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legislation Human medicines regulation Flashcards

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1
Q

The United Kingdom is divided into three distinct legal jurisdictions

A

English law in England and Wales;
Northern Ireland law in Northern Ireland;
Scots law in Scotland

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2
Q

What is “Law”?

A

The regulation of human affairs and human relationships
Complex concepts of:-
Rights
Duties
Rules
Regulations
Authority
Morality
Settling disputes
Dynamism (changing as society develops)

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3
Q

Categories of English law

A
  • Criminal law (Statute law)
    Relationship between an individual and the state
  • Civil law
    Relationship between individuals
    Tort & breach of duty of care
  • Administrative law
    Part of civil law which deals with supervisory roles courts have in relation to the activities of public bodies
  • Judicial precedent (Common law)
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4
Q

Tort

A

Wrongful act for which someone can be sued for damages in a civil law court
Includes such acts as libel, trespass, injury done to someone
whether intentionally or by negligence
examples might include mis-diagnosis, inappropriate prescribing, dispensing error

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5
Q

Judicial precedent

A

The principles of judicial precedent are such that when a case is decided in higher courts, lower courts have to follow the decision
Judges can manipulate the common law provided without waiting for parliament to enact legislation.
Judges can be subsequently overruled

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6
Q

The courts

A

Responsibility of courts to determine whether the law has been breached and to settle disputes.
Criminal courts
Civil courts

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7
Q

How does Parliamentary law come into effect?

A

Green & White Papers
Private Member’s Bill
Act of Parliament
Delegated legislation

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8
Q

Government papers

A

Green papers
-Consultative documents – what the government might do
White papers
-Firm proposals – what the government will do, given the acceptance of a parliamentary majority

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9
Q

Advantages of delegated legislation

A

Saving of Parliamentary time
Delegated legislation is enacted by appropriate minister
Greater flexibility
Greater speed of action and implementation in an emergency
Allows greater use

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10
Q

Current UK pharmaceutical legislation

A

Medicines Act 1968
Misuse of Drugs Act 1971
Poisons Act 1972 and Rules
Heath Act 2006
Pharmacy Order 2010 established the GPhC
Human Medicines Regulations 2012
The Human Medicines (Amendment) Regulations 2013-2019 etc.
The Human Medicines (Amendment etc.) (EU Exit) Regulations 2021
Medicines and Medical Devices Act 2021

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11
Q

Provision of Care

A

Both NHS and Private
1.Primary Care
GPs
Dentists
Community Pharmacists
Optometrists
2.Secondary Care
Hospitals
3.Tertiary care.
Specialities eg Neurosurgery, Transplant

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12
Q

The National Health Service5th July 1948

A

The NHS Act established a ‘comprehensive health service to secure the improvement in the physical and mental health of the people . . . and the prevention, diagnosis and treatment of illness’.

Aim to provide healthcare based on need, not the ability to pay

Originally free at the point of delivery
Now charges for some services including prescriptions
The NHS Act 1977 repealed the whole of the 1946 Act.

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13
Q

Human Medicines Regulations: Part 1- General

A

Special provisions for pharmacies –
Exempts the need for manufacturing licence when extemporaneous dispensing.
Classification of medicinal products
GSL (medicinal product covered by authorisation that states it should be available on general sale).
POM (medicinal product covered by authorisation that states it should be available only on prescription).
P (medicinal product that is not a prescription only medicinal product or a medicinal product on general sale- covered by authorisation that states it is to be available only from a pharmacy).

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14
Q

Definition of Medicinal Product (MP)

A

Medicinal Product means-
Any substance or combination of substances presented as having properties of preventing or treating disease in human beings, or
Any substance or combination of substances 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

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15
Q

Commission on Human Medicines (CHM).

A

The Commission on Human Medicines (CHM) advises ministers on the safety, advising on applications for National marketing authorisations

considering further representation against our provisional advice in respect of national applications
advising on the need for, and content of, 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 adding warnings, restricting or suspending use of a medicine
advising the licensing authority on changes to legal status of marketing authorisations
efficacy and quality of medicinal products

Advised by expert advisory Groups
minimum of 8 members they are appointed by ministers
proactively give info to ministers and advise them when asked
meet once a month

provides independent expert advice to the regulatory agency the MHRA

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16
Q

parliamentary procure in enacting legislation

A
  1. consultation
  2. consultative documents - green and white papers
  3. sponsored Bill- initiated by government or private member
  4. bill drafted into house of commons
  5. bill passed to house of lords for reading
    6.final readings in the house of commons
  6. royal assent
    8.statute books
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17
Q

primary legislation

A

Act of parliament misuse of drugs act 1971

18
Q

examples of secondary legislation

A

ORDERS- misuse of drug Act - amendment order 2008
Regulations- Notification of and supply to addict regulations 1997
RULES-misuse of drug at tribunal rules 1974

19
Q

the national health insurance act 1911

A

Act gave statutory recognition to dispensing by or under the supervision of a pharmacist

20
Q

Why did we need the Medicines Act?

A

Until the introduction of the Medicines Act 1968 most medicines were regulated as poisons with no control over the marketing of new medicines.

