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Professional Practice 1 > Law > Flashcards

Law Flashcards

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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
Characters of NHS healthcare
Provided by government Available to all Funded by taxation - national insurance
26
Character of private healthcare?
Provided by businesses and individual practitioners Available to all who pay Funded by patient- insurance
27
4 Provisions of care
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
28
What's the year of NAtional health insurance act come out
1911 | Able to dispense with provision of panrmacist ss
29
NHS established when?
5th July 1948
30
NHS act in what year replaced what act?
Nhs act 1977 repealed the whole of 1946 act (when NHS act is created) actual organisation created in 1948 July 5th
31
What year is the therapeutic substances act (TSA)
1925
32
TSA provided a form of licensing which includes:
Inspection of manufacturing sites Personnel suitability Record keeping Labelling requirements introduced
33
What year did thalidomide tragedy happen?
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)
34
What's Pharmacovigilance?
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
35
Whats the medicine act 1968 is replaced by?
Human medicines regulations 2012 14th August
36
What does human medicines regulations 2012 regulate?
``` MDI SLP Manufacturing Distribution Importation Sales and supply Labelling and advertising Pharmacovigilance ```
37
What's the procedure of parliamentary in enacting legislation
Consultation -consultative document- sponsored bill- bill drafted into House of Commons- Bill passed to House of Lords for reading -royal assent - statute book
38
What are the advantages of delegated registration?
1) save parliamentary time 2) greater flexibility 3) faster of action in an emergency 4) greater use of consultation
39
What's delegated legislation? (Enabling act)
Minister has the power to alter laws without going through the whole process of making new laws by the parliament
40
What's judicial precedent
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.
41
What's green paper?
Consultative documents (what they might do）
42
Whats white paper?
Firm proposal (what they will do)
43
What does the council of minister do?
Decision making body of EU Minister appointed by member states President change every 6 months
44
What's the role of commission
Implementation of treaties. 25 of commissioners appointed for 5 period. Each has an area of responsibility
45
What's the role of European Parliament?
Give opinions on commission proposals | Control of EU budget
46
What's role of economic and social committee
representative of Eco& social groups in member states
47
What's the role of the court of justice of EU
The European ensures that EU laws are propelled implemented in member states
48
What's regulation (from categories of EU law)
Become law in member states no need to change or further implementation
49
What's directives (from EU law categories) What's decision? What's recommendations
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
50
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
1968 1971 1972 2006 (2010) 14th August 2012
51
What are the healthcare provision in the uk?
NHS AND private
52
Characters of NHS healthcare
Provided by government Available to all Funded by taxation - national insurance
53
Character of private healthcare?
Provided by businesses and individual practitioners Available to all who pay Funded by patient- insurance
54
4 Provisions of care
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
55
What's the year of NAtional health insurance act come out
1911 | Able to dispense with provision of panrmacist ss
56
NHS established when?
5th July 1948
57
NHS act in what year replaced what act?
Nhs act 1977 repealed the whole of 1946 act (when NHS act is created) actual organisation created in 1948 July 5th
58
What year is the therapeutic substances act (TSA)
1925
59
TSA provided a form of licensing which includes:
Inspection of manufacturing sites Personnel suitability Record keeping Labelling requirements introduced
60
What year did thalidomide tragedy happen?
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
What's Pharmacovigilance?
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
Whats the medicine act 1968 is replaced by?
Human medicines regulations 2012 14th August
63
What does human medicines regulations 2012 regulate?
``` MDI SLP Manufacturing Distribution Importation Sales and supply Labelling and advertising Pharmacovigilance Preparation of BP & other books of standards ```
64
Why did we need the medicine act?
The medicine act 1968 | Because most medicines were regulated as poisons with no control over the marketing of new medicines
65
When does the Committee on safety of drug established?
1963
66
What's the purpose of Committee on safety of drug?
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
What does the Medicine act 1968 regulate?
MDI Manufacture Distribution Importation
68
How did the medicine act regulate MDI?
Did so by licence and enforced by MHRA | Advised by Medicines commission
69
Since 1968, many more rules and legislation made under medicines act, what's the secondary legislation?
Statutory instrument SI
70
How does the HMR 2012 achieve its regulations (MDI SLP)?
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
What part of Medicines act still apply?
Registration of retail pharmacies
72
What are the main aims of HMR?
QSE | Maintain Quality/ safety/ efficacy of a medicinal product
73
What are the special provisions for pharmacies
Exempts the need for manufacturing licence when extemporaneous (making up drugs) dispensing
74
What are the classifications of medicinal products?
GSL POM P (pharmacy only)
75
What's the definition of MP-medicinal product?
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
Who is an appropriate practitioner in relation to a POM
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
What is MHRA in relation to department of health?
Executive agency of department of health
78
What's the mission of MHRA?
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
What do we mean by medical devices?
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
Part 2 of the HMR is administration, this allows for continuation of
Advisory bodies: CHM (commission on human medicines) BPC (British pharmacopoeia commission) EAG (expert advisory group)
81
What are the functions of CHM?
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
What's MA?
An application submitted by a drug manufacturer seeking permission to bring a newly developed drug to the MARKET
83
Structure of the CHM...
