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Clinical Trials Phases

Discuss about the Safe Administration of Medications for Morbidity and Mortality.

Medication-related errors are some of the significant causes of morbidity and mortality. Therapeutic Goods Administration(TGA) manages the developments on medication and determent of medication errors. This report would be a short examination of the questions in the area of medicine.

Clinical trials usually take four stages (Cingi & Muluk, 2016). In phase I, practitioners study the maximum dose that a human can handle. It also examines the extent of the toxicity of the drug. Besides, Griffin (2009) says that phase 1 examines the pharmacokinetics of the drug, pharmacodynamics, and its safety. Phase II trials assess the drug's efficacy, its therapeutic dose limit, length of treatment, and the accurate dosage with least side effects. In Muluk (2016), this phase occurs once the drug gets its first-time use.

In phase III trials, (Cingi & Muluk, 2016) states that practitioners evaluate real results in diverse patients. Phase III correlates new medications with the regular medicines. This correlation intends to test the new drug's long-term safety and tolerability. Phase IV is the last phase of the trials. Phase iv comes after the drug's approval for sale and consumption (Cingi & Muluk, 2016). These tests strive to deal with any further accounts of adverse reactions. They also aim to study drug's effect on morbidity of mortality (Cingi & Muluk, 2016).

The Therapeutic Goods Administration (TGA) administers Therapeutic Goods Act (1989). This Act regulates all therapeutic goods used, produced or imported to Australia. TGA manages this role by monitoring the quality, safety, efficacy and timely availability.

b) Describe TWO (2) ways medications are regulated by the TGA for use in Australia (4 marks)

There are two main avenues of TGA's medical regulations. One is Clinical Trial Notification (CTN) Scheme. Forrester and Griffiths (2011) states CTN requires the sponsor to the trial proposal to the Human Research Ethics Committee (HREC). The HREC examines the proposal's trial design, efficacy, safety, and the ethical position the medicines (Forrester & Griffiths, 2011). The second one is the Clinical Trial Exemption (CTX) scheme (Forrester & Griffiths, 2011). In this one, the sponsor presents the clinical trial proposal to the TGA for evaluation.

The main difference is that in CTN, HREC examines the trial proposal and signs the reviewed trial proposal. In CTX, HREC is only responsible for the consideration of the scientific and ethical position of the trial

Therapeutic Goods Administration

Pharmacokinetics is adopted from two Greek words. These are pharmacon which means drug, and kinesis which means motion (Halter, 2017). Therefore, pharmacokinetics is the examination of the drug absorption, distribution, and elimination from the body (Halter, 2017). In particular, it involves looking at the time that the body takes to metabolize the drug in different body tissues. For instance, Halter (2017) states that toxicokinetics as one principle found in pharmacokinetics. This principle studies the drug clearance process in the body. It looks at the entire process of excretion.

On the other hand, pharmacodynamics is the study of biochemical, physiological, and molecular consequences of the drug on the body (Halter, 2017). Pharmacodynamics correlate the drug concentration on the site position and the and the degree of the effects created by the drug (Halter, 2017). In short, pharmacodynamics deals actions of the drug on the body while Pharmacodynamics deals with the body's response to the drug.

The first-pass effect is a process by which the liver metabolizes the drugs before they pass into the circulation. Robertson (2017) states that after swallowing the drug, the digestive system of the body absorbs it through the alimentary canal. From there, the drug enters the hepatic portal system and where it the portal vein picks it and takes it to the liver before it reaches the other organs of the body (Robertson, 2017).

In the liver, the drugs come into contact with the hepatic enzymes. These enzymes one being hepatic enzyme metabolize the drug to the extent of reducing its active amount (Robertson, 2017). After the reduction, the remaining small amount emerges from the liver to the bloodstream. However, this first pass action that happens in the liver significantly decreases the bioavailability of the medicine (Robertson, 2017). One of the medications that suffer first pass effects is nitroglycerin. When a patient takes this drug orally, it undergoes the first pass process which makes it inactive. When administered sublingually, it bypasses the liver and enters the superior vena cava nitroglycerin.

The work of (Dev, Mundke, Pawar, & Mohanty (2016) states that when glyceryl trinitrate is taken sublingual, it is absorbed via the buccal mucosa and enters the bloodstream. However, when taken orally, it suffers the extensive first-pass effect.

(b) List TWO(2) specific areas of education you should deliver to the patient that only relate to the medication Glyceryl Trinitrate (2 marks)

The two specific areas of education are adverse interactions and tolerance.

Pharmacokinetics and Pharmacodynamics

For Adverse interactions, the patient may experience nasal decongestion (Fox, 2013). Glyceryl trinitrate can also cause an increase the blood pressure hence rendering anti-hypertensive drugs ineffective (Fox, 2013). Also, patients may experience low blood pressure while standing, and it causes dizziness or even fainting when used with tricyclic anti-depressants or the general tranquilizers. Notably, cannabis deactivates glyceryl trinitrate.

