Herbals And Homeopathics Flashcards

1
Q

Define a herbal medicinal product

A

A medicinal product whose only active ingredients are herbal substances, herbal preparations or both

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Define a herbal substance

A

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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Define a herbal preparation

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Define a traditional herbal product

A

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)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Name the 4 types of herbal medicines

A
  1. Licenced herbal medicines (needs an MA, legal classification etc) example senna
  2. Registered traditional herbal medicines - hold traditional herbal registrations
  3. Unlicensed herbal products - not industrially produced, supplied to individuals following a face to face consultations
  4. Not medicines - don’t require MA or THR (food supplements or cosmetics)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Why are herbals related to pharmacy

A

The medicines act recognises pharmacists as suppliers of herbal medicines.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Who are the three types of people who can supply herbal remedies

A

Pharmacists
Dealers (people with herb shops)
Herbal practitioners

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Detail the processes surrounding unlicensed herbal products

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is the herbalist exemption

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Which regulatory body oversees medicinal herbalists

A

There isn’t one

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

There are no restrictions on any herbs which can be prescribed

A

False, MHRA restricts the use of some herbs such as kava kava (risk of hepatoxicity) and the selection species (potentially veno- occlusive disease)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Where can some drugs which contain generally banned plants extracts (listed in part 1 of legislation) still be sold

A

Community pharmacies under the supervision of a pharmacist

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Give examples of some herbs (anthelmintic and irritants) which can only be sold by pharmacists from registered pharmacies

A

Areca, Canadian hemp, embelia, male fern, strophathus

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Give some examples of herbs found in part 2 of the legislation

A

They are alcaloids:

Aconite, adonis vernalis, belladonna herbs, conium leaf, ephedra, lobelia

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What are the dangers surrounding aconite

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Where can products containing substances in part one be sold?
What about part 2?
Gsl and thmrs

A

Pharmacies only
Pharmacies and herbal practitioners
Pharmacies, herbal practitioners and shops

17
Q

What is the key condition a drug must meet to be considered a traditional herbal medicine

A

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
18
Q

What other conditions need to be met for a traditional herbal medicine

A

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)

19
Q

What can be found on all OTC traditional herbal medicines

A

Traditional herbal medicines registration

20
Q

What must be included on the label of thmp

A

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

21
Q

What is the European positive list

A

A list which contains info on all herbal substances for which traditional use and safety will not need to be demonstrated by individual manufacturers

22
Q

What are the rules surrounding maufscture, wholesale dealing and imports for thmps

A

Manufacturers need a manufacturers licence
Wholesalers need a wholesalers licence
A company which imports them needs a wholesalers (import) licence

23
Q

What do advertisements for THMPs require to have stated on them

A

“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”

24
Q

Name some significant interactions between herbal medicines and prescription drugs

A

Cranberry juice and warfarin
Grapefruit juce and statins
St John’s wort and many drugs

25
Q

Which of the following are authorised medicinal products
Relevant medicinal products
Traditional herbal medicines
Registered homeopathic products

A

All of them

26
Q

Who founded homeopathy

A

Dr Samuel Hahnemann

27
Q

What is the principle of homeopathy

A

Like cures like

28
Q

What is a product licence of right

A

For products on the market before the medicines act

These products may have indications for minor conditions suitable for self treatment

29
Q

What is the simplified registration scheme

A

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

30
Q

What is the national rules scheme

A

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

31
Q

Examples of these products

A

Nux vomica pillules - HR registration (no indicayion)
Teetha teething gel
Weleda muscular pain relief oromucosal spray

32
Q
Which of the following are authorised medicinal products
Relevant medicinal products
Dispensed medicinal product
Traditional herbal medicines
Registered homeopathic products
A

RMP, THM, RHP

33
Q

What type of authorisation do traditional herbal medicines need to hold

A

A traditional herbal registration

34
Q

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

A

Product holding a product licence of right

Product registered under the national rules scheme

35
Q

When is a Traditional Herbal Medicines Registration required

A

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