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In Practice: Defect alert for insulin brands


Morgan Liotta


25/01/2024 3:28:06 PM

The TGA has issued an urgent product defect alert for glass cartridge insulin products on behalf of the manufacturer, Novo Nordisk.

Person injecting insulin
An urgent product defect alert has been issued for some glass cartridge insulin products.

This week’s In Practice also includes details about eligibility for scholarships for dermatology surgical workshops, and new resources from the Department of Veterans’ Affairs (DVA).
 
Urgent insulin product defect alert
Novo Nordisk Pharmaceuticals, in consultation with the Therapeutic Goods Administration (TGA) has announced a potential product manufacturing issue that affects the 3 mL glass cartridges which contain Actrapid, NovoRapid, NovoMix 30, Mixtard 30/70, and Protaphane.
 
During manufacture, circular non-penetrating cracks on the outer surface around 4–6 mm below the ‘shoulder’ of the glass cartridge were found. These outer-surface cracks do not compromise the integrity of the cartridge.
 
As the integrity of the cartridge remains intact, there is no risk of evaporation or contamination of the product. If the cartridge cracks while being handled, the product will leak and be detectable by the patient. The pen will not work if the cartridge is cracked.
 
The manufacturing root cause that created this issue has been identified and resolved.
 
The TGA has assessed this to be a ‘Class II’ risk: a situation in which the use of or exposure to the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
 
This notice is only relevant to the products mentioned above and not any other Novo Nordisk products. Patients can continue to take their medication as normal unless they observe a crack in, or of, the glass cartridge. If they do, patients should not use the product and may return it for a replacement. GPs are reminded to ensure all relevant staff members are informed of this communication.

Any complaints or adverse events relating to this issue should be reported to Novo Nordisk via aunrccc@novonordisk.com. For any other information, the Customer Care Centre can be contacted on 1800 668 626.
 
Department of Veterans’ Affairs Provider News
A suite of updates and resources are available for GPs providing care to veterans:
 
Have your say on improving DVA’s Coordinated Veterans’ Care Program
DVA is evaluating the Veterans’ Care Program to investigate how it can improve and best meet needs of the veteran community.
 
New compensation medical assessment forms now available
DVA’s second suite of new compensation medical assessment forms helps providers to submit medical information.
 
Smoke alarm packages for hearing impaired veterans
GPs can help eligible hearing-impaired veteran clients to be bushfire ready by prescribing smoke alarm packages.
 
New and improved register of DVA approved ready-made medical grade footwear  
The ready-made medical-grade footwear register has been updated so health providers can assess and find the most clinically appropriate footwear for DVA clients.
 
Scholarships for Dermatological Surgery Workshop
The RACGP and Rural Workforce Agency of Victoria (RWAV) are offering an additional 60 scholarships in 2024 to Victorian GPs in Modified Monash Model (MMM) 3–7 areas, or GPs working in an Aboriginal community controlled health organisation to be part of the Dermatological Surgery Workshop.
 
This two-day workshop accommodates all skill levels and includes a combination of technology, presentations and small group practical sessions performing basic surgery and flap repairs.
 
Attendees must be able to complete the DermCert 4: Practical Procedures in Dermatology course prior to attending the workshop.
 
Travel and accommodation will be reimbursed by RWAV at the completion of the workshops, which are held in Sale and Warrnambool, Victoria. Full terms and conditions, and application form are available on the RACGP website.
 
CPD link of the week
It’s time to start planning your 2024 CPD. Login to myCPD home and begin your Professional Development Plan (PDP) using the RACGP’s simple tool.
 
Log in below to join the conversation.



CPD dermatology diabetes medication In Practice insulin veterans’ health


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