Patient safety adverse reactions

The two recombinant hepatitis B vaccine products available in the United States (Recombivax HB, Merck Engerix-B, SmithKline Beecham) have comparable immune responses and safety profiles. The vaccines contain 5 to 40 meg HBsAg protein per milliliter adsorbed onto aluminum. Neither brand of hepatitis B vaccine contains thimerosal. The recent availability of a combined HAV and HBV vaccine allows for a more accelerated schedule for immunization. For a more detailed comparison of the potential vaccination schedules refer to the cited reference. These vaccines are some of the safest available. Side effects of the vaccine are soreness at the injection site, headache, fatigue, irritability, and fever. The number of patients experiencing adverse reactions decreases with each vaccine dose, and adverse reactions are less common in infants and children than in adults. There is no association between Guillain-Barre syndrome and the recombinant vaccine, and the vaccine does not transmit HIV. The hepatitis B vaccine is contraindicated for patients with anaphylaxis to... 

The nurse observesthe elderly patient receiving a cholinergic blocking drug at frequent intervals for excitement, agitation, mental confusion, drowsiness urinary retention, or other adverse effects. If any of these should occur, it is important to withhold the next dose of the drug and contact the primary health care provider. The nurse ensures patient safety until these adverse reactions disappear. 

Visual difficulties (eg, adverse reactions of blurred vision and diplopia) may be evidenced by the patient s sudden refusal to read or watch television or by the patient bumping into objects when ambulating. The nurse carefully evaluates any sudden changes in the patient s behavior or activity and reports them to the primary health care provider. The patient with visual difficulties may need assistance with ambulation. The room should be kept well lighted, the use of scatter or throw rugp should be avoided, and any small pieces of furniture or objects that might increase the risk of falling should be removed. The nurse carefully assesses the environment and makes the necessary adjustments to ensure the patient s safety. 

Monitor laboratory parameters to ensure patient safety and reduce the risk of adverse reactions. 

Rifaximin has revealed as excellent safety profile in clinical trials adverse reactions were observed in less than 2% of patients most of the side effects were of gastrointestinal type or origin (such as nausea, vomiting, flatulence/ meteorism, abdominal pain/cramp) while a mild to moderate urticarioid rash was infrequent [45]. 

Phase IV. Studies or trials conducted after a medicine is marketed to provide additional details about the medicine s efficacy or safety profile. Different formulations, dosages, durations of treatment, medicine interactions, and other medicine comparisons may be evaluated. New age groups, races, and other types of patients can be studied. Detection and definition of previously unknown or inadequately quantified adverse reactions and related risk factors are an important aspect of many Phase IV studies. If a marketed medicine is to be evaluated for another (i.e., new) indication, then those clinical trials are considered Phase II clinical trials. The term postmarketing surveillance is frequently used to describe those clinical studies in Phase IV (i.e., the period following marketing) that are primarily observational or nonexperimental in nature, to distinguish them from well-controlled Phase IV clinical trials or marketing studies. 

Between 1980 and 1991, only a few published studies examined the safety and the hypnotic efficacy of the 0.125-mg dose of triazolam in elderly patients ( 318, 319, 320, 321, 322, 323 and 324). These studies and case reports indicate that with continued use, the initial efficacy of the 0.125-mg dose of triazolam in elderly patients begins to wane after 1 week and progressively diminishes to ineffectiveness, usually by the sixth week of continuous administration. During the same period, the risk of potentially serious adverse reactions increases. 

To support approval as a nonbotanical drug, adequate and well-controlled clinical studies are required. Not only must the treatment be shown to be effective, with real patient benefits in morbidity and/or mortality to justify the safety risk of adverse reactions as observed, but the clinical data must also provide practical instructions for use, which can be reasonably followed by health care professionals. There is no reason why these requirements should be different for botanical drugs, because patient suffering and treatment benefits are independent of medical theory or practice. Regardless of medical systems and terminology used, courses of diseases/conditions should be established and treatment effects must be clinically meaningful. Incorporation of alternative medical practice into the clinical studies will be acceptable if the new set of instructions derived from such studies will be practical. 

The increased used of vaccines has drawn attention to ethical issues associated with safety and the risk-benefit ratio in some cases has come under scrutiny. Vaccines are usually given to patients who are otherwise healthy and have a lower tolerance for risk. Adverse reactions are either quite common ( 10%) or very rare ( 0.0001%). The question of justifiable risk in a healthy population then becomes problematic and difficult to identify. 

Given its many adverse reactions, the safety of using nicotinic acid continues to be discussed. Some are of the opinion that it should only be given to patients with marked dyslipidemia and under close monitoring, and that the initial expectations of fewer adverse reactions... 

Results of clinical investigations involving human subjects, including investigator and enrollment information, protocol information, study population, study period, safety and effectiveness data, adverse reactions and complications, patient discontinuations, patient complaints, device failures and -replacements, data tabulations, subject report forms for deaths and discontinuations, statistical analyses, contraindications, and precautions for use of the device. Studies conducted under an IDE should be identified. 

Immunogenicity concerns are based on a number of potential safety concerns. Adverse reactions can be based on the formation of immune complexes that can give rise to renal toxicity, complement activation, and, as recently reported, the induction of autologous antibodies that cross-react with the patient s own endogenous protein [23-28]. 

Risperdal was first marketed in 1994 as an atypical neuroleptic. The clinical trials, most of which lasted a few weeks, were too short to determine the rate of tardive dyskinesia and many other adverse effects. Indeed, the brief controlled clinical trials used for the approval of both clozapine and risperidone do not provide sufficient information to determine either efficacy or safety since the drugs would be used for months and years in individual patients, rather than for a few weeks (see chapter 13). Patients taking the medications over the coming years will provide the experimental data. However, since Risperdal is a potent dopamine blocker, it should have been anticipated that it would cause similar adverse reactions as the older neuroleptics. In my own experience, I have evaluated many cases of tardive dyskinesia caused by Risperdal, Zyprexa, and Geodon. Meanwhile, the Food and Drug Administration (FDA) has required the same tardive dyskinesia and neuroleptic malignant syndrome warnings on the labels of clozapine and risperidone as on the labels of the older neuroleptics. 

Consider the difference in response to drugs between older and younger people. Treatment should reflect biological age (rather than chronological). Pharmacokinetics, pharmacodynamics, tolerability, adverse reactions, economy and patient choice will all influence therapy chosen. Most commonly, car-bamazepine or sodium valproate are chosen for older people as their effects in older people are well documented. Both show a favourable balance of safety, efficacy and economy. Phenytoin is less preferable because of drug interactions, adverse effects and potential for toxicity (zero order kinetics). 

As implied by its title, the safety update report is not submitted with the original BLA, but is submitted in the form of updates at specific points in the application review process. Applicants must submit safety update reports 4 months after the BLA submission, after receipt of a complete response letter, and other times requested by CBER. In these reports, the sponsor must update the pending BLA with new safety information learned about the product that may reasonably affect the labeling statements in the contraindications, warnings, precautions, and adverse reactions sections. The updates must include the same types of information from clinical studies, animal studies, and other sources, and must be submitted in the same format as the BLA s integrated safety summary. They must also include case report forms for each patient who died during a clinical study or who did not complete the study because of an adverse event. 

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