Phase I studies examine the safety of a drug or device. It involves healthy volunteers ranging from 20 to 100, who are rewarded for being involved in the research. The objective is to ascertain the effects of the drug or device on humans and can last for several months.
Phase II
This phase tests the drug or device efficacy. It includes multiple hundred patients and lasts for months to two years. The study is mostly randomized control trials comprising of experimental and control groups
Phase III
Involves randomized and blind testing of multiple hundreds to thousand patients and can take many years. Pharmaceutical companies can ask for FDA approval after the completion of phase III. It provides the company with an in-depth understanding of the efficacy of the drug.
Phase IV
Phase IV studies are undertaken after the approval for consumer purchase. Pharmaceutical companies at this phase are aimed at comparing the drug with the ones existing in the market. It involves thousands of participants (Pocock, 2013).
Pharmacokinetics is the study of the time taken for a drug to be absorbed, distributed, metabolized, and excreted. Pharmacokinetics is significant in improving efficacy and minimizing the toxicity of a patient’s drug therapy. Pharmacokinetics has enabled physicians to comprehend the association between drug concentrations and their pharmacologic feedbacks. The impact of a drug is associated with its site of action. Thus it’s significant to observe this concentration.
Pharmacodynamics is the association between drug concentration at the active site and the resultant impact, in addition to the time taken and the concentration of therapeutic and severe effects. The effect of a drug existing at the site of action is ascertained by the binding between a receptor and the drug. There exists an association between the drug concentration at the receptor site and the pharmacologic impact (Wang, Wang, & Balthasar, 2008).
Some orally administered drugs such as pentazocine and morphine are immediately absorbed from the intestines and transported first through the portal system to the liver, in which they are expansively metabolized. This process is referred to as the hepatic first pass effect. Initial metabolic processes can take place during the phase of absorption in the gut wall or liver before reaching the bloodstream. This leads to a reduction in the drug concentration before it arrives in the circulation. This implies that some portion of the drug is lost. Most of the oral drugs first pass through the liver and are then transported to the systemic circulation from the gastrointestinal tract.
Therefore, the liver can extract substances from the GI tract, thus preventing its dissemination to other parts of the body. First pass metabolism (the bioavailable fraction) determines the amount of oral dose that will end up in the circulation. Drugs that are 100% bioavailable such as intravenous drugs do not undergo the first pass effect. If drugs with the bioavailability of less than 20% are to be administered orally, then they will have to be delivered five times the dose that is administered intravenously in order to have the same impact (Wu, Kulkarni, Basu, Zhang, & Hu, 2011).
A registered nurse has the role of reporting errors. Hoffmann, Beyer, Rohe, Gensichen, and Gerlach, (2008) observes that nurses have a function of disclosing any medication errors or hazards as a way of them improving in their practice and ensuring safe patient care environment. The nurses have the responsibility of incorporating pharmacodynamic and pharmacokinetic principles when administering medications to ensure patient safety.
They also have the role of recognizing perceptual factors to avoid mistakes made due to familiarity, similarity, and expectancy. Nurses have a responsibility of understanding the system and environmental factors to avoid any factors that may lead to medication errors. They also have the role of appreciating human factors such as inadequate communication and endeavor to address them (Durham, 2015).
Conduct review and assessment of case reports for each handed in from clinical studies, random, and petitioned reports. Conduct triage of cases and ascertain severity and associations of all products as provided. Doctors also assess and confirm proper selection of extreme events from source documents, find out appropriate MedDRA code, assess labeling and review the narrative. Doctors also identify regulatory report potential of cases handed in from clinical studies, random and petitioned reports within specific therapeutic team. Doctors also play the role of attaining and maintaining existing knowledge of product selection and safety profiles for drugs in the entire therapeutic segment (James Lind Institute, 2016).
The American Pharmacists Association (2016) reports that pharmacists across the world have the primary responsibility of improving patient safety by ensuring that they receive appropriate medication. They ensure that access to medication by assessing the patient’s ability to pay for the correct medication and provide alternative medication options or means of payment. They also supply medication information by educating patients and care providers on the safety use of medication. Pharmacists also evaluate the appropriateness of medication. Additionally, pharmacists improve medication adherence by assisting patients to take medications based on prescriptions. They also assess the health status of the patients before and after medication.
Knowledge-based errors. This is caused by lack of knowledge relevant to the given drug prescription. For instance, prescribing penicillin to a patient without first determining whether the patient is allergic or not, thus necessitating the importance of education (Aronson, 2009).
Rule-based errors- these are medication errors caused by misapplying an appropriate rule or using a bad rule. For example, administering diclofenac via injection on the thigh instead of on the buttock. They can be avoided by using computerized systems of prescription (Aronson, 2009).
Action-based errors. These are errors caused by lack of attention or distraction while carrying out medical procedures. For example, reaching out for diazepam bottle from the shelves instead of diltiazem which was initially intended.
Memory-based errors. These medication errors are caused by memory lapse or forgetting while knowing the right thing to do. For example, prescribing penicillin to an allergic patient due to forgetfulness. These errors are difficult to avoid and can be mitigated through cross-checking and by using a computerized system of prescription (Aronson, 2009).
