Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Quality Use of Medicines > Therapeutic Goods Administration (TGA) > Flashcards

Therapeutic Goods Administration (TGA) Flashcards

1
Q

What is the TGA?

When was it launched?

A

Australia’s medicines regulator established in 1990 (origins of TGA early 60s)

Safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What are the Types of Therapeutic Goods?

A

Medicines and blood products

Medical Devices

Biologicals

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Types of Therapeutic Goods: What are Medicines and blood products?

A

Prescription medicines

OTC medicines

Complementary medicines

Blood, blood components and plasma derivatives

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Types of Therapeutic Goods: What are Medical Devices?

A

Implants (artificial hips, breast implants)

In-vitro diagnostics (pregnancy tests, BGM)

Low risk medical devices (bandages, tongue depressors, condoms)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Types of Therapeutic Goods: What are Biologicals?

A

Human stem cells

Tissue-based products (skin and bone)

Cell-based products

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What is the Australian Register of Therapeutic Goods (ARTG)?

A

All goods must be entered in the ARTG before they can be supplied in, imported to, or exported from Australia

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Australian Register of Therapeutic Goods (ARTG): What are Registered Medicines?

A

Prescription medicines, most OTC medicines, some complementary medicines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Australian Register of Therapeutic Goods (ARTG): What are Listed Medicines?

A

Some OTC medicines, most complementary medicines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Australian Register of Therapeutic Goods (ARTG): How are Medical Devices Classified?

A

Devices are classified according to their risk level. Class I (lower risk) e.g. urine collection bottles to Class III (higher risk) e.g. antibiotic bone cements

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What is Low Risk Premarket Assessment?

A

Complementary medicines and low risk medical devices are assessed for quality and safety

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What is High Risk Premarket Assessment?

A

Prescription medicines assessed for quality, safety and efficacy

High risk medical devices are assessed for quality, safety and performance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Regulated medicines include what?

A 
o	Prescription medicines
o	OTC medicines
o	Complementary medicines
o	Vaccines
o	Blood, blood components and plasma derivatives
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Registered Medicines

What are their risks?

What are they evaluated for?

What is their Product information approved by?

A

Higher risk medicines

Evaluated for quality, safety and efficacy

Product information approved by TGA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Listed Medicines

What are their risks?

What do they contain?

What claims can they make?

A

Lower risk medicines

Contain pre-approved, low risk ingredients

Can only make limited claims and can’t imply that they will be useful in the treatment or prevention of serious illnesses

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Registering a New Medicine: How long does it take to evaluate one new higher risk prescription medicine?

A

Takes approximately 11 months to evaluate one new higher risk prescription medicine

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Registering a New Medicine: Who is the evaluation undertaken by?

A

Evaluation undertaken by scientists and clinicians who look at data on:
o Quality
o Safety and efficacy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Medicines used for rare diseases can apply for listing as what?

Discuss the Applications for these

A

As an orphan drug

Assess applications for these medicines and are processed at no charge to the applicant

18
Q

Decisions are Based on Evidence: Quality data is supplied by the applicant and evaluated by chemists, biochemists, microbiologists and others working for the TGA - What data is Provided?

A

The composition of the substance and the product

Batch consistency

Stability data

Sterility data (if applicable)

The impurity content

Safety and Efficacy Data

Non-Clinical Data: Pharmacology data, Pharmacokinetic data, Toxicology data

Clinical Data: Evaluated by a medical doctor

19
Q

What does an Australian Public Assessment Report provide?

A

Provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application to register a prescription medicine

20
Q

Assessing and Managing Risk: TGA will what?

A

o Consider risks
o Balance benefits with risks
o Consider whether a medicine should be used in the proposed population of the proposed indication
o Use the Product Information as a risk management tool

21
Q

Product Information is a Risk Management Tool approved by who?

What is the product authorised for?

What is ‘off-label’ use?

What does the Precautions section detail?

A

Approved by the TGA

Product is only authorised for specified patient population for specified indications

All other use is ‘off-label’ and the benefit-risk profile has not been considered by the TGA

Precautions section: details of some of the risks involved

22
Q

When a product is registered or approved for marketing, there’s a risk management plan associated for that drug. What does this Plan state?
Is it required?

A

States how safety concerns will be identified and mitigated

Required component in the premarket authorisation process

23
Q

What does a Risk Management Plan Consist of?

