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pharmacy semester 2 > lecture 3: Herbals and homeopathic > Flashcards

lecture 3: Herbals and homeopathic Flashcards

1
Q

the HMR 2012 definition of a herbal medicinal product?

A

medicinal substance who’s only active ingredients are:

  • herbal substances
  • herbal preparations
  • both
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2
Q

define a herbal substance?

A

a plant or part of a plant, algae, fungi, lichen or unprocessed exudate of a plant
can be fresh or dried but otherwise unprocessed

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3
Q

define a herbal preparation

A

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

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4
Q

4 types of herbal remedies?

A
  • licensed herbal medicines
  • registered traditional herbal medicines
  • unlicensed herbal products
  • not medicines
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5
Q

licensed herbal medicines: what is legally required?

A
  • MA and a legal classification etc
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6
Q

registered traditional herbal medicine, what’s legally required?

A

to hold a traditional herbal registration (THR)

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7
Q

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

A

not industrially produced

supplied to individual patients following a face to face consultation

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8
Q

what are ‘not medicines’?

legally require?

A

food supplement or cosmetics

don’t require a MA or THR

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9
Q

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

A

pharmacists
dealers- merely sell remedy requested by customer
practitioners

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10
Q

herbal practitioners role?

A

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

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11
Q

where can practitioners practise from?

A

consulting rooms

from a shop where they also act as the dealer

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12
Q

conditions for herbal practitioners?

A

can deal in any herb after a

  • one to one consultation
  • patient must be present in the room
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13
Q

when do HMR medicinal product restrictions on sale and supply not apply?

A
  • 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
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14
Q

the medicines order 2001 SI states?

A

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

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15
Q

the medicines for human use order 2002 SI states?

A

prohibits the Sale, supply and importation of unlicensed medicines containing Kava-Kava except those for external use only

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16
Q

the medicines for human use senecio and miscellaneous amendments order 2008 states?

A

prohibits the sale, supply and importation of any medicinal product consisting of or contains senecio

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17
Q

when can MHRA ban the sale/ supply of herbal remedies?

A

if suspected adverse effects arise from their use

18
Q

risk with unlicensed Kava Kava?

A

hepatotoxicity

19
Q

risk with senecio?

A

fatal veno-occlusive disease

20
Q

part 1 of the HMR 2012 schedule 20 restrictions on HMP supplied by herbalists

A 
-prohibits the sale or supply of herbal medicines in the UK is it contains 
Areca			
Canadian hemp		
Embelia		
Male fern			
Strophanthus
21
Q

exemption to part 1?

A

if sold in the premises which are registered pharmacies and under the supervision of a pharmacist

22
Q

part 2 of the HMR 2012 schedule 20 restrictions on HMP supplied by herbalists

A

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

23
Q

part 2 herbal medicines and max doses?

A

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)

24
Q

what is aconite also known as?

A

monkshood

25
Q

what is aconite

A

extremely poisonous plant, toxic to the heart

serious if consumed

26
Q

3 reposts of adverse reactions to aconite?

A
  • palpitations, breathless, malice
  • kidney issues
  • hospitalisation with dizziness
27
Q

HMR 2012 regulation 125:

Product must have been in use for?

A

continuous period of at least 30 years and in EU for continuous period of at least 15 years

28
Q

what herbal medicines are covered by a registration scheme?

A

manufactured, finished, OTC traditional herbal medicines

29
Q

what is this registration schemes name?

A

traditional herbal medicines registration scheme (THMRS)

30
Q

what happens to the registered products?

A

get given a reg number similar to MA number

31
Q

2 requirements for THMs labelling?

A

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

32
Q

all manufacturers of THMP don’t need a ML? True or False?

A

FALSE

all need a ML

33
Q

all Wholesale dealings with THMPs need a WL?

A

true

34
Q

any company that imports THMP from a non EU country will need a wholesalers import license?

A

true

35
Q

any advert for THMP will require the statement?

A

‘traditional herbal medicinal product for use in (indication) exclusively based upon long standing use as a traditional remedy ‘

36
Q

MHRA only oversees the registration of the THMP? True or False?

A

false, oversees the registration, manufacture, summary of product characteristics as well

37
Q

any suspected adverse reactions to herbal remedies should be reported via?

A

yellow card scheme

38
Q

what is the basic principles of homeopathy?

A

‘like cures like’
law of similars
in high dilutions the disease diluted can HELP the disease

39
Q

the more diluted the disease the more _____

A

potent

40
Q

when are homeopathics allowed?

A

indications for the relief or treatment of minor NOT major symptoms and conditions are allowed

41
Q

rules for homeopathics MA’s?

A

the same MA rules that normally apply except the authorisation number will have the prefix NR in place of MA

42
Q

do THMPs need to prove efficacy?

A

no- only safety and quality

pharmacy semester 2 (15 decks)

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