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Applied Pharmacy Practice > The Law, The Med Act, & Licensing Of Meds > Flashcards

The Law, The Med Act, & Licensing Of Meds Flashcards

1
Q

What are the 3 legal systems in the Uk?

A
  • England & Wales
  • Northern Ireland
  • Scotland
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2
Q

How are the laws applying to England and Wales categorised?

A
  • by origin
  • COMMON LAW: originates from judges / imposed by judges (aka case law)
  • STATUTE LAW: created by parliament in the form of legislation
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3
Q

Does legislation take precedence over common law?

A

-yes
Statute law takes precedence over common law.

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4
Q

What are the 2 areas of law in England and wales?

A
  • PRIVATE LAW: applies to people in private relations as citizens or organisations e.g breach of an employment contract, negligence, fitness to practice proceedings , civil cases brought by people looking for compensation. \
  • PUBLIC LAW: applies to e/o e.g criminal, constitutional, administrative law i.e health and safety regulations an employer provides for you.
  • BOTH MAY INCLUDE STATUE LAW - i.e LEGISLATION.
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5
Q

What is statutory law?

A
  • PRIMARY LEGISLATION = acts of parliament (come after a bill is put forward and passed in parliament).
  • SECONDARY LEGISLATION= set out by Act to give the detail of implementation
    Statutory instruments (SI) - Numbers are often associated with/ them.
    Includes regulations, orders, rules and directions
    I.e Health act 1999 allows an order of regulation of certain professions
    Such as pharmacy order 2010- General pharmaceutical council (GPhC)
    OR
    GPhC order 2010- GPhC ( Fitness to practice and disqualification etc) rules 2010.
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6
Q

What are the codes of practice?

A
  • They are not law/ legislation.
  • They support legislation and help one adhere to legislation
  • Set standards for how to comply with/ legislation.
  • If you fail to comply or don’t reach the standards you are likely to breach legislation.
  • If you are found to have breached legalisation & not followed the relevant code= highly likely to be found guilty of a criminal offence.
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7
Q

What are GPhC standards?

A
  • Standards for pharmacy professionals.
  • Standards for registered Pharmacies.
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8
Q

What is the Medicines Act 1968?
&
What is it used for?

A
  • Was the main legislation until 2012.
  • Regulated the authorisation, sale & supply of medicinal products for human use.
  • Mostly replaced and condensed by the ‘Human Medicines Regulations (HMR) 2012.
    Registration & conduct of pharmacies remains under the Medicines Act 1968:
  • Pharmacy premises must be registered (GPhC) - hospitals or health centres don’t have to be.
  • Superintendant pharmacist required for corporate bodies responsible for conduct of pharmacy related professional activities
  • Title ‘Pharmacy’ is protected.
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9
Q

THE MEDICINES ACT 1968
Why is legislation and regulation needed? PART 1

A
  • To regulate the authorisation, sale & supply of medicinal products for human use.
  • Makes sure that meds are safe.
  • That they are not making misleading or false claims.
  • That the product is of a good quality.
  • So no harm is caused to the patient.
  • Ensure patient safety.
  • Claims must be backed by evidence and support.
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10
Q

THE MEDICINES ACT 1968
Why is legislation and regulation needed? PART 2
EXAMPLE

A
  • Charlotte Winslow - Paediatric Nurse (1849).
  • Soothing syrup widely marketed in N. America and Uk.
  • 1 teaspoon contained enough morphine to kill a a child.
  • Popular, selling 1.5 mil bottles annually.
  • Caregivers didn’t link deaths to syrup use.
  • Thousands believed to have died from overdose or withdrawal or addiction.
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11
Q

Are medicinal gases like oxygen classed as medicines?

A

-Yes

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12
Q

What is the definition of a medicine?

A

-Medicine =
- 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 w/ a view to:
i) Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action.
OR
ii) Making a medical diagnosis.

