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From 1 July , under specific circumstances, certain medical practitioners will be able to prescribe:. MDMA and psilocybine are unapproved therapeutic goods in Australia. This means MDMA and psilocybine products have not undergone safety, efficacy and tolerability evaluation. MDMA and Psilocybine cannot be dispensed or supplied directly to patients or clinical trial participants under any circumstances. Penalties apply. Schedule 8 MDMA and Schedule 8 psilocybine can only be administered to patients or participants by authorised medical practitioners, nurses or nurse practitioners. Psychologists, therapists, counsellors and pharmacists cannot administer Schedule 8 MDMA or Schedule 8 psilocybine to patients or participants. This means that Schedule 9 legislative requirements apply to MDMA and psilocybine for the chain of custody manufacturing, import, wholesale, compounding. Psilocybine remains as a Schedule 9 substance for indications other than treatment-resistant depression TRD. Storage and record keeping requirements are the same for Schedule 8 and Schedule 9 substances. Information about these requirements is available at the Possession and storage webpage. For importers, MDMA and psilocybine are Schedule 9 substances and the relevant legislative requirements for Schedule 9 substance apply. Importers also need to comply with Commonwealth legislative requirements. For wholesalers, MDMA and psilocybine are Schedule 9 substances and the relevant legislative requirements for Schedule 9 substance apply. Wholesalers are required to apply for a Victorian wholesaler license to supply Schedule 9 substances, in addition to complying with Commonwealth legislative requirements. For manufacturers, MDMA and psilocybine are Schedule 9 substances and the relevant legislative requirements for Schedule 9 substance apply. Manufacturers are required to apply for a Victorian manufacturing license to manufacture and supply Schedule 9 substances. If pharmacists import or wholesale MDMA or psilocybine, they must comply with wholesale and importation requirements, in addition to complying with Commonwealth legislative requirements. Pharmacists must not dispense or supply MDMA or psilocybine directly to patients or their representatives, even if patients present with a prescription for MDMA or psilocybine or pharmacists are directed to do so by a medical practitioner. Psychiatrists need to ensure that MDMA and psilocybine products are appropriately stored in secure facilities i. Psychiatrists are required to maintain appropriate records i. Please see further information on storage and recording requirements. Medical practitioners need to ensure that MDMA and psilocybine products are appropriately stored in secure facilities i. Medical practitioners are required to maintain appropriate records i. The notification is substance specific, doctor specific and patient specific. The notification form can be found here External Link. Once you have completed and submitted the notification form, you do not need to wait for permission or acknowledgement from the Victorian Department of Health. If you have reason to believe your patient to be drug-dependent, you must apply and hold a Schedule 8 permit for MDMA prior to prescribing or administering MDMA, in addition to making the above notification. You need to notify the Victorian Department of Health at least 7 days prior to prescribing or administering psilocybine for treatment-resistant depression to your patient. This means, for every patient that you intend on prescribing psilocybine for treatment-resistant depression, you are required to submit a notification in respect of that patient. If you have reason to believe your patient to be drug-dependent, you must apply and hold a Schedule 8 permit for psilocybine prior to prescribing or administering psilocybine, in addition to making the above notification. The notification form should only be completed by psychiatrists with TGA Authorised Prescriber approval for psilocybine. The notification is substance specific, doctor specific and participant specific. The notification form can be found here. External Link. If you have reason to believe your participant to be drug-dependent, you must apply and hold a Schedule 8 permit for MDMA prior to prescribing or administering MDMA, in addition to making the above notification. You need to notify the Victorian Department of Health at least 7 days prior to prescribing or administering psilocybine for treatment-resistant depression to the trial participant. This means, for every patient that you intend on prescribing psilocybine for treatment-resistant depression, you are required to submit a notification in respect of that participant. If you have reason to believe your participant to be drug-dependent, you must apply and hold a Schedule 8 permit for psilocybine prior to prescribing or administering psilocybine, in addition to making the above notification. The notification form should only be