Mr Blonde
Bluelighter
From a communication from the TGA SUSMP list on 21.12.11
Once again, instead of using the analogue act to try and prosecute sales and possession of a substance it has been decided to add it directly to the federal Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). I'm sure the states and territories will follow soon...
Interim Decisions & Reasons for Decisions by Delegates of the Secretary to the Department of Health and Ageing
DECEMBER 2011 INVITATION FOR FURTHER SUBMISSIONS
...
2.2.5 3, 4-Methylenedioxypyrovalerone (MDPV)
DELEGATE’S REFERRAL TO EXPERT ADVISORY COMMITTEE
3,4-Methylenedioxypyrovalerone (MDPV) – seeking advice on a proposal to include 3,4-methylenedioxypyrovalerone in Schedule 9 with a cross-reference from the common name MDPV to the 3,4-methylenedioxypyrovalerone entry.
EXPERT ADVISORY COMMITTEE RECOMMENDATION
The Committee recommended that a new Schedule 9 entry be created for
3,4-methylenedioxypyrovalerone. The Committee also recommended a cross-reference be included in the index of the SUSMP from the common name MDPV to the 3,4-methylenedioxypyrovalerone entry. The Committee agreed to an implementation period of no more than six months after the delegate’s final decision (i.e. 1 May 2012).
BACKGROUND
3,4-Methylenedioxypyrovalerone (MDPV) is an alkaloid designer drug of the phenethylamine class that is structurally related to cathinone or N-ά-[methyl-3,4-methylenedioxy)phenethyl]hydroxylamine (MDMA) (Schedule 9). Cathinone is an active alkaloid found in the khat plant and is related to methamphetamine (Schedule 8). MDPV, MDMA, cathinone and methamphetamine act on dopamine release.
MDPV is also an analogue of pyrovalerone (Schedule 4), a psychoactive drug which is infrequently used due to problems with abuse and dependence. Pyrovalerone is a Schedule V controlled substance in the US and Class C category in the UK.
MDPV is a stimulant and was first seized in Germany in 2007. Recently (in March 2011) the US Drug Enforcement Authority noted that the abuse of MDPV was increasing, particularly in Europe and Australia.
XXXXX submitted an application regarding MDPV direct to the Scheduling Secretariat. A delegate agreed that this was a matter warranting advice from the ACMS and referred this to the October 2011 ACMS meeting.
SCHEDULING STATUS
MDPV is not specifically scheduled. MDPV is an analogue of pyrovalerone and may be captured by the Schedule 4 entry. MDPV is also structurally related to cathinone, listed in Schedule 9. There is uncertainty as to which substance would capture MDPV as a derivative.
In NZ, MDPV is not specifically classified. Pyrovalerone and cathinone, however, are listed as Class B2 Controlled Drugs.
INITIAL SUBMISSIONS
Application
XXXXX requested that 3,4-methylenedioxpyrovalerone (MDPV) be included in Schedule 9 with a cross-reference in the SUSMP index from the common name MDPV to the schedule entry.
Members noted the following from the submission:
There were no systematic trials of the effects of MDPV in humans. There were reports of misuse and abuse of MDPV. Anecdotal reports from the Internet and published case reports indicate that MDPV may cause effects similar to methylphenidate (at lower doses) and amphetamine or cocaine (at higher doses).
Access to MDPV has been controlled in the UK, some European countries and some states in the USA.
There had been seizures of products containing MDPV in New South Wales, Western Australia and South Australia. There were reports of use of ‘bath salts’ in the UK, Europe and the USA.
Commonly reported adverse effects include tachycardia, hypertension, restlessness and agitation. There had also been reports of paranoia and severe panic attacks associated with the use of MDPV. The psychoactive effects of MDPV desired by users include mental stimulation, increased concentration, sexual stimulation/aphrodisiac effects and mild empathogenic effects.
The adverse effects of MDPV include hyperpyrexia, increased and/or irregular heart rate, headache, dyspnoea, bruxism, restlessness, anxiety, loss of appetite and gastrointestinal disturbances. Higher doses of MDPV had cause intense panic attacks in stimulant intolerant users. Users had reported psychosis induced by sleep deprivation and becoming addicted after using higher doses, or using at more frequent dosing intervals.
