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Pharmacy Pre Reg Exam 2019 > Legislation & Professional Issues > Flashcards

Legislation & Professional Issues Flashcards

1
Q

What does the Human Medicines Regulations 2012 cover?

A

• Legislation regulating the authorisation, sale and supply of medicinal products for human use, made under the Medicines Act 1968

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2
Q

True or False

The Medicines Act of 1968 has been replaced fully

A

• False

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3
Q

What does the Veterinary Medicines Regulations cover? 2005 updated 2013

A

• The prescribing and supply for animals

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4
Q

What is the responsibility of the Programme Board for Rebalancing Medicines Legislation and Pharmacy Regulation?

A

• Reviews relevant pharmacy legislation and regulation to ensure it provides safety for users of pharmacy services

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5
Q

How many classes of medicinal products for humans do pharmacist deal with under the Human Medicines Regulations 2012?

A

• Three

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6
Q

True or False

Medicines should be considered normal items of commerce

A

• False

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7
Q

Where can general sale medicines (GSL) be sold?

A
  • In registered pharmacies
  • In retail outlets

That can close so as to exclude the public

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8
Q

How are medicines classified as GSL medicines?

A
  • Through EU or UK marketing authorisation (product license)
  • Traditional herbal registration
  • Certificate of registration as a GSL medicine homeopathic product
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9
Q

What does (PO) medicine refer to? What is an example?

A
  • A product that is licensed as a GSL medicine for which the manufacturer wishes to restrict sales or supplies through pharmacies ONLY
  • 30-sachet packs of Fybogel
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10
Q

When can GSL medicines be sold, within pharmacy?

A

• When a pharmacist has assumed the role of a RP, even if physically absent for a limited period whilst still the RP

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11
Q

Where can P meds be sold?

A

• From a registered pharmacy premises by a pharmacist/representative

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12
Q

Which classifications of medicines are considered OTC (non-prescription)?

A
  • P meds

* GSL meds

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13
Q

True or False

Pharmacy medicines must be accessible to the public by self-selection

A

• False

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14
Q

True or False

POMs require a prescription written by an appropriate practitioner before it can be sold or supplied

A

• True

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15
Q

What does medicine classification depend upon?

A
  • Formulation
  • Strength
  • Quantity
  • Indication
  • Marketing authorisation
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16
Q

What are pseudoephedrine and ephedrine?

A

• Decongestant P meds – potential for misuse

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17
Q

Which drug are they a used in the illicit production of?

A
  • Methylampehtamine (crystal meth)

* Class A Controlled Drug

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18
Q

What is the max strength of pseudoephedrine that can be supplied without a prescription?

A

• 720mg

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19
Q

What is the max strength of ephedrine that can be supplied without a prescription?

A

• 180mg

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20
Q

What are signs of possible pseudoephedrine and ephedrine misuse?

A
  • Lack of symptoms: cough, cold or flu symptoms
  • Rehearsed answers
  • Impatient or Aggressive
  • Opportunistic: waiting for busy periods
  • Specific products: brands containing only pseudoephedrine or ephedrine
  • Paraphernalia: lithium batteries/acetone
  • Large quantities
  • Frequent requests
21
Q

What are red flag products, if bought with pseudoephedrine/ephedrine products?

A
  • Lithium batteries

* Acetone

22
Q

True or False

It is lawful to sell or supply any pseudoephedrine product at the same time as an ephedrine

A

• False

23
Q

If misuse of ephedrine/pseudoephedrine products suspected, who can you report to?

A
  • Local GPhC inspector
  • Local Controlled Drugs liaison police officer
  • Accountable officer
24
Q

Which are licensed as pharmacy medicines for emergency hormonal contraception: EHC?

A
  • Levonorgestrel 1500mcg tablet

* Ulipristal acetate 30mg tablet

25
Q

Levonorgestrel is licensed for women aged______or over for emergency contraception within________of unprotected sexual intercourse or failure of a contraceptive method.

A
  1. 16 years

2. 72 hours

26
Q

Ulipristal acetate is licensed for emergency contraception within _______ of unprotected sexual intercourse or failure of a contraceptive method.

