Vancomycin: The Importance Of Adverse Events In Medicine

liver and kidneys. Normal adult dose of some medications can be toxic to an older patient.

Adverse reactions to drugs are common and almost any drug can cause an adverse reaction.

Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility

Are there any contraindications for this drug? Hypersensitivity, cross-sensitivity with other NSAID’s such as aspirin, history of allergic reactions, asthma, advanced renal disease, hepatic dysfunctions, perioperative pain.

161) A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed after the discovery of the adverse event occurrence?

Any adverse event for which the specificity or severity is not consistent with the protocol-related documents, including the applicable investigator brochure, IRB approved consent form, Investigational New Drug (IND) or Investigational

Preventable adverse events or sentinel events are defined as events that cause an injury to a patient as a result of medical intervention or inaction on the part of the healthcare provider whereby the injury cannot reasonably be said to be related to the patient's underlying medical condition (California Healthcare Foundation (CHCF), 2001). VHS has documentations, forms and processes laid to address occurrences of any preventable adverse events. The first step is conducting the Root Cause Analysis. In order to scrutinize and evaluate adverse events that lead to health injury or death, a Root Cause Analysis can be used as part of the Risk Resiliency method to investigate causal relationships of various factors that can ultimately

Having a system in place for reporting adverse events would bring them to their attention and allow for review. Curative Health would benefit from completing a root cause analysis to review their current processes and determine how to prevent another error like this from occurring. Having input from all disciplines involved would help to create a centralized process to be used in all areas.

In this patient, the drugs that he is on can lead to many severe side effects. Firstly he is on a number of medications that can cause CNS depression, hypotension, bradycardia, and sedation potentially leading to falls.

He could make a fatal mistake; this could result in the death or harm a patient.

Table 5 summarises the national number of patient assessments which showed each of the four harms and which showed none of the harms – ‘harm free’ - for the period from March 2015 to March 2016. It should be noted that a patient may have all, some, one, or none of the

Interrater reliability, Hosmer-lemeshow test, DFBETAS analysis (goodness-of -fit-test), Regression analysis, Bivariate analysis, Logistic regression models (failures), Binary logistic regression (get better) (Dubois et al., 2013, p. 113) were used as part of their data collection. Had these statistics been explained and the reason for testing would have had more reliability in the testing outcomes. The significance is that any event that causes implications on a patient is significant, because in the article 1/3 of patients experienced harm which was not part of their diagnosis. In nursing, we are taught one harmful event is to many.

The results also showed that vancomycin trough level of 15 mcg/mL or greater was associated with increased risk of developing nephrotoxicity.5 Another retrospective study done by Kim et al demonstrated that among a total of 228 patients, the incidence of acute kidney injury (AKI) was lowest in the vancomycin group at 4.0% (p=0.003), 15.4% (p=0.047) in the piperacillin/tazobactam group, and 18.8% in the combination group.6 Also, Gomes et al conducted a cohort study with a total of 224 patients where two groups of patients received either piperacillin-tazobactam with vancomycin or cefepime with vancomycin. The results showed that the incidence of AKI was significantly higher in the piperacillin-tazobactam with vancomycin group compare to the cefepime with vancomycin group (34.8% and 12.5% respectively; p4 g/day), critically ill patients who are likely to experience rapid renal function changes, or receiving concurrent nephrotoxic agents.1,2 The authors mentioned that such toxicity may be confirmed if multiple (at least 2 or 3 consecutive) high serum creatinine concentrations (increase of 0.5 mg/dL or ≥50% increase from baseline) are noted after several days of vancomycin therapy in the absence of alternative explanations.1

Medications that can cause interactions include anticoagulants, probenecid, bisphosphonates, angiotensin-converting enzyme (ACE) inhibitors, anticoagulants (Warfarin), antiplatelet medicines (Clopidogrel), aspirin, corticosteroids (Prednisone), heparin, other NSAIDs (Ibuprofen), Rivaroxaban, or Selective Serotonin Reuptake Inhibitors (SSRIs) (Fluoxetine) due to the risk of stomach bleeding may be increased. Bisphosphonates (Alendronate), Cyclosporine, Hydantoins (Phenytoin), Lithium, Methotrexate, Quinolones (Ciprofloxacin), Sulfonamides (Sulfamethoxazole), and Sulfonylureas (Glipizide) side effects may be increased by Naproxen. The effectiveness of Angiotensin-converting enzyme (ACE) inhibitors (Enalapril), Beta-blockers (Propranolol), or diuretics (Furosemide, Hydrochlorothiazide) may be decreased by Naproxen (Lexi-Comp,

However, if the baseline level was greater than 3 mg/dL, then a rise greater than or equal to 1 mg/dL was required. Patients with another cause for renal failure were excluded from the study. Nephrotoxicity developed in 10 of 50 (20%) patients given both furosemide and an aminoglycoside and in 38 of 222 (17.1%) patients given an aminoglycoside alone. The difference amongst these groups in incidence of nephrotoxicity was not statistically significant. Additionally, the total dose and duration of furosemide administration did not show any correlation to occurrence of nephrotoxicity. (5)