P&GSL - GSL meds Flashcards

1
Q

3 legal clases of products in UK?

A

GSL
P
POM

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2
Q

PO

A
  • ‘pharmacy only’
  • sale restricted to pharmacies by the manufacturer
  • all GSL
  • don’t confuse with ‘P’ medicines
  • ‘PO’ is NOT a legal classification
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3
Q

Is ‘PO’ a legal classification?

A

NO

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4
Q

What meds are OTC?

A

P and GSL

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5
Q

How to find the legal classification?

A
  • BNF
  • packaging of the medicinal product
  • SPC
  • PAGB OTC Directory
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6
Q

When can meds move class?

A

if they are re-classified by the MHRA

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7
Q

usual move for meds

A

POM - P - GSL

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8
Q

what can med restrictions include

A
  • indication
  • pack size
  • strength
  • route of administration
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9
Q

recent POM to P switches

A

sildenafil
desogestrel
topical vaginal oestrogen

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10
Q

Can med move from POM - GSL without being P medicine?

A

yes

eg. nexium, fexofenadine

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11
Q

diff between P/POM and GSL

A

GSL do not need to be sold from a registered pharmacy under supervision of a pharmacist

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12
Q

T/F: If a pharmacist prepares a medicine in a pharmacy using GSL ingredients the legal classification of the product is P?

A

TRUE

because made in the pharmacy

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13
Q

T/F: GSL medicines can be sold from an automatic vending machine located in a pub?

A

TRUE

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14
Q

T/F: GSL medicines for human use can be sold from a stall at a music festival?

A

FALSE

can’t close the permesis

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15
Q

T/F: Water for injection is classified as a GSL medicine because water is not a medicine?

A

FALSE

it’s a POM, all injections are POM

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16
Q

T/F: A medicine for treating threadworms will never be classified as GSL?

17
Q

T/F: GSL medicines may be sold from a car boot in a car boot sale?

A

FALSE

can’t be closed

18
Q

T/F: When GSL medicines are sold the pack must be unopened?

A

TRUE

and made up for sale somewhere else, can’t pre-package then there

19
Q

T/F: Eye ointments are never classified as GSL?

20
Q

T/F: In a pharmacy, GSL medicines may legally be sold by any member of staff?

A

TRUE

legally anybody, good practice that thay have had training

21
Q

T/F: The packaging for GSL medicines will include the letters ‘GSL’ in a rectangle?

22
Q

definition of GSL in HMR 2012

A

a product that is
- not a POM or a P
- and is covered by a marketing authorisation that the product is to be available on general sale

23
Q

products that are NOT GSL

A
  • products containing greater than a specified maximum daily dose of vitamin A or vitamin D
  • for use as an eye ointment
  • for use as an anthelmintic**
  • for parenteral administration**
  • for use as an enema**
  • for use wholly or mainly for irrigation of wounds or of the bladder, vagina or rectum**
  • for admin wholly/mainly to children being a preparation of aloxiprin or aspirin**

** = unless the MA classifies them as GSL

24
Q

How can GSL meds be sold legally?

A

can only be sold/supplied at a registered pharmacy or anywhere else where the following conditions are fulfilled:
- the premises can be closed to exclude the public
- the product must have been made up for sale in a container elsewhere and not have been opened since then

** if the product is included in Schedule 15 then it must be sold in accordance with the requirements specified in that Schedule

25
Can GSL be sold from vending mechines?
YES provided the requirements are complied with
26
sale of GSL from a pharmacy
if sold from a pharmacy, a ‘responsible pharmacist’ must have signed in and assumed this role
27
exceptions to sale of GSL meds
in the event or anticipation of a pandemic disease
28
sale of GSL meds from plane/train
- sale is permitted from aircraft and trains - sale must be made by the operator or commander of an aircraft or the operator of a train ** the med sold must: - been made up for sale or supply in a container elsewhere than at the place it is sold/supplied - stored in a part of the aircraft or train which the operator is able to close to exclude the public
29
GSL stimulant laxative drugs
senna/sennosides bisacodyl sodium picosulfate
30
stimulant laxatives that are POMs
co-danthramer co-danthrusate
31
changes to legal status of OTC stimulant laxatives
- pack size restrictions, revised rec ages, new safety warnings - smaller pack sizes still GSL -> ST/occassional constipation, adults only - GSL = limited to pack size of 2 short Tx courses (up to 20 std strength tabs, 10 max strength tabs, 100ml solution) - larger pack sizes up to 100 tabs = P - GSL for O18yrs only - stimulant avoided U12yrs - 12-17yrs = P meds (supervision of pharmacist)
32
warnings for OTC stimulant laxatives
- overuse can be harmful due to risk of fluid and electrolyte disturbances and disruption of intestinal function - do not aid weight loss