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PHAM01 > P&GSL - GSL meds > Flashcards

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?

A

FALSE

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?

A

TRUE

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?

A

FALSE

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
Q

Can GSL be sold from vending mechines?

A

YES provided the requirements are complied with

26
Q

sale of GSL from a pharmacy

A

if sold from a pharmacy, a ‘responsible pharmacist’ must have signed in and assumed this role

27
Q

exceptions to sale of GSL meds

A

in the event or anticipation of a pandemic disease

28
Q

sale of GSL meds from plane/train

A
  • 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
Q

GSL stimulant laxative drugs

A

senna/sennosides
bisacodyl
sodium picosulfate

30
Q

stimulant laxatives that are POMs

A

co-danthramer

co-danthrusate

31
Q

changes to legal status of OTC stimulant laxatives

A
  • 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
Q

warnings for OTC stimulant laxatives

A
  • overuse can be harmful due to risk of fluid and electrolyte disturbances and disruption of intestinal function
  • do not aid weight loss

PHAM01 (22 decks)

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