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Open Access Publications from the University of California

Scholarly Works (122 results)

  • Thesis
  • Peer Reviewed
UCLA Electronic Theses and Dissertations (2012)

Background: Prescribing medications for an indication or age outside of the terms of U.S. Food and Drug Administration (FDA) approval is called off label prescribing. In children, off label prescribing has resulted in drug disasters and increased adverse events and has been the subject of recent legislation promoting medication study. Off label prescribing appears to be a very common pediatric practice; nonetheless, the pharmacoepidemiology of off label prescribing has not been systematically studied and could inform approaches to interventions.

Methods: The National Ambulatory Medical Care Surveys (NAMCS), a nationally representative population based sample of U.S. outpatient medical visits collected by the Centers for Disease Control and Prevention (CDC) were utilized over a four year period (2001 2004). We evaluated an estimated 312 million prescription visits by children 0-17 years old (based on a sample of 7901 prescription visits). FDA approved age and indication were compared to the to the child's age and diagnoses. Descriptive and regression analyses were used to determine epidemiological characteristics and predictors of: (1) pediatric off label prescribing in general, (2) prescribing to infants and toddlers (0-3 yrs; n=81 million visits) and (3) off label prescribing for age versus off label prescribing for indication.

Results: Sixty two percent of U.S. outpatient pediatric prescription visits included off label prescribing, with 25% (95% CI: 23%, 27%) including off label prescribing for age and 53% (95% CI: 50%, 56%) off label prescribing for indication. Approximately 96% of cardiovascular renal, 86% of pain, 80% of gastrointestinal, and 67% of pulmonary and dermatologic prescriptions were off label. Anti infectives, upper respiratory and pulmonary medications were much more commonly prescribed off label for indication (41%, 52%, and 61%) than for age (6%, 16%, and 24%). For infants and toddlers, off label prescribing occurred in 65% of prescription visits (52.7 million), with a higher risk of exposure to off label prescribing for age than older children. Physician specialists were 14% (95% CI: 7%, 20%) more likely to prescribe off label for age than general pediatricians or family physicians. Most top prescribed off label medications have remained unchanged over time.

Conclusions: Despite legislation resulting in studies and labeling changes of pediatric medications, the majority of pediatric outpatient visits involve off label prescribing, across all medication categories, to the youngest children, especially by physician specialists, and with medications that are off label for indication; this exposure is disproportionate compared to adults. Many off label prescriptions are for medications with unproven benefit or safety concerns. FDA policies should be strengthened to require prioritized study of all medications commonly prescribed off label; mandate patient registries to assess off label prescribing over time; and provide physicians more accessible prescribing information. Medical education and prescribing incentives and tools should target the most commonly off label prescribed drugs. Future research should determine outcomes, causes, and appropriateness of off label prescribing to children.

