Massachusetts tightens rules for compounding pharmacies

BOSTON (Reuters) – Massachusetts adopted new regulations on Thursday that it said will allow it to keep a closer eye on compounding pharmacies, a class of drug supplier linked to the U.S. meningitis outbreak that has so far killed 29 people.

The state, home to the New England Compounding Center that produced the injectable steroids at the heart of the outbreak, said the new rules give it the authority to track the volume and distribution of drugs that compounding pharmacies sell to determine if they are operating like manufacturers.

Compounding pharmacies – which are meant to assemble the raw ingredients of any medication one prescription at a time, not in industrial scale runs – had prior to this year’s outbreak largely escaped the U.S. Food and Drug Administration‘s attention.

“Together with our federal partners, we will ensure that Massachusetts fulfills its responsibility in overseeing this transforming industry,” said Dr. Lauren Smith, interim commissioner of the Massachusetts Department of Public Health.

The outbreak of fungal meningitis was triggered by steroids used as a treatment for back pain. Health authorities have said the New England Compounding Center failed to make medications in sterile conditions in its facility in Framingham, Massachusetts, outside Boston.

Massachusetts has closed three compounding pharmacies since the start of the outbreak.

(Reporting By Scott Malone. Editing by Andre Grenon)

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Lloyds PPI bill up another £1bn

1 November 2012 Last updated at 08:18 ET

Continue reading the main story

Lloyds Banking Group has set aside a further £1bn to cover compensation for customers who were mis-sold payment protection insurance (PPI).

It brings the bank’s PPI bill to £5.275bn so far.

The further provision means Lloyds has been pushed into a loss of £144m for the third quarter of the year.

After Barclays’ recent decision to set aside a further £700m for PPI compensation, the banking industry’s bill now stands at just over £12bn.

Despite the news, Lloyds’ shares rose 7% in morning trading, as investors took heart from the bank’s underlying financial position.

Lloyds described the further PPI provision as a disappointing “legacy issue”.

“The volume of complaints received in relation to legacy PPI business during the third quarter declined when compared to the previous quarter,” said Lloyds Banking Group’s chief executive Antonio Horta-Osorio.

“However, it remained above the level which we anticipated at the time of our half-year results and as a result the group believes it is appropriate to increase its provision for expected PPI costs by £1bn.

“This increases the expected cost of contact and redress, including administration expenses, to £5.3bn,” he explained.

The bank warned that the eventual final bill for PPI was still uncertain, suggesting it may rise further.

Marc Gander of the Consumer Action Group said banks still had no incentive to avoid bad behaviour in the future.

Continue reading the main story

Ian Pollock Business reporter, BBC News

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When, in April 2011, the banks lost their High Court challenge to the FSA’s rules on PPI mis-selling, the compensation cost was put at £4.5bn.

It has been rising ever since.

Initial estimates by the FSA itself were based on the assumption that just 20% of PPI victims would claim.

It seems that many more people – millions in fact – are now doing so.

In some cases they have been encouraged by claims management firms.

In others cases, the individual payments have been huge.

What the saga shows is just how much profit banks were able to squeeze out of their customers simply by getting them to buy an insurance policy.

“What the banks don’t reveal is that while they have had their hands on their customers’ money – the ill-gotten money – they have been lending it out at interest rates as high as 28% – compound,” he said.

“Yet they are only being required to refund at 8% simple.”

More complaints

The cost to the banking industry of compensating customers is rising fast, as complaints from aggrieved customers continue to pour in.

The Financial Ombudsman Service (FOS), which handles grievances that banks reject, has now received half a million complaints from disgruntled people who claim they have been unfairly denied any compensation.

PPI was widely sold by banks in the last decade, and the insurance was supposed to make sure that mortgage and credit card borrowers would be able to repay their loans if they fell ill or lost their jobs.

However, it became apparent that many customers had been mis-sold the insurance because they either did not need it in the first place, or would have been automatically excluded from making a valid claim, typically because they were self-employed.

Under instruction from the financial authorities, the industry is now going back through past sales and alerting customers to the possibility that they can now make a claim for compensation – a process which is generating a huge bill for the UK’s banks.

MoneyBoomerang, an online claims management company, said banks like Lloyds were still stalling on many legitimate claims.

“Lloyds has made a huge additional provision and yet it is not showing any interest in dealing with the very valid claims it is receiving,” said the company’s managing director, Craig Lowther.

“We are just about to send roughly 8,000 Lloyds cases to the FOS. We firmly believe these are valid claims and if so they will cost the bank millions.”

But Lloyds replied that it every incentive to settle legitimate complaints, because banks have to pay for each case that goes to the ombudsman.

“We… have to pay the costs of each claim (£850) as well as incremental administrative costs regardless of who the FOS upholds in favour of,” a bank spokesman pointed out.

