Posts Tagged ‘FDA’

Fungi in Medicine

October 9th, 2012

You’ve no doubt heard about the multi-state outbreak of fungal meningitis among patients who received an epidural steroid injections recently.  Here’s what we know right now:  Starting sometime in September some shipments of a steroid sometimes used to relieve back pain were contaminated with a fungus called Aspergillus fumigatus. Shortly thereafter patients in 23 states (not in Arizona at least so far) became ill with a form of fungal meningitis.  The only manufacturer that’s implicated in the outbreak is the New England Compounding Center.

The CDC, FDA, and all of the state (and some local) health departments are coordinating efforts to get to the bottom of the outbreak, identify who might be at risk, and providing information to clinicians to help them manage patients that may have been exposed but aren’t symptomatic yet.  The CDC has dedicated a special webpage about the investigation- including recommendations for clinicians and the public. Here’s the FDA’s list of recalled products (which includes more than the implicated product in case there were bigger problems at the plant.)

The contaminated product is called “preservative-free methylprednisolone acetate (80mg/ml)” and was prepared by the New England Compounding Center in Framingham, Mass. So far there have been over 100 cases and several deaths.  Initial symptoms seem to start 1 to 4 weeks after the injection and include fever, a worsening headache, nausea, and neurological deficit (like a stroke).  Fortunately, the records suggest that the steroid wasn’t shipped to Arizona- but we’re working with the county health departments to make sure that clinicians are on the lookout for symptoms in case the sales records aren’t correct.

STAND

September 19th, 2012

Our chronic disease prevention team and the county health departments, community partners, and Pima Prevention Partnership, officially launched STAND last week.  It’s a coalition of local youth groups that have banded together in a common cause against tobacco use.  It’s the culmination of a three-year effort to engage more youth in the actual planning and implementation of tobacco control.  Through adult and youth trainings, an annual celebratory conference, and an increased online presence via STAND Facebook and www.Standaz.com, local coalitions retain their identities while maximizing their impact on a statewide basis. 

Trainings for adult coalition leaders, as well as youth coalition members, have been held regionally during both the fall and spring in Phoenix, Flagstaff and Tucson.  Adult coalition leaders learn how to effectively foster youth coalition development, assist the coalition members where needed and provide additional logistical support. Individual technical assistance is provided where needed to both youth and adults.  Trainings for the youth include education on advocacy, public speaking, social media and message development. A winter summit is in the works that will bring together youth to start planning for the end of the year youth tobacco coalition conference. 

Building on the momentum and outcomes of the highly-successful Venomocity campaign, this represents an expansion of our youth prevention efforts that now includes youth coalition activities, prevention outreach, point-of-sale efforts including the Attorney General’s sting operations, and the FDA program.  As the centralized hub of activity STAND will provide information and resources for youth and adult leaders.  Facebook and YouTube sites have also been created to tap into the social media opportunity that presents itself when working with youth. 

While overall use of tobacco among Arizona youth has mirrored the national trend of leveling off, Arizona has seen the single largest decrease in overall consumption (measured by teens who report smoking more than ten cigarettes per day).  This new launch of intensifying youth-to-youth involvement is the result of our robust formative research in figuring out the how’s and why’s of successful interventions.

Political Convention Food Tested by Our Lab

September 11th, 2012

Our State Lab performed chemical and biological surveillance testing on food samples from the Republican National Convention.  We were selected to participate in the testing because of our reputation and previous experience working with the Food Safety Inspection Service for the detection of biological and chemical agents in food.  The samples arrived at the State Laboratory the week of August 20 and were tested the same week.  Our lab performs this work as part of the national Food Emergency Response Network using funds from cooperative agreements obtained USDA and FDA.  Everything was OK.

Breastfeeding & Cannabis

September 4th, 2012

Some AZ health care providers and parents have asked questions about whether medical marijuana is safe for use while breastfeeding.  The short answer is no, because the active chemical in marijuana is passed to the baby through breast milk. For this reason, most experts, including the American Academy of Pediatrics and the CDC advise moms not to use marijuana (medical or not) while breastfeeding.   

