James D. Hoehns

Assessment of Patients' Perceptions and Beliefs Regarding Herbal Therapies

We evaluated the demographics and beliefs regarding safety and efficacy of herbal therapy among individuals in Iowa and assessed the willingness to discuss the use of these products with health care providers. We distributed 1300 surveys to two random samples: patients attending eight clinics, and residents of the state (mailing). Data were categorized according to herb use and compared between users and nonusers. The response rate was 61% (794 people), with 41.6% of respondents reporting herb use. They were predominately white women and were likely to have had education beyond high school (p<0.05). Their use of prescription drugs was high (p<0.05). Although users rated safety and efficacy of herbs higher than nonusers (p<0.05), both groups believed that health care providers should be aware of use and would provide this information.

Analgesic Efficacy of Calcitonin for Vertebral Fracture Pain

OBJECTIVE: To evaluate the analgesic efficacy of calcitonin for treating the pain of vertebral fractures associated with osteoporosis. DATA SOURCES: Searches of MEDLINE (1966–July 2002), Cochrane Library, International Pharmaceutical Abstracts (1977–July 2002), and an extensive manual review of journals were performed using the key search terms calcitonin, analgesic, osteoporosis, vertebral fracture, and pain. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated and all information deemed relevant was included for this review. DATA SYNTHESIS: Fractures, especially vertebral fractures, are a common complication of osteoporosis, leading to significant pain. Calcitonin has been studied for its analgesic properties. Fourteen double-blind, placebo-controlled trials that evaluated the analgesic efficacy of calcitonin for osteoporosis-related vertebral fracture pain were identified and reviewed. Thirteen of these studies demonstrated statistically significant improvement in pain or function in calcitonin-treated patients. CONCLUSIONS: Calcitonin has proven efficacy in acute pain associated with osteoporosis-related vertebral fractures. Analgesic effects are seen with intranasal, parenteral, and rectal administration. Future studies comparing calcitonin with other commonly used analgesics are needed to more clearly define its place in therapy.

Sudden Cardiac Death with Clozapine and Sertraline Combination

OBJECTIVE: To report a case of sudden cardiac death in a patient receiving combination therapy with clozapine and sertraline. CASE SUMMARY: A 26-year-old white man was discovered dead at his residence. His medical history included chronic paranoid schizophrenia, obsessive—compulsive disorder, major depressive disorder, obstructive sleep apnea, and akathisia. He had no prior history of cardiovascular disease. His medication regimen included clozapine 100 mg twice daily (started 4 y prior to his death), risperidone 3 mg twice daily, sertraline 200 mg once daily, atenolol 50 mg twice daily, and lorazepam 0.5 mg four × daily. Autopsy and toxicology studies revealed cardiomegaly suggestive of idiopathic cardiomyopathy, single-vessel coronary artery disease, sertraline and clozapine blood concentrations in the expected range, undetectable lorazepam and risperidone blood concentrations, obesity, and moderate fatty changes to the liver. The most likely cause of death was sudden cardiac death due to acute cardiac arrhythmia. DISCUSSION: Clozapine is structurally similar to the tricyclic antidepressants, which have type 1A antiarrhythmic properties. Case reports have described electrocardiographic abnormalities, cardiomyopathy, and fatal myocarditis associated with its use. Unexplained death in patients on clozapine therapy has also been reported. Sertraline appears to have less cardiac effect; however, one report has observed clinically significant QT prolongation during sertraline therapy. CONCLUSIONS: Clozapine-induced cardiomyopathy and cardiac arrhythmia from clozapine and/or sertraline use may have contributed to this mans death.

Women's quality of life is decreased by acute cystitis and antibiotic adverse effects associated with treatment

