Antimicrobial Susceptibility of Neisseria gonorrhoeae in Adult Patients Seeking Care at Military Hospitals in Thailand From 2014 to 2020

ABSTRACT Introduction The effective dual antibiotics ceftriaxone (CRO) and azithromycin (AZM) have successfully treated Neisseria gonorrhoeae (GC) infection, however, the CRO- and AZM-resistant strains have been sporadically detected globally and in Thailand. Furthermore, there are no currently antimicrobial susceptibility profiles of the GC isolates obtained from soldiers reported in Thailand. Hence, this is the first study to describe the antimicrobial susceptibility profiles of GC isolates obtained from predominately soldiers who seeking care at Military Camp Hospitals, in Thailand from 2014 to 2020. Materials and Methods A total of 624 symptomatic gonococcal samples were received from 10 military hospitals during 2014-2020. They were collected from urethral swabs and inoculated into selective media. The suspected GC isolates were subcultured and presumptively identified using conventional microbiology techniques. Antimicrobial susceptibility test was performed by Etest to determine minimal inhibitory concentration (μg/mL) against AZM, benzylpenicillin, cefepime, cefixime, ceftriaxone (CRO), ciprofloxacin, spectinomycin, and tetracycline using the criteria outlined in the Clinical and Laboratory Standards Institute guidelines. This study was approved by Institutional Review Board, Royal Thai Army Medical Department under protocol number S036b/56 and Walter Reed Army Institute of Research, and Silver Spring, MD under protocol number WR #2039. Results A total of 624 samples were collected from symptomatic gonococcal infectious patients with 91.5% (571/624) of samples obtained from soldiers. Of those, 78% (488/624) were identified as GC and 92% (449/488) of them were isolated from soldiers. All GC samples collected were susceptible to CRO (first-line treatment) with only one GC isolate identified as non-susceptible to cefepime and three isolates identified as non-susceptible to AZM. Conclusion The recommended dual treatment of GC infections with CRO and AZM is currently an effective empirical treatment for patients who are seeking care at military hospitals in Thailand. Nevertheless, cefepime is a fourth-generation cephalosporin with documented high activity against GC strains equal to other “third-generation” cephalosporins such as CRO. Due to the active duty of military personnel, they concerned about the confidentiality and frequently seek treatment at civilian clinics. Additionally, due to the availability of antibiotics over the counter in Thailand, many choose the option to self-medicate without a physician’s prescription. These could be subsequently driven the gradual increase of multidrug-resistant gonococcal strains throughout the country. Thus, the GC surveillance would be needed for further Force Health Protection and public health authorities in response to the drug-resistant GC threats.

2018 Survey of factors associated with antimicrobial drug use and stewardship practices in adult cows on conventional California dairies: immediate post-Senate Bill 27 impact

Background Antimicrobial drugs (AMD) are critical for the treatment, control, and prevention of diseases in humans and food-animals. Good AMD stewardship practices and judicious use of AMD are beneficial to the preservation of animal and human health from antimicrobial resistance threat. This study reports on changes in AMD use and stewardship practices on California (CA) dairies, following the implementation of CA Senate Bill 27 (SB 27; codified as Food and Agricultural Code, FAC 14400–14408; here onward referred to as SB 27), by modeling the associations between management practices on CA conventional dairies and seven outcome variables relating to AMD use and stewardship practices following SB 27. Methods A survey questionnaire was mailed to 1,282 grade A licensed dairies in CA in spring of 2018. Responses from 132 conventional dairies from 16 counties were included for analyses. Multivariate logistic regression models were specified to explore the associations between survey factors and six outcome variables: producers’ familiarity with the Food and Drug Administration’s (FDA), Silver Spring, WA, USA medically important antimicrobial drugs (MIAD) term; change in over-the-counter (OTC) AMD use; initiation or increased use of alternatives to AMD; changes to prevent disease outbreaks; changes in AMD costs; and better animal health post SB 27. We employed machine learning classification models to determine which of the survey factors were the most important predictors of good-excellent AMD stewardship practices of CA conventional dairy producers. Results Having a valid veterinary-client-patient-relationship, involving a veterinarian in training employees on treatment protocols and decisions on AMDs used to treat sick cows, tracking milk and/or meat withdrawal intervals for treated cows, and participating in dairy quality assurance programs were positively associated with producers’ familiarity with MIADs. Use or increased use of alternatives to AMDs since 2018 was associated with decreased use of AMDs that were previously available OTC prior to SB 27. Important variables associated with good-excellent AMD stewardship knowledge by CA conventional dairy producers included having written or computerized animal health protocols, keeping a drug inventory log, awareness that use of MIADs required a prescription following implementation of SB 27, involving a veterinarian in AMD treatment duration determination, and using selective dry cow treatment. Conclusions Our study identified management factors associated with reported AMD use and antimicrobial stewardship practices on conventional dairies in CA within a year from implementation of SB 27. Producers will benefit from extension outreach efforts that incorporate the findings of this survey by further highlighting the significance of these management practices and encouraging those that are associated with judicious AMD use and stewardship practices on CA conventional dairies.

