Unlicensed Medicines

Question 1

What are unlicensed medicines?

Answer 1

1. Medicinal products without a UK marketing authorisation as issued by MHRA
2. Licensed products identified by PL or MA followed by number
3. Reffered to as OFF LABEL

Question 2

What do the marketing authorisation do?

Answer 2

Guarantee of the quality, safety, efficacy of medicine when used in accordance with summary of product characteristics

Question 3

What does the human medicines regulation of 2012 state?

Answer 3

1. Provides an exemption from the need for a marketing authorisation for a medicinal product which is supplied
2. Has to be manufactured and assembled in accordance of a person who is a doctor, dentist, nurse independent, pharmacist independent
3. Person treating patient is responsible

Question 4

How is something classed as an unlicensed medicine? What is it outside the boundaries of?

Answer 4

1. Age
2. Dose
3. Condition

Question 5

According to MHRA guidance note 14 (Human medicines regulations 2012), when can unlicensed medicines be used?

Answer 5

1. Only justified when there are no licensed medicine which fully meets patients clinical needs- patient may be intolerant to an excipient
2. This does not include: cost, convenience or operational
3. Records of supply kept for 5 years

Question 6

Who is responsible when an unlicensed medicine is given out?

Answer 6

The prescriber and the pharmacist

Product needs to be the best and patient is at least risk

Question 7

What are the rigorous assessments that a UK licensed medicine may have undergone?

Answer 7

1. Quality
2. Safety
3. Efficacy- depending on patient and condition

Question 8

How do you obtain an imported product licensed in country of origin?

Answer 8

Using a import agency that has a whole dealers licence that’s registered on MHRA

Question 9

What quality tests are done to ensure that a licensed medicine can be for the public?

Answer 9

Certificate of analysis:
1. British Pharmacopeia used as guide

2. Process and product checks- broth fill test for aseptic products
3. Sterility test

Certificate of conformity
Only complies with specification: 
Uniformity of content
Uniformity of Mass
Friability
Hardness
Disintegration

Question 10

Describe what an extemporaepously dispensed medicine is?

Answer 10

1. Medicines made in pharmacy under supervision of pharmacist
2. No end product testing
3. Quality- professional responsibility
4. Safety and efficacy is not formally tested

Question 11

How do you ensure patient safety in unlicensed medicines?

Answer 11

1. Communication- ask the right questions
2. Constant change- new products being developed, more information gained for existing products
3. Maintenance of supply- bioavailability - may choose to purchase for patients safety