The Four Phases of Clinical Trials
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 volunteers ranges from a minimum of 20 to a maximum of 80. The testing at this phase is to check how the drug 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 on volunteers. Mostly blinded trial phase, where two groups of participants are involved, one being administered with the drug tested and the other group with a placebo or standard available medicine. 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 number of 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 drug. The comparisons with other drugs present in the market are also done at this stage. (Overview of Clinical trials)
Administration (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 in the market are up to the standards specified. The TGA is also responsible for import, export of drugs, advertisements for therapeutic goods in Australia. (Australian Government Department of Health)
Since all therapeutic products carry some amount of risk and benefits, the TGA tests them with scientific and clinical expertise to assess if the benefits of a drug outweigh its side effects.
- Identifying, evaluating and assessing any risks that the drugs might pose on usage.
- Applying any corrective measures to reduce the risk or eradicate it
- Monitoring the progress after the corrective measures are taken to ascertain the safety of the drugs.
After such processes, the medicines are awarded two numbers depending upon the type of drug under certification:
- The Australian Register of Therapeutic Goods registers all the high risk medicines by evaluating the quality of the drug, its safety and effectiveness. After the clinical trials, they get awarded the AUST R number.
- 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 in supermarkets, or health shops. (Australian Government Department of Health. TGA, 2013)
The pharmacokinetics are defined as “ the study of the movement of drugs in the body, including the processes of absorption, distribution, localization, bio-transformation and excretion.“ (Pharmacokinetics-Medical Dictionary)
- Absorption- This is a phase which defines the course which the drug takes from the time it is administered to when it enters the blood stream.
- Distribution – This phase is when the drug is transported through the blood stream to the intended site. The distribution of each drug differs depending upon its action.
- Metabolism (bio-transformation)is a stage where the drug is metabolized and the drug becomes inactive. It happens in the liver.
- Excretionis when the drug, after metabolism, is eliminated from the body, through the kidneys (The Free Dictionary, 2017).
It is a branch of pharmacology which studies the effect of drug and its biochemical, molecular and physiological effects of drugs on the human body. This study acts as a deciding factor for dosage of a drug and also helps in predicting the response to a particular illness. Pharmacodynamics of a drug can be affected, by any disorder, age, and involvement of other drugs within the system. (Farinde, 2016)
The Role of the Therapeutic Goods Administration
The hepatic first pass effect or the first pass metabolism is a process where some of the active substance present in the drug is removed or metabolized from the blood stream before it enters the general circulation system. The concentration of drug, is reduced through the first pass effect. It is called the Hepatic First pass effect, since the site of metabolism of the drug is liver. This effect is a process which happens during the absorption and transfer of drugs from the administration site to the site of action. The gut wall and the liver are the possible metabolism sites (Study.com, 2017)
A drug, when it is administered orally, passes through the digestive tract and enters the hepatic system. The portal veins from the hepatic system carry the drug to the liver. The liver, with its potential enzymes metabolizes the drug, (any active ingredient present) and thus, only some of the potentially active ingredients of the drug manages to escape into the circulatory system. The bio-availability of a drug is greatly reduced by the hepatic first pass effect. The enzymes present in the liver, gut wall, hepatic system and the gastrointestinal lumen, act on the active ingredients of the drug to metabolize it.
Thus, the drugs which have a high hepatic first pass effect are usually given in higher oral doses, to allow at least a substantial amount of active ingredients to reach the potential site(and the circulatory system), after its passage through the liver. Examples of such drugs are morphine and diazepam (Encyclopedia.com, 2016)
The area below the tongue and cheek has a lot of capillaries (tiny blood vessels). This helps in absorption of medication immediately into the bloodstream, instead of taking the long route of the digestive system, and the liver.
Glyceryl Trinitrate is a drug usually administered to help improve the working of the heart. Since it needs to be absorbed instantly, in case of seizures and heart attacks, it is administered sublingually (Marshall, 2015).
- List TWO (2) specific areas of education you should deliver to the patient that only relate to the medication Glyceryl Trinitrate
Glyceryl Trinitrate needs to be used carefully and the following instructions have to be adhered strictly:
- Do not chew or suck the tablets. They are to be placed under the tongue and allowed to dissolve slowly.
- One should always sit down and rest while taking the tablet, to avoid dizziness.
- The tablet should be placed under the tongue in case of heart pain and a repeat dose can be given in case the chest pain does not ease. However, if the pain persists for longer than 15 minutes, medical intervention is required.
- Registered Nurse
Registered nurses or RNs have a great many support role in clinics, hospitals and healthcare units. The place they work decides upon the duties of a nurse, and their active involvement in diagnosis and treatment of patients.
- Monitor, register and record patients’ conditions (changes, stability, and so on)
- Maintain detailed and accurate reports about the conditions and changes
- Educate patients on drugs to be taken, with prescribed dosage and timings
- Evaluate diagnostic tests and interpret the reports to make changes in medications
- Prepare the patients for examination and assist the consultants during physical examination (Greenwood, 2017).
