Haida Gwaii Quake & Tsunami Advisories

Credit USGS

 

 

# 6672

 

Overnight, while I was offline, a 7.7 quake struck the sparsely populated Haida Gwaii region, or Queen Charlotte Islands, on the northern coast of British Columbia. 

 

There are no reports, as yet, on injuries or damages.  Since the initial quake, there have been dozens of aftershocks, some as strong as 5.1.

 

Crawford Kilian, over at Crofsblog, lives south of there on Vancouver Island, and has blogged a number of times on the quake including here, here, and here.

 

Although a minor tsunami was apparently generated, the Pacific Tsunami Warning Center has recently downgraded the earlier alerts for Hawaii with the following advisory.

 

TSUNAMI MESSAGE NUMBER  10

NWS PACIFIC TSUNAMI WARNING CENTER EWA BEACH HI
101 AM HST SUN OCT 28 2012

TO - CIVIL DEFENSE IN THE STATE OF HAWAII

SUBJECT - TSUNAMI ADVISORY

THE TSUNAMI WARNING IS NOW CANCELLED FOR THE STATE OF HAWAII.

A TSUNAMI ADVISORY IS ISSUED FOR THE STATE OF HAWAII EFFECTIVE

AT 1254 AM HST.

AN EARTHQUAKE HAS OCCURRED WITH THESE PRELIMINARY PARAMETERS

   ORIGIN TIME - 0504 PM HST 27 OCT 2012
   COORDINATES - 52.8 NORTH  131.8 WEST
   LOCATION    - QUEEN CHARLOTTE ISLANDS REGION

   MAGNITUDE   - 7.7  MOMENT

EVALUATION

BASED ON ALL AVAILABLE DATA THE TSUNAMI THREAT HAS DECREASED AND IS NOW AT THE ADVISORY LEVEL AND NOT EXPECTED TO INCREASE. SEA  LEVEL CHANGES AND STRONG CURRENTS MAY STILL OCCUR ALONG ALL COASTS  THAT COULD BE A HAZARD TO SWIMMERS AND BOATERS AS WELL AS TO PERSONS  NEAR THE SHORE AT BEACHES AND IN HARBORS AND MARINAS. THE THREAT  MAY CONTINUE FOR SEVERAL HOURS. MESSAGES WILL BE ISSUED HOURLY OR SOONER AS CONDITIONS WARRANT.

 

 

During the summer of 2011 I wrote extensively on Canada & the United State’s west coast earthquake and tsunami threat in a blog called Just A Matter Of Time.

 

The location of this quake, well north of the populated centers of Vancouver and Washington state, greatly diminished its impact. 

 

The next time, we may not be so lucky.

 

Which is why, 10 days ago, more than a half million residents of British Columbia took part in The Great British Columbia Shakeout drill.

 

 

They, along with a dozen other regions around the world, practiced Drop, Cover, and Hold On! as part of this yearly event (see NPM12: A Whole Lotta Shakeouts Going On).

 

A destructive quake somewhere along the Pacific Northwest coast is, as I said earlier, just a matter of time. We can’t predict when, and we certainly can’t stop it from happening.

Leaving being ready for it as the only logical recourse.

 

For a comprehensive guide on how you can prepare for `the big one’ (even if you live someplace other than Los Angeles), I would recommend you download, read, and implement the advice provided by the The L. A. County Emergency Survival Guide.

 

Everyone should have a disaster plan.  Everyone should have a good first aid kit, a `bug-out bag’, and sufficient emergency supplies to last a bare minimum of 72 hours.

 

For more on  disaster preparedness, I would invite you to visit:

 

When 72 Hours Isn’t Enough

The L. A. County Emergency Survival Guide

An Appropriate Level Of Preparedness

Resources To Follow The Northeast Storm Online

 

 

Credit NWS Binghamton,NY

 

# 6671

 

Hurricane Sandy is being billed as having the potential to become a major New England storm when it merges with a mid-latitude trough coming in from the west early next week. It is even being compared with the `perfect storm’ of 1991, and so local, state and Federal emergency planners are burning the midnight oil this weekend in preparation.

