Introduction
Pharmacovigilance is “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine related problem.” Regulated in the US by the Food and Drug Administration (FDA) with the expectation of volunteer reporting by health care professionals (HCP) and mandatory reporting by drug developers/manufacturers, this field of study is essential in the improvement of patient outcomes and safety. Its peripheral importance lies in contributions to cost effectiveness and risk management in the public health care arena. Responsible and aggressive implementation of adverse event reporting procedures promote awareness and value to the importance of the identification of harmful effects of medication use.
The stages of pharmacovigilance coincide with the stages of clinical trials. Each stage of a clinical trial has a pharmacovigilant component. The preclinical phase which is restricted to animal testing is the first stage of research and development that determines safety. Once a compound is determined to be safe in laboratory animals and has potential to be therapeutic in humans, it can be considered for Clinical Trials. Phase 1 of a clinical trial is primarily to evaluate a new compound’s safety in general and therefore is conducted with less than 100 participants which are expected to be healthy. If the Phase 1 safety profile suggests a low risk factor for a drug, Phase 2 and 3 studies continue with the
absence of input in regards to patients' drug hypersensitivities. Unfortunately because of most medical administration mistakes aren’t identified it had been significantly impact on medication errors.
Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.
Each year, roughly 1.5 million adverse drug events (ADEs) occur in acute and long-term care settings across America (Institute of Medicine [IOM], 2006). An ADE is succinctly defined as actual or potential patient harm resulting from a medication error. To expound further, while ADEs may result from oversights related to prescribing or dispensing, 26-32% of all erroneous drug interventions occur during the nursing administration and monitoring phases (Anderson & Townsend, 2010). These mollifiable mishaps not only create a formidable financial burden for health care systems, they also carry the potential of imposing irreversible physiological impairment to patients and their families. In an effort to ameliorate cost inflation, undue detriment, and the potential for litigation, a multifactorial approach must be taken to improve patient outcomes. Key components in allaying drug-related errors from a nursing perspective include: implementing safety and quality measures, understanding the roles and responsibilities of the nurse, embracing technological safeguards, incorporating interdisciplinary collaborative efforts, and continued emphasis upon quality control.
During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies.
Outcome measures assess whether the interventions to improve medication safety practice will be successful. During the interview of the new employee, competency evaluation related to medication administration will be applied first. In addition, during the orientation for these new employees, adequate training will be provided to ensure the importance of preventing medication errors. They will be given a list of similar and look-alike medications and will focus on medications that cause the most adverse reactions when errors may occur. Then, after training and when staff start working, they will be supervised during their first few months. When they are not supervised, they will be assessed and evaluated for any errors. During this process,
Adverse drug events are estimated to cause more than 1 million emergency department visits and 125,000 hospital admissions, affecting approximately 1.9 million hospital stays each year.
Continue to develop new medication measures that address the detection and prevention of adverse medication-related patient safety events that can be used in future Quality Improvement Organization (QIO) Statements of Work and in CMS provider reporting programs; and
Medication errors in the hospital setting have significant potential to result in serious injury and even death, thus effecting patients, families, health care professionals, and hospitals. Approximately 400,000 adverse drug effects (ADE) occur each year (Institute of Medicine, 2006). Considering that not all medication errors are discovered and reported, this number is likely to be underestimated. These errors not only contribute to patient morbidity and mortality, but also cause increased length of stay and hospital expenses. It is estimated by the Institute of Medicine (IOM) that $3.5 billion is spent annually as a result of ADEs (IOM, 2006).
With the growing reliance on medication therapy as the primary intervention for most illnesses, patients receiving medication interventions are exposed to potential harm as well as benefits. Medicines have proven to be very beneficial for treating illness and preventing disease. This success has resulted in a dramatic increase in medication use in recent times. Unfortunately, this increase in use and expansion of the pharmaceutical industry has also brought with it an increase in hazards, error and adverse events associated with medication use.
It is the nurse’s and pharmacist’s job to be cautious and aware of every medication they are administering by using their critical thinking skills and applying what they know to every situation. Although it is important for these individuals to be able to advocate for their patients, it also imperative that prescribers be aware of the impact they have on their patients as their actions have a domino effect. In conclusion, it is not the responsibility of a single profession to maintain safety in medication administration. It is the responsibility of everyone involved in the patient’s care. Each person who takes steps to improve the process and promote the patient as the number one priority is doing their part in refining how the healthcare system views medication
Balancing activity of medication botches relies upon epidemiological data, area of bungles, and changes in execution. Support of principles is the best quality level in recognizing troublesome prescription related events and, in future, automated watching will be the system for getting threatening events beforehand they happen. Specifying reveals arrangement bungles, can trigger notification, and backings the scattering of a culture of safe practice. Audit is a for the most part clear instrument for evaluating bona fide execution and in masterminding remedial exercises to diminish the peril of arrangement goofs.
Medication error is defined as the following by the National Coordinating Council for Medication Error Reporting and Prevention: “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling; packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use” (Anthony, Wiencek, Bauer, Daly, & Anthony, 2010). Medication errors cause increased length of patient hospitalization and morbidity and mortality (Pape
“According to the Institute of Medicine’s Preventing Medication Errors report, the average hospitalized patient is subject to at least one medication error per day” (Barnsteiner, 2008, p. 2-459). A patient’s home medication regimen is frequently continued during hospitalization. It is often found that during the process of interviewing a patient to collect all relevant data associated with their medication history, over 60% of inpatients had at least one error on their prior to admission medication list (Salanitro et al., 2012). The many challenges and current inability to accurately identify medications taken at home can lead to potential adverse events. “An adverse drug event (ADE) is defined as harm experienced by a patient as a result
These programs can be successful when applied but without a physician being required to participate they can be unuseful as it leads to lack of accurate information for public health records. Doctors and pharmacist should both have a legal obligation to check a drug monitoring database and participate further in drug monitoring programs. Doctors and pharmacies should also be investigated for prescribing large quantity of prescription medication resulting in legal action if perhaps they are found guilty of overprescribing. With legislators onboard to curb the misuse of prescription medication this problem can finally be
Evaluating evidence-based articles and literature in making decisions to change the severity of the interaction by looking at specific drug-drug,