bluuebunny/crossref_metadata_2025 huggingface dataset:
Pleural Effusion Associated with Chronic Dantrolene Administration
Authors: Mahoney Janelle M. , Bachtel Michelle D.
Published: January 2017

OBJECTIVE:

To report a case of pleural effusion associated with chronic dantrolene administration.

DESIGN:

Case report.

SETTING:

Private, university-affiliated, teaching hospital.

RESULTS:

Twelve years after the initiation of low-dose dantrolene therapy for chronic spasticity, a 35-year-old man developed a pleural effusion with pleural and peripheral eosinophilia. This reaction gradually resolved over several months after discontinuation of the dantrolene therapy.

CONCLUSIONS:

In patients treated with chronic dantrolene therapy, the presence of pleural effusions should raise the suspicion of dantrolene-induced disease. Withdrawal of dantrolene therapy has generally been associated with an alleviation of signs and symptoms within several months.
Should All Patients with Dilated Cardiomyopathy Receive Chronic Anticoagulation?
Authors: Cheng Judy W.M. , Spinier Sarah A.
Published: January 2017

OBJECTIVE:

To review the mechanism of intracardiac thrombus formation, describe the risk of systemic thromboembolization, critically evaluate the literature regarding the use of oral anticoagulation, review the American College of Chest Physicians (ACCP) guidelines, and provide recommendations for oral anticoagulation in patients with dilated cardiomyopathy (DCM).

DATA SOURCES:

English language clinical studies, abstracts, and review articles pertaining to oral anticoagulation and DCM.

STUDY SELECTION AND DATA EXTRACTION:

Relevant human studies examining the role of anticoagulation for preventing systemic thromboembolism in patients with DCM.

DATA SYNTHESIS:

Potential mechanisms and risk factors for systemic thromboembolization in patients with DCM are discussed. Studies evaluating the benefits and risks of chronic oral anticoagulation to prevent systemic thromboembolization are critiqued. Recommendations for oral anticoagulation in patients with DCM from the second and third ACCP Consensus Conferences are reviewed. Suggestions for study design of a new clinical trial are presented.

CONCLUSIONS:

The second ACCP Consensus Conference recommended chronic anticoagulation for all patients with DCM, but the third conference did not address this issue. Review of demographic data from clinical trials demonstrates reluctance to use anticoagulation in all patients with DCM because of lack of support from prospective, controlled trials. Recent data from large clinical trials suggest that the risk of systemic embolization may be lower than previously believed. We recommend the use of chronic anticoagulation with warfarin in patients for whom the risk of embolism is greater than the risk of major bleeding, such as those with atrial fibrillation or previous systemic embolization. Lack of compliance with ACCP guidelines suggests that clinicians require additional information regarding the bleeding risk and systemic embolization rate reduction of chronic anticoagulation in patients with DCM who remain in normal sinus rhythm. It is only through prospective, controlled trials that this risk/benefit ratio to prevent systemic embolism in patients with DCM can be established.
Interferon Beta for Multiple Sclerosis
Authors: Connelly Julie F.
Published: January 2017

OBJECTIVE:

To introducereaders to the use of a new agent, interferon beta-1b (IFNser), in the treatment of relapsing-remitting multiple sclerosis(RRMS). Therapeuticand economic issues surrounding IFNβser are discussed, as are its pharmacology, clinical efficacy, adverse effects, and dosage guidelines.

DATA SOURCES:

A MEDLINE search was used to identify pertinent literature, including clinical trials and reviews.

STUDY SELECTIONS:

All available trials were reviewed.

DATA EXTRACTION:

Since trials evaluating subcutaneously administered interferon beta are sparse, clinical trials evaluating intrathecal IFNβser were included, as was toxicology information from the oncology population.

DATA SYNTHESIS:

IFNβser has recently been approved by the Food and Drug Administration for the treatmentof RRMS. Its exact mechanism of action is unknown, but it may downregulate interferon gamma (IFNγ) production and the IFNγ-stimulated major histocompatibility complex antigen expression, and/or augment T-suppressor cell function. Primary adverse effects include flu-like symptoms, fever, chills, myalgia, sweating, and injection-site reactions. Clinical efficacy has been investigated in 372 ambulatory patients with RRMS. IFNβser treatment resulted in a reduction in the annual exacerbationrate and a greater proportionof exacerbation-free patients. Burden of central nervous system disease was also significantly reduced in treated patients. However, no reductions were detected on the Scripps Neurologic Rating Scale or with confirmed endpoint scoreson the Kurtzke Expanded Disability Status Scale. Although many questions remain concerning IFNβser's long-term efficacy, its benefits in patients with other types of multiple sclerosis (MS), and its effect on progressionof disease and ultimate disability, IFNβser is the first treatment modality that has substantially altered the natural course of MS in a controlled clinical trial.

CONCLUSIONS:

IFNβser is not a cure for MS, but it is well tolerated and patients with RRMS have shown significant improvements in exacerbation rates and burden of central nervous system disease. IFNβser should be considered a definite improvementin RRMS treatment, although many therapeutic issues remain unanswered. Additional clinical trials are needed.
Identification of Patient-Controlled Analgesia Overdoses in Hospitalized Patients: A Computerized Method of Monitoring Adverse Events
Authors: Whipple Julianne K. , Quebbeman Edward J. , Lewis Kelly S. , Gaughan Linda M. , Gallup Edward L. , Ausman Robert K.
Published: January 2017

OBJECTIVE:

To describe and validate a computer-based quality assurance method that detects narcotic overdoses associated with patient-controlled analgesia (PCA) use.

