Podcast
Questions and Answers
What is required for a herbal medicine making a medicinal claim in the UK?
What is required for a herbal medicine making a medicinal claim in the UK?
- It must contain no more than 5 ingredients.
- It must be registered as a traditional herbal medicine or licensed with marketing authorization. (correct)
- It must be devoid of traditional use evidence.
- It must be sold as a dietary supplement only.
Which directive was passed to regulate the use of herbal medicines within the EU?
Which directive was passed to regulate the use of herbal medicines within the EU?
- Traditional Herbal Medicinal Products Directive (THMPD)
- Directive 2004/24/EC (correct)
- Directive 2006/123/EC
- Directive 2000/83/EC
What is the minimum duration of evidence required for traditional use of herbal medicines in the EU?
What is the minimum duration of evidence required for traditional use of herbal medicines in the EU?
- A decade or longer of therapeutic success.
- 5 years of evidence.
- 30 years of evidence in the EU or 15 years both in the EU and outside. (correct)
- 15 years of evidence within the EU.
What can unregistered herbal products be marketed as in the UK?
What can unregistered herbal products be marketed as in the UK?
Which of the following statements about herbal medicines regulation is true?
Which of the following statements about herbal medicines regulation is true?
What percentage of participants did not inform their doctor about their use of herbal medicines?
What percentage of participants did not inform their doctor about their use of herbal medicines?
Which of the following herbal medicines is known for its anti-emetic properties?
Which of the following herbal medicines is known for its anti-emetic properties?
What could be a potential interaction when taking St John's Wort with citalopram?
What could be a potential interaction when taking St John's Wort with citalopram?
Which herbal medicine is highlighted for its anticoagulant effect?
Which herbal medicine is highlighted for its anticoagulant effect?
What risk is associated with combining garlic and aspirin?
What risk is associated with combining garlic and aspirin?
Which herbal medicine could decrease the effectiveness of amlodipine?
Which herbal medicine could decrease the effectiveness of amlodipine?
What potential effect occurs when herbal medicines and ciclosporin are taken together?
What potential effect occurs when herbal medicines and ciclosporin are taken together?
Which of the following herbal products is known for enhancing physical stamina?
Which of the following herbal products is known for enhancing physical stamina?
What is a disadvantage of herbal medicines?
What is a disadvantage of herbal medicines?
Which statement accurately reflects conventional medicines compared to herbal medicines?
Which statement accurately reflects conventional medicines compared to herbal medicines?
Which herbal medicine is noted for potentially decreasing the effectiveness of warfarin?
Which herbal medicine is noted for potentially decreasing the effectiveness of warfarin?
In which decade did the regulation of herbal medicines in the UK begin requiring a product license for medicinal claims?
In which decade did the regulation of herbal medicines in the UK begin requiring a product license for medicinal claims?
What is a common misconception about herbal medicines?
What is a common misconception about herbal medicines?
What is a key characteristic of herbal medicines compared to conventional medicines?
What is a key characteristic of herbal medicines compared to conventional medicines?
What is the primary purpose of Ayurvedic medicine?
What is the primary purpose of Ayurvedic medicine?
Under the Medicines Act 1968, what allowed a herbal remedy to be exempt from licensing?
Under the Medicines Act 1968, what allowed a herbal remedy to be exempt from licensing?
What is a misconception regarding the cost of herbal medicines?
What is a misconception regarding the cost of herbal medicines?
Which of the following best describes the term 'dosha' in Ayurveda?
Which of the following best describes the term 'dosha' in Ayurveda?
Which elements correspond to the dosha 'pitta'?
Which elements correspond to the dosha 'pitta'?
What does the Traditional Herbal Registration Scheme (THR) relate to?
What does the Traditional Herbal Registration Scheme (THR) relate to?
Which of the following is NOT a type of therapy included in Complementary and Alternative Medicines (CAM)?
Which of the following is NOT a type of therapy included in Complementary and Alternative Medicines (CAM)?
How many main doshas are recognized in Ayurvedic medicine?
How many main doshas are recognized in Ayurvedic medicine?
Which statement accurately represents Ayurveda's approach to health?
