Tag Archives: diabetes

High Strength, Fixed Combination and Biosimilar Insulin Products: Minimising the Risk of Medication Error

A new document has been posted on the NECS MO website

High Strength, Fixed Combination and Biosimilar Insulin Products: Minimising the Risk of Medication Error. This is a briefing document which summarises the current guidance and recommendations on ways to minimise the risk of medication errors with newer insulin preparations.

A number of new insulin products have recently come to the UK market:
– Three high strength insulins which have concentrations greater than 100 units/mL:
o Insulin degludec 200 units/ml (Tresiba)
o Insulin lispro 200 units/ml (Humalog)
o Insulin glargine 300 units/ml (Toujeo)
– A biosimilar insulin
o Insulin glargine 100 units/ml biosimilar (Abasaglar) – launched August 2015
– A fixed combination of insulin with another medicine
o Insulin degludec 100 units/ml with liraglutide 3.6 mg/ml (Xultophy)

Also available as an unlicensed medicine in the UK is Humulin R U-500, containing 500units/ml. It is usually classed as a red drug (secondary care specialist only) in the UK and can be prescribed only on a named patient basis for use in a very small number of insulin resistant patients who require very high doses

A copy of the document can be found here

 

New NICE Guidance on Type 2 Diabetes

On 2nd December 2015 NICE published NICE Guidance (NG28) “Type 2 diabetes in adults: management”.

This guideline covers the care and management of type 2 diabetes in adults (aged 18 and over). It focuses on patient education, dietary advice, managing cardiovascular risk, managing blood glucose levels, and identifying and managing long-term complications.

As part of the guidance NICE has issued a suite of resources and a link to the algorithm for blood glucose lowering therapy in adults can be found here.

When the guideline was launched NICE said:

“The guideline update focuses on tailoring advice and treatments to the person’s circumstances, including considering co-existing illnesses, and reassessing their needs at each review.

The guideline underlines the importance of structured education for adults with type 2 diabetes and/or their family members or carers to help them develop the knowledge and skills to self-manage diabetes. New recommendations on blood glucose management give clarity on the sequence of drug treatments to offer, and when to consider adding further drugs, to achieve and maintain target blood glucose (sugar) levels. An algorithm to help clinicians make decisions on drug treatments is a key feature of the guideline.

In addition to making recommendations on managing blood pressure and dietary advice, the guideline also covers managing complications including eye disease and erectile dysfunction, and points to related NICE guidance on diabetic foot problems”.

This guideline updates and replaces ‘Type 2 diabetes’ (NICE guideline CG87).

Use of Abasaglar (Biosimilar Insulin Glargine)

The patent for Lantus® (Insulin glargine) has expired and a biosimilar preparation called Abasaglar®, which has a lower cost, has been launched. It has yet to be considered in the Local medicines decision making process, guidance for use with defined patient criteria is pending.

NB: The administration devices for Lantus and Abasaglar are slightly different. Lantus uses the Solostar pen, and Abasaglar the Kwikpen device.

Existing patients should continue to receive Lantus.  Patients should not be routinely switched between brands.

Automatic substitution, defined here as the practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber is not appropriate for biological medicines, including biosimilar medicines and is not permitted at this time. Prescribers, of course, are always able to switch treatments for a given patient, provided it is safe to do so and there are appropriate monitoring arrangements in place.

As biosimilar medicines often use the same international non-proprietary name (INN) as their reference product, the main way to ensure automatic substitution does not take place is through brand name prescribing. Brand name prescribing should be adhered to by all prescribers for biological medicines, including biosimilar medicines, and is in line with recommendations from the MHRA and NICE, as well as being enshrined in EU law.

Prescribing

It is essential that patients stay on the same brand. All prescribing should be by Brand Name as recommended in local prescribing guidance for all insulin prescribing.
In primary care we recommend that all practices search for any patients currently prescribed insulin glargine generically and change to the existing branded product, Lantus® before Abasaglar® becomes more widely available, to avoid later confusion.

Dispensing

Pharmacists should dispense the brand ordered and not substitute. If a brand is not specified the prescription needs to be returned to the prescriber for this to be added.
Please note that pharmacists will not dispense insulin glargine unless prescribed by brand as they are not authorised to amend prescriptions.

Administration/ record keeping

It is important that a record is kept within the patient’s notes of the brand used. This is to facilitate reporting of adverse effects.

Adverse reactions (whether suspected or established) should be documented on Yellow Card reports to the MHRA as previously.