The scientific research on ibogaine provides insights into its potential effectiveness and safety concerns in treating drug dependence. Here are key findings from various studies:

1. Efficacy in Treating Drug Dependence: A retrospective study in Brazil found that ibogaine treatment, combined with psychotherapy, led to abstinence in 61% of participants, with no serious adverse reactions or fatalities reported. Those treated multiple times showed a statistically significant increase in abstinence duration compared to single treatments (Schenberg et al., 2014).
2. Animal Model Efficacy: A systematic review and meta-analysis of animal studies concluded that ibogaine reduced drug self-administration, especially within the first 24 hours after administration. However, it also caused motor impairment and cerebral cell loss (Belgers et al., 2016).
3. Transitioning to Sobriety: Clinical observations and treatment outcomes suggest that ibogaine may effectively transition opioid and cocaine-dependent individuals to sobriety. This conclusion is based on public testimonials and preclinical studies, although rigorous validation in humans is needed (Mash et al., 2018).
4. Potential Safety Concerns: The relationship between ibogaine and heart health is delicate, with alarming reports of life-threatening complications and sudden deaths associated with its use. These adverse reactions are thought to be linked to ibogaine’s tendency to induce cardiac arrhythmias (Koenig & Hilber, 2015).
5. Cardiac Risks and Safety in Detoxification: A descriptive open-label observational study on the safety of ibogaine in opioid-dependent individuals showed clinically relevant but reversible QTc prolongation, bradycardia, and severe ataxia. This highlights the importance of close monitoring during treatment (Knuijver et al., 2021).
6. Systematic Review of Ibogaine/Noribogaine: A systematic review assessing the role of ibogaine and noribogaine in treating substance use disorders (SUD) highlighted some efficacy but also raised concerns about cardiotoxicity and mortality, underscoring the need for further research to evaluate their therapeutic efficacy and safety (Mosca et al., 2022)

The New Zealand Experience
In New Zealand, Ibogaine has been a subject of significant interest, especially after legislative changes in 2010 that allowed its prescription as a non-approved medicine for therapeutic use. The New Zealand model of Ibogaine treatment involves comprehensive assessment, the development of a treatment plan, and post-treatment support, emphasizing the importance of aftercare and continued counselling.

Ibogaine in Australia
Ibogaine has been subject to quite a few critical new stories in Australia due to its potential for cardiotoxicity however, looking at the science, relative to methadone (a popular treatment for opioid addiction) it has a much better mortality rate profile. As such Ibogaine is classified as a Schedule 4 substance on the Therapeutic Goods Administration poisons list in Australia. This classification makes it a prescription-only medicine. However, it’s important to note that Ibogaine is not a controlled substance under Australian state and federal laws.

MDMA-assisted therapy has shown significant promise in the treatment of various psychiatric disorders, including post-traumatic stress disorder (PTSD), depression, and anxiety. This article provides an overview of the best practices in MDMA-assisted therapy, synthesized from recent scientific research.

Introduction

MDMA, commonly known as ecstasy, when used in a controlled therapeutic setting, has been shown to enhance the effectiveness of psychotherapy for certain mental health conditions.

Best Practices in MDMA-Assisted Therapy

1. Therapeutic Setting: MDMA is administered in a controlled clinical setting, often accompanied by psychotherapy sessions. This combination is critical for achieving the desired therapeutic outcomes (Yazar‐Klosinski & Mithoefer, 2017).
2. Dosage and Administration: Clinical trials have experimented with different dosages to find the optimal amount for therapeutic use. Typically, MDMA is administered in a single dose during therapy sessions (Oehen, Traber, Widmer, & Schnyder, 2013).
3. Safety and Tolerability: Research indicates that MDMA can be safely administered in a clinical setting, with no significant drug-related serious adverse events (Feduccia & Mithoefer, 2018).
4. Efficacy: Studies have shown that MDMA-assisted psychotherapy can lead to clinically significant improvements in PTSD symptoms and potentially other disorders (Smith, Sicignano, Hernández, & White, 2021).
5. Extended Benefits: MDMA catalyzes shifts toward openness and introspection that can result in lasting benefits without the need for ongoing administration (Danforth, Struble, Yazar-Klosinski, & Grob, 2016).
6. Patient Diversity: Recent trials indicate the efficacy of MDMA therapy across a diverse range of patients, including those with severe PTSD and other comorbidities (Mitchell et al., 2021).
7. Mechanism of Action: MDMA enhances the release of neurotransmitters and hormones that modulate emotional memory circuits, aiding in the reprocessing of traumatic memories and facilitating fear extinction (Feduccia & Mithoefer, 2018).