 

There is always the possibility that Sandy will prove less damaging than feared, but one can’t simply assume that the Mid-Atlantic and New England states will get lucky.

 

The internet provides a unique platform for watching Sandy’s trek across Northeastern states, with resources that include live coastal radars, NOAA weather radio broadcasts, streaming radio and TV coverage from cities all across the region,  beach front and traffic webcams and even scanners to listen to local emergency radio traffic.

 

For those in the path of the storm, or those with friends or family in the affected area, this can help provide valuable information as to what is going on during and after the storm.

 

And for those who are simply curious as to the impact of this hurricane, this is a convenient way to monitor it.

 

Disclaimer: These links are offered without warranty or endorsement (except for the NHC & NOAA links), and you visit them at your own risk.

 

It is always prudent to use up-to-date antivirus software, and decline to install any software from vendors you do not trust, when surfing the net.

 

Official sources are always your best option, so when it comes to getting the latest information on hurricanes, your first stop should be the National Hurricane Center in Miami, Florida.

 

These are the real experts, and the only ones you should rely on to track and forecast the storm.

 

To get their latest forecasts – particularly if the power is out in your area – you really need a battery operated Weather radio. Once thought of as mainly a source of local weather information, it has now become an `All-Hazards' alert system as well.

 

 

You’ll find that  NOAA Weather Radio All Hazards broadcasts are available online via live streaming audio hosted by other entities, like  Weather Underground. This allows you to listen to broadcasts outside of the range of your receiver.

 

The second official information source you should have bookmarked is your local Office of Emergency Management.  There you will find information about evacuation zones, shelters, and emergency decrees in your area.

 

If you are on Twitter, you should also follow @FEMA, @CraigatFEMA, @NHC_Atlantic, @NHC_Pacific and @ReadydotGov.

 

You can access live feeds from the nation’s array of NEXRAD and TDWR radar installations, via this link at Weather Underground.

 

Live beach cams line the coast, and as this screen capture this morning from Kill Devil Hills, NC shows, the weather there is already deteriorating.

Raleigh broadcaster WRAL.Com has an interactive map with a number of these cams available.

The most extensive list of Northeastern Webcams I’ve found so far is HERE, although one should expect that some  of these will be out of commission as the storm approaches, or slow to load due to heavy internet traffic.

 

Live streaming radio on the internet has grown remarkably over the past few years, and this site has links to thousands of stations. Choose Radio Stations by State to narrow down your search.

 

 

 

Local, county and state emergency services frequencies (fire, police, EMS) can be assessed via RadioReference.com.  Their interactive maps allows you to first pick a state, and then drill down to the county you are looking for, where you’ll be presented with a list of feeds.

 

With more than 3,300 feeds there’s a pretty good chance you can monitor nearly every place in the country.

 

Hurricane City, a well known hurricane tracking site and forum, broadcasts on USTREAM when hurricanes approach the coast and you can watch it HERE.

 

You’ll also find live hurricane coverage and chaser cam footage from Mark Sudduth’s HurricaneTrack.com.

 

USTREAM, mentioned earlier, provides a venue for all types of broadcasting.  Enter  HURRICANE  or SANDY or FRANKENSTORM  in the search box for a list of current streaming video. You’ll find everything from storm chaser video to live feeds from hotels on the Altantic beaches.

 

Since anyone can broadcast on USTREAM, accept anything you see or hear cautiously. Still, USTREAM can be a terrific resource.

 

I’ll try to have more resources later, and will update this blog post if I find anything tonight. But this should give you a pretty good start on following the storm.

Novartis Fluad And Agriflu Vaccines Suspended In Canada

 

# 6670

 

 

Over the past several days Italy, Germany, France, and Switzerland have all temporarily suspended the use of two Novartis seasonal flu vaccines (Fluad & Agriflu) due to reports of `clumping of proteins’ observed in one batch produced at their facility in Italy.

 

Both flu shots are distributed in single-dose, thimerosal free, pre-loaded syringes.

 

Fluad, an adjuvanted vaccine, is not marketed in the United States. Agriflu is listed on the CDC’s Flu Vaccine Supply for the U.S. 2012-2013 as being approved for sale in the U.S..

 

Yesterday Canada announced that they would join with a number of other European nations in suspending the use of these two vaccines until a proper safety review could be completed.  

 

Here is the Health Canada statement.

 

Novartis Suspends Distribution of Seasonal Flu Vaccines Agriflu and Fluad in Canada as a Precaution

Information Update
2012-162
October 26, 2012
For immediate release

OTTAWA - Health Canada would like to provide further information to Canadians about its assessment of the voluntary suspension of use in Europe of the seasonal flu vaccines Agriflu and Fluad.

 

Agriflu and Fluad are two of the seasonal flu vaccines produced by Novartis that have been pulled from use in several European countries pending further examination of white floating material discovered clumping in the vaccines.

 

Health Canada rigorously reviewed Agriflu and Fluad for safety and effectiveness before it was authorized for use in Canada.

 

Clumping of the kind noted in Europe is common in vaccines. Health Canada has previously seen such particles before in other vaccines and has observed no impact on their safety or effectiveness. The Public Health Agency of Canada monitors for adverse events following immunization. To date it has received no reports of serious or unexpected adverse events related to these vaccines.

 

As a precautionary step, Health Canada asked Novartis to suspend distribution of the vaccines in Canada until a full review of the situation is completed. Novartis has agreed. The Public Health Agency of Canada is also recommending that health care professionals in possession of these vaccines refrain from using them until the review is complete.

 

The Public Health Agency of Canada and Health Canada will continue to work with the company to monitor the safety and effectiveness of the vaccine used here in Canada. Should a safety concern be identified, immediate and appropriate action will be taken.

 

 

Novartis reports that well over a million shots have already been administered in Europe, with no signs of increased adverse effects.  

 

This statement appeared on their website yesterday.

 

October 26, 2012

To date, data from the ongoing seasonal vaccination campaign have shown no unexpected adverse events.

 

Novartis is confident in the safety and efficacy of its seasonal influenza vaccines Agrippal^® and Fluad^® manufactured in Italy. Patient safety is of the highest priority to Novartis. Novartis internal assessments and the clinical data gathered during the 2012-2013 seasonal influenza studies required for European licensure of Agrippal and Fluad demonstrate a safety and immunogenicity profile similar to that of prior years.

 

The protein aggregates observed in the one batch that led to precautionary measures in some markets can occur in the normal vaccine manufacturing process and have no impact on the safety or efficacy of the vaccines.

 

The company is proactively engaging with local health authorities to answer remaining open questions and is fully committed to providing high quality vaccines to patients.

 

For more on this story we turn to Helen Branswell of The Canadian Press, who has the following report.

 

Canada suspends dispersal of Novartis flu shots following similar move in Europe

Helen Branswell,  Friday, October 26, 2012 9:21 PM

 

Given that we’ve seen this sort of protein clumping in the past with no ill effect, these suspensions may eventually be lifted. 

 

But given the nightmare surrounding contaminated steroid injections in the United States in recent months – a proactive stance by public health officials – even if there is only a hint of a problem, is not unreasonable.

FDA Statement On Conditions Reported At NECC Facility

 

Photo Credit CDC

 

 

# 6669

 

The FDA has released a report citing the conditions they observed at the New England Compounding Center, the compounding pharmacy who’s steroid products are linked to a multistate fungal meningitis outbreak.

 

The report cited finding unopened vials of preservative-free methylprednisolone during an inspetion on October 2nd that were observed to have `greenish black foreign matter’ and/or `white filamentous material’ inside.

 

Additional testing `confirmed the presence of viable microbial growth in 50/50 vials tested’.

 

It’s an 8-page report, and may be read in its entirety at this link.  Here is the FDA press announcement.

 

 

 

FDA NEWS RELEASE

For Immediate Release: Oct. 26, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA reports conditions observed at New England Compounding Center facility

Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.

 

The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.

 

The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.

 

The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.

 

The FDA considers the 483 along with an Establishment Inspection Report (EIR), prepared by FDA investigators, and any other relevant information, including any responses received by the company. The agency then considers whether further action, if any, is appropriate. The inspection report for NECC has not been completed and is not being shared at this time.

 

The FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid.

For more information: 

• FDA Form 483 for New England Compounding Center
• FDA Form 483: Frequently Asked Questions
• FDA Inspections, Compliance, Enforcement, and Criminal Investigations
• Update on Fungal Meningitis

# # #

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CDC Fungal Meningitis Update – Oct. 26th

# 6668

 

The CDC has posted Friday’s update on the number of cases, and deaths, associated with contaminated steroid injections produced by a Massachusetts compounding pharmacy. 

 

The highest risk period according to the CDC is within the first 6 weeks following injection. Since the suspect lots of steroids were identified and recalled a month ago, it is hoped the number of new cases will begin to decline in the next few weeks.  

 

That said, no one knows for sure how long before a person can be declared `out of the woods’. 

 

During a similar incident in 2002, one case did not develop signs of infection until nearly 6 months after exposure (see Revisiting An Earlier Fungal Meningitis Outbreak).

 

The CDC breaks down today’s numbers:

331 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 7 peripheral joint infections (e.g., knee, hip, shoulder, elbow). No deaths have been associated with peripheral joint infections.

 

For more details on the ongoing investigation, and clinical and patient guidance documents, you can visit the CDC’s website:

 

Multistate Fungal Meningitis Outbreak Investigation

Florida Issues Suspension Order Against Compounding Pharmacy

 

 

# 6667

 

In the midst of the investigation into the devastating multistate meningitis outbreak linked to products from the New England Compounding Center, it is of little surprise that officials around the country are taking a hard look at compounding pharmacies operating in their jurisdictions. 

 

Today, the State of Florida DOH issued an emergency suspension order (ESO) against a compounding pharmacy located in Boca Raton, Fl. citing conditions that posed `an immediate serious danger to public health’. 

 

That said, the target of this suspension has a right to a hearing before any final decree is rendered, as is explained below (from the press release).

 

The subject is entitled to a hearing before final action is taken by a regulatory board or by DOH. However, the ESO will remain in effect until final disciplinary action is taken, the suspension is lifted, or the case is successfully appealed. 

 

Excepts from the announcement follow:

 

 

TALLAHASSEE- The Florida Department of Health (DOH) today issued an Emergency Suspension Order (ESO) of Rejuvi Pharmaceuticals, Inc., a compounding pharmacy located in Boca Raton. The ESO immediately suspends Rejuvi from operating as a community compounding pharmacy in the state of Florida.

"The Florida Department will take swift action to ensure the safety of medications compounded in our state," said State Surgeon General and Secretary of Health Dr. John Armstrong. "We continue to collaborate with the Food and Drug Administration, Centers for Disease Control and Prevention, and Florida's health professional and health care associations to promote safe compounding practices in Florida."

Earlier this month, DOH conducted a routine inspection of Rejuvi, and the inspection revealed that the pharmacy was in violation of a number of statutes and rules relating to the cleanliness of the prescription department, the dispensing of medications, the compounding of medications, and record keeping. A review of previous inspections revealed that Rejuvi had previously been notified of these violations and failed to correct them.

 

 
Prior to the ESO being issued, Rejuvi was permitted to engage in the sterile preparation, or compounding, of injectable (parenteral) drugs and medications entered through injection or through a specially coated pill into the intestine (enteral). 

 

(Continue . . . )