bluuebunny/crossref_metadata_2025_split huggingface dataset:
Reliability of a Modified Medication Appropriateness Index in Ambulatory Older Persons
Authors: Fitzgerald Lynn S , Hanlon Joseph T , Shelton Penny S , Landsman Pamela B , Schmader Kenneth E , Pulliam Charles C , Williams Mark E 
Published: January 2017

OBJECTIVE: To evaluate the reliability of a medication appropriateness index (MAI) modified for elderly outpatients in a non-Veterans Affairs setting. DESIGN: Reliability study. SETTING: General community. PARTICIPANTS: Ten community-dwelling elderly (> 65 y) taking five or more regularly scheduled medications and participating in a university-based health service intervention study. MAIN OUTCOME MEASURES: Interrater reliability of MAI ratings of 65 medications made by two clinical pharmacists for individual items and for an overall summed score was calculated by use of κ statistics and intraclass correlation coefficient. RESULTS: The interrater agreement for each of the individual MAI items was high for both appropriate and inappropriate ratings and ranged from 80% to 100% (overall κ = 0.64). Overall agreement for the summed score was good (intraclass correlation = 0.80). CONCLUSIONS: The modified MAI is a reliable instrument for evaluation of medication appropriateness in a non-Veterans Affairs, ambulatory, elderly population and may provide pharmacists with a practical and standard method to evaluate patients' drug regimens and identify some potential drug-related problems.
Nifedipine Interaction with Tacrolimus in Liver Transplant Recipients
Authors: Seifeldin Raafat A , Marcos-Alvarez Amadeo , Gordon Fredric D , Lewis W David , Jenkins Roger L 
Published: January 2017

OBJECTIVE: To examine the possible drug interaction between nifedipine and tacrolimus in liver transplant recipients. STUDY DESIGN: A retrospective study was done comparing two groups of liver transplant recipients. The starting time for comparison was the same after transplant. One group (n = 22) consisted of hypertensive patients who were treated with nifedipine; the other group (n = 28) did not receive nifedipine. The two groups were compared over 1 year. The effect of nifedipine on tacrolimus was measured in terms of tacrolimus whole blood trough concentrations, daily tacrolimus dosages, and cumulative tacrolimus dosages at 1, 3, 6, and 12 months. All patient charts were reviewed with regard to concurrent medication that could affect the metabolism of tacrolimus and eventually affect tacrolimus concentrations and dosages. DATA COLLECTION: All required information was retrieved from medical records. RESULTS: There was a statistically significant difference between daily dosage requirements of tacrolimus at 90 (p = 0.03), 180 (p = 0.004), and 365 (p = 0.0004) days between the nifedipine and no-nifedipine groups. The tacrolimus daily dosage in the nifedipine group was decreased by 26%, 29%, and 38% at 3, 6, and 12 months, respectively, compared with the dosage of the no-nifedipine group. Statistically significant differences in cumulative dosages of tacrolimus were observed at 180 (p = 0.02) and 365 (p = 0.003) days between the nifedipine and no-nifedipine groups, with cumulative dosage reduction of 25% and 31% by 6 and 12 months, respectively, in the nifedipine group compared with the no-nifedipine group. CONCLUSIONS: Nifedipine decreased the daily and cumulative dosage requirement of tacrolimus. The interaction observed between nifedipine and tacrolimus is the first reported in humans and is clinically important. As a result of this drug interaction, it is recommended that blood concentrations of tacrolimus be monitored during coadministration of these drugs and that the tacrolimus dosage be adjusted accordingly.
Spironolactone-Induced Agranulocytosis
Authors: Whitling Anna M , Pérgola Pablo E , Sang John Lee , Talbert Robert L 
Published: January 2017

OBJECTIVE: TO report a case of agranulocytosis secondary to spironolactone in a patient with cryptogenic liver disease. CASE SUMMARY: A 58-year-old Hispanic woman with cryptogenic cirrhosis was admitted to University Hospital on October 31, 1995. Laboratory data revealed a leukocyte count of 1.0 × 103/mm3 and an absolute neutrophil count (ANC) of 10 cells/mm3. Prior to treatment with spironolactone, the leukocyte count was 10.2 × 103/mm3 and ANC 8400 cells/mm3. Agranulocytosis resolved 5 days following the discontinuation of spironolactone. Results from the bone marrow biopsies before and after treatment with spironolactone suggested that agranulocytosis was caused by the drug's toxic effect on the bone marrow. DISCUSSION: Drug-induced agranulocytosis is a serious adverse effect, occurring at a rate of approximately 6.2 cases per million persons each year. In addition to the case reported here, three other reports of agranulocytosis secondary to spironolactone have been published in the literature. Several factors have been identified that may increase a patient's risk for developing agranulocytosis, including increased age, hepatic or renal impairment, drag dosage and duration, and concurrent medications. CONCLUSIONS: Agranulocytosis secondary to spironolactone is a serious potential adverse effect. Patients with risk factors for developing this adverse effect should be closely monitored since early detection and discontinuation of spironolactone can improve prognosis.
Pegaspargase: An Alternative?
Authors: Holle Lisa M 
Published: January 2017

OBJECTIVE: TO review the chemistry, pharmacology, pharmacokinetics, clinical activity, adverse effects, dosage, and administration guidelines for pegaspargase. DATA SOURCES: A MEDLINE search (1980–1996), a CANCERLIT search (1983–1996), and a CURRENT CONTENTS search (1980–1996) using the terms pegaspargase, PEG-asparaginase, PEG-L-asparaginase, polyethylene glycol L-asparaginase, polyethylene glycol conjugated L-asparaginase, and Oncaspar were conducted. STUDY SELECTION AND DATA EXTRACTION: All articles were considered for possible inclusion in this review. Abstracts were included only when they were judged to add critical information not otherwise available in the medical literature. DATA SYNTHESIS: L-Asparaginase has been a main component of treatment regimens for acute lymphocytic leukemia. A key limiting factor of L-asparaginase use has been the development of hypersensitivity to the drug. Recently, a polyethylene glycol (PEG) conjugated form of L-asparaginase, pegaspargase, has been made available. PEG modification of L-asparaginase has been shown to alter the tendency of the enzyme to induce an immune response and to extend the half-life of the drug. The majority of patients with hypersensitivity to the native enzyme preparations tolerate pegaspargase without further clinical hypersensitivity. The adverse effect profile of pegaspargase is similar to that of the native forms of L-asparaginase. The recommended dosage of pegaspargase is 2500 IU/m2 administered by intramuscular or intravenous injection every 2 weeks in combination with other chemotherapeutic agents. CONCLUSIONS: Pegaspargase is a safe, effective alternative to L-asparaginase in patients who have had clinical hypersensitivity reactions to both Escherichia coli- and Erwinia carotovora-demed L-asparaginase. However, pegaspargase should not be routinely substituted for L-asparaginase.
Implementation of Pharmaceutical Care Services for Patients with Hyperlipidemias by Independent Community Pharmacy Practitioners
Authors: Shibley Michelle CH , Pugh Carol B 
Published: January 2017

OBJECTIVE: To implement and evaluate pharmaceutical care services for patients with hyperlipidemias in the community pharmacy setting, to evaluate the results of a pharmaceutical care training process for pharmacists by using an assessment quiz, and to measure patient outcomes resulting from provision of pharmaceutical care to patients with hyperlipidemia. DESIGN: A prospective study was conducted over a 1 -year period. Patients served as their own controls. SETTING: Two independent community pharmacies in Richmond, Virginia. PARTICIPANTS: Twenty-five adult patients with confirmed dyslipidemias completed the study. INTERVENTIONS: Study pharmacists assessed each patient and assisted in setting therapeutic goals; patients also completed a visit with a registered dietitian. Drug therapy recommendations were made to physicians by the pharmacist when appropriate. Follow-up was scheduled with the pharmacist to ensure positive outcomes and reduce adverse effects. MAIN OUTCOME MEASURES: Fasting lipoprotein profiles were measured initially and at 6 and 12 months. The SF-36 survey, the MacKeigan-Larson satisfaction survey, and a patient opinion survey were administered initially and at the conclusion of the study. RESULTS: Total cholesterol and low-density lipoprotein cholesterol values were significantly decreased at 12 months compared with either the baseline or 6-month values (p < 0.02). Significant improvement was found in several domains of the surveys; quality of life, patient satisfaction with pharmacy services, and patient opinions on the role of the pharmacist improved after the intervention. CONCLUSIONS: Pharmaceutical care may positively affect lipid values, quality of life, and patient satisfaction.
Suspected Lamotrigine-Induced Toxic Epidermal Necrolysis
Authors: Chaffin Julie J , Davis Steven M 
Published: January 2017