Applicant’s specific arguments against Section 52E
a) Risks and benefits of the use of a substance
Indicated that there did not appear to be any current legitimate therapeutic uses for MDPV. Reports from users warned about the ease of overdose (producing long lasting panic attacks), potency, and the dangers of regular and/or heavy use (with lasting consequences on cognitive function and affect).
b) The purpose and extent for which a substance is to be used
Asserted that none of the cathinones had any recognised efficacy as a plant fertiliser, nor would they function as a bath salt.
Noted that there had been seizures of MPDV in Australia (in New South Wales, South Australia and Western Australia). There was a recent seizure in South Australia of tablets containing MDPV which were thought likely to have been sold as a ‘legal high’ type product.
Indicated that there had been an increase in the number of reports about use of ‘bath salts’ containing MDPV or 4-methylmethcathinone (mephedrone) to Poison Control Centres in the USA. There had been reports of abuse of new cathinone derivatives including MDPV in Sweden and Finland.
Products marketed as ‘bath salts’, ‘plant fertiliser’, ‘plant food’ or ‘research chemicals’ which were sold via the Internet, at head shops and herb shops may contain various cathinones including MDPV and 4-methylmethcathinone (mephedrone). [Members noted that a head shop was a retail outlet specializing in drug paraphernalia used for consumption of cannabis, other recreational drugs, legal highs, legal party powders and New Age herbs].
c) Toxicity of the substance
Indicated that there was limited information available about the toxicological effects of MDPV. There were, however, anecdotal reports from the Internet and the few published case reports appear to be highly dose dependent.
Noted that a report from Michigan in the US, provided details about 35 patients who had visited an Emergency Department (ED) in the period 13 November 2010 to 31 March 2011 after ingesting, inhaling or injecting recreational designer drugs sold as ‘bath salts’ and asserted that these products could contain stimulant compounds such as MDPV or 4-methylmethcathinone (mephedrone). Seventeen patients were hospitalised, of these nine were admitted to the Intensive Care Unit. One person was dead upon arrival at the ED. The toxicological report for the person who died revealed a high level of MDPV, along with cannabis and prescription drugs. Autopsy results revealed MDPV toxicity to be the primary factor contributing to death.
Indicated that there had been reports in the US media about deaths in persons who had used ‘bath salts’. A recent media report (9 April 2011) indicated that two men whose bodies were found in a forest in March 2011 had ‘bath salts’ in their system (the active substance in the ‘bath salts’ was not identified in the media report). The Coroner, however, declared that the deaths were due to hypothermia. Also noted that an article published on 12 May 2011 indicated that the death of a 42 year old woman who was an abuser of ‘bath salts’ prompted legislators in that state to move to prohibit MDPV and its derivatives.
Also noted that the Finnish Poisons Information Centre reported 33 calls regarding exposures to MDPV during the period of January 2008 to October 2009. The substance was used intranasally, orally, rectally or intravenously. Doses used were 10 to 30 mg orally and 5 mg intravenously. Five of the patients required hospitalisation. All of them had tachycardia, agitation, dyspnoea and hypertension. Two of the patients had reduced level of consciousness, one of them had convulsions and required intubation.
d) The dosage formulation, labelling, packaging and presentation of substance
Users of MDPV reported that 5 mg was an active dose and typical doses were in the range of 5-20 mg. The onset of effect was at 1 hour with a peak effect at 90 minutes (lasting 1 hour) and the come-down occured at 2.5 hours (lasting 1 hour). The effects and length of high vary with the dose and the individual (reportedly from 0 to 12 hours plus). Re-dosing in a single session was common. Methods of intake of MDPV include ingestion, insufflation, smoking, intravenous injection or rectal administration.
Indicated that the ‘bath salt’ products suspected to contain MDPV, (e.g. Ivory Wave), were labelled as ‘not for human consumption’ and specifically warn against using the product as snuff. The ingredients listed on the packaging did not refer to MDPV. The instructions for use indicated that the product was concentrated, that for the first few hours the user should only use one application and there was no need for a second application for hours. The labelling strongly recommended that the bath salts were not mixed with other similar products and for health and safety reasons it was always best to stay away from alcohol and prescription medication, or be intoxicated when bathing using the product or any other bath salts sold on the website.
Argued that the presentation of these products, labelled for use as ‘bath salts’, ‘plant fertiliser’, ‘plant food’ or ‘research chemicals’ potentially increased the risk of inappropriate use.
e) The potential for abuse of a substance
There had been reports of intense cravings for MDPV by users not unlike those experienced by methamphetamine users, which resulted in larger doses being consumed, which could result in a difficult come-down.
