Evaluating Medicines for Entry to the Australian Register of Therapeutic Goods - Medical Science Assignment Help

Assignment Task:

Task:

The Therapeutic Goods Administration (TGA) is responsible for all of the following except:
Select one:
a.Evaluating medicines for entry to the Australian Register of Therapeutic Goods
b.Ongoing monitoring of the quality of medicines manufacturing 
c.Regulating the packaging and product information documents of medicines
d.Evaluating medicines for entry to the Pharmaceutical Benefits Scheme
e.Post-market surveillance of adverse drug events
f.Regulating the advertising of medicines
The AMH provides the following information of dependence occurring with benzodiazepine use: "Use of benzodiazepines can lead to physical and psychological dependence (even if used for short periods), tolerance and misuse (as a result, alprazolam and flunitrazepam are controlled drugs)". 
Which of the following statements describes the pharmacokinetic basis for why alprazolam is a controlled (Schedule 8) drug, whereas diazepam is a prescription only (Schedule 4) drug?
Select one:
a.Alprazolam has a longer half-life than diazepam
b.Alprazolam has active metabolites and diazepam does not
c.Diazepam has active metabolites and alprazolam does not
d.Alprazolam has a shorter half-life than diazepam
A 50-year old female is initiated on metformin 1 g extended release tablets at a dose of one tablet daily with dinner for type 2 diabetes mellitus. After three months on metformin, the patient experiences fatigue, myalgia, abdominal pain and diarrhoea. She presents to the emergency department of her local hospital and is treated for lactic acidosis. Lactic acidosis is a rare but serious adverse effect associated with metformin, which is featured as a "boxed warning" in the Product Information for metformin products. 
Based on the lactic acidosis "boxed warning" for metformin, select the most likely explanation for lactic acidosis occurring in this patient from the options below. 
Select one:
a.Reduced renal function
b.High metformin dose 
c.Age >40 years 
d.Reduced hepatic function 
In one sentence, state one promotional strategy that is being used in the advertisement for Lipitor (atorvastatin) below that was published in a journal read by medical practitioners (maximum 25 words). 

If a drug is particularly valuable, an important strategy for evergreening is for the manufacturer to develop a slightly modified follow-on drug, in anticipation of patent expiry and generic competition. 
All of the following pairs are examples of drugs with their respective slightly modified follow-on drugs, except for: 
Select one:
a.Perindopril and Irbesartan
b.Omeprazole and esomeprazole
c.Venlafaxine and desvenlafaxine
d.Dexamphetamine and lisdexamphetamine 
e.Citalopram and escitalopram 
Tom is a 25-year old male who was recently discharged from hospital after being treated for an acute asthma exacerbation. Based on Tom's characteristics, it was estimated that he will be at relatively high (20%) risk of having an asthma relapse in the next month. It has been reported that for patients like Tom, use of an inhaled corticosteroid reduces the risk (i.e. relative risk reduction) of relapse by 38%. As such, Tom is initiated on a prescription for inhaled budesonide at a follow-up appointment with his GP following his discharge from hospital. 
What is the relative risk of experiencing an exacerbation of asthma with corticosteroid treatment? Please provide your answer as a percentage. 
What is the absolute risk reduction (ARR) of experiencing an asthma exacerbation with budesonide? Please provide your answer as a percentage. 
What is the number needed to treat (NNT) for budesonide? 
Describe the specific meaning of the NNT value you have just calculated. The description should clearly and concisely convey the meaning in a manner that is easily understood by well-educated non-expert (e.g. a health professional who is not familiar with the term NNT).
Sam is a 65-year old retiree that has previously suffered a myocardial infarction. His serum LDL cholesterol levels have been found to be 3.3 mmol/L and his GP is aiming to reduce Sam's LDL levels to below 2 mmol/L in order to significantly reduce his risk of another myocardial infarction. 
The following table has been adapted from table 2 in the publication ‘M R Law, N J Wald, A R Rudnicka. BMJ 2003;326:1423’ (http://dx.doi.org/10.1136/bmj.326.7404.1423) and provides average reductions in serum LDL cholesterol concentration according to statin and daily dose.  