Current state of cardiac troponin testing in Duchenne muscular dystrophy cardiomyopathy: review and recommendations from the Parent Project Muscular Dystrophy expert panel

Cardiac disease is now the leading cause of death in Duchenne muscular dystrophy (DMD). Clinical evaluations over time have demonstrated asymptomatic cardiac troponin elevations and acute elevations are associated with symptoms and cardiac dysfunction in DMD. Clinicians require a better understanding of the relationship of symptoms, troponin levels and progression of cardiac disease in DMD. As clinical trials begin to assess novel cardiac therapeutics in DMD, troponin levels in DMD are important for safety monitoring and outcome measures. The Parent Project Muscular Dystrophy convened an expert panel of cardiologists, scientists, and regulatory and industry specialists on 16 December 2019 in Silver Spring, Maryland and reviewed published and unpublished data from their institutions. The panel recommended retrospective troponin data analyses, prospective longitudinal troponin collection using high-sensitivity cardiac troponin I assays, inclusion of troponin in future clinical trial outcomes and future development of clinical guidelines for monitoring and treating troponin elevations in DMD.

Evaluation of a Distributed Streamflow Forecast Model at Multiple Watershed Scales

Demand for reliable estimates of streamflow has increased as society becomes more susceptible to climatic extremes such as droughts and flooding, especially at small scales where local population centers and infrastructure can be affected by rapidly occurring events. In the current study, the Hydrology Laboratory-Research Distributed Hydrologic Model (HL-RDHM) (NOAA/NWS, Silver Spring, MD, USA) was used to explore the accuracy of a distributed hydrologic model to simulate discharge at watershed scales ranging from 20 to 2500 km2. The model was calibrated and validated using observed discharge data at the basin outlets, and discharge at uncalibrated subbasin locations was evaluated. Two precipitation products with nominal spatial resolutions of 12.5 km and 4 km were tested to characterize the role of input resolution on the discharge simulations. In general, model performance decreased as basin size decreased. When sub-basin area was less than 250 km2 or 20–40% of the total watershed area, model performance dropped below the defined acceptable levels. Simulations forced with the lower resolution precipitation product had better model evaluation statistics; for example, the Nash–Sutcliffe efficiency (NSE) scores ranged from 0.50 to 0.67 for the verification period for basin outlets, compared to scores that ranged from 0.33 to 0.52 for the higher spatial resolution forcing.

The Silver Spring monkey controversy: changing cultures of care in twentieth-century laboratory animal research

In September 1981 police raided the Institute for Behavioral Research (Silver Spring, Maryland, USA) seizing a number of macaque monkeys in response to accusations of animal cruelty against the neuroscientist Edward Taub. Over the following decade a volatile battle was fought as Taub, the National Institutes of Health (NIH), and the nascent animal rights group People for the Ethical Treatment of Animals (PETA), contested the claims and decided the monkeys’ fate. In spite of the monkeys having been surgically altered so as to be incapable of feeling pain a loose alliance of veterinarians, ethologists and animal advocates argued that they nonetheless suffered. Whilst this episode is often seen as a polarized confrontation between science and society, this paper argues that the Silver Spring monkey controversy saw two historically distinct cultures of laboratory animal care meet resulting in the development of new approaches to animal welfare in biomedical science.

Perspectives on the draft ICH-M10 guidance: an interview with Boris Gorovits

Biography Boris Gorovits is a Senior Director of the Bioanalytical lab at Pfizer. Boris earned his PhD in Enzymology from the Moscow State University and later completed postdoctoral research studies in protein biophysics at the Medical Center, University of Texas at San Antonio, TX, USA. In 2000, Boris joined Wyeth Research (later Pfizer Inc) to work as a bioanalytical group lead with a growing scope of responsibilities. Currently, he leads the Bioanalytical group within Biomedicine Design department which is responsible for many aspects of the Regulated and Nonregulated Bioanalytical support for the pan-Pfizer Biotherapeutic portfolio. Boris co-chairs Pfizer internal Immunogenicity Expert Working Group, which is responsible for review of the biotherapeutic immunogenicity risk assessment and mitigation strategies. Recently, Boris has been actively involved in industry discussions focusing on PK and immunogenicity assessment, bioanalytical support of various biotherapeutic modalities, including mAbs, bi-specific antibodies, antibody–drug conjugates, ADCs and gene therapy. Boris is proud to be an active member of the American Association of Pharma Scientists. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (Silver Spring, MD, USA), 11 June 2019.