OBJECTIVE: To describe a patient who developed toxic epidermal necrolysis (TEN) possibly secondary to lamotrigine use. CASE SUMMARY: A 74-year-old white man with a history of probable complex partial seizures was admitted to the neurology service for a prolonged postictal state. His antiepileptic regimen was changed while he was in the hospital to include lamotrigine. After 19 days of hospitalization and 14 days of lamotrigine therapy, the patient became febrile. The next day he developed a rash which progressed within 4 days to TEN, diagnosed by skin biopsy. All suspected drugs were discontinued, including lamotrigine. The patient was treated with hydrotherapy in the burn unit. His symptoms improved and he was discharged from the hospital 26 days after the rash developed. DISCUSSION: During lamotrigine's premarketing clinical trials, the manufacturer reported several cases of Stevens-Johnson syndrome and TEN. There are several published case reports of lamotrigine-induced severe skin reactions. All of these reports included patients being treated with both valproic acid and lamotrigine. Our patient was exposed to phenytoin, carbamazepine, clindamycin, and lamotrigine, but not valproic acid. The patient reported prior use of phenytoin with no skin rash. Carbamazepine was the antiepileptic drug the patient was maintained on prior to his hospital admission, and the symptoms of TEN resolved while he was still receiving carbamazepine. The patient received only two doses of clindamycin, which makes this agent an unlikely cause of TEN. CONCLUSIONS: Because of the temporal relationship of the onset of the patient's rash and several drugs that are known to cause severe rashes, it is not certain which drug was the definite culprit. However, based on the evidence from the literature, lamotrigine appears to be the causative agent.
Controversies Surrounding Estrogen Use in Postmenopausal Women
Authors: Witt Daniel M , Lousberg Tammy R 
Published: January 2017

OBJECTIVE: To provide an overview of controversies regarding the use of estrogen in postmenopausal women. DATA SOURCES: A MEDLINE search was conducted to identify pertinent literature published since 1990. Recently published textbooks devoted to the subjects of menopause and women's health were also reviewed, particularly their bibliographies. The bibliographies of selected review articles were also reviewed. STUDY SELECTION: Due to the vast amount of literature, only the most relevant published studies were reviewed. Review articles and book chapters authored by researchers of international reputation were also reviewed. DATA EXTRACTION: Identified studies from the primary literature and selected reviews were carefully reviewed. Information regarding the use of estrogen in postmenopausal women was extracted. Particular attention was given to areas of controversy commonly dealt with in the lay media. DATA SYNTHESIS: The number of postmenopausal women in the US will approach 60 million in the next decade. Despite numerous potential benefits, many women elect to not take estrogen due to fear of cancer or poor understanding of the long-term consequences of menopause and the beneficial effects of estrogen replacement therapy. Many women rely on the news media for information about hormone therapy and subsequently become confused regarding the benefits and risks. Estrogen relieves climacteric symptoms such as hot flushes and symptoms related to genitourinary tissue atrophy. Outcomes from controlled clinical trials are lacking, but numerous epidemiologic studies document clinically significant decreases in cardiovascular disease and osteoporotic morbidity and mortality. Unopposed estrogen increases the risk for endometrial cancer, but addition of a progestin for at least 10 days per cycle effectively reduces this risk to that of women who do not take estrogen. The association between postmenopausal estrogen use and breast cancer remains controversial, despite the results of numerous observational studies. This uncertainty regarding estrogen replacement and breast cancer risk can actually be reassuring when placed in proper perspective.
Phenolphthalein-Induced Toxic Epidermal Necrolysis
Authors: Artymowicz Richard J , Childs Arthur L , Paolini Lawrence 
Published: January 2017

