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phar24 > week 9 > Flashcards

week 9 Flashcards

1
Q

what organisation is responsible for the import, supply or export of medicines in AU

A

TGA = checks medicines

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2
Q

what does the TGA 1989 act require

A

requires products must be entered on the Australian Register of Therapeutic Goods & the drug needs a sponser aka a company that will supply the product

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3
Q

what three categories fall under “therapeutic goods”

A
  1. medicines = prescription
  2. biological = smth made from or containing human cells
  3. medical devices = includes instruments, implants etc
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4
Q

what are the 5 regulated medicines

A
  1. prescription medicines
  2. over-the-counter medicines
  3. complementary medicines = herbs, vitamins
  4. vaccines
  5. blood, blood components, plasma derivatives
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5
Q

what are the two broad categories of medicines

A
  1. registered medicines: higher risk (easily overdose), evaluated for quality, safety & efficacy, product info is approved by TGA, all prescription
  2. listed medicines: lower risk medicines, evaluated for quality and safety, contain pre-approved, low risk ingredients, can only make limited claims & cannot imply that they will be useful in the treatment or prevention of serious illness (CAUSE THEY ARE NOT ASSESSED)
    * assessed listed are tested for efficacy –> can make claims
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6
Q

if a medicine has ‘R’ on the container it means

A

it is registered

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7
Q

if a medicine has ‘L’ but ‘A’ in brackets it means

A

it is listed but also has been assessed for efficacy

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8
Q

are most over-the-counter medicines registered

A

yes

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9
Q

what are OTC medicines

A

medicine you can buy without prescription = safe and effective when directions on label followed/directed by health care professional

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10
Q

are some complimentary medicines registered

A

yes = have been assessed for efficacy

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11
Q

who evaluates the quality data of the drug

A

chemists, biochemists, microbiologists & others working for the TGA

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12
Q

what 5 things are evaluated regarding the quality of the drug

A
  1. composition of the substance & the product
  2. batch consistency
  3. stability data (how long it lasts/shelf life)
  4. sterility data (if applicable) e.g., eye drops
  5. the impurity content
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13
Q

two types of evaluations of safety and efficacy data

A
  1. nonclinical data = evaluated by toxicologists & pharmaceutical chemists
  2. clinical data = usually evaluated by a medical doctor
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14
Q

what is involved in nonclinical evaluation

A
  • pharmacology data - laboratory data investigating efficacy
  • pharmacokinetic data
  • toxicology data - laboratory data investigating safety
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15
Q

what is involved in clinical data

A
  • mostly results of clinical trials conducted by pharmaceutical companies and/or hospitals or research organisations, using volunteers
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16
Q

what is the TGA role

A

assessing & managing risk

  • consider risks? what are they
  • does the benefit outweigh risk
  • consider whether a medicine should be used in the proposed population for the proposed indication = clinical trials accurate age etc
  • use product information document as a risk management tool
  • consider other risk management
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17
Q

what is the product information document

&

  • who is it approved by
A

= a risk management tool

  • the document is approved by TGA
  • the product is only authorised for specified patient population for specific indications
  • all other use is ‘off-label’ and the benefit-risk profile has not been considered by the TGA = if something happens to children due to breast milk issue then they are taking blame off themselves
  • the precautions section gives details of some of the risks involved
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18
Q

what is medicine scheduling

A

= method used to control the use of the medicine

more dangerous drugs are scheduled higher to restrict their use, this enables their safe and effective use

  • scheduled 2-8
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19
Q

what are the different levels of scheduled medicines & what are examples of each

A

schedule 2 = pharmacy only medicine e.g., large packet sizes of paracetamol

schedule 3 = pharmacist only medicine e.g., protein pump inhibitors

schedule 4 = prescription only medicine e.g., blood pressure medications

schedule 8 = controlled drug e.g., S8 has additional restrictions on the storage & supply medicines

