Correspondence

Control of pregabalin and gabapentin under the Misuse of Drugs Act 1971

Published 29 March 2019

1. Introduction

This circular draws attention to the contents of the below Statutory Instruments (SIs), S.I. 2018/1356 and 2018/1383, which will come into force at 00.01 on 1 April 2019:

• The Misuse of Drugs Act 1971 (Amendment) Order 2018 (S.I. 2018/1356)
• The Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) (England and Wales and Scotland) Regulations 2018 (S.I. 2018/1383)

The Misuse of Drugs Act 1971 (Amendment) Order 2018 classifies pregabalin and gabapentin as Class C drugs under paragraph 1 (b) of Part 3 of Schedule 2 to the Misuse of Drugs Act 1971 (“the 1971 Act”). Pregabalin and gabapentin are inserted into Schedule 3 to the Misuse of Drugs Regulations 2001 (“2001 Regulations”), with the effect that they will be subject to regulations 14 (documentation), 15 (prescription writing), 16 (supply on prescription), 18 (marking of containers), 22, 23 and 24 (record-keeping and preservation of registers), 26 (furnishing of information) and 27 (destruction of the drugs only in presence of an authorised person) of the 2001 Regulations.

Pregabalin and gabapentin are also being inserted into Schedule 1 to the Misuse of Drugs (Safe Custody) Regulations 1973 (“the 1973 Regulations”), which means that they are exempted from the safe custody requirements under the 1973 Regulations.

The SIs together with explanatory memoranda are available at www.legislation.gov.uk, as follows:

• S.I. 2018/1356

• S.I. 2018/1383

They are also published by The Stationery Office. Telephone orders and general enquiries: 033 202 5070 or online at www.tso.co.uk.

2. Background

The 1971 Act controls drugs that are ‘dangerous or otherwise harmful’, primarily under a three tier system of classification (Classes A, B and C) which provides a framework within which criminal penalties are set with reference to the harm a drug has, or is capable of having, when misused and the type of illegal activity undertaken in regard to that drug. The control and classification of the drugs listed above is predicated on an assessment of their respective harms and is made in accordance with recommendations of the Advisory Council on the Misuse of Drugs.

The Misuse of Drugs Regulations 2001 (as amended) (S.I. 2001/3998) regulates the availability of controlled drugs by placing them in one of five schedules to the Regulations according to their recognised uses as medicines or research compounds. The Schedule into which a drug is placed primarily dictates the extent to which it is lawful to import, export, produce, supply and administer and possess the drug and also imposes requirements about prescription writing, record keeping, labeling and safe custody.

3. Gabapentin and pregabalin – Class C

Gabapentin and pregabalin are anticonvulsant drugs. These have an established role in the management of a number of disabling long-term conditions. These include: epilepsy, postherpetic neuralgia, diabetic peripheral neuropathy and fibromyalgia, in the management of neuropathic pain, and, as an adjunct therapy for partial seizures. Pregabalin is also licensed for the treatment of generalised anxiety disorder.

Pregabalin and gabapentin had been increasingly reported as drugs with a potential for misuse. They also present a risk of addiction and a potential for illegal diversion and medicinal misuse.

The ACMD recommended that gabapentin and pregabalin be controlled as Class C drugs under the 1971 Act, and placed in Schedule 3 to the 2001 Regulations.

For more information about these compounds, see the ACMD’s advice.

4. Annex A Offence recording codes

The codes for recording offences by the police and the courts for statistical purposes within the Home Office Recorded Crime and Ministry of Justice Court Appearance Database (CAD) – which includes cautions – are as follows:

Gabapentin and pregabalin be placed under existing codes relating to “Other Class C” drugs as follows:

• 092/28 - Production of or being concerned in production of a controlled drug – Class C - other
• 092/48 - Supplying or offering to supply or being concerned in supplying or offering to supply a controlled drug – Class C - other
• 092/68 - Possession of a controlled drug – Class C - other
• 092/88 - Possession of a controlled drug with intent to supply – Class C - other
• 093/28 - Permitting premises to be used for unlawful purposes – Class C - other

Offences under s. 19(a) and 19(b) of the Criminal Justice (International Co-operation) Act 1990 will fall under the appropriate sub-classification code for either Class A, B or C drugs. For gabapentin and pregabalin, codes 77/55, and 77/58, which relate to Class C drugs, refer.

Importation and Exportation offences under s. 50(2), (3) & (5) and s. 68(2) & (4)) and s. 170 (1), (2), (3) & (4) of the Customs and Excise Management Act 1979 will fall under the appropriate sub-classification code for either Class A, B or C drugs. Codes, 92/05, and 92/08 relate to Class C Drugs.

Forces are required to record seizures of controlled drugs for the National Statistics Drug Seizures publication. Home Office analysts will advise of the relevant drug codes to record pregabalin and gabapentin seizures when the 2019/20 data template and guidance are distributed in the autumn of 2019.