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Professional Practice 1 > Law > Flashcards

Law Flashcards

1
Q

What is law?

A

The regulation of human affairs and human relationships.

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2
Q

Name the categories of English law

A 
1 criminal law 
2 civil law 
3 administrative law 
4 judicial precedent (common law)
5 EU law
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3
Q

What’s the difference between criminal and civil law?

A

Criminal law focuses on the relationship between an individual and the state, public action of apprehension and disposition. Cases are brought to criminal court (magistrate court, crown court)

whereas civil law focuses on the relationship between individuals, actions are taken privately including compensation and restitution of wrongdoers. Civil court (county court) jury

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4
Q

What’s tort? Examples

A

Wrongful act for which someone can be sued for damages (inc. acts as libel trespass injury done to someone) in a civil law court.

Mis-diagnosis
Inappropriate prescribing
Dispensing error

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5
Q

EU institutions that dealing with law making

A

The council of minister

The commission

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6
Q

Who’s the uk’s EU commissioner?

A

The European Parliament
The economic and social committee
Court of justice of EU

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7
Q

What are the categories of EU law?

A

Regulations
Directives
Decisions
Recommendations

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8
Q

What are the current uk pharmaceutical legislation?

A 
Medicine act 1968
Misuse of drugs act 1971
Poisons act 1972
Health act 2006
Human medicines regulations 2012
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9
Q

What’s PMR?

A

Patient medication record

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10
Q

What’s the procedure of parliamentary in enacting legislation

A

Consultation -consultative document (green,white papers)- sponsored bill- bill drafted into House of Commons- Bill passed to House of Lords for reading- final reading by House of Commons -royal assent (agree)- statute book

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11
Q

What are the advantages of delegated registration?

A

1) save parliamentary time
2) greater flexibility
3) faster of action in an emergency
4) greater use of consultation

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12
Q

What’s delegated legislation? (Enabling act)

A

Minister has the power to alter laws without going through the whole process of making new laws by the parliament

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13
Q

What’s judicial precedent

A

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

Judges can manipulate the common law without waiting for parliament to enact legislation.

Judges can be overruled.

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14
Q

What’s green paper?

A

Consultative documents (what they might do）

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15
Q

Whats white paper?

A

Firm proposal (what they will do)

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16
Q

What does the council of minister do?

A

Decision making body of EU
Minister appointed by member states
President change every 6 months

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17
Q

What’s the role of commission

A

Implementation of treaties.
25 of commissioners appointed for 5 year period.
Each has an area of responsibility

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18
Q

What’s the role of European Parliament?

A

Give opinions on commission proposals

Control of EU budget

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19
Q

What’s role of economic and social committee

A

representative of Eco& social groups in member states

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20
Q

What’s the role of the court of justice of EU

A

The European ensures that EU laws are propelled implemented in member states

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21
Q

What’s regulation (from categories of EU law)

A

Become law in member states no need to change or further implementation

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22
Q

What’s directives (from EU law categories)

What’s decision?

What’s recommendations

A

Binding on member states (say France taking that number of refugee)
Must be enacted by national legislation

Binding on individuals or institutions to which they are addressed

Advisory statements

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23
Q

Current UK pharmaceutical legislation

Medicine act -statutory instrument (SI)

Misuse of drug act

Poison act

Health act
-2ndary law pharmacy order establish GPhC

Human medicines regulation

A

1968

1971

1972

2006 (2010)

14th August 2012

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24
Q

What are the healthcare provision in the uk?

A

NHS AND private

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25
Q

Characters of NHS healthcare

A

Provided by government
Available to all
Funded by taxation - national insurance

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26
Q

Character of private healthcare?

A

Provided by businesses and individual practitioners

Available to all who pay

Funded by patient- insurance

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27
Q

4 Provisions of care

A

Both NHS, private
Primary care - GPs, dentists, pharmacists, optometrists

Secondary care- care provided by medical specialist dental specialist and others who do NOT have contact with patients
Cardiologist, urologist.

Tertiary care - specialised consultative health care eg cancer treatment, plastic surgery

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28
Q

What’s the year of NAtional health insurance act come out

A

1911

Able to dispense with provision of panrmacist ss

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29
Q

NHS established when?

A

5th July 1948

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30
Q

NHS act in what year replaced what act?

