Safe Supply

We are invested in providing the safest supply of natural and synthetic psychedelics to the international market.

An In Demand Medicinal Alternative

Populations across the world are realizing that psilocybin and synthetic psychedelics can help alleviate severe depression and end-of-life distress, among many other palliative and non-palliative conditions.

Optimi is the leader of Safe Supply in Canada. Our facility produces the purest natural and synthetic pharmaceutical-grade investigational drugs to authorized patients and physicians in Canada with Section 56 Exemptions or permission under the Special Access Program (SAP). We also supply eligible academic researchers and clinical trials advancing the interest and understanding of psychedelic science as an innovative medical component to alleviate mental suffering.

Optimi Supplied Drugs:

  • EU-GMP psilocybin:
      • Bulk form API
      • Dried biomass
      • Dried biomass encapsulated (standardized to desired strength)
      • Extract (pure or encapsulated)
      • Isolate
  • EU-GMP 3,4-methylenedioxy-methamphetamine (MDMA)

Why Safe Supply Matters

"There's an emerging consensus to do more to reverse this devastating trend."

- Hon. Carolyn Bennett,
Canadian Minister of Mental Health and Addictions
Optimi is committed to building a healthier world, and we believe for that to happen people need access to the safest supply of medical psychedelics possible. Safe supply would protect the integrity of the psychedelic supply chain by guaranteeing all licensed dealer’s operate under the strictest GMP controls and standards. 

Reasons why safe supply is needed today:
    • The grey and black markets are thriving online and in neighbourhoods across Canada. One way to combat this health and safety risk is to allow for licensed dealers to provide directly to consumers.
    • Many of the illegal drugs bought off the street risk being tainted with fentanyl, which is between 50 to 100 times stronger than morphine. Heroin, cocaine, oxycodone, and many other drugs found on the street can be cut with fentanyl, in powder, liquid, or pill form, rendering them even more toxic. You can’t see it, smell it or taste it.
    • Illegal drugs on the dark web only emerged a decade ago but major ones are now worth at least US$ 315 million in annual sales. Rapid technological innovation, combined with the agility and adaptability of those using new platforms to sell drugs and other substances, is likely to usher in a globalized market where all drugs are more available and accessible everywhere. This, in turn, could trigger accelerated changes in patterns of drug use and entail public health implications.
    • Globally, over 11 million people are estimated to inject drugs, half of whom are living with Hepatitis C. Opioids continue to account for the largest burden of disease attributed to drug use.
    • Self-medicating with psychedelics is risky.
    • Clinical trials take time to assess consistent dosing when taking natural psilocybe mushrooms. That data does not currently exist.
    • Therapists and patients looking to utilize psychedelics are unable to measure levels of natural psilocybin contained in mushrooms.
    • Section 56 exemption holders would have access to a regulated market in which to purchase mushrooms.

Why Safe-Supply?

Risks of not having Safe Supply:

  • Supply: Toxicity of Supply Designer Drugs
  • Quality of Ingredient Contamination
  • Drug Mixing
  • Poisonous
  • Microbial Adulterants
  • Supply Shortage
  • Lost Tax Revenue
Benefits of Safe Supply:

  • Healthy Patient Outcomes
  • EU-GMP
  • Safety
  • Data Efficacy
  • Quality Control
  • Tax Revenue
  • Science Education
  • Set & Setting
  • Therapeutic Continuity

Safe Supply for Patients

Optimi produces the safest, most consistent, and purest natural psilocybin mushrooms available to authorized patients and physicians with Section 56 Exemptions or permission under the Special Access Program. We ensure quality to patients seeking therapeutic relief under the gradually-expanding prescription models for psilocybin.

Safe Supply for Researchers

Studies from leading institutions are establishing the efficacy of psilocybin as an alternative treatment for various mental health disorders. The US Food and Drug Administration has granted a Breakthrough Therapy designation to psilocybin.

Health Canada has come forward in support of the ongoing research, but recognizes the lack of studies using natural psilocybin and psilocin. Further progress is possible only with GMP-standardized natural psilocybin.

Optimi is working with Health Canada to provide that research using safe and standardized doses of natural psilocybin.

Optimi’s commercial facility can provide up to 5000 kilograms of dried psilocybin mushrooms, capable of producing 10 kilograms of psilocybin and 100 grams of psilocin at the highest operational standards of safety and quality, to supply authorized private and public sector researchers.

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FAQs

After decades of stigma, psychedelics are emerging into the medical limelight as potential treatments for a wide variety of mental health disorders.

The Multidisciplinary Association for Psychedelic Studies, or MAPS, dates all the way back to 1986 and has helped move psychedelic science from the fringe back to the laboratories of major institutions while pioneering MDMA-assisted psychotherapy for sufferers of PTSD.

The groundbreaking research undertaken by Johns Hopkins University since the early 2000s has led investigations into the medical potential of psilocybin. The Johns Hopkins Center for Psychedelic and Consciousness Research was formally launched in 2019, and continues to conduct research into indications such as major depressive disorder and smoking cessation, among more esoteric inquiries into spiritual fulfillment.

On the other side of the Atlantic, UK non-profits and academic institutions such as the Beckley Foundation and the Centre for Psychedelic Research at Imperial College London have been responsible for landmark developments in brain imaging and psychedelic neuroscience and investigations into the use of psilocybin for depression, as well as investigating substances such as LSD and Mescaline.

