Week 1 Study guide 2020 PDF

Preview

Summary

Download Week 1 Study guide 2020 PDF

Description

Week 1: Study guide Activity 2: TGA Go to: https://www.tga.gov.au/about-tga and answer the following questions: Estimated time 15 mins: 1. What is the role of the TGA? (Hint: https://www.tga.gov.au/role-tga ) - you can just read the transcript below the video if you wish A part of the Australian Government Department of Health - they are responsible for the regulation of the supply, import, export, and manufacturing/advertising of therapeutic goods in Australia. -ensure manufacturers meet standards -authorise supply of therapeutic goods here in Australia -monitor products for safety -This is also where we REPORT ADRs! 2. What does the TGA classify as therapeutic goods? -medications -supplements -complementary medicines -medical devices: bandages through pace makers! -tests and diagnostic materials -vaccines -biologic products -sunscreen -surgical implants 3. What is the difference between AUST L and AUST R numbers? Give an example of each. How are each assessed? (Hint: https://www.tga.gov.au/registered-and-listed-medicines ) - there is an option to simply read the transcript of this video below the video window) AUSTL: - Listed medicine: low risk -e.g vitamins, mineral supplements, herbal medications -safety and quality are assessed NOTE: NO EVIDENCE IS ASSESSED! -packaging must not make claims or imply that they will be useful in the treatment or prevention of serious illnesses that would require the involvement of a health professional. AUSTR: Registered medicine: high risk -e.g. all prescription meds, most OTC, some complementary meds -safety, quality AND evidence all assessed

**It’s important to tie back the relevance in these early weeks as to why they need to know this information for the cases and the assessment**

CSB601 Introduction to Clinical Therapeutics for Health, Study guide Week 1

Page 1 of 4

Activity 3: CASE 1 1. What is the difference between an active ingredient and a brand name? Active: chemical in the medicine that has a therapeutic effect, or that “makes it work” Brand name: manufacturers use a more memorable name 2. What does original brand/innovator mean? Original brand: first patented brand of a medicine. This is the first to gain a patent, which means no one else can manufacture/sell that medication for a specified time. 3. What is bioequivalence? Are all generic medicines “exactly the same”? Why/why not? Bioequivalent= the active ingredient is identical and the medicine is manufactured to have the same effect in the body. NOTE: it’s the TGA who determine this! All generics are not EXACTLY the same- they have the same active ingredient, but excipients/fillers/even dosage forms may change! e.g. tablets vs capsules, some may have lactose and others may not. 4. Where would you look to find what the brand names are of products containing morphine? Name 3 examples of Brand names of morphine available in Australia. -AUSDI, AMH -Sevredol, Anamorph, Ordine, MS Contin. MS Mono, etc… 5. What dosage forms does morphine come in? Where did you look to find this information? -tablet -AMH/AUSDI 6. Where can you confirm that this medication is registered in Australia? TGA 7. According to the eTG, what is the likely therapeutic indication for John regarding his morphine? Is it the same as AMH? What about MIMS Online or AusDI? (Use the chart below): Tutors please show them how to access eTG and AMH through QUT library (online) – once in, show them how to use the search bars to find things quickly! They should have done this as prework, but… Drug’s Therapeutic Indication from key resources Drug name (active ingredient, Brand Name)

E-TG

chronic non-malignant pain management

morphine

AMH

Moderate-to-severe pain (chronic)

AusDI/ MIMS Online

Opioid responsive chronic severe pain)

Now check for possible dosages and dosage ranges of morphine in all the different resources: Drug’s Therapeutic Dosage or Dosage Range from key resources Drug name (active ingredient, Brand Name)

E-TG

Controlled release, 5 to

morphine

10 mg orally, daily to twice daily

AMH

Controlled release, oral 5–20 mg twice daily

AusDI/MIMS Online Individualise dose. Adults: usually initially 30 mg every 12 hrsPatients > 50 yrs (incl elderly), debility, decr respiratory, renal function: initially ½ usual dose

SHARE your team’s collated responses to the classroom – facilitated by the tutors.

CSB601 Introduction to Clinical Therapeutics for Health, Study guide Week 1

Page 2 of 4

Activity 4 Adverse Drug Reactions (ADRs) Estimated time 20 mins Potential ADRs & frequency of ADRs from key resources Drug name (active ingredient)

morphine

e-TG

respiratory cardiovascular neurological dermatological gastrointestinal musculoskeletal neuroendocrine urinary Other tolerance physical dependence addiction pseudoaddiction […]

AMH Common (>1%) nausea and vomiting (below), dyspepsia, drowsiness, dizziness, headache, orthostatic hypotension, itch, dry mouth, miosis, urinary retention, constipation (below) Infrequent (0.1–1%) dose-related respiratory depression (below), bronchospasm, confusion, hallucinations, delirium, agitation, mood changes, tremor, visual disturbances, urticaria, hypothermia, bradycardia or tachycardia, hypertension, ureteric or biliary spasm, paralytic ileus, raised liver enzymes, muscle rigidity, myoclonus (with high doses), flushing due to histamine release (except alfentanil, fentanyl and remifentanil), hypogonadism (more frequent with long-term use and in men) Rare (...