1807NRS - Safe Administration of Medication
Added on 2020-03-04
17 Pages3522 Words129 Views
Healthcare and Research
|
|
|
Nursing Workbook 1Nursing WorkbookStudent's Name:Instructor's Name:Date:
Nursing Workbook 2Q. 1. Pharmaceutical companies conduct clinical trials to determine the efficacy(effectiveness) and safety of a medication. Briefly outline the FOUR (4) phases of clinicaltrials.Answer: The clinical trials are spread out in four phases and each step has a definite goal to perform:Phase – 1: The first step involves testing the drug on the volunteers. Usually, the number of volunteersranges from a minimum of 20 to a maximum of 80. The testing at this phase is to check how thedrug is metabolized and excreted and also to monitor the side-effects, if any.Phase – II: This phase lasts from several months to two years and is used to test the efficacy of the drug onvolunteers. Mostly blinded trial phase, where two groups of participants are involved, one beingadministered with the drug tested and the other group with a placebo or standard availablemedicine. The safety of the drug to the patients is also tested.Phase – III:Further efficacy, safety and the effect of drugs on the patients is tested in this phase. The numberof volunteers increases to thousands. Phase – IV:This phase is done as a ‘Post marketing surveillance’ of the drug, to further test its effectiveness,safety features and the quality of health endured by the patients who are administered with the
Nursing Workbook 3drug. The comparisons with other drugs present in the market are also done at this stage.(Overview of Clinical trials)Q. 2 a) Briefly outline the main responsibility of the Therapeutic GoodsAdministration (TGA) Answer: TGA is the regulatory authority for therapeutic goods including drugs, medical devices,and other related products. It is the responsibility of the TGA to ascertain if the drugs available inthe market are up to the standards specified. The TGA is also responsible for import, export ofdrugs, advertisements for therapeutic goods in Australia. (Australian Government Department ofHealth)b) Describe TWO (2) ways medications are regulated by the TGA forUse in Australia Answer:Since all therapeutic products carry some amount of risk and benefits, the TGA tests them withscientific and clinical expertise to assess if the benefits of a drug outweigh its side effects. Accordingly, medicines are tested in two ways:1.Identifying, evaluating and assessing any risks that the drugs might pose on usage.2.Applying any corrective measures to reduce the risk or eradicate it3.Monitoring the progress after the corrective measures are taken to ascertain the safety ofthe drugs.
Nursing Workbook 4After such processes, the medicines are awarded two numbers depending upon the type of drugunder certification:a.The Australian Register of Therapeutic Goods registers all the high risk medicines byevaluating the quality of the drug, its safety and effectiveness. After the clinical trials,they get awarded the AUST R number.b.The Listed medicines, such as vitamin and herbal medications, which contain pre-approved as well as low risk ingredients get an AUST L number and can be purchased insupermarkets, or health shops. (Australian Government Department of Health. TGA,2013)Q. 3 Briefly define the terms pharmacokinetics and pharmacodynamics.Answer:The pharmacokinetics are defined as “ the study of the movement of drugs in the body, includingthe processes of absorption, distribution, localization, bio-transformation and excretion.“(Pharmacokinetics-Medical Dictionary)The four phases of pharmacokinetics are:1.Absorption- This is a phase which defines the course which the drug takes from the timeit is administered to when it enters the blood stream.2.Distribution – This phase is when the drug is transported through the blood stream to theintended site. The distribution of each drug differs depending upon its action.3.Metabolism (bio-transformation) is a stage where the drug is metabolized and the drugbecomes inactive. It happens in the liver.
End of preview
Want to access all the pages? Upload your documents or become a member.
Related Documents
1807NRS Safe Administration of Medication | Reportlg...
|12
|3228
|260
Safe Administration of Medications: Understanding Pharmacokinetics and Pharmacodynamicslg...
|12
|3279
|331
Safe Administration of Medications: Clinical Trials, TGA Regulation, Pharmacokinetics, Medication Errors and Swiss Cheese Modellg...
|15
|3241
|482
Safe Administration of Medicationslg...
|12
|3237
|42
Medication Safetylg...
|15
|3615
|224
Clinical Trial in a Pharmacylg...
|7
|1401
|95