A
  1. 120 hours (5 days)

Supply is not contraindicated <16 years; however, pharmacist may wish to consider additional factors e.g. consent, Gillick competency

27
Q

True or False If true, why? If false, why not?

Pharmacist can provide an advanced supply of oral emergency contraception

A

• True – assess competency & intent to use appropriately and clinical appropriateness

Prior to unprotected sexual intercourse or in case of failure of a contraceptive method

28
Q

Are children under 13 years legally able to consent to any sexual activity? Where should cases be reported?

A
  • No

* Report cases to social services

29
Q

Is sexual activity under the age of 16 an offence? Can it be consensual?

A
  • Yes

* Yes

30
Q

Can pharmacist provide contraception/sexual health advice to a child under the age of 16?

A
  • Yes and patient confidentiality applies

* Decision to share information, consent should be sought – child’s best interest (prevent harm & protect welfare)

31
Q

Where can patients be referred if sale of EHC inappropriate (sale outside of MA)?

A
  • Family planning clinics
  • General practice clinics
  • Providers of PGDs for EHC
  • Genitourinary medicine clinics (GUM)
32
Q

What is the OTC legal restrictions for paracetamol?

A

• Not more than 100 non effervescent tablets or capsules can be sold to a person at any one time

There are no legal limits on the quantity of OTC
effervescent tablets, powders, granules or liquids that can be sold to a person at any one time.

33
Q

What is the OTC legal restrictions for aspirin?

A

• Not more than 100 non effervescent tablets or capsules can be sold to a person at any one time

There are no legal limits on the quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time.

34
Q

Why are there tighter controls and new warnings on packaging of OTC solid dose medicines (tablets/capsules) containing codeine/dihydrocodeine?

A

• To minimise risk of overuse and addiction

35
Q

What are the indications for OTC solid dose codeine/dihydrocodeine?

A

• Short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone

All other previous indications – flu, cold, sore throats and minor pain – have been removed

36
Q

What is the maximum pack size of OTC codeine/dihydrocodeine?

A

• 32 dose units (>32 requires MA as a POM)

This includes effervescent formulations

37
Q

What warning must now be positioned in a prominent clear position on the front of the pack of OTC codeine/dihydrocodeine?

A

• ‘Can cause addiction. For three days use only’

38
Q

What does the PIL and packaging of OTC codeine/dihydrocodeine need to state?

A
  • The indication
  • The medicine can cause addiction/overuse headache if used for more that 3 days
  • Warning signs of addiction
39
Q

How many packs of codeine/dihydrocodeine should be sold OTC?

A

• 1

40
Q

True or False

Many cough and cold medicines are no longer used in children under six years of age.

A

• True

41
Q

What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Antitussives

A
  • Dextromethorphan
  • Pholcodine

Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days

42
Q

What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Expectorants

A
  • Guafenesin
  • Ipecacuanha

Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days

43
Q

What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Nasal Decongestants

A
  • Ephedrine
  • Oxymetazoline
  • Phenylephrine
  • Pseudoephedrine
  • Xylometazoline

Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days

44
Q

What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Antihistamines

A
  • Brompheniramine
  • Chlorphenamine
  • Diphenhydramine
  • Doxylamine
  • Promethazine
  • Triprolidine

Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days

45
Q

What is best practice (1st line) for treating children with cough &/cold?

A
  • Drink plenty of fluids
  • Treat fever and pain with paracetamol/ibuprofen if child doesn’t respond to paracetamol. Using paracetamol & ibuprofen together is not recommended for <5 year olds
  • Treat nasal congestion with saline nasal drops, vapour rub or decongestant or steam inhalation
  • Treat cough with warm clear fluids or warm lemon and honey drinks (if >1 years old), simple cough mixtures: glycerol/simple linctus
46
Q

Most colds will resolve within_______days

A

• 5 to 7

47
Q

What age can OTC liquid preparations containing codeine be used?

A

• 18 years

48
Q

What are some newly classified P medicines?

A
  • Amorolfine nail lacquer
  • Chloramphenicol eye drops and eye ointment
  • Levonorgestrel and ulipristal acetate
  • Omeprazole and pantoprazole
  • Orlistat
  • Sumatriptan
  • Sildenafil
  • Tamsulosin
  • Tranexamic acid

Pharmacy Pre Reg Exam 2019 (2 decks)

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