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PHAM01 > Licencing of Medicines 2 > Flashcards

Licencing of Medicines 2 Flashcards

1
Q

2 types of unlincenced meds

A

1) Use of an unlicenced product

2) Use of a licensed product for an unlicensed use = ‘off label use’

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2
Q

unlicensed product

A

has NO MA

does not have a SPC

does not have a monograph in the BNF

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3
Q

unlicensed use of a licensed medicinal product

A

med is licensed but the indication it is being prescribed for is not

unlicensed use may/may not be in BNF monograph for the licensed product

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4
Q

only time can Rx/dispense unlicenced meds

A

should only be prescribed or dispensed if no equivalent licensed product exist

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5
Q

What to do if unlicenced med Rx?

A
  • carries an increased risk
  • ensure that prescribers knows medicine is unlicensed
  • can inform prescriber about a suitable licensed alternative or advise on an alt med
  • inform patients that med is unlicensed and what this means
  • ADRs should be reported on a yellow card
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6
Q

liability of Rx/dispensing unlicenced med

A

liability with the prescriber and dispenser

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7
Q

licencing of extemporaneous meds

A

unlicenced

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8
Q

What are specials?

A

unlicensed med products prepared by a Special’s Licence holder that are made on the order of a Dr, dentist, nurse IP, pharmacist IP, or SP for use by their patients

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9
Q

What does manufacture have to have/do to manufacture SPECIALS?

A
  • have specials manufacturer’s licence
  • cannot advertise or get orders for the product
  • carry out manufacture under certain conditions to ensure quality of the product
  • keep written records
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10
Q

Does specials manufacture need MA, why?

A

NO

product may have a small market demand

so not worth the expenditure needed to obtain a MA

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11
Q

How long does specials manufacturer need to keep records for?

A

5 years

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12
Q

What needs to be in records of specials manufacturer?

A
  • patient name
  • quantity of product
  • who manufactured it
  • batch number
  • date supplied to patient
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13
Q

ADRs of specials products

A

reported to MHRA via yellow card scheme

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14
Q

specials manufacturer and advertising

A

can’t advertise products

can advertise their service

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15
Q

key principles of GPhC guidance for registered pharmacies preparing unlicenced medications

A

1) Governance arrangements safeguard the health, safety & wellbeing of pts and public
2) Staff are empowered & competent to safeguard the health, safety, wellbeing of pts and public
3) The environment & condition of the premises from which services are provided & associated premises safeguard the health, safety and wellbeing of pts and public
4) The way pharmacy services are delivered safeguards the health, safety, wellbeing of patients and public, inclused management of meds/med devices
5) Equipment & facilities used in providing services safeguard health, safety, wellbeing of pts and public

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16
Q

When does GPhC guidance for pharmacies preparing unlicenced meds apply?

A
  • one off Rxs of unlicenced med in accordance with Rx for individual pt
  • prep of stock of unlicenced med (anticipation of Rx) which will be supplied by/under supervision of pharmacist against Rx for indiv pt
  • prep of methadone for supply with Rx (immediate supply or as stock, supervision)
  • perp of unlicenced med based on pharmacist’s judgement (Chemist’s Nostrum)
  • prep of unlicenced med by/under supervision based on specification of pt
17
Q

What is unlicenced (off label) use?

A

prescribing of a licensed medicinal product which is being used outside of its license

(outside of what the SPC states)

18
Q

What can unlicensed use be due to?

A
  • Dose
  • Age (especially children)
  • Route
  • Indication
19
Q

who has responsibility/liability of unlicenced (off-label) med

A

prescriber - legal and clinical

20
Q

when prescribing unlicenced use

A

inform patient

make sure prescriber aware of the unlicensed use for liability reasons

21
Q

crushing a tablet if patient unable to swallow

A

unlicenced

alternative? (liquid, dissolvable)

(can’t crush if MR)

22
Q

** Why may a medicine be used ‘off label’?

A
  • licensed indications do not reflect established current knowledge or do not include well proven uses of a drug
  • licensed indications vary between different brands or between the brand and generic versions of the same medicine
23
Q

generics and unlicenced/off-label

A

sometimes generic won’t have same licencing as branded

esp OTC

if pharmacists recommends this, liability on them

24
Q

hierarchy of meds based on risk

A
  1. UK licenced med
  2. off label use of a UK licenced med
  3. imported product licenced in country of origin
  4. UK manufactured special made in MHRA licenced facilities
  5. extemporaneously dispensed medicine
  6. imported product not licenced in country of origin
  7. non-UK made unlicenced med/food supplement
25
Q

What are parallel imports?

A

medicines imported from another country which are a version of one already available in the UK which has a UK marketing authorisation

26
Q

countries can parallel import from

A

country must be on the approved country for imports list

countries in the EEA are the only countries included on this list

27
Q

What must product for parallel import have?

A
  • must have a MA from the country of manufacture
  • must have no diff therapeutic effect from the product covered by the UK MA
  • must have UK MA
28
Q

Need full MA with all data from clinical trials to be submitted of parallel import?

A

NO

application for a product licence (parallel import) can be made instead

PL (PI)

29
Q

cost of parallel imports

A

usually cheaper than UK products

30
Q

labelling and PILs of parallel imports

A

must be re-labelled in English

must have a PIL in English inserted into the packaging

31
Q

dispensing parallel imports

A
  • check authenticity before dispensing – PL(PI)
  • aware of counterfeit medicines
  • brand name may be different from the UK brand name (Loratidine – Clarityn (UK), Clarityne (PI))
  • if Rx written generically then can give either version BUT if written by UK brand name, EXACT SAME brand name must be dispensed
  • consider re-boxing the product if packaging includes a lot of foreign language
  • watch out for calendar packs, expiry dates, pack size
32
Q

calendar packs and parallel imports

A

should be re-labelled with English days of the week

33
Q

expiry date on parallel imports

A

may be different from the UK version

34
Q

pack size and parallel imports

A

may be different from UK version

35
Q

definition of counterfeit meds

A

medicine which is deliberately and fraudulently mislabelled with respect to identity or source

36
Q

Why is there an increasing risk of counterfeit meds in EU?

A
  • Better technology to produce labels
  • Lifestyle med have created a demand for supply
  • Internet sales from websites based abroad
  • Inc in self-prescribing culture
  • Organised crime (profitable, less risky than other drug crime)
  • Weak enforcement & penalties in many countries
37
Q

meds at risk of being counterfeit

A
  • Lifestyle drugs (weight loss, ED)
  • High cost drugs
  • High use drugs
  • Markets where medicines are expensive

(any meds at risk)

38
Q

types of counterfeit medicine

A
  • Illegally labelled authentic product
  • Relabelled expired product
  • Generic medicine packaged as branded
  • Sub-standard ‘copy’
  • Product containing no active ingredient
  • Product containing toxic ingredient
39
Q

preventing counterfeit medicines

A
  • Packaging (good quality, security seal)
  • Better internet regulation
  • Supply chain security
  • Inc public awareness
  • A UK system to detect counterfeits by scanning barcodes on packaging and comparing to a central database of codes

PHAM01 (22 decks)

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