Mastering Extemporaneous Compounding:

A Comprehensive Guide for Health Professionals

Mastering Extemporaneous Compounding:

A Comprehensive Guide for Health Professionals

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Gain New Clinical Insights

Enhance your clinical skills and provide unparalleled care to your patients.

Gain invaluable insights to navigate the Regulatory Landscape:
Learn about the TGA guidelines, exemptions, and regulatory considerations essential for natural health practitioners.
Practical Skills in Extemporaneous Compounding:
Learn the step-by-step process, operational best practices, and the art of creating effective, custom formulations from ingredient selection to the final product.
Advancing Patient Care through Innovation:
Explore the benefits, challenges, and real-world applications of extemporaneous compounding, including case studies and evidence-based outcomes that underscore its impact on patient health and wellness.

Explore New Bespoke Medication

As healthcare continues to evolve towards more individualised treatment plans, the demand for extemporaneous compounding has surged, marking a pivotal moment for practitioners to enhance their skill set in this crucial area.

Diana Boot will share how to bridge the gap between traditional healthcare practices and patients’ personalised needs today, offering a deep dive into the world of bespoke medication.

This session thoroughly reviews extemporaneous compounding, from the basics to more advanced techniques, ensuring you will gain a comprehensive understanding and practical knowledge.

Naturopaths, nutritionists, and other health professionals will develop their clinical skills through the art and science of extemporaneous compounding (EC).

Learn from Diana Boot’s Wealth of Experience

Register with Natural Script for compounded nutritionals as well as bespoke liquid herbs, herbal creams:

Natural Script Bespoke Dispensary

Diana’s webinar about creating bespoke prescriptions with Natural Script’s compounding tool:

Compound Prescribing with Natural Script Webinar

Med Free Me

Diana Boot
B. Pharmacy, Dip Nut Med
B. HSc (Naturopathy)

Diana is a compounding pharmacist and naturopath passionate about integrative and personalised medicine.

She co-founded Natural Chemist and is the senior partner in two independent community and compounding pharmacies. She has over 30 years of experience as a pharmacist and 12 years as a nutritionist/naturopath.

Natural Chemist provides a dispensary service, Natural Script, which provides the unique capability to formulate bespoke liquid herbs; herbal creams including vaginal applicators; nutritional compounds including powders, suppositories, troches, and capsules; and pharmaceutical compounds (for medical doctors).

Diana’s clinical practice, Med Free Me, is collaborative and focused on safe and supervised deprescribing. She works directly with patients and mentors other practitioners on how to help their clients reduce their reliance on prescription medicines.

Your Webinar Host and MC
Fiona Wing ND, Dip Nut

Fiona Wing has been a qualified Naturopath and Nutritionist for 20 years and worked in retail, clinic and behind the scenes for complementary medicine sponsors. She has been working in Regulatory Affairs for the last four years. 

She has a passion for learning all there is to know about nutritional and herbal biochemistry and pharmacology, which suits her in her current role as Regulatory and NPD Manager at DFH.

Fiona’s role requires a strong focus on TGA guidelines and legislation, being current with evidence and research, and keeping an eye on emerging, well-researched ingredients and product innovation.

Mastering Extemporaneous Compounding:
Webinar Highlights and Key Takeaways

Note to practitioners… We have used our experimental AI prompting methods to develop the following webinar summary and takeaways. It is based on the webinar transcript, the PowerPoint Slides, and the participants’ engaging live chat file. We hope you find it useful. Feedback welcome. Designs for Health Team.

As a compounding pharmacist and naturopath with over 30 years of experience, Diana Boot has witnessed firsthand the transformative potential of extemporaneous compounding. In her comprehensive webinar, “Mastering Extemporaneous Compounding,” Diana shares her insights on the benefits, regulations, techniques, and practical applications of compounding. This article serves as a thorough reference document for participants, offering a guide and links to follow up and refresh memories about the content.

Key Takeaways

Extemporaneous compounding allows for the creation of unique, personalised medicines tailored to individual patient needs
TGA regulations, including labelling requirements and dose limits, must be strictly adhered to when compounding
Proper equipment, techniques, and record-keeping are essential for ensuring the quality and safety of compounded products
Collaboration with compounding pharmacies and the use of specialised software can streamline the compounding process

Introduction

Extemporaneous compounding is a powerful tool for creating personalised treatments in the ever-evolving world of naturopathic and nutritional medicine. As Diana explains,

“Extemporaneous compounding, then, is the preparation of the therapeutic product to meet the needs of an individual patient.”

This art and science allows practitioners to unlock the full potential of personalised medicine and revolutionise their approach to patient care.

Benefits of Compounding

Boot highlights several key benefits of extemporaneous compounding:

Creating unique, personalised medicines tailored to individual patient needs
Formulating medicines with low excipients and additives, suitable for those with sensitivities
Combining multiple products into one, improving patient compliance
Accessing new and exciting ingredients not yet available in listed medicines
Improving patient retention through personalised care

Diana Boot explains:

“I feel like when I prescribe a bottle of liquid herbs and a bottle of compounded medicine for somebody, they feel like it’s especially well, it is especially for them.”