A

Nhs act 1977 repealed the whole of 1946 act (when NHS act is created) actual organisation created in 1948 July 5th

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31
Q

What year is the therapeutic substances act (TSA)

A

1925

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32
Q

TSA provided a form of licensing which includes:

A

Inspection of manufacturing sites
Personnel suitability
Record keeping
Labelling requirements introduced

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33
Q

What year did thalidomide tragedy happen?

A

1961
Marketed as sleeping tablet and antiemetic
Prescribed for morning sickness of pregnant woman
But increased incidence of new born babies with phocomelia (hand and feet attached to body)

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34
Q

What’s Pharmacovigilance?

A

The practice of monitoring the effect of medical drugs after they been licensed for use, especially in order to identify and evaluated perviously unreported adverse effects

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35
Q

Whats the medicine act 1968 is replaced by?

A

Human medicines regulations 2012 14th August

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36
Q

What does human medicines regulations 2012 regulate?

A 
MDI SLP
Manufacturing 
Distribution 
Importation 
Sales and supply
Labelling and advertising
Pharmacovigilance
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37
Q

What’s the procedure of parliamentary in enacting legislation

A

Consultation -consultative document- sponsored bill- bill drafted into House of Commons- Bill passed to House of Lords for reading -royal assent - statute book

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38
Q

What are the advantages of delegated registration?

A

1) save parliamentary time
2) greater flexibility
3) faster of action in an emergency
4) greater use of consultation

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39
Q

What’s delegated legislation? (Enabling act)

A

Minister has the power to alter laws without going through the whole process of making new laws by the parliament

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40
Q

What’s judicial precedent

A

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

Judges can manipulate the common law without waiting for parliament to enact legislation.

Judges can be overruled.

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41
Q

What’s green paper?

A

Consultative documents (what they might do）

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42
Q

Whats white paper?

A

Firm proposal (what they will do)

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43
Q

What does the council of minister do?

A

Decision making body of EU
Minister appointed by member states
President change every 6 months

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44
Q

What’s the role of commission

A

Implementation of treaties.
25 of commissioners appointed for 5 period.
Each has an area of responsibility

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3
4
5
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45
Q

What’s the role of European Parliament?

A

Give opinions on commission proposals

Control of EU budget

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46
Q

What’s role of economic and social committee

A

representative of Eco& social groups in member states

How well did you know this?
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47
Q

What’s the role of the court of justice of EU

A

The European ensures that EU laws are propelled implemented in member states

How well did you know this?
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48
Q

What’s regulation (from categories of EU law)

A

Become law in member states no need to change or further implementation

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49
Q

What’s directives (from EU law categories)

What’s decision?

What’s recommendations

A

Binding on member states (say France taking that number of refugee)
Must be enacted by national legislation

Binding on individuals or institutions to which they are addressed

Advisory statements

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50
Q

Current UK pharmaceutical legislation

Medicine act -statutory instrument (SI)

Misuse of drug act

Poison act

Health act
-2ndary law pharmacy order establish GPhC

Human medicines regulation

A

1968

1971

1972

2006 (2010)

14th August 2012

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
51
Q

What are the healthcare provision in the uk?

A

NHS AND private

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
52
Q

Characters of NHS healthcare

A

Provided by government
Available to all
Funded by taxation - national insurance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
53
Q

Character of private healthcare?

A

Provided by businesses and individual practitioners

Available to all who pay

Funded by patient- insurance

How well did you know this?
1
Not at all
2
3
4
5
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54
Q

4 Provisions of care

A

Both NHS, private
Primary care - GPs, dentists, pharmacists, optometrists

Secondary care- care provided by medical specialist dental specialist and others who do NOT have contact with patients
Cardiologist, urologist.

Tertiary care - specialised consultative health care eg cancer treatment, plastic surgery

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
55
Q

What’s the year of NAtional health insurance act come out

A

1911

Able to dispense with provision of panrmacist ss

How well did you know this?
1
Not at all
2
3
4
5
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56
Q

NHS established when?

A

5th July 1948

57
Q

NHS act in what year replaced what act?

A

Nhs act 1977 repealed the whole of 1946 act (when NHS act is created) actual organisation created in 1948 July 5th

58
Q

What year is the therapeutic substances act (TSA)

A

1925

59
Q

TSA provided a form of licensing which includes:

A

Inspection of manufacturing sites
Personnel suitability
Record keeping
Labelling requirements introduced

60
Q

What year did thalidomide tragedy happen?

