Question 1

What does it mean when a medicine is sold under patent?

Accepted Answer

When a medicine is sold under patent, it means that the pharmaceutical company that manufactured it has exclusive rights for a certain period of time (usually 20 years) to market and sell the medicine under a particular brand name. This prevents other pharmaceutical companies from producing and selling the same medicine under the same name, but they may be able to produce and sell generic versions of the drug once the patent has expired.

Question 2

Into which medicines in pregnancy category is a drug assigned that has caused or is suspected of causing fetal harm,but not malformations?

Accepted Answer

Category B medications are considered safe in animal studies but there are no well-controlled studies in pregnant women, or animal studies have shown an adverse effect, but well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities. Category C medications may have adverse effects on the fetus in animal studies and there are no well-controlled studies in pregnant women. Category D medications have demonstrated risk to the human fetus, but potential benefits may outweigh the potential risks in certain situations. Category X medications have demonstrated fetal abnormalities and/or risks outweigh any potential benefits and should not be used in pregnancy. Therefore, a drug that has caused or is suspected of causing fetal harm, but not malformations, would fall under Category B.

Question 3

A type of hypersensitivity reaction to a drug,described as anaphylaxis,which is mediated by IgE antibodies,is a:

Accepted Answer

Anaphylaxis is a classic example of a type I hypersensitivity reaction, which is considered an immediate hypersensitivity response and involves the production of IgE antibodies. In this type of reaction, mast cells release histamine and other mediators in response to the binding of the allergen to IgE molecules on their surface, causing a range of symptoms such as vasodilation, increased vascular permeability, smooth muscle contraction and bronchoconstriction. Other examples of type I hypersensitivity reactions include allergic rhinitis, food allergies, asthma, and allergic dermatitis.

Question 4

Only a few medicines are excreted in breast milk.

Accepted Answer

Many medicines can be excreted in breast milk, and some can cause harm to the nursing infant. It is important for breastfeeding mothers to discuss any medications they are taking with their healthcare provider to determine if they are safe to take while breastfeeding.

Question 5

Subacute toxicity tests are characterised by:

Accepted Answer

Subacute toxicity tests involve repeated drug doses over a period of days to reveal tissue targets for damage. This test helps to identify adverse effects that may occur with prolonged exposure to the drug.

Question 6

Which of the following tests characterises the drug screening process?

Accepted Answer

The identification of a chemical with potential therapeutic action is a key step in the drug screening process, as it determines whether or not a potential drug candidate should be further developed and tested for safety and efficacy. Testing for drug potency in humans and monitoring adverse effects come later in the process, while assessing drug toxicity in animals is an early step but not necessarily a defining characteristic of the screening process.

Question 7

Which form of hypersensitivity reaction is characterised by antibody-antigen complexes that precipitate out of the blood and lodge in tissues such as skin and joints,inducing an inflammatory response?

Accepted Answer

Type III hypersensitivity reactions involve the formation of immune complexes (antibody-antigen complexes) that are deposited in tissues like skin and joints, leading to an inflammatory response. This type of reaction is also sometimes called immune complex-mediated hypersensitivity.

Question 8

The ability of a drug to produce an effect at a receptor is referred to as:

Accepted Answer

Affinity refers to how strongly a drug binds to a receptor, specificity refers to the selectivity of the drug for a particular receptor, and potency refers to the concentration of drug required to produce a certain effect. Efficacy refers to the ability of a drug to produce a maximal effect at a receptor, regardless of its potency or affinity. Therefore, the correct answer is C- efficacy.

Question 9

A protein-bound drug may get displaced by another drug through competition for binding sites on plasma proteins.The displaced drug may then exert toxicity if it has a lower margin of safety.

Accepted Answer

When a protein-bound drug is displaced by another drug, it may lead to an increase in the free, unbound concentration of the displaced drug which may increase its toxicity if it has a lower margin of safety. This is known as displacement interaction. Therefore, the statement is true.

Question 10

The transfer of drugs from the maternal circulation into fetal circulation depends on the dose and physicochemical properties of the drug,and transplacental transport systems.

Accepted Answer

The statement is true.

Question 11

The final decision to approve a drug for marketing in Australia and New Zealand rests with the:

Accepted Answer

The final decision to approve a drug for marketing in Australia and New Zealand rests with the ministerial council (health). The Medicines Assessment Advisory Committee and the Australian Drug Evaluation Committee provide recommendations to the council, but do not have the final decision-making authority. The Pharmaceutical Society is a professional society for pharmacists and does not have a regulatory role in drug approvals.

Question 12

The terms side effect and adverse effects are interchangeable.

Accepted Answer

While side effects refer to any unintended effects of a medication or treatment, adverse effects specifically refer to negative or harmful effects that can lead to injury, illness or death. Therefore, adverse effects are a subset of side effects, and the terms should not be used interchangeably.

Quiz 17: Drug Development, Evaluation and Safety