    Cover page: Putting Pediatric Off Label Prescribing on the Map: A Study to Understand which Children, Medications and Physicians are Involved in Prescribing Drugs for Unapproved Uses
    • Article
    • Peer Reviewed
    Dermatology Online Journal, Volume 24, Issue 11 (2018)
    Acquired trichorrhexis nodosa is an uncommon hair disorder, defined as a cuticle response to extrinsic or environmental insults, such as certain chemical agents. In the following report, we present a clinical case of acquired trichorrhexis nodosa and make a critical comparison by trichoscopy, optical microscopy, and scanning electron microscopy. Some diagnostic tools can provide high quality information, but their high cost and low access make them an inconvenient option. When comparing the cost-benefit ratio of each one, we conclude that acquired trichorrhexis nodosa can be easily diagnosed with a careful clinical history and examination using a dermatoscope with non-polarized light.
      Cover page: Acquired trichorrhexis nodosa: how to diagnose it?Creative Commons 'BY-NC-ND' version 4.0 license
      • Article
      • Peer Reviewed
      UC Davis Previously Published Works (2019)
      Selenium and vitamin E protect the body against oxidative stress. Clinical manifestations of their deficiency in equids include neurologic and muscular symptoms. Despite the importance of donkeys as working and production animals, there is a dearth of scientific data on selenium and vitamin E normal values. Therefore, the aim of this study was to investigate the plasma concentrations of selenium and vitamin E in healthy donkeys belonging to different ages, sexes, and productive phases. Animals were divided into five groups including foals (group A: n = 7, n = 4 males and n = 3 females), weanlings and yearlings (group B: n = 7, n = 2 males and n = 5 females), nonpregnant nonlactating jennies (group C: n = 5), pregnant nonlactating jennies (group D: n = 9), and adult males (group E: n = 9). Plasma samples obtained from each animal were tested for vitamin E and selenium concentration. One-way analysis of variance showed significant differences in selenium concentrations (P = .001) between group A and group E. In this study, we found the selenium range for donkeys to be 0.02-0.14 μg/mL, which is lower than the recommended range for horses. The results suggest that donkeys may have a lower selenium requirement than horses. Plasma vitamin E levels were 3.29-12.99 μmol/L, with foals having lower concentrations than adults. Knowing specific reference ranges for vitamin E and selenium in healthy donkeys can help improve our understanding of how to prevent deficiencies that could compromise their overall health and well-being.
        Cover page: Selenium and Vitamin E Concentrations in a Healthy Donkey Population in Central Italy
        • Article
        • Peer Reviewed
        UC Davis Previously Published Works (2022)
        The investigation of acute phase proteins in veterinary medicine has opened the doors towards the identification and use of new markers for a timely assessment of health status in both companion and food-producing animals. The aim of this paper is to review the literature available on the use of serum amyloid A (SAA), an acute phase protein, for the diagnosis and monitoring of reproductive disorders in animals. This review critically appraises the usefulness of such marker in clinical practice and summarizes the current state of knowledge. Recent advances in the diagnosis and monitoring of reproductive diseases are presented, highlighting where SAA evaluation may enhance early diagnostic tools for dogs, cats, cattle, and equines.
          Cover page: Serum Amyloid A as a Promising Biomarker in Domestic Animals’ Reproduction: Current Knowledge and Future Perspective
          • Article
          • Peer Reviewed
          Dermatology Online Journal, Volume 28, Issue 4 (2022)
          Mohs micrographic surgery (MMS) is a surgical technique used to remove skin tumors with a complete evaluation of the margins. The keystone flap technique is generally used to repair large surgical defects on limbs. We present a case where a modified keystone flap technique was used to close a large defect after Mohs micrographic surgery in a patient with a basal cell carcinoma on the nose. An excellent functional and aesthetic result was obtained with no complications during or after the procedure. We offer a novel indication for this technique for surgical defects in this area.
            Cover page: Modified keystone flap used to repair nose defect after Mohs micrographic surgeryCreative Commons 'BY-NC-ND' version 4.0 license
            • Article
            • Peer Reviewed
            UCLA Previously Published Works (2014)
            The authors studied a health promotion program called PM-Prep (Peer-Mentored Prep), which was designed to improve disaster preparedness among adults living independently in the community. PM-Prep consists of four 2-hour classes co-taught by a health educator and peer-mentors. Adults were randomly assigned to an experimental arm or a wait-list control arm. Earthquake safety knowledge and preparedness supplies were assessed prior to the intervention and at 1 month after the intervention (N  =  82). Adults in the experimental arm significantly increased preparedness by 19 percentage points, from 56% to 75% completed (p < .0001), and improved their knowledge by 8 percentage points, from 79% to 87% correct (p  =  .001). This is the first peer-mentored, targeted, and tailored disaster preparedness program tested with this population.
              Cover page: Peer-Mentored Preparedness (PM-Prep): A New Disaster Preparedness Program for Adults Living Independently in the Community
              • Article
              • Peer Reviewed
              UC Davis Previously Published Works (2022)
              According to FAO reports, the global mule population counts about 9 million mules. This hybrid cross of a male donkey and a female horse is mainly used for draft purposes because they are thought to be strong and hardy animals. Most consider mules to be less susceptible to disease and fatigue compared to horses. Therefore, the aim of this study was to investigate the effects of fieldwork on biochemical variables and serum amyloid A in working mules. Blood samples were collected from 10 healthy, female, working mules before and after 8 h of fieldwork. According to statistical analysis, a significant influence (p < 0.05) of fieldwork was found on mules’ electrolyte profile with increased levels of sodium, chloride, and calcium, as well as on blood urea nitrogen and creatinine. After a day of fieldwork, serum sodium, chloride, calcium, urea, and creatinine concentrations were increased, supporting decreases in body water and renal blood flow. However, without comparison to a group of mules that were not exercised yet maintained under similar ambient conditions, it is uncertain whether these changes can be attributed to exercise. Further, no change in SAA concentration was found after exercise, indicating that the work performed did not result in systemic inflammation.