Conclusion

MDMA-assisted therapy represents a breakthrough in the treatment of certain psychiatric disorders, offering a unique combination of pharmacological and psychotherapeutic interventions. The controlled use of MDMA in therapeutic settings has shown significant efficacy and safety, making it a promising option for patients who are resistant to traditional treatments.

The information presented in this article is based on current scientific research and is subject to change as new studies emerge. Always consult with a healthcare professional for medical advice and treatment.

1. Objective Setting:
   • Define the scope and objectives of the penetration test. Focus on systems that store, process, or transmit patient data, including pharmacy management systems, electronic health records, and online prescription services.
2. Compliance Considerations:
   • Ensure the test aligns with NHS and General Pharmaceutical Council (GPhC) guidelines.
   • Understand the requirements of the DSPT and the UK’s General Data Protection Regulation (GDPR).
3. Choosing a Testing Provider:
   • Select a reputable and certified penetration testing provider.
   • Ensure they have experience in healthcare and are aware of the specific needs and regulations of the sector.
4. Pre-Test Preparations:
   • Notify all relevant parties, including staff and possibly the Information Commissioner’s Office (ICO), if required.
   • Back up all systems and ensure that there are contingency plans in place in case of system disruptions.
5. Conducting the Test:
   • Perform the test during off-peak hours to minimize disruption.
   • Include both external (networks, applications, and perimeter defenses) and internal (behind the firewall) aspects.
   • Test for a wide range of threats, including SQL injection, cross-site scripting, and ransomware.
6. Data Handling:
   • Ensure that all data collected during the test is handled securely and in compliance with GDPR.
   • Sensitive data should not leave the premises or be exposed to unauthorized personnel.
7. Post-Test Analysis:
   • Review the test results with the testing provider.
   • Prioritize vulnerabilities based on their potential impact and the likelihood of exploitation.
8. Remediation Plan:
   • Develop a prioritized action plan to address identified vulnerabilities.
   • Consider both technical fixes and changes in processes or staff training.
9. Documentation and Reporting:
   • Document the entire process and results for compliance purposes.
   • Report significant vulnerabilities and incidents to the relevant authorities as required by law.
10. Review and Continuous Improvement:
    • Schedule regular penetration tests (at least annually).
    • Review and update security policies and procedures in light of test findings.

Additional Considerations:

• Staff Awareness and Training: Ensure staff are aware of the test and understand the importance of cybersecurity.
• Legal and Ethical Considerations: The test should be legal, ethical, and not harm patients or their data.
• Budget and Resources: Allocate sufficient budget and resources for both the test and the subsequent remediation actions.

Remember, the specifics of the plan will vary based on the size of the pharmacy, the complexity of its IT systems, and the types of data handled. It’s also important to stay updated with NHS and GPhC guidelines, as they may change over time.

There has been a recent increase in interest in MDMA therapy as Lykos Therapeutics intends to launch MDMA as a licensed medicine towards the end of 2024. This marks a significant milestone in the evolving landscape of psychedelic-assisted therapy, particularly for conditions like post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD).

MDMA-assisted psychotherapy represents a novel approach to mental health treatment. Its efficacy primarily revolves around its ability to enhance the therapeutic process by fostering a sense of openness, empathy, and reduced fear response during psychotherapy sessions. This environment is conducive for patients to process and integrate challenging emotions and memories, particularly those related to traumatic experiences.