A

1961
Marketed as sleeping tablet and antiemetic
Prescribed for morning sickness of pregnant woman
But increased incidence of new born babies with phocomelia (hand and feet attached to body)

61
Q

What’s Pharmacovigilance?

A

The practice of monitoring the effect of medical drugs after they been licensed for use, especially in order to identify and evaluated perviously unreported adverse effects

62
Q

Whats the medicine act 1968 is replaced by?

A

Human medicines regulations 2012 14th August

63
Q

What does human medicines regulations 2012 regulate?

A 
MDI SLP
Manufacturing 
Distribution 
Importation 
Sales and supply
Labelling and advertising
Pharmacovigilance  
Preparation of BP & other books of standards
64
Q

Why did we need the medicine act?

A

The medicine act 1968

Because most medicines were regulated as poisons with no control over the marketing of new medicines

65
Q

When does the Committee on safety of drug established?

A

1963

66
Q

What’s the purpose of Committee on safety of drug?

A

Voluntary agreement by minister of health to look at the safety of NEW drugs.
It’s consist of scientist etc
Products already on the market were granted a provisional LICENCE OF RIGHT

67
Q

What does the Medicine act 1968 regulate?

A

MDI
Manufacture
Distribution
Importation

68
Q

How did the medicine act regulate MDI?

A

Did so by licence and enforced by MHRA

Advised by Medicines commission

69
Q

Since 1968, many more rules and legislation made under medicines act, what’s the secondary legislation?

A

Statutory instrument SI

70
Q

How does the HMR 2012 achieve its regulations (MDI SLP)?

A

Does so by licence (licensing authority is either or both the Ministers [secretary of State and the Minister of Health, social services and public safety] –>MHRA (licensing in UK based in London) EMA (European medicines agency-for Europe based in London)
GPhC
“Drug authority” local council

71
Q

What part of Medicines act still apply?

A

Registration of retail pharmacies

72
Q

What are the main aims of HMR?

A

QSE

Maintain Quality/ safety/ efficacy of a medicinal product

73
Q

What are the special provisions for pharmacies

A

Exempts the need for manufacturing licence when extemporaneous (making up drugs) dispensing

74
Q

What are the classifications of medicinal products?

A

GSL
POM
P (pharmacy only)

75
Q

What’s the definition of MP-medicinal product?

A

Any substance or combination of substances presented as having properties of preventing or treating disease in human beings

Or substance that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action or making a medical diagnosis.

76
Q

Who is an appropriate practitioner in relation to a POM

A

1) A doc
2) A dentist
3) A supplementary prescriber
4) A nurse independent prescriber
5) A pharmacist independent prescriber

Exceptions:
6) community practitioner nurse prescriber
7) optometrist independent prescriber
(Any POM for ocular, but not CDs)
8) EEA health professional (European economic area) any Uk MA POM not CD sch1,2,3

77
Q

What is MHRA in relation to department of health?

A

Executive agency of department of health

78
Q

What’s the mission of MHRA?

A

Is to enhance and safeguard the health of public by ensuring that medicines and medical devices work, and are acceptably safe.

responsible for
Regulation of medicines (QSE)
Medical devices and equipment used in healthcare
Investigate harmful events (yellow card scheme)
Look after blood and blood products

79
Q

What do we mean by medical devices?

A

All products, expect medicines, used in healthcare for the diagnosis, prevention, monitoring, or treatment of illness or disability

Eg. Urine test stripes, condoms, dressing, inhaler, contact lenses

80
Q

Part 2 of the HMR is administration, this allows for continuation of

A

Advisory bodies:
CHM (commission on human medicines)
BPC (British pharmacopoeia commission)

EAG (expert advisory group)

81
Q

What are the functions of CHM?

A

Advise the appropriate minister about -duty imposed by the HMR 2012 or clinical trails regulations CTR
-generally advise about QSE of medicinal products
- promote collection and investigation of ADR’s
(Yellow card)
- the CHM provides INDEPENDENT expert advice to the MHRA

Advising on applications for both national and European MA

Advising on the need for risk management plans for new medicines

Advising on the impact of new safety issues on the balance of risks and benefits of licensed medicines eg add warnings, withdraw drugs

Advising the license authorities on changes of legal status of MA

82
Q

What’s MA?