SETTING:

Two acute care teaching hospitals.

PATIENTS:

4669 patients who received PCA.

INTERVENTIONS:

The following patient lists were obtained during a two-year period from both hospital information systems: those who received PCA and (1) received naloxone, a narcotic antagonist, (2) were transferred to an intensive care unit, (3) had a cardiac or respiratory arrest, or (4) died. Possible overdoses were defined as patients who appeared on the PCA list and one of the other lists. Charts were reviewed if the patient's name appeared on the PCA and one of the other lists. Patients were judged to have experienced a narcotic overdose if there was an immediate improvement in blood pressure, respiratory rate, or mental status after the administration of naloxone.

RESULTS:

The search strategy identified 294 possible overdoses in 1499 patients who received PCA. Ten charts were unavailable for review. An actual overdose occurred in 11 patients. The accuracy of the new method was compared with that of the hospitals' present reporting methods. Eleven overdoses were identified by the computer search, but only 6 overdoses were identified in incident and adverse drug reaction reports.

CONCLUSIONS:

The systematic computer search identified almost twice as many adverse incidents than were reported by the traditional hospital methods.
Healthcare Resource Use and Costs Associated with Migraine in a Managed Healthcare Setting
Authors: Clouse Jon C. , Osterhaus Jane T.
Published: January 2017

OBJECTIVE:

To compare healthcare use and associated costs in patients with migraine and patients without migraine headache.

DESIGN:

Retrospective review of a managed care organization's medical and pharmacy claims databases for claims filed between January 1, 1989 and June 30, 1990.

PATIENTS:

Patients between 18 and 64 years old with a 12-month minimum enrollment in the health plan, including enrollment for the prescription drug benefit. Migraine group (n=1336) inclusion required a medical claim with the diagnosis of migraine headache and a pharmacy claim for a medication potentially used for migraine treatment. Comparison group (n=1336) inclusion required at least one medical claim with no diagnosis of migraine; a pharmacy claim was not required. Comparison group patients were matched to migraine group patients by age, gender, enrollment status, and subscriber or dependent enrollment status.

OUTCOME MEASURES:

Total health services use, diagnosis-specific use of services, diagnostic procedures performed, comorbid conditions, medication use, and associated costs were tallied.

RESULTS:

Migraineurs generated nearly twice as many medical claims as comparison group patients, and nearly 2.5 times as many pharmacy claims. Number of claims generated and numbers of patients who generated claims within each of 19 diagnostic categories indicated greater comorbidity in the migraine group. Migraineurs used emergency services more than did patients in the comparison group. Total medical and pharmacy claims costs were $3.4 million for the migraine group and $2.1 million for the comparison group. The average amount paid per member-month of enrollment was significantly greater in the migraine group than in the comparison group. Comorbid conditions were responsible for a significant portion of costs in the migraine group. The migraine group incurred $83 537 for diagnostic procedures compared with $13 140 incurred by the comparison group.
Safety of Esmolol in Patients with Acute Myocardial Infarction Treated with Thrombolytic Therapy Who Had Relative Contraindications to Beta-Blocker Therapy
Authors: Mooss Aryan N. , Hilleman Daniel E. , Mohiuddin Syed M. , Hunter Claire B.
Published: January 2017

OBJECTIVE:

This study was conducted to evaluate the safety of esmolol in 114 patients treated with thrombolytic therapy for acute myocardial infarction who also had relative contraindications to beta-blockade, and the predictive value of patient tolerance to esmolol and subsequent patient tolerance of oral beta-blocker therapy.

PATIENTS:

One hundred and fourteen patients with myocardial infarction documented by enzyme concentrations and electrocardiographic changes who also had relative contraindications to beta-blockade.

METHODS:

Esmolol was initiated during acute myocardial infarction for myocardial ischemia (n=88), hypertension (n=13), or supraventricular tachycardia (n=13). Relative contraindications to beta-blocker therapy included either active signs/symptoms of left ventricular dysfunction or a history of congestive heart failure (n=40), a history of chronic obstructive pulmonary disease or asthma (n=31), bradycardia (HR <60 beats/min; n=18), peripheral vascular disease (n=15), or hypotension (systolic BP <100 mm Hg; n=14).

RESULTS:

During initial esmolol dose titration, 69 patients tolerated 300 μg/kg/min, 12 patients tolerated 200 μg/kg/min, 17 patients tolerated 100 μg/kg/min, and 16 patients tolerated 50 μg/kg/min. Twenty-eight patients (25 percent) developed dose-limiting adverse effects during esmolol maintenance infusions. Sixteen patients required esmolol dose reduction and 12 required esmolol discontinuation. Adverse effects reversed within 30–45 minutes following dose reduction or discontinuation. The 86 patients who tolerated esmolol infusions without dose reduction or drug discontinuation were subsequently treated with oral beta-blockers. Eleven of these patients (13 percent) developed adverse effects requiring oral beta-blocker discontinuation. Nine of these patients had tolerated only 50 μg/kg/min of esmolol, and the other 2 patients had tolerated only 100 μg/kg/min.

