Implementation Of The Reporting And Subsequent

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

6. Use certified EHR technology to identify patient-specific education resources and provide to patient, if appropriate

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

The challenges of integrating diverse healthcare standards, intranet and Internet communications, patient and consultant accessibility to EHRs and internal business systems require an exceptionally mobile, intuitive and secure platform. EMR and EHR software are designed to integrate electronic health records into healthcare businesses to provide HIPAA compliance. However, to meet or exceed these requirements and offer patients, medical staff, insurance providers and outside consultants access to EMRs and EHRs, healthcare businesses need a robust communications platform to connect these stakeholders. The benefits of offering Web access to health records include better patient care, cost savings and efficiencies, better coordination between medical service providers and greater patient participation in his or her own care.

“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

Providers will have an explanation and a glimpse into outlook of future performance. As EHR is befitting to every provider’s practice, providers should have an understanding that EHR implementation will objectively promote their practice through considerable, and reasonable designs. In consideration of the status, providers quality of care, systems employed would be scrutinized, and evaluation of desirability to stay in touch with patients or potentially change in system processes. In addition, appraisal of current systems such as quality of documentation, work flow, and staff’s ability to fully utilize the systems would happen. Given the opportunity to swiftly access patient information from a central place, patient history, instant check of drug interactions and allergies and e-prescription would occur. Provider’s determination towards favorable choices and patient safety will continue because, instant communication of patient information, and alerts will occur. Furthermore, promotion of diagnostic and beneficial choices for patients will exist. Ideally, providers should have a grasp of how EHR will promote practice, resources available to manipulate through the entire

Furthermore, I will try to understand the terminology and the technology language that is associated with EHR information in general. In doing so, I will seek the assistance of a professional physician, undertake research on different sites and discuss with potential vendors to help me understand the terminologies.

To realize this goal, a number of challenges—cost and availability to patients—must be addressed. However, partial solutions are currently available to conquer some of them. In addition, in order to clear the way for widespread adoption of personalized medicine, joint efforts from people in different roles and with different skills will be required. Education, basic research, software development, policy construction, and law making will be needed to remove the security concerns related to sensitive genetic information and their applications in clinical care. In conclusion, personalized medicine is a more advanced means to treat patients with illnesses. With the advancement of diseases and cancers, the “cookie-cutter” approach to medicine is no longer effective. Personalized medicine gives patients the treatment they deserve, a unique and customized approach that effectively cures their disease and possibly prevents new ones from

Therefore, with the knowledge of these genomic profiles, nursing interventions could be more individualized to the patient. “Pharmacogenomics is the study of genetic determinant of interindividual variation in the drug response” (Munro, 2014, p. 37). Pharmacogenomics helps with the direct influence of healthcare and medication administration to a patient’s specific genotype. The information in this study can help medical personnel determine precise dose requirements when referring to a patient with a genetic variant. “Pharmacogenomics offers promise of a future where medications will be rationally selected and dosed based on individualized genotypic information, resulting in better efficacy, fewer adverse effect and more efficient use of healthcare funds” (2014, p. 37). Ways to improve outcomes for patients would be utilizing genetic and genomic variabilities in nursing interventions. Applying the knowledge of these variabilities could help with the overall health of the patient, prevent further disease and manage symptoms associated with the current disease the patient has. It is important to realize that interventions should be personalized for each patient and not generalized to multiple patients when considering

At Flatiron, I will serve as the clinical data expert to support terminology integration, perform quality assurance checks, and contribute to terminology mapping editorial policies. I have demonstrated these capabilities previously as an oncologic clinical trial contractor at PAREXEL International (CRO). Having a consistent, rational attitude throughout all stages of the regulatory filing process helped me deliver high-quality deliverables to regulatory authorities, and allowed me to become the single point of contact (SPOC) for all trial-related concerns. As a regulatory/quality assurance CMC specialist at Forest Laboratories (now Allergan), I not only learned how to generate high-quality regulatory submissions, but I have also pioneered the composition of Module 3 specifications of the NDA in regards to Quality Control policies during drug development.

However, the long-term safety of biologic agents is an unresolved issue and will be addressed in a satisfactory manner only if there is optimal use of and investment in post marketing surveillance of these drugs, including the development of comprehensive registries of biologic drugs (Gladman et al.,

The definition of the EHR is a place in which patient records are created, stored and retrieved. Most professionals have incorporated them into their practice. EHR’s are known to have allowed the sharing of information between a patients’ caregivers in an increased amount of time. They increase safety and efficiency in the clinical setting by delivering legible information.

+ Genomics and healthcare information technology such as Digital Imaging, Electronic Patient Records and Disease Management Systems make personalized medicine and personalized diagnostics possible. Moreover, healthcare practice move from cure to prevention. These changes require expertise in biomedical sciences rather than in engineering and physics; and also investment, collaboration with pharmaceutical companies which facilitate the creation of imaging equipment necessity to alter GEMS business model which is away from engineering heritage toward bio-chemistry and develop drug based on genetic code for specific individual, or small group rather than entire

According to the Australian Law Reform Commission, pharmacogenomics is describes as “the capacity to predict disease development and influence decisions about lifestyle choices or to tailor medical practices to an individual”2. This concept

The idea that human beings are as different to one another as they are alike is not new and these differences are related to the genetic make-up of each individual. Because all human beings are not identical, one can safely assume that medications that treat a particular illness for one person can have a totally different effect on another. To support this theory, the article What You Need To Know About Pharmacogenomics, written by Dennis Cheek discusses a growing area of research known as pharmacogenomics where medications are being tailored based on patient’ genetic make-up. The main goal of pharmacogenomics is to help health care providers improve patients’ outcome with medications that are tailored to patients based on their genetic make-up. The main areas of pharmacogenomics include antiplatelet therapy, mental health, HIV therapy, and oncology (Cheek, 2013).