Which statement accurately represents Ayurveda's approach to health?
Which two elements are combined in the dosha 'kapha'?
Which two elements are combined in the dosha 'kapha'?
Which principle of homeopathy suggests that substances causing symptoms in healthy individuals can be used to treat illnesses?
Which principle of homeopathy suggests that substances causing symptoms in healthy individuals can be used to treat illnesses?
What is the significance of succussion in the preparation of homeopathic medicines?
What is the significance of succussion in the preparation of homeopathic medicines?
Which of the following is NOT a source material used in the preparation of homeopathic medicines?
Which of the following is NOT a source material used in the preparation of homeopathic medicines?
What method is employed to create potentisation in homeopathic medicine manufacturing?
What method is employed to create potentisation in homeopathic medicine manufacturing?
Which of the following preparations is NOT a form of homeopathic medicine?
Which of the following preparations is NOT a form of homeopathic medicine?
What is typically recommended regarding food intake when administering homeopathic medicines?
What is typically recommended regarding food intake when administering homeopathic medicines?
Which homeopathic preparation is made from an extraction of fresh, raw plant material?
Which homeopathic preparation is made from an extraction of fresh, raw plant material?
Which glass container characteristic is preferred for the storage of homeopathic medicines?
Which glass container characteristic is preferred for the storage of homeopathic medicines?
What is one of the main disadvantages of homeopathic medicines?
What is one of the main disadvantages of homeopathic medicines?
How are homeopathic medicines different from herbal medicines?
How are homeopathic medicines different from herbal medicines?
What does the National Rules Scheme (NRS) allow for homeopathic medicines?
What does the National Rules Scheme (NRS) allow for homeopathic medicines?
Which organization’s directive regulates homeopathic medicines in the EU?
Which organization’s directive regulates homeopathic medicines in the EU?
What is the first dilution required for products to be registered under the Simplified Registration Scheme?
What is the first dilution required for products to be registered under the Simplified Registration Scheme?
What is a key belief held by homeopaths regarding the potency of their medicines?
What is a key belief held by homeopaths regarding the potency of their medicines?
What must applications under the National Rules Scheme include?
What must applications under the National Rules Scheme include?
What does the Product License of Right (PLR) mainly grant?
What does the Product License of Right (PLR) mainly grant?
Under which regulations must homeopathic medicinal products comply for registration?
Under which regulations must homeopathic medicinal products comply for registration?
Why should NHS doctors avoid referring patients to homeopaths?
Why should NHS doctors avoid referring patients to homeopaths?
Flashcards
Ayurveda
Ayurveda
A system of medicine that originated in India over 5,000 years ago. Balances the five elements (space, air, fire, water, earth) within the body.
Doshas in Ayurveda
Doshas in Ayurveda
The life forces or energy patterns in Ayurveda. They influence our health and personality.
Vata, Pitta, and Kapha
Vata, Pitta, and Kapha
Ayurveda's three main doshas: Vata, Pitta, and Kapha. Each represents a combination of two elements and controls specific functions.
Vata (Air & Space) Dosha in Ayurveda
Vata (Air & Space) Dosha in Ayurveda
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Pitta (Fire & Water) Dosha in Ayurveda
Pitta (Fire & Water) Dosha in Ayurveda
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Kapha (Water & Earth) Dosha in Ayurveda
Kapha (Water & Earth) Dosha in Ayurveda
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Dosha Imbalance in Ayurveda
Dosha Imbalance in Ayurveda
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Restoring Balance in Ayurveda
Restoring Balance in Ayurveda
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What are herbal medicines?
What are herbal medicines?
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What are the types of effects herbal medicines can have?
What are the types of effects herbal medicines can have?
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What are the potential risks of combining herbal medicines with conventional medications?
What are the potential risks of combining herbal medicines with conventional medications?
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Why should you be cautious about combining blood thinners with garlic, ginger, or turmeric?
Why should you be cautious about combining blood thinners with garlic, ginger, or turmeric?
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What medications can be affected by St. John's wort?
What medications can be affected by St. John's wort?
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What is the potential risk of combining St. John's wort with citalopram?