``` 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
Enforcement- what does GPhC responsible for
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
Enforcement- What does the local council responsible for
Sale of GSL med
86
Enforcement - what does ministers respoible for?
LPH Licensing - MHRA,EMA Practitioners premises Hosptial
87
Describe the role and the structure of EAG
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
What are the licences a MP must have?
1) MA 2) homeopathic certificate of registration 3) traditional herbal registration 4) article 126a authorisation
89
Which body acts as the "licensing authority" Inthe UK?
Secretary of State
90
The GPhC is responsible for
RDRS REGISTER for pharmacy pharmacists pharmacy technician Disciplinary control of pharmaceutical profession Restructuring of titles Sale and supply of MPS (except GSL
91
What's restriction on titles?
``` 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
Define A retail pharmacy business RPB?
A business includes the retail sale mp that are not GSL
93
Who can legally operates a retail pharmacy? (Pharmacy order 2010)
PLCRPB (person lawfully conducting a retail pharmacy business) Pharmacist & partnership Body corporate (company) Pharmacist representatives
94
What are the requirement for registering a pharmacy
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
Pharmacy order 2010 includes:
Establish the GPhC Regulates PP&PT Registration (pharmacy) renewed annually Fees paid
96
What are the powers of GPhC under HMR 2012
P
97
What's a PLCRPB
Persons lawfully conducting a retail pharmacy business
98
RP records must include?
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
How long does pharmacy owner need to keep the Responsible pharmacist record for?
5 years
100
What are The 3 GPhC regulation of the pharmacy profession (displinary)
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
What did the equality act come out?
Oct 2010
102
What are the 9 protected characteristics covered by the equality act 2010?
Age, disability, sex, sexual orientation, gender reassignment, race, religions, maternity and pregnancy, marriage
103
What's the name of the white paper that split the RPSGB in 2010?
Trust, assurance and safety- the regulation of health professionals in the 21st century'
104
When did the GPhC become a legal entity
18th March 2010
105
How many council member/ employees/ registrants are there in the GPhC?
14 council members 7 lay (inc chair) 7 registrants -6 pharmacist, 1 pharmacy technician
106
What's the mission of GPhC?
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
What are the 6 GPhC values?
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
When did the GPhC become a legal entity
18th March 2010
109
How many council member/ employees/ registrants are there in the GPhC?
14 council members 7 lay (inc chair) 7 registrants -6 pharmacist, 1 pharmacy technician
110
What's the mission of GPhC?
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
What are the 6 GPhC values?
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
Definition of fraud
A deception deliberately practiced to secure unfair or u lawfully gain
113
How long is the time limit for starting MPharm degree to applying to join GPhC register pharmacist
8 years
114
What does charter must have, must not have? (2004)
Enabling, empowering, a legal document, robust and flexible, last for 30-50 years Detailed Strategy n policy documents
115
RPS membership categories
``` Member Fellow Associate (pre- reg) Student Pharmaceutical scientist ```
116
What are the 4 part of organisation RPS?
The assembly National boards Local practice forum (LPF) Membership catagrories
117
What shapes patient centred professionalism? 11 themes
``` Safety Prof characterise Patient characteristics Condifidentiality Relationship with patient Traning Accessibility Serivices Environment Changing prof roles Prof pressure ```
118
What year did medicinal product (RX by nurses) act came out?
1992
119
What year did health and social care act came out
2001
120
What are the two reports related to non medical prescribing? NMP
The cumberledge report 1986 | The crown report 1989
121
PhIP (pharmacist independent prescriber) can work as ward pharmacists only if..?
Prescribing interventions are actioneD by a FY1/FY2 doctor
122
What does NPC framework stands for
National prescribing centre
123
What can A nurse/ pharmacist non medical IP prescribe?
Any licensed medicines inc CD sch 2,3,4,5
124
How can a supplementary prescriber SP perscribe?
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
What are the secondary legistlation of misuse of drug act 1971?
Orders: misuse of drug act order 1973 Reg: safe custody reg 1973 Rules: misuse of drug tribunal rule 1974
126
What's a clinical governance?
A systematic approach to ensure patient get excellent and safe clinical care.
127
Name the 7 pillars of clinical governance?
``` 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
What year did Francis report come out | Keogh review n Berwick report
2013 | 2014
129
Creatinine clearance can be determined using?
Cockcroft gault equation 140- age) x BW / C X 1.23 male X 1.04 female
130
When did register of pharmacy technician become mandatory? Within the GPhC enforcement
June 2011
131
How long does it take for MHRA to issuee clinical trial authorisation CTA, Ma, ml, WDL?
CTA 60 days Ma 7 months, 1 months to notify Ml 90 days WDL 90 days
132
CTA is introduced when?
2004 May
133
What licence is needed for CTA?
Manufacturers trials licence
134
When did register of pharmacy technician become mandatory? Within the GPhC enforcement
June 2011
135
How long does it take for MHRA to issuee clinical trial authorisation CTA, Ma, ml, WDL?
CTA 60 days Ma 7 months, 1 months to notify Ml 90 days WDL 90 days
136
CTA is introduced when?
2004 May
137
What licence is needed for CTA?
Manufacturers trials licence
138
The requirement for grating of ma
``` 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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