Technical errors. These errors are caused by a technical miss-up such as the illegible writing of ‘panadol’ instead of ‘priadel’ (Aronson, 2009).
Poor organizational policies. For instance, an intricate surgical antibiotic prophylaxis protocol is likely to increase the incidences of incorrect doses in a single unit (Ghaleb, Barber, Franklin, & Wong, 2010). The second possible latent condition is equipment that is not designed correctly. An example is the lack of safety mechanisms to reset the rate of infusion pumps, leading to over-infusion of medications (Wilson et al., 1998). Protocols that are poorly written and the application of dose escalation trials can result in prescription errors (Parshuram, To, Seto, Trope, Koren, & Laupacis, 2008).
Active failures
Attentional slips are possible active failures that take place when the clinician fails to observe the progress of standard actions at some critical phase. Memory lapse occurs when an individual forgets the initially intended action like forgetting to inquire ones allergic condition before administering penicillin. Another example is rule-based errors such as the inappropriate application of existing procedures. For example administering diclofenac via injection on the thigh instead of on the buttock (Aronson, 2009).
Distractions in the environment caused by carrying out tasks simultaneously such as undertaking drug round while at the same time supervising staff and responding to phone calls (Brady, Malone, & Fleming, 2009).
Training and education. McMullan, Jones, and Lea (2010) found out that the modern approach of drug calculations in most of the nursing institutions did not factor in the clinical context and made was dependent on the ability of the students to manipulate numbers. Students’ poor in basic mathematical skills ended up with wrong drug calculations.
Overworking. Studies had indicated that the risk of making medication errors substantially increased among registered nurses when they were engaged in work shifts of over 12 hours each week (Griffiths et al., 2014).
Understaffing and inadequate resources. Keers, Williams, Cooke, and Ashcroft (2013) found out that workplace conditions such as understaffing and scarce resources led to multiple medication errors
Wrong patient and wrong dose. Al-Shara (2011) conducted a study on the factors that influence to medication errors and found out that selecting the wrong patient or dose led to different medication errors. This was likely caused by Ineffective organizational protocols on treatment.
References
Al-Shara, M. (2011). Factors contributing to medication errors in Jordan: a nursing
perspective. Iranian journal of nursing and midwifery research, 16(2), 158.
American Pharmacists Association. (2016). Pharmacists’ Impact on Patient Safety: A Joint
Project of the American Pharmacists Association Academy of Pharmacy Practice and Management and Academy of Pharmaceutical Research and Science. Washington, DC. Retrieved from https://www.pharmacist.com/pharmacists-impact-patient-safety
Aronson, J. K. (2009). Medication errors: what they are, how they happen, and how to avoid
them. QJM: An International Journal of Medicine, 102(8), 513-521.
Brady, A. M., Malone, A. M., & Fleming, S. (2009). A literature review of the individual and
systems factors that contribute to medication errors in nursing practice. Journal of nursing management, 17(6), 679-697.
Durham, B. (2015). The nurse’s role in medication safety. Nursing2018, 45(4), 1-4.
Ghaleb, M. A., Barber, N., Franklin, B. D., & Wong, I. C. K. (2010). The incidence and
nature of prescribing and medication administration errors in paediatric inpatients. Archives of disease in childhood, adc158485.
Griffiths, P., Dall’Ora, C., Simon, M., Ball, J., Lindqvist, R., Rafferty, A. M., … & Aiken, L.
Hoffmann, B., Beyer, M., Rohe, J., Gensichen, J., & Gerlach, F. M. (2008). “Every error
counts”: a web-based incident reporting and learning system for general practice. BMJ Quality & Safety, 17(4), 307-312.
James Lind Institute. (2016). Role of Physicians in Drug Safety. Retrieved from
https://www.jliedu.com/blog/role-of-physicians-in-drug-safety/
Keers, R. N., Williams, S. D., Cooke, J., & Ashcroft, D. M. (2013). Causes of medication
administration errors in hospitals: a systematic review of quantitative and qualitative evidence. Drug safety, 36(11), 1045-1067.
McMullan, M., Jones, R., & Lea, S. (2010). Patient safety: numerical skills and drug
calculation abilities of nursing students and registered nurses. Journal of advanced nursing, 66(4), 891-899.
Parshuram, C. S., To, T., Seto, W., Trope, A., Koren, G., & Laupacis, A. (2008). Systematic
evaluation of errors occurring during the preparation of intravenous medication. Canadian Medical Association Journal, 178(1), 42-48.
Pocock, S. J. (2013). Clinical trials: a practical approach. John Wiley & Sons.
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Shakya, P., Madhav, N. S., Shakya, A. K., & Singh, K. (2011). Palatal mucosa as a route for
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Van Beuzekom, M., Boer, F., Akerboom, S., & Hudson, P. (2010). Patient safety: latent risk
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Wang, W., Wang, E. Q., & Balthasar, J. P. (2008). Monoclonal antibody pharmacokinetics
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Wu, B., Kulkarni, K., Basu, S., Zhang, S., & Hu, M. (2011). First-pass metabolism via UDP-
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