What is the potential risk of combining St. John's wort with citalopram?
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Why does the manufacturer of digoxin advise against using St. John's wort?
Why does the manufacturer of digoxin advise against using St. John's wort?
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What's the most important thing to remember about using herbal medicines?
What's the most important thing to remember about using herbal medicines?
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Herbal Medicines in Food or Cosmetics
Herbal Medicines in Food or Cosmetics
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Medicinal Claim for HM
Medicinal Claim for HM
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Unregistered HM Products
Unregistered HM Products
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THMPD (Traditional Herbal Medicinal Products Directive)
THMPD (Traditional Herbal Medicinal Products Directive)
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HM Marketing Before 2004
HM Marketing Before 2004
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Drug Interactions with Herbal Medicines
Drug Interactions with Herbal Medicines
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Herbal Medicines: Natural ≠Safe
Herbal Medicines: Natural ≠Safe
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Regulation of Herbal Medicines
Regulation of Herbal Medicines
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Advantages of Herbal Medicines
Advantages of Herbal Medicines
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Herbal vs. Conventional: Source
Herbal vs. Conventional: Source
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Herbal vs. Conventional: Evidence Base
Herbal vs. Conventional: Evidence Base
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Herbal vs. Conventional: Cost
Herbal vs. Conventional: Cost
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Herbal vs. Conventional: System
Herbal vs. Conventional: System
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What is Homeopathy?
What is Homeopathy?
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What is the Law of Similars?
What is the Law of Similars?
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What is the principle of Minimal Dose?
What is the principle of Minimal Dose?
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What is Potentisation?
What is Potentisation?
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What is a Mother Tincture?
What is a Mother Tincture?
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What is the Principle of Single Medicine?
What is the Principle of Single Medicine?
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What is Succussion?
What is Succussion?
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What is the Holistic Approach in Homeopathy?
What is the Holistic Approach in Homeopathy?
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Distinguish homeopathy from herbal medicines.
Distinguish homeopathy from herbal medicines.
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How are homeopathic medicines prepared?
How are homeopathic medicines prepared?
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Is there scientific evidence for homeopathy?
Is there scientific evidence for homeopathy?
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How are homeopathic medicines regulated in the UK?
How are homeopathic medicines regulated in the UK?
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What is the Simplified Registration Scheme (SRS)?
What is the Simplified Registration Scheme (SRS)?
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What is the National Rules Scheme (NRS)?
What is the National Rules Scheme (NRS)?
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What regulations govern the registration of homeopathic products?
What regulations govern the registration of homeopathic products?
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How are homeopathic products classified?
How are homeopathic products classified?
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Study Notes
Herbal & Homeopathic Medicines
- Herbal and homeopathic medicines are used alongside conventional medicine
- Current legislation and professional issues concerning the manufacturing and supply of complementary and alternative medicines (CAM) are important - including Traditional Herbal Registration Scheme (THR)
- Herbal and Homeopathic medicines need to be differentiated
- CAM covers over 700 types of therapies, including acupuncture, Ayurveda, chiropractic, diet/dietary supplements, herbal medicines, homeopathy, massage, osteopathy, reflexology, reiki, traditional Chinese medicine (TCM) and yoga
- Ayurveda is a holistic, natural system of medicine that originated in India over 5,000 years ago. The name comes from Sanskrit words ayur (life) and veda (knowledge)
- Five elements make up Ayurveda's view of the world - space (ether), air, fire, water and earth
- Doshas (vata, pitta, and kapha) are life forces that influence health and personality and are assessed via physical and mental characteristics
- Ayurvedic medicine suggests imbalances in doshas can lead to illness and lifestyle changes, nutrition, and natural treatments can help restore balance
- Traditional Chinese Medicine (TCM) includes acupuncture, herbal medicine, moxibustion, cupping therapy, Tui Na, Qi Gong, Tai Chi, and dietary therapy
- Chi is regarded as a vital life force permeating the body. Balanced chi is indicative of health and vitality.
