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103 - Law > Law > Flashcards

Law Flashcards

1
Q

What are the three categories of law?

A

1) Criminal law (Statute law) = Relationship between an individual and the state.
2) Civil law = Relationship between individuals. Tort & breach of duty of care
3) Administrative law = Part of civil law which deals with supervisory roles courts have in relation to the activities of public bodies.

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2
Q

What is Tort?

A

Tort = 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
e.g. mis-diagnosis, inappropriate prescribing

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3
Q

What is 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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4
Q

What are examples of Primary, Secondary & Tertiary Care?

A

Primary Care: GPs, Dentists, Community Pharmacists, Optometrists
Secondary Care: Hospitals
Tertiary care: Specialities eg Neurosurgery, Transplant

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5
Q

Describe: 1925 Therapeutic Substances Act

A
  • MP were increasingly coming from a chemical origin rather than a plant source.
  • Therapeutic Substances Act (TSA) provided a form of licensing which included:
    + Inspection of manufacturing sites
    + Personnel suitability
    + Record keeping
    + Labelling requirements introduced
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6
Q

Describe: 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 + pharmacists
    checking for “reasonable safety of a drug’s intended purpose”.
  • Products already on the market were granted a provisional Licence of Right.
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7
Q

Describe: The Human Medicines Regulations 2012

A

Regulates:
+ Manufacture + Distribution
+ Importation + Sale & supply
+ Labelling & advertising
+ Pharmacovigilance

Enforcement lies with:
+ Secretary of State
+ General Pharmaceutical Council (GPhC)
+ “Drugs authority” – Local Council

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8
Q

Describe: MP

A

MP:
- Any substance/s presented as having properties of preventing or treating disease in human beings.
- Any substance/s usable for:
+ Correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action
+ Making a medical Diagnosing

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9
Q

Describe: Medicines & Healthcare products Regulatory Agency (MHRA)

A

Mission - The MHRA’s mission is to enhance & safeguard the health of the public by ensuring that medicines and medical devices work, & are acceptably safe.

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10
Q

Describe: Medical Device

A

Medical device: covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.

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11
Q

Describe: Commission on Human Medicines (CHM).

A
  • The exercise of any power from HMR 2020 & CTR.
  • MPs
  • Risk management plans
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12
Q

British Pharmacopoeia Commission (BPC)

A
  • Contains substances which are or may be used in the practice of medicine or surgery (not vet), dentistry or midwifery
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13
Q

What is the GPhC is responsible for?

A
  • Register of Pharmacists, Pharmacy Technicians & Pharmacy premises
  • Pharmacy Order 2010 (Medicines Act 1968)
    Revalidation
  • Disciplinary control of Pharmaceutical profession
  • Sale & Supply of POM’s & P medicines
  • Restriction of Titles (Medicines Act 1968)
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14
Q

Purpose of: Marketing Authorisation

A

Needed for every MP before being prescribed/sold

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15
Q

Purpose of: Manufacturer’s or wholesale dealer’s license

A
  • Rules for manufacturing, importing & wholesale dealing
    + Requires a licence
    + Establishes licence requirements
    + Establishes requirements for Responsible Persons & Qualified Persons
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16
Q

Marketing Authorisation requirements:

A
  • Submission of necessary documentation
  • Fees
  • Validation
  • Ensure forms completed accurately
  • Assessment of Safety, Quality & Efficacy
17
Q

What does the Marketing Authorisation grant?

A

Authorises the holder to:
- Sell, supply or export the Medicinal Product (MP)
- Procure the sale, supply or export of the MP
- Procure the manufacture or assembly of the MP for sale, supply or export
- Import the MP

18
Q

Every MP must have: Summary of Product Characteristics (SPC)

A
  • Name, strength & pharmaceutical form.
  • Qualitative & quantitative composition
  • Clinical particulars
  • Pharmacological properties
  • Pharmaceutical particulars
  • Name of UK MA holder
  • Number of UK MA, etc, etc.
19
Q

Parallel Import Licence (PLPI)

A

Allows Medicinal Products with a Marketing Authorisation to be bought in one European Member State and sold in another.

