Online Prescribing https://onlineprescribing.com Online Prescribing Best Practice Fri, 21 Feb 2025 04:45:26 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://i0.wp.com/onlineprescribing.com/wp-content/uploads/2022/08/cropped-android-chrome-512x512-1.png?fit=32%2C32&ssl=1 Online Prescribing https://onlineprescribing.com 32 32 209681591 Cannabis Online Prescribing Australia https://onlineprescribing.com/cannabis-online-prescribing-australia/ https://onlineprescribing.com/cannabis-online-prescribing-australia/#respond Thu, 13 Feb 2025 23:46:27 +0000 https://onlineprescribing.com/?p=1937

In Australia, the use and possession of non-medicinal cannabis remain illegal in most states and territories. However, patients with specific medical conditions may be eligible for medicinal cannabis under strict regulations. The Therapeutic Goods Administration (TGA) oversees prescribing, allowing access only when conventional treatments have failed or caused intolerable side effects. To prescribe medicinal cannabis, healthcare providers must navigate regulatory pathways such as the Special Access Scheme (SAS) or obtain Authorised Prescriber status, as most cannabis-based products are not registered on the Australian Register of Therapeutic Goods (ARTG).

Cannabis Usage in Australia

Medical cannabis usage in Australia is skyrocketing.

  • In 2019, there were 28,000 cannabis prescription approvals
  • In 2021, there were over 70,000 SAS-B prescriptions approved
  • In 2022, there were around 326,000 SAS-B prescriptions approved

Today it is estimated that roughly 2.7% of the population (of ~30 million) is using legally prescribed medicinal cannabis products¹.

Who can be prescribed cannabis in Australia?

Medicinal cannabis may be prescribed for conditions such as

  • Cancer pain and/or symptoms.
  • To relieve vomiting resulting from chemotherapy (a cancer treatment).
  • Severe epilepsy (seizures).
  • Treating muscle spasticity and pain in Multiple Sclerosis.
  • Pain caused by nervous system damage.
  • Palliative care – to relieve pain or symptoms related to a terminal illness.

Prescribing decisions must consider patient-specific factors, including potential contraindications like age, psychiatric disorders, cardiovascular conditions, and pregnancy. Ongoing patient monitoring, informed consent, and compliance with state and territory regulations are essential components of the prescribing process.

Online Prescribing Algorithms

Online prescribing of cannabis varies considerably among different providers. Below is a summary of the main points…

Step 1: Pre-Screen Patient Eligibility Assessment

This stage is conducted before a prescriber is consulted. It is intended to exclude high-risk and contraindicated patients. Steps within this stage include:

  • Checking patient identification (KYC) and obtaining informed consent
  • Confirming the patient has a diagnosed medical condition with symptoms potentially alleviated by medicinal cannabis (e.g., chronic pain, epilepsy, multiple sclerosis, chemotherapy-induced nausea).
  • Screen the patient’s history of substance use and mental health conditions and conduct a mental health screening (e.g., DASS-21 or Kessler K10) if indicated.
  • Ensure the patient has tried conventional therapies and found them ineffective or with intolerable side effects.
  • Exclude patients with:
    • Age under 25 yo.
    • History or family history of psychosis, schizophrenia, or bipolar disorder.
    • Current or past cannabis use disorder (CUD), those recovering from alcoholism, opioid dependence, or other drug addictions may be at a higher risk.
    • Uncontrolled cardiovascular conditions (e.g., hypertension, arrhythmias, angina or a history of myocardial infarction).
    • Pregnant, planning pregnancy, or breastfeeding.
    • Narrow therapeutic window medication (unless blood monitoring is possible)

Step 2: Risk Assessment

Additional risk factors include:

  • Taking an enzyme inducer / inhibitor / substrate
Enzyme Interaction and Effect Drugs
CYP 3A4 Inducers: May decrease THC and/or CBD
Inhibitors: May increase THC and/or CBD
Substrates: CBD is a potential inhibitor of CYP3A4 and could increase 3A4 substrates. Caution with medications with a smaller therapeutic index (e.g., tacrolimus). Unlikely to have an effect on THC.
Inducers: Carbamazepine, phenobarbital, phenytoin, rifampin, St. John’s wort
Inhibitors: Azole antifungals, clarithromycin, diltiazem, erythromycin, grapefruit, HIV protease inhibitors, macrolides, mifepristone, verapamil
Substrates: Alprazolam, atorvastatin, carbamazepine, clobazam, cyclosporine, diltiazem, HIV protease inhibitors, buprenorphine, tacrolimus, cyclosporine, phenytoin, sildenafil, simvastatin, sirolimus, verapamil, zopiclone
CYP 2C9 Inducers: May decrease THC concentration. Unlikely to have effect on CBD.
Inhibitors: May increase THC concentration. Unlikely to have effect on CBD.
Substrates: THC and/or CBD may increase drug levels; should monitor for toxicity.
Inducers: Carbamazepine, rifampin
Inhibitors: Amiodarone, fluconazole, fluoxetine, metronidazole, valproic acid, sulfamethoxazole
Substrates: Warfarin, rosuvastatin, phenytoin
CYP 2C19 Inducers: May decrease CBD and THC.
Inhibitors: May increase CBD and THC.
Substrates: CBD may increase the level of medications metabolized by 2C19 such as norclobazam (active metabolite in clobazam). CBD may also prevent clopidogrel from being activated. Unlikely to have an effect on THC.
Inducers: Carbamazepine, rifampin, St. John’s wort
Inhibitors: Cimetidine, omeprazole, esomeprazole, ticlopidine, fluconazole, fluoxetine, isoniazid
Substrates: Aripiprazole, citalopram, clopidogrel, diazepam, escitalopram, moclobemide, norclobazam, omeprazole, pantoprazole, sertraline
CYP 1A1 and 1A2 Substrates: Smoking cannabis can stimulate these isoenzymes and increase the metabolism of these medications. Amitriptyline, caffeine, clozapine, duloxetine, estrogens, fluvoxamine, imipramine, melatonin, mirtazapine, olanzapine, theophylline
p-Glycoprotein Substrates: CBD may inhibit p-glycoprotein drug transport. Should monitor for toxicity. No effect from use of THC. Dabigatran, digoxin, loperamide

Double check:

  1. Precautions and contraindication
  2. Screen for interactions
  3. Consider the safety of the route of administration
  4. Consider the safety of chemovars (strain)

Step 3: Treatment Plan

  • The prescriber selects a specific cannabis formulation (THC, CBD, or combination) based on symptoms and condition.
  • This usually entails starting with the lowest effective dose (beginning with THC doses <10 mg) and titrating upward as needed.

Step 4: Regulatory Compliance

  • The prescriber documents the consultation and discusses potential benefits, risks, and legal considerations.

Step 5: Monitoring and Review

  • Schedule follow-up appointments to monitor efficacy, side effects, and adherence.
  • Use validated tools to track symptom changes and side effects.

References

¹ Medical cannabis treating at least 2.7 percent of population (no date) The University of Sydney. Available at: https://www.sydney.edu.au/news-opinion/news/2022/12/16/medical-cannabis-treating-population.html (Accessed: 13 February 2025).

² MacCallum CA, Lo LA, Boivin M. “Is medical cannabis safe for my patients?” A practical review of cannabis safety considerations. European Journal of Internal Medicine. 2021;89:10-18. doi:https://doi.org/10.1016/j.ejim.2021.05.002

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Distance Selling Pharmacy – GPhC Updates 2025 https://onlineprescribing.com/distance-selling-pharmacy-gphc-updates-2025/ https://onlineprescribing.com/distance-selling-pharmacy-gphc-updates-2025/#respond Wed, 05 Feb 2025 00:53:22 +0000 https://onlineprescribing.com/?p=1931

The General Pharmaceutical Council (GPhC) has recently published updated guidance for registered pharmacies providing services remotely. This guidance, issued in February 2025, underscores the importance of maintaining high standards of patient care while addressing the unique challenges associated with distance pharmacy services. In this blog post, we’ll break down the key elements of the guidance and explore what it means for pharmacies, pharmacists, and patients.

Why Is This Guidance Important?

With the rise of online pharmacies and remote healthcare services, the need for clear regulations has become paramount. Distance pharmacy services offer convenience and accessibility, but they also bring risks such as the potential for improper medication use, data breaches, and reduced patient engagement. The GPhC’s updated guidance aims to mitigate these risks by ensuring that registered pharmacies uphold their responsibilities, even when services are delivered remotely.

Key Highlights of the Guidance

Here are the primary aspects covered in the GPhC’s guidance:

1. Patient Safety and Care

Pharmacies must prioritize patient safety in all aspects of their operations. This includes ensuring that:

  • For higher-risk medicines, the prescriber now cannot base prescribing decisions on the information provided in a questionnaire alone. Instead, the prescriber has to independently verify the information the person provides.
  • Patients receive adequate information to use their medicines safely.
  • Pharmacists are available to provide advice and address concerns.

