Specials

Question 1

What is a marketing authorisation

Answer 1

A license that is required by law for any pharmaceutical product, issued by the regulator for that country

Question 2

what is the regulator in the UK

Answer 2

medicines and healthcare products regulatory agency (MHRA)

Question 3

why is licensing necessary

Answer 3

guarantees the medicine is safe and effective for human use, which must be proved by extensive testing before the marketing authorisation will be given
- guarantees product quality

Question 4

what does the marketing authorisation include

Answer 4

includes details of exactly which patients, conditions and clinical situations the medicine can be used for, including the specific doses

Question 5

what is a special product

Answer 5

an unlicensed medicine, used for patients with unique clinical requirements or unusual circumstances

Question 6

describe the manufacture of special products

Answer 6

1. made by a company who have a specials manufacturing licence from the MHRA
2. normally made according to specific prescription
3. must comply with certain standards and keep specific records
4. companies can also perform limited batch manufacturing of specials

Question 7

how common are medication errors

Answer 7

account for 10% of all incidents reported to the national reporting and learning system
- include many look alike/sound alike errors

Question 8

when can LASA errors occur

Answer 8

can occur during prescribing, dispensing, supply or administration of medicines and can lead to administration of the wroth medication with potentially fatal consequences

Question 9

what needs to be included in the labelling of unlicensed medicines

Answer 9

1. the international non proprietary name
2. a statement of the active ingredients
3. intended route of administration
4. instructions for use, including any special warnings
5. the pharmaceutical form
6. the contents of the container by weight, volume or number of doses
7. excipients of known effect
8. keep out of reach and sight of children
9. expiry date
10. any special storage precautions
11. the manufacturers MS number
12. manufacturers name and address
13. batch number
14. statutory warnings

Question 10

what are unlicensed medicines

Answer 10

medicines with no marketing authorisation at all

Question 11

what is meant by unlicensed use

Answer 11

using a medicine with a marketing authorisation, in a way that is different to the conditions stipulated on the MA

Question 12

what is the need in specials

Answer 12

1. always situations where patient requirements are unique
2. doesn’t merit applying for a full MA (costly and takes years to approve)
3. to avoid extemporaneous preparations

Question 13

who might need specials

Answer 13

1. babies and children
2. people with swallowing difficulties
3. long term or permanent feeding tubes
4. allergies and intolerances
5. specific treatment required but no licensed products available in the UK
6. to avoid extemporaneous preparation in a pharmacy

Question 14

when should we consider a special

Answer 14

1. under MHRA rules we should always use a licensed product where possible
2. must consider a licensed product in an unlicensed way, before resorting to a special

Question 15

list the order of choosing an option for a product

Answer 15

1. licensed product, sued within the conditions of the license
2. if not suitable, is there an alternative licensed product?
3. if not suitable, is there a licensed product that can be used in an unlicensed way?
4. consider use of a special

Question 16

give examples of batch manufacture

Answer 16

• common liquids for children
• ophthalmic preparations (eye drops, ointment)
• many preservative free products
• non routine parenteral products
• epidural infusions
• dermatology preparations that would be made extemporaneously

Question 17

what does the law say about using special products

Answer 17

1. specials have an exemption for the need of an MA
2. manufactured and supplied in accordance with prescriber specifications
3. patient falls into category of having special needs
4. clear reason why licensed alternative is not clinically appropriate

Question 18

outline the responsibilities as a pharmacist in using special products

Answer 18

1. patient care is always primary concern
2. ensure all medicines prescribed and supplied are safe, effective and appropriate for condition
3. make certain no other licensed alternatives can be used
4. should always be an exception, never routine supply
5. patient and prescriber made fully aware of unlicensed status and patient must share decision to use a special
6. ensure the quality of the special product
7. use reputable specials manufacturers
8. keep all records in relation to purchase and supply
9. you share accountability with the prescriber

Question 19

what is involved in making a clinical assessment for the use of a special

Answer 19

1. need to establish this patients clinical situation is different from normal
2. should not be in relation to cost
3. should not be in relation to simple convenience, must be justifiable

Question 20

what are the 5 principles in the professional practice guide

Answer 20

1. establish the patients special clinical need
2. understand patients experience
3. identify a preparation and a supplier
4. ensure effective governance is in place
5. monitor patient and review need for the special

Question 21

what are the disadvantages of specials

Answer 21

1. no robust testing like a licensed medicine so can’t guarantee safety and efficacy
2. short expiry dates and instability are common, especially if preservative free
3. very expensive, Gps struggle to fund them in the longer term for chronic diseases