- Diagnose and prescribe medicines, order diagnostic tests depending upon the conditions of the patients.
- Perform surgeries, including emergency surgeries where and when required.
- Neurologists, cardiologists and aesthetics have their own specific role as surgeons, in major operations.
- Doctors make important decisions in patient care and instruct the health care workers and nurses as to how and what medications needs to be administered or what instructions to be given to the primary caregivers.
- Doctors have the authority to make any changes in medication, increase dosages or introduce new drugs to improve patient’s conditions.
- c) Pharmacist
- Be able to provide appropriate and prescribed medications to the patients. Should have managerial and computer skills to handle emergency situations with panache.
- Collaborate with the physicians and health care workers to deliver medications as the prescription demands and whenever the necessity arises.
- Have in depth knowledge of the medications, their use, any side effects and interactions with other drugs.
- Supervise the pharmacy store and counsel and advise patients on health and nutrition.
- Specialize in dispensing medications appropriate for a specific purpose, such as heart condition, cancer, and so on.
- Error in prescribing, includes wrong dose, wrong route of administration, wrong frequency, wrong drug and wrong time.
- Dispensing errors, including incorrect preparation of an infusion solution, dispensing of an expired drug, equipment failures (syringe defect), IV fluid leak or the line struck, dispensing a drug too late, and so on.
- Infusion pump – forgetting to set the infusion line, no written communication or non-compliance failure (Allard et al., 2008).
- Fragmented care errors, such as lack of proper communication between the physician and health care professional.
- Wrong drug preparation error, where the medicines to be administered intravenously is done orally or vice versa.
- Lapse in memory, where a nurse might just forget that a patient is allergic to a drug. This happens due to distraction. Not remembering the maximum daily dose and administering more than required or less than necessary can also be the cause of memory lapse.
- Problems with systems, such as not labelling the drugs categorically, medicines of similar names placed nearby or lack of bar coding can cause the errors.
- Lack of understanding or proper knowledge in health workers can lead to errors in remembering or administering drugs with generic name.
- No proper patient information or lack necessary information such as previous history or allergies can lead to errors.
- An overworked nurse or health care worker might, due to exhaustion, causes errors.
A person-centered approach is where the whole system, from care to drug administration revolves around the patient (a person). The person here is at the center, and he is educated to administer the dosage of drug prescribed. The problem here is that since the patient is not knowledgeable enough, he or she might take excess, less or can time the drug intake wrong, to create the error.
Understanding Pharmacokinetics and Pharmacodynamics
In a system centered approach, the system is in the middle, and the system involves everyone, from doctors, nurse to health care workers. Here, the error arises due to several factors, such as no proper communication, overworked staff, no proper lighting in the area, negligence and lapse of memory.
Reason’s (1990) ‘Swiss Cheese Model’. Briefly explain how these factors can prevent a medication error from occurring (4 marks)
The Swiss cheese model described defence layer as a prevention of errors. The high-technological operations in many hospitals have alarm systems and physical barriers for ‘defence’, which might prevent an error from occurring.
The barriers might come up in the form of ‘holes’ not aligned with each other- where a health worker might be required to report to the nurse on the drug administered, and they might pinpoint the error. Hence, one point failure might not lead to complete error, where there are ‘safeguards’ in the system in the form of several layers.
Doctors- Nurse- health care workers- patient- This whole sequence may become impenetrable, since ‘holes’ or ‘errors’ can be reverted due to non-alignment, as per the Swiss cheese model.
As the model predicts, having one system over the other, or having ‘defenses in place (in line) can save the errors from occurring. If one in the line fail, (say, a health care worker has mislaid information), the nurse who is monitoring can revert the error immediately. Thus, Swiss Cheese model can help in error defection (Duke University School of Medicine, 2016).
- c) Holes in the defences arise because of active failures and latent conditions. In relation to medication errors identify:
Latent or dormant conditions, are, within the system, and sometimes, becomes inevitable.
- Time-pressure of the nurses and health workers
- Overworking, understaffing conditions and no proper equipment in place
- No alarms or efficient indicators, no standard procedures in place or design deficiencies in the equipments.
The latent failures, may or may not cause an error, because, the other person who is monitoring, or in charge, might prevent the error from happening. However, latent conditions, if persistent, can cause a long lasting holes within the system (Reason, 2000)
- Violations caused by nurses and health care workers (who are in direct contact with the patient), such as slips in care, mistakes in drug administration, and violations in procedure.
- Instructions not read properly or not understood or simply ignored.
- Mistakes due to negligence, while administering infusions, or IV fluids or potent drugs and not reading the patients’ allergy reports.
Errors occur in every system, and the medical field is no less immune to it.
There are several factors which contribute to medication errors.
- Mistakes in drug administration– giving wrong dosages, wrong drug or not noting down the allergy symptoms.