A

An overview of the safety profile

Pharmacovigilance plan

Risk minimisation plan

24
Q

A risk management plan might require the sponsor to what?

A

Report on adverse events

Develop educational program

Limit supply to authorised prescribers

Keep a registry of patients

Automatically recruit on registry when product is prescribed

25
Q

Listed Medicines must not contain what?

What must they contain?

A

Must NOT contain substances that are scheduled in the Poisons Standard

Must contain pre-approved ingredients

26
Q

Discuss Advertising of Medicines

A

Labelling, packaging and description – regulated by TGA

Advertising of prescription medicines to consumers is illegal

27
Q

Discuss Access to Unapproved Medicines

A

Approval can be given so that health professionals can access products that their patients need, but which have not been approved for use in Australia

28
Q

What are the 3 Ways a Health Professional can Access Unapproved Medicines? Describe these

A

Clinical Trial Exemption (CTX) and Clinical Trial Notification (CTN): Access through participation in clinical trial

Special Access Scheme: Import and/or supply an unapproved therapeutic good for a single patient on a case-by-case basis

Authorised Prescribers: Authorised prescribers can prescribe a specified therapeutic good to a patient with a particular medical condition

29
Q

What Products are Biologicals?

A

Products in tissue banks

Stem cell therapy

Excludes in vitro fertilisation products, fresh organs and blood

30
Q

Discuss the Risks Associated with Biologicals

A

Higher and possibly unknown risks, including an increased risk of infectious disease transmission

31
Q

Discuss the Experience Associated with Biologicals compared to medicines

A

Experience with biologicals limited compared to medicines

32
Q

A risk classification system is used for biologicals to be included on the Australian Register of Therapeutic Goods (ARTG). The risk class depends on what?

A

How much they have been manipulated during the extraction and production process and how closely the intended use matches the natural biological function

33
Q

A risk classification system is used for biologicals to be included on the Australian Register of Therapeutic Goods (ARTG) - If there has been minimal manipulation what is this called?

A

Centrifugation

34
Q

A risk classification system is used for biologicals to be included on the Australian Register of Therapeutic Goods (ARTG) - If there has been high manipulation what is this called?

A

Genetic modification

35
Q

What are the Current Uses of Biologicals?

A

Biological heart valves

Bone transplants (often donated by hip replacement patients)

Tendon transplants to help restore mobility to arms, elbows, hands etc

Skin grafts – patients with burns

Turning human stem cells into heart cells, pancreatic beta cells, intestinal cells, liver cells and nerve cells

36
Q

What Biologicals Currently Used in Australia?

A
  • Ocular tissue
  • Skin
  • CV tissue
  • Bone and tendons
37
Q

Inclusion of Biologicals in the ARTG: Evaluation is undertaken by scientists and clinicians who look at data on what?

A

Quality - Evaluated by biologists, virologists and others working for the TGA (Donor selection and testing, Control of manufacturing and transport, Microbial control, Stability, Labelling to allow donor traceability)

Safety and Efficacy

Non-Clinical Data - Evaluated by toxicologists (biological dynamics and kinetics and toxicological data)

Clinical Data - usually evaluated by medical doctor

38
Q

Requirements of Biologicals: Biologicals must?

A

Specify donor selection to minimise the chance of infectious disease transmission

Require traceability of each product to the donor

Require bioburden (microbial growth) testing

Describe acceptable storage and transport conditions

Required to be manufactured according to Good Manufacturing Practice (GMP)

39
Q

What are Exceptional Release Provisions?

A

The TGA can apply exceptional release provisions to treat life-threatening conditions E.g. a paediatric heart valve becomes available at a valve bank for a critically ill baby but it’s not possible to wait 10 days for tissue microbial testing results

Doesn’t meet required safety standards but TGA releases product due to exceptional circumstances

40
Q

Post-Marketing Monitoring of Adverse Events

Sponsors are required to?

Medical Practitioners and patients?

The role of TGA?

In addition to the mandatory reporting requirements, there’s also?

A

Sponsors are required to monitor, record and report all adverse events to the TGA

Medical practitioners, patients and others are encouraged to report

The TGA will investigate and respond to adverse events as appropriate

In addition to the mandatory reporting requirements, there’s also a voluntary incident reporting scheme where any incidents involving a biological can be reported

Quality Use of Medicines (16 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions