Drug Kardexes were gathered and audited under certain criteria in order to identify potential risk areas in drug prescribing and administration, and also to provide ways in which these risks can be reduced or eliminated and reinforce drug management policies’ and guidelines. NICE (2002) audit cycle will be applied to this assignment to provide an acceptable framework (Appendix 1). Step 1: Preparing for Audit. The first step in the audit process is to identify which type of audit is to be carried out.
Pharmacovigiliance is defined by the World Health Organisation as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” . In other words, pharmacovigilance can be simply defined as drug safety. Adverse reactions can be explained as when medicines affect the body in a harmful and unintended manner. Prior to obtaining marketing authorisation for a new drug, the drug has to be tested and the corresponding data has to be gathered. These tests are known as clinical trials, and the relevant regulatory bodies must use this data to decide whether the drugs benefits outweigh the associated risks.
This is an interesting study for the journal since it addresses with a novel approach the nursing diagnoses of surveillance in cases of patients suffering from cardiac arrest. There are few published studies dealing with this issue and, even less, using a non-NANDA-I taxonomy. The authors introduce the ATIC terminology that seems to have a wide range of adequate risk diagnoses to improve the nursing surveillance interventions planning for patients with severe health status in the hospital setting. Therefore, we believe that the research approaching is appropriate and pertinent to advance in these issues´ knowledge. Introduction: page 2, lines 48: the sentence ending with "...
Pharmocovigilance Pharmocovigilance as define by the oxford dictionary is "the practice of monitoring the effects of medical drugs after they have been licensed for use especially in order to identify and evaluate previously unreported adverse reactions". In the EU all medicine is strictly analysed and tested for their quality , efficacy and safety before it is authorised for market. Even as these drugs are on the market they are continuously monitored to ensure any particulate which could affect the safety of the drug is identified and assessed and the necessary measures are taken .The Pharmocovigilance legislation was put into place to reduce the risks and increase the benefit of medicine and was "developed based on the observation that adverse drug reactions caused roughly 197,000 deaths in the EU". Since 1995 there have not been any major changes in the EU regulations of human medicine until the new Pharmocovigilance legislation came into effect during the month of July 2012.
Therapeutic drug monitoring (TDM) is the clinical practice of measuring specific drugs at timed intervals in order to maintain a relatively constant concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. It is not necessary to use therapeutic drug monitoring for all the of medications, and it is used mainly for monitoring drugs with some narrow therapeutic ranges, drugs with marked variability in pharmacokinetic, medications with target concentrations which are difficult to monitor, and drugs that are known to cause therapeutic and adverse effects. The process of therapeutic drug monitoring is based on the assumption that there is a specific relationship between dose and plasma or blood drug concentration, and between concentration and therapeutic effects. Therapeutic drug
Drugs Abuse Introduction In this Digital Age, we have undoubtedly moved into an era where the fields of medical research play one of the most important roles in maintaining the balance of the world today. Mankind had successfully created a huge number of drugs to aid in medicinal fields. A drug is a chemical that influences biological function other than providing nutrition or dehydration which may come from plants and laboratories (Kleiman, Caulkins & Hawken, 2011) However, problems arise when these drugs are intentionally abused to satisfy unjust desires.
A similar definition exists in the text “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the Food and Drug Administration (FDA) (3). While both the European Agency for the Evaluation of Medicinal Products (EMEA) and the FDA recognize the concept that pharmaceutical alternatives may be shown to be bioequivalent, the Orange Book (3) clearly states that only therapeutic equivalents that are pharmaceutical equivalents can be considered substitutable, whereas the EMEA states that either pharmaceutical equivalents or pharmaceutical alternatives may be considered as therapeutic equivalents provided that the excipients contained in the formulation do not impact on the safety and efficacy profile of the dosage form (2). Pharmaceutical equivalents are defined in the Orange Book (3) as drug products that contain the same active ingredient(s), are of the same dosage form, route of administration and are identical in strength or
Recently, researchers did an experiment which include the screening of chemical substance that will treat the disease and also the information from the genomic used to create a drugs for people who have specific genetic data. In developmental process, there were some drugs that were left before and pharmacogenomics used these drugs back. For example, Gencaro is an improvement of β-blocker drug bucindolol which prohibited by the FDA (Food and Drug Administration) because of this substance can lead to heart failure. But after several tests, Gencaro shows that the drugs work effectively in heart function in two different
The same mind-body power that can heal you, can also harm you; this is where the Nocebo effect takes place. The basis behind these two events is called the “meaning response” and it alludes to the brain’s power to lead to effects in reaction to whatever it considers the truth or, positive or negative. If the substance is seen as beneficial it can heal, but if it’s considered as damaging, it is more likely to produce negative effects. For example, when patients in double-blinded clinical tests are warned about the side effects they may encounter if they’re given the real drug, approximately 25% experience sometimes severe reactions, even when they’re only taking a placebo, such as sugar pills. Some of these symptoms include weakness, puking, lack of muscular strength, colds, ringing in the ears, confusion with their taste recognition, memory loss or disorder, and other symptoms that should not result from these fake medications.
The results were limited to published studies in the English. The literature search on medication adherence in HF patients was done by using common words “medication adherence,” “non- adherence,” “compliance,” “heart failure.” The pharmacist intervention literature search was conducted using the common key words “pharmacist,” “patient counselling” to evaluate any pharmacist intervention in the treatment of HF patients. The review also included studies that did not contain pharmacist intervention, instead of that improves medication adherence is
Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. Such “unapproved” or, more precisely, “unlabeled” uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature”. Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations, subsequently confirmed by well-planned and executed clinical investigations. Denying a medication for being used off-label would run contrary to the FDA’s own intent regarding the effect of its labeling, therefore, I respectfully request an exception for Zejula to be approved for Grace at this time so her therapy is no longer, unnecessarily delayed. I believe that Zejula should not be lost to those who could benefit from this treatment, and strongly feel adding Zejula will increase her chances of remission which will extend and improve her quality of life.
One study by Arnold et al. (2010) directly compared the two drugs in question for this project and provided credible information to the development of an evidenced-based answer to the problem (Arnold et al., 2010). A second systematic review by Akl et al. (2014) researched the effects of the two drugs in question in the thromboprophylaxis treatment of patients (Akl et al.,
Each veteran will be administered a new VA identification card that has “bar-lines” for scanning purposes. When a veteran’s medication is administered, the nurse scans the veteran’s card, in addition to scanning the medication that is to be administered. The veterans are asked their full name and last four of their social security number, however with the scanning of their cards, it provides the additional security when confirming their allergies, age, weight, and gender. The study will use a monitoring system that is used by the VA’s called Surveillance of adverse drug events (ADEs).
This bill was passed by the House on April 14, 2014. The bill carefully describes a “drug-related overdose”, clarifies that an “opioid antagonist” means naloxone, and states that a licensed healthcare provider may prescribe naloxone to people who are at risk of an opioid overdose, or people who are in a position to assist others in an opioid overdose event. The bill goes on to state that those who act in good faith to administer naloxone will be exempt from disciplinary actions under title
Similarly, specialty court recidivism research needs to do the same. This prompted the authors to measure specialty court’s influence on clients who did not complete the program. This data is and should be required to determine specialty court’s efficacy. This approach to measure unsuccessful clients is essential and should not be discarded. The authors measured other factors besides recidivism, time to recidivism, and drug use.