Blood level testing in a community pharmacy: consumer demand and financial feasibility.
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Biomedical subjects
Publications and source records attributed to T R Einarson.
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A case report is presented of a patient having a history of gouty arthritic attacks who suffered similar attacks subsequent to receiving cimetidine and ranitidine. The patient was rechallenged twice with each drug and reacted on each occasion. During the therapy with H2-receptor antagonists, he suffered no attacks that were not immediately preceded by one of these drugs. It is suggested that alternate forms of therapy such as antacids, sucralfate, or carbenoxalone may be preferable in patients suffering from ulcers and gouty arthritic problems.
Meta-analysis, a quantitative method of combining the results of independent research studies, is described as a method for reviewing research literature. Four steps are taken to summarize the research in an area. First, a thorough literature review is conducted to identify a group of research studies with the relevant treatment variable. Second, an effect size is calculated for each study. Third, an overall (composite) effect size is determined by a weighted combination of the obtained effect sizes. Fourth, a fail-safe N (the number of unpublished studies with opposing conclusions needed to negate the published literature) is calculated to assess the certainty of the overall effect size. Meta-analysis was applied to 33 studies of chymopapain in an illustrative example. The analysis produced a large effect size of 0.8082 and a fail-safe N of 214, indicating strong support for the effectiveness of the treatment with chymopapain. Meta-analysis can be a useful tool if it is used properly. It is particularly useful as an adjunct to other methods of review that are used in pharmacy practice.
The use of decision analysis is discussed as it relates to pharmacy practice. Decision analysis is a valuable approach to selecting a choice from among several uncertain alternatives. It encourages the practitioner to define his views explicitly and weigh the merits of each alternative. The decision maker lists the choices or options to be considered. These choices are incorporated into a decision tree with their probability of occurrence and the relative worth of each potential outcome (utility) to the concerned party. A limitation of the method is that utility values and probabilities are often estimated on the basis of the decision makers' biases. Examples of applying decision analysis to clinical and administrative choices in pharmacy practice are presented.
A survey of consumers who had used a state-supported drug information center (DIC) was conducted to determine reasons for and frequency of use of the DIC and opinions about the services of the DIC. The Arizona Poison and Drug Information Center (APDIC) mailed questionnaires to 281 lay persons who had requested information about use of prescription or nonprescription drugs. The questionnaires were sent only to callers who responded affirmatively when asked to participate in the survey. Of 154 (54.8%) respondents (83.8% women), 40.9% were using no prescription drugs at the time of the survey and 83.8% purchased fewer than two nonprescription drugs per month. Approximately 44% said they tried to obtain drug information at least once per month. Pharmacists were named as the most frequent source of drug information for nonprescription drugs, but information about prescription drugs was sought more frequently from physicians and reference books. APDIC was mentioned most frequently as a source of information about all drugs (both prescription and nonprescription). Nearly all respondents said the information from APDIC was helpful and the service should be continued. Drug information consumers looked to this DIC to meet a demand not being met by pharmacists or physicians in the community. Consumers viewed the information as valuable and used this service because it was available and accessible.
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Three cases of orgasmic inhibition by clomipramine are reported, one in a male and two in females. All were depressed patients with obsessive-compulsive features. Orgasmic dysfunction manifested shortly after beginning clomipramine therapy despite a return of libido as the depression lifted. Two of these patients switched to desipramine which led to a resolution of sexual dysfunction while maintaining the patients depression free. The third patient manipulated dosage times to diminish the orgastic problem. Strong anticholinergic and/or anti-adrenergic properties of clomipramine are suspected to underlie the development of this problem.
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The authors describe a patient with changes in oculocutaneous pigmentation that cleared after chlorpromazine was discontinued. They suggest that loxapine may be a suitable alternative to phenothiazines when skin pigmentation and ocular involvement occur, although the patient must be carefully monitored for ocular problems.
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The introduction of a new antidepressant, venlafaxine, a serotonin norepinephrine reuptake inhibitor (SNRI), has provided researchers with the opportunity to take a closer look at the issues involved in selecting a product for a formulary. To aid decision makers in considering the adoption of this new therapy, a pharmacoeconomic simulation model was developed to evaluate the cost-effectiveness of SNRIs versus traditional oral therapies in the management of patients with major depressive disorders (MDDs) from a cost-based payer perspective. Four treatment regimens for MDD were compared: tricyclic antidepressants, selective serotonin reuptake inhibitors, heterocyclic antidepressants, and SNRIs. The principles of decision analysis were used to calculate outcome probabilities based on data from a meta-analysis. The expected cost of each regimen was calculated using cost data from a survey of three health maintenance organizations located in Missouri, Massachusetts, and California. The model suggests that SNRI therapy demonstrates the highest level of cost-effectiveness in an inpatient setting when using both brand and generic acquisition costs of the drugs. When comparing treatment regimens for out-patients, the generic heterocyclic antidepressants demonstrate the highest level of cost-effectiveness: when using band acquisition costs, the SNRIs demonstrate the highest level of cost-effectiveness. Sensitivity analysis calculated the robustness of the conclusions to all major parameters.
In a recent trial, we found that nursing women reported diarrhea in their nursing infants after maternal use of antibiotics. However, because they were told that this could occur during a medication counseling session, the observed effect could have been due to a reporting bias. The objectives of this study were to determine if counseling nursing women about side effects of antibiotic they used could (a) influence the adverse event reporting rate or (b) influence maternal nursing and medication compliance behavior. In a randomized, controlled trial, nursing women calling a teratogen information service for advice about selected antibiotics received one of two possible counseling formats (A and B). Both groups were informed that the antibiotics were safe to use. Mothers in group B were also informed about a theoretical risk of diarrhea in the infant. Mothers later reported clinical events they noted in the infants and judged whether they were due to the antibiotic. Eighty-seven percent (54/62) of group A subjects compared to 68% (52/76) of group B subjects reported clinical events in their infants during their antibiotic therapy (P = 0.017). The incidence of reported diarrhea was 26% in group A compared to 17% in group B (P = 0.3); 34% of subjects in both groups attributed clinical events to antibiotic therapy (P = 1.0). Diarrhea was attributed to antibiotic therapy in 13% of group A and 12% of group B subjects (P = 1.0). No differences were observed between groups in breastfeeding pattern and antibiotic compliance. Breastfeeding women counseled about adverse effects were not more likely to report side effects in their infants or to change nursing behavior and medication compliance.
Newer antibiotics have higher acquisition costs than the first-line antibiotics but may offer superior outcomes, including enhanced eradication of resistant organisms, safety, and compliance in the treatment of acute otitis media. A rational choice among differing therapies should systematically address all these factors. We conducted a cost-utility analysis to compare the commonly used second-line antibiotics--cefaclor (CEF), amoxicillin-clavulanate (AMX-CLA), and erythromycin-sulfisoxazole (ERY-SULF). A meta-analysis of comparative clinical trials was performed to derive point estimates with a 95% confidence interval for rates of success and adverse events. Costs for drugs, laboratory tests, and physician visits were obtained from the government formulary and fee schedules. The cost for management of adverse events was estimated from the findings of a survey of pediatricians. Utilities (preferences or ratings of health states) were derived from responses of physicians to a standardized scenario of acute otitis media with combinations of adverse events. These utilities were used to obtain quality-adjusted life-day (QALD) scores over a 30-day horizon as a measure of effectiveness. Overall cost and QALD were calculated using decision analytic modeling. CEF performed significantly better than the two other drug treatments with the lowest expected cost ($108.00) and highest outcome (28.15 QALD); AMX-CLA was second in cost and third in outcome ($119.00, 27.98 QALD); and ERY-SULF was third in cost and second in outcome ($120.00, 28.03 QALD). These rankings were robust to variations in event rates over the 95% confidence interval. In this analysis, CEF was the most cost-effective antibiotic strategy for second-line therapy when differential success rates, adverse-event profiles, and impact on quality-of-life were considered.
This paper presents a method for summarizing clinical success rates across studies or arms of studies. Topical lacquers for the treatment of onychomycosis are used to illustrate the approach. A modification of Cochran's method, later modified by Der-Simonian and Laird, is presented in a stepwise fashion. A summary point estimate weighted by both within- and between-study variance is produced, along with a 95% confidence interval. This method can be applied to any set of proportions. In the example, the success rate of ciclopirox lacquer was 81.6% (standard error, 3.5%) and of amorolfine lacquer was 71.4% (standard error, 2.3%). A stricter definition of success (ie, cure only) produced success rates of 31.3% (standard error, 2.4%) and 35.8% (standard error, 1.9%), respectively. This stepwise approach for combining single proportions is suggested as a useful method for summarizing success rates across different trials.
BACKGROUND: A very large number of women in the reproductive age group consume cocaine, leading to grave concerns regarding the long term health of millions of children after in utero exposure. The results of controlled studies have been contradictory, leading to confusion, and, possible, misinformation and misperception of teratogenic risk. OBJECTIVE: To systematically review available data on pregnancy outcome when the mother consumed cocaine. METHODS: A meta-analysis of all epidemiologic studies based on a priori criteria was conducted. Comparisons of adverse events in subgroups of exposed vs. unexposed children were performed. Analyses were based on several exposure groups: mainly cocaine, cocaine plus polydrug, polydrug but no cocaine, and drug free. RESULTS: Thirty three studies met our inclusion criteria. For all end points of interest (rates of major malformations, low birth weight, prematurity, placental abruption, premature rupture of membrane [PROM], and mean birth weight, length and head circumference), cocaine-exposed infants had higher risks than children of women not exposed to any drug. However, most of these adverse effects were nullified when cocaine exposed children were compared to children exposed to polydrug but no cocaine. Only the risk of placental abruption and premature rupture of membranes were statistically associated with cocaine use itself. CONCLUSIONS: Many of the perinatal adverse effects commonly attributed to cocaine may be caused by the multiple confounders that can occur in a cocaine using mother. Only the risk for placental abruption and PROM could be statistically related to cocaine. For other adverse effects, additional studies will be needed to ensure adequate statistical power.