Causes: Look-alike drugs and should –like medicines can cause confusion in health care workers, no proper system to convey information, no proper knowledge to administer drugs or understand instructions. Medical abbreviations used by professionals might lead to confusion, and as a result, can cause serious errors (Medcom Trainex, 2017)
- Errors in prescription of drugs by nurses and doctors, wherein the patient condition was not monitored properly and thereby making the mistake of giving wrong medication.
Causes: Poor communication – Poor communication in the system- between nurses and health care workers, doctors and nurses, patients and nurses, and patients and doctors. The allergic symptoms not noted clearly.
- Way of administering a drug:An IV fluid administered orally or through infusion, can cause serious error.
Causes: Here again, the cause may be due to improper communication, no knowledge of the drug or its administration techniques.
- Inaccurate or incomplete diagnosis of a disease or illness
Causes: No proper knowledge about the disease or its cause, communication error between the patients and the doctor, the patient not able to relate the problems clearly, error in the diagnosis report.
- Errors in nursing care due to negligence.
Causes: Overworked staff, poor knowledge of conditions, uncooperative patients or no systems in place for essential information to be passed between consultants and care takers.
References:
U.S. Food and Drug Administration Commissioner (2017). The Drug Development Process – Step 3: Clinical Research. Retrieved from https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm [Accessed on 21st Aug 2017]
Center Watch (2017). Overview of Clinical Trials. Retrieved from https://www.centerwatch.com/clinical-trials/overview.aspx [Accessed on 21st Aug 2017]
Australian Government Department of Health. Therapeutic Goods Administration. (n.d.). About the TGA. Retrieved from https://www.tga.gov.au/about-tga [Accessed on 21st Aug 2017]
Australian Government Department of Health. Therapeutic Goods Administration. (2013). Listed medicines: The role of Australia’s medicines regulator. Retrieved from https://www.tga.gov.au/community-qa/listed-medicines-role-australias-medicines-regulator [Accessed on 21st Aug 2017]
Australian Government Department of Health. Therapeutic Goods Administration. (n.d.). Medicines and TGA classifications. Retrieved from https://www.tga.gov.au/medicines-and-tga-classifications [Accessed on 21st Aug 2017]
Duke University School of Medicine (2016). Swiss Cheese Model. Retrieved from https://patientsafetyed.duhs.duke.edu/module_e/swiss_cheese.html [Accessed on 21st Aug 2017]
The Free Dictionary (2017). Pharmacokinetics. Retrieved from https://medical-dictionary.thefreedictionary.com/pharmacokinetics [Accessed on 21st Aug 2017]
Farinde, A. (2016). Overview of Pharmacodynamics – Clinical Pharmacology. Retrieved from https://www.msdmanuals.com/professional/clinical-pharmacology/pharmacodynamics/overview-of-pharmacodynamics [Accessed on 21st Aug 2017]
Study.com (2017). The First Pass Effect in Pharmacology. Retrieved from https://study.com/academy/lesson/the-first-pass-effect-in-pharmacology.html [Accessed on 21st Aug 2017]
Encyclopedia.com (2016). First-pass metabolism. Retrieved from https://www.encyclopedia.com/caregiving/dictionaries-thesauruses-pictures-and-press-releases/first-pass-metabolism [Accessed on 21st Aug 2017]
Marshall, H. (2015). GTN sublingual tablets (glyceryl trinitrate). Retrieved from https://www.netdoctor.co.uk/medicines/heart-and-blood/a6820/gtn-sublingual-tablets-glyceryl-trinitrate/ [Accessed on 21st Aug 2017]
Greenwood, B. (2017). Role of a Nurse in Health Care. Retrieved from https://work.chron.com/role-nurse-health-care-6967.html [Accessed on 21st Aug 2017]
Learn.org (2017). What are the duties of a Pharmacist? Retrieved from https://learn.org/articles/What_are_the_Job_Duties_of_a_Pharmacist.html [Accessed on 21st Aug 2017]
Allard, J., Carthey, J., Cope, J., Pitt, M., & Woodward, S. (2008). Medication Errors: Causes, Prevention and Reduction. Retrieved from https://onlinelibrary.wiley.com/doi/10.1046/j.1365-2141.2002.03272.x/full [Accessed on 21st Aug 2017]
Medcom Trainex (2017). Medication Errors in Nursing: Common Types, Causes, and Prevention. Retrieved from https://www.medcomrn.com/index.php/articles/common-nursing-medication-errors-types-causes-prevention/ [Accessed on 21st Aug 2017]
Terry’s Post (2013). Describe Person-Centred ways of Administering Medicines whilst adhering to Administration. Retrieved from https://pensbyterry.com/describe-person-centred-ways-administering-medicines-whilst-adhering-administration/ [Accessed on 21st Aug 2017]
Reason, J. (2000). Human error: models and management. West J Med., 172(6), 393-396.
Order an Essay Now & Get These Features For Free:
Turnitin Report
Formatting
Title Page
Citation
Outline
