Licensing and legal classification of medicines

Question 1

What is the medicines act 1968

Answer 1

Act of parliament of the united kingdom introduced following the thalidomide disaster
Governs the control of medicines for human and veterinary use and also the supply of the drugs it covers

Question 2

What is a medicinal product

Answer 2

Any substance presented as having properties for treating or preventing disease in human beings

Question 3

What is needed before a medicinal product can be marketed in the UK

Answer 3

Marketing Authorisation

Question 4

Who is the licensing authority in the UK

Answer 4

Medicines and Healthcare products Regulatory Agency

Question 5

What do the MHRA do

Answer 5

Responsible for ensuring that medicines and medical devices work, are safe and of appropriate quality
Primary aim is to safeguard public health through a system of regulations

Question 6

What is off-licence use

Answer 6

using a medicine that has a UK licence, but in a different way to that which the licence dictates

Question 7

What should you check or do before prescribing an unlicensed medicine or using a medicine ‘off-label’

Answer 7

An licenced alternative would not meet the patients needs
There is sufficient evidence base and/or experience of using the medicine to show its safety and efficacy
Take responsibility for prescribing the medicine and overseeing the patients care
record the medicine prescribed and where common practice is not followed and the reasons for prescribing this medicine

Question 8

What are prescription only medicines

Answer 8

Available only on prescription
Covered by a MA
Controlled drug
Substances that generate or emit radiation
Cyanogenic substances

Question 9

What are Pharmacy medicines

Answer 9

Any medicinal product that is not a POM or GSL
Covered by a MA
Medicines made by pharmacists
Cannot be sold without a pharmacist present

Question 10

What is a general sales list medicine

Answer 10

Not a POM or a GSL
Covered by an MA
Can be sold in registered pharmacies but also in other retail outlets

Question 11

Where can you find out about the classification of a drug

Answer 11

BNF
Electronic medicines compendium
MHRA
pack itself

Question 12

What are CAMs

Answer 12

Complementary and Alternative medicines

Fall outside of mainstream healthcare

Question 13

What is the difference between alternative and complementary medicines

Answer 13

Complementary is when non-mainstream practice is used together with conventional medicine whereas alternative is used instead of

Question 14

What is the Traditional herbal registration

Answer 14

MHRA scheme which every herbal medicine that is marketed in the UK requires to hold
Limited to medicinal products for minor health conditions where medical supervision is not required
Must show that herbal medicine has been traditionally used to treat state condition for minimum of 30 years, and have a plausible effect on the basis of long-standing use and experience

Question 15

Definition of homeopathy

Answer 15

Homeopathy is a system of medicine which involves treating the individual with highly
diluted substances, given mainly in tablet form, with the aim of triggering the body’s natural system of healing

Question 16

What are the three principles that homeopathy is based off

Answer 16

Something in large dose creates the symptoms of the disease, will, in small doses, treat it
Extreme dilution enhances the medicine’s healing properties and eliminates undesirable side-effects
The whole person must be taken into consideration when choosing a remedy

Question 17

What are two regulatory schemes for homeopathic medicines

Answer 17

Require company to submit data to demonstrate safety, quality and use
Relief or treatment of minor symptoms and conditions which do not require the supervision of a doctor