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13
Q

What are the 17 parts of THE HUMAN MEDICINES REGULATIONS 2012?
General, administration, manufacturing - require s marketing, certificates, traditionally, authorisations boderlining exemptions perhaps dealing- packaging, advertising, British, enforcement , miscellaneous

A

1- General provisions 9-Borderline substances
2- Administration 10- Exemptions to requirement for marketing authorisation
3- Manufacturing & wholesale 11- Pharmacovigilance
4- Requirement for authorisation 12- Dealings w/ medicinal products
5- Marketing authorisations 13- Packaging & leaflets
6- Certification of homeopathic 14-Advertising
Medicinal products 15- British Pharmacopoeia
7-Traditional herbal registration. 16- Enforcement
8- Article 126a authorisations 17- Miscellaneous

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14
Q

2= Administration

A

-How legislation is seen and implemented
2 bodies authorised:
1) COMMISSION ON HUMAN MEDICINES= Advisory body to the govt.Advise govt on safety & efficacy of meds
Part of the administration of the human med regulations. Committee of the MHRA
2) BRITISH PHARMACOPOEIA COMMISSION (BPC)= Produces the British Pharmacopoeia
See Bp at the ed of some drugs and formulations
Sets standards and quality of meds and for the testing of meds.

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15
Q

15= British Pharmacopoeia (BP)

A
  • UK standards for medial products.
  • Birthish approved names (BANS) FOR MEDS
    Names of drugs change in diff countries i.e paracetamol is known as acetaminophen i the US.
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16
Q

3= Manufacturing & wholesale
4= Requirement for authorisation

A
  • Manufacturers must hold a Manufacturing Authorisation (MA)
  • Wholesalers must hold a Wholesale Distribution Authorisation (WDA) -for sale or supply to a person who is not the end user.
  • Additional authorisations for import or export
  • Authorisations often know as licenses
  • HMR controls what licensed you need
17
Q

Manufacturing Authorisation (MA)

A

MA holder for a medicinal product may:
- Sell, supply or export the product
- Procure its sale, supply or exportation
- Procure its manufacture

18
Q

Manufacture

A

Any process carried out while making a medicinal product but does NOT include dissolving or dispensing or diluting or mixing w/ another substance used as a vehicle for administration.
Doesn’t include putting into an injection or vehicle or dilution.

19
Q

Assembly

A

Packaging
To enclose a product in a container which labelled before the product is sold or supplied or where already enclosed in a container in which it is to be sold or supplied, it means to label the container before the product is sold or supplied.

20
Q

Exemptions from licensing

A
  • For certain registered practitioners acting in the course of their profession
21
Q

MA exemptions

A
  • Drs or Dentists where a medical product is manufactured by them & supplied to a patient during treatment.
  • Nurses and Midwives where a medical product is assembled by them and supplied to a patient during treatment.
22
Q

WDA exemptions

A
  • Pharmacists (community & hospital) may supply to other healthcare providers to meet the needs of a patients as long as they are not receiving any profit.
  • Pharmacists can supply small quantities to anybody other than patients as long as they are not receiving profit.
23
Q

Exemptions from licensing:
Pharmacists can prepare or dispense a medicinal product….

A
  • in accordance w/ a prescription from a practitioner
  • in accordance w/ a request (signed order) from certain practitioners (to who the product is to be sold) for use in their professional practice. (E.g certain eyes drops for an optician to administer to someone in their care) OR (certain meds to veterinarians for administration to an animal in their care).
  • For administration to a person, when requested to do so by that person, using their professional judgement as to the treatment required. = COUNTER PRESCRIBING , the person must be present in the pharmacy at the time of the request.
24
Q

5= Marketing Authoristaions

A
  • Before going on the UK market, medicinal products must be licensed & given a unique identifier called a MARKETING AUTHORISATION = a product licence (PL). -PL number.
  • The licence sets out the agreed terms & conditions of use such as indicators and dosage ( dose and frequency).
  • ALL LICENCES GRANTED BY THE MHRA
25
Q

How are Marketing Authorisations obtained ? MHRA= Medicines & Healthcare Products Regulatory Agency

A
  • Manufacturers submit evidence of safety, quality & efficacy. ( Clinical trial data where appropriate e.g new products) & ( Equivalence where appropriate e.g existing products already on the market).
    Summary of Product Characteristics (SPC or SmPC) defines:
  • What the medicine is to be used to treat - indications for use.
  • Dosing (i.e dose & frequency of administration).
  • Side effects
  • Contraindications - when it should not be used
  • Trials
26
Q