TGA Guidelines and Regulations

In Australia, the Therapeutic Goods Administration (TGA) oversees the regulation of medicines. Practitioners must be aware of the following key points when compounding:

Most complementary medicines are “Listed” (AUST L) on the Australian Register of Therapeutic Goods (ARTG), while compounded products use ingredients not yet listed
Practitioners have an exemption to compound without a manufacturing license, but only for a named patient after a consultation
Compounding must be done on a per-patient basis, not in bulk
Labelling requirements include patient name, prescriber name, form and quantity of medicine, ingredients including strength, clear directions for patient, storage conditions, dispensing date, expiry date, unique identifying number, compounder details, and safety warnings
Dose limits set by the Poisons Standard (SUSMP) must be adhered to

Compounding Setup and Equipment

To ensure quality and safety, Boot emphasizes the importance of a dedicated clean space and appropriate equipment:

Personal protective equipment (PPE)
Calibrated scales with three decimal places
Ceramic mortar and pestle for grinding, glass for mixing
Sieves and other tools for ensuring uniform particle size

Compounding Methods and Techniques

Diana Boot covers several key methods and techniques for achieving homogeneous, effective compounded products:

Understanding molecular weights and conversions, such as the difference between elemental magnesium and the citrate salt
Trituration, or grinding, to achieve a uniform particle size
Geometric dilution, starting with the smallest quantity ingredient and gradually doubling
Considering density for homogeneity and dosing

Example Formulas and Ingredients

The webinar presents several example formulas and ingredients for various health conditions:

Designs for Health compounding ingredients: L-theanine, myo-inositol, magnesium threonate, N-acetylcysteine, and calcium D-glucarate
Sample formulas for menopause, insomnia, depression, and endometriosis
A case study involving bronchitis and insomnia, with a prescription summary including food as medicine, lifestyle medicine, herbal medicine, and nutritional medicine

Diana Boot also shares insights on creating a master spreadsheet for formulations, making it easier to develop and track customised treatments.

Dosing, Pricing, and Dispensing

Calculating doses and raw material quantities is a critical skill in compounding. Boot discusses:

Measuring and recording actual amounts
Determining scoop sizes and using fillers like microcrystalline cellulose
Pricing considerations and markup
Various dose forms for compounded products, including powders, creams, liquid herbs, capsules, pessaries, suppositories, troches, and nasal sprays

Natural Script Software

To streamline the compounding process, Boot co-founded Natural Script, a free compounding tool for practitioners. This software allows for the creation and sharing of pre-made formulas, facilitating collaboration and learning among practitioners.

Questions and Answers

Throughout the webinar, participants asked several pertinent questions:

Are there any powders that are incompatible with each other?
- Most powders are stable when combined, but hygroscopic ingredients may be slightly more reactive. Consult safety data sheets for specific incompatibilities.
Can we create our compound and have it made at a compounding pharmacy?
- Yes, compounding pharmacists can prepare formulas created by naturopaths and nutritionists, but only for individual patients, not in bulk.
Regarding the TGA 1g limit for NAC, many practitioners are dosing much higher. Is it legal?
- Dosing above 1g NAC pushes the product into Schedule 2, which is pharmacy-only. Practitioners should be cautious and consider the legal implications of exceeding this limit.
Where can we find ingredients like zinc carnosine, magnesium glycinate, and other forms of magnesium?
- These ingredients are available through compounding pharmacy suppliers, which are restricted to pharmacies. Purchasing from overseas may not guarantee TGA-approved quality.
How do you make extemporaneously compounded products more appealing for client compliance?
- Flavoring options include a flavor pack from a practitioner-only company, adding dried fruit, or using a sweetened base like Csspend. Mixing with food or liquids can also help.
Are there any references or information on compounding for pediatrics, such as upper limits of ingredients or dosage guidelines?
- The Nutrient Reference Values (NRVs) provide a range of safe doses for various age groups. Consult original research for specific conditions and ingredients.
Can we compound for transdermal application?
- Yes, transdermal compounding is possible. Start with a 1:1 dose ratio compared to oral dosing and adjust based on patient response.

Conclusion

Extemporaneous compounding is a valuable skill for naturopaths and nutritionists seeking to provide personalised care. By understanding the regulations, mastering the techniques, and partnering with compounding pharmacies when needed, practitioners can unlock the potential of this powerful therapeutic tool. Boot encourages all practitioners to embrace the art and science of compounding, as it can truly transform how they support their patients on their healing journeys.

Resources

By mastering the art and science of extemporaneous compounding, naturopaths and nutritionists can revolutionise their approach to patient care and provide truly personalised treatments that address each individual’s unique needs.

Personalised Medicine with Extemporaneous Compounding

Key Learning Objectives:

The Fundamentals of Extemporaneous Compounding: Understand the concept of EC, its importance in healthcare, and how it fits into current practice.
Ingredient Classification and TGA Guidelines: Understand how ingredients are classified and the significance of these classifications, and navigate through TGA guidelines pertinent to naturopaths and other health professionals.
Regulatory Considerations and Practices: How the regulatory landscape affects nutritionists and chiropractors involved in EC.
From Theory to Practice: Learn about the diverse range of compounds, their benefits, and evidence-based practices to enhance patient care.
Operational Excellence: Explore the operational side of EC, including dispensing guidelines, labelling, handling, and record-keeping.
Overcoming Challenges: Address the challenges and risks in EC, focusing on mitigating them while maximising benefits such as increased profit margins and customised formulations.

Diana Boot Shares Powerful Principles
During Her Interactive Presentation

Discussion of latest EC methods

Review Diana Boot's Question and Answer session

Review Diana Boot's approach to personalised treatment plans

Review EC prescribing principles

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I really enjoy your webinars. The presenters are engaging and concise, presenting information pertinent to the clinician setting rather than emphasising research facts is welcome. Personal stories also provide an authentic connection. Thank you

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Thanks for this clear, insightful information. I have found any of the webinars or seminars I’ve attended have been useful, with little nuggets that pop back into mind when relevant.

Roz Fitzgerald

Excellent in-depth training, provides extensive and well-illustrated explanations and summaries, easy to understand. Really appreciate this comprehensive self-paced practitioner training.

Duong Tran

I really enjoyed the webinar on Autoimmunity. The simplicity of the treatment protocols and the results were mind-blowing! The research studies to back up treatment protocols are great resources too.

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