All of this is only the beginning. Hundreds of clinical trials are underway into the use of psychedelic substances for mental health treatments.

Psilocybin is a Schedule III Controlled Substance under Canadian Law. It is also an approved medicine for these select few patients.

Thanks to Section 56 exemptions to the Controlled Drugs and Substances Act as well as recent amendments by Health Canada to the Special Access Program, Canadians with urgent, unmet medical needs have been allowed to access psilocybin mushrooms for medical, therapeutic and mental health purposes.

Internationally, research into psychedelic medicine for mental health treatments has never been more robust, with hundreds of clinical trials in progress.

Through the Special Access Program, health care professionals may request access to drugs that are not currently authorized for sale in Canada to treat patients with serious or life-threatening conditions. Access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable. Patients can apply to the Special Access Program through a qualified medical practitioner. For more information, please click here.

We encourage qualified medical practitioners to review the Special Access Program application process here.

Patients consuming psilocybin for therapeutic purposes are best served by a safe consistent dosage to manage treatment outcomes. A safe supply of psilocybin means that these naturally-sourced medicines are held to the same standards as all other approved pharmaceuticals, namely GMP standards.

Patients allowed to consume psilocybin by federal health authorities deserve the same level of transparency, scientific rigour and accountability in terms of the sourcing and processing of their medicine that they would receive from any other approved medication.

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

According to the World Health Organization, “Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.”

Our psilocybin products are available for medicinal use only, meaning we are legally able to supply clinical trials and Special Access Program requests.

However, we do have a robust catalog of natural functional supplements which we are selling through our nutraceutical line. Functional mushroom nutraceuticals are known for their wide range of benefits in areas such as immunity, anti-inflammation, mood, cognition.

For more information or to make a purchase, please visit www.optimilife.com

We have legitimate concerns about the message being filtered in the media which suggests black or grey market psilocybin (and other synthetic psychedelics) is Canada’s best pathway to legalization. While we support Health Canada’s policy on access through clinical trials and the Special Access Program, we do believe that more needs to be done to provide safe supply to patients, consumption sites, and trials operating through the Section 56 (1) process.

Based on current science and research, Optimi believes at minimum patients at end-of-life deserve unfettered access to psilocybin through a qualified medical practitioner. We support the Psychedelic Association of Canada’s Memorandum of Regulatory Analysis (MORA) which would provide this level of access.

Because it only takes one toxic, designer drug laced with other contaminants or microbial adulterants to put someone at risk of serious harm. Properly sourced, pharmaceutical grade psilocybin is the only way to know for sure that you’re giving your body the highest, purest, and most bioavailable form of an ingredient possible. Our psilocybin and functional mushrooms are analyzed in our state-of-the-art laboratory and sent for third party analytical testing to ensure an extremely high standard of purity and maximum absorption.

Distributors and retailers who sell these products illegally are putting Canadian consumers and their businesses at risk, and that is why Optimi is 100% committed to taking the time to cultivate, research, and test our products for when the regulatory environment improves.

Strong evidence suggests yes. Fully legal, well-funded research programs in the mid-20th century found that carefully monitored and controlled use of psilocybin may be beneficial for many psychiatric disorders, personal and spiritual development, and creative enhancement.However, after psilocybin was banned in 1970, clinical research to evaluate its medical safety and efficacy of psychedelics was effectively halted until the late 90s and early 2000s.

Today, there are dozens of studies taking place to evaluate the medical safety and efficacy of psychedelics, including psilocybin. Much of the early research did not stand up to today’s standards, as they often lacked a placebo control group or double-blinding procedures (in which neither the subject of the research nor the investigators knew whether the subject received psilocybin or placebo). Nevertheless, their promising findings have been revisited and spurred a resurgence of new, more rigorous research on the potential benefits of psychedelics as a treatment for cluster headaches, anxiety, addiction to alcohol and other drugs, depression, obsessive-compulsive disorder, as well as neuroimaging experiments furthering the understanding of its effects on the brain.

Because of the expensive and time-consuming approval process for research with Schedule I drugs, as well as the political influence of the war on drugs, research evaluating psilocybin’s beneficial uses does not receive funding from academic or government institutions, and instead relies on non-profit organizations like the Multidisciplinary Association for Psychedelic Studies, the Beckley Foundation, and the Heffter Research Institute.

Knowing the actual effects of psilocybin mushrooms, information on dosing, and resources for handling difficult experiences can help prevent dangerous situations, while enhancing their potential benefits. Mushrooms used non-medically are usually taken orally either by eating dried caps and stems, or steeped in hot water and drunk as a tea, with a common dose around 1-2.5 grams, though potency may vary regardless of the amount. Dried mushrooms are typically more potent than fresh ones. Due to the lack of quality control regulations under prohibition and the risk of consuming things growing in nature, there is potential for people attempting to pick psilocybin mushrooms in the wild to accidentally take poisonous mushrooms instead. Similarly, though also very unlikely, poisonous mushrooms are sometimes misrepresented and sold as psilocybin, and these do come with more physical risks, including fatal overdose.

Source Link: Psilocybin_Mushrooms_Fact_Sheet.pdf

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