2. Verification of Patient Identity

Pharmacies providing distance services must have robust systems to verify the identity of patients. This helps prevent fraudulent activities and ensures that medications are supplied to the correct individuals.

3. Safeguarding and Vulnerable Patients

Pharmacies must take extra care when serving vulnerable patients. This includes:

  • Identifying and supporting patients who may be at risk.
  • Taking appropriate steps to ensure their safety and access to care.

4. Prescription Legaility

Pharmacies are required to verify the validity and authenticity of prescriptions before dispensing medications. This step is crucial in combating the misuse of online platforms for obtaining prescription medicines.

The guidance goes on to highlight that online pharmacies need to follow the law and guidance on the advertising and promotion of medicines.

5. Data Protection and Privacy

With sensitive patient information being handled electronically, pharmacies must adhere to data protection laws and ensure robust cybersecurity measures are in place.

6. Transparency in Operations

Pharmacies must provide clear and accessible information about their services, including:

  • Contact details.
  • The process for raising concerns or complaints.
  • The identity of the superintendent pharmacist or pharmacy owner.

What Does This Mean for Pharmacies?

Registered pharmacies providing distance services must review their policies and processes to ensure compliance with the GPhC’s updated guidance. Key steps include:

  • Training staff on the new requirements.
  • Implementing secure systems for patient identity verification and data protection.
  • Regularly reviewing practices to identify and mitigate risks.

Final Thoughts

The GPhC’s updated guidance on distance pharmacy services is a significant step toward ensuring the safe and effective delivery of pharmacy services in an increasingly digital world. By prioritizing patient safety, data protection, and operational transparency, the guidance sets a robust framework for the future of remote pharmacy care. However, implementing these changes is often costly and difficult to achieve.

If you would like more information about how to achieve these new standards, get in contact with our distance-selling pharmacy consultant here.

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Is ibogaine legal in Australia? https://onlineprescribing.com/is-ibogaine-legal-in-australia/ https://onlineprescribing.com/is-ibogaine-legal-in-australia/#comments Wed, 15 Jan 2025 03:29:27 +0000 https://onlineprescribing.com/?p=1906 Ibogaine, a naturally occurring psychoactive substance derived from the root bark of the African shrub Tabernanthe iboga, has been gaining attention for its potential to treat addiction and facilitating profound psychological insights. However, the legality of ibogaine varies significantly across the globe, raising questions about its status in Australia.

What Is Ibogaine?

Ibogaine is classified as a psychoactive alkaloid, primarily known for its hallucinogenic and anti-addictive properties. It has been used traditionally in West African spiritual ceremonies and more recently in alternative medicine to treat opioid, alcohol, and other substance dependencies. Despite anecdotal reports of success, its safety profile and efficacy remain topics of ongoing scientific investigation.

The Legal Status of Ibogaine in Australia

In Australia, ibogaine is classified as a Schedule 9 substance under the Poisons Standard. Substances in this category are considered prohibited and are only available for research purposes under strict regulatory control. Schedule 9 substances are deemed to have a high potential for abuse or cause harm, and their use is not approved for medical treatments outside of specific clinical trials or research programs.

This classification means that the possession, sale, importation, or distribution of ibogaine without proper authorization is illegal in Australia. Even therapeutic use in private settings or clinics is not permitted under current regulations.

Why Is Ibogaine Restricted?

Several factors contribute to the restricted status of ibogaine in Australia:

  1. Lack of Extensive Research: While preliminary studies and anecdotal evidence suggest ibogaine’s potential in addiction treatment, robust clinical trials are limited.
  2. Safety Concerns: Ibogaine has been associated with serious side effects, including heart complications, neurological issues, and in rare cases, fatalities.
  3. Potential for Misuse: As a psychoactive substance, there are concerns about its misuse and the risks associated with unregulated administration.

Are There Exceptions?

Although ibogaine is prohibited for general use, there are avenues for authorized research. Researchers and institutions can apply for approval to study ibogaine under tightly controlled conditions. This pathway is crucial for advancing scientific understanding and potentially revisiting its legal classification in the future.

Pursuing Treatment in New Zealand

For those seeking ibogaine treatment, an alternative option is travelling to New Zealand, where ibogaine is legally available through registered medical practitioners. New Zealand has established a regulatory framework that allows licensed professionals to administer ibogaine in controlled clinical settings. This ensures that patients receive proper medical supervision, reducing the risks associated with unregulated treatments. Anyone considering this option should consult with qualified healthcare providers to assess their suitability for the treatment and ensure a safe and legal approach.