BackgroundAlthough acute cystitis is a common infection in women, the impact of this infection and its treatment on womens quality of life (QOL) has not been previously described.Objectives: To evaluate QOL in women treated for acute cystitis, and describe the relationship between QOL, clinical outcome and adverse events of each of the interventions used in the study.MethodsDesign. Randomized, open-label, multicenter, treatment study.Setting. Two family medicine outpatient clinics in Iowa.Patients. One-hundred-fifty-seven women with clinical signs and symptoms of acute uncomplicated cystitis.Intervention. Fifty-two patients received trimethoprim/sulfamethoxazole 1 double-strength tablet twice daily for 3 days, 54 patients received ciprofloxacin 250 mg twice daily for 3 days and 51 patients received nitrofurantoin 100 mg twice daily for 7 days.Measurements. QOL was assessed at the time of enrollment and at 3, 7, 14 and 28 days after the initial visit. QOL was measured using a modified Quality of Well-Being scale, a validated, multi-attribute health scale. Clinical outcome was assessed by telephone interview on days 3, 7, 14 and 28 using a standardized questionnaire to assess resolution of symptoms, compliance with the prescribed regimen, and occurrence of adverse events.ResultsPatients experiencing a clinical cure had significantly better QOL at days 3 (p = 0.03), 7 (p < 0.001), and 14 (p = 0.02) compared to patients who failed treatment. While there was no difference in QOL by treatment assignment, patients experiencing an adverse event had lower QOL throughout the study period. Patients treated with ciprofloxacin appeared to experience adverse events at a higher rate (62%) compared to those treated with TMP/SMX (45%) and nitrofurantoin (49%), however the difference was not statistically significant (p = 0.2).ConclusionPatients experiencing cystitis have an increase in their QOL with treatment. Those experiencing clinical cure have greater improvement in QOL compared to patients fail therapy. While QOL is improved by treatment, those reporting adverse events have lower overall QOL compared to those who do not experience adverse events. This study is important in that it suggests that both cystitis and antibiotic treatment can affect QOL in a measurable way.

Antimuscarinic Intoxication Resulting from the Ingestion of Moonflower Seeds

OBJECTIVE: To report a case in which ingestion of moonflower seeds resulted in antimuscarinic intoxication. CASE SUMMARY: An 18-year-old man was found at a local convenience store hallucinating and incoherent. Upon presentation to the emergency department, his signs and symptoms included tachycardia, confusion, dilated pupils, and dry, flushed, hot skin. He was admitted to the intensive care unit. Hallucinations and symptoms resolved within 36–48 hours after hospitalization. The patient then reported that he had ingested moonflower seeds. He recovered and was released 4 days after admission. DISCUSSION: Based on the patients description and clinical presentation, the moonflower seeds were believed to be Datura inoxia. This species of plant is similar to jimson weed, or Datura stramonium. These plants are known to contain high concentrations of anticholinergic substances; ingestion can result in anticholinergic intoxication. Signs and symptoms that commonly occur include hallucinations, tachycardia, dilated pupils, and disorientation. In our patient, use of the Naranjo probability scale indicated a possible relationship between the moonflower seed ingestion and the patients signs and symptoms. CONCLUSIONS: Ingestion of the Datura species can result in severe toxicity. Each plant varies in the concentrations of alkaloid substances. For this reason, it is very important for individuals to become educated on the toxicities and potential risks associated with recreational use of these plants.

Oral Antivirals for the Acute Treatment of Recurrent Herpes Labialis

OBJECTIVE To evaluate the use and benefit of oral antivirals in the acute treatment of episodic, recurrent herpes labialis. DATA SOURCES A literature search was performed in MEDLINE (1966—August 2003) using acyclovir, famciclovir, valacyclovir, cold sores, herpes labialis, and HSV-1 as search terms. DATA SYNTHESIS We reviewed 5 placebo-controlled and 2 comparative studies evaluating oral antivirals for acute treatment of recurrent herpes labialis. No studies directly compared different antivirals. Studies discussing the efficacy of antivirals for chronic suppression of herpes simplex virus-1 infection were not included. CONCLUSIONS Treatment with oral antivirals decreases the duration of lesion episodes and pain by approximately one day; however, the antivirals do not abort lesions from developing. Clinical implications of these results appear relatively modest.