CONCLUSIONS:

Esmolol can be used safely in most patients treated with thrombolytic therapy for acute myocardial infarction who have relative contraindications to beta-blockers. Tolerance to higher maintenance doses of esmolol is a good predictor of subsequent outcome with oral beta-blocker therapy.
Stability of Ondansetron Stored in Polypropylene Syringes
Authors: Casto Daniel T.
Published: January 2017

OBJECTIVE:

To evaluate the stability of ondansetron hydrochloride undiluted and mixed in dextrose 5% injection or NaCl 0.9% injection during storage in polypropylene syringes when frozen, refrigerated, or at room temperature.

DESIGN:

Batch quantities of ondansetron 0.25, 0.5, 1.0, and 2.0 mg/mL were prepared and individual doses of 10.5 mg were drawn into polypropylene syringes that were stored at −20 °C for up to 3 months, at 4 °C for up to two weeks, or at 22–25 °C for two days, and various combinations of these conditions. At defined sampling times aliquots were withdrawn from syringes, the solution visually inspected, pH measured, and ondansetron concentration determined by HPLC. Drug loss of ≥10 percent of the original content of the solution was considered clinically significant.

RESULTS:

The ondansetron concentration in each solution, regardless of storage conditions, remained above 90 percent of the original concentration at each observation time (range 92–107 percent). No changes in color or clarity of any of the solutions were observed, and only slight fluctuations in pH (≤0.05) were noted.

CONCLUSIONS:

Ondansetron 2 mg/mL undiluted, or at concentrations of 0.25, 0.5, or 1 mg/mL, mixed in dextrose 5% injection or NaCl 0.9% injection was determined to be stable when stored in polypropylene syringes for each storage condition at all time points studied, including the maximum for each: three months at −20 °C, followed by 14 days at 4 °C, and by 48 hours at 22–25 °C.
Erythema Multiforme and Hypersensivity Myocarditis Caused by Ampicillin
Authors: Garty Ben Zion , Offer Itamar , Livni Ella , Danon Yehuda L.
Published: January 2017

OBJECTIVE:

To report a case of erythema multiforme and hypersensitivity myocarditis caused by ampicillin.

CASE SUMMARY:

A 13-year-old boy was treated with ampicillin and gentamicin because of suspected septicemia. Medications were discontinued when erythema multiforme and congestive heart failure caused by myocarditis occurred. The patient was treated with methylprednisolone and gradually improved. Macrophage-migration inhibition (MIF) test with ampicillin was positive.

DISCUSSION:

After most infections causing erythema multiforme and myocarditis were ruled out, a drug-induced allergic reaction was suspected. Positive MIF test for ampicillin showed sensitization of the patient's lymphocytes to ampicillin.

CONCLUSIONS:

Hypersensitivity myocarditis is a rare and dangerous manifestation of allergy to penicillins.
Tacrine: First Drug Approved for Alzheimer's Disease
Authors: Crismon M. Lynn
Published: January 2017

OBJECTIVE:

To review the pharmacology, biopharmaceutics/pharmacokinetics, clinical efficacy, adverse effects, and therapeutic considerations regarding the use of tacrine in patients with Alzheimer's disease.

DATA SOURCES:

Data from the scientific and professional literature were analyzed, interpreted, and summarized. Citations were obtained by performing a MEDLINE search using the following indexing terms: tacrine, tetrahydroaminoacridine, and Alzheimer's drug therapy. Data also were obtained from a summary of the New Drug Application (Summary Basis of Approval of Cognex) and from the approved product labeling.

STUDY SELECTION:

Studies in Alzheimer's disease have been plagued by methodologic inconsistencies and deficiencies. Only efficacy studies subsequent to the Food and Drug Administration's (FDA) issuance of recommendations for studies in Alzheimer's disease (1991) were used. Therefore, only double-blind, placebo-controlled, parallel design studies of at least three-month's duration using the Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Clinical Interview-Based Impression of Change as efficacy parameters were included.

DATA EXTRACTION:

Trials were assessed according to the criteria listed above. Results were evaluated on the basis of both completed patients and last observation carried forward models.

DATA SYNTHESIS:

Tacrine is a cholinesterase inhibitor that increases the availability of acetylcholine in muscarinic neurons. It has a mean bioavailability after oral administration of about 17 percent and an elimination half-life of approximately three hours. Although drug interactions are poorly studied, tacrine is metabolized by isoenzyme P-450IA2 and may interact with other drugs metabolized by this isoenzyme. Tacrine has been shown to have efficacy in mildly to moderately impaired Alzheimer's patients on both psychometric testing and a clinician's structured interview. Although efficacious, its effects are not dramatic, and it does not affect the ultimate course of the disease. Adverse effects are frequent, and significantly elevated hepatic transaminase concentrations may occur in approximately 25 percent of patients.

CONCLUSIONS:

Tacrine is the first drug approved by the FDA for treatment of Alzheimer's disease. Although it may improve psychometric test scores in mild to moderately impaired patients, it is not a panacea and does not affect the course of the disease. Patients must be monitored closely for elevated transaminase, cholinergic adverse effects, and interactions with drugs metabolized through P-450IA2.
Beyond Thrombolysis: Other Effects of Thrombolytic Drugs
Authors: Stringer Kathleen A.
Published: January 2017

OBJECTIVE:

To review the effects of plasminogen activators (tissue plasminogen activator, streptokinase, and anistreplase) on fibrinogen and thrombin, platelets, complement, blood rheology, and neutrophils.

DATA SOURCES:

A MEDLINE search, as well as a review of recent scientific abstracts, was conducted to identify pertinent literature.

