Personalised and bespoke medicines Flashcards

1
Q

What is the aim of personalised medicine?

A

Aim is maximum efficacy of treatment and significant reduction in the risk of undesirable side effects.

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2
Q

What is the definition of personalised medicine in the US Genomics and Personalised Medicine Act 2008?

A

Personalised medicine is the application of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, help determine a person’s predisposition to a particular disease or condition, and identify any targeted prevention strategies for that predisposition.

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3
Q

Which CYP enzyme acts on half of all known drugs?

A

CYP3A4

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4
Q

Genotyping has found gene variants in what enzymes that metabolise warfarin? what has been the outcome of this?

A

CYP2C9
Vitamin K epoxide reductase gene variant

Has led to commercially available testing that enables more accurate dosing based on algorithms that take into account the age, gender, weight and genotype of an individual.

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5
Q

When are specials appropriate?

A
Dosage form is inappropriate
Discontinued/withdrawn products
Compassionate use products
Off label use
Bespoke dispensing of medicines in specialised unit dose systems to enable patients to adhere to their medication e.g. patient with an excipient allergy
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6
Q

Define ‘special’

A

A special can be defined as a non-licensed medicine manufactured to fulfil the prescribers requirements, if it is in the best interest of the patient.

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7
Q

What license is required to manufacture a special?

A

Special Manufacturing license (MS) issued by the MHRA

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8
Q

An imported MP with a licence in the country of origin but not in the UK is a special - true/false?

A

True

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9
Q

Do specials require a MA?

A

NO - HMR 2012 Part 10 states that specials are an exception to the requirement of an MA

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10
Q

The HMR 2012 Part 10 - exempts the need for MA for a relevant medicinal product which is supplied to fulfil a special need providing that certain conditions are met. What are these conditions?

A
  1. in response to a bona fide unsolicited order
  2. formulated in accordance with the specification of a doctor/dentist/supplementary prescriber
  3. for use by prescribers individual patients on his direct responsibility
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11
Q

Who holds responsibility for unlicensed medicines?

A

A pharmacist shares with the prescriber accountability for supplying a special to a patient

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12
Q

Patient consent is not needed when prescribing an unlicensed medicine…true or false?

A

FALSE

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13
Q

If requesting a special from a specials manufacturer who holds responsibility for the quality of the medicine?

A

The requesting pharmacist retains responsibility for the formulation NOT the manufacturer

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14
Q

In the medicines act 1968 ‘Section 10 exemption’ what does it state regarding the requirements of extemporaneous dispensing?

A

Must be carried out in a registered pharmacy and under supervision of a pharmacist.

Made as a one off- no requirement for product testing

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15
Q

Extemporaneously prepared medicines must undergo product testing - true/false

A

false

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16
Q

What are the risks associated the extemp dispensing?

A
Un-proven formulations 
Lack of standards/specifications
Calculation errors
Formulation failures - over/under dose, stability issues, binding od drug to excipeints, microcontamination 
Measurement and labelling errors
Use of concentrated raw materials 
Raw material toxicity/contamination
Safety and efficacy is untested
QA/GMP issues
17
Q

What are the risks to staff associated with extemp dispensing?

A

Exposure to harmful substances associated with crushing tablets, weighing out powders, handling volatile liquids
Liability

18
Q

What is the quality commitment?

A

Unlicensed medicines only made in licensed premises, which are subject to inspection by the MHRA

Premises must comply with GMP and have PQA and QA system in place

19
Q

The liability when using a licensed product lies with who?

A

Manufacturer