lecture 3: Herbals and homeopathic Flashcards by Sophie Hayton

the HMR 2012 definition of a herbal medicinal product?

medicinal substance who’s only active ingredients are:

herbal substances
herbal preparations
both

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

4 types of herbal remedies?

licensed herbal medicines
registered traditional herbal medicines
unlicensed herbal products
not medicines

How well did you know this?

Not at all

Perfectly

licensed herbal medicines: what is legally required?

MA and a legal classification etc

How well did you know this?

Not at all

Perfectly

registered traditional herbal medicine, what’s legally required?

to hold a traditional herbal registration (THR)

How well did you know this?

Not at all

Perfectly

unlicensed herbal product, what is it and when can be supplied?

not industrially produced

supplied to individual patients following a face to face consultation

How well did you know this?

Not at all

Perfectly

what are ‘not medicines’?

legally require?

food supplement or cosmetics

don’t require a MA or THR

How well did you know this?

Not at all

Perfectly

WHO DOES THE MEDICINES ACT 1968 recognise as a supplier of herbal remedies?

pharmacists
dealers- merely sell remedy requested by customer
practitioners

How well did you know this?

Not at all

Perfectly

herbal practitioners role?

use specialist knowledge to prescribe for persons seeking treatment and accept legal liability

How well did you know this?

Not at all

Perfectly

where can practitioners practise from?

consulting rooms

from a shop where they also act as the dealer

How well did you know this?

Not at all

Perfectly

conditions for herbal practitioners?

can deal in any herb after a

one to one consultation
patient must be present in the room

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

the medicines order 2001 SI states?

cannot manufacture, import, sell or supply any unlicensed medicine in the UK which contains:
-Aristolochia and Mu Tong

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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

How well did you know this?

Not at all

Perfectly

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