For tolerance and dependence, glyceryl trinitrate may become tolerant on regular consumption (Fox, 2013). Also, other mechanisms of its use like ointments, discs, and patches which offer 24-hour absorption may have tolerance effects (Fox, 2013).

Registered Nurse (5 marks)

There are different roles of registered nurses (RNs) One of the roles is the administration of medicines. In this, the nurse must ensure the patients receive correct drugs. Second is supervisory duties. This one happens where there are individuals under self-administration of medicines (Hamlin, Richardson-Tench & Davies, 2011). Thirdly, conducting patient education. Patient education help in ensuring that consumers have knowledge on the medication regimen. Also, they have role for conducting medication review. In (Hamlin, Richardson-Tench & Davies, 2011), nurses compare the drugs administered with the patient’s record to ensure there is rationality on each drug administered. This is more of a co-ordinational or implementational duty. Lastly, nurses undertake researchers as a support for improving practice and health medication.

Pharmacist (5 marks),

As medical professionals, one of the roles of pharmacists is reviewing prescriptions. In (Carnes, 2017) This means that it’s their role to review prescriptions either in the care units or in the pharmacy to minimize medication error. The second role is to assist physicians in the selection of the drug product, its dosage form, and its schedules. This role can help in minimizing wrong dose error (Carnes, 2017). Thirdly, clinical pharmacists help in monitoring medication. For example, they can monitor the patients’ corrective drug levels. A pharmacist also takes a non-medical role like prescribing drugs (Carnes, 2017). Lastly, it’s their duty to ensure safe storage of drugs and labeling them appropriately.

Doctor (5 marks)

The duties and responsibilities of doctors are working as the key prescribers on all medications. Their competence is significantly required to reduce medical errors (Scott-Brown & Van der Kogel, 2008). Second is obtaining information regarding patients' medical history. This helps the doctor to eliminate chances of prescribing the same previous drugs or extra-dose error. Thirdly, pharmacological management of care. This role involves drug’s administration. Also, it's the work of the doctors to initiate therapy process. Still, their competence would reduce wrong dose error by avoiding drug’s spelling mistakes (Scott-Brown & Van der Kogel, 2008). Finally, doctors also rule on the therapeutic and adverse effects of the drug therapy on the patients' condition and modifying medication plan.

The Hepatic First Pass Effect

A wrong-dose error happens when a patient receives a dose containing the wrong number of dosage units (Feleke, Mulatu & Yesmaw, 2015). The error occurs when during the counting of tablets, or during the measuring of liquid medicines. Also, (Feleke, Mulatu & Yesmaw, 2015) explains wrong-route errors as an error that happens when the patient receives the drug through an unplanned site. For example, giving the medicine via the left ear instead of the right ear.

On wrong-time errors (Feleke, Mulatu & Yesmaw, 2015), these usually happen when the set date of drug administration is missed. It can be either giving the dose 60 minutes earlier or before the intended or time of administration. An extra-dose error happens when the patient takes more dose than what the physician ordered (Perry, Potter & Ostendorf, 2016). Such error occurs when a patient receives an expired order or the drug or when the patient receives the drug when it’s still on hold.

The person-centered approach looks at failure as a result of unsafe acts and procedural violations of the people at the sharp end (Willson, Ison & Tabakov, 2013). These acts or violations are, for example, tiredness, forgetfulness, poor motivation, etc. The approach argues that behind every failure, there must be someone to take the blame. For this, the countermeasures are meant to reduce the undesired human behavior.

In contrast. system approach assumes that failure is an unavoidable outcome of human systems (Willson, Ison & Tabakov, 2013). That is, people are prone to mistakes. Therefore, countermeasures come in place on the basis that people cannot depart from their conditions, but they can modify their working conditions. So, this approach looks at failure as a system problem instead of people's weakness.

b) Defences, barriers, and safeguards are components of James Reason’s (1990) ‘Swiss Cheese Model.' Briefly, explain how these factors can prevent a medication error from occurring (4 marks)

The Swiss cheese model (SCM) was an explanation of (Reason, 2000) on error prevention. The(SCM) explains that a system can have numerous barriers (slice) for errors. Naturally, these barriers have defects(holes) that may permit errors. Since barriers open and close randomly, this will prevent a mistake from passing through the barriers. However, if barriers open at the same time, an error would reach the patient end. In a practical illustration, Slice 1 can be practitioner’s training. Slice 2 can be computer pop-ups for confirming medication. Slice 3 can be structured surgical briefings, handoffs, checklists, etc. Slice 4 could be institutional policies requiring a practitioner to read, approve, and commit.

