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Pharmacy flashcards > Law and Ethics Year 1 Law And Legislation Lectures > Flashcards

Law and Ethics Year 1 Law And Legislation Lectures Flashcards

0
Q

What is judicial precedent?

A

When a case is decided in higher courts, lower courts have to follow the decision 

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1
Q

What is Tort? 

A

a wrongful act for which someone can be sued for damages in a civil law court,
Eg a dispensing error, mis-diagnosis, inappropriate prescribing

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2
Q

What is the misuse of drugs act in terms of legislation?

A

It is an act of parliament

You can get orders, regulations and rules within this act

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3
Q

What triggered the Medicines Act to be developed?

A

Required to regulate medicinal products following the Thalidomide tragedy
Medicines act was adopted to cover the process for manufacture, marketing, and supply of medicines in the UK
Updated: human medicines regulations 2012, regulates medicines by licensing!

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4
Q

When is a manufacturing Liscence not needed?

A

Not needed by a person who imports a medicinal product for personal use
Manufacturing Liscence doesn’t apply to mixing of medicines

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5
Q

What products need a marketing authorisation (/product licence?)

A

Needed for every medicinal product before being prescribed/ sold.

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6
Q

What licences are needed for a medicinal product?

A

Clinical trial authorisation
Manufacturers authorisation (Manufacturing license = Manufacturing authoriSation)
Wholesale dealers licence
all these are issued by the MHRA
Manufacturers license needed to MAKE a medicinal product.

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7
Q

What’s a manufacturers licence needed for?

A

Any medicinal product in the uk needs to be produced on a Site that holds an appropriate manufacturers licence.
Needed for production of products to be given to public
(needed to make or import a medicinal product, and to possess and medicinal product for any activity)

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8
Q

What’s a Clinical trial authorisation needed for?

A

Needed for new products under development

Needed before being tested on humans

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9
Q

Who needs a wholesale dealers licence?

A

Any company/ individual wishing to wholesale dale (selling, supplying)
All medicinal products in the EU must hold a wholesale dealers licence
Needed for distribution to patients stage

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10
Q

What is quality, when assessing products quality?

A

A products physical, pharmaceutical and biological characteristics to ensure that each batch of this medicine is capable of performing reliably and consistently

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11
Q

An assessor will evaluate the safety, Quality and Efficacy of a product, who can they seek further advice from?

A

CHM or EAG

They may advise to licence or refuse

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12
Q

What does a marketing authorisation allow the holder to do?

A

Sell, supply, export the Medicinal product (MP), and obtain the money for this.
Allows them to carry out the manufacture or assembly of the MP for sale, supply and export
Also allows them to import the Medicinal product
The holder of the MA is either the manufacturer or the person who orders the product to be made

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13
Q

How long is a marketing authorisation valid for?

A

Up to 5 years initially

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14
Q

What class are new medicines usually?

A

POMs

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15
Q

How long have the manufacturer got to get the product on the market after granting of a marketing authorisation?

A

Must be on market within 3 years of the granting of the marketing authorisation

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16
Q

What four systems are used to register medicines in Europe?

A

Centralised
National
Decentralised
Mutual recognition

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18
Q

In the UK, what body can medicines be registered to?

A

In the UK medicines are registered via the MHRA

This application for a licence will be for a licence only in the UK 

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19
Q

For medicines to gain licence across the EU, who must they apply for a licence via? 

A

Centralised license:
 One single application is made to the EMEA
 One single European Authorisation is granted by EMEA
Also: national for only one country in EU, decentralised, and mutual recognition systems

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20
Q

What medicines will ONLY be licensed via a European Authorisation, so that they are guaranteed to be available to every EU member state?

A

• Gene therapies
• Medicines for HIV/AIDS, cancer, diabetes, Altzheimer’s
• Orphan drugs (medicines for rare diseases, occurring in less
than 5 in 10,000 people)


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21
Q

What three types of products are Marketing Authorisation applications done for?

A

 New active substances 
 Biological and biotechnology products
 Abridged products such as Generics, Existing drugs with new route, form or indication, Existing drugs in new combinations, and ‘well established’ drugs and products

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22
Q

What must every medicinal product dispensed have?

A

Summary of Product Characteristics (SmPC)
Label
PIL

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23
Q

What is a Summary of product characteristics document?

A

A Legal document containing factual information about an MP based on data generated during the development of the product

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24
Q

What must a Summary of Product characteristics document include?

