The Observatory

Oct. 24, 2016

Following years of decline, the percentage of employees in the combined U.S. workforce testing positive for drugs has steadily increased over the last three years to a 10-year high, according to an analysis of nearly 11 million workforce drug test results released by Quest.

4%
is the increase rate for positive urine drug tests in the combined U.S. workforce.

6.2%
is the increase rate for positive post-accident urine drug testing in both the general U.S. and federally-mandated, safety-sensitive workforces.

47%
is the increase rate over the last three years in the general U.S. workforce, largely driven by double-digit increases in marijuana positivity.

45%
is the rate of individuals in the general U.S. workforce with a positive drug test for marijuana.

9%
of oral fluid test results were positive for one or more drugs.

1 in 11
is the number of job applicants that were unable to pass an oral fluid drug screen.

10.3%
is the increase rate for the general U.S. workforce’s hair drug tests.

146%
is the increase rate for positive heroin tests.

4.5%
is the increase rate for positive heroin urine test results for federally-mandated, safety-sensitive employees since 2014, and a relative 84 percent since 2011.

Source: The Quest Diagnostics Drug Testing Index examines illicit drug use by America’s workforce based on an analysis of de-identified results of more than 9.5 million urine, 900,000 oral fluid, and 200,000 hair laboratory-based tests performed nationally by the company for employers in 2015.

Zika Virus

CDC continues to build lab capacity to rapidly detect ZIKV infection. The U.S. Centers for Disease Control and Prevention (CDC) has purchased approximately $2.5 million in laboratory supplies and equipment to enhance United States laboratory capacity to test for ZIKV. These purchases help to ensure that states can meet the growing demand for testing and rapid identification of Zika infection by providing them with materials that allow them to perform testing for ZIKV infection.

Relatively few labs in the U.S. are certified to test for Zika. As a result, when samples are collected, they often have to be shipped to a local health department lab for testing. If the local health department lab doesn’t currently perform Zika testing, it will coordinate testing and ship the samples to the CDC. Depending on the CDC lab’s workload, processing and reporting time of a result may take two to four weeks.

To help states expand access to Zika testing and reduce the amount of time to receive results, the CDC has sent materials to help them expand lab capacity and perform testing to detect both current and recent cases of ZIKV infection.

Forty-three states, the District of Columbia, Puerto Rico, and nine Department of Defense (DOD) laboratories have received material that allows them to conduct testing for recent Zika infection using the CDC-developed MAC-ELISA test.

MAC-ELISA tests are intended for use in detecting antibodies that the body makes to fight a ZIKV infection. These antibodies (in this case, immunoglobulin M, or IgM) appear in the blood of a person infected with ZIKV beginning four to five days after the start of illness and last for about 12 weeks.

The CDC has also sent material to all states plus the District of Columbia and Puerto Rico and 16 DOD labs that allows them to use a second CDC-developed Zika test, called the Trioplex rRT-PCR test, which allows doctors to tell if an individual is currently infected with chikungunya, dengue, or Zika using just one test, rather than three separate tests for each virus.

CDC awards $13M for Vector Control Unit in Puerto Rico. The U.S. Centers for Disease Control and Prevention (CDC) has awarded $13 million to the Puerto Rico Science, Technology, and Research Trust (ST&R Trust) to establish the first Vector Control Unit (VCU) in Puerto Rico. The ST&R Trust will oversee and implement comprehensive mosquito-control activities to help prevent and manage diseases spread by mosquitoes.

The best way to reduce the spread of Zika and other viruses spread by Aedes aegypti mosquitoes throughout Puerto Rico is to rapidly implement a combination of mosquito control methods, or integrated vector management, to reduce the mosquito population.

The CDC funding will support the ST&R Trust as it sets up the VCU, which will develop an integrated mosquito surveillance and control plan and carry out mosquito-control activities throughout Puerto Rico. The CDC and the government of Puerto Rico will assist the ST&R Trust as it begins the mosquito control program, starting in areas of greatest need. If additional funding becomes available, it may be provided for the VCU.

Integrated vector management uses several approaches to reduce mosquito populations, including elimination of standing water sources where mosquitoes lay eggs and use of adulticides, larvicides, and mosquito traps. Community engagement and education is also an integral part of this approach, so that members of the community understand the risks of diseases like Zika and how they can best protect themselves from mosquito bites.

The ongoing Zika outbreak and previous outbreaks of mosquito-borne diseases have highlighted the need for an integrated vector management approach to control Aedes aegypti mosquitoes in Puerto Rico.

Diabetes

FDA approves first automated insulin delivery device for type 1 diabetes. The U.S. Food and Drug Administration (FDA) has approved Dublin, Ireland-based Medtronic’s MiniMed 670G hybrid closed looped system. It is the first device intended to automatically monitor glucose and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes (T1D) to be approved.

The MiniMed 670G hybrid closed looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption.

According to the CDC, approximately five percent of people with diabetes have T1D, which is typically diagnosed in children and young adults. Because the pancreas does not make insulin in people with T1D, patients have to consistently monitor their glucose levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen, or insulin pump to avoid becoming hyperglycemic. In addition, management of T1D includes following a healthy eating plan and physical activity.

Risks associated with use of the system may include hypoglycemia and hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. This version of this device is unsafe for use in children six years of age or younger and in patients who require less than eight units of insulin per day.