20
Q

define up schedule & down schedule

A

for example increase issues with misuse of opioids they up-scheduled it to make it harder for patients to access, they needed a prescription

opposite

21
Q

do listed drugs contain any drugs that are scheduled in the poisoned standard

A

no

22
Q

are most ‘listed medicines’ complementary

A

yes most

23
Q

are some over-the counter medicines listed

A

yes some

24
Q

what 5 things are regulated for listed medicines premarket

A
  1. only pre-approved low risk ingredients
  2. listed medicines including only complementary medicines, receive a lesser degree of checking than higher degree products
  3. regulation centres on the safety of the ingredients & consistency of manufacturing process –> sponsors must hold evidence to support claims
  4. independence expert advice may be sought on new ingredients proposed for use in listed medicines
  5. listing on the ARTG is the final stage of the process & occurs once the sponsor has paid their fees & signed a statutory declaration
25
Q

what is ARTG

A

Australia register therapeutic goods

26
Q

conditions for supplying low risk medicine

A
  1. contains pre-approved low-risk ingredients
  2. does not claim or imply it will be useful in the treatment of prevention of serious illnesses
  3. the TGA inspects & licenses manufacturing sites in Au & assess sites overseas
27
Q

why does the TGA assess sites of manufacture

A

allows them to enforce standards in relation to sterility & quality of the ingredients used and the process followed

28
Q

three special cases where the drug hasn’t being approved yet due to time but is needed for special cases

A
  1. Clinical Trial exemption (CTX) & Clinical Trial Notification (CTN) schemes
  2. Special Access Scheme (SAS)
  3. authorised prescribers
29
Q

Clinical Trial exemption (CTX) & Clinical Trial Notification (CTN) schemes involves:

A

access unapproved medicines through participation in a clinical trial

30
Q

SAS involves:

A

import &/or supply an unapproved therapeutic good for a single patient on a case-by-case basis

31
Q

Authorised prescribers involves:

A

authorised prescribers can prescribe a specified therapeutic good (more than once) to a patient with a particular medical condition

32
Q

can prescription medication be advertised in au

A

no it is illegal

33
Q

does the label and packaging need to be approved by TGA

A

yes

34
Q

define active ingredient

A

therapeutically active component

35
Q

define excipient

A

an ingredient in a medicine’s final formulation that isn’t active

36
Q

examples of excipient

A

preservatives, tablet coatings

37
Q

define bioequivalent

A

refers to whether the generic medicine releases the active ingredient into the bloodstream at the same rate and to the same extent as the original medicine

38
Q

how are the generic and original medicine compared

A

blood samples are taken at different times and the rate and extend of absorption of the active ingredient into the blood is compared

39
Q

define generic medicines

A

an additional brand of an existing medicine

40
Q

what must generic medicines contain

A

the same active ingredient as the existing medicine & must be bioequivalent

41
Q

what has to be the same between generic and original

A
  • active ingredients
  • excipient
  • strength/concentration
  • dosage form
  • route of administration
  • rates & extents of bioavailability of the active ingredient
42
Q

define biosimilars

A

a version of an already registered biological medicine

  • is comparable in quality, safety, efficacy
  • physio
43
Q

similar characteristics between biosimilar & original

A
  • physiochemical
  • biological
  • immunological
  • efficacy & safety
44
Q

what is the Pharmaceutical benefit scheme

A

= aus gov program that benefits all Australians by making medicines more affordable

45
Q

how does the PBS work

A

they have a list of all the medicines available to be dispersed to patients at a gov subsidised price = not all medicines

  • sometimes medicines are subsidised for one indication but not for others, or condition applies (usually it is related to quality of evidence & cost)
  • more affordable for elderly
46
Q

is all medication approved by TGA listed in PBS?

A

no - some approved by TGA but not PBS

e.g., PBS might approve a cheaper version of the same drug but not the more expensive drug

47
Q

TGA role vs PBS

A

approve/allow drug sold in australia whereas PBS make cheaper/subsidise for Australians

phar24 (12 decks)

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