Proposed restrictions for pregabalin and gabapentin have been labelled as ‘onerous’ and unjustified by the BMA, in response to the Government’s consultation.
The Home Office proposed three options for reclassifying gabapentinoids under the Misuse of Drugs Act, and while all three recommended categorising them as class C controlled substances, the severity of restraints varied.
The consultation, which ended yesterday, followed calls by the Advisory Council on the Misuse of Drugs for tighter restrictions after a sharp increase in deaths related to the two drugs. Official figures showed that pregabalin-related deaths rose from four to 111 between 2012 and 2016, and gabapentin-related deaths went from eight to 59 within the same period.
Option one, recommended by the ACMD, would require both drugs be stored in a safe and for prescriptions to be ‘written to very specific requirements, including the wet signature of the prescriber’, along with many other restrictions.
Option two would not require storage in a safe, although it would ‘impose a number of auditing requirements, including the mandatory requisition form’.
Option three states that while pregabalin and gabapentin would be controlled as Class C drugs under the 1971 Act and be placed in Part 1 of Schedule 4 to the 2001 Regulations, it would ‘not provide the same safeguards against diversion into the illicit drugs market as the other two options’.
The official BMA response letter said it was concerned about the increased restrictions in option one, as they could ‘lead to shortages and leave patients having to face rapid withdrawal’ if premises were unable to store sufficient quantities onsite.
However, the BMA did agree that option three would not ‘provide the necessary safeguards against the misuse’, and therefore it is supporting option two.
Clinical and prescribing policy lead for the BMA’s GP Committee Dr Andrew Green told Pulse: ‘Pregabalin does have accepted uses for some types of long-term pain as well as for some psychiatric problems, but has over recent years become increasingly popular as a recreational drug.
‘It was for this reason that the BMA passed the motion at the ARM calling for it to be made a controlled drug, and we are pleased that the consultation is taking place.’
Dr Green continued: ‘However, we also need to make sure that no unnecessary burdens are placed on GPs and community pharmacies. The pregabalin tablets that are abused do not come from break-ins, so there is no justification for imposing onerous safe-custody requirements in these settings.’
RCGP’s clinical lead for chronic pain Dr Martin Johnson also highlighted issues with the increased restrictions for both patients and GPs.
He said: ‘Patients with epilepsy, pain and anxiety who benefit from taking the drugs, for example, have valid concerns because this move will mean having to visit their GP every 28 days in order to review and renew their prescription, and this will inevitably increase workload for GPs.’
Dr Johnson went on to question the use of gabapentinoids in pain management, adding: ‘This is one that NICE may wish to review in the context of their neuropathic pain guidelines, and their forthcoming persistent pain guidelines.
‘Whilst a pharmacological approach can be effective, the risk benefits of treatment with gabapentinoids with other therapies will need to be continuously assessed.’
As revealed by Pulse last year, both the BMA and the RCGP have been driving plans to review the use of opioids, which could see GPs introducing annual assessments of patients using the drugs.
Note: The BMA’s initial repsonse to the Home Office consultation expressed support for option three, however it has since clarified that this was a mistake which has been flagged with – and accepted by – the Home Office.
Consultation proposals in full
Option 1: Place pregabalin and gabapentin in Schedule 3 to the 2001 Regulations, apply provisions under the Misuse of Drugs (Safe Custody) Regulations 1973.
This option is recommended by the ACMD. This would place pregabalin and gabapentin in Schedule 3 and require that all prescriptions for pregabalin and gabapentin comply with the requirements set out in Regulation 15 (prescription writing) of the 2001 Regulations. Under this option both pregabalin and gabapentin will be subject to:
• Regulation 141 – which requires a compliant requisition to be provided to a supplier before stocks of pregabalin and gabapentin are supplied to the recipient;
• Regulations 15 and 16 – which require prescriptions for pregabalin and gabapentin to be written to very specific requirements, include the wet signature of the prescriber; and
• Storage in a safe compliant with the Misuse of Drugs (Safe Custody) Regulations 1973 (‘The 1973 Regulations’).
They would also be subject to the following Regulations:
• Regulation 18 – which requires the marking of bottles or containers;
• Regulation 22 – record keeping with details about the quantity of the drug;
• Regulation 23 – the preservation of record keeping registers for two years;
• Regulation 24 – keeping of invoices of similar documents by the producer and wholesaler of the drugs (this does not apply to schedule 4 drugs);
• Regulation 26 – furnish information as required about the drugs; and
• Regulation 27 – the destruction of drugs in front of an authorised person.
As an example, temazepam which is used to treat insomnia, anxiety and breathlessness is subject to these requirements.
Note: Regulation 27 – which requires expired stocks to be destroyed in the presence of, and in accordance with the instructions of, an Authorised Witness only applies to a producer of a Schedule 3 controlled drug.
Option 2: Place pregabalin and gabapentin in Schedule 3 to the 2001 Regulations, (but exclude application of the safe custody requirements)
This option is similar to option 1 above with the difference that pregabalin and gabapentin will be exempted from provisions under the 1973 Regulations. This option would not require controlled drugs to be stored in safes, although all the requirements of the 2001 Regulations, summarised in paragraph 13 above would apply to both substances. The provision is likely to help restrict the availability of the two drugs. While not as stringent as the measures in option 1 – given that this option would exclude the safe custody requirements, it would impose a number of auditing requirements, including the mandatory requisition form, to prevent diversion.
Option 3: Place pregabalin and gabapentin in Part 1 of Schedule 4 to the 2001 Regulations
This option will place gabapentin and pregabalin in Part 1 of Schedule 4 to the 2001 Regulations with the effect that the prescription requirements under Regulation 15 and 16 will not apply to its prescribing, (although they would still be subject to Regulations 22, 23, 26 and 27). Under this option, gabapentin and pregabalin would not be subject to provisions under the 1973 Regulations. This option would provide similar benefits to option 2 but does not provide the same safeguards against diversion into the illicit drugs market as the other two options.
Source: Home Office