Term Paper on Medical Administration

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Term Paper on Medical Administration

The Four Phases of Clinical Trial

According to Lee (2016), the clinical trial includes phase1, phase 2, phase 3 and phase 4. Phase1involves the earliest trials for a new drug or treatment are done. The trials are conducted under full-time observation by staffs in an inpatient clinics. Phase1 trials are conducted to obtain information such as safety, tolerability, pharmacokinetic and pharmacodynamics among others. Phase1 trials include Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and Food Effect. Phase2 trials are typically therapeutic exploratory. It involves studies which are done to determine effectiveness of drug for specific indications, side effects and risks. Phase 2A and phase 2B determines dosing requirement and efficacy respectively. Phase3 involves random controlled multicenter trials done on a large number of patient to confirm and demonstrate therapeutic benefits. Phase4 is a post marketing surveillance trial such as pharmacovigilance and technical support of drug. It involves therapeutic use studies done to optimize drug’s use.

Main Responsibility of Therapeutic Goods Administration and its Application in Australia

Therapeutic Goods Administration (TGA) is a body that regulates the therapeutic goods such medicines, blood, medicine devices, blood products and gene technology among others (Grant, 2014). Therefore, the main responsibility of Therapeutic Goods Administration is to carry out an evaluation and checking all activities to ascertain the fact that the available therapeutic goods meet the acceptable standards. Apart from that, it ensures that therapeutic advances can be accessed on time. In Australia, Therapeutic Good Administration is the main government agency regulating medicines. For one reason, TGA conducts pre-market evaluation and monitoring of therapeutic goods, assesses and regulates advertisements of medicines as well as carrying out the post market vigilance. Besides, TGA ensures that rights of the patients are respected at all times (Grant, 2014). Through this regulatory agency, Australian government ensures that access to medical advances is easy and timely.

Definition of Pharmacokinetics and Pharmacodynamics

  Pharmacokinetics is the study of the time taken by a drug to be absorbed, distributed, metabolized and excreted by the body. Clinically, pharmacokinetics involves the application of the principles to realize an effective and secure therapeutic administration of drugs in a particular patient (Kim et al, 2015). It is aimed at reducing toxicity of drug therapy administered to a patient while enhancing efficacy. It is important to monitor the concentration of drug at the site of action because concentration determines the effect of the drug. On the other hand, pharmacodynamics describes the relationship between the concentration of drug at the action site and its consequential effects coupled with period of time taken, therapeutic intensity as well as adverse effects. The drug binding receptor is what determines the effects of drug at the site (Kim et al, 2015).What is more, both pharmacokinetics and pharmacodynamics are important studies in clinical trial. 

Hepatic First Pass Effect

The first pass effect otherwise known as pre-systemic or fist-pass metabolism is a drug metabolism phenomenon that results into a great reduction of drug concentration before reaching the systemic circulation (Choi, Kim & Lee, 2006). This involves the portion of drug that is lost through walls of gut and liver during absorption. Some of the drugs known to undergo significant fist pass effect include propranolol, diazepam cimetidine, imipramine, lidocaine and morphine among others. During the oral administration of drug, the drug is swallowed, absorbed by digestive system and finally enters the hepatic portal system. From here, the drug is transported to the liver by portal vein just before it is taken to the rest of the body. Drug metabolism happens in the liver and just small amount of active drug is taken to the rest of the body circulation system. First pass occurs in the liver hence, greatly reducing drug bioavailability (Choi, Kim & Lee, 2006). The first pass effect is affected by four main systems such as gut wall enzymes, gastrointestinal lumen enzymes, hepatic enzymes and bacterial enzymes. Due to biochemical selection of drug, a good drug candidate can still fail first pass metabolism even though he/she has good drug-likeness.

Why Glyceryl Trinitrate is administered sublingually

Glyceride Trinitrate is a drug that is used to treat chest pain, heart failure and high blood pressure among others.  Glyceride Trinitrate undergoes high first pass effect. The high first pass metabolism result into a significant loss of drug portion hence reducing the bioavailability of the active drug. Therefore, if glyceride Trinitrate is administered orally, there would be very little or no effect of the drug on the body due to first pass effect (Choi, Kim & Lee, 2006). For this drug to work effectively and to avoid the first pass metabolism of the drug, a para-enteric route is necessary thus, administering it sublingually. The two areas of education to deliver to patient relating to medication glyceryl Trinitrate include education on how to take or use glyceride Trinitrate such administering methods including spraying, sublingual, patches and ointment. Another area of education is the need to disclose the patient’s condition before starting the GTN. For instance, pregnancy, breastfeeding, low blood pressure and so on.

Roles of Registered Nurse, Doctor and Pharmacist

According to (Pittman & Forrest, 2015), registered nurse plays various roles which include being a caregiver, communicator, decision maker, patient advocate as well as manager of care. To begin with, nurse ensures that there is effective communication by applying communication techniques to curb barriers. They effectively communicate to everyone so as to enhance the healing process. They are responsible for both written communication and talking with patients for the sake of care continuity. Secondly, nurses ensure a cohesive patient’s care through managing the care. They coordinate and direct care processes in manner that ensures patients’ desires are achieved. Thirdly, nurses have an important role of being patients advocates. They protect the rights of patients and represent their best interests at all times. Fourthly, nurses offer hands on care to patients in different settings such as disease prevention and physical needs among others. Lastly, nurses has a role to make decisions, set goals and enhance patients’ outcomes through critical thinking skills. Registered nurses are central to the smooth running of clinical operations.