STUDY SELECTION:

Focus was placed on studies conducted in humans. However, many in vitro studies have been performed to fully elucidate the effect of plasminogen activators on different aspects of hemostasis and on the fibrinolytic and immune systems.

DATA EXTRACTION:

Data from in vitro, human, and animal studies were evaluated.

DATA SYNTHESIS:

There is a discrepancy between 9O-minute patency and mortality in acute myocardial infarction patients treated with thrombolytic drugs. This could be caused, in part, by other hematologic and immunologic effects of thrombolytic drugs. Though the emphasis of clinical trials has been infarct-related artery patency, left ventricular function, and mortality, some studies have evaluated the effect of thrombolytic agents on fibrinogen and thrombin, platelets, blood rheology, complement, and neutrophils. This review discusses the alteration of systemic hematologic and immunologic parameters by thrombolytic drugs and the possible clinical implications of these effects.

CONCLUSIONS:

Although the interactions between thrombolytic drugs, hemostasis, and the fibrinolytic and immune systems are complex and still not fully understood, it appears that these drugs differ in their effects on these systems. A greater understanding of these properties and their clinical implications may ultimately enhance the care and outcome of acute myocardial infarction patients treated with thrombolytic therapy.
Immunization Requirements for Pharmacy Students
Authors: Mallet Louise , Bucci Kathryn K.
Published: January 2017

OBJECTIVE:

To identify current immunization requirements for pharmacy students throughout the US.

DESIGN:

Self-administered questionnaire.

SETTING:

Seventy-five colleges and schools of pharmacy in the US.

MAIN OUTCOME MEASURES:

Immunization policies, immunologic requirements, timing of vaccination in relation to the beginning of clerkship experience, payment, mechanism to revise policies.

DATA ANALYSIS:

Descriptive statistics.

RESULTS:

Overall, 57 programs (81 percent) have an immunization program in place, but 13 programs (19 percent) have no immunization program. More than 50 percent of the colleges or schools reported requiring that pharmacy students have measles, mumps, rubella, tetanus, and purified protein derivative of tuberculin (PPD) vaccinations upon entry of clerkship. Only 25 colleges or schools of pharmacy (44 percent) required students to have the hepatitis B vaccine and 8 (14 percent) to have a PPD evaluation upon completion of clerkship experience. Responsibility for the immunization program was shared evenly between the clerkship coordinator and the student health clinic. Approximately 65 percent of programs maintain an immunization record on file for each student. Completion of immunizations was required in 36 schools (64 percent) before entering clerkship activities, 15 (26 percent) before entrance to the professional program, and 3 (5 percent) in the first year of the program. Six schools (11 percent) had a program in place for less than one year, 27 (47 percent) between one and five years, and 24 (42 percent) for more than five years. At the majority of schools, students are responsible for the cost of immunization.

CONCLUSIONS:

Most schools of pharmacy do not adhere to the specific immunization recommendations described by the Centers for Disease Control and Prevention for healthcare workers. Pharmacy schools need to reexamine their immunization policies and update them to reflect the most current standards. We suggest a policy for immunization of pharmacy students.
Lisinopril Overdose and Management with Intravenous Angiotensin II
Authors: Trilli Lauren E. , Johnson Kjel A.
Published: January 2017

OBJECTIVE:

This report describes a case of lisinopril overdose managed in part with an infusion of angiotensin II in a patient with dilated cardiomyopathy and reviews other literature reporting angiotensin-converting enzyme (ACE) inhibitor overdose.

DATA SOURCES:

Information concerning this patient was obtained through review of the medical chart, conversation with the attending physician, and personal involvement late in the course of the patient's therapy. We conducted MEDLINE and PAPERCHASE searches of the English language literature (restricted to human studies) from 1976 to the present, manually searched Current Contents and references from each publication reviewed, and contacted the manufacturer of lisinopril for any further references they could provide.

STUDY SELECTION:

All case reports that described an ACE inhibitor overdose.

DATA EXTRACTION:

Case reports were evaluated for the ACE inhibitor involved, amount ingested, and therapeutic management.

DATA SYNTHESIS:

Ten patients with ACE inhibitor overdose have been reported, most of whom required only intravenous fluids for blood pressure support. The case presented here is the second report in which the patient's blood pressure was not adequately controlled with fluid and traditional vasopressors and required an infusion of angiotensin II.

CONCLUSIONS:

Although only a few cases of ACE inhibitor overdose have been reported, it is possible that with widespread use of these agents, overdose may become a more common problem. Management of ACE inhibitor overdose should include general supportive care, gut decontamination when possible, intravenous fluids, and vasopressors if necessary. Intravenous angiotensin II may be effective in situations in which traditional vasopressors fail, and is a physiologically rational treatment.
Worsening of Liver Function with Fluconazole and Review of Azole Antifungal Hepatotoxicity
Authors: Gearhart Maureen O.
Published: January 2017

OBJECTIVE:

To report a case of fluconazole worsening of liver dysfunction.

CASE SUMMARY:

A patient with hepatitis experienced worsening of her liver function when treated with fluconazole for a Candida infection in her urine. Elevations in aspartate aminotransferase, alanine aminotransferase, and total bilirubin concentrations along with increased prothrombin time and activated partial thromboplastin time were noted as early as the second day of therapy. After discontinuation of the fluconazole, the liver parameters returned to their normal baseline level.

DISCUSSION:

Hepatotoxicity associated with azole antifungal therapy is reviewed. This patient experienced elevations in liver function enzymes; the literature relating to this topic is evaluated.