21
Q

what year was the arsenic act

A

1851

22
Q

what year was the poisons and pharmacy Act

A

1908 and 1933

23
Q

what year was the pharmacy Act

A

1868

24
Q

what year was the therapeutics substance Act

A

1925

25
Q

what year was the pharmacy and medicines act

A

1941

26
Q

what year was the therapeutics substances( prevention of misuses)act ( manufacture and supply

A

1953

27
Q

1925 Therapeutic Substances Act

A

Medicinal products (MP) were increasingly coming from a chemical origin rather than a plant source
Anti-syphylis drug Salversan contained 606 toxic impurities
Therapeutic Substances Act (TSA) provided a form of licensing which included
Inspection of manufacturing sites
Personnel suitability
Record keeping
Labelling requirements introduced

28
Q

Committee on Safety of Drugs 1963

A

Voluntary agreement by the Ministers of Health to look at the safety of new drugs.
The Committee on Safety of Drugs consisted of:
scientists, physicians, toxicologist, statistician and pharmacists
checking for “reasonable safety of a drug’s intended purpose”.
Products already on the market were granted a provisional Licence of Right.

29
Q

The Medicines Act 1968

A

regulate;
manufacture
distribution
importation

did so by license and enforcement by MHRA

Advised by medicine commission

Achieved by Statutory Instruments (SI)
Orders & Regulations
Referred to as secondary legislation

Much of Medicines Act 1968 now revoked

30
Q

The Human Medicines Regulations 2012

A

Regulates
Manufacture
Distribution
Importation
Sale and supply
Labelling and advertising
Pharmacovigilance
Does so by licence
Licensing authority is either or both of the ministers [Secretary of State and the Minister of Health, Social Services and Public Safety].
MHRA
Regulates everything to do with Human Medicines.
SI due to European legislation
Replaces much of the Medicines Act and around 200 SI’s.
Medicines Act still exists.
As based on EU legislation was amended due to Brexit in 2020 & 2021
Supply of Medicines to the public
Labelling and Containers
Sales promotion (advertising)
Preparation of BP & other books of standards

Maintain
Quality
Safety
Efficacy

From HMR 2012 application for Marketing Authorisation “..the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product”

31
Q

Medicinal Purpose (from MA 1968 still)

A

Medicinal Purpose means any one or more of the following
(a) treating or preventing disease
(b) diagnosing disease or ascertaining the existence, degree or extent of a physiological condition
(c) Contraception
(d) Inducing anaesthesia
(e) Otherwise preventing or interfering with the normal operation of a physiological function whether permanently or temporarily and whether by way of terminating, reducing or postponing or increasing or accelerating the operation of that function in any other way

32
Q

paramedics independent prescribers

A

limited as cannot prescribe CDs currently

33
Q

Physiotherapists independent prescribers

A

can prescribe CDs fentanyl ( transdermal)

34
Q

podiatrist independent prescriber

A

can prescribe some CDs Diazepam oral

35
Q

Advisory bodies- Human Medicines Regulations 2012:Part 2 - Administration

A

Commission on Human Medicines (CHM)
British Pharmacopoeia Commission (BPC)
Expert Advisory Groups (EAG)

36
Q

Medicines and Healthcare products Regulatory Agency (MHRA)

A

mission- The MHRA mission is to enhance and safeguard the health of the public by ensuring the medicines and medical devices work, and are acceptably safe

activities- Assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK for human use
Overseeing the UK Notified Bodies that audit medical device manufacturers
Operating Yellow card scheme (medicines + devices)
Operating a proactive compliance programme for medical devices
Sampling and testing of medicines, including imported.
Regulating clinical trials of medicines and medical devices
Ensuring compliance with statutory obligations (inspection and enforcement)
Promoting good practice in the safe use of medicines and medical devices
Managing the General Practice Research Database (GPRD) and the British Pharmacopoeia (BP).
Information provision to public and professions – informed choice

37
Q

Yellow card - MHRA new reporting site

A

reporting suspected problems or incidents
for side effects
medical device adverse incident
defective medicine
counterfeit or fake medicine or medical devices

38
Q

What do we mean by “devices”?

A

The term ‘medical device’ covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.
E.g. IV admin sets
Dressings
Orthotics
Catheters
Condoms, Urine test strips, contact lenses, etc., etc.
This year (2023) UK has introduced its own mark

39
Q

British Pharmacopoeia Commission (BPC)

A

Functions:
Preparation of British Pharmacopoeia
Contains substances which are or may be used in the practice of medicine or surgery (not vet), dentistry or midwifery
Separate compendia for Veterinary medicine/surgery.
Preparation of other appropriate compendia
Preparation of cumulative list of rINN
European Pharmacopoeia
At intervals as it thinks appropriate

the book
Comprises descriptions for substances which may be used in the practice of medicine & the manufacture of medicinal products
Specifies the standards for medicinal products

40
Q

Expert Advisory Groups (EAG)

A

1.appointed by either BPC or CHM
2.ministers may instruct BPC or CHM to appoint an EAG
3.Members of EAG do not have to be members of CHM or BPC
4.chair appointed by CHM/BPC
5.independent and transparent

41
Q

Enforcement-The GPhC is responsible for

A

Register of Pharmacists, Pharmacy Technicians and Pharmacy premises
Pharmacy Order 2010 (Medicines Act 1968)
Revalidation
Disciplinary control of Pharmaceutical profession
Sale & Supply of MPs
POM’s and P medicines (not GSL)
Restriction of Titles (Medicines Act 1968)

The registrar & chief executive of the GPhC keeps a Register of premises, pharmacists & pharmacy technicians
A registered pharmacy means premises entered for the time being on the Register
A registered pharmacist means a person registered in the Register of pharmacists
A registered pharmacy technician means a person registered in the Register of pharmacy technicians
Technician registration is mandatory since June 2011

GPhC :
Quality & purity of medicines for sale
Labelling, Packaging & Advertising of MPs for sale.

Local Council responsible for:
Sale of GSL medicines

pharmacy law (10 decks)

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