10= Exemptions to requirement for marketing authorisation

A
  • Unlicensed meds ‘specials’ - s/ conditions may require special meds
  • Rare conditions may require this as there is not enough patients to put them on clinical trials to test.
  • Unlicensed use of a med ‘off-label’ - Indication for a condition that is not covered w/i the license.
  • Certain prescribers may prescribe ‘specials’ or ‘off-label’ to fulfil special patient needs where no licensed alternative are available.
  • Must make the patient aware.
  • The prescriber takes clinical responsibility.
27
Q

12= Dealing w/ medicinal products

A

3 Main Categories of Medicines:
ALL 3 categories must have a PL number
- POM= Prescription Only Medicines
- P= Pharmacy Medicines
- GSL= General Sales List
Applied by the MHRA when granting MAs

28
Q

POM (Prescription Only Medicines)

A
  • POM must be on the manufacturer’s packaging.
  • Can only be prescribed to a patient on a prescription.
  • Packaging must contain POM.
  • Must be sold or supplied w/ a prescription
  • Includes Controlled Drugs (CDs) -additional requirements as specified by the Misuse of Drugs Act 1971.
  • i.e morphine
29
Q

Medicinal products that can ONLY be licensed as a POM - For safety reasons

A
  • Parenteral administrations (e.g any injections).
  • Controlled Drugs ( unless of low strength & deemed safe for sale to the public as a P or GSL e.g codeine linctus 15mg pe mL =P med).
  • Radiation emitting (e.g radioactive isotopes for cancer diagnosis & treatment.
30
Q

P ( Pharmacy Medicines)

A
  • Must be on the manufacturer’s packaging.
  • Must only be sold under the supervision of a or by a pharmacist in a registered pharmacy.
31
Q

GSL ( General Sales List)

A
  • GSL may or may not be on manufacturer’s packaging.
  • MUST have PL number.
  • Can we/ reasonable safety be sold or supplied to the public w/o pharmacist supervision.
  • May be sold from premises which are not registered pharmacies i.e supermarkets.
  • MUST be in original pack.
32
Q

Medicinal products may only be licensed as POM or P medicines

A

e.g
- Eye ointments
- Vitamin A products (over a specified strength).
- Vitamin D products (over a specified strength).

33
Q

Medicinal products may be licensed as POM &/or P medicines &/or GSL medicines

A
  • It is safe to sell certain quantities but not larger quantities i.e paracetamol is not safe to sell in large quantities due to risk of overdosing ( long term side effects).
  • Classification dependant on pack size e.g.
    Paracetamol 500mg tablets, max pack size for GSL = 16 (over 16 = P or POM).
    Ibuprofen 400mg tablets, max pack size for GSL = 16 (Over 16= P or POM).
34
Q

What is not a legal category/ classification?

A
  • OTC (Over The Counter) Meds
35
Q

13= Packaging & leaflets
14= Advertising

A
  • Specific packaging & labelling requirements.
  • Must have patient info leaflets provided w/ them.
  • Rules around advertising. (Not making any false claims about the med) & ( Can’t advertise certain meds).
36
Q

16= Enforcement

A

Enforced by the:
- MHRA
- Police = It is the law so the police can enforce it.
- GPhC ( General Pharmaceutical Council)= Enforces legislation around pharmacy premises and your registration & the premises registration & the use of the name ‘pharmacy’.

37
Q

MHRA

A
  • Medicines & Healthcare Products Regulatory Agency
38
Q

MHRA

A
  • Enforce legislation for human medicines.
  • Operate the licensing system for meds their wholesale, manufacture & to the med themselves.
  • Regulate the manufacture, sale, supply & advertising of human medicines.
  • Ensure product labels, leaflets, prescribing info & advertising meets legislative requirements.
  • Administer as system of continuous safety monitoring (pharmacovigilance) = monitoring the safe of meds.
  • AIM to ensure safety, quality and efficacy.

Applied Pharmacy Practice (19 decks)

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