CSB601 Week 1

What does QUM stand for?

Quality Use of Medicines.

What are the four principles of QUM?

Judicious, appropriate, safe and effective medicine use.

What does judicious use mean in QUM?

Use a medicine only when needed; consider whether a non-drug option is preferable.

What does appropriate use mean in QUM?

Match the medicine and regimen to the patient's condition and circumstances.

What does safe use mean in QUM?

Minimise adverse effects, interactions, contraindications and medication errors.

What does effective use mean in QUM?

Achieve the intended benefit and monitor treatment response.

Why must QUM be person-centred?

Choice must consider evidence alongside the patient's needs, preferences, circumstances and ability to follow treatment.

What is the key clinical question before starting any medicine?

Does this patient need a medicine for this problem at all?

What are the 5 linked therapeutic decision questions in QUT Week 1?

What is the problem? Is medicine needed? Which treatment is best? Is it safe? Is it working?

Name two ways to judge whether treatment is working.

Clinical symptom/functional change and objective monitoring such as blood pressure or laboratory results.

What is shared decision-making?

Clinician and patient weigh evidence, risks, benefits and preferences to agree on treatment.

What does interprofessional collaboration improve in medication management?

Communication, medicine reconciliation, monitoring and medication safety.

Which Australian resource focuses on evidence-based information about a specific medicine?

Australian Medicines Handbook (AMH).

Which Australian resource mainly recommends treatment for a specific condition?

Therapeutic Guidelines (eTG).

Which two Australian databases are useful for screening several concurrent drug interactions?

MIMS/eMIMSelite and AusDI.

Which database is particularly useful for herbal/complementary medicine evidence?

Natural Medicines (NatMed).

Which body regulates therapeutic goods in Australia?

Therapeutic Goods Administration (TGA).

Which register is used to confirm therapeutic goods are registered/listed in Australia?

Australian Register of Therapeutic Goods (ARTG).

Which resource checks medicine subsidies and restrictions in Australia?

Pharmaceutical Benefits Scheme (PBS).

Is PBS registration the same as TGA registration?

No. TGA regulates registration/listing; PBS determines subsidy listings and restrictions.

Which resources together best support evidence-based antibiotic selection and medicine details?

Therapeutic Guidelines (treatment choice) plus AMH (medicine details).

Where would you look for official Australian medicine Product Information?

TGA Product Information, or medicine references such as MIMS/AusDI.

Which resource would you consult for a multi-drug interaction screen in polypharmacy?

MIMS or AusDI; assess clinical significance, not just the alert.

Which source is particularly relevant to echinacea or St John's wort efficacy and safety?

Natural Medicines (NatMed).

Which resource would you choose for a drug's usual dose, cautions and adverse effects?

AMH; MIMS/AusDI also contain useful medicine monographs.

Why use more than one source for a difficult medicine decision?

Different sources cover treatment choice, medicine specifics, special populations and interactions differently.

What does AUST R mean?

Registered medicine: evaluated for quality, safety and efficacy before registration.

What does AUST L mean?

Listed medicine: lower-risk, with safety/quality requirements; no routine TGA premarket efficacy assessment of its claims.

What does AUST L(A) mean?

Assessed listed medicine: a listed product with TGA-assessed supporting efficacy evidence for permitted indications.

Does AUST L(A) automatically require a prescription?

No. Assessed listed status is not the same as prescription-only status.

Which category includes prescription medicines: AUST R or AUST L?

AUST R.

Does an AUST L number prove that a herbal product is effective for its claim?

No. Standard listing does not mean efficacy evidence was individually assessed before marketing.

What is the key evidence difference between AUST L and AUST L(A)?

AUST L(A) undergoes evaluation of evidence supporting assessed indications; ordinary AUST L does not.

What types of products can the TGA regulate beyond tablets?

Vaccines, medical devices, sunscreens, supplements, tests and other therapeutic goods.

Where can consumers and clinicians report suspected adverse drug reactions?

To the TGA.

Which authority authorises supply and monitors the safety of therapeutic goods in Australia?

TGA.

What is an active ingredient?

The substance responsible for a medicine's pharmacological effect.

What is a brand name?

A manufacturer's proprietary name for a product containing an active ingredient.

What is a generic medicine?

A medicine with the same active ingredient and demonstrated bioequivalence to its reference product, subject to relevant requirements.

What does bioequivalence mean in QUT Week 1?

The active ingredient reaches the body at a sufficiently similar rate and extent to the reference medicine.

Can bioequivalent brands have different excipients or packaging?

Yes. Fillers, colours or formulations may differ despite equivalent active ingredient exposure.

Does generic substitution mean every excipient must be identical?

No. The relevant active ingredient and bioequivalence requirements matter; excipients may differ.

Why check both brand and ingredient names during reconciliation?

Different brands may contain the same active ingredient, creating accidental duplicate therapy.

What is an adverse drug reaction (ADR)?

An unintended harmful response to a medicine taken at usual doses.

Does a symptom starting after a medicine prove it caused the symptom?

No. Assess timing, clinical features, other medicines and alternative explanations.

What is a medication error?

A preventable mistake in prescribing, dispensing, administration or monitoring that can cause inappropriate medicine use or harm.

What must a best possible medication history include?

Prescription, OTC, complementary, PRN and intermittent medicines, plus what the patient actually takes.

What is medication reconciliation?

Comparing a verified medication history with orders/records to identify and resolve discrepancies.

What is adherence?

The extent to which medicine-taking behaviour matches the agreed treatment plan.

What should be assessed first if a patient often misses doses?

The reason: forgetting, side effects, cost, beliefs, swallowing difficulty or regimen complexity.

How would you respond to unintentional forgetting of doses?

Consider reminders, routine linking or a suitable dose organiser after checking the regimen.

Why ask specifically about herbal products and supplements?

Patients may omit them from medicine lists, yet interactions and adverse effects are possible.

Why is 'natural' not the same as 'safe'?

Complementary products can cause harm, interactions or delay effective treatment.

What is a prescribing cascade?

A drug adverse effect is mistaken for a new illness, prompting another unnecessary medicine.

What is deprescribing?

A planned and supervised reduction or discontinuation of medicine no longer appropriate or causing harm.

What is the first action before changing an elderly patient's complex medicines after discharge?

Reconcile all actual medicines with records and explore safety/adherence problems.

A patient reports feeling fine after six weeks on a lipid drug. What proves efficacy?

Compare current and baseline lipid profiles against individualised targets.

Why should dose decisions consider both benefit and harm?

Higher doses may improve effect but also increase adverse effects; individual therapeutic windows vary.

How should a clinician assess an uncertain ADR?

Examine medicine exposure and timing, symptoms, other causes, interactions and appropriate monitoring.

What is the safest counselling approach when a patient struggles with a regimen?

Explore their specific barrier before choosing a practical, person-centred solution.

What safety issue arises when two OTC products contain paracetamol?

Accidental duplication of the active ingredient and excessive total daily dose.