CONCLUSIONS:

It is probable that fluconazole therapy was involved in the worsening of this patient's liver function. Liver function should be monitored during the course of fluconazole therapy in patients with underlying liver dysfunction. It appears from the published reports that HIV-positive patients may be at risk for hepatotoxicity with fluconazole.
Repeated Assessment of Methylprednisolone Pharmacokinetics During Chronic Immunosuppression in Renal Transplant Recipients
Authors: Tornatore Kathleen M. , Reed Kristine A. , Venuto Rocco C.
Published: January 2017

Objective:

To compare the pharmacokinetics of methylprednisolone in renal transplant recipients on 2 occasions separated by at least 1 month during chronic immunosuppression.

Design:

A prospective unblinded trial.

Patients:

Ten renal transplant recipients (aged 25–62 years) evaluated in a public university-affiliated hospital clinic.

Interventions:

All patients received their chronic oral dose of methylprednisolone as a 10–20-minute intravenous infusion during the 2 study periods.

Main Outcome Measures:

Serum methylprednisolone concentrations were determined by HPLC and were used to generate the pharmacokinetic parameters of the drug.

Results:

During study 1, which ranged from 1.2 to 24 months posttransplant, the mean ± SD methylprednisolone dose was 13.2 ± 6.4 mg. In study 2 (2.5–38,5 mo posttransplant), the mean dose was 10.6 ± 3 mg. During both study periods, methylprednisolone concentrations exhibited a monoexponential decline. Considerable variability in methylprednisolone clearance was observed between periods in certain patients. Four of the 10 patients demonstrated a reduction in clearance from study 1 to study 2, which ranged from a 28% to a 53% decrease. Two patients exhibited an increase in clearance of 40% and 49%. The mean ± SD total body clearance in study I was 363 ± 330 mL/min/kg, whereas the mean volume of distribution was 1.18 ± 0.53 L/kg. The mean elimination rate constant was 0.29 ± 0.14 h−1, with a mean serum half-life of 2.87 ± 1.15 h during the first phase. In study 2, the mean methylprednisolone clearance was 261 ± 150 mL/min/kg (p > 0.05) and the mean volume of distribution was 0.89 ± 0.31 L/kg (p > 0.05). The mean serum half-life of methylprednisolone was 2.91 ± 0.60 h (p > 0.05), with the mean elimination rate constant of 0.25 ± 0.06 h−1(p > 0.05).

Conclusions:

These data demonstrate that intrapatient variability in methylprednisolone clearance exists among certain renal allograft recipients. As a result of the observed variability, patients who are continued on the same dose of methylprednisolone during the posttransplant period of chronic immunosuppression will be subjected to a changing pattern of exogenous glucocorticoid exposure. The impact of these changing patterns requires further prospective evaluation.
Sulpiride: an Antipsychotic with Selective Dopaminergic Antagonist Properties
Authors: Caley Charles F. , Weber Stanley S.
Published: January 2017

Objective:

To review the pharmacology, pharmacokinetics, clinical investigations, and adverse effects of sulpiride as a treatment for schizophrenia.

Data Sources:

Information was selected from a MEDLINE search of English-language medical literature using “sulpiride” as the search term. Manual searches of pertinent journal article bibliographies also were performed.

Study Selection:

Clinical investigations with a blind, controlled, randomized design and treatment durations of at least 6 weeks were preferred. Formal assessment of a patient's schizophrenia was required. One clinical investigation using a 4-week treatment duration and 1 open investigation were included for purposes of adverse reaction assessment.

Data Extraction:

Clinical investigations were evaluated for design, sample size, diagnosis, duration, and outcome. Data from all investigations were selected by 1 author and reviewed by both authors.

Data Synthesis:

Sulpiride is a substituted benzamide with selective dopaminergic blocking activity. Early pharmacology reports hypothesized that sulpiride was selective for dopamine (D)2 receptors only, but sulpiride also blocks D3 and D4 receptors. Sulpiride does not block D1, adrenergic, cholinergic, gamma-aminobutyric acid–ergic, histaminergic, or serotonergic receptors to an appreciable extent. The oral bioavailability of sulpiride is poor, with estimates approximating 35%. Sulpiride does not appear to have an extensive first-pass metabolism, nor is it extensively protein-bound. There have been no identified active metabolites, and elimination appears to depend primarily on the kidneys. Clinical studies support sulpiride as being equally effective as active controls in the acute treatment of patients with schizophrenia. Daily doses permitted in these clinical investigations ranged from 100 to 3200 mg. Further investigation is required to determine the usefulness of sulpiride as a chronic treatment of schizophrenia and its effectiveness in treating the negative symptoms of schizophrenia. Sulpiride may cause extrapyramidal effects, autonomic effects, tardive dyskinesia, and the neuroleptic malignant syndrome. The incidence of these adverse reactions has not been established.

Conclusions:

Sulpiride is a safe and effective pharmacotherapeutic treatment for the acute management of schizophrenia. A unique pharmacology does not appear to provide sulpiride with a greater effectiveness than the standard antipsychotics, but may provide it with minor safety advantages.
Use of Erythropoietin in Premature Neonates: Controversies and the Future
Authors: Wandstrat Todd L. , Kaplan Barbara
Published: January 2017

Objective:

To review and evaluate current research on the use of recombinant human erythropoietin (rhEPO) for the treatment of anemia of prematurity (AOP).

