Showing posts with label pharmacy. Show all posts
Showing posts with label pharmacy. Show all posts

Sunday, January 27, 2013

Massachusetts shuts down another compounding pharmacy after inspection prompted by meningitis outbre | Synopsis

Massachusetts shuts down another compounding pharmacy after inspection prompted by meningitis outbre

Library at the South Carolina State Hospital, Dec. 2012
Library at the South Carolina State Hospital, Dec. 2012 by Hunter-Desportes
License (according to Flickr): Attribution License
Excerpt:

Vials of the steroid distributed by New England Compounding Center (NECC) - implicated in a meningitis outbreak - are pictured in this undated handout photo obtained by Reuters October 14, 2012. The outbreak has killed 15 people and put 14,000 at risk of contracting meningitis. REUTERS/Minnesota Department of Health/Handout. Massachusetts shut down another compounding pharmacy over sterility concerns after a surprise inspection prompted by the nationwide meningitis outbreak linked to a different company, state officials have said. Dr. Madeleine Biondolillo of the state Department of Public Health said inspectors went to the Waltham location of Rhode Island-based Infusion Resource last week and found significant issues with the environment in which drugs were being mixed. The company was inspected when it first opened in December 2009 and there had been no complaints since.

People:

Dr. Madeleine Biondolillo

Overall Sentiment: 0.0233117

Relevance: 0.491501

Sophia Pasedis

Overall Sentiment: -0.184004

Relevance: 0.468415

Dr. Lauren Smith

Overall Sentiment: 0.0246622

Relevance: 0.458194

Tom Kiley

Overall Sentiment: -0.188028

Relevance: 0.414721

SentimentQuote
0"As a practical matter it doesn't make sense," Kiley said. ...
0.124196"As a practical matter it doesn't make sense," Kiley said. "What she's going to do is whatever she can to contribute to the board and assist the board."
Sentiment Stats:
  • Number of Quotes: 2
  • Aggregate Sentiment: 0.124196
  • Mean: 0.062098
  • Standard Deviation: 0

Bernard F. Lambrese

Overall Sentiment: 0

Relevance: 0.353221

SentimentQuote
0"No issues were cited relating to the integrity of our products nor to the quality of our compounding practices," Lambrese said. ...
0.117753"No issues were cited relating to the integrity of our products nor to the quality of our compounding practices," Lambrese said. "I want to reassure our patients and the general public of the safety, purity and efficacy of our solutions produced at our Waltham pharmacy since we were first licensed in 2009. Patient safety is something we take very seriously."
Sentiment Stats:
  • Number of Quotes: 2
  • Aggregate Sentiment: 0.117753
  • Mean: 0.0588765
  • Standard Deviation: 0

Key:

  • Aggregate Sentiment is meant to be an indicator of an individual's overall sentiment.
  • The Mean is meant to be an indicator of an individual's average comment sentiment.
  • The Standard Deviation, when there are enough quotes, will indicate an individual's consistency of sentiment (i.e. a Standard Deviation of 0 would mean they were very consistent in their sentiment and 1 would mean they were very inconsistent).

Note that quote stats are likely to be meaningless beyond the aggregate score due to the tiny sample size. However, they are always provided just in case you find something useful there.

Additional Info:

StateOrCounty: Massachusetts

Overall Sentiment: -0.166623

Relevance: 0.336981

Disambiguation: Location | PoliticalDistrict | AdministrativeDivision | GovernmentalJurisdiction | USStateReferences:

Organization: NECC

Overall Sentiment: -0.234011

Relevance: 0.875399

Organization: Department of Public Health

Overall Sentiment: -0.047918

Relevance: 0.354197

Company: Ameridose

Overall Sentiment: -0.0409803

Relevance: 0.383757

HealthCondition: meningitis

Overall Sentiment: -0.416313

Relevance: 0.620897

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Friday, January 25, 2013

FDA seeks more authority amid meningitis outbreak | Redux

FDA seeks more authority amid meningitis outbreak

Excerpt:

The head of the Food and Drug Administration asked Congress Wednesday for more authority to police pharmacies like the one that caused a fatal meningitis episode, even as lawmakers questioned why the company didn't do more with its existing powers. FDA Commissioner Margaret Hamburg called for new laws to clarify her company 's authority to crack down on companies like the New England Compounding Center, which distributed polluted pain injections that have actually sickened more than 460 Americans and caused 32 deaths. Members of the House Energy and Commerce Committee invested most of the first hearing on the episode questioning state and federal regulatory authorities about why they didn't act faster against the company. A timeline constructed by the committee's Republican personnel showed that the FDA and the Massachusetts board of pharmacy examined the pharmacy more than a lots times in the past years.

People:

Margaret Hamburg

Overall Sentiment: -0.0544845

Relevance: 0.970679

SentimentQuote
-0.121442Hamburg told lawmakers that the problems uncovered in inspections were "very serious," ...
-0.018666"The challenge we have today is that there is a patchwork of legal authorities that oversee the regulatory actions we can take," said Hamburg, ...
-0.0733732Hamburg said that when her agency tries to intervene in those cases they face a "crazy quilt," ...
0Hamburg to answer simple "yes or no" ...
-0.252622"No, I'm saying it's very hard to know if any one action we might have taken would have stopped this terrible tragedy," Hamburg said. ...
Sentiment Stats:
  • Number of Quotes: 5
  • Aggregate Sentiment: -0.4661032
  • Mean: -0.09322064
  • Standard Deviation: 1.4142135623731

Mr. Cadden

Overall Sentiment: -0.164826

Relevance: 0.447736

SentimentQuote
0.0386955Cadden told lawmakers, "Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment."
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: 0.0386955
  • Mean: 0.0386955
  • Standard Deviation: 1.4142135623731

Eddie Lovelace

Overall Sentiment: -0.0868411

Relevance: 0.355734

SentimentQuote
-0.107705"My family is bitter, we are angry, we are heartbroken and devastated. I come here begging you to do something about the matter," Lovelace said. ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: -0.107705
  • Mean: -0.107705
  • Standard Deviation: 1.4142135623731

Rep. Diana DeGette

Overall Sentiment: -0.371104

Relevance: 0.327097

SentimentQuote
-0.22888"We have to figure out how to give you the jurisdiction to do what you need to do ... and these inconclusive answers are not helping us," said Rep. Diana DeGette, ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: -0.22888
  • Mean: -0.22888
  • Standard Deviation: 1.4142135623731

Rep. Fred Upton

Overall Sentiment: -0.219384

Relevance: 0.315949

SentimentQuote
-0.178079"I was stunned and angered to learn that an inspection of the NECC by the FDA and the Massachusetts board of pharmacy over 10 years ago identified contamination in the very same drug at issue in the current outbreak," said Rep. Fred Upton, ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: -0.178079
  • Mean: -0.178079
  • Standard Deviation: 1.4142135623731
Disambiguation: Politician | U.S.CongresspersonReferences:

Rep. Cliff Stearns, R-Fla.

Overall Sentiment: -0.724764

Relevance: 0.302713

SentimentQuote
0.173939"You're the grand poobah of the FDA and I'm asking you, `could you have prevented this tragedy?' and you're saying you couldn't have because you don't have jurisdiction," said Rep. Cliff Stearns, R-Fla., ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: 0.173939
  • Mean: 0.173939
  • Standard Deviation: 1.4142135623731

President Obama

Overall Sentiment: 0

Relevance: 0.300015

Stearns

Overall Sentiment: -0.189617

Relevance: 0.27947

SentimentQuote
-0.139313"Mr. Cadden, what explanation can you give the families who have lost their loved ones, and those who are gravely ill, for the actions of your company?" asked Stearns, ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: -0.139313
  • Mean: -0.139313
  • Standard Deviation: 1.4142135623731

Key:

  • Aggregate Sentiment is meant to be an indicator of an individual's overall sentiment.
  • The Mean is meant to be an indicator of an individual's average comment sentiment.
  • The Standard Deviation, when there are enough quotes, will indicate an individual's consistency of sentiment (i.e. a Standard Deviation of 0 would mean they were very consistent in their sentiment and 1 would mean they were very inconsistent).