                Cover page: Measuring Biochemical Variables and Serum Amyloid A (SAA) in Working Mules in Central Italy
                • Article
                • Peer Reviewed
                UC Davis Previously Published Works (2020)
                Ivermectin (IVM) is an anthelmintic compound commonly used off-label in mules due to its broad-spectrum of activity. Despite the general use of IVM in mules with the same dose and route of administration licensed for horses, significant pharmacokinetic differences might exist between horses and mules, as already observed for donkeys. The aim of the present study was to evaluate the pharmacokinetic profile and anthelmintic efficacy of an oral paste of IVM in mules naturally infected with cyathostomins. Fifteen adult mules with fecal egg counts (FEC) ≥200 eggs per gram (EPG), with exclusive presence of cyathostomins, were included in the study. All mules were orally treated with IVM according to the manufacturer's recommended horse dosage (200 µg/kg body weight). FECs were performed before (day-10 and day-3) and after treatment at days 14 and 28 by using a modified McMaster method. The FEC reduction (FECR%) was also calculated. Blood samples were collected from five animals at various times between 0.5 h up to 30 days post treatment to determine pharmacokinetic parameters. The maximum IVM serum concentration (Cmax) was 42.31 ± 10.20 ng/mL and was achieved at 16.80 ± 9.96 hours post-treatment (Tmax), area under the curve (AUC) was 135.56 ± 43.71 ng × day/mL. FECR% remained high (>95%) until the 28th day.
                  Cover page: Anthelmintic Efficacy and Pharmacokinetics of Ivermectin Paste after Oral Administration in Mules Infected by Cyathostomins
                  • Article
                  • Peer Reviewed
                  UC San Diego Previously Published Works (2014)
                  Dietary protein has been shown to increase urinary Ca excretion in randomised controlled trials, and diets high in protein may have detrimental effects on bone health; however, studies examining the relationship between dietary protein and bone health have conflicting results. In the present study, we examined the relationship between dietary protein (total, animal and vegetable protein) and lumbar spine trabecular volumetric bone mineral density (vBMD) among participants enrolled in the Multi-Ethnic Study of Atherosclerosis (n 1658). Protein intake was assessed using a FFQ obtained at baseline examination (2000-2). Lumbar spine vBMD was measured using quantitative computed tomography (2002-5), on average 3 years later. Multivariable linear and robust regression techniques were used to examine the associations between dietary protein and vBMD. Sex and race/ethnicity jointly modified the association of dietary protein with vBMD (P for interaction = 0·03). Among white women, higher vegetable protein intake was associated with higher vBMD (P for trend = 0·03), after adjustment for age, BMI, physical activity, alcohol consumption, current smoking, educational level, hormone therapy use, menopause and additional dietary factors. There were no consistently significant associations for total and animal protein intakes among white women or other sex and racial/ethnic groups. In conclusion, data from the present large, multi-ethnic, population-based study suggest that a higher level of protein intake, when substituted for fat, is not associated with poor bone health. Differences in the relationship between protein source and race/ethnicity of study populations may in part explain the inconsistent findings reported previously.
                    Cover page: Protein intake and lumbar bone density: the Multi-Ethnic Study of Atherosclerosis (MESA)
                    • Article
                    • Peer Reviewed
                    UC San Diego Previously Published Works (2019)
                    Background Among people with lower extremity peripheral artery disease, obesity is associated with faster functional decline than normal weight. The association of weight loss with functional decline in peripheral artery disease is unknown. Methods and Results Adults with an ankle-brachial index <0.90 were identified from Chicago-area hospitals in 2002-2004. Weight and 6-minute walk distance were measured annually. Weight change categories were weight loss or gain (≥5 pounds/year at ≥1 visit) or stable (weight change <5 pounds at each visit). Participants reported whether weight loss was "intentional" or "unintentional." Calf muscle area was measured with computed tomography every 2 years. Associations of weight change with changes in calf muscle area and 6-minute walk distance were analyzed using mixed-effects models and adjusted for age, body mass index, ankle-brachial index, physical activity, and other confounders. Among 389 participants, mean ankle-brachial index was 0.63±0.16, mean age was 74.5±7.8, and mean body mass index was 28.1±5.1 kg/m2. Over 3.23±1.37 years, muscle area declined more in adults with intentional weight loss versus stable or gain (pair-wise comparisons, P<0.001). Intentional weight loss was associated with less annual decline in 6-minute walk distance than weight gain (intentional loss, 3.7 m; stable, -14.0 m; gain, -28.5 m; unintentional loss, -20.8 m; pair-wise comparison intentional loss versus gain, P=0.003). Conclusions Despite a greater loss of calf muscle area, adults with peripheral artery disease who intentionally lost ≥5 pounds experienced less functional decline than those who gained weight. A randomized trial is needed to establish whether benefits of weight loss in peripheral artery disease outweigh potential adverse effects.
                      Cover page: Associations of Weight Change With Changes in Calf Muscle Characteristics and Functional Decline in Peripheral Artery Disease
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