The safety and tolerability of MDMA therapy have been major points of consideration. Recent studies indicate that when administered in a controlled clinical setting, MDMA treatment is well-tolerated by participants. Adverse events have been rare and non-life-threatening, emphasizing the controlled use of MDMA in clinical environments as a key factor for safety. Research shows that MDMA therapy for PTSD is entering the final phase of drug development, with an aim for FDA and EMA licensing in the near future. This progress indicates the potential for MDMA to become a medicine, assuming clinical efficacy criteria are achieved (Sessa, Higbed, & Nutt, 2019).

Further, MDMA-assisted therapy has shown promising results in treating social anxiety in autistic adults and anxiety associated with life-threatening illnesses. Unlike conventional drug treatments, MDMA-assisted therapy is not intended for ongoing administration. It is used on one to several occasions within a psychotherapy protocol, potentially reducing the frequency of adverse events and improving the risk/benefit ratio. This aspect may present a significant advantage over medications that require daily dosing (Danforth, Struble, Yazar-Klosinski, & Grob, 2016).

As such, there are lots of ongoing clinical research on the subject, the most important of which include:

1. MDMA-Assisted Therapy for PTSD: A study analyzed brain activity and connectivity via functional MRI during both rest and autobiographical memory response before and two months after MDMA-assisted therapy in veterans and first responders with chronic PTSD. The study found reduced activation contrast after MDMA-assisted therapy in the cuneus and a correlation between recovery from PTSD and changes in functional connections during autobiographical memory recall (Singleton et al., 2023).
2. DNA Methylation and MDMA-Assisted Therapy: A pilot study suggested that DNA methylation of the glucocorticoid receptor gene is associated with treatment response in severe PTSD following MDMA-assisted therapy. The study examined epigenetic changes in key hypothalamic-pituitary-adrenal (HPA) axis genes before and after MDMA and placebo with therapy, finding significant methylation changes that may predict treatment response (Lewis et al., 2023).
3. Effects of MDMA-Assisted Therapy on Self-Experience in PTSD: Another study reported on the effects of MDMA-assisted therapy on patients with severe PTSD. It found that MDMA-assisted therapy, compared with psychotherapy alone, significantly altered domains of alexithymia, self-compassion, and altered self-capacities, suggesting substantial improvement in mental processes associated with poor treatment response (van der Kolk et al., 2023).

Other MDMA studies include:

Alongside this, there is a wide range of small investigator-led MDMA trials including:

• ICAN1: A Phase 2 Open-Label Treatment Development Study of MDMA-Assisted Psychotherapy in Conjunction with Cognitive Processing Therapy (CPT) for Chronic Posttraumatic Stress Disorder (PTSD)
• Influence of MDMA on Risk and Reward Circuits of the Brain
• MDMA-Assisted Psychotherapy for the Treatment of Social Anxiety Disorder
• Low-dose MDMA Versus Standard-dose MDMA in Therapy for Mood and Anxiety Symptoms in Advanced-stage Cancer Patients
• Feasibility Trial of MDMA-Assisted Psychotherapy for Depression
• Adjustment Disorder (AD) in Dyads (patient pairs) of Patients with Breast Cancer and a Concerned Significant Other

The development of MDMA-assisted psychotherapy heralds a new era in mental health treatment, promising a potentially transformative approach for patients with conditions resistant to current treatments. As Lykos Therapeutics prepares to introduce MDMA as a licensed medicine, the medical community and patients alike await with anticipation the outcomes and broader implications of this novel therapeutic approach.

i. What their key operational services are,

ii. What technologies and services their operational services rely on to remain available and secure,

iii. What other dependencies the operational services have (power, cooling, data, people etc.),

iv. The impact of loss of availability of the service.

Understanding Health and Care Services Provided by [Organization Name]

I. Key Operational Services:

[Provide a comprehensive list of the key operational services offered by the organization. These services are at the core of the organization’s mission and activities. For example:]

1. Patient Care: Delivering medical care, diagnosis, and treatment to patients.
2. Prescription Management: Ensuring the accurate dispensing of medications to patients.
3. Medical Records Management: Maintaining and safeguarding patient health records.
4. Appointment Scheduling: Facilitating patient appointments with healthcare professionals.

