Pregabalin  –  prescription group B

The Danish Medicines Agency moves pregabalin from prescription group C to prescription group B from 1 June 2018. The purpose is to remind doctors about the risk of addiction when using pregabalin.

Pregabalin received marketing authorization in Norway in 2004. As early as 2007, 21,000 patients used pregabalin. The number of users has been stable.

Approved indications:
Peripheral and central neuropathic pain in adults. Additional treatment for epilepsy in adults with partial seizures with or without secondary generalization. Generalized Anxiety Disorder (GAD) in adults.

The Pharmaceutical Handbook states: “Pregabalin is a GABA analogue without direct GABA-erg effect. It works by binding to a component of voltage-dependent calcium channels in the CNS. There is a proven effect in focal seizures with or without generalization and neurological pain. Effect is also documented by anxiety states ».

The active substance was placed on the surveillance list in 2010 due to reports of addiction, abuse and discontinuation reactions. Following a comprehensive investigation, the Swedish Medicines Agency has decided that pregabalin is now moved to prescription group B.

Pregabalin on white prescription
When pregabalin becomes “B preparation”, it means that the doctor can no longer reiterate white prescriptions on the drug. As a transitional scheme, it is decided that rehearsal of pregabalin prescriptions issued before 1 June is still valid.

Pregabalin on “blue prescription”
Vesicles on pregabalin can be reiterated as before.
The blueprints issued before June 1 are still valid.
In the treatment of epilepsy, pregabalin is refunded as before on blue prescription (§2).
Individual benefits already granted from Helfo can still be used.

Application for individual benefit (§ 3) for new patients
It applies to your own requirements for individual benefit to addictive drugs. Following a change in prescription status, these requirements will mainly apply to pregabalin.

In the application for individual benefit for pregabalin, the doctor must document:

That the danger of addiction is considered.
That there is a plan for the treatment.
That pain analysis has been done (when the application concerns chronic pain).
Planned maximum daily dose.
In addition, the current terms and conditions for individual benefits will be continued. Among other things, this requirement applies to trying gabapentin first with strong neuropathic pain.

See ​​for more details about conditions for individual benefit to pregabalin.

The application must be obtained from the relevant specialist or doctor at the relevant hospital department. In the treatment of resolved chronic severe pain, the GP may also apply.

Pharmacy Advice:

– Inform patients about the background of the change in prescription status for pregabalin. Pregabalin prescriptions issued prior to 01.06.18 are still valid.
– After 1 June, the doctor can no longer reiterate white prescriptions.
– Vesicles on pregabalin can be reiterated as before.
Individual benefits already granted from Helfo are still valid.
– Pregabalin will then be subject to the same rules for storage and safety as for other drugs in prescription group B.

Advice for patients and relatives:

– Remember that a regular (white) prescription for pregabalin (Lyrica) is only valid for one extradition from 1 June 2018. Recipes issued before 1 June may be used as before.
– There are no changes for the delivery of pregabalin (Lyrica) on blue prescription. It can be collected for 1 year of use if the doctor decides.
– Individual benefits already granted from Helfo are still valid after 1 June 2018.

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