Expert peer review No.2 Agenda item 4.16: 4‐FMC

Expert Committee on Drug Dependence Thirty‐sixth Meeting Geneva, 16‐20 June 2014

1. Comments based on the review report a. Evidence on dependence and abuse potential

Flephedrone is a synthetic cathinone, which has been used in recent years for recreational purposes by substance users for its psychostimulant properties. Research evidence on the prevalence of use, its dependence and abuse potential, and impact on public health is substantially less In comparison with mephedrone.

Limited animal data indicate that it affects behaviour similarly to mephedrone and other psychostimulants. Data on self‐administration and reinforcement of use in experimental animals are presently not available. It can substitute for cocaine and amphetamine in experimental animals which have been subjected to repeated administration of these psychostimulants respectively. An unexpected observation in experimental animal studies is that central nervous system depressant effects are observed prior to the onset of the psychostimulant effects. Overall, it seems that flephedrone is less potent than classical psychostimulants.

Data on human subjects are limited to one case report of a young male who may have suffered psychosis relating to the use of flephedrone, although another cathinone was present in the sample of substance he was reported to have taken. It is not clear that he was serially abusing flephedrone or had developed dependence on it. Detailed clinical studies in humans assessing dependence potential, and the description of features of dependence in humans are not presently available. b. Risks to individual and society because of misuse

The risks to the individual are not directly established. By analogy and interpretation of the limited animal data, it may be assumed that abuse and dependence are a significant risk because of self‐administration of flephedrone. Estimating the risks to society because of misuse would at this stage be speculative. c. Magnitude of the problem in countries (misuse, illicit production, smuggling etc)

No population‐level data on the prevalence of flephedrone use are available. Flephedrone has been identified in seizures in 13 European countries.

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WHO member states report on various illegal activities with flephedrone including trafficking, the availability of it via the Internet and processing of the raw chemical into consumer products. d. Need of the substance for medical (including veterinary) practice

There is no known therapeutic use of flephedrone and it is not available as a therapeutic preparation in any country for human or veterinary use. e. Need of the substance for other purposes (e.g. industrial)

There is no known industrial use. f. Measures taken by countries to curb misuse

Many WHO member states have legislated for control of flephedrone. In some cases flephedrone is listed specifically as a controlled substance. In other countries it is controlled under generic definitions of controlled substances, given its chemical and pharmacological similarity to mephedrone and other controlled cathinones. g. Impact if this substance if scheduled

Scheduling would be one method of limiting the use of flephedrone in that it would provide a basis for countries which are signatories to the international conventions taking steps to interrupt manufacture, importation and trafficking on the basis of its illegal status.

The caveat to the above is that fewer data are available on flephedrone than for other cathinones and psychostimulants.

2. Additional information to the critical review report

I have not located additional studies to those referenced in the critical review that substantially add to our knowledge or the review’s conclusions.

3. Other comments or opinions

I have enquired of substance users in the Asia‐Pacific Region who report that flephedrone is readily available through Internet sites, but that it is not a preferred psychostimulant for them. It does not appear to be typically distributed through the usual drug distribution networks in this region.

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4. Expert reviewer’s view on scheduling with rationale

Although there is a paucity of data on the abuse and dependence potential of flephedrone and no evidence of widespread harm, given the similarity of many of the effects to mephedrone, it should be assumed that the potential for adverse effects and abuse is considerable. At present and given the absence of any therapeutic indications, this merits the scheduling of flephedrone in Schedule III of the 1971 Convention on Psychotropic Substances.

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