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PCDS Newsletter: Interruption to the supply of Apidra® (insulin glulisine)

Apidra® (insulin glulisine) is a short-acting insulin analogue which is often used in combination with a long-acting insulin analogue and is dispensed in the UK in increasing amounts.

There has been a break in the production of Apidra® in both the 3 ml cartridge form (used in the ClikSTAR® pen) and also in the 3 ml SoloSTAR® device. This is due to a problem that took place at the manufacturing line in Frankfurt, Germany, in July 2011.

It is important to note that Sanofi have advised that currently available stock of Apidra® in both cartridge form and SoloSTAR® are safe to use.

The manufacturing problem has not affected supplies of Apidra® in the vial. Availability of Lantus® (insulin glargine) and Insuman® Rapid (short-acting human insulin) are not affected.

Sanofi has worked very hard to try to support clinicians in managing the situation, aiming for the smallest amount of disruption to Apidra® users.

  • Sanofi will provide local diabetes teams with information on where stocks are currently present in local pharmacies so that they are able to give advice to Apidra® users (visit http://bit.ly/peZhAZ for further information).
  • As production of vials has not been affected, injection of Apidra® drawn from a vial and delivered via syringe is a potential available option. Sanofi has offered support with any training required.
  • Some areas have a stock of “returned” Optiset® pens that may be made available again – the Sanofi representative can be contacted to see if this is an option in specific localities. However, it may then cause later confusion with the imminent withdrawal of Optiset®.
  • For those people considered “vulnerable” and for whom a change of insulin would be clinically unwise, a copy of the prescription can be photocopied and forwarded to the medical team at Sanofi for request of protected supplies. The number to contact for more information on this is 0800 281 973.

Alterative approaches may include switching from Apidra® to another rapid-acting insulin analogue such as Humalog® (insulin lispro) or NovoRapid® (insulin aspart). Slight dose adjustments may be required and blood glucose levels should be observed initially so that appropriate titration can take place. Support from the healthcare professional with such skills is available in the usual way locally.

The manufacturing problem has now been solved and availability of Apidra is expected to return in January 2012.

Please contact your local specialist team or your local Sanofi representative for further information.

Optiset® and OptiPen® Pro devices will be discontinued after December 2011.

Educational and research grants available from the PCDS
The PCDS is strongly committed to improving education for healthcare professionals working with people with diabetes and conducting research into the prevention or management of the condition. Two subcommittees meet regularly to discuss how the PCDS can support its members educationally or in conducting research. A grant is available in both of these areas. The grants are awarded to professional individuals involved in primary care diabetes for education in patient care and healthcare delivery, or for research or audit relevant to primary care in the UK. Each request will be reviewed on an individual basis.

To apply for a grant for education or research, please visit www.pcdsociety.org.

Apidra® (insulin glulisine) is a short-acting insulin analogue which is often used in combination with a long-acting insulin analogue and is dispensed in the UK in increasing amounts.

There has been a break in the production of Apidra® in both the 3 ml cartridge form (used in the ClikSTAR® pen) and also in the 3 ml SoloSTAR® device. This is due to a problem that took place at the manufacturing line in Frankfurt, Germany, in July 2011.

It is important to note that Sanofi have advised that currently available stock of Apidra® in both cartridge form and SoloSTAR® are safe to use.

The manufacturing problem has not affected supplies of Apidra® in the vial. Availability of Lantus® (insulin glargine) and Insuman® Rapid (short-acting human insulin) are not affected.

Sanofi has worked very hard to try to support clinicians in managing the situation, aiming for the smallest amount of disruption to Apidra® users.

  • Sanofi will provide local diabetes teams with information on where stocks are currently present in local pharmacies so that they are able to give advice to Apidra® users (visit http://bit.ly/peZhAZ for further information).
  • As production of vials has not been affected, injection of Apidra® drawn from a vial and delivered via syringe is a potential available option. Sanofi has offered support with any training required.
  • Some areas have a stock of “returned” Optiset® pens that may be made available again – the Sanofi representative can be contacted to see if this is an option in specific localities. However, it may then cause later confusion with the imminent withdrawal of Optiset®.
  • For those people considered “vulnerable” and for whom a change of insulin would be clinically unwise, a copy of the prescription can be photocopied and forwarded to the medical team at Sanofi for request of protected supplies. The number to contact for more information on this is 0800 281 973.

Alterative approaches may include switching from Apidra® to another rapid-acting insulin analogue such as Humalog® (insulin lispro) or NovoRapid® (insulin aspart). Slight dose adjustments may be required and blood glucose levels should be observed initially so that appropriate titration can take place. Support from the healthcare professional with such skills is available in the usual way locally.

The manufacturing problem has now been solved and availability of Apidra is expected to return in January 2012.

Please contact your local specialist team or your local Sanofi representative for further information.

Optiset® and OptiPen® Pro devices will be discontinued after December 2011.

Educational and research grants available from the PCDS
The PCDS is strongly committed to improving education for healthcare professionals working with people with diabetes and conducting research into the prevention or management of the condition. Two subcommittees meet regularly to discuss how the PCDS can support its members educationally or in conducting research. A grant is available in both of these areas. The grants are awarded to professional individuals involved in primary care diabetes for education in patient care and healthcare delivery, or for research or audit relevant to primary care in the UK. Each request will be reviewed on an individual basis.

To apply for a grant for education or research, please visit www.pcdsociety.org.

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