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Ibogaine Treatment in Australia: A Revolutionary Approach to Addiction Therapy https://onlineprescribing.com/ibogaine-treatment-in-australia-a-revolutionary-approach-to-addiction-therapy/ https://onlineprescribing.com/ibogaine-treatment-in-australia-a-revolutionary-approach-to-addiction-therapy/#respond Tue, 16 Jan 2024 03:19:49 +0000 https://onlineprescribing.com/?p=1867
Ibogaine, a psychoactive indole alkaloid found in the West African shrub Tabernanthe iboga, has gained recognition for its potential in treating substance use disorders (SUDs). It has a historical background in Western medicine, initially used as a neuromuscular stimulant and later for its unique properties in attenuating cravings and withdrawal symptoms in addiction cases.

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.

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MDMA therapy for PTSD in Australia https://onlineprescribing.com/mdma-therapy-for-ptsd-in-australia/ https://onlineprescribing.com/mdma-therapy-for-ptsd-in-australia/#respond Fri, 12 Jan 2024 00:06:05 +0000 https://onlineprescribing.com/?p=1864

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.

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Penetration Test Action Plan https://onlineprescribing.com/penetration-test-action-plan/ https://onlineprescribing.com/penetration-test-action-plan/#respond Thu, 11 Jan 2024 23:49:38 +0000 https://onlineprescribing.com/?p=1849 This is to meet Evidence item 9.2.3 in the NHS DSP toolkit. i.e. The person responsible for IT has reviewed the results of the latest penetration testing, with an action plan for its findings.
Provide the action plan (with confirmation of review by the person with delegated responsibility for data security).

  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.

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List of MDMA Clinical Trials https://onlineprescribing.com/list-of-mdma-clinical-trials/ https://onlineprescribing.com/list-of-mdma-clinical-trials/#respond Thu, 11 Jan 2024 22:58:38 +0000 https://onlineprescribing.com/?p=1858

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:

Study TypeTrial ID or DOIConditionYear RegisterednIntervention
Phase 2ACTRN12619001334190Late-stage cancer patients, mood and anxiety201932120mg MDMA (supplemented 60mg) with psychotherapy​
Phase 1/2​ACTRN12621001078842PTSD2021480 or 120mg MDMA (supplemented 40 or 60mg) with psychotherapy​
Phase 1No ID yet​Mechanism2021100n = 100 for MDMA arm
Phase 0ACTRN12613000685718Tinnitus20134030 or 70mg MDMA
Observational​ACTRN12620001068954Attitudes of psychotherapists towards MDMA-assisted psychotherapy2020200MDMA-assisted psychotherapy questionnaire
Phase 3 / Phase 2ACTRN12622000883718pBrain Activity in Healthy Adults202220080 or 120mg MDMA; or 25, 30, 35mg psilocybin
Phase 2ACTRN12623000838617PTSD2023587 + 43.5 mg
Phase 1ACTRN12622001335785Healthy2023575; 125; 175; 225 mg EMP-01 (MDMA analogue)
Phase 2ACTRN12623000971639PTSD, veterans202324120 + 40 mg
Phase 2ACTRN126220 01525774TR-OCD202340100 mg

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.

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Understanding Health and Care Services https://onlineprescribing.com/understanding-health-and-care-services/ https://onlineprescribing.com/understanding-health-and-care-services/#respond Wed, 03 Jan 2024 03:39:35 +0000 https://onlineprescribing.com/?p=1846 This document covers information needed by the NHS DSP Toolkit under Evidence item 7.1.1. Key attributes addressed include:

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.

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Pharmacy Training Needs Analysis (TNA) – Data Security and Protection https://onlineprescribing.com/pharmacy-training-needs-analysis-tna-data-security-and-protection/ https://onlineprescribing.com/pharmacy-training-needs-analysis-tna-data-security-and-protection/#respond Wed, 03 Jan 2024 03:15:14 +0000 https://onlineprescribing.com/?p=1844 1. Introduction:

  • 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.
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Pharmacy Privacy Notics for Data Security and Protection https://onlineprescribing.com/pharmacy-privacy-notics-for-data-security-and-protection/ https://onlineprescribing.com/pharmacy-privacy-notics-for-data-security-and-protection/#respond Wed, 03 Jan 2024 02:41:55 +0000 https://onlineprescribing.com/?p=1842 (Name and address of pharmacy) Privacy Notice

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)

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