Data Sources:

A Medline search (1985–September 1994) was used to identify and retrieve pertinent data about erythropoietin's use in premature neonates. Bibliographies in the relevant literature and International Pharmacy Abstracts were reviewed as well.

Study Selection:

The authors extrapolated data from trials and other literature in which the entire paper or abstract was published. Because of the paucity of data on the use of rhEPO in neonates, all available literature was reviewed and cited, regardless of study methodology.

Data Synthesis:

Most data support that rhEPO is efficacious in treating AOP. Until recently, the published investigations have included only small numbers of patients. Larger, multicenter, placebo-controlled trials suggest that infants weighing less than 1500 g benefit from rhEPO therapy. Questions remain concerning the rhEPO dose and nutrient requirements for optimal efficacy.

Conclusions:

Published clinical trials that have examined the efficacy of rhEPO in the treatment of AOP vary considerably with regard to methodology, rhEPO dose, nutrient doses, and outcome measurement. At present, many questions remain to be answered including ascertaining rhEPO's long-term benefit versus cost/risk as well as its potential contribution to improving the care of the premature neonate.
Japanese Pharmacy: Innovation Mixed with Tradition
Authors: Armstrong Edward P. , Akaho Eiichi , Fujii Masami
Published: January 2017

Objective:

To report the current status of pharmacy practice in Japan.

Data Sources:

Published conference reports, journal articles, human resource consultation with medical and pharmacy practitioners, and site visitation by the authors.

Data Extraction And Synthesis:

Data on areas related to Japanese history, practice of pharmacy, and professional innovations were obtained through interviews and the literature. Information is provided to give an appreciation of current pharmacy practice in Japan.

Conclusions:

Japanese pharmacy practice is a strong combination of tradition and professional innovation. The potential for professional growth is immense; Japanese pharmacy has successfully established payment for nondistributive pharmacy services. Payment for cognitive services creates many positive incentives for the future practice of pharmacy in Japan.
Prescribing Patterns of Anttlipemic Drugs and Prevalence of Hypercholesterolemia in the Nova Scotia Population More than 65 Years Old
Authors: Sketris Ingrida S , Kephart George C , Hicks Vern A , Hubbard Eleanor J , Brown Murray G , Chandler R Frank , Maclean David R
Published: January 2017

Objective:

To examine the prevalence of antilipemic drug use, demographic characteristics of patients using these drugs, and the prevalence of hypercholesterolemia in the Nova Scotia population over 65 years of age.

Design:

Information was collected on the prescribing of antilipemic drugs using Nova Scotia Medical Services Insurance Pharmacare program data from October 1991 through March 1992. Pharmacare data were compared with prevalence data on increased low-density lipoprotein (LDL) cholesterol concentrations obtained from the Nova Scotia Heart Health Survey (NSHHS).

Setting:

Pharmacare is a centrally administered drug insurance system maintained in computerized claims files since 1974. It provides prescription drugs to all residents of Nova Scotia who are at least 65 years old and who are insured under the provincial Medicare program.

Participants:

In the 1991–1992 fiscal year, 47 000 men and 65 700 women were eligible for Pharmacare. The NSHHS was administered to a probability sample of 2108 individuals, representative of the 1986 population aged 18–74 years.

Main Outcome Measures:

Prescriptions for antilipemic agents.

Results:

The NSHHS data indicated that 3.7% of women and 2.3% of men at least 65 years old and 4.8% of women and 2.8% of men 65–74 years old received a prescription for antilipemics. Approximately 10% of men and approximately 16% of women aged 65–74 years had LDL cholesterol concentrations in excess of 4.9 mmol/L.

Conclusions:

Elderly women received antilipemic drugs more frequently than did elderly men. The proportion of Nova Scotia's senior population using antilipemic drugs was less than the proportion with increased serum total cholesterol and LDL cholesterol concentrations. More specific studies need to assess the use of antilipemic drugs in relation to patients' risk factors for cardiovascular disease, patient adherence with antilipemic drug therapy, and the effectiveness of antilipemic drugs.
Probable Propafenone-Induced Transient Global Amnesia
Authors: Jones Ronald J , Brace Steven R , Vander Tuin Elton L
Published: January 2017

Objective:

To describe a probable case of transient global amnesia caused by propafenone. This adverse effect has not been previously described for this agent.

Case Summary:

A 61-year-old man with a history of sick sinus syndrome with persistent atrial fibrillation and infrequent premature ventricular contractions was admitted to the hospital for symptoms of amnesia and disorientation to time, place, and date. He began taking propafenone only 6 days prior to admission because of uncontrolled atrial fibrillation and symptoms of fatigue. His atrial fibrillation subsequently had converted to normal sinus rhythm while he received propafenone without adverse effects prior to this episode. His symptoms of amnesia resolved approximately 6–7 hours after discontinuing the propafenone therapy.

Discussion:

Propafenone is a class 1C antiarrhythmic agent that blocks fast sodium channels in heart muscle and Purkinje fibers similar to the action of encainide and flecainide. It also produces weak beta- and calcium-channel blockade. It has a significant adverse effect profile, with 30–45% of patients reporting cardiac adverse effects and 15–20% experiencing noncardiac events. Central nervous system effects that parallel amnesia have been reported in 10–15% of the patients, including dizziness, ataxia, drowsiness, fatigue, confusion, and paranoia. Propafenone's distribution, clearance, and structural similarity to propranolol contribute to its central nervous system effects.

