Law Flashcards
What is law?
The regulation of human affairs and human relationships.
Name the categories of English law
1 criminal law 2 civil law 3 administrative law 4 judicial precedent (common law) 5 EU law
What’s the difference between criminal and civil law?
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
What’s tort? Examples
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
EU institutions that dealing with law making
The council of minister
The commission
Who’s the uk’s EU commissioner?
The European Parliament
The economic and social committee
Court of justice of EU
What are the categories of EU law?
Regulations
Directives
Decisions
Recommendations
What are the current uk pharmaceutical legislation?
Medicine act 1968 Misuse of drugs act 1971 Poisons act 1972 Health act 2006 Human medicines regulations 2012
What’s PMR?
Patient medication record
What’s the procedure of parliamentary in enacting legislation
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
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
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
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.
What’s green paper?
Consultative documents (what they might do）
Whats white paper?
Firm proposal (what they will do)
What does the council of minister do?
Decision making body of EU
Minister appointed by member states
President change every 6 months
What’s the role of commission
Implementation of treaties.
25 of commissioners appointed for 5 year period.
Each has an area of responsibility
What’s the role of European Parliament?
Give opinions on commission proposals
Control of EU budget
What’s role of economic and social committee
representative of Eco& social groups in member states
What’s the role of the court of justice of EU
The European ensures that EU laws are propelled implemented in member states
What’s regulation (from categories of EU law)
Become law in member states no need to change or further implementation
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
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
What are the healthcare provision in the uk?
NHS AND private
Characters of NHS healthcare
Provided by government
Available to all
Funded by taxation - national insurance
Character of private healthcare?
Provided by businesses and individual practitioners
Available to all who pay
Funded by patient- insurance
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
What’s the year of NAtional health insurance act come out
1911
Able to dispense with provision of panrmacist ss
NHS established when?
5th July 1948
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
What year is the therapeutic substances act (TSA)
1925
TSA provided a form of licensing which includes:
Inspection of manufacturing sites
Personnel suitability
Record keeping
Labelling requirements introduced
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)
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
Whats the medicine act 1968 is replaced by?
Human medicines regulations 2012 14th August
What does human medicines regulations 2012 regulate?
MDI SLP Manufacturing Distribution Importation Sales and supply Labelling and advertising Pharmacovigilance
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
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
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
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.
What’s green paper?
Consultative documents (what they might do）
Whats white paper?
Firm proposal (what they will do)
What does the council of minister do?
Decision making body of EU
Minister appointed by member states
President change every 6 months
What’s the role of commission
Implementation of treaties.
25 of commissioners appointed for 5 period.
Each has an area of responsibility
What’s the role of European Parliament?
Give opinions on commission proposals
Control of EU budget
What’s role of economic and social committee
representative of Eco& social groups in member states
What’s the role of the court of justice of EU
The European ensures that EU laws are propelled implemented in member states
What’s regulation (from categories of EU law)
Become law in member states no need to change or further implementation
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
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
What are the healthcare provision in the uk?
NHS AND private
Characters of NHS healthcare
Provided by government
Available to all
Funded by taxation - national insurance
Character of private healthcare?
Provided by businesses and individual practitioners
Available to all who pay
Funded by patient- insurance
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
What’s the year of NAtional health insurance act come out
1911
Able to dispense with provision of panrmacist ss
NHS established when?
5th July 1948
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
What year is the therapeutic substances act (TSA)
1925
TSA provided a form of licensing which includes:
Inspection of manufacturing sites
Personnel suitability
Record keeping
Labelling requirements introduced
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)
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
Whats the medicine act 1968 is replaced by?
Human medicines regulations 2012 14th August
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
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
When does the Committee on safety of drug established?
1963
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
What does the Medicine act 1968 regulate?
MDI
Manufacture
Distribution
Importation
How did the medicine act regulate MDI?
Did so by licence and enforced by MHRA
Advised by Medicines commission
Since 1968, many more rules and legislation made under medicines act, what’s the secondary legislation?
Statutory instrument SI
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
What part of Medicines act still apply?
Registration of retail pharmacies
What are the main aims of HMR?
QSE
Maintain Quality/ safety/ efficacy of a medicinal product
What are the special provisions for pharmacies
Exempts the need for manufacturing licence when extemporaneous (making up drugs) dispensing
What are the classifications of medicinal products?
GSL
POM
P (pharmacy only)
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.
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
What is MHRA in relation to department of health?
Executive agency of department of health
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
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
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)
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
What’s MA?
An application submitted by a drug manufacturer seeking permission to bring a newly developed drug to the MARKET
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
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
Enforcement- What does the local council responsible for
Sale of GSL med
Enforcement - what does ministers respoible for?
LPH
Licensing - MHRA,EMA
Practitioners premises
Hosptial
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
What are the licences a MP must have?
1) MA
2) homeopathic certificate of registration
3) traditional herbal registration
4) article 126a authorisation
Which body acts as the “licensing authority” Inthe UK?
Secretary of State
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
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
Define A retail pharmacy business RPB?
A business includes the retail sale mp that are not GSL
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
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
Pharmacy order 2010 includes:
Establish the GPhC
Regulates PP&PT
Registration (pharmacy) renewed annually
Fees paid
What are the powers of GPhC under HMR 2012
P
What’s a PLCRPB
Persons lawfully conducting a retail pharmacy business
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
How long does pharmacy owner need to keep the Responsible pharmacist record for?
5 years
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
What did the equality act come out?
Oct 2010
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
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’
When did the GPhC become a legal entity
18th March 2010
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
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
What are the 6 GPhC values?
- Be focused on improvement
- Be responsive to change
- Develop policies that are inclusive
- Be independent and fair
- Demonstrate respect
- Ensure regulation is proportionate
When did the GPhC become a legal entity
18th March 2010
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
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
What are the 6 GPhC values?
- Be focused on improvement
- Be responsive to change
- Develop policies that are inclusive
- Be independent and fair
- Demonstrate respect
- Ensure regulation is proportionate
Definition of fraud
A deception deliberately practiced to secure unfair or u lawfully gain
How long is the time limit for starting MPharm degree to applying to join GPhC register pharmacist
8 years
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
RPS membership categories
Member Fellow Associate (pre- reg) Student Pharmaceutical scientist
What are the 4 part of organisation RPS?
The assembly
National boards
Local practice forum (LPF)
Membership catagrories
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
What year did medicinal product (RX by nurses) act came out?
1992
What year did health and social care act came out
2001
What are the two reports related to non medical prescribing? NMP
The cumberledge report 1986
The crown report 1989
PhIP (pharmacist independent prescriber) can work as ward pharmacists only if..?
Prescribing interventions are actioneD by a FY1/FY2 doctor
What does NPC framework stands for
National prescribing centre
What can A nurse/ pharmacist non medical IP prescribe?
Any licensed medicines inc CD sch 2,3,4,5
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
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
What’s a clinical governance?
A systematic approach to ensure patient get excellent and safe clinical care.
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
What year did Francis report come out
Keogh review n Berwick report
2013
2014
Creatinine clearance can be determined using?
Cockcroft gault equation
140- age) x BW / C
X 1.23 male
X 1.04 female
When did register of pharmacy technician become mandatory? Within the GPhC enforcement
June 2011
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
CTA is introduced when?
2004 May
What licence is needed for CTA?
Manufacturers trials licence
When did register of pharmacy technician become mandatory? Within the GPhC enforcement
June 2011
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
CTA is introduced when?
2004 May
What licence is needed for CTA?
Manufacturers trials licence
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
