How will the reclassification of pregabalin affect the supply chain

by | Mar 18, 2019 | Blog

From the 1st of  April 2019 pregabalin and gabapentin will be re-classified as class C controlled substances in the UK. The change has been prompted due to a sharp increase in deaths which toxicology has proved an association with the medicines. In addition the medicines have been associated with illegal diversion, addiction and prescribing had been escalating. The off label prescribing had also been increasing to reduce the prescribing of opioid analgesics.

The change is expected to result in the reduction in the prescribing and supply of the medicines. Prescribers, need to be reminded that unless patients have signs and symptoms of neuropathic pain then the prescribing of pregabalin of gabapentin  they may be more harmful than beneficial to the patients.

Prescribers and pharmacists must remember that they cannot be prescribed using the “repeat dispensing” process. Prescribers will have to hand sign the prescriptions. Patients with epilepsy, pain and anxiety  will have to be told they need to request a prescription monthly and prescribes must be flexible to accommodate the patients as pharmacists will not be able to give patients emergency supplies of medicines if they run out.

Pharmacists will have to dispense the medicines within 28 days before the prescription will expire.

Wholesalers who do not have a Home Office Licence or narcotics on the scope of their  wholesale distribution authorisation, WDA ,will have to stop procuring , holding , supply and exporting the medicines until they have MHRA approval of the addition of narcotics to the scope of their wholesale licence and the Home Office have approved their Home Office Licence application. Bona fides of the supply chain will have to be checked to ensure that all suppliers and customers are compliant.

The supply chain will not have to store the medicines in a controlled drug cabinet as the safe custody requirement has been wavered.

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