A

 Name, strength and pharmaceutical form.
 Qualitative and quantitative composition
 Clinical particulars
 Pharmacological properties
 Pharmaceutical particulars
 Name of UK MA holder
 Number of UK MA, etc, etc.

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25
Q

Any product being manufactured must have a Marketing authorisation…..

A

Otherwise there would be no point in manufacturing it as you wouldn’t be able to sell it! The MA must be held by the manufacturer or the person ordering the manufacture of the product.

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26
Q

Who is a site of manufacture of Medicinal products inspected by?

A

MHRA Inspectorate 
Site inspected at least every two years
Products need to be manufactured to the standards detailed by the EC guide to Good manufacturing practice

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27
Q

What does a parallel import licence allow?

A

It allows medicinal products with a marketing authorisation to be bought in one European Member State and sold in a another.
The product cant be a vaccine, toxin, blood product, radioactive,or homeopathic.
Product must have a European MA, is a version of a product that hold a UK MA, and have the same therapeutic effect as the UK product. Must have a PIL in English

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28
Q

What does a WHOLESALE DEALERS licence EXCLUDE?

A

Pharmacy supplying to a healthcare professional for administration
to patient
Pharmacy supplying to a patient
Supply by one hospital to another in the same trust
Supply by a hospital pharmacy to a ward for administration to a patient
But it DOES include; sale of a medicinal product to a doctor to give to his patients, and this hasn’t come from a pharmacy

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29
Q

What do phase 1 clinical trials involve?

A

Usually involve healthy people, to try and find out how the medicine works in the body.
Usually less than 100 people

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30
Q

What do phase 2 clinical trials involve?

A

Look out how the drug works in a particular condition

Usually for around several hundred people

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31
Q

What do phase 3 clinical trials involve?

A

Look at how well the medicine works and how safe it is in the general population
Involves hundreds to thousands of people

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32
Q

For a clinical trials application, inspections for standards of ____ and ______ are carried out. A __________ licence is required for clinical trials.

A

Inspections for standards of good clinical practice and good manufacturing practice.
A Manufacturers trials licence is required.

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33
Q

What Is a Manufacturers “Specials” licence?

A

These are required for a manufacturer to Make an UNLICENCED medicinal product.
Inspected by MHRA (like with manufacturers licence)
If doctor chooses to use an UNLICENCED MP, they take responsibility for the efficacy of the product, ie how well it works.
The Licence holder takes responsibility of the the Quality of the product.

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34
Q

What are traditional herbal medicines registered with?

A

Traditional herbal registration (THR) scheme

can on,y be for external, oral or inhalation

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35
Q

For homeopathic medicines, the simplified scheme;

A

Safety and quality demonstrated
No medical claims or indications allowed
Restricted to products for oral & external use
Products must be sufficiently dilute to ensure safety (max 1 part in 10,000 of mother tincture)

36
Q

For homeopathic medicines, the National (UK scheme):

A

 Product can be registered with indications for relief or
treatment of minor symptoms
 Applications supported by data on safety and quality with appropriate labelling
 Evidence that it has been used as a homeopathic treatment in the indication sought

37
Q

Is a marketing authorisation subject to pharmacovilagance?

A

Yes

ie. black triangle drugs, yellow card reporting

38
Q

What replaced most of the medicines act in 2012? Does the medicines act still exist?

A

The human medicines regulations
Regulates everything to with medicines for humans use by licence.
The MA does still exist, eg the registration of retail pharmacies still lies with the Medicines act

39
Q

What is the MHRA?

A

Medicines and healthcare products regulatory agency
An executive agency of the department of health
Their mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe

40
Q

What is a medical device?

A

All products except medicines themselves used in healthcare

Eg dressing,s catheters, contact lenses, IV admin sets

41
Q

Does the human medicines regulations deal with Phamacovilagance? What is this?

A

YES
It’s to do with black triangle drugs, and yellow cards etc
Reporting adverse side effects, monitoring safety of drugs

42
Q

The MHRA is the licensing authority for the ___.

The EMA is the licensing authority for ____.

A

MHRA: UK
EMA: Europe 

43
Q

What is a GSL medicine?

A

A medicinal product covered by authorisation that states it should be available on general sale
A MP is authorised as this if the product can with reasonable safety be sold or supplied otherwise by a pharmacist

44
Q

What is a P medicine?

