3. Legislation And Professional Issues Flashcards Preview

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

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

A

The human medicines regulations 2012

2
Q

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

A
General sale (GSL) 
Pharmacy (P) 
Prescription only (POM)
3
Q

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

A

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

4
Q

Max quantity of pseudoephedrine that can be sold without a prescription

A

720mg

5
Q

Max quantity of ephedrine that can be sold without a prescription

A

180mg

6
Q

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

A

FALSE - this would be unlawful

7
Q

Licensing for levonorgestrel 1500mcg (EHC)

A

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

8
Q

Licensing for ulipristal (EHC)

A

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

9
Q

Legal restrictions of non-effervescent paracetamol tablets OTC?

A

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

10
Q

Legal restrictions of non effervescent OTC aspirin

A

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

11
Q

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

A

32

3 days

12
Q

Name two antitussives

A

Dextromethorphan

Pholcodine

13
Q

Name two expectorants

A

Guaifenesin

Ipecacuanha

14
Q

Name 5 nasal decongestants

A
Ephedrine 
Oxymetazoline
Phenylephrine
Pseudoephedrine 
Xylometazoline
15
Q

Name 6 antihistamines

A
Brompheniramine
Chlorphenamine 
Diphenhydramine 
Doxylamine 
Promethazine 
Triprolidine
16
Q

17 yr old wants codeine linctus for dry unproductive cough

A

No! Has to be 18 or over

17
Q

7 legal requirements on a prescription

A
Signature 
Address of practitioner
Date 
Particulars of practitioner
Name of patient 
Address if patient 
Age of patient (if <12)
18
Q

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?

A

2 years

19
Q

How long should a POM book be retained for?

A

2years from date of last entry

20
Q

What five things should be in a POM book

A

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

21
Q

What medicines are not available on an EEA prescription?

A

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

22
Q

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

A

Within 72hours

23
Q

Can you supply CDs in an emergency?

A

Only schedule 4,5 and phenobarbital for epilepsy

24
Q

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

A

5 days

25
Q

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

A

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

26
Q

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

A

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

27
Q

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

A

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

28
Q

Do regulated poisons require additional record keeping in a poisons register

A

YES

29
Q

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?

A

True

30
Q

MHRA requires homeopathy to demonstrate efficacy, quality and safety

A

False doesn’t need to demonstrate efficacy

31
Q

What licensing do herbal remedies require

A

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

32
Q

All medical devices are regulated by what

A

Medicines and healthcare products regulatory agency (MHRA)

33
Q

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

A

CE mark

34
Q

Name the four groups under the new psychoactive substances

A

Synthetic cannabinoids
Stimulants
Downers
Hallucinogens

35
Q

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

A

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

36
Q

What’s the points of the veterinary cascade

A

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

37
Q

How long do you keep veterinary documents/records for

A

At least 5 years

38
Q

What are the 9 GPhC standards for pharmacy professionals

A

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
Q

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

A

General pharmaceutical council

40
Q

What is the pharmacy record

A

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

41
Q

How should the pharmacy record be kept?

A

In writing, electronically or in both forms

42
Q

Who must maintain the pharmacy record

A

The responsible pharmacist

43
Q

How long should the pharmacy record be kept for

A

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

44
Q

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

A

Max 2 hours

45
Q

Information that’s included on the pharmacy notice

A

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

46
Q

What’s required on the pharmacy record

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