3. Legislation And Professional Issues Flashcards Preview

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Flashcards in 3. Legislation And Professional Issues Deck (46):
1

What consolidates most of the legislation regulating the authorisation, sale and supply of medicinal products for human use, made under the medicines act 1968?

The human medicines regulations 2012

2

Name the three classes of medicinal products for humans under the human medicines regulations 2012

General sale (GSL)
Pharmacy (P)
Prescription only (POM)

3

Why is there restrictions on the quantities of selling pseudoephedrine and ephedrine?

Due to their potential for misuse in the illicit production of methylamphetamine (Crystal meth) - a class A controlled drug

4

Max quantity of pseudoephedrine that can be sold without a prescription

720mg

5

Max quantity of ephedrine that can be sold without a prescription

180mg

6

True or false: you can sell a pseudoephedrine product at the same time as an ephedrine product

FALSE - this would be unlawful

7

Licensing for levonorgestrel 1500mcg (EHC)

For women aged 16 years or over for emergency contraception within 72hours of unprotected sexual intercourse or failure of contraception method

8

Licensing for ulipristal (EHC)

Emergency contraception within 120 hours (five days) of unprotected sex

9

Legal restrictions of non-effervescent paracetamol tablets OTC?

Not more than 100 - most pack sizes are 16 or 32

10

Legal restrictions of non effervescent OTC aspirin

Not more than 100 - most are packs of 16 or 32

11

Pack size of OTC codeine and how many days can it be used for?

32
3 days

12

Name two antitussives

Dextromethorphan
Pholcodine

13

Name two expectorants

Guaifenesin
Ipecacuanha

14

Name 5 nasal decongestants

Ephedrine
Oxymetazoline
Phenylephrine
Pseudoephedrine
Xylometazoline

15

Name 6 antihistamines

Brompheniramine
Chlorphenamine
Diphenhydramine
Doxylamine
Promethazine
Triprolidine

16

17 yr old wants codeine linctus for dry unproductive cough

No! Has to be 18 or over

17

7 legal requirements on a prescription

Signature
Address of practitioner
Date
Particulars of practitioner
Name of patient
Address if patient
Age of patient (if <12)

18

Private prescriptions for a POM must be retained for how long from the date of the sale or supply or for repeatable prescriptions from the date of the last sale or supply?

2 years

19

How long should a POM book be retained for?

2years from date of last entry

20

What five things should be in a POM book

1) supply date
2) prescription date
3) medicine details
4) prescriber details
5) patient details

21

What medicines are not available on an EEA prescription?

Schedule 1,2 and 3 CDs and medicinal products without a marketing authorisation

22

Emergency supply at the request of a prescriber: when should the prescriber give the prescription by?

Within 72hours

23

Can you supply CDs in an emergency?

Only schedule 4,5 and phenobarbital for epilepsy

24

If supplying schedule 4,5 or phenobarbital as emergency supply how many days can you give?

5 days

25

Emergency supply (not including CDs) can be for how long treatment?

30 days- unless insulin, creams, inhalers, COC I.e packs not to be broken

26

Who can provide a signed order for salbutamol inhalers for a school?

Written order signed by the principal or head teacher at the school

27

What info should be included in the signed orders for salbutamol for a school

Signed by principal/head teacher
Name of school
Purpose for product
Total quantity required

28

Do regulated poisons require additional record keeping in a poisons register

YES

29

When medicines are dispensed from an 'in-house' pharmacy for administration or supply to patients within a prison, the pharmacy does NOT need to be registered with the GPhC - true or false?

True

30

MHRA requires homeopathy to demonstrate efficacy, quality and safety

False doesn't need to demonstrate efficacy

31

What licensing do herbal remedies require

Full marketing authorisation based upon efficacy, quality and safety or a traditional herbal registration (THR) based upon efficacy, quality and safety

32

All medical devices are regulated by what

Medicines and healthcare products regulatory agency (MHRA)

33

All medical devices are required to carry what mark denoting compliance with the medical devices regulations

CE mark

34

Name the four groups under the new psychoactive substances

Synthetic cannabinoids
Stimulants
Downers
Hallucinogens

35

What extra details are required on vet CD prescriptions (schedule 2 and 3)

Prescribed for the treatment of an animal or herd under my care and the royal college of veterinary surgeons (RCVS) Reg number

36

What's the points of the veterinary cascade

To allow the supply of medicines that are not licensed for animals

37

How long do you keep veterinary documents/records for

At least 5 years

38

What are the 9 GPhC standards for pharmacy professionals

1) provide person centred care
2) work in partnership with others
3) communicate effectively
4) maintain, develop and use professional knowledge and skills
5) use professional judgement
6) behave in professional manner
7) respect and maintain the persons confidentiality and privacy
8) speak up when they have concerns or when things go wrong
9) demonstrate leadership

39

Who is the regulator for pharmacists, pharmacy technicians and registered pharmacy premises in England, Scotland and Wales

General pharmaceutical council

40

What is the pharmacy record

An important legal document that shows who the responsible pharmacist is at any given date and at any time

41

How should the pharmacy record be kept?

In writing, electronically or in both forms

42

Who must maintain the pharmacy record

The responsible pharmacist

43

How long should the pharmacy record be kept for

At least five years
Electronic: 5yrs from day the record created
Written: 5yrs from the last day to which record relates

44

The responsible pharmacist may be absent for up to how long during the working hours (including if there was two responsible pharmacists)

Max 2 hours

45

Information that's included on the pharmacy notice

Your name
Your registration number
That you are the responsible pharmacist in charge of that registered pharmacy premises

46

What's required on the pharmacy record

Responsible pharmacist name
RP reg number
Date and time commencing being RP
Date and time stopping being RP
Details of absence (date, time)