II. Technologies and Services Dependencies:

[Detail the technologies and services that are crucial for the availability and security of the key operational services. For example:]

1. Electronic Health Records (EHR) System: A secure EHR system is essential for managing patient data and ensuring its availability to healthcare providers.
2. Pharmacy Management Software: Reliable software for prescription management, inventory control, and patient interactions.
3. Telecommunication Infrastructure: Ensuring a stable network for telehealth services and communication between healthcare providers.
4. Cybersecurity Solutions: Implementing robust cybersecurity measures to protect patient data and maintain service availability.

III. Other Dependencies:

[Identify other dependencies beyond technology that are critical for operational services. These may include power, cooling, personnel, and more. For example:]

1. Power Supply: Reliable and uninterrupted power is necessary to run medical equipment, computers, and communication systems.
2. Cooling and Environmental Controls: Maintaining suitable environmental conditions for sensitive equipment and medication storage.
3. Qualified Healthcare Staff: Having a skilled and adequately staffed healthcare team to deliver patient care and manage operations.
4. Supply Chain Management: Ensuring a steady supply of medications, medical equipment, and other essential materials.

IV. Impact of Loss of Availability of the Service:

[Describe the potential consequences and impact on patients, staff, and the organization if the key operational services become unavailable. This may include:]

1. Patient Safety: Disruption in healthcare services may jeopardize patient safety and well-being.
2. Data Security: A loss of availability can lead to data breaches and compromise patient privacy.
3. Reputation Damage: Service unavailability can harm the organization’s reputation and trust among patients and stakeholders.
4. Financial Implications: Loss of revenue, fines, and legal liabilities resulting from service unavailability.
5. Operational Disruption: Delays in patient care, appointment cancellations, and increased workload on staff.

[Include any additional information specific to your organization’s services and dependencies.]

This document serves as a foundational understanding of the critical elements related to health and care services provided by [Organization Name]. It highlights the importance of safeguarding these services, their dependencies, and the potential impact of service unavailability on patient care and the organization’s overall performance.

• Pharmacy Name: [Your Pharmacy Name]
• Date of Analysis: [Date]

2. Objectives:

• To assess the current knowledge and skills of pharmacy staff regarding data security and protection.
• To identify gaps in knowledge and skills.
• To determine the specific training needs required to enhance data security and protection.

3. Data Collection:

A. Staff Roles and Responsibilities:

• List all job roles within the pharmacy.
• Describe the responsibilities of each role regarding data security and protection.

B. Skill Assessment:

• Conduct an initial assessment of each employee’s knowledge and skills related to data security and protection.

4. Identify Training Needs:

A. Training Objectives:

• Define clear training objectives for data security and protection. These objectives should align with the pharmacy’s compliance requirements and best practices.

B. Training Topics:

• List the key areas of data security and protection that are relevant to the pharmacy setting, such as patient data protection, secure handling of prescriptions, and cybersecurity.

C. Training Gaps:

• Based on the skill assessment, identify the gaps in knowledge and skills of employees in each of the training topics.

D. Prioritize Training Needs:

• Prioritize the identified training needs based on the level of risk and importance to the pharmacy’s operations and compliance.

5. Training Methods:

• Identify the most suitable training methods for each topic and audience. These may include:
  • In-person training sessions
  • Online courses or modules
  • Workshops or seminars
  • On-the-job training
  • Self-paced learning materials

6. Training Plan:

A. Training Schedule:

• Create a training schedule that outlines when and how often each training session will be conducted.

B. Training Materials:

• Develop or source training materials, including presentations, handouts, and digital resources, for each training topic.

C. Trainers or Facilitators:

• Identify who will deliver the training sessions, whether it’s internal trainers, external experts, or a combination.

7. Evaluation:

A. Pre-Training Assessment:

• Conduct a pre-training assessment to measure participants’ baseline knowledge before the training.

B. Training Delivery:

• Ensure that training sessions are delivered as planned and that participants actively engage in the learning process.

C. Post-Training Assessment:

• Conduct post-training assessments to evaluate the effectiveness of the training in addressing identified gaps.