Tetrahydrocannabinol (the psychoactive ingredient in Cannabis) stays in the body for four to six weeks.  It’s found in the urine of breastfeeding babies whose mothers use marijuana. It’s also fat soluble, which means it builds up with chronic use and can be stored in fat tissue for months. We also know that babies are much more vulnerable than adults to illness, infection, chemicals, and so on. That alone is a good reason to avoid marijuana and anything else potentially harmful that can enter your baby’s body through your milk.  

The Academy of Breastfeeding Medicine has a protocol that you can use to make breastfeeding decisions.  For more information about the effects of marijuana and other medications, go to the National Libraries of Medicine’s LactMed database. For answers to this and other breastfeeding questions, call the ADHS 24-hour breastfeeding hotline at 1-800-833-4642. 

Of course- all sorts of prescription and over-the-counter medicines are also transferred to infants in breast milk- but pediatricians are more familiar with which medicines are safe to take while breastfeeding because they’re tested by the FDA- and most medicine labels discuss breastfeeding.

Arizona’s Food Safety Network

October 11th, 2011

The Listeria monocytogenes outbreak has captured the public’s attention these days- so I thought I’d do a piece on Arizona’s food safety network. Let’s start at the farm & ranch.  The Arizona Department of Agriculture is responsible for ensuring that the base of the food safety pyramid is solid in Arizona.  They have several divisions that are responsible for everything from Arizona farm-grown fruits and vegetables to livestock and poultry.  They also work with the USDA & the FDA to ensure that imported foods are safe and from an approved source.  So, basically, the AZ Dept. of Agriculture is responsible for food safety from the farm or ranch until the food hits the wholesaler or “jobber’s” warehouse. 

Once foods hit the middleman- it’s our job to ensure that food is safely handled until it makes it to your plate at a restaurant or leaves the grocery store in your cart. While our environmental health shop has the overall responsibility for ensuring that your food is safe from the warehouse to you- it’s our partnerships with the local health departments and departments of environmental services that make the system work.  We use the framework outlined in state law and our food safety rules to help guide the counties to make effective decisions in the field.  You can see a more detailed summary of the statewide activities in our latest annual food safety report (the new report is due out in a month or so). 

We delegate our food safety authority to the local health departments who use our authority do the actual inspections for restaurants and food retailers.  But, some of the counties actually act on their own- using authority granted from their board of supervisors.  For example, Maricopa County Environmental Services acts under their county authority rather than using our statewide authority.  All the inspections are done by people called Registered Sanitarians, who are required to have at least 30 hours of college credits in the natural sciences and pass a registration test

Of course, no food safety network would be complete without a robust foodborne illness surveillance system including the laboratory capacity to identify and track foodborne illnesses.  This part of the network also includes collaboration with the local health departments.  Physicians and private labs that identify or diagnose foodborne illness infections report that info to their local health department.  By pulling together the statewide data- we’re able to identify trends and sources- and along with the CDC’s resources, the public health system provides the feedback loop to the food safety network- allowing the system to track down and stop sources.

Flu Down Under

August 4th, 2011

This is the time of year that public health folks start watching the flu reports from the southern hemisphere.  We’re watching for a couple of things – the circulating strains and how it’s spreading.  The Australian Government Department of Health is reporting 6 times as many cases as they had at this time last season.  It could be an early season for them or it could be that it will end up being a blockbuster flu season for them.  The good news is that the circulating strains are all covered by the vaccine strains approved by the FDA last week –meaning that there aren’t any surprise strains going around (at least so far).  The H1N1 pandemic strain is dominant in Australia right now.

FDA Approves Vaccines for the 2011-2012 Influenza Season

July 25th, 2011

The FDA approved the 2011-2012 influenza vaccine this week. The strains in this year’s vaccine were recommended by the CDC and the World Healthy Organization after studying virus samples collected from around the world to find the influenza viruses that are the most likely to cause illness during the upcoming flu season.  The strains selected for this season are the same as last year: A/California/7/09 (H1N1)-like virus (pandemic H1N1 2009 influenza virus), A/Perth /16/2009 (H3N2)-like virus and B/Brisbane/60/2008-like virus. 

