Adverse drug reaction determinants

SALICYLATES The nurse observes the patient for adverse drug reactions. When high doses of salicylates are administered (eg, to those with severe arthritic disorders), the nurse observes the patient for signs of salicylism. Should signs of salicylism occur, the nurse should notify the pri-rnary health care provider before the next dose is given because a reduction in dose or determination of the plasma salicylate level may be necessary. Therapeutic salicylate levels are between 100 and 300 meg/ mL. Symptoms associated with certain salicylate levels are ... 

At each follow-up visit, compliance with a healthy lifestyle should be determined, as well as measurement of physical parameters, including weight, blood pressure, and heart rate. Waist circumference should be measured intermittently. A complete assessment also would include identification of adverse drug reactions or drug interactions if weight-loss medications have been initiated. 

None of these factors alone should be considered to indicate a Type B reaction, and any taken singly can be associated with a Type A reaction. This list should be taken as a starting point in determining if an adverse drug reaction is a type of drug allergy. The following are additional considerations. 

It can be seen that although one may suspect an adverse drug reaction as a diagnosis, it is not easy to determine a causal relationship, unless there is a special investigation result which is specific. How therefore do you manage a patient with a suspected drug reaction ... 

Age-related changes in phase I metabolism coupled with the use of multiple medications place older patients at increased risk for adverse drug reactions. Adverse drug reactions occur due to either inhibition or induction of CYP enzymes, especially CYP3A, which is believed to be involved in the metabolism of more than one half of the currently prescribed drugs.Clinical outcomes are determined by... 

On September 12, 1989, Anello reported within the FDA on Triazolam and Temazepam—Comparison Reporting Rates. He found that adverse drug reactions were reported 11 times more frequently with triazolam than with temazepam. The relative reporting rate was 46 to 1 for amnesia, 9 to 1 for agitation, anxiety and nervousness, 16 to 1 for psychosis ( psychosis, hallucinations, paranoid reaction, and acute brain syndrome ), and 19 to 1 for hostility and intentional injury. Anello s (1989) analysis indicated that there were no convincing explanations for these differences other than actual drug effects, but he did not make a formal determination of causality. However, in a handwritten analysis attached to the document, obtained through the Freedom of Information Act, there is a summary titled Other Evidence in Favor of Effect of Triazolam, which I quote in full ... 

An important issue in the Lacuzong case was the capacity of one, two, or three daily doses of Paxil 10 to cause severe mental disturbances. During my site visit to the offices of GSK, I combed through adverse drug reaction reports to determine how early in treatment they began. I discovered that the first few days were the greatest time of risk. 

ADI Acceptable daily intake the amount of a specific food additive or contaminant (e.g., pesticide) thought to be the maximum level that should be consumed on a daily basis. ADI values are normally determined by experts of the WHO/FAO Codex Alimentarius Committee ADME Absorption, distribution, metabolism, and distribution ADR Adverse drug reaction... 

Lennard MS. Genetically determined adverse drug reactions involving metabolism. Drug Saf 1993 9 6(U77. 

Continue therapy until apparent cure has been achieved most acute infections are treated for 5-10 days. There are many exceptions to this, such as typhoid fever, tuberculosis and infective endocarditis, in which relapse is possible long after apparent clinical cure and so the drugs are continued for a longer time, determined by comparative or observational trials. Otherwise, prolonged therapy is to be avoided because it increases costs and the risks of adverse drug reactions. 

The adverse effects of iron formulations have resulted in trials to optimize dose regimens. A large database of clinical variance reports from Fresenius Medical Care North America (FMCNA) has been analysed to determine the incidence of suspected adverse drug reactions of iron dextran and the associated patient characteristics, dialysis practice patterns, and outcomes (8). A case-cohort design was used, comparing individuals who had suspected adverse drug reactions with the overall population. Out of 841 252 intravenous iron dextran administrations over 6 months, there were 165 reported suspected adverse drug... 

In clinical trials of IMPs without a MA, sponsors must report all serious unexpected suspected adverse drug reactions (SUSARs) within eight calendar days if they were fatal or life threatening, and within fifteen days for other serious cases. The initial report has to be followed up within seven days for fatal or life-threatening cases and within fifteen days for other serious reports. These expedited reporting requirements mean that the treatment code in blinded trials must be broken, as it is otherwise impossible to decide which treatment the patient received and, therefore, impossible to determine whether an event could possibly be a reaction if a patient received placebo, then there is no suspicion of a possible adverse reaction to the IMP and authorities do not require expedited... 

A document prepared by the pharmaceutical manufacturer, containing [among other things] all relevant safety information, such as adverse drug reactions, which the manufacturer requires to be listed for the drug in all countries where the drug is marketed. It is the reference document by which labeled and unlabeled are determined [for the purpose of international ADR reporting]... 

The plan of care should be developed initially and updated as needed. Based on the drug(s) used and the potential for side effects and adverse drug reactions, the pharmacist should determine what type of monitoring is needed (e.g., labs, physical findings) and the frequency at which it is to occur. The pharmacist must communicate this plan to others involved and provide updates as needed. 

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