Fluconazole is an antifungal agent available for oral and parenteral use. Drug dosage is based on the type and severity of infection, identity of the causative organism, the patient's renal function as determined by creatinine clearance, and response to therapy. To determine whether or not IV fluconazole was being dosed appropriately based on the above parameters, the pharmacy department at St. Joseph Hospital in Flint, Michigan, decided to perform a 3-month drug usage evaluation. As had been speculated, many fluconazole-treated patients were receiving inappropriate dosages. Specifically, renal function was not being taken into consideration in 30% of the cases. Additionally, 33% of patients received higher than necessary doses based on site and severity of infection. With the help of the P & T Committee, an educational program was implemented to assist physicians in the appropriate dosing of fluconazole.
A quality assurance (QA) technique that measured process and outcome was tested on a clinical pharmacokinetic dosing service (CPDS). The process measurement criteria evaluated the CPDS pharmacists' ability to maintain serum aminoglycoside levels within the desired range (peak 6-10 micrograms/ml, trough less than 2.0 micrograms/ml). The outcome measurement criteria evaluated the patients' clinical response to the aminoglycoside therapy based on changes in the patients' temperature, white blood cell count, bacterial cultures, and other variables. The process evaluation found that in a majority of the patients (80 percent), the CPDS pharmacist was performing at a level exceeding the process criteria. The outcome evaluation found that in a majority of the patients (76 percent), the therapeutic outcome criteria were not met. Statistical analysis using Spearman's Rho was not able to relate process and outcome measures significantly (p greater than 0.05). The patient outcome criteria may not have accurately measured patient outcome because of inflexibility, not measuring other patient variables, and the lack of a subjective component. Validation of the QA technique was not possible in this study.
The various legal theories under which pharmacists may be found liable are reviewed. The pivotal element in determining pharmacist malpractice is the study that was owed to the patient. A pharmacist's principal duties to the patient are to dispense the correct drug and to label it correctly; failure to fulfill either of these responsibilities had led to successful claims of malpractice. There have been only a few cases in which the court ruled that the pharmacist had a duty to warn the patient about a potential adverse drug effect or interaction. However, as the role of the pharmacist expands, more courts may begin to find pharmacists liable for failing to warn the patient under specific circumstances. Pharmacists have a heightened duty to warn the patient about potential problems associated with nonprescription drugs that they recommend. A pharmacist may escape liability if there was a lack of proximate cause. Similarly, the defenses of contributory or comparative negligence and voluntary assumption of risk are based on some conduct by the plaintiff that negates or modifies the pharmacist's negligence. Statutes of limitation can also exclude liability. Courts have not found pharmacists liable under strict liability theories. A breach of warranty claim has rarely been successful. Pharmacists could be found liable for negligent selection of therapeutic alternatives but probably not for injuries allegedly caused by correctly selected equivalent agents. Although no cases have been reported, pharmacists could be subjected to negligence-based liability for nondistributive pharmaceutical services. As pharmacists assume more responsibilities, pharmacist malpractice law will expand.
Differences in outcome between patients whose aminoglycoside dosing regimens were individualized by a clinical pharmacokinetic dosing service (CPDS) and patients who did not receive CPDS consultation were evaluated by retrospective chart review. Data for a number of dependent variables that might affect patient outcome were collected from the medical records of 42 patients with culture-proven gram-negative pneumonia or sepsis who had received CPDS dosing consultations and 60 similar patients who had not received CPDS consultations. Data were also collected for a number of analytical and categorical independent variables to evaluate sources of variation between the groups. Variables were compared using both parametric and nonparametric statistical tests. For patients whose dosing regimens had been individualized by the CPDS, length of aminoglycoside therapy and length of stay were significantly shorter, changes in serum creatinine concentration from baseline were significantly smaller, and mortality was significantly lower; morbidity was reduced by significantly fewer incidences of aminoglycoside nephrotoxicity. Significant differences existed between the mean dosing intervals, mean numbers of serum aminoglycoside concentration determinations, and mean baseline serum creatinine concentrations for the two groups. Although a favorable difference in patient outcome was demonstrated for patients whose dosing regimens were individualized by the CPDS, unmeasurable differences between the two groups of patients make it difficult to attribute the difference solely to the effect of the dosing service.