Conclusions:

The rapid resolution of this patient's symptoms after discontinuing propafenone therapy and the absence of recurrence lend credence to the probability of this effect. Comparable adverse effects, such as disorientation and temporary amnesia, have been reported in patients on the analogous agent, propranolol. Consequently, this is a likely, although rare, possible adverse effect with propafenone for which patients should be monitored.
Risperidone: Review and Assessment of Its Role in the Treatment of Schizophrenia
Authors: Cardoni Alex A
Published: January 2017

Objective:

To review pharmacologic, pharmacokinetic, therapeutic, and safety information for the antipsychotic agent risperidone and to evaluate its place in the treatment of schizophrenia.

Data Sources:

MEDLINE and Exerpta Medica databases; Janssen Pharmaceuticals; Food and Drug Administration Psychopharmacology Advisory Committee; PJB Publications; published articles and abstracts; unpublished research reports and abstracts.

Study Selection:

In vivo animal studies (pharmacology); volunteer studies (pharmacokinetics); clinical case reports, open clinical studies, and controlled clinical studies (clinical efficacy and adverse effects; long-term studies; studies in special populations.

Data Extraction:

Relevant data were extracted from published and unpublished source documents, evaluated, and summarized in tables for comparative review. Abstracts were used in 6 of 8 pharmacokinetic studies, 4 of 8 open clinical studies, and 2 of 9 controlled clinical studies. Use of abstracts limits the extent of data extracted.

Data Synthesis:

Risperidone is an effective treatment for positive symptoms of schizophrenia and may be effective for negative symptoms. Efficacy in treatment-resistant patients is inconclusive. In patients in whom low-to-moderate dosage is effective, there should be fewer and less severe adverse effects with risperidone than with haloperidol. Optimal dosage for schizophrenia appears to be 6 mg/d. Although data are limited, risperidone may be toxic on overdose.

Conclusions:

Risperidone is a useful addition to the antipsychotic drug armamentarium, but it should not be viewed as an atypical antipsychotic agent. It is reasonable to consider a trial of risperidone in treatment-resistant schizophrenic patients prior to the use of clozapine and as a first-line treatment for newly diagnosed patients with schizophrenia.
Shock, Metabolic Acidosis, and Coma Following Ibuprofen Overdose in a Child
Authors: Zuckerman Gary B , Uy Cherry C
Published: January 2017

Objective:

To report a child who developed shock, loss of consciousness, and metabolic acidosis following an ibuprofen overdose.

Case Summary:

A 6-year-old boy with no prior medical problems ingested approximately thirty 200-mg tablets of ibuprofen. The patient developed shock, coma, and metabolic acidosis. He was treated successfully with intubation and mechanical ventilation, fluid resuscitation, and decontamination with activated charcoal. The patient was discharged without any clinical sequelae.

Discussion:

Serious adverse complications following ibuprofen overdose have been reported rarely in children. We reviewed literature pertaining to the etiology, pharmacology, pathophysiology, and management of complications following ibuprofen overdoses, as well as other case reports.

Conclusions:

Coma, metabolic acidosis, and shock were noted in a child who ingested a large quantity of ibuprofen. These complications have been described rarely in children. We attribute his favorable clinical outcome to early and aggressive intervention consisting of tracheal intubation, fluid resuscitation, and decontamination with activated charcoal. Although ibuprofen overdoses are usually benign, healthcare professionals should be aware of the various potentially serious complications that may occur.
Oral Vitamin K1: An Option To Reduce Warfarin'S Activity
Authors: Harrell Colleen C , Kline Sandra S
Published: January 2017

Objective:

To report 6 patients taking oral vitamin K1 (phytonadione) to reduce warfarin's activity.

Case Summary:

Six patient cases are summarized in which oral vitamin K1 was used to reduce the international normalized ratio (INR) in patients at risk of bleeding.

Discussion:

The use of oral vitamin K1 to antagonize warfarin's effects is discussed, as well as the benefits of oral vitamin K1 administration and the disadvantages of parenteral vitamin K1 administration. In addition, an extensive literature review of the discovery and clinical development of warfarin and vitamin K1 is described.

Conclusions:

In patients receiving warfarin therapy who have an increased INR and are at risk of bleeding, oral vitamin K1 therapy may be safer, less painful, and more cost-effective than the traditional parenteral route of administration.
Granisetron: The Second Serotonin-Receptor Antagonist
Authors: Adams Val R , Valley Amy W
Published: January 2017

Objective:

To review the pharmacology, pharmacokinetics, clinical efficacy, and adverse effects of granisetron, focusing on critical analysis of published clinical trials and comparison with other antiemetic agents, including ondansetron.

Data Sources:

MEDLINE (1966–1995) and CANCERLIT (1991–1995) searches of English-language literature using the terms “granisetron” and “granisetron (m)” were performed.

Study Selection And Data Extraction:

All articles were considered for possible inclusion in this review. Abstracts of clinical trials were included only when they were judged to add critical information not otherwise available in the medical literature. For studies published more than once, the most recent publication was cited.

Data Synthesis:

Nausea and vomiting are rated by patients as the most distressing chemotherapy-related adverse effects and may produce potentially life-threatening complications. The discovery of the role of serotonin in nausea and vomiting and the development of selective serotonin3-receptor (5-HT3) antagonists has significantly diminished the incidence and consequences of chemotherapy-related nausea and vomiting. Granisetron is the second 5-HT3-receptor antagonist to be marketed in the US. Granisetron has been compared with other antiemetic agents, including ondansetron, against highly and moderately emetogenic chemotherapy. The results of these trials have shown granisetron to be superior to conventional antiemetics and as effective as ondansetron in the prevention of chemotherapy-induced nausea and vomiting. The optimal dose of granisetron has yet to be determined. Formulary decisions should be based on a cost comparison among the 5-HT3-receptor antagonists at individual institutions.