 People should get immunized against the flu every year- even when there’s no change in the strain from the previous year (like this time).  Immunity to influenza viruses declines over time and might be too low to provide protection after a year.

New Cigarette Warning Labels launched today

June 21st, 2011

Today the FDA released the new, graphic warning labels that will be on cigarette packs.  The labels educate smokers and others, including kids, about the dangers of tobacco use and encourage smokers to quit.  Using this proven techique, the U.S. joins 43 other countries that already require pictures or images on cigarette packs.

The warning labels encourage smokers to try to quit and list a national phone number (1-800-QUITNOW) When smokers call that national number from an Arizona area code, they’ll be directed to our own Arizona Smokers’ Helpline (ASHLine). For free help to quit, call ASHLine at 1-800-55-66-222.

For more information from the FDA visit:  http://www.fda.gov/cigarettewarnings. For more information on the ASHLine visit www.ashline.org.

New Proposed Food Labeling Rules

April 20th, 2011

The FDA issued proposed regulations regarding calorie labeling on menus and menu boards in chain restaurants, retail food establishments, and vending machines this week. They’re inviting the public to comment on the new rules at: http://www.regulations.gov.  Their objective is to provide information so that consumers have more information when they make their own food choices at restaurants.  The menu labeling rule proposed today applies to restaurants and similar retail food establishments that are part of a chain with 20 or more locations.  Examples of these establishments include fast food establishments, bakeries, coffee shops and certain grocery and convenience stores. Movie theaters, airplanes, bowling alleys, and other establishments whose primary purpose is not to sell food wouldn’t be subject to this proposed regulation.

These days, Americans get about 1/3 of their daily calories from foods at these kinds of facilities, so it’s a substantial portion of the diet.  Right now, it’s easy for folks to find calorie and other nutrition information on packaged foods; it’s not generally available in restaurants or similar retail establishments. This proposal is aimed at giving consumers consistent and easy-to-understand nutrition information.  Under the proposal, this information would be displayed clearly and prominently on menus and menu boards, including menu boards in drive-through locations; and for individual foods on display.

The FDA is seeking public comment on the proposed rule for menu labeling until June 6.   Folks can submit electronic comments on the FDA’s website by entering the docket number FDA-2011-F-0172.

AZ Public Health Laboratory Capacity

December 21st, 2010

A few years ago it became pretty clear that we were facing some budget reductions.  At the time, we had no idea that our budget reductions would be as extensive as they turned out to be.  However, we did know that if we were going to maintain our laboratory capacity to protect the folks of AZ, we’d have to diversify our funding sources.  We looked toward the federal government primarily (mostly the FDA), but also toward places like the Arizona Biomedical Research Commission.  We’ve been quite successful on both fronts in the laboratory, and we’ve been able to just about break even in terms of capacity after our steep state budget reductions.

A couple of weeks ago our Lab found out that we’ve been awarded a new cooperative agreement from the USDA Food Safety Inspection Service, which is part of the Food Emergency Response Network.  The new grant will support the development of new methods and validation of new technologies to rapidly detect pathogens like Salmonella and E. coli in food allowing for more rapid recalls in instances where food is contaminated.  We recently used some of these technologies to isolate E. coli from certain kinds of cheese.

Our new funding will also cover training activities as part of the FERN Regional Training Program where laboratory professionals and National Guard Civil Support Teams from other states come to Arizona to be trained on new state of the art instruments and methods developed to detect not only dangerous pathogens in food but also toxins and poisons in food. Finally, we were one of the few states selected to participate in developing methods to detect melamine in pig tissues as part of an ongoing USDA surveillance program for melamine in the food supply. Thanks to laboratory staff  who participate in these very important FERN programs as we have been able to secure this funding and more importantly contribute to better food safety not only in Arizona but across the nation.