lecture 3: Herbals and homeopathic Flashcards
the HMR 2012 definition of a herbal medicinal product?
medicinal substance who’s only active ingredients are:
- herbal substances
- herbal preparations
- both
define a herbal substance?
a plant or part of a plant, algae, fungi, lichen or unprocessed exudate of a plant
can be fresh or dried but otherwise unprocessed
define a herbal preparation
preparation obtained by subjecting herbal substances to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation AND includes comminuted or powdered herbal substance expressed as a juice or a processed exudate
4 types of herbal remedies?
- licensed herbal medicines
- registered traditional herbal medicines
- unlicensed herbal products
- not medicines
licensed herbal medicines: what is legally required?
- MA and a legal classification etc
registered traditional herbal medicine, what’s legally required?
to hold a traditional herbal registration (THR)
unlicensed herbal product, what is it and when can be supplied?
not industrially produced
supplied to individual patients following a face to face consultation
what are ‘not medicines’?
legally require?
food supplement or cosmetics
don’t require a MA or THR
WHO DOES THE MEDICINES ACT 1968 recognise as a supplier of herbal remedies?
pharmacists
dealers- merely sell remedy requested by customer
practitioners
herbal practitioners role?
use specialist knowledge to prescribe for persons seeking treatment and accept legal liability
where can practitioners practise from?
consulting rooms
from a shop where they also act as the dealer
conditions for herbal practitioners?
can deal in any herb after a
- one to one consultation
- patient must be present in the room
when do HMR medicinal product restrictions on sale and supply not apply?
- if the product is manufactured/ assembled by a herbalist practitioner on their premises which can exclude the public
- herbal product is for administration to a person in that persons presence
the medicines order 2001 SI states?
cannot manufacture, import, sell or supply any unlicensed medicine in the UK which contains:
-Aristolochia and Mu Tong
the medicines for human use order 2002 SI states?
prohibits the Sale, supply and importation of unlicensed medicines containing Kava-Kava except those for external use only
the medicines for human use senecio and miscellaneous amendments order 2008 states?
prohibits the sale, supply and importation of any medicinal product consisting of or contains senecio
when can MHRA ban the sale/ supply of herbal remedies?
if suspected adverse effects arise from their use
risk with unlicensed Kava Kava?
hepatotoxicity
risk with senecio?
fatal veno-occlusive disease
part 1 of the HMR 2012 schedule 20 restrictions on HMP supplied by herbalists
-prohibits the sale or supply of herbal medicines in the UK is it contains Areca Canadian hemp Embelia Male fern Strophanthus
exemption to part 1?
if sold in the premises which are registered pharmacies and under the supervision of a pharmacist
part 2 of the HMR 2012 schedule 20 restrictions on HMP supplied by herbalists
these can only be sold in herbal medicines following a one to one consultation with a practitioner. at the max doses. if exceeded the herbal medicines containing these plants can only be supplied in registered pharmacies with pharmacist supervision
part 2 herbal medicines and max doses?
adonis vernalis: 100mg(MD), 300mg (MDD)
Aconite: external 1.3%
belladonna herb: 50mg(MD), 150(MDD)
conium leaf: external 7%
ephedra: 600mg(MD), 1800 mg (MDD)
lobelia: 200mg (MD), 600mg (MDD)
what is aconite also known as?
monkshood
what is aconite
extremely poisonous plant, toxic to the heart
serious if consumed
3 reposts of adverse reactions to aconite?
- palpitations, breathless, malice
- kidney issues
- hospitalisation with dizziness
HMR 2012 regulation 125:
Product must have been in use for?
continuous period of at least 30 years and in EU for continuous period of at least 15 years
what herbal medicines are covered by a registration scheme?
manufactured, finished, OTC traditional herbal medicines
what is this registration schemes name?
traditional herbal medicines registration scheme (THMRS)
what happens to the registered products?
get given a reg number similar to MA number
2 requirements for THMs labelling?
statement that its a traditional herbal medicinal product
statement that the user should consult a doctor/ health care practitioner if symptoms persist or if adverse effect not mentioned on packaging or leaflet occour
all manufacturers of THMP don’t need a ML? True or False?
FALSE
all need a ML
all Wholesale dealings with THMPs need a WL?
true
any company that imports THMP from a non EU country will need a wholesalers import license?
true
any advert for THMP will require the statement?
‘traditional herbal medicinal product for use in (indication) exclusively based upon long standing use as a traditional remedy ‘
MHRA only oversees the registration of the THMP? True or False?
false, oversees the registration, manufacture, summary of product characteristics as well
any suspected adverse reactions to herbal remedies should be reported via?
yellow card scheme
what is the basic principles of homeopathy?
‘like cures like’
law of similars
in high dilutions the disease diluted can HELP the disease
the more diluted the disease the more _____
potent
when are homeopathics allowed?
indications for the relief or treatment of minor NOT major symptoms and conditions are allowed
rules for homeopathics MA’s?
the same MA rules that normally apply except the authorisation number will have the prefix NR in place of MA
do THMPs need to prove efficacy?
no- only safety and quality