Glyceryl Trinitrate Administration and Education

c) Holes in the defenses arise because of active failures and latent conditions. In relation to medication errors identify:

i. THREE (3) possible Latent conditions (3 marks)

Latent conditions are typically hidden failures that set-up holes in the Swiss cheese and they are hard to identify or find (Carroll, 2013). Some of them are poor work policies, unfavorable environmental factors, faulty equipment and protocols etc.

ii. THREE (3) possible Active failures (3 marks)

Active conditions are those resulting from a professional's appropriate behavior (Carroll, 2013). Examples of them are violating safety policy, not following up on a patient promptly, and missing a diagnosis.

Q9: Describe FIVE (5) factors that contribute to medication error AND a possible cause for each (10 marks)

There is a clear indication of a relationship between work environment, human activities, medication errors. These factors take two classifications either individual or organizational factors. For instance, one factor that leads to medical error is heavy workloads and staffing (Koch, Gloth & Nay, 2010). Examples of these are a rapid change of situation, shortage of staffs, unfamiliar professionals, etc. Second is team factor (Gluyas & Morrison, 2013). Poor communication between the team members can cause a medication error, and effective communication will limit it. For instance, during handovers, poor communication among team members may cause clinicians to miss some information. Another factor is medication packaging, management, storage and delivery (Gluyas & Morrison, 2013). For example, similar drug packaging or labeling will increase chances for an error.

Next is policy and procedure factors (Gluyas & Morrison, 2013). For example, a rule requiring that a second checker to confirm the 'five rights' of the correct dose, time, person, medication can easily be violated. Lastly is inadequate continuity of care (Koch, Gloth & Nay, 2010). This factor comes when patients stop their care before actual discharge. When this happens, patients lack their medication which is one of the errors.

Conclusion

Patient safety is an essential health care problem due to consequences of medication accidents. For instance, medication mistakes in acute care conditions are frequent and sometimes predictable. Therefore, an approach to identify these failures can be helpful in redesigning the faulty systems and restore trust from consumers.

References

Dev, A., Mundke, S., Pawar, P., & Mohanty, S. (2016). Critical aspects in sublingual route of drug delivery. Pharmaceutical and Biological Evaluations, 3(1), 42-49. Retrieved from https://www.onlinepbe.com/index.php/PBE/article/view/70

Feleke, S. A., Mulatu, M. A., & Yesmaw, Y. S. (2015). Medication administration error: Magnitude and associated factors among nurses in Ethiopia. BMC Nursing, 14, 53. https://doi.org/10.1186/s12912-015-0099-1

Carnes, R. (2017). The Wall Street Journal Guidebook On Pharmacy (1st ed.). Lulu Press, Inc.

Cingi, C., & Muluk, N. (2016). The Phases of Clinical Studies. Quick Guide To Good Clinical Practice, 105-114. https://dx.doi.org/10.1007/978-3-319-44344-7_12

Forrester, K., & Griffiths, D. (2011). Essentials of law for medical practitioners (1st ed.). Chatswood, N.S.W.: Elsevier.

Carroll, R. (2013). Risk Management Handbook for Health Care Organizations, 3 Volume Set (6th ed.). John Wiley & Sons.

Fox, K. (2013). Ischaemic heart disease (2nd ed.). Springer.

Griffin, J. (2009). The textbook of pharmaceutical medicine (6th ed.). Chichester, West Sussex: Wiley-Blackwell.

Halter, M. (2017). Varcarolis' Foundations of Psychiatric-Mental Health Nursing - E-Book (8th ed., p. 48). Elsevier Health Sciences.

Hamlin, L., Richardson-Tench, M., & Davies, M. (2011). Perioperative Nursing. London: Elsevier Health Sciences APAC.

Perry, A., Potter, P., & Ostendorf, W. (2016). Nursing interventions & clinical skills. St. Louis, Missouri: Elsevier.

Robertson, D. (2017). First pass metabolism. Nurse Prescribing, 15(6), 303-305. https://dx.doi.org/10.12968/npre.2017.15.6.303

Scott-Brown, M., & Van der Kogel, A. (2008). Basic Clinical Radiobiology (5th ed.). London: Hodder Arnold.

Willson, K., Ison, K., & Tabakov, S. (2013). Medical equipment management (1st ed.). CRC Press.

Reason, J. (2000). Human error: models and management. BMJ?: British Medical Journal, 320(7237), 768–770.

Gluyas, H., & Morrison, P. (2013). Patient Safety: An Essential Guide (1st ed.). Palgrave Macmillan.

Koch, S., Gloth, F., & Nay, R. (2010). Medication Management in Older Adults. New York, NY: Springer New York.

Legislation

Therapeutic Goods Act (1989). Canberra. Australia

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