OBJECTIVE: To report a case of phenolphthalein-induced toxic epidermal necrolysis (TEN) in a patient maintained on several other medications more commonly known to be associated with TEN. CASE SUMMARY: A 78-year-old white man presented with intractable lower back pain and constipation. On day 1 of admission, the patient exhibited a diffuse urticarial rash over his trunk and extremities. History revealed that the patient had taken a combination phenolphthalein/docusate sodium (Correctol) over-the-counter laxative 1 day prior to admission. He had a similar urticarial rash 1.5 years earlier with this product and was instructed not to use it. A biopsy was performed and evidence from light microscopic analysis of the tissue led to a diagnosis of TEN. Furosemide, spironolactone, allopurinol, and hydroxyurea were considered possible causes of the reaction and were discontinued. Despite this, the lesions worsened in severity. The patient subsequently responded well to intravenous antibiotics, intravenous corticosteroids, and local wound care. Furosemide, spironolactone, hydroxyurea, allopurinol, and docusate were all reintroduced without reactivation of the lesions. DISCUSSION: phenolphthalein is the active ingredient in several over-the-counter laxative preparations and has only rarely been reported to cause TEN. (It is no longer contained in Correctol.) To our knowledge, this case report represents only the third description of laxative-induced TEN. Although this patient had been exposed to several other medications more commonly associated with TEN, his long-term tolerance of and uneventful rechallenge with these medications exclude them as potential catalysts to this drug reaction. The patient's previous rash and the temporal relation of this event and the ingestion of phenolphthalein, as well as the similarity of this case to other reports, point to phenolphthalein as the cause of TEN in this patient. CONCLUSIONS: TEN is a rare disorder that can be fatal in up to 30% of patients. Clinicians should include phenolphthalein in their list of possible causes of drug-induced TEN. A careful and complete medication history can help avoid unnecessary discontinuation of clinically important medications and inadvertent rechallenge with the causative agent.
Amphotericin B Lipid Complex
Authors: Rapp Robert P , Gubbins Paul O , Evans Martin E 
Published: January 2017

OBJECTIVE: To evaluate the published data on the effectiveness and safety of amphotericin B lipid complex (ABLC) for the treatment of invasive mycosis and to evaluate data describing the pharmacologic properties and pharmacokinetic behavior of ABLC in both animals and humans. DATA SOURCE: A MEDLINE search was conducted to identify literature published from 1965 to January 1997 for amphotericin B deoxycholate (DCAB) and ABLC. In addition, preliminary data published as abstracts and presented at national conferences on infectious disease and hematology within the last 6 years were also included in this review. STUDY SELECTION: Both human and animal studies were reviewed. Animal and in vitro studies were selected to evaluate the pharmacologic and toxicologic properties of ABLC. For the evaluation of the efficacy, safety, and pharmacokinetic behavior of ABLC, large, well-controlled studies were reviewed. In addition, data from open-label and emergency use protocols were also included in the review. DATA EXTRACTION: The study and analytical methods, results, and conclusions of the selected studies were evaluated. Pharmacokinetic data for both ABLC and DCAB that were derived from human subjects were also evaluated. DATA SYNTHESIS: DCAB has been the cornerstone for the treatment of invasive mycosis, even though it has a narrow therapeutic index. Infusion-related toxicities (e.g., fever, chills, rigors) are likely due to DCAB stimulation of cytokine and prostaglandin synthesis. Conversely, nephrotoxicity, the primary non-infusion-related toxicity, likely results from the nonselective cytotoxic interaction between DCAB and cholesterol-containing mammalian cells. ABLC represents a new approach to improving the therapeutic index of DCAB. Mammalian cytotoxicity is attenuated by complexing amphotericin B to a mixture of phospholipids. This alters the affinity of amphotericin B and decreases its selective transfer from the complex to cholesterol-containing mammalian cells. Fungi also possess lipase, which improves the selective transfer from the complex to ergosterol-containing cell membranes. In humans, the lipid formulation increases the volume of distribution of amphotericin B. Thus, compared with DCAB, larger doses of ABLC can be administered for a longer duration with less nephrotoxicity. However, the prevalence of infusion-related toxicities associated with ABLC is similar to that of DCAB. Whether the alteration in distribution improves efficacy by improving tissue concentrations of amphotericin B has not been determined. The cost of this agent will limit its use. CONCLUSIONS: ABLC has been shown to be at least as effective as DCAB, and it has been well tolerated in the clinical studies to date. Despite large dosages and extended courses of administration, there is little nephrotoxicity associated with its use. However, the cost of this agent will limit its use to the treatment of refractory mycosis or to cases where DCAB is contraindicated due to significant renal insufficiency.
Compatibility and Stability of Paclitaxel Combined with Cisplatin and with Carboplatin in Infusion Solutions
Authors: Zhang Yanping , Xu Quanyun A , Trissel Lawrence A , Gilbert Doward L , Martinez J Frank 
Published: January 2017

