Week 4

Question 1

T or F
Generics are usually higher in cost in comparison to brand names

Answer 1

F

Question 2

T or F
Dosage may differ between a brand name and a generic drug

Answer 2

F

Question 3

When can other manufacturers make generic versions of a drug?

Answer 3

When the patent of an innovator drug expires

Question 4

T or F
Generics and brand names are marketed under similar names

Answer 4

F
Not necessarily

Question 5

T or F
Generics try to make their packaging look similar to brand-name packaging

Answer 5

F

Question 6

T of F
The inactive ingredients of generics and brand names are identical

Answer 6

F
May differ but proven to be acceptable by regulatory body

Question 7

T or F
A generic medicine is a pharmaceutical product that is intended to be interchangeable with the market leader (innovator) product in an individual patient

Answer 7

T

Question 8

T or F
A generic medicine is a pharmaceutical product that is usually manufactured without a licence from the innovator company

Answer 8

T

Question 9

T or F
A generic medicine is a pharmaceutical product that is marketed after expiry of the patent, or other exclusivity rights, associated with the innovator company

Answer 9

T

Question 10

T or F
Generic medicines are often prescribed for economic purposes. Generics lower the benchmark price when a patent expires, thus freeing up funds for listing of newer, drugs

Answer 10

T

Question 11

T or F
Generic substitution policy in Australia allows for the pharmacist, without reference back to the prescriber, to dispense a different brand of a drug if desired, even though the prescriber has written a prescription for a particular brand.

Answer 11

T

Question 12

T or F
Prescribers can’t endorse a prescription to prevent generic substitution.

Answer 12

F

Question 13

T or F
The pharmacist does not have to obtain patient consent before substitution from a brand name to a generic because the active ingredient is the same.

Answer 13

F
The pharmacist must obtain patient consent before substitution.

Question 14

Who evaluates all pharmaceutical products that are intended to be listed on the PBS as interchangeable or generic bands?

Answer 14

The Australian Therapeutic Goods Administration (TGA)

Question 15

Before the Australian Therapeutic Goods Administration (TGA) lists a products on the PBS as interchangeable it assesses these products for…

Answer 15

quality and bioequivalence.

Question 16

Define a bioequivalent (generic) medicine

Answer 16

An identical version of an already registered medicine that provides similar plasma concentrations of the same active ingredient.

Question 17

Define a biosimilar medicine

Answer 17

A highly similar version of an already registered biological medicine that has been assessed to be highly similar to the reference biological medicine in terms of safety, effectiveness, physiochemical characteristics, biological characteristics, and immunological characteristics.

Question 18

Under the PBS …-flags are used to indicate that different pharmaceutical benefit items are equivalent for the purposes of substitution by the pharmacist at the time of dispensing, without reference to the prescriber.

Answer 18

‘a’-flags

Question 19

T or F
If a medicine is not ‘a’-flagged under the PBS with a brand name it cannot be substituted

Answer 19

F
Not being ‘a’-flagged does not necessarily indicate a lack of safety or efficacy, but in these circumstances, caution should be taken if brands are interchanged. Any decisions to substitute one brand for another should not place patients at risk.

Question 20

Why should pharmacists aim to provide a patient with the same brand for long-term therapies?

Answer 20

To avoid patient confusion and duplication in therapy

Question 21

In which situations is it highly advisable to avoid or not appropriate to substitute between drug brands?

Answer 21

• Medicines with a narrow therapeutic index (critical dose medicines)
• Risk of confusion, anxiety or harm (e.g. patients on complex medicine regimes, those with cognitive or vision impairments, ESOL). Some patients may start taking the same medication twice not realising the two different packets contain the same medication!
• Possible negative impact on adherence (patients taking drugs for a mental illness need consistency)
• Excipients (allergies, intolerances, religious or cultural concerns e.g. gelatin)
• Device. Where a device is used to administer, the advice my differ between brands.

Question 22

What pharmacokinetic parameters are compared between the innovator and the generic drug product during bioequivalence testing?

Answer 22

CMAX, TMAX and AUC 0-infinity

Question 23

What is the most important pharmacokinetic parameter to measure during bioequivalence testing?

Answer 23

AUC 0-infinity

Question 24

The 90% confidence limit for the mean value of the ratios of a pharmacokinetic parameter (over all subjects) must fall within the range…

Answer 24

0.8-1.25

Question 25

T or F
Having a higher AUC means that you clear a drug quickly

Answer 25

F
more slowly

Question 26

T or F
All drugs must be dosed every half-life?

Answer 26

F

Question 27

T or F
It is drug in the blood that is exposed to hepatic or renal elimination.

Answer 27

T

Question 28

T or F
Generally speaking the larger the volume of distribution of a drug, the more the drug is
concentrated in a person’s body blood compared to their tissues.

Answer 28

F
Generally speaking the larger the volume of distribution of a drug, the more the drug is
concentrated in a person’s body tissues compared to their blood.

Question 29

T or F
If the volume of distribution of a drug is small, most of the drug is in the blood rather than the body tissues.

Answer 29

T

Question 30

t1/2 and k are determined by both …

Answer 30

CL and V