Overview of Personalised & Bespoke Medicines

Question 1

What do Regional Pharmaceutical Quality Assurance Pharmacists do?

Answer 1

• Develop medicines
• Test medicines & environments
  
  • > Chemical
  • > Microbiological
  • > Cleanroom Air Quality
• Audit and Inspection

Question 2

What is the main problem with modern medicine?

Answer 2

Many medicines do not work effectively for a large number of the patients that they are supposed to treat

Question 3

How does personalised & bespoke medicine aim to improve the main problem with modern medicine?

Answer 3

• Correct diagnosis required
• Right dose in Right place
• Right patient
• Right time (cell cycle, circadian rhythm etc.)
• Reduced cost, time and complications

Question 4

Why are there differences between people when taking medicines?

Answer 4

• We are all different
• Genetic differences (e.g. metabolic profiles)
• Traditional pharmacology tends to use the ‘one disease, one drug’ approach
• Recognition of individual differences is growing thanks to the human genome project

Question 5

How is genetics being utilised in medicine?

Answer 5

• Diagnosis
• Treatment
• Determine which drugs may be the most effective for an individual
• How likely it is for a cancer to return
• Disease susceptibility

Question 6

What terms are commonly used to describe tests to see which drug is the most suitable for a patient?

Answer 6

• Companion diagnostics
• Theranostics
• Therapy genetics

Question 7

What is the DEFINITION of Personalised Medicine? (According to the USA)

Answer 7

The application of genomic and molecular data to better target the delivery of health care and help determine a person’s predisposition to a particular disease or condition and identify any targeted prevention strategies for that predisposition.

Question 8

What is the INTENTION of Personalised Medicine?

Answer 8

To ensure treatments meet the needs (medical, biological and biomolecular) of the individual patient.

Question 9

What is the AIM of Personalised Medicine?

Answer 9

Maximum efficacy of treatment and significant reduction in the risk of undesirable side effects

Question 10

What is the main group of enzymes responsible for unique responses to drugs?

Answer 10

CYP450s

Question 11

What are some examples of ‘specials’?

Answer 11

Calculated cytotoxic chemotherapy
Parenteral Nutrition
Modified antibiotic therapy regimens

Question 12

Who are ‘Specials’ for?

Answer 12

Often for the most vunerable patients

• Premature babies who can’t tolerate the normal doses
• Intensive care patients with specific IV needs
• Patients who can’t swallow (e.g. stroke or elderly)
• Cancer patients
• Dermatology patients (e.g. who are allergic to a specific excipient)
• Acute eye infections that need antibiotic eye drops

Question 13

What is the definition of a ‘Special’?

Answer 13

A non-licensed medicine manufactured to fulfil the prescriber’s requirements
- Manufactured under a Special Manufacturing Licence (MS)

Question 14

When the pharmacist is presented with a prescription for a ‘Special’ what options are available to get it?

Answer 14

Either:

• Make the product
• Purchase from a ‘Specials’ manufacturer

Question 15

‘Specials’ Definitions:

- What is an ‘Import’?

Answer 15

Product with product license in a country of origin (not in the country of use)

Question 16

‘Specials’ Definitions:

- What is an ‘Extemporaneous preparation’?

Answer 16

a product made under the supervision of a pharmacist

- (under section 10 exemption of Medicines Act 1968)

Question 17

‘Specials’ Definitions:

- What is a ‘Ward based manipulation’?

Answer 17

Crushing, dispersing, dissolving, cutting etc

Question 18

Which piece of legislation states that a licensed medicine should be used wherever possible?

Answer 18

MHRA Guidance Note 14

- The supply of unlicensed relevant medicinal products for individual patients

Question 19

What do the Humans Medicines Regulations 2012 state with regards to ‘Specials’?

Answer 19

Part 10
- Exception to requirement for marketing authorisation

Exempts the need for a marketing authorisation for a relevant medicinal product which is supplied to fill a special need

Question 20

Which conditions need to be met in order to supply a special under the Humans Medicines Regulations 2012 exemption?

Answer 20

• In response to a bona fide unsolicited order
• Formulated in accordance with the specification of a doctor, dentist or supplementary prescriber
• For use by prescriber’s individual patients on his direct responsibility

Question 21

The GMC rules allow prescribing of unlicensed medicines as long as the licensed form is…

Answer 21

• Inappropriate for the patient
• There is evidence that the medicine is safe and effective
• They must also monitor and follow up patients

Question 22

Who holds responsibility for deciding whether a patient has ‘special needs’ which a licensed product cannot meet?

Answer 22

The prescriber on advice of the pharmacist

Question 23

Legally, products are commissioned by who?

Answer 23

The Pharmacist

Question 24

Who holds responsibility for the formulation?

Answer 24

The Requesting Pharmacist (NOT the manufacturer!)

Question 25

What are the roles of the pharmacist in ‘specials’?

Answer 25

• Work as part of the Nutritional Support Team (PN)
  
  • > Assess patient & requirements
• Assess potential risks and problems (e.g. stability and compatibility)
• Formulate regimen
• Minimise hazardous reactions
• Provide, deliver safer and effective products

Question 26

What legislation is ‘Extemporaneous Dispensing’ carried out under?

Answer 26

Section 10 exemptions to the Medicines Act 1968

Question 27

What are the requirments for ‘Extemporaneous Dispensing’ under ‘section 10 exemptions’ to the Medicine Act 1968

Answer 27

• Must be carried out in a registered pharmacy and under the supervision of a pharmacist
• Usually made as a ‘one-off’ for individual patients (therefore no requirement for product testing)

Question 28

What are the formulation risks associated with Extemp Dispensing? (Learn!)

Answer 28

• Un-proven formulations
• Lack of standards/specifications
• Calculation errors
• Formulation failures (Over/under dose, dose uniformity, stability, excipients, contamination, BA issues)
• Measurement and labelling errors
• Raw material toxicity/contamination
• Safety & Efficacy untested
• QA/GMP issues

Question 29

What are the staff risks associated with Extemp Dispensing? (Learn!)

Answer 29

Exposure to harmful substances

• Crushing tablets
• Preparation of powders
• Pouring
• Handling volatile liquids

Liability

Question 30

What is stated in the Unlicensed Medicines Guidance 2014?

Answer 30

• Risk assessment
• Record keeping and accountability
• Staff training
• Patient information (have adequate info about pt)
• Equipment and facilities

Question 31

What Quality Commitments should you implement when extemporaneously dispensing?

Answer 31

• Premises comply with GMP
• Pharmaceutical Quality Assurance (QA) system in place
• Batch testing/certificate of analysis
• Certificates of compliance (for single products)
• Best practice labelling
• Customer support
• Unique product codes on all items made