As part of this approval, the FDA is requiring a post-market study to better understand how the device performs in real-world settings. While the device has been approved for use in people 14 years of age and older with T1D, Medtronic is currently performing clinical studies to evaluate the safety and effectiveness of the device in diabetic children from seven to 13 years of age.

Infectious Diseases

Global leaders commit to act on antimicrobial resistance. The World Health Organization (WHO) reports that world leaders recently signaled an unprecedented level of attention to curb the spread of infections that are resistant to antimicrobial medicines. Antimicrobial resistance (AMR) happens when bacteria, viruses, parasites, and fungi develop resistance against medicines that were previously able to cure them.

For the first time, heads of state have committed to taking a broad, coordinated approach to address the root causes of AMR across multiple sectors, especially human health, animal health, and agriculture. This is only the fourth time that a health issue has been taken up by the United Nations General Assembly (the others were HIV, noncommunicable diseases, and Ebola). The high-level meeting was convened by the President of the 71st session of the UN General Assembly, H.E. Peter Thomson.

Countries reaffirmed their commitment to develop national action plans on AMR, based on the “Global Action Plan on Antimicrobial Resistance”—the blueprint for tackling AMR developed in 2015 by WHO in coordination with the Food and Agriculture Organization of the United Nations (FAO) and the World Organization for Animal Health (OIE). Such plans are needed to understand the full scale of the problem and stop the misuse of antimicrobial medicines in all sectors.

Leaders recognized the need for stronger systems to monitor drug-resistant infections and the volume of antimicrobials used in humans, animals, and crops, as well as increased international cooperation and funding. They pledged to strengthen regulation of antimicrobials, improve knowledge and awareness, and promote best practices, as well as to foster innovative approaches using alternatives to antimicrobials and new technologies for diagnosis and vaccines.

Cancer

Researchers say extending cervical screening beyond five years for some women is safe. Extending the cervical cancer screening interval beyond five years for women aged 40 and older who test negative for human papilloma virus (HPV) is safe, say researchers from the Netherlands, publishing in the British Medical Journal last month. Extending screening for women who test positive for HPV, however, is not recommended.

Trials have shown that screening for HPV leads to earlier detection of abnormal cells (known as cervical intraepithelial neoplasia or CIN) than cytology (smear) testing, and offers better protection against cervical cancer. CIN is divided into grades: CIN1, 2, or 3. The higher the number, the more of the cervix is affected by abnormal cells.
Evidence on the safety of screening intervals beyond five years is limited, and screening intervals in general have been a subject of controversy in the United States and elsewhere. So a team of researchers based in the Netherlands decided to assess the safety of extending screening intervals beyond five years.

They base their findings on 14-year follow-up data from more than 43,000 women aged 29 to 61 years who took part in a large trial of three cervical screening rounds (each round done every five years). Women were randomly assigned to receive both HPV and cytology testing (intervention) or cytology testing only (control) and were managed according to their test results.

The data show that HPV negative women aged at least 40 have a very low risk of CIN3+ (the highest grade of abnormal cells) in the long term, “indicating that extension of the current screening interval in the Netherlands is justifiable,” say the authors. But they stress that for HPV positive women, the long term risk of CIN3+ is too high to support extending screening beyond five years.

The use of the HPV test result and age to define the year of next screen is a first step towards tailoring screening to individual risks—and could improve screening efficiency and eventually provide optimal prevention for all women, researchers say.

New Research

Rapid blood test can rule out serious infections in children. Using a simple decision rule and a finger prick to test blood, general practitioners may now be able to detect serious infections in children very quickly. This ensures that seriously ill children don’t have to wait for a diagnosis until they’re hospitalized—a delay that may have fatal consequences. The procedure also prevents unnecessary hospital referrals for less serious cases. Those are the conclusions of a study conducted by a clinical team at KU Leuven (University of Leuven, Belgium) in collaboration with Ghent University and the University of Oxford.

In the early stages, serious infections such as meningitis, pneumonia, kidney or bone infections, or dangerous inflammations of the skin have symptoms that resemble those of more common viral infections. They are also very rare. “As a result, serious infections tend to stay off the general practitioner’s radar for too long. We asked ourselves how rapid diagnostic tests might help solve this problem,” says Jan Verbakel, general practitioner and postdoctoral researcher at the KU Leuven Faculty of Medicine.

Testing is not a very common practice among general practitioners yet. “Testing is often complex, expensive, and most of all time-consuming: it usually takes a few days for the lab results to come in,” says Verbakel. “But recently, point-of-care tests have become available that can be performed in the general practitioner’s office and provide results within minutes. For the detection of serious infections, point-of-care CRP testing by means of a finger prick holds potential. The test measures the level of the C-reactive protein (CRP) in a drop of blood. The concentration of this protein increases in response to a pathogen.”

A one-year study involving more than 3,100 ill children from across the Flanders region of Belgium showed that five mg of CRP per liter of blood is a good threshold value to rule out serious infections, but only after the GP has performed a clinical evaluation of the patient’s symptoms and vital functions. “Point-of-care CRP testing cannot replace a general practitioner. Does the GP sense that something is off? Is the child short of breath, or running a fever of more than 40°C? If the answer to any of these questions is yes, it’s useful to perform a point-of-care CRP test. Our study showed that with this procedure, all serious infections were detected during the first visit to the general practitioner. But there’s no need to test all ill children.”