completed by medical practitioners engaged in clinical trials for psilocybine for treatment-resistant depression. If you have already submitted a notification form for your patient but details associated with this notification have changed or are no longer correct, you are required to submit a new notification with the updated details. If you have submitted a notification form, you are not required to submit another notification if details of the notification form have not changed. The notification only applies to the period of treatment as indicated on the notification form. If your patient requires additional dosing sessions, you need to submit another notification. For example, if your initial notification states that you intend to prescribe for and dose a patient on 1 August only, but after the 1 August you then decide your patient requires another dose after this date, you need to submit a new notification with the second dose date at least seven days before this date. This could be an Australian wholesaler, a community pharmacy, a hospital pharmacy or an Australian manufacturer. The notification form is prescriber and participant specific. The medical practitioner who is allocated to prescribe MDMA or psilocybine for a specific participant within a clinical trial should complete and submit the notification form. However, the notifying medical practitioner may authorise:. Another nurse or nurse practitioner engaged in the clinical trial to administer MDMA or psilocybine. This does not apply to psychiatrists with TGA Authorised Prescriber approval who are prescribing or administering MDMA or psilocybine to patients outside clinical trials. Approved TGA Authorised Prescribers must only administer MDMA or psilocybine directly to specified patients under their immediate care and must not supply to other practitioners to prescribe or administer, as stipulated by the TGA Authorised Prescriber approval requirements. If you are engaged in a clinical trial of psilocybine for treatment-resistant depression or a clinical trial of MDMA for PTSD and the clinical trial has human research ethics approval and is approved by or notified to the TGA, you can prescribe psilocybine for treatment-resistant depression or MDMA for PTSD for the clinical trial participants — provided you notify the department at least seven days prior to prescribing or administering. If you are prescribing psilocybine for an indication other than treatment-resistant depression or prescribing MDMA for an indication other than PTSD, you must apply and hold a Schedule 9 permit prior to prescribing or administering psilocybine or MDMA. Schedule 9 permits are only issued for clinical trials which have been approved by a human research ethics committee. Please see Schedule 9 permits for clinical trials for the process to obtain Schedule 9 permits for clinical trials. If the clinical trial is psilocybine for treatment-resistant depression, medical practitioners do not need to apply and hold a Schedule 9 permit. The medical practitioners must submit a notification at least seven days prior to prescribing or administering psilocybine and where there is reason to believe the participant is a drug-dependent person, medical practitioners must also hold a Schedule 8 permit prior to prescribing or administering psilocybine. The medical practitioners must submit a notification at least seven days prior to prescribing or administering MDMA and where there is reason to believe the participant is a drug-dependent person, medical practitioners must also hold a Schedule 8 permit prior to prescribing or administering MDMA. You need to ensure that MDMA and psilocybine products are appropriately stored in secure facilities i. You are required to maintain appropriate records i. Medicines and Poisons Regulation Department of Health. Skip to main content. On this page. When are they considered to be Schedule 8? MDMA and Psilocybine can only be supplied to: A psychiatrist with Authorised Prescriber approval for MDMA or psilocybine OR A medical practitioner engaged in a clinical trial for MDMA for the treatment of post-traumatic stress disorder PTSD or for psilocybine for treatment resistant depression TRD OR A medical practitioner, nurse practitioner or nurse authorised by the psychiatrist in i or medical practitioner in ii to act on their behalf Schedule 8 MDMA and Schedule 8 psilocybine can only be administered to patients or participants by authorised medical practitioners, nurses or nurse practitioners. If MDMA or psilocybine is supplied by a pharmacist, all MDMA and psilocybine dose forms are classified as Schedule 9 substances until they are: labelled and dispensed by the pharmacist for a specific patient on a prescription issued by a specialist psychiatrist with Authorised Prescriber approval for MDMA for the treatment of post-traumatic stress disorder PTSD or for psilocybine for treatment resistant depression TRD OR labelled and dispensed by the pharmacist for a specific patient on a prescription issued by a medical