Improvement

Despite the loss in the third quarter, Lloyds said its underlying financial position was improving.

Although the bank’s income has fallen by 14% in the first nine months of the year, this was outstripped by further benefits from cost-cutting – which saw 4,796 jobs cut – and a reduction in the amount of money it has had to set aside for losses on past loans that have turned bad.

Those provisions in its accounts are down to £4.4bn, from £7.4bn in the first nine months of the previous financial year.

With restrictions on sales commission on financial policies being imposed by the Financial Services Authority (FSA) early in 2013, Lloyds has decided to stop offering independent financial advice to anyone who has less than £100,000 to invest.

“Customers with over £100,000 of investible assets who would benefit from holistic financial planning will be referred to our private banking service,” the bank said.

“For customers who hold less than £100,000 in savings and investments we will not offer an investment advice service but will continue to give these customers information and help with savings products on a non-advised basis.”

Lloyds is still partly owned by the UK taxpayer following its bail-out at the height of the financial crisis in 2008.

As such, it is still not paying any dividends to its investors.

The bank is still in the process of negotiating the sale of 632 of its branches to the Co-operative Bank.

BBC News – Business

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Microsoft pushes new Windows to developers

SEATTLE (Reuters) – Days after launching Windows 8, Microsoft Corp is mounting a strong campaign to win over the software developers it needs to kick-start its new operating system.

A lack of apps is Microsoft’s Achilles heel as it attempts to catch Apple Inc and Google Inc in the rush toward mobile computing.

Windows 8, the new Surface tablet and a range of Windows-based phones – all unveiled in the past week – are designed to close that gap, but the world’s largest software company still needs to convince developers to recreate the thriving ‘ecosystem’ that made PCs so successful.

“Please go out and write lots of applications,” Microsoft Chief Executive Steve Ballmer pleaded with 2,000 developers on Tuesday, kicking off an annual, four-day meeting at its campus near Seattle.

The event, called ‘Build,’ is the equivalent of Apple’s Worldwide Developer Conference and Google’s I/O event.

Microsoft gave each paying attendee one of its Surface tablets and 100 gigabytes of free space on its SkyDrive online storage service. On top of that, handset partner Nokia threw in a free Lumia 920 smartphone running Windows Phone 8.

The unprecedentedly generous give-away signals the intent of what Microsoft openly calls “evangelism.” Most developers at the meeting, who paid up to $ 2,000 to attend, are already converted to the Windows religion. But this year there is a feeling that Microsoft can re-establish itself as a relevant platform for developers.

“The sessions are overflowing. Everybody wants to learn,” said Greg Lutz, product manager at development tools company ComponentOne, who is attending the conference.

“The Surface is really exciting. It’s been interesting to see people that would normally be critics of Microsoft surprised to see how good it is,” said Lutz, whose company makes features that developers can use in apps, such as calendars or charts.

Microsoft recognizes it needs apps to flesh out its new online Windows Store and make Windows 8 machines more attractive to users, said Russ Whitman, chief strategy officer at Ratio Interactive, a design agency that helps companies create apps.

“The catalog (of apps) is where they are weak, there’s no doubt,” he said. “But if Microsoft stays focused on quality not quantity, they can win.”

DEVELOPER DOUBTS

When Windows 8 launched on Friday, some major content providers had prominent apps in the Windows store, such as Netflix Inc, the New York Times and Rovio’s Angry Birds Space. But big names such as Facebook and Twitter were missing.

Twitter moved to rectify that on Tuesday, announcing that a native Windows app would be rolled out “in the months ahead.” Dropbox, a fast-growing cloud storage service, also announced it would soon have a Windows app, as did online payment firm PayPal and sports network ESPN.

But Facebook, which now has more than 1 billion users, has not yet made public any plans for a Windows app, despite the fact Microsoft is a minor shareholder.

And Microsoft still has to overcome indifference from many developers who do not see demand from users or simply do not have the resources to build Windows apps alongside iOS and Android.

“Windows 8 is getting good reviews and the tile user interface is a great fit with our geo-visual content,” said Jason Karas, CEO at website Trover, where users can share photos of interesting discoveries. “It’s on the roadmap for Trover, but we are still a very lean team, so we’re hesitant to support a third platform until we have all the innovations we want to see in iPhone and Android in place.”

Microsoft has yet to persuade other influential online services, for example car-rental firm Zipcar or real estate information firm Zillow, to develop for Windows 8.

To get more developers on board, Microsoft is spending this week demonstrating how it is making it easier to develop apps for Windows and get them into the real world.

A key part of that is a new set of tools tying in its Azure cloud service, which allows Windows apps to easily harness data stored in remote servers.

“Some of the new changes are pretty incredible and are going to make developing, especially some of the mobile apps, much easier,” said Mike Cousins, a software developer following the conference by webcast from Calgary, Canada.