 On the other hand, doctor’s roles and responsibilities include respecting confidentiality, to ensure patients give free and informed consent, duty to provide information, diagnose and treat patients and to promote quality and safety. The doctor’s responsibilities encapsulate own actions, the actions of their assistant including nurses, residents and medical students among others. What is more, doctors must discharge their duties and responsibilities with professionalism and utmost good faith at all times (Mayur et al, 2016). Pharmacists’ roles include preparing medications through assessing and interpreting the orders from the physician, noticing therapeutic inconsistencies and administrating medication through compounding. Apart from these, pharmacist plays the role of packaging drugs, labeling pharmaceuticals as well as controlling medication through offering advisory interventions as well as monitoring drug therapies. Without pharmacies, drug administration is almost impossible.

Types of Medication Errors and their Courses

There are different types of medication errors and they include prescribing errors, omission errors, wrong time errors, improper dosing errors and wrong drug preparation errors. The prescribing error involves incorrect selection of drug following the patient’s indication. Omission error occurs when there is no medication dosage is given before scheduling the nest one. Wrong time error involves giving medication outside the scheduled time and its intervals. Improper dosing error involves delivering improper proportions of medication thus contravening the appropriate amount required to manage the condition of the patient. The wrong drug preparation error involves incorrect formulated drugs being administered. It entails too little or too much reconstitution of medication (Stavroudis, Miller & Lehmann, 2008). The cause of medication errors include distraction, lack of knowledge and understanding, incomplete patient information, memory lapses and systematic problems among others. When a nurse is distracted, she/he may confuse one drug with another hence causing prescription error. Lack of knowledge may cause errors such as improper dosing among others. Incomplete information about the patient may cause wrong dose error and omission errors among others. Systemic problems such improper labeling can cause prescription errors. Memory lapses can result into all errors.

Person Centered Versus System Focused Approaches to Error

A person centered approach to error has been applied in health care a long time. It operates on the assumption that errors are human generated due to human weaknesses. As such, the approach assumes that some people are more fallible than others. Therefore, the model identifies individual differences and capitalize on those individuals who make more errors. In essence, the approach is blame oriented with the likelihood of creating fear as well as imposing disciplinary actions and holding people liable to their mistakes. It is speculated that blaming people is more satisfying than blaming an institution. Besides, it is more convenient compared to addressing the whole system (Grant, 2014). On the other hand, system approach assumes that the system causes errors and that human form just a part of the system. Based on this approach, it is more effective to address environmental factors and tasks than to administer disciplinary actions on concerned individuals. The approach considers range of factors including the organization and policies to reduce errors such as using incident reporting to identify and share lessons, implement changes to reduce chances of error occurring in future (Grant, 2014). System centered approach is more effective than people centered approach. 

How Defenses, Barriers and Safeguards Prevent Medication

According to Stavroudis, Miller & Lehmann (2008), defenses, safeguard and barriers are considered best in preventing errors emerging from the system based approach. Barriers are viewed as cheese slice and lacks holes in the ideal world.  However, holes exist in the real world causing a system failure or an error as a result of latent or active failure in the system. Latent error include organizational processes and management decisions. These failures can be noticed and prevented before actual error occur. Each layer is a defense against potential error. The different positioning of holes act as a safeguard against the occurrence of an error. Products such as drugs may be similar hence causing substitution of drugs. 

Latent Conditions and Active Failures

Latent conditions prompt active errors into harmful outcomes. They include poor design, bad decisions by management, incorrect installation and faulty management. Mistakes slips and lapses do not often result into harmful outcomes latent conditions are difficult to notice on the surface. The three latent conditions can be described in terms of providers, procedures and products. Under providers, latent condition involves reducing the number of pharmacists as an action taken by the health board or trust. Procedures resulting into inadequate beds, late arrivals of patients and giving late notices to patients with pre-assessing or giving advises (Kim et al, 2015). Active failures occur at frontline operator level and effects are felt instantly. Active failures include misdiagnosis of illness, administration a wrong drug and incorrect prescription of medicines to patients. Active failure in healthcare can actually result into premature death of patients. All necessary measures should be taken to prevent the occurrence of active errors or active failures.

Factors for Medication Error and their Course

Factors contribution to medication error can be categorized into two namely individual factors and organization related factors. Individual errors are those arising for the fallible nature of individuals. Factor under this category that contribute to medication errors include misreading of labeling on the medication packages, miscommunication factors medication doxology miscalculation, lack of proper adherence to outlined medication preparation procedures, personal neglect, physical exhaustion of medical practitioners, difficulties in using medication devises such as infusion services, unclear verbal directions as well as illegible handwriting of physicians (Stavroudis, Miller & Lehmann, 2008). Organization related factors encompass healthcare system, interactions and relationships in the organization.  Some of these factors include high nurse-patient ratio, heavy work load, interruptions, new staffs and similar names, packaging and labeling among others (Stavroudis, Miller & Lehmann, 2008). Clinical operation is presented with a complex and busy environment which is characterized with numerous interruptions and distractions are indispensable. These are usually fueled by new tasks arising when the medical practitioner has not completed the current activity. Therefore, practitioners are forced to multitask hence, increasing chances to commit errors. Apart from that, increased work load put pressure of practitioners causing them to rush in their bid to meet deadlines.