Fatal Aspiration Pneumonia during Transition from Donepezil to Rivastigmine

OBJECTIVE: To report a case of fatal aspiration pneumonia in a patient shortly after initiation of rivastigmine and discontinuation of donepezil, with no washout period between therapies. CASE SUMMARY: An 83-year-old white man presented to the emergency department in respiratory distress (O2 saturation 70%; RR 44 breaths/min) secondary to aspiration. He had started rivastigmine 1.5 mg twice daily that same day. The patient had been previously treated with donepezil 10 mg/d, and there was no washout period. He was intubated due to worsening respiratory status and was transferred to the cardiac care unit. He then became hypotensive and required dopamine and fluid support. Brief bronchoscopy revealed food particles in the lower airways and bile-stained secretions. Intubation was notable for the large amount of secretions. The patient died approximately 27 hours after presentation to the emergency department. Blood and sputum cultures were subsequently positive for Haemophilus influenzae. DISCUSSION: Cholinesterase (ChE) inhibitors approved for treatment of Alzheimer disease are associated with nausea and vomiting in a sizable percentage of patients, ranging from 5% to 31% in clinical trials. Most of these adverse events occur during the initiation/titration phase of therapy. An additive risk of adverse events may be expected with coadministration of ChE inhibitors or cholinergic agents or, potentially, with an inadequate washout period between such agents. Review of MEDLINE (1966–July 2002) and International Pharmaceutical Abstracts (1970–July 2002) failed to identify any previous reports of aspiration with rivastigmine or donepezil. CONCLUSIONS: A washout period should be considered when switching between ChE inhibitors to minimize the risk of vomiting and aspiration.

Investigation of Simulated Pharmacist Decision Making Involving Prescriptions With a High Probability of Causing Patient Harm

Background: Medication errors pose a significant risk to patients, resulting in morbidity, mortality, and unnecessary health care utilization. Pharmacists, using their professional judgment, have an important role as a final check for identifying and resolving these problems. Little is known, however, about pharmacist perspectives and experiences with dispensing or withholding potentially dangerous prescriptions. Objectives: To (a) evaluate the extent to which pharmacists would not dispense a likely harmful prescription which has been confirmed by the prescriber and (b) assess pharmacist attitudes and experiences with dispensing likely harmful prescriptions. Methods: An anonymous, self-administered, 25-item survey was emailed to members of a state pharmacy association and a pharmacy college alumni list. A series of static prescription vignettes (1 reasonable and 4 likely dangerous doses) were presented and asked if they would fill each prescriber-confirmed prescription. Pharmacists also were asked a series of Likert-type, open-ended, multiple choice, and demographic items regarding their professional experiences and role perceptions. Results: There were 497 usable responses. Three of the 4 dangerous prescriptions were withheld by the majority of pharmacists (sumatriptan as the exception). No demographic variable was universally associated with filling dangerous vignette prescriptions; rather, there were vignette-specific differences. The majority of pharmacists reported refusing to fill a potentially harmful prescription during their career. Conclusions: There appears to be meaningful variation in how pharmacists react when presented with likely harmful prescriptions. More research is needed to better understand this role, its determinants, and the potential effects on patient safety.

Administration of Direct Oral Anticoagulants Through Enteral Feeding Tubes

Objective: To review literature regarding direct oral anticoagulants (DOACs) and determine their viability of administration in solution or via enteral tubes. Data Sources: MEDLINE literature searches identified articles published 2007-present using MeSH terms: factor Xa inhibitors, antithrombins, biological availability, and enteral nutrition. Package inserts were included. Manufacturers were asked to provide literature. Study Selection and Data Extraction: We included studies emphasizing bioavailability or enteral administration. Data Synthesis: Dabigatran and edoxaban package inserts recommend against altering the dosage form, and against enteral administration. One rivaroxaban study was identified. Given with food, enteral administration was comparable to the oral tablet. The mean AUC (0.889, 90% CI 86.12-91.84%) was within the equivalency margins; however Cmax (0.820, 90% CI 78.84-85.86%) was slightly below the 80% threshold. One apixaban study was identified. They showed bioequivalence between oral and enteral administration in different vehicles, but decreased bioavailability when crushed tablets were given along with nutritional support. AUC and Cmax were 32% and 19% lower, respectively, when apixaban solution was given via nasogastric (NG) tube with nutritional supplement versus oral administration of solution. Conclusions: Dabigatran capsules should not be altered, due to large variations in drug exposure. Rivaroxaban can be given as oral solution or via NG tube. Larger doses must be given with nutritional supplementation and enteral tubes must not be distal to the stomach. Apixaban can be given as oral solution or via nasogastric or gastric tube on an empty stomach. Food impairs bioavailability of the crushed tablets. There are insufficient data to recommend enteral administration of edoxaban and the package insert recommends against altering tablets.

Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease

The objectives of this study were to determine if hypertensive patients with comorbid diabetes mellitus (DM) and/or chronic kidney disease (CKD) receiving a pharmacist intervention had a greater reduction in mean blood pressure (BP) and improved BP control at 9 months compared with those receiving usual care; and compare Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline and 2014 guideline (JNC 8) BP control rates in patients with DM and/or CKD.