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Pharmacy Practice 1 > pharmacy law questions > Flashcards

pharmacy law questions Flashcards

1
Q

what are the three legal classes of drugs and what do they stand for

A

GSL = general sales list
P = pharmacy only medicines
POM = prescription only medicine

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2
Q

what must be placed on the codeine and dihydrocodiene label and patient information leaflet

A

‘Can cause addiction. For three days use only

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3
Q

What can it cause for more than 3 days
codeine and dihydrocodiene

A

can cause headache (Overuse headache)

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4
Q

what is the dosage units of a codeine or dihydrocodiene product

A

over 32 tablets = a POM

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5
Q

Pseudoephedrine and Ephedrine what is unlawful?+ doseage

A

to sell 720 mg of p and 180 mg of e at any one time without a prescription
it is also unlawful to sell them together without prescription

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6
Q

what does legal class refer to

A

the product (strength, pack size and use) and not the active substance

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7
Q

legal classes for paracetamol and aspirin

A

GSL - 16
P - 32
POM - 100

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8
Q

what two drugs are used for emergency hormonal contraception

A

levonorgestrel and uliprisal acetate

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9
Q

what is levogesterel
in micrograms and what class
what age ?

A

1500 micrograms is a P med
16 and over

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10
Q

what is uliprisal acetate in mg and what class
whofor?

A

P med
30 mg tablets
child bearing age

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11
Q

what is a PO med

A

contains gsl ingredients only sold in a pharmacy NOT A LEGAL CLASS ONLY P IS

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12
Q

ibuprofen, bisocodyl ranatidine and daktakort

A

ibuprofen 200 mg max strength GSL
bisocodyl 40 tablets are GSL and more are p
ranitidine 75 mg 12 tablets GSL
daktacort 15 g = P
daktacort 30 g = POM

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13
Q

what does MHRA stand for

A

medicines and healthcare products registration agency

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14
Q

what act in 1999 and what did it replace and what was it

A

The Health Act
modernise and strengthen regulations
replaces pharmacy act 1954

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15
Q

what is CPD and what was it

A

STATUTORY
continuing professional development

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16
Q

The responsible pharmacist

A

after first of october 2009
Statutory duty for RP to secure safe and effective running of pharmacy
To establish, maintain and keep under review procedures for safe working
Keep a record of the pharmacist responsible at any one time
Display a notice- name and registration number of RP and the fact that they are in charge
statutory duty for pharmacy owner to ensure RP properly maintains the pharmacy record

17
Q

RP regs

A

Enable the RP to be absent from the pharmacy for a max of 2 hours (in 24 hours)
RP must remain contactable
GSL can be sold

18
Q

what regulation came in 2012

A

HUMAN MEDICINES REGULATION
minor updated to reflect modern practice
first major consolidation and review of UK medicines legalisation since 1968

19
Q

What major change did the Human
Medicines Regulations 2012 make to practice?

A

Legislation allowed for the use of professional judgement when labelling medicines

  • Can change directions (if we feel they are not correct)
  • Can change name or common name of medicine
  • Can change precautions for use on label
20
Q

What comes under Can change directions

A

arbitrary dose not supporting patient (morning, night)
overdose: oral suspension in kids
differ from advicee of gp
poorly constructed directions (reducing dose od predilosone)

21
Q

limitations of human medicine regulation

A

Limitations:
* Only allows changes to labelling
* Does not allow generic substitution
* Cannot change strength or quantity
* Doesn’t change conventions for incomplete prescriptions
* Does not apply to schedule 2 and 3 controlled drugs

22
Q

what regulations came in 2013?
what were they

A

pharmacy regulations, replaces 2012
reflects new NHS architecture
NHS is responsible for maintaining pharmaceutical lists
HWB responsible for pharmaceutical needs assessments, routine applications for new pharmacists

23
Q

what came in 2016?

A

human medicines regulations 2016

24
Q

what is in the human medicines regulations 2016 (4 things)

A

allowing registered therapeutic radiographers independent prescribers to mix, prescribe, sell or supply certain types
adding registered dieticians to the list of health professionals who are included in the definition of a supplementary prescriber
enabling the general sale pharmacy and certain prescription only medicines to be supplied by registered orthoptics
enable the prescriptions only medicines diamorphine, morphine and pethidine hydrochloride to the supplied by registered midwives

25
Q

poisons
date, what act

A

from the 26th may 2015, the Poisons act 1972 was amended changing how poisons were classified

26
Q

Before supplying a posion to a member of the public
5 THINGS

A

1) check the purchaser has a Home Office license
2) see if its unaltered and in-date
3) Check id, supplies CANNOT be made to a third party
4) check substance requested and total quantity match the details on the license
5) record details of transaction on the license

27
Q

Labelling on a poison

A

needs to be REACH (registration, evaluation, authorisation and restriction of chemical compliant

27
Q

For P2 regulated poisons make an entry into the poisons register
5 THINGS

A

1) date of supply
2) name and address of purchaser
3) name and quantity of regulated poison
4) purpose of purchase
5) signature of purchaser

28
Q

poisons reportable substances

A

supplies don’t require purchaser to hold a home office license
if pharmacy supplies poisons or chemicals consider whether the request is suspicious+if any alternatives available

29
Q

CD’s (controlled drugs)
controlled by?

A

misuse of drugs act 1971 + misuse of drugs regulations 2001
scheduled according to the risk and potential harms from abuse
schedules determine the degree of control storage requirements and record keeping required

30
Q

what doesn’t require a home office license?

A

supplies of poison

31
Q

REACH acronym

A

registration
Evaluation
authorisation
restriction of chemical

32
Q

medicines act 1968

A

licensing, sales promotion, regulation, wholesale dealing

33
Q

what should be kept with schedule 1 and 2 CDS

A

controlled drug register

34
Q

For Controlled Drugs received, the following must be recorded:

A

Date supply received
Name and address from whom received
Quantity received.

35
Q

what 2 legal class of drugs are amended regularly

A

POM AND GSL

36
Q

what was the legal classification of medicines established by and what must they have

A

medicines act 1968
must have a marketing license

Pharmacy Practice 1 (15 decks)

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