Using the percentage reductions reported in the table above, what is the minimum dose of simvastatin that Sam would be expected to need in order to achieve his target LDL cholesterol level? 
Select one:
a. 5 mg of simvastatin
b.10 mg of simvastatin
c.20 mg of simvastatin
d.40 mg of simvastatin
e.80 mg of simvastatin
f. No dose will achieve the required reduction
Using the percentage reductions reported in the table above, what is the minimum dose of atorvastatin that Sam would be expected to need in order to achieve his target LDL cholesterol level? 
Select one:
a.5 mg of atorvastatin
b.10 mg of atorvastatin
c.20 mg of atorvastatin
d.40 mg of atorvastatin
e.80 mg of atorvastatin
f.No dose will achieve the required reduction
Following a short stay in hospital following a myocardial infarction, Robert is discharged with a number of new medications including an anti-platelet drug called prasugrel. It is common to use dual anti-platelet therapy for 12 months following a myocardial infarction in order to reduce the risk of a second myocardial infarction. For many years a combination of aspirin and clopidogrel has been used for this purpose. However, the use of a newer anti-platelet drug prasugrel in place of clopidogrel is now being considered.
Per individual treated prasugrel costs $96.77 per month, in comparison to $19.33 for clopidogrel. As prasugrel can reduce the risk of a second myocardial infarction, it is estimated that there will be reduced hospitalisation resulting in a cost savings of $187 per person treated with prasugrel instead of clopidogrel (i.e. over the entire treatment period). It is estimated that if prasugrel is used a person will have 13.325 QALYs on average, whereas if clopidogrel is used a person will have 13.300 QALYs on average.
What is the incremental (additional) cost of prasugrel assuming that individuals will use the drugs 12 months following a myocardial infarction? Please provide your answer to the nearest cent.
How many additional days at full quality of life does prasugrel confer over clopidogrel? Please round your answer down to the nearest full day. 
What is the incremental cost-effectiveness ratio (i.e. cost per QALY) of prasugrel assuming that individuals will use the drugs 12 months following a myocardial infarction? Please provide your answer to the nearest cent. 
The third part of the assignment asks you to discuss the evidence surrounding the efficacy and safety of drugs of your choice in a series of short-answer questions. 
This section of the assignment requires that you select two medicines that you will compare to answer the following questions. Please select medicines that you have an interest in exploring the efficacy and safety of (e.g. medicines that you use or will prescribe in your area of practice). 
Both medicines must be used for the same indication.
Preferably, the medicines will be from different classes (e.g. an ACE inhibitor and an angiotensin receptor blocker for hypertension). 
Please do not select a medicine previously mentioned in this assignment. 
i) State the generic name of the chosen medicines.
ii) State the indication that you will focus on with respect to answering the following questions (some medicines have multiple indications, but it is important you choose one specific indication for the purposes of this assignment). 

•  
• Discuss and critically evaluate the main evidence (e.g. from clinical trials and/or meta-analysis) supporting the efficacy/effectiveness of your medicines with respect to the treatment of the primary indication of interest (maximum 250 words). 
• Note: You will need to conduct a brief literature search to identify the main evidence. 
• i) State one potential adverse effect of medicine 1 that you believe is particularly important for a prescriber of the drug to be aware of (maximum 1 sentence). 
• ii) Briefly explain the pharmacological/mechanistic basis of the adverse effect. If the pharmacological basis is not well understood, please indicate that this is the case and focus on the most likely theory (maximum 150 words). 
• Discuss and critically evaluate the main evidence (e.g. from clinical trials, meta-analysis) supporting the relationship between medicine 1 and the adverse effect (maximum 200 words). 
• Note: You will need to conduct a brief literature search to identify the main evidence. 

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