D. Feedback and Improvement:

• Gather feedback from participants and trainers to make improvements to the training program for future sessions.

8. Monitoring and Continuous Improvement:

• Establish a system for ongoing monitoring of data security and protection practices in the pharmacy.
• Regularly review and update the training program to adapt to evolving threats and regulatory changes.

9. Conclusion:

• Summarize the key findings from the TNA and the proposed training plan to enhance data security and protection within the pharmacy.

10. Approval and Implementation:

• Seek approval from pharmacy management or relevant authorities to implement the training plan.

We process your personal data, which includes your name, contact details, prescription medicines and data from other pharmacy and health care services we provide to you (for example pharmacy medicines, pharmacy services, flu vaccinations) for the purposes of:

Your care: providing pharmacy services and care to you and, as appropriate, sharing your information with your GP and others in the wider NHS

Our payments: sharing your information with the NHS Business Services Authority, others in the wider NHS and sometimes local authorities, and only limited information to those external to the NHS who negotiate and check the accuracy of our payments

Management: sharing only limited information with the NHS Business Services Authority and others in the wider NHS and sometimes local authorities, as well as those external to the NHS who ensure we maintain appropriate professional and service standards and that your declarations and ours are accurate.

We hold your information for as long as advised by the NHS. You have a right to a copy of the information we hold about you, generally without charge. You may seek to correct any inaccurate information.

We process your personal data in the performance of a task in the public interest, for the provision of healthcare and treatment and the management of healthcare systems. A pharmacist is responsible for the confidentiality of your information. You may object to us holding your information. You may also lodge a complaint with the Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF. Please ask if you want more information.

Our Data Protection Officer is (name and contact details)

In 6 months (around June 2024) the FDA (US medicine regulator) will likely approve MDMA (ecstasy) as a licensed medicine in the US. This will present a pivotal moment for mental health care around the world as the efficacy rates of MDMA relative to traditional treatments for PTSD, depression and addictions are impressive.

As you can see from above, the most recent data indicates high rates of remission from PTSD (red) with MDMA in comparison to placebo (blue). Further comparing these rates (see picture below) to traditional antidepressant effectiveness rates i.e. from 19 to 70% within SSRIs (Prozac et al.), from 31 to 70% within the SNRI (Duloxetine et al.) treatment arms, and from 23 to 54% within TCAs (Amitriptyline et al.).

This may not seem very impressive, however, there is one major distinction, MDMA is curative. The importance of this cannot be stressed enough. Aside from the cost of having to take traditional antidepressants every day which comes with a wide range of side effects, such as with, TCAs treatment: dry mouth (58%), sweating (28%) and constipation (26%)² there’s the additional burden of anhedonia (not being able to feel anything good, or bad!).

MDMA is different. The medicine treats the root cause of the disease instead of just tranquilising the symptoms such as poor mood or lack of motivation. MDMA does this through a process known as fear memory extinction, which modulates fear memory consolidation. At its simplest, this means MDMA can dissolve bad feelings associated with a memory which in extreme cases is termed trauma. This makes it more comparable to traditionally stronger, last-line treatments like ECT which has its major side effects of memory loss.

When will MDMA be available in Australia?

Well in theory, due to the changes put forth by the TGA on 1 July 2023, it should already be available. However, due to the huge amount of red tape and high demand, the vast majority of 1 in 7 depressed patients in Australia cannot get access. This is why the licensing by MAPS is so important, it puts the medicine in a licensed category meaning, that doctors will have better coverage by indemnity insurance if something were to go wrong, therefore, they will have a higher propensity to prescribe. i.e. the risk to them is a lot lower and therefore, given the demand this should cause an upsurge in supply.

So where to go from here? Stay updated with the latest developments. Whilst it’s likely the FDA will license the medicine in the US in June, it will take a bit of time to come to Australia (usually another 6 months). At this point, it is more than likely it will be considered a Controlled Drug and hopefully be prescribable by regular doctors (however this may be limited to psychiatrists only). By whichever route, it should be available this time next year, for a high price due to the overwhelming demand, this is why we have created the Psychedelic Buyers Club to ensure a lower cost via a bulk buy.