A

An application submitted by a drug manufacturer seeking permission to bring a newly developed drug to the MARKET

83
Q

Structure of the CHM…

A 
Advised by EAG's
Minimum of 8 members
-chair appointed by ministers 
Proactively give info to minister 
Advise ministers when asked
Meet once a month
84
Q

Enforcement- what does GPhC responsible for

A

RDRS
Registration of pharmacists, Pharmacy premises and technicians (pharmacy order 2010)
Disciplinary control of pharmaceutical profession
Restriction of titles (med act 1968)
Sale and supply of MPs

Also quality/ purity control of MPs for sale
L,P,A

85
Q

Enforcement- What does the local council responsible for

A

Sale of GSL med

86
Q

Enforcement - what does ministers respoible for?

A

LPH

Licensing - MHRA,EMA
Practitioners premises
Hosptial

87
Q

Describe the role and the structure of EAG

A

Role: undergo detailed examination of issues prior to referral to CHM and BPC- new med licensing, risk management plan

Structure: chair /org appointed by CHM BPC
Minister can instruct to appoint
Member of EAG DONT need to be men of CHM
Independent and transparent

88
Q

What are the licences a MP must have?

A

1) MA
2) homeopathic certificate of registration
3) traditional herbal registration
4) article 126a authorisation

89
Q

Which body acts as the “licensing authority” Inthe UK?

A

Secretary of State

90
Q

The GPhC is responsible for

A

RDRS
REGISTER for pharmacy pharmacists pharmacy technician

Disciplinary control of pharmaceutical profession

Restructuring of titles

Sale and supply of MPS (except GSL

91
Q

What’s restriction on titles?

A 
No person shall take the title of pharmacist 
Member of PS Northern Ireland 
Fellow of PS Northern Ireland 
Pharmaceutical chemist 
Phaermaceutist 
C+D
Druggist 
Dispensing c+d
Member/ fellow RPSGB
Unless they are REGISTERED
92
Q

Define A retail pharmacy business RPB?

A

A business includes the retail sale mp that are not GSL

93
Q

Who can legally operates a retail pharmacy? (Pharmacy order 2010)

A

PLCRPB (person lawfully conducting a retail pharmacy business)
Pharmacist & partnership
Body corporate (company)
Pharmacist representatives

94
Q

What are the requirement for registering a pharmacy

A

If service includes:

Sale of P
Supply of P or POM against prescription
Supply of P or POM against vet RX for animal under the ‘cascade’

Registration fee paid
Advanced services like consultation

95
Q

Pharmacy order 2010 includes:

A

Establish the GPhC
Regulates PP&PT
Registration (pharmacy) renewed annually
Fees paid

96
Q

What are the powers of GPhC under HMR 2012

A

P

97
Q

What’s a PLCRPB

A

Persons lawfully conducting a retail pharmacy business

98
Q

RP records must include?

A

Name and registration no. Of RP
Date and time that they became RP
Date and time that they ceased to be rp
Date and time any absence began and ceased

99
Q

How long does pharmacy owner need to keep the Responsible pharmacist record for?

A

5 years

100
Q

What are The 3 GPhC regulation of the pharmacy profession (displinary)

A

Fitness to practice role of GPhC
(Overseen by the professional standards authority for health and social care)

GPhC committes- the investigating committee

  • fitness to practice committee
  • appeals to high court

Restoration to register after removal

101
Q

What did the equality act come out?

A

Oct 2010

102
Q

What are the 9 protected characteristics covered by the equality act 2010?

A

Age, disability, sex, sexual orientation, gender reassignment, race, religions, maternity and pregnancy, marriage

103
Q

What’s the name of the white paper that split the RPSGB in 2010?

A

Trust, assurance and safety- the regulation of health professionals in the 21st century’

104
Q

When did the GPhC become a legal entity

A

18th March 2010

105
Q

How many council member/ employees/ registrants are there in the GPhC?

A

14 council members
7 lay (inc chair)
7 registrants -6 pharmacist, 1 pharmacy technician

106
Q

What’s the mission of GPhC?

A

To protect promote and maintain the health, safety and wellbeing of mementos or public to uphold standards and public trust in pharmacy in England Scotland and Wales

107
Q

What are the 6 GPhC values?