Indicated that there was reference to use and abuse of MDPV on various websites. Some users of MDPV reported developing cravings for MDPV. Noted that increases in tolerance with use were also reported.
Asserted that there appeared to be a risk of abuse, including a risk that users would re-dose with the product resulting in excessive doses, with a difficult come down similar to that experienced with methamphetamine.
Other matters
Noted that the UK, some European countries and several states in the US had prohibited or regulated the use of MDPV. The 31 March 2010 report of the UK Advisory Council on the Misuse of Drugs Consideration of the cathinones indicated that the harms associated with mephedrone and related cathinones were commensurate with the amphetamines and the substances in Class B. The Council recommended that the cathinones (including MDPV) be controlled as Class B substances under the Misuse of Drugs Act 1971.
[Members noted that the UK’s Misuse of Drugs Act 1971 determines three classes (A, B and C) of substances for misuse, based on the level of harm caused. For example Class A includes cocaine, methadone, morphine, MDMA, LSD, heroin; Class B includes codeine, some amphetamines; and Class C includes amphetamines, cannabis, benzodiazepines, buprenorphine].
Indicated that following regulation of the cathinones in the UK, other substances such as naphthyl analogues of pyrovalerone had been marketed in the UK as ‘legal highs’.
Asserted that MDPV qualified for a Schedule 9 listing, as the structurally related substances cathinone and MDMA are listed in Schedule I to the United Nations Convention on Psychotropic Substances 1971, as well as in Schedule 9 of the SUSMP.
Members noted that strong opioid analgesics were listed as ‘narcotics’ under ScheduleI of the United Nations Convention on Psychotropic Substances 1971, they were subject to a system of annual reporting on production, importation/exportation and inventory by the signatory countries. Inclusion in Schedule I is a Schedule 9 factor as set out in the Scheduling Policy Framework.
October 2011 Pre-meeting Submissions
A pre-meeting submission was received from the XXXXX The submission supported the inclusion of MDPV in Schedule 9. The submission also stated the harm associated with the use of this substance was documented in literature and it had no medicinal value.
EXPERT ADVISORY COMMITTEE DISCUSSION
Members agreed that relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included (b) the purpose and extent of use; (c) toxicity; (d) dosage; formulation and presentation; and e) potential for abuse of a substance.
Members noted that there was no evidence of legitimate therapeutic use for MDPV. Members also noted the potency of the substance and the danger associated with heavy and repetitive use. A Member stated that MDPV had been a hot topic for discussions at recent conferences in toxicology. The Member advised the Committee that there were documented cases of psychosis and cerebral haemorrhage in MDPV users. A Member stated a recent letter to the New England Journal of Medicine about ‘bath salts’ intoxication noted that MDPV was the primary ingredient in these products. The letter warned clinicians to be aware that the severity and lethality from overdoses with these products often necessitated care and monitoring in an intensive care unit.. The Member also stated that there was also a concern about MDPV being marketed in a misleading way, e.g. ‘bath salts’.
Members noted the international controls applied to MDPV, and agreed that MDPV should be listed in Schedule 9.
DELEGATE’S INTERIM DISCUSSION
The delegate concluded that the recommendations of the ACMS were clear and appropriately supported. The delegate agreed with these recommendations.
The delegate agreed that relevant matters under section 52E(1) of the Therapeutic Goods Act 1989 included (b) the purpose and extent of use; (c) toxicity; (d) dosage; formulation and presentation; and e) potential for abuse of a substance.
DELEGATE’S INTERIM DECISION
The delegate decided to create a new Schedule 9 entry for 3,4‑methylenedioxypyrovalerone. The delegate decided that an implementation date of 1May 2012 was appropriate (i.e. three months after publication of the final decision). The delegate also decided to create a cross-reference in the index of the SUSMP from the common name MDPV to the 3,4- methylenedioxypyrovalerone entry.
Schedule 9 – New entry
3,4-METHYLENEDIOXYPYROVALERONE *(MDPV).
SUSMP Index – New cross-reference.
MDPV
See 3,4-METHYLENEDIOXYPYROVALERONE.
Once again, instead of using the analogue act to try and prosecute sales and possession of a substance it has been decided to add it directly to the federal Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). I'm sure the states and territories will follow soon...
. My friend did some pretty serious damage to his foreskin after a good dance with MDPV, he swore off it after that. 
