Herbals And Homeopathics Flashcards
Define a herbal medicinal product
A medicinal product whose only active ingredients are herbal substances, herbal preparations or both
Define a herbal substance
A plant or part of a plant, algae, fungi or lichen or an unprocessed exudate of a plant, defined By the plant part used and botanical name of the plant, either fresh or dried, but otherwise unprocessed.
Define a herbal preparation
Any preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation, and includes a comminuted or powdered herbal substance, a tincture, an extract, an essential oil, an expressed juice or a processed exudate
Define a traditional herbal product
A herbal medicinal product to which regulatiom 125 applies - its registration
“Traditional herbal registration” is a traditional herbal registration granted by the licencing authority (under these regulations)
Name the 4 types of herbal medicines
- Licenced herbal medicines (needs an MA, legal classification etc) example senna
- Registered traditional herbal medicines - hold traditional herbal registrations
- Unlicensed herbal products - not industrially produced, supplied to individuals following a face to face consultations
- Not medicines - don’t require MA or THR (food supplements or cosmetics)
Why are herbals related to pharmacy
The medicines act recognises pharmacists as suppliers of herbal medicines.
Who are the three types of people who can supply herbal remedies
Pharmacists
Dealers (people with herb shops)
Herbal practitioners
Detail the processes surrounding unlicensed herbal products
Herbal practitioners apply their knowledge to treat person seeking treatment
They accept legal liability for this
Its a mostly unregulated profession
They may practice from a counselling room or a shop
They can, in general, prescribe any herb
Conditions: they must have a one to one consultation and the patient must be present in person
What is the herbalist exemption
HMR restrictions on sale and supply don’t apply if
the herbal product or manufactured by a herbalist practitioner on the premises they occupy which can exclude the public and
the herbal medicinal product is for administration to the person after being requested by or on behalf of that person and in that persons presence
Which regulatory body oversees medicinal herbalists
There isn’t one
There are no restrictions on any herbs which can be prescribed
False, MHRA restricts the use of some herbs such as kava kava (risk of hepatoxicity) and the selection species (potentially veno- occlusive disease)
Where can some drugs which contain generally banned plants extracts (listed in part 1 of legislation) still be sold
Community pharmacies under the supervision of a pharmacist
Give examples of some herbs (anthelmintic and irritants) which can only be sold by pharmacists from registered pharmacies
Areca, Canadian hemp, embelia, male fern, strophathus
Give some examples of herbs found in part 2 of the legislation
They are alcaloids:
Aconite, adonis vernalis, belladonna herbs, conium leaf, ephedra, lobelia
What are the dangers surrounding aconite
Aconite is an extremely poisonous plant, toxic to the heart. It can cause serious and potentially fatal adverse reactions if consumed
Patients have experienced palpitations, shortness of breath, kidney problems, paraesthesia
Where can products containing substances in part one be sold?
What about part 2?
Gsl and thmrs
Pharmacies only
Pharmacies and herbal practitioners
Pharmacies, herbal practitioners and shops
What is the key condition a drug must meet to be considered a traditional herbal medicine
The product has been in medicinal use for
- continuous period of at least 30 year and
- in EU for continuous period of at least 15 year
What other conditions need to be met for a traditional herbal medicine
Use without the need for medical supervision
Product needs.to be administered at a particular strength/dose
Product cannot be parenteral
There is sufficient info about its affects (not harmful and has plausible efficacy)
What can be found on all OTC traditional herbal medicines
Traditional herbal medicines registration
What must be included on the label of thmp
Statement that the product is a traditional herbal product
Statement that the user should consult a doctlre if symptoms persist and if adverse affects not mentioned on the package occur
What is the European positive list
A list which contains info on all herbal substances for which traditional use and safety will not need to be demonstrated by individual manufacturers
What are the rules surrounding maufscture, wholesale dealing and imports for thmps
Manufacturers need a manufacturers licence
Wholesalers need a wholesalers licence
A company which imports them needs a wholesalers (import) licence
What do advertisements for THMPs require to have stated on them
“Traditional herbal medicinal product for the use in (specify 1 or more indications consistent with the terms of its registration) exclusively based upon long standing use as a traditional remedy”
Name some significant interactions between herbal medicines and prescription drugs
Cranberry juice and warfarin
Grapefruit juce and statins
St John’s wort and many drugs
Which of the following are authorised medicinal products
Relevant medicinal products
Traditional herbal medicines
Registered homeopathic products
All of them
Who founded homeopathy
Dr Samuel Hahnemann
What is the principle of homeopathy
Like cures like
What is a product licence of right
For products on the market before the medicines act
These products may have indications for minor conditions suitable for self treatment
What is the simplified registration scheme
For new products since the medicines act
These products are assessed for safety and quality.
No therapeutic indication is allowed - they cannot make medical claims.
They are restricted to oral and external use
Relates to homeopathic remedies
What is the national rules scheme
Similar to marketing authorisations except these are just for homeopathic
Allows for indications (for the treatment of minor symptoms)
Efficacy data is not required
Safety rules do apply
Authorisation number has prefix NR not MA
Examples of these products
Nux vomica pillules - HR registration (no indicayion)
Teetha teething gel
Weleda muscular pain relief oromucosal spray
Which of the following are authorised medicinal products Relevant medicinal products Dispensed medicinal product Traditional herbal medicines Registered homeopathic products
RMP, THM, RHP
What type of authorisation do traditional herbal medicines need to hold
A traditional herbal registration
Which of the following homeopathic products can carry therapeutic indications:
Product holding a product licence of right
Product registered under the simplified registration scheme
Product registered under the national rules scheme
Product holding a product licence of right
Product registered under the national rules scheme
When is a Traditional Herbal Medicines Registration required
Manufactured, finished, OTC traditional herbal medicines are covered by a registration scheme
This is known as the Traditional Herbal Medicines Registration Scheme (THMRS)
All registered products are given a registration number (THR) similar to a MA number