20
Q

Parallel Import Licence (PLPI): Requirements

A

Conditions must be met that the product:
- Is not a vaccine, toxin, blood product, radioactive isotope or homeopathic product
- Is covered by a European MA & is a version of a product which already holds UK MA
- Bioequivalent to UK product
- Made by, or under licence to the UK manufacturer or by a member of the same group of companies
- Must be labelled & have PIL in English
- Importer must have: Marketing Authorisation & Wholesale Dealers’ Licence

21
Q

Manufacturer’s Specials Licence

A

For a manufacturer to make an unlicensed MP (a “Special”), they must hold a Manufacturer’s “Specials” Licence
No advertising of products only of the service
Doctor takes responsibility for efficacy of product
Licence holder takes responsibility for quality of product
Inspected by MHRA as per ML
Specials are products specifically requested for manufacture or import

22
Q

GSL (General Sales List)

A

These are MPs which can with reasonable safety be sold or supplied other than under the supervision of a pharmacist.

23
Q

Pharmacy Only MP

A

PO: A substance which is licensed as a GSL medicinal product but the manufacturer stipulates that it be available only through pharmacies:

24
Q

Pharmacy Medicines

A

A MP that is not a POM product or a medicinal product subject to general sale

25
Q

Supply of P Medicines

A

A person may not sell or supply, or offer for sale or supply, a MP that is not subject to general sale, unless:
- It is by a person lawfully conducting a retail pharmacy business
- From premises that are a registered pharmacy
- Acts under the supervision of a pharmacist.
- A responsible pharmacist has taken control of premises

26
Q

POM to P

A

POM to P when MP is safe to be supplied without a prescription and NOT
Likely to present danger to human health if used without the supervision of a prescriber
Frequently and to a great extent used incorrectly
Containing substances of which the activity or side effects require investigation
Normally prescribed for parenteral administration

27
Q

P to GSL

A

P to GSL when MP is safe to be supplied without the supervision of a pharmacist

28
Q

GSL to P

A

GSL to P when MP is no longer safe to be supplied without the supervision of a pharmacist

29
Q

P to POM

A

P to POM if new risks are identified which require the involvement of a prescriber

30
Q

Details required for valid PGD

A
  • Clinical Condition:
    + Condition / situation defined
    + Inclusion & exclusion criteria
    + Cautions
  • Description of Treatment:
    + Name, Dose, etc
    + Advice to patient – verbal or written
    + Records required
    -Characteristics of Pharmacist or other HCP:
    + Qualifications & training required
  • Management of PGD
31
Q

Pharmacy Order 2010

A
  • Establishes the GPhC
  • Regulates pharmacists & pharmacy technicians in Great Britain
  • Regulation of pharmacies.
  • Registration renewed annually
  • Fees paid
32
Q

Responsible PharmacistIn their absence: staff

A

Can
Sell GSL medicines over the counter
Take in prescriptions.
Put dispensary stock away

Cannot –
Supply a GSL medicine against a prescription
Sell P medicines
Hand out pre bagged and checked medicines to patients or delivery drivers

33
Q

MDA (1971) & MDR (2001)

A

MDA (1971) imposes a total ban on the possession, supply, manufacture, import and export of CDs

The MDR (2001) permit possession, supply, manufacture, import and export of some CDs, by some people in certain conditions

34
Q

Sch 1

A

Schedule 1 (CD Lic POM)
Drugs with no therapeutic use. A licence needs to be granted for legal production, possession or supply
Examples: Ecstasy (MDMA) and related substances, hallucinogens (e.g. LSD), raw opium

35
Q

Sch 2

A

Schedule 2 (CD POM)
Pharmacists (and others named in MDR, 2001) have a general authority to possess, supply and procure these when acting in their professional capacity
Examples: diamorphine, morphine, methadone, amfetamines, ketamine.

36
Q

Sch 3

A

Schedule 3 (CD No Register POM)
Minor stimulants and various other drugs less likely than schedule 2 to be misused (and less harmful if they are)
Examples: benzphetamine, buprenorphine, temazepam, tramadol, midazolam, phenobarbital

37
Q

Sch 4

A

Part 1 (CD Benz POM)
Benzodiazepines (bz), non-bz hypnotics (e.g. zopiclone) and Sativex (cannabinoid mouth spray)
Part II (CD Anab POM)
Most anabolic and androgenic steroids, clenbuterol, growth hormones.

38
Q

Sch 5

A

Schedule 5 (CD Inv POM or P)
Preparations of certain CDs that are exempt from full control because they are present in low strengths (codeine, pholcodeine, morphine)
Can be POM or P

39
Q

Sch 1 Possession

A

Schedule 1 CD normally require a Home Office licence to possess

There are two specific exemptions for pharmacists to take possession of such drugs:
When possession is for the purpose of destruction
When possession is for the purpose of handing to the police
See MEP 3.6.3 - page 106 and make additional notes

103 - Law (1 decks)

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