A
  1. Be focused on improvement
  2. Be responsive to change
  3. Develop policies that are inclusive
  4. Be independent and fair
  5. Demonstrate respect
  6. Ensure regulation is proportionate
108
Q

When did the GPhC become a legal entity

A

18th March 2010

109
Q

How many council member/ employees/ registrants are there in the GPhC?

A

14 council members
7 lay (inc chair)
7 registrants -6 pharmacist, 1 pharmacy technician

110
Q

What’s the mission of GPhC?

A

To protect promote and maintain the health, safety and wellbeing of mementos or public to uphold standards and public trust in pharmacy in England Scotland and Wales

111
Q

What are the 6 GPhC values?

A
  1. Be focused on improvement
  2. Be responsive to change
  3. Develop policies that are inclusive
  4. Be independent and fair
  5. Demonstrate respect
  6. Ensure regulation is proportionate
112
Q

Definition of fraud

A

A deception deliberately practiced to secure unfair or u lawfully gain

113
Q

How long is the time limit for starting MPharm degree to applying to join GPhC register pharmacist

A

8 years

114
Q

What does charter must have, must not have? (2004)

A

Enabling, empowering, a legal document, robust and flexible, last for 30-50 years

Detailed
Strategy n policy documents

115
Q

RPS membership categories

A 
Member 
Fellow
Associate (pre- reg)
Student 
Pharmaceutical scientist
116
Q

What are the 4 part of organisation RPS?

A

The assembly
National boards
Local practice forum (LPF)
Membership catagrories

117
Q

What shapes patient centred professionalism? 11 themes

A 
Safety
Prof characterise 
Patient characteristics 
Condifidentiality 
Relationship with patient
Traning 
Accessibility 
Serivices
Environment 
Changing prof roles 
Prof pressure
118
Q

What year did medicinal product (RX by nurses) act came out?

A

1992

119
Q

What year did health and social care act came out

A

2001

120
Q

What are the two reports related to non medical prescribing? NMP

A

The cumberledge report 1986

The crown report 1989

121
Q

PhIP (pharmacist independent prescriber) can work as ward pharmacists only if..?

A

Prescribing interventions are actioneD by a FY1/FY2 doctor

122
Q

What does NPC framework stands for

A

National prescribing centre

123
Q

What can A nurse/ pharmacist non medical IP prescribe?

A

Any licensed medicines inc CD sch 2,3,4,5

124
Q

How can a supplementary prescriber SP perscribe?

A

Can only prescribe in accordance with a written patient specific clinical management plan CMP that is signed by doc or dentist
Can prescribe any med n CD

125
Q

What are the secondary legistlation of misuse of drug act 1971?

A

Orders: misuse of drug act order 1973
Reg: safe custody reg 1973
Rules: misuse of drug tribunal rule 1974

126
Q

What’s a clinical governance?

A

A systematic approach to ensure patient get excellent and safe clinical care.

127
Q

Name the 7 pillars of clinical governance?

A 
1 patient involvement
2 staffing
3 clinical audit 
4 clinical risk and management plan
5 clinical effectiveness 
6 education n CPd
7 use of info
128
Q

What year did Francis report come out

Keogh review n Berwick report

A

2013

2014

129
Q

Creatinine clearance can be determined using?

A

Cockcroft gault equation

140- age) x BW / C
X 1.23 male
X 1.04 female

130
Q

When did register of pharmacy technician become mandatory? Within the GPhC enforcement

A

June 2011

131
Q

How long does it take for MHRA to issuee clinical trial authorisation CTA, Ma, ml, WDL?

A

CTA 60 days
Ma 7 months, 1 months to notify
Ml 90 days
WDL 90 days

132
Q

CTA is introduced when?

A

2004 May

133
Q

What licence is needed for CTA?

A

Manufacturers trials licence

134
Q

When did register of pharmacy technician become mandatory? Within the GPhC enforcement

A

June 2011

135
Q

How long does it take for MHRA to issuee clinical trial authorisation CTA, Ma, ml, WDL?

A

CTA 60 days
Ma 7 months, 1 months to notify
Ml 90 days
WDL 90 days

136
Q

CTA is introduced when?

A

2004 May

137
Q

What licence is needed for CTA?

A

Manufacturers trials licence

138
Q

The requirement for grating of ma

A 
1 validation (completed form)
2 submission of document (fees)
3 assessment (QSE, CHM and EAG advises to license or refuse)
4 applicant can appeal

Professional Practice 1 (8 decks)

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