Perspectives on the draft ICH-M10 guidance: an interview with Eric J Woolf

Biography Dr Woolf is currently Executive Director of the regulated PK Bioanalysis Group of Merck Research Laboratories, West Point, PA, USA. He received his BA in Chemistry from LaSalle College in 1982, and a PhD in Analytical Chemistry from Seton Hall University in 1986. From 1986 to 1990, he was a member of the Drug Metabolism/Pharmacokinetics Department of Berlex Laboratories. He joined Merck Research Laboratories in 1990 as a research fellow. Dr Woolf and his group have supported numerous clinical development projects that have led to the successful registration of Merck compounds. Since 1986, he has authored or coauthored over 50 research papers pertaining to bioanalysis and pharmacokinetics. This interview was conducted by Sankeetha Nadarajah, Managing Commissioning Editor of Bioanalysis, at the AAPS ICH-M10 Public Consultation Workshop (Silver Spring, MD, USA), 11 June 2019.

The GEBCO and NOAA Chart Adequacy Workshop

<p><strong>Abstract.</strong> On July 23, NOAA Coast Survey hosted a three-day Chart Adequacy Workshop that included participants from 13 countries. This is the fourth Chart Adequacy Workshop held at National Oceanic and Atmospheric Administration’s (NOAA) Silver Spring, Maryland campus. This was the fourth workshop hosted by NOAA and Nippon Foundation / General Bathymetric Chart of the Oceans (GEBCO) Training Program at the Center for Coastal and Ocean Mapping, UNH. Unlike previous years (2017, 2016, 2015), the focus of this week was on networking and support for the upcoming International Cartographic Association (ICA) Working Group on Marine Cartography meeting held on July 26 and in preparation for next year’s International Cartographic Conference (ICC).</p><p> The main goal of the workshop is to provide training for professional cartographers and hydrographers on techniques for assessing nautical chart adequacy using publicly-available information, such as satellite images and maritime automatic identification system (AIS) data. . The participants received an overview on Coast Survey datasets, processes, and requirements for nautical charts. They also learned about pre-processing hydrographic data, such as loading charts, uploading imagery, and applying electronic navigation charts (ENCs) and AIS point data. Through a series of lab units, the attendees practiced performing the concepts they learned.</p><p>The 2018 participants were from Australia, Greece, Ireland, Japan, Latvia, Madagascar, Mexico, Nigeria, Peru, Poland, St. Vincent and the Grenadines, Taiwan, and Trinidad and Tobago. The international nature of the event allows the participants to meet and learn from cartographers from a variety of backgrounds and expertises. Thee individuals include Nippon Foundation / GEBCO training program students and those nominated by their home hydrographic offices and their travel was sponsored through funds secured by the workshop organizers.</p><p> The workshop was developed in part too address the need to improve the collection, quality, and availability of hydrographic data world-wide, and increase the standardization of chart adequacy evaluations across the globe. Coast Survey is currently working with the International Hydrographic Organization (IHO) to recommend participants for next year’s workshop towards the end of July, 2019.</p>

New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997 through 2015

Background The opioid epidemic, driven in part by increased prescribing, is a public health emergency. This study examines dispensed prescription patterns and approvals of new opioid analgesic products to investigate whether the introduction of these new drugs increases prescribing. Methods Prescribing patterns based on dispensed prescription claims from the U.S. retail setting were assessed with new brand and generic opioid analgesic products approved in the United States from 1997 through 2015. Results From 1997 through 2015, the U.S. Food and Drug Administration (Silver Spring, Maryland) approved 263 opioid analgesic products, including 33 brand products. Dispensed prescriptions initially increased 80% from 145 million prescriptions in 1997 to a peak of 260 million prescriptions in 2012 before decreasing by 12% to 228 million prescriptions in 2015. Morphine milligram equivalents dispensed per prescription increased from 486 in 1997 to a peak of 950 in 2010, before decreasing to 905 in 2015. In 2015, generic products accounted for 96% (218/228 million prescriptions) of all opioid analgesic prescriptions dispensed. The remaining prescriptions were dispensed for brand products, of which nearly half were dispensed for one brand product (OxyContin, Purdue, USA). Conclusions There has been a dramatic increase in prescriptions dispensed for opioid analgesics since 1997 and an increasing number of opioid analgesic approvals; however, the number of prescriptions dispensed has declined since 2012 despite an increasing number of approvals. Examination of dispensed prescriptions shows a shifting and complex market where multiple factors likely influence prescribing; the approval of new products alone may not be sufficient to be a primary driver of increased prescribing.