A

A medicinal product that is not a prescription only medicine (POM) or a medicinal product on general sale, covered by authorisation that states it’s to be available only from a pharmacy, ie an OTC that can only be bought in the pharmacy
Eg eye ointments, vitamin A and D, anthelmintics (drugs used to get rid of worms), enemas

45
Q

Who can appropriately prescribe a POM?

A

A doctor, dentist, supplementary prescriber, nurse IP, pharmacist IP

46
Q

What can a community practitioner nurse prescriber prescribe? (note: this is NOT the same as a Nurse Independent Prescriber!!)

A

Laxatives
Mebendazole
Nystatin

(but remember Nurse IPs can prescribe Any POM!!)

47
Q

What can a optometrist (optician) independent prescriber prescribe?

A

Any POM except CDs and ones for parenteral application (injection)

48
Q

What can an EEA health proffessional prescribe?

A

Any POM, except for CDs

49
Q

What’s an EAG?

A

Expert advisory group

They advise on CHM (commission on human medicines) or BPC

50
Q

What does the British Pharmacopeia contain info on? 

A

Contains info on substances which are or may be used in the practice of medicine or surgery, dentist or midwifery (not vet)
Contains descriptions on the manufacture of medicinal products
Specifies standards for medicinal products.

51
Q

What is the GPhC responsible for?

A

The register of pharmacists, technicians and premises
Disciplining the pharmacy proffession
Sale and supply of POMS and P medicines (a local council is responsible for the sale of GSL medicines)
also control labelling, packaging and advertising, and quality/purity

52
Q

What is a CHM?

A

Commission on Human medicines
8 members minimum
Advise on safety, quality and efficacy of medicinal products
Promote the Collection of info on Adverse Drug Reactions
Report back to Ministers

53
Q

What is the BPC?

A

British Pharmacopeia commission
They prepare the British pharmacopeia 
Prepare compendia
Minimum 8 members

54
Q

What do BPC and CHM have in common?

A

Both are advisory bodies

Both may appoint Expert Advisory groups (EAGs)

55
Q

Is mixing of medicines classified as manufacturing?

A

No

Mixing can be done by a nurse/ pharmacist without a Manufacturing authorisation/ manufacturing licence

56
Q

What is a relevant medicinal product?

A

A medicinal product that is not either:
A registerable Homeopathic product
A Traditional herbal Medicinal product

57
Q

What language must an application for a Marketing authorisation be in?
What must it state?

A

In English
States whether it’s A POM/P/GSL
Must be applied for within EU
Must be signed by applicant

58
Q

How long can it take for a Marketing authorisation to be decided?

A

Can take 210 days for the licensing authority to decide
Once given they’re valid for 5 years
Once granted it can take 3 years to place item in market

59
Q

What are 126a authorisations?

A

Allows medicinal products with no UK MArketing authorisation but authorised in another EEA state to be placed on the market for public health reasons
Ie want public to have quick access to this drug from a diff country, maybe it’s anti cancer or something very significant..?

60
Q

What are borderline products?

A

Applies if the licensing authority Thinks a product without a Marketing authorisation, herbal or homeopathic registration or 126a authorisation is a medicinal product.
If the licensing authority thinks this, then a MA /herbal registration etc is needed

61
Q

What does pharmacovilagance apply to?

A

Marketing authority, herbal, 126a authorised.
The licensing authority of these needs to encourage reporting of ADRs
It is the continuous process of evaluating the risks of a medicinal product. This means suspension/ withdrawal of a product may be possible

62
Q

EEA health professional, what is EEA?

A

European Economic Area

They’re international health care professionals (ie health care professional not from the UK)

63
Q

What are Patient group direction (PGDs)?

A

These are written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment.
(group protocols)

64
Q

It’s illegal to sell/ supply a POM or parenterally administer a POM unless?

A

Unless under direction to do so by an appropriate prescriber eg via a prescription.

65
Q

How long is a POM prescription valid for?

A

Valid for 6 months from Appropriate date on prescription.

66
Q

When can the title”pharmacy” or “chemist “ be used?

A

Only when it is a registered pharmacy
Only when it’s the pharmaceutical department of a hospital or health centre
Implies the person is a registered pharmacist (body corporate/ PLCRPB)

67
Q

HMR definition of a RPB (retail pharmacy business)…

A

A business which includes the retail sale of medicinal products that are not subject to general sale

68
Q

What does PLCRPB stand for?

