Showing posts with label Shortage. Show all posts
Showing posts with label Shortage. Show all posts

Friday, December 27, 2013

Spot Shortages Of Tamiflu Reported In Some Regions

image

Photo Credit – Wikipedia

 


# 8109

 

With the 2013-14 influenza season now well underway, and concerns over the severity of the H1N1 virus – particularly in younger patients and those with co-morbidities – the CDC is urging doctors to consider the early use of antivirals in high risk patients with suspected or confirmed influenza (see CDC HAN Advisory On Early pH1N1 Influenza Activity).

 

While there does not seem to be a national shortage of oseltamivir (Tamiflu ®) – the most commonly prescribed antiviral for influenza – in a few regions (mainly in the South) that have already been hit hard by the flu, some pharmacies are reporting trouble keeping the drug in stock.

 

A couple of  reports on these shortages, after which I’ll be back with a little more on Tamiflu, and this year’s H1N1 flu.

 

Shortage in flu medication worries pharmacists

LITTLE ROCK, Ark. (KTHV) - "We can't find the regular adult dose anywhere right now," Dr. Ray Turnage explained.

Turnage is one of many pharmacists dealing with a shortage of Tamiflu. He said, "There's only one manufacturer for that drug and nationwide all the wholesalers are saying it's a manufacture delay."

Tamiflu is the only medication on the market used to treat the flu and with a shortage in the drug, it could create problems for patients needing it. "Probably the demand is exceeding their supply. So that's the problem is we can't even get adult doses right now," Turnage continued.

Although there have been very minimal cases of the flu this year in Little Rock, with 3 to 4 months left in the flu season, that could change pretty quickly. If it does, Tamiflu in stock could disappear. Turnage said, "That's part of the situation is a few families can, if they can find it, can take all that the pharmacy may have."

(Continue . . .)

 

Shortage reports on Tamiflu in Atlanta, local pharmacies stocked – WSOC-TV

 

The bottom line is, that if you are prescribed Tamiflu, you may have to call around to more than one pharmacy to locate the drug.


While Tamiflu continues to get a strong recommendation from the CDC (see CDC Research On Benefits Of Antivirals For Uncomplicated Influenza), you’ll find no shortage of critics of the drug.  Due in large part to a prolonged reluctance on the part of Roche laboratories to release all of their clinical trial data, and a not totally undeserved reputation of `Big Pharma’ to massage test results. 

 

This has resulted in a vociferous backlash against the government stockpiling of Tamiflu in some quarters (see Dr. Ben Goldacre Opinion Piece). 

 

While academics and activists tend to have a dim view of Roche and their antiviral drug, clinicians obviously see value in oseltamivir,  and continue to prescribe it.  The CDC continues to recommend its use – particularly for high-risk influenza patients - or for the treatment of novel flu (see 2012 blog The CDC Responds To The Cochrane Group’s Tamiflu Study).

 

Although this year’s flu season is being billed in the media as `The Return of Swine Flu’, in truth, the H1N1 virus never departed.  But it has been dominated in North America by the H3N2 virus for the past couple of years.   The following snapshot of last year’s moderately severe flu season comes from last summer’s  MMWR Influenza Activity — United States, 2012–13 Season and Composition of the 2013–14 Influenza Vaccine.

 

Among the seasonal influenza A viruses, 34,922 (68%) were subtyped; 33,423 (96%) were influenza A (H3N2) viruses, and 1,497 (4%) were pH1N1 viruses. In addition, two variant influenza A (H3N2v) viruses were identified.

 

The season before that (2011-12) was the mildest flu season in decades (see 2011-2012 Flu Season Draws to a Close), that while H3N2 dominated, neither strain had a huge impact.

 

The truth is, flu seasons can vary greatly in impact from year-to-year,and with two influenza A strains in global circulation, we usually see one strain or the other dominate (although what strain is dominant in North America my differ from what is dominant in Europe, or Asia the same year).  Often we see 2 or 3 years with one strain in control, and then – as community immunity levels wane – the other takes hold.

 

The CDC’s most recent attempt to estimate the number of deaths associated with flu in the United States finds:

 

An August 27, 2010 MMWR report entitled “Thompson MG et al. Updated Estimates of Mortality Associated with Seasonal Influenza through the 2006-2007 Influenza Season. MMWR 2010; 59(33): 1057-1062.," provides updated estimates of the range of flu-associated deaths that occurred in the United States during the three decades prior to 2007. CDC estimates that from the 1976-1977 season to the 2006-2007 flu season, flu-associated deaths ranged from a low of about 3,000 to a high of about 49,000 people.

 

As much as a 16-fold difference in the number of estimated deaths between a mild flu season, and a heavy one. 

 

Thus far, its been H1N1’s year to roar, and since that strain often impacts those under the age of 65, it tends to get more publicity. The flu death of a young adult from influenza is more unexpected, and has more societal impact, than that of an octagenarian.  And this year, sadly, we are seeing a fair number of such reports (see Texas DSHS Statement On Recent Spike In Flu Activity).

 

Regardless of the strain of flu in circulation, you are much better off avoiding infection rather than treating it. So while it may only provide moderate protection, getting the flu shot each year is cheap insurance. 


That, and following good flu hygiene practices (covering coughs, washing hands frequently, staying home when sick, avoiding close contact with those who are sick),  are your best defense against our yearly flu epidemic.

Thursday, January 10, 2013

FDA: Scattered Shortages Of Tamiflu Liquid Suspension

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Photo Credit – Wikipedia

 

# 6845

 

On Tuesday of this week it was announced that Canada Released Tamiflu From Their National Emergency Stockpile to deal with temporary shortages due to high demand this flu season.

 

Today, the FDA  announced that there are some places in the United States where the pediatric or liquid suspension version of that antiviral is in short supply as well.

 

First the FDA announcement, then what you can do if you need this medicine, and it is not immediately available.

 

FDA Current Drug Shortages: Oseltamivir Phosphate (Tamiflu) for Oral Suspension (6mg/mL 60 mL)

Thursday, January 10, 2013 3:15:00 PM

Company:

Genentech, Inc.

Product:

Oral Suspension 6 mg/mL 60 mL (NDC 00004-      0820-09)

Availability:

Genentech has Tamiflu for Oral Suspension on intermittent backorder, however supplies remain in distribution at  wholesalers and pharmacies.

Related Information:

Tamiflu 30 mg, 45 mg and 75 mg capsules remain available.

For those patients who have difficulty swallowing capsules, the contents can be mixed into sweetened liquids, such as chocolate syrup, as directed by a healthcare professional.

If there is difficulty locating commercial Tamiflu for Oral Suspension, FDA would like to remind healthcare professionals of the FDA-approved Instructions for the emergency compounding of an oral suspension from Tamiflu 75 mg capsules. These instructions provide for an alternative oral suspension when commercially manufactured oral suspension formulation is not readily available. Please see the following link for information for healthcare professionals regarding compounding an oral suspension from Tamiflu 75 mg capsules:
http://www.tamiflu.com/hcp/resources/hcp_resources_pharmacists.jsp disclaimer icon

Alternatives to Tamiflu treatment for influenza are described on the CDC website: http://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm

Shortage Reason
(per New Legislation-FDASIA)*

Demand Increase for the Drug

 


It is a fairly simple matter for a qualified pharmacist to compound an oral solution using 75mg Tamiflu capsules and an appropriate syrup.

 

Directions for doing so are available at the link below, but given the importance of precisely calibrating the dosage for the intended patient, this should not be considered a do-it-yourself-at-home project.

 

 

Emergency Compounding

 

Directions for the Emergency Compounding of an Oral Suspension from Tamiflu 75-mg Capsules (Final Concentration 6 mg/mL)

These directions are provided for use only during emergency situations when Tamiflu for Oral Suspension is not commercially available in a pharmacy. These directions are not intended for use if the FDA-approved, commercially manufactured Tamiflu for Oral Suspension is readily available from wholesalers or the manufacturer. Compounding an oral suspension with this procedure will provide 1 patient with enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.

Commercially manufactured Tamiflu for Oral Suspension (6 mg/mL) is the preferred product:

  • For pediatric and adult patients who have difficulty swallowing capsules, or where lower doses are needed.

In the event that the commercially manufactured Tamiflu for Oral Suspension is not available, the pharmacist may compound a suspension (6 mg/mL) from Tamiflu 75-mg capsules using one of these vehicles: Cherry Syrup (Humco®), Ora-Sweet® SF (sugar-free) (Paddock Laboratories), or simple syrup. Other vehicles have not been studied. This compounded suspension should not be used for convenience or when the FDA-approved Tamiflu for Oral Suspension is commercially available.

(Continue . . . )

Saturday, October 31, 2009

Canada’s Vaccine Shortfall

 

# 3918

 

As the United States struggles with its slower than anticipated roll out of the pandemic vaccine, so do officials in Canada, where news of additional delays became public yesterday.

 

Crof at Crofsblog has done a terrific job following this story over the past couple of days, with entries such as Must-read of the day  and Canada: BC downplaying H1N1 vaccine shortage.

 

As I pointed out in Murphy's Laws And Vaccine Production last July, and in A Vaccine Reality Check back in May, there are a lot of things that can go wrong during vaccine manufacturing.

 

 


From Healthzone.ca  we get details on the announced shortfall of vaccine in Canada due to production problems at the GSK plant in Ste-Foy, Quebec.

 

 

Vaccine glitch delays H1N1 flu shots

October 31, 2009

Theresa Boyle

Joanna Smith

What has been touted as the largest vaccination campaign in Canada's history hit a major hurdle Friday when health officials announced a production glitch had resulted in a significant shortfall in vaccine supply.

 

Instead of beginning mass immunizations next week, Ontario public health units are being forced to ration limited inventories, delaying plans to vaccinate healthy people so that those at risk of complications from the H1N1 virus and health-care workers can get their shots first.

 

And beginning Saturday, as the number of clinics in Toronto increases to four, Toronto public health officials will beef up screening efforts and turn away from clinics anyone deemed not high priority for the flu shot.

 

While healthy individuals had been invited to start getting their shots at some clinics starting Monday, it's now uncertain when there will be enough vaccine for them.

 

"We have added staff who will be walking along the line and screening to ensure that the people that will get the vaccine will only be in the priority groups," warned Toronto's associate medical officer of health, Dr. Barbara Yaffe.

 

The head of the Public Health Agency of Canada, Dr. David Butler-Jones, said Friday only about 625,000 doses of the H1N1 vaccine are expected to reach flu clinics across the country in next week, compared to the 2 million doses that have been shipped in each of the past three weeks.

 

Ontario, which had been expecting to receive 1 million doses of vaccine next week, will instead receive only 170,000 doses of the regular version of the vaccine that contains an adjuvant – a chemical additive that stretches supply and boosts immunity – and 86,800 doses of the adjuvant-free version for pregnant women.

 

(Continue . . . )