practitioner engaged in a clinical trial for MDMA for the treatment of post-traumatic stress disorder PTSD or for psilocybine for treatment resistant depression TRD. MDMA and Psilocybine legislative requirements for importers, wholesalers and manufacturers Importers For importers, MDMA and psilocybine are Schedule 9 substances and the relevant legislative requirements for Schedule 9 substance apply. Wholesalers For wholesalers, MDMA and psilocybine are Schedule 9 substances and the relevant legislative requirements for Schedule 9 substance apply. Manufacturers For manufacturers, MDMA and psilocybine are Schedule 9 substances and the relevant legislative requirements for Schedule 9 substance apply. Medical practitioners engaged in clinical trials for Schedule 8 MDMA and Schedule 8 psilocybine Medical practitioners need to ensure that MDMA and psilocybine products are appropriately stored in secure facilities i. External Link Once you have completed and submitted the notification form, you do not need to wait for permission or acknowledgement from the Victorian Department of Health. However, the notifying medical practitioner may authorise: Another medical practitioner engaged in the clinical trial to administer MDMA or psilocybine. Share this page Facebook , opens a new window X formerly Twitter , opens a new window LinkedIn , opens a new window. Was this page helpful? 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Buy MDMA pills Geelong
A white powder sold in Melbourne as cocaine contains the potent opioid 'protonitazene'. Opioids are central nervous system depressants, typically producing a range of effects including pain relief, sedation and respiratory depression dangerously slow breathing. Respiratory depression often appears more quickly with novel synthetic opioids NSOs , increasing the risk of life-threatening overdose. Protonitazene is an extremely potent NSO , which means it can produce strong effects in very small amounts. Protonitazene has a potency over times that of heroin. Cocaine and protonitazene are very different substances. Cocaine produces stimulant effects, whereas protonitazene produces sedative effects and may lead to opioid overdose. Using protonitazene with depressants such as alcohol, GHB or depressant drugs such as Xanax or Valium increases the risk of overdose. There have been recent serious harms in Melbourne associated with a white powder sold as cocaine that contained protonitazene. The product appears to produce strong adverse effects such as loss of consciousness, respiratory depression, and life-threatening hypoxia insufficient oxygen for normal functioning. Signs of opioid overdose include breathing slowly and reduced consciousness meaning someone is hard to wake up. In some cases, there may also be tiny pupils. More information about opioid overdose symptoms can be found on the Penington Institute website External Link. Naloxone is an easy-to-use medication that can reverse opioid overdose — it is safe to use even if you are not sure whether someone has taken opioids. Naloxone can be accessed free of charge at participating pharmacies , needle and syringe programs and the medically supervised injecting centre. You can find an approved naloxone provider on the Take Home Naloxone program webpage. If you experience toxic drug effects, or are present when someone has an unexpected reaction, seek help immediately by calling Triple Zero Talk to DanceWize volunteers by email at info dancewize. If you or someone you know needs help with alcohol or drug use, call DirectLine on or visit DirectLine External Link for information and support to access treatment. Skip to main content. Cocaine adulterated with protonitazene A white powder sold in Melbourne as cocaine contains the potent opioid 'protonitazene'. Protonitazene is a novel synthetic opioid that can produce life-threatening toxic effects in very small amounts Opioids are central nervous system depressants, typically producing a range of effects including pain relief, sedation and respiratory depression dangerously slow breathing. Know the signs of opioid overdose and carry naloxone There have been recent serious harms in Melbourne associated with a white powder sold as cocaine that contained protonitazene. Reduce the risk of harm If you experience toxic drug effects, or are present when someone has an unexpected reaction, seek help immediately by calling Triple Zero All alcohol and other drug use comes with risks, so take the following precautions: Be aware that other false or contaminated drug products may circulate in Victoria, even if no specific warning has been issued about them. Downloads Drug alert - Cocaine adulterated with protonitazene docx On this site. Drug alerts. Subscribe to our alerts, advisories and newsletters. Share this page Facebook , opens a new window X formerly Twitter , opens a new window LinkedIn , opens a new window. Was this page helpful? Yes No. Tell me your email for content rating.
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