OBJECTIVE: To evaluate the physical compatibility and chemical stability of paclitaxel at concentrations of 0.3 and 1.2 mg/mL with cisplatin 0.2 mg/mL in NaCl 0.9% injection and with carboplatin 2 mg/mL in NaCl 0.9% injection and dextrose 5% injection over 7 days at 4, 23, and 32°C. DESIGN: The test samples were prepared in polyolefin bags of the infusion solutions at the required drug concentrations. Evaluations were performed initially and after 4 hours, and 1, 3, 5, and 7 days of storage at temperatures of 4, 23, and 32°C for physical and chemical stability. Physical stability was assessed by using visual observation in normal light and using a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the three drugs was evaluated by using three stability-indicating HPLC analytical techniques. RESULTS: All samples were physically stable through 1 day. However, microcrystalline precipitation of paclitaxel occurred in 3 days in some samples and within 5 days in all samples. Paclitaxel concentrations remained above 90% in all samples throughout the study. Cisplatin admixtures exhibited paclitaxel concentration-dependent decomposition with cisplatin losses of approximately 5–8% in 4 hours and approximately 20% in 1 day at 23 and 32°C in the paclitaxel 1.2 mg/mL admixtures. With paclitaxel 0.3 mg/mL in the admixtures, cisplatin losses were about 10% in 7 days at these temperatures. Carboplatin in admixtures with both concentrations of paclitaxel was stable for 7 days at 4°C, but sustained losses of about 10% and 12% in 3 days at 23 and 32°C, respectively. CONCLUSIONS: Admixtures of paclitaxel 0.3 and 1.2 mg/mL with cisplatin and carboplatin are limited in their utility time by both paclitaxel microcrystalline precipitation and decomposition of cisplatin and carboplatin. The admixture of paclitaxel 1.2 mg/mL with cisplatin 0.2 mg/mL in NaCl 0.9% injection exhibits unacceptable cisplatin loss in 24 hours. All other combinations were physically and chemically stable for at least 24 hours at 4, 23, and 32°C.
Routine Monitoring of Gentamicin Serum Concentrations in Pediatric Patients with Normal Renal Function is Unnecessary
Authors: Logsdon Beth A , Phelps Stephanie J 
Published: January 2017

OBJECTIVE: Due to increasing demands for cost containment within the healthcare system, we evaluated the need for routine gentamicin concentrations (i.e., peak and trough with third dose). DESIGN: Single-institution study performed concurrently with hospitalization. SETTING: A 225-bed pediatric teaching hospital. PARTICIPANTS: The study population consisted of 150 hospitalized pediatric patients (53% medicine, 47% surgical patients) from 3 months to 15 years old with normal serum creatinine. OUTCOME MEASURES: If the administered dose produced diagnoses-appropriate peak concentrations of at least 4 μg/mL or 5 μg/mL in bacteremia/septicemia and at least 6 μg/mL or 8 μg/mL in patients with pneumonia if trough serum gentamicin concentrations were less than 2 μg/mL, if the patient was noted by the attending physician to be clinically responding as well as objectively having a decreased white blood cell count and was afebrile, and if there was not an increase of 0.5 mg/dL or more in serum creatinine during the course of therapy. RESULTS: Patients received a mean dose of gentamicin 2.51 ± 0.14 mg/kg iv q8h, which resulted in a mean peak concentration of 6.1 ± 1.7 μg/mL (range 2.4–11.7) and a mean trough concentration of 0.5 ± 0.3 μg/mL (range 0.1–1.8). Peak and trough concentrations were at least 4 μg/mL and less than 2 μg/mL in 96% and 100% of patients, respectively. No patient required a dosage change due to lack of clinical response. CONCLUSIONS: Our data do not support the routine monitoring of gentamicin concentrations in pediatric patients older than 3 months of age who are receiving appropriate standard doses of gentamicin and have normal renal function.