References

¹ MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Published in the Nature Medicine Journal: 10 May 2021: Jennifer M. Mitchell. Accessed on 2 January 2024 via: https://www.nature.com/articles/s41591-021-01336-3

² Tricyclic Antidepressants. Moraczewski J, Awosika AO, Aedma KK. [Updated 2023 Aug 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557791/

³ Remission, dropouts, and adverse drug reaction rates in major depressive disorder: a meta-analysis of head-to-head trials. Review published: 2006. Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. M Machado, M Iskedjian, I Ruiz, and TR Einarson. https://www.ncbi.nlm.nih.gov/books/NBK73259/

If you are a distance-selling pharmacy attached to a private high street-based, pharmacy, the GPhC may want to inspect your premises to ensure that you are not offering face-to-face NHS essential services to the public. In this case, a risk assessment of P medicine sales would be essential. Creating one requires a deep understanding of the local regulations, pharmacy operations, and the specific risks associated with the sale of Pharmacy Only (P) medicines. Here’s a simplified outline to guide you:

1. Identification of Risks:
   • Expiry date check
   • Incorrect Dispensing
   • Pharmacist Sale Approval
   • Miscommunication about medicine usage
   • Adverse reactions or interactions
2. Analysis of Risks:
   • Likelihood of occurrence
   • Potential impact
3. Evaluation of Risks:
   • Tolerability
   • Priority for addressing
4. Mitigation Strategies:
   • Staff training and certification
   • Clear procedures for the sale of P medicines
   • Patient counseling
   • Proper signage and information
   • Systems for verifying patient details and medicine details
5. Monitoring and Review:
   • Regular audits
   • Feedback collection from staff and patients
   • Review of adverse incidents
6. Documentation:
   • Recording all identified risks, analysis, mitigation strategies, and reviews
7. Compliance with GPhC Standards:
   • Ensuring all processes comply with the General Pharmaceutical Council (GPhC) standards and other relevant regulations.

This outline is quite general and should be tailored to the specific circumstances of the pharmacy in question. Consulting with a legal professional or a pharmacy consultant with experience in UK regulations is advisable for a thorough risk assessment. If you would like to get in contact with one please drop us a line.

Note: As of October 2023, psilocybin remains a Class A drug in the UK. The following article provides informational content and does not endorse or encourage illegal activities. Always adhere to local laws and regulations.

Introduction

The world of mental health treatments is rapidly evolving, and among the emerging therapies are psilocybin as a medicine. Traditionally psilocybin is consumed as the dry weight of magic mushrooms, however, in recent years, as there has been an explosion in clinical trials of psychedelics; psilocybin has been isolated / manufactured and formulated as pills.

1. Psilocybin: A Brief Overview

Psilocybin is a naturally occurring compound found in certain mushrooms. Historically used in ritualistic and spiritual contexts, modern science is now exploring its potential therapeutic benefits, especially for conditions like depression and anxiety.

2. Legal Status in the UK

In the UK, psilocybin is currently classified as a Class A drug. This classification makes its production, possession, and supply illegal. However, for research purposes, certain exceptions may apply, given the proper licensing and permissions.

3. The Rise of Psilocybin Pills

While traditional consumption methods involved eating raw mushrooms, advancements have led to the extraction and encapsulation of psilocybin into pill form. These pills offer a controlled dosage, making them more suitable for therapeutic and research settings.

4. Ongoing Research and Trials

The UK has been home to several groundbreaking studies on psilocybin. Prestigious institutions are delving into its efficacy as a treatment for various mental health disorders. Preliminary results have shown promise, though extensive research is still needed.

5. The Future of Psilocybin Pills in the UK

Given the growing body of evidence supporting the therapeutic potential of psilocybin, there is hope that regulations might evolve. However, any changes would require rigorous scientific backing, coupled with societal and political will.

Conclusion

Psilocybin pills in the UK represent a fascinating intersection of tradition, science, and regulation. As research progresses and our understanding deepens, the landscape may shift, offering new avenues for mental health treatments. Until then, it’s crucial to stay informed, adhere to current laws, and watch this space for developments.