“It just makes it super-easy to integrate mobile clients into your application,” said Cousins, who is developing Shuttr, a site for photographers to display and sell their work. “It’s been reduced from probably a week’s work to minutes.”

400 MILLION NEW MACHINES

Microsoft’s best argument to developers is the sheer size of the Windows user base.

Microsoft sold 4 million upgrades to Windows 8 in its first four days, a mere fraction of the 670 million or so machines running Windows 7. Ballmer said there would be 400 million new devices running Windows next year, including PCs, tablets and phones, and the company would be marketing heavily to consumers.

That is an attractive audience for developers, and Whitman at Ratio Interactive said he saw many new faces at Microsoft’s event this week who previously were more interested in web-based apps and other platforms.

“There’s a new generation of developers that can build on Windows 8 that have been building using JavaScript and HTML,” he said. “Seeing some of those developers show up and talk about building apps using other languages is pretty cool. It’s a whole different group than Microsoft has traditionally been able to court.”

One Wall Street analyst said developers may even be tempted to switch back to Microsoft after working with Apple’s iOS platform.

“There does seem to be some excitement about the new operating system and many of the new devices that are coming to market,” said Jason Maynard, an analyst at Wells Fargo Securities. “We have heard some developers talk about ‘re-Microsofting’ and moving from their Macs for app development.”

Cousins said that once developers see the user base for Windows 8 grow, the momentum will start to have an effect.

“All the new PCs people buy will be Windows 8, and people will start demanding Windows 8 apps from companies, and then they will start making them,” he said. “I think we’ll see a wave of apps coming out pretty soon.”

(Reporting By Bill Rigby; Editing by Steve Orlofsky)

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A Minute With: Rapper RZA putting on “Iron Fists” for new movie

LOS ANGELES (Reuters) – Rapper and music producer RZA is best known as the leader of the hip-hop group the Wu-Tang Clan which also includes such popular members as Method Man, Ghostface Killah and the late Ol’ Dirty Bastard.

RZA branched out into film, taking on small acting roles and scoring music, including the soundtrack for Quentin Tarantino‘s “Kill Bill: Vol. 1.”

Now, nearly a decade later, 43-year-old RZA has combined his childhood love of martial arts movies to co-write with Eli Roth the feature film “The Man With the Iron Fists,” which he also directs and acts in the title role.

Shot on location in China, and co-starring Russell Crowe and Lucy Liu, Iron Fists is set during the 19th century and sees several groups of warriors and assassins descend on a village in search of gold. The quiet and unassuming local blacksmith (RZA) ends up being the village defender.

RZA, whose real name is Robert Fitzgerald Diggs, sat down with Reuters in Hollywood to talk about the film and the future of the Wu-Tang Clan.

Q: You had to pull double duty, working simultaneously in front and behind the camera. How did you balance that?

A: “My spirit had to be extra strong to pull this off. It was difficult because in the morning (as the director) I’m worrying about everybody else, I’m talking fast. Then I have to get ready for the scene and I gotta sync my voice down to this guy. I gotta sync my spirit to him. He doesn’t smile once in the film. I smile. I’m not this morbid dude. He’s almost empty.”

Q: This is your biggest acting role to date. What did you learn as an actor?

A: “The thing about playing him that I could attest to as an actor was that I was lonely in China. I was personally lonely. And I think that shows on screen (in the character).”

Q: You’re in an exotic location with Russell Crowe and some of the biggest names in martial arts. How could you be lonely?

A: “I had no love, yo. You know what I mean? Going into a massage parlor is not gonna give you no love. I was yearning for it. For a brief minute there, I learned why actors fall in love with their co-stars.”

Q: How’s that?

A: “Because the only girl I had was (co-star/love interest) Jamie Chung. We all went out one night after shooting and Jamie had a guy friend with her. I looked over and I was so jealous. I felt weird. I told my buddy, ‘I’m about to punch this guy in the face!’ In that moment, I just felt that she was my woman. And the sad thing for me is, it would have been a one way street because she wasn’t interested in me at all.”

Q: Looking back on your first experience directing a studio movie, what do you think?

A: “It was hard work. It was 18 hour days. It was cold. The food was terrible sometimes and the language was an issue. But I kept it fun. I didn’t let nothing deter me from this path. I’m grateful and happy I had a chance to learn this craft and express it. I feel that out of everything I do as an artist – I make music, I write lyrics, I’m into fashion and clothing – filmmaking is the perfect medium and accumulates it all. I found what I should be doing. I matured into being this kind of person.”

Q: So many members of the Wu-Tang Clan are doing their own thing. Will you be assembling again soon for another album?

