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PH1122- The Role of the Pharmacist > Medicines Law > Flashcards

Medicines Law Flashcards

1
Q

Human Medicines Regulations 2012

A

Brought together simplified medicines legislations

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2
Q

Medical Devices Regulations 2002

A

Covers **non-medicinal product items that pharmacists deal with

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3
Q

Misuse of Drugs Act 1971 and Regulations 2001

A

Controls supply of medicines likely to be misused

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4
Q

Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008

A

Introduced the role of the Responsible Pharmacist

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5
Q

Medicinal Products Regulation

A

Any substance or combination of substances presented as having properties of preventing or treating disease in human beings or restore or make a medical diagnosis

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6
Q

What authorisations are medicines supposed to get before they are sold/supplied?

A

Marketing Authorisations (MA). Medicines which meet standard of safety, quality and efficacy are granted a Marketing Authorisation

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7
Q

What does MHRA stand for?

A

Medicines and Healthcare Products Regulatory Agency

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8
Q

Off-label medicines

A

A product that can be used outside the terms of its MA e.g product licensed adults given to a children, treat a different condition ect.

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9
Q

Unlicensed medicines

A

If patients needs still not met, further options are:
- Import a medicine licensed in home country
- Unlicensed UK medicine
- Unlicensed abroad medicine
- Non-medicine (chemical or supplement)

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10
Q

The three classifications of medicinal products

A
  • General Sales List (GSL)
  • Pharmacy (P)
  • Prescription Only Medicines (POM)
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11
Q

General Sales List medicines rules

A
  • Can be sold without supervision of a pharmacist
  • Can be sold by retail
  • Must be in the original packs and unopened
  • Cannot be sold from a vehicle or market stall (except trains and planes under certain conditions)
  • Label not required to have GSL
  • Can sell maximum 16 paracetamol
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12
Q

Pharmacy Medicines

A
  • Supplied from a registered pharmacy by or under the supervision of a pharmacist
  • Label must contain ‘P’ in a box with no other material
  • Must not be accessible to the public for self-selection
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13
Q

Prescription Only Medicines (POM)

A
  • Only supplied on production of prescription (usually)
  • Only supplied from registered pharmacy, by/under pharmacist supervision
  • Label must contain POM in a box with no other material
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14
Q

When is a medicinal product considered a POM?

A
  • Needs medical supervision to reduce possibility of harm
  • Widely and frequently misused
  • A new active substance
  • For parenteral administration
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15
Q

Paracetamol (500mg) or aspirin (<325) tablets and capsules pack size

A

GSL = 16
P = 32
POM = n/a

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16
Q

Paracetamol (500mg) or aspirin (<325) tablets and capsules maximum no. tabs

A

GSL = 100
P = 100
POM= n/a

17
Q

Paracetamol or aspirin pack size and tab exception

A
  • Aspirin e/c 75mg tablets pack size up to 28 GSL, max 100
  • Doesn’t apply to granules, powders, effervescent tablets, liquids
18
Q

Ibuprofen tablets and capsules quantity/pack size

A

MHRA only permit a max of 16 tablets/capsules (200mg only) to be sold GSL, 32 P

19
Q

Pseudoephedrine and ephedrine capsules quantity/pack size

A
  • POM= a prescription is required to supply more than 720 mg of pseudoephedrine or more than 180mg ephedrine TOTAL in pack
  • P= less than 720mg or 180mg
  • Cannot be sold together
20
Q

Codeine and dihydrocodeine quantity/pack size

A

P= Max pack size 32 (including effervescent).
Not available as GSL

21
Q

What factors can affect the classification of a drug?

A
  • Formulation
  • Strength
  • Indication (the type of condition its being used for)
  • Marketing Authorisation
22
Q
A
23
Q

What does a CE mark indicate

A

Indicates it is a device and not a medicine

24
Q

Why may a medicines category/classification change?

A
  • To make it more/less restricted
  • A change in category is often associated with limitations on pack size/dose/indication
25
Q

What are herbal products marked with?

A

A THR number (Traditional Herbal Registration). They must comply with law but doesn’t have an MA so cannot make claims about efficacy

26
Q

What are homoeopathic products?

A
  • Made from natural substance and are highly diluted to produce remedies (the more diluted the more effective)
  • Contains no active ingredient and the royal pharmaceutical society does not endorse it as a form of treatment because there is no evidence to support its efficacy
27
Q

What are the responsibilities of a Responsible Pharmacist?

A
  • Check procedures are in place that support the safe + effective running of the pharmacy
  • Complete the pharmacist record to show who the RP is at any given time
  • Display a notice with name + registration number stating they are in charge
  • There can only be RP for a pharmacy at any given time
  • A pharmacist can only be responsible for one pharmacy at a time
  • Remains responsible for activities undertaken when he/she is absent
28
Q

What can run when the RP is absent and there is no other pharmacist present?

A
  • Sell GSL medicine
  • Take in prescriptions
  • Get prescriptions ready
29
Q

What can run when the RP is absent and there is another pharmacist present?

A
  • Sell GSL, P medicine
  • Take in prescriptions
  • Get prescriptions ready
  • Give out prescriptions
30
Q

In what conditions is the pharmacy allowed to run when the RP is not physically on the premises?

A
  • RP remains contactable
  • Adequate standard operating procedures are in place so pharmacy runs effectively and safely
  • RP is able to return (can be absent for max 2 hrs in 24 hrs period)
31
Q

What is required for the pharmacy record?

A
  • Must be kept for 5 years after last entry if paper or indefinitely if electronic
  • Date, full name, Gphc number, sign in/sign out time, time of leaving/returnin
  • Total time absent and reason for absence

PH1122- The Role of the Pharmacist (12 decks)

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