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ACMD Chair: Professor Owen Bowden-Jones
Technical Committee Secretary: Matthew Brace
1st Floor (NE), Peel Building
2 Marsham Street
London
SW1P 4DF
ACMD@homeoffice.gov.uk
Rt Hon Chris Philp MP
Minister of State for Policing, Crime and Fire
2 Marsham Street
London
SW1P 4DF
2nd December 2022
Dear Minister,
RE: ACMD Advisory on Classification and Scheduling of Remimazolam (Bifevo).
The Advisory Council on the Misuse of Medicines (ACMD) is grateful to the Medicines and Healthcare Products Regulatory Agency (MHRA) for providing a written dossier and an oral presentation on the ultra-short-acting benzodiazepine remimazolam (Bifavo). In addition to these representations, the ACMD is able to advise on the appropriate classification and scheduling for this drug under the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 respectively.
Bifevo was approved for marketing by the European Commission on 26 March 2021 for the use of procedural sedation in adults. A wide range of medical endoscopic procedures, imaging techniques and minor surgical procedures require procedural sedation.
Classification
As a benzodiazepine, it is likely that the potential harm will be similar to that of other benzodiazepine drugs that are already regulated under Class C.
Recommendation 1
The ACMD recommends that remimazolam should be controlled as a Class C drug under the Misuse of Drugs Act 1971.
Lead section
Home Office.
Measure of implementation
Legislative changes in the Misuse of Drugs Act 1971.
Scheduled
Benzodiazepines are currently scheduled under Schedule 3 or Schedule 4 (Part 1) of the Misuse of Drugs Regulations 2001.
Remimazolam is a prescription-only medication that can only be given by a healthcare professional experienced in sedation.
The safety profile, toxicity and behavioral effects of remimazolam are consistent with those of other benzodiazepines in Schedule 3. Dependence and diversion potential is consistent with that of other short-acting benzodiazepine drugs and is comparable to that of midazolam, which is used for sedation in many settings and exists. Schedule 3 drug. Midazolam has previously been identified as a potential ‘date wrap’ drug because of its ability to induce anterograde amnesia and rapid-acting sedative effects.
However, several key factors were considered by the ACMD to support remimazolam being placed in Schedule 4 (Part 1) as opposed to Schedule 3.
First, compared to midazolam, remimazolam has a much shorter duration of action and its effects wear off within minutes. Remimazolam has much lower oral bioavailability than midazolam and a bitter taste, so the ACMD concluded that it is unlikely to be an attractive ‘date wrap’ drug. Furthermore, the need for remimazolam to be administered by a physician in a controlled setting for procedural sedation only means that the availability of remimazolam is lower than that of midazolam.
Recommendation 2
ACMD recommends that remimazolam should be scheduled under Schedule 4 (Part 1) of the Drugs of Abuse Regulations 2001.
Lead section
Home Office.
Measurement of impact
Legislative changes to the Misuse of Drugs Regulations (as amended).
yours yours
Professor Owen Bowden-Jones Chair of ACMD
ACMD Technical Committee Chair Professor Roger Nags
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