A: “Only time will tell. For now, I will say Iron Fists is Wu-Tang. We have all the members participating on the soundtrack. And if you look closely, you’ll notice that when (Rick Yune’s character) needs a second suit of knives, there are W’s on that second suit. You gotta look closely though. So the Wu-Tang is there. I made it subtly into the film so fans can enjoy it and feel the energy.”

Q: Some groups have their time in the spotlight and disappear. Others manage to evolve and stay relevant. Where is Wu-Tang at?

A: “To me, film is the medium that Wu-Tang needs to be at. I don’t think Wu-Tang needs to be in clubs while we gettin’ drunk and dancing. We need to be in theaters now where we sitting with our families and really appreciating our childhood in a different way. This is the reason why (movies like) ‘Iron Man’, ‘Captain America’, ‘Thor’, ‘The Avengers’ all work. Because we are adults who read comics and now we want our children to understand what we love.”

Q: So Iron Fists is the beginning of that for Wu-Tang – having others understand and appreciate the martial arts you all love?

A: “If Iron Fists goes over well and people accept it, we got great ideas for part two already. We’ve got a great sequel for all the characters and back stories that are so remarkable.”

Q: Sounds like you’re creating your own Marvel universe in a sense.

A: “Essentially, yes.”

(Reporting by Zorianna Kit, editing by Jill Serjeant)

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Many women stop their asthma meds while pregnant

NEW YORK (Reuters Health) – Almost a third of women on asthma control medications stop using them during the first few months of pregnancy – despite advice that a mother’s uncontrolled asthma is more dangerous to the developing fetus than the drugs, according to a new study from the Netherlands.

The researchers could not determine why moms-to-be stop taking their asthma meds, or whether it led to any negative health effects, but the findings are concerning, said Lucie Blais, a pharmacy professor at the University of Montreal, who was not involved in the study.

“Some studies show that uncontrolled asthma is bad for the fetus. You can have babies that will be small for their gestational age or low birth weight,” Blais told Reuters Health.

Both the Global Initiative for Asthma (GINA) and the U.S. National Asthma Education and Prevention Program recommend that women continue taking asthma medications throughout pregnancy, because the risks of exacerbated asthma are greater than the risks of the medication.

A lack of oxygen during development, known as hypoxemia, is one of the dangers to a fetus when its mother has uncontrolled asthma.

According to the GINA guidelines, there is not much evidence showing that asthma medications are harmful to the fetus, and “using medications to obtain control of asthma is justified even when their safety in pregnancy has not been unequivocally proven.”

To see how well pregnant mothers stick to their prescriptions, Priscilla Zetstra-van der Woude at the University of Groningen and her colleagues used information on more than 25,000 pregnancies from a prescription database in The Netherlands.

More than 2,000 of those pregnant women (about 8 percent) received a prescription for an asthma medication at least once during the study period, from 1994 to 2009.

Between 1994 and 2003, the women’s rate of asthma control medication prescriptions held steady before, during and after pregnancy.

From 2004 to 2009, however, the researchers saw a drop of 30 percent in the rate of asthma prescriptions filled in the first three months of pregnancy, compared to a woman’s pattern in the months before becoming pregnant.

When Zetstra-van der Woude’s group looked at the types of medications that women were cutting out, they saw that long-acting bronchodilators and combinations of these drugs with inhaled corticosteroids – used to keep moderate to severe asthma under control – were less popular during pregnancy than shortly before.

Prescriptions for these drugs declined by about 50 percent during the first trimester, from roughly 1.2 percent of pregnancies in the database down to 0.6 percent.

“Long-acting bronchodilators are usually prescribed for patients with more severe asthma, and discontinuation could lead to severe symptoms of respiratory distress,” the authors wrote in their report in the Journal of Allergy and Clinical Immunology.

Zetstra-van der Woude’s study could not say whether the drop off in asthma medications had any negative effects on the mother or baby, and it’s possible that women did not have any worsening of symptoms.

“The course of asthma often changes during pregnancy and some women may experience a relief of asthma symptoms, and as a consequence can do with less or with no medication at all. This is no problem as long as the asthma is under control,” Zetstra-van der Woude said in an email to Reuters Health.

“Doctors as well as women themselves should be informed about the importance of adequate asthma control during pregnancy and about the risks of poorly controlled asthma…for the unborn child,” said Zetstra-van der Woude.

Blais said asthma patients are not especially good at sticking to their medications to begin with, and pregnancy could add an extra hurdle because women might be afraid of taking any drugs during pregnancy.

On the other hand, pregnancy could serve as an opportunity to get women to become more adherent to their prescriptions if it means keeping their asthma in check.

“Maybe pregnancy could be a period in a woman’s life where she might listen more to the recommendations because it’s about her health, but also the fetus’s health,” she said.

SOURCE: http://tinyurl.com/9uuelcy The Journal of Allergy and Clinical Immunology, online October 15, 2012.

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Canadian dollar ends near flat after GDP data shows contraction

TORONTO (