A

Persons lawfully conducting a Retail Pharmacy business

69
Q

Who can a pharmacy be lawfully conducted by?

A

A pharmacist or partnership where ALL partners are pharmacists
Body corporate (a legal entity such as an association or a company)
The pharmacists representative if pharmacist dies, becomes bankrupt or mentally ill, or if they are the owner of the pharmacy.

70
Q

What are “certain conditions 1” that have to be within a pharmacy premises?

A

Must have a RESPONSIBLE PHARMACIST present

A notice that states the name and registration number of the Responsible pharmacist must be on show.

71
Q

What “certain conditions” must a Body Corporate meet?

A

A body corporate is an association or company,
They Must Employ a Superintendent pharmacist,
They must be a superintendent to only one company at a time
The term chemist can only be used if the Superintendent is a member of the board, must notify GPhc of this.

72
Q

What do Body corporates consist of?

A

Single pharmacy
Small multiple pharmacies- branches managed by pharmacists
Large multiple - with a head office

Remember each pharmacy must have a responsible pharmacist each

73
Q

The GPhC are responsible for registering Pharmacies, or renewing registrations. What must the pharmacy be able to do if they want to get on this register?

A

Sell P medicines
Supply P or POMs against prescriptions
Supply P or POMs against prescriptions written by Vets

74
Q

What happens if a pharmacist needs to obtain small quantities of a MP from another pharmacist to meet a patients individual needs? Do they need a wholesale dealers license?

A 
No they don't,
As long as:
It only happens occasionally 
The quantity needed is small
The supply is made on a not-for-profit basis
75
Q

Can a GPhC inspector enter a pharmacy at any time?

A

Yes especially if it’s a registered pharmacy with the GPhC
If its private then they should be given 24 hours notice
They do this to enforce regulations of sale and supply of P and POM medicines
Inspector should show ID

76
Q

When a responsible pharmacist is in charge of a pharmacy, a responsible pharmacist record needs to be filled out. What does this include?

A

name and registration number of the responsible pharmacist
date and time they became the responsible pharmacist
date and time they finished being the responsible pharmacist
date and time any absence began

It is the pharmacy Owners responsibility that this record is kept and not chucked out for at least 5 years!

77
Q

How long may a responsible pharmacist be absent from a pharmacy for in 24 hours?

A

Only 2 hours every 24 hours
May delegate roles to trained staff during their absence
Whilst gone the pharmacist must remain contactable 

78
Q

What are staff able to “can and can’t do” in the absence of a pharmacist?

A

They can sell GSL medicines, but only OTC
They can Take in prescriptions off patients
But they CAN’T:
Supply any GSL against a prescription
Sell any P medicines
Hand out any Pre bagged or checked medicines to patients/ delivery drivers 

79
Q

What are the GPhCs regulations on CPD entries?

A

Must make at least 9 records a year
Minimum of 3 reflective entries
Must be able to submit these to the GPhC on request

80
Q

What do the GPhC insist must be in place when selling medicines?

A

SOPs, protocols to be followed when a medicines supplied, or when advice on treatment is requested
All medicines and counter staff must have taken or be undertaking an approved course of training.

81
Q

Part 10 of the Humans medicines regulation Is about the Exceptions to the requirement for a Marketing Authorisation. What does this allow?

A

Allows for unlicensed medicinal products to be supplied with certain provisions
Records of this supply must be kept for 5 YEARS!
A product used in response to:
pathogens or toxins which may harm human beings,
and also to chemicals and nuclear radiation
Can be supplied without an MA
Remember this last point!!

82
Q

What product types does pharmacovilagance (recording of bad reactions) apply to?

A

Marketing Authorisation Products
herbals 
126a authorised products

83
Q

What do the British Pharmacopeia Comission (BPC) do?

A

Publish the BP
Prepare the Compendia
Lists names of drugs and their monographs

84
Q

What can water for injections also be used for now other than just injections when sold/ supplied in a pharmacy? 

A

Inflate balloons on catheters 

85
Q

What has a recent change in the humans medicines regulation now mean pharmacists can do when labelling?

A

Can possibly change directions on a prescription if they’re considered inappropriate and put the improved directions on the label

86
Q

A lot of OTC products have had their statutory warnings removed, apart from those containing _______

A

Paracetamol

“Do not take anything else containing paracetamol while taking this medicine…”

87
Q

What does NCSO stand for?

A

No cheaper stock available/ obtainable

Pharmacy flashcards (52 decks)

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