- A study by Royal Marsden (2004) found 50% of participants did not tell their doctor about using herbal medicines
- A study by Bhamra et al. (2017) found 69% of participants did not tell their doctor about using herbal medicines, and even more didn't tell their pharmacist
Herbal Medicines
- A herbal medicinal product is a medicinal product whose only active ingredients are herbal substances or herbal preparations (HMR 2012)
- Herbal substances are mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen, in unprocessed/usually dried, form but sometimes fresh
- Herbal preparations are obtained by subjecting herbal substances to treatments like extraction, distillation, expression, fractionation, purification, concentration or fermentation (Directive 2004/24/EC)
- In the UK, 20% of adults use herbal medicines
- The use of CAM in cancer patients is high
- There is a potential risk of adverse effects if herbal and conventional medicines are taken together
- Examples of potential drug interactions include garlic, ginger, turmeric, aspirin, Clopidogrel, Warfarin. This can result in an increased risk of bleeding
- There are other herb-conventional medicine interactions: St. John's wort with Ciclosporin, Amlodipine, Citalopram,and Digoxin; Garlic with Antiplatelet drugs and Warfarin; and Ginseng with Warfarin
- Herbal medicines, while having advantages such as being effective for health conditions, being natural, and potentially cheaper than conventional medicines, have disadvantages such as not being well-regulated, variable dosing, lack of clinical evidence.
Homeopathic Medicines
- Homeopathy is a complementary discipline based on the law of similars, involving administration of ultra-dilute medicines prepared according to methods specified in homeopathic pharmacopoeias, aiming at stimulating a person's own healing capacity.
- Homeopathic medicinal product is a medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure.
- Homeopathic medicines are based on the principles of "like cures like," minimal dose, and single medicine
- Developed by German doctor Samuel Hahnemann in the 1700s.
- Homeopathic medicines are prepared from various sources like plants, animals/insects, biological material, and chemical material.
- Mother tinctures are made from extracting the source material (plant or herb) in alcohol and water.
- Homeopathic medicines are often diluted using a serial dilution and succussion method
- Formulations of homeopathic medicine include oral preparations (tablets, pills, granules, powders), liquid preparations (drops), topical preparations (cream, gel, ointment, paste)
- Absorption may be affected by food (usually a 30-minute gap is recommended)
- Patients should avoid smoking or strongly flavoured products (e.g. peppermint toothpaste) and not touch the product with their hands
- Homeopathic medicines can be supplied on the NHS or via a private prescription.
- There are disadvantages of homeopathic medicines including lack of clinical evidence, effects compared to a placebo effect, and that they are not always evidence based.
Legislation
- Regulation of herbal medicines in the UK passed through several phases, with early 1970s requirements for a product license for medicinal claims.
- Section 12.2 of the 1968 Medicines Act allowed exemption from licensing for herbal remedies that contained only herbal substances and no medicinal claims.
- Human Medicines Regulations (HMRs) 2012 requires that herbal medicines making a medicinal claim either be registered under the Traditional Herbal Registration Scheme (THR) or licensed with marketing authorisation.
- Unregistered products cannot make any therapeutic claim.
- Traditional Herbal Medicinal Products Directive (THMPD) was passed in 2004 to regulate the use of HMs.
- The legislation required herbal medicinal products to have at least 30 years of evidence of traditional use in the EU, or 15 years within the EU and 15 years elsewhere.
- Safety data, quality, and pharmacovigilance were also required.
- There are various details about registrations, validity, and conditions for homeopathic medicines which were granted by the MHRA
Risk of Buying Herbal Medicines Online
- Fake, substandard, unlicensed contaminated or adulterated products may contain banned ingredients or substances.
- Products may be made in unlicensed factories with no Quality Assurance
- Claims such as "100% safe," "Safe because they are natural," and "Has no side effects" should be avoided.
Herbal Medicines vs. Conventional Medicines
- Herbal medicines are alternative, with a poor evidence base, and are natural. Traditional use is not well documented
- Herbal medicines are not well regulated, marketing authorisation is not always necessary, and there is a lack of clinical evidence that proves their efficiency
- Conventional medicines are conventional, evidence based, synthetic/manufactured/purified and regulated which has well established use. Necessary product licenses or marketing authorisation is required.
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