus fail to deliver the dose of the medicine when needed. Today we wish to provide updated information on this issue.
- Laboratory testing data covering the period 2014 - July 2019 show a slight increase in the defect rate in the Emerade auto-injector pens from 0.015% to 0.019% since last year (i.e. July 2018). Taking the more confined period 2018 (when the defect first manifested) - July 2019, simulated laboratory testing of in date product shows an estimated defect rate of 0.121%, i.e. 1.21 per 1000 pens
- It is important to note that no reports of a blocked needle have been received from the Irish marketplace for Emerade to date. However, there is still the potential for units on the market to have a blocked needle and this could lead to an Emerade auto-injector pen not firing.
- The risk presented by this defect can be reduced by the patient or carer always carrying two pens as described in the approved patient information for Emerade.
Please be advised that this is a precautionary notice and that no batches of Emerade are being recalled as a result of this issue.
What has been happening since July 2018?
The HPRA has, since July 2018, continued to oversee the manufacturer’s investigation into the blocked needle issue. The manufacturer has performed an investigation into the issue and it has identified actions that will prevent the needle blockage issue from recurring. The HPRA will continue to monitor this matter and we will provide further updates as necessary.
A Caution-in-Use Notification was issued to Pharmacists by Bausch + Lomb on 2 July 2018 to provide information and advice to pharmacists at that time. Another Caution-in-Use Notification will be issued to Pharmacists by Bausch + Lomb over the coming days to provide updated information on the issue and to reiterate the advice that needs to be given to patients and carers.
Advice to Patients and Carers:
The advice to patients in Ireland is to continue to adhere to current medical advice that they carry two pens. This greatly reduces the risks of a patient not getting a dose of adrenaline when they go to use this medicine.
The package leaflet supplied with Emerade advises patients to always carry two pens. Please see the package leaflet supplied with your pens for full information on how to safely use this product.
Emerade is indicated as an emergency supportive therapy and the HPRA reminds patients of the need to seek immediate medical attention following administration. It also recommends that patients with any concerns in relation to this matter should consult their doctor or pharmacist.
Specific Information for Pharmacists and other Healthcare Professionals:
For All Pharmacists:
Pharmacists are requested to perform the following actions:
- Please endeavor to contact patients to whom you have dispensed any in-date batch of Emerade. (The shelf-life of Emerade is 18 months, so the earliest relevant dispensing date would be January 2018.)
- If any patient that you contact is in possession of an in-date Emerade pen, please remind them of the importance of always carrying two Emerade pens, in accordance with the Package Leaflet.(We acknowledge that pharmacists were requested to take this same action in July 2018, but due to the nature of the defect and the fact that there are still batches in the marketplace that may have a blocked needle, it is important that patients and carers are reminded of the key risk-mitigating action of always carrying two pens.)
- When dispensing new Emerade pens, please ensure that all patients are advised to carry two pens at all times, in accordance with the Package Leaflet.
For Hospital Pharmacists only:
We kindly request that this communication is highlighted and made available to the relevant healthcare professionals within your hospital; for example Dermatologists, Immunologists, Emergency Medical Officers and Paediatricians.
For other Healthcare Professionals:
Healthcare professionals should be aware of the information in this Advisory Notice and they are requested to reiterate to patients the importance of reading the package leaflet for Emerade. The package leaflet supplied with these pens advises patients that, in circumstances where a single dose of adrenaline does not completely reverse the effect of an allergic reaction, a repeat injection may be given after 10 to 15 minutes. For this reason, it is important for users to always carry two pens with them at any one time.