Conclusions:

Granisetron is a safe, effective antiemetic agent for the management of nausea and vomiting caused by cancer chemotherapy.
The Future of Pharmacy: Armageddon or Pollyanna?
Authors: Stewart Ronald B
Published: January 2017

Objective:

To review important events and predictions about pharmacy that have occurred in the practice since my career began and describe changes in opportunities that have developed over the past 35 years.

Data Sources:

I used personal recollections and information from the State of Florida Pharmacy Association journal over a 35-year period. Other supporting data were used to describe current practice opportunities.

Data Synthesis:

Over the past 35 years many people have predicted the demise of the pharmacy profession. The reasons stated for this demise have varied over the years and include government interference, the expansion of chain and mail-order pharmacies, managed care, loss of the compounding function, Medicaid reimbursement, national health insurance, and pharmacy technicians. Despite these gloomy predictions, community and hospital pharmacies have flourished over the past 35 years and new roles for pharmacists have emerged in managed care, consultant pharmacy, academic pharmacy, and the pharmaceutical industry. with the enactment of the Omnibus Budget Reconciliation Act of 1990 requirements, it appears that the public has even greater expectations from community pharmacists as medication advisors. The pharmacy profession is changing more rapidly than ever and pharmacists must prepare for these rapid changes. Colleges of pharmacy should inculcate in their students the importance of lifelong learning to keep abreast with change.

Conclusions:

Society will always need experts on drugs. Pharmacists must rise to the challenge and accept new and changing roles in drug therapy management. If that occurs the future of pharmacy will be ensured.
Identification and Clarification of Drug Therapy Problems by Indian Health Service Pharmacists
Authors: Smith Cynthia P , Christensen Dale B
Published: January 2017

OBJECTIVE:

To describe drug therapy problem intervention activities of Indian Health Service (IHS) pharmacists and to characterize the types of drug therapy problems encountered.

DESIGN:

Longitudinal descriptive study of documented potential drug therapy problems detected by pharmacists during the conduct of routine dispensing activities during a 6-month period.

SETTING:

All 18 IHS hospitals and ambulatory care facilities in one geographic area.

MAIN OUTCOME MEASURES:

Potential drug therapy problem detection rates by pharmacists and problem detection rates per 100 dispensed prescriptions are reported. Problems are characterized as to type, nature of intervention activities undertaken, and results of interventions. Changes in problem detection rate across clinics and over time are reported.

RESULTS:

Pharmacists detected and reported problems at a rate of slightly less than one per 100 prescriptions dispensed; however, drug therapy changes occurred 78% of the time as a result of the interventions. The types of drug therapy problems occurring most frequently were incorrect information (40.7%), prescription clarification (39.6%), clinical problems (10.4%), and inappropriate drug (9.3%). Physician acceptance of pharmacist interventions varied by type of drug therapy problem. Drug therapy changes occurred 77.7% of the time as a result of the interventions. Pharmacists at several sites used records of the drug therapy problems to make changes in policy or procedures as a part of continuous quality improvement activities. As a result, the problem detection rate declined over time in several settings.

CONCLUSIONS:

In comparison with other settings where cognitive services have been reported, IHS pharmacists detected fewer problems, but their interventions resulted in a higher percentage of drug therapy changes.
Effect of Ranitidine on Theophylline Metabolism in Healthy Koreans Living in China
Authors: Kehoe William A , Sands Charles D , Long Li Feng , Lan Han Hui , Harralson Arthur F , Shin Hyun Taek , Jones Daniel W
Published: January 2017

OBJECTIVE:

To evaluate the effect of concurrent ranitidine therapy on theophylline metabolism in healthy Koreans.

DESIGN:

A 4-week, double-blind, randomized, placebo-controlled, crossover study.

SETTING:

The Clinical Research Unit, Department of Pharmaceutical Sciences, Yanbian Medical College, Yanji, China.

SUBJECTS:

Six young, healthy, nonsmoking Korean volunteers residing in China with no known factors that would alter theophylline metabolism.

INTERVENTIONS:

Subjects received extended-release oral theophylline at a constant dosage over 4 weeks to yield a serum concentration (Cp) between 5 and 10 μg/mL. Week 1 was the dosage titration phase. During week 2 subjects randomly received either ranitidine or a matching placebo. Week 3 was a washout phase, and during week 4 subjects were crossed over to receive either placebo or ranitidine. At the end of each treatment week, serum and urinary metabolite concentrations were measured.

OUTCOME MEASURES:

Theophylline serum concentrations and urinary concentrations of 1-methylxanthine, 1-methyluric acid, 3-methylxanthine, and 1,3-dimethyluric acid were measured. Estimates of clearance (Cl), volume of distribution (Vd), and half-life (t1/2) were determined.

RESULTS:

Concurrent administration of ranitidine with theophylline did not significantly alter theophylline Cp, Cl, Vd, or t1/2. Urinary concentrations of major theophylline metabolites also were not changed.

CONCLUSIONS:

Ranitidine does not significantly alter the metabolism of theophylline in healthy Koreans residing in China.