Note that quote stats are likely to be meaningless beyond the aggregate score due to the tiny sample size. However, they are always provided just in case you find something useful there.

Additional Info:

Organization: Food and Drug Administration

Overall Sentiment: -0.0271861

Relevance: 0.772541

Organization: House Energy and Commerce Committee

Overall Sentiment: -0.10601

Relevance: 0.441513

Organization: Massachusetts board of pharmacy

Overall Sentiment: 0

Relevance: 0.371064

Organization: Centers for Disease Control

Overall Sentiment: -0.2309

Relevance: 0.320554

Organization: Obama administration

Overall Sentiment: -0.183037

Relevance: 0.318022

Organization: Congress

Overall Sentiment: 0.132858

Relevance: 0.315815

Disambiguation: Dedicator | GovernmentalBody | Legislature | NaturalOrCulturalPreservationAgencyReferences:

Organization: federal government

Overall Sentiment: 0.0154779

Relevance: 0.301365

StateOrCounty: Massachusetts

Overall Sentiment: -0.0881699

Relevance: 0.391728

Disambiguation: Location | PoliticalDistrict | AdministrativeDivision | GovernmentalJurisdiction | USStateReferences:

HealthCondition: meningitis

Overall Sentiment: -0.415729

Relevance: 0.455877

FieldTerminology: federal law

Overall Sentiment: 0

Relevance: 0.318721

Drug: methylprednisolone

Overall Sentiment: 0.223987

Relevance: 0.308931

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Tuesday, December 18, 2012

Feds tried to close New England Compounding Center a decade before fungal meningitis outbreak | Reduction

Feds tried to close New England Compounding Center a decade before fungal meningitis outbreak

Pharmacist Compounding
Pharmacist Compounding by The U.S. Food and Drug Administration
License (according to Flickr): United States Government Work
Excerpt:

The New England Compounding Center, the pharmacy connected to a deadly outbreak of fungal meningitis, was already on the radar of federal health inspectors a decade ago, according to congressional investigators. Back then, inspectors had wanted to close the facility down until it cleaned up its operations. As of early November 9, 428 patients have been presumed to be diagnosed with fungal meningitis stemming from contaminated steroid shots distributed by New England Compounding Center, and more than 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention. An additional 10 cases of fungal joint infections in caused by injections in sites such as the knee, hip, shoulder and elbow have also been reported. That has put the Framingham, Mass.

People:

Barry Cadden

Overall Sentiment: -0.0494561

Relevance: 0.416637

SentimentQuote
0Cadden told officials "that he was no longer willing to provide us with any additional records," ...
Sentiment Stats:
  • Number of Quotes: 1
  • Aggregate Sentiment: 0
  • Mean: 0
  • Standard Deviation: 1.4142135623731

Laura Strickler

Overall Sentiment: -0.0873042

Relevance: 0.148307

Greg Conigliaro

Overall Sentiment: -0.332478

Relevance: 0.139784

Margaret Hamburg

Overall Sentiment: 0.282327

Relevance: 0.131671

Lauren Smith

Overall Sentiment: 0.411015

Relevance: 0.130949

Key:

  • Aggregate Sentiment is meant to be an indicator of an individual's overall sentiment.
  • The Mean is meant to be an indicator of an individual's average comment sentiment.
  • The Standard Deviation, when there are enough quotes, will indicate an individual's consistency of sentiment (i.e. a Standard Deviation of 0 would mean they were very consistent in their sentiment and 1 would mean they were very inconsistent).

Note that quote stats are likely to be meaningless beyond the aggregate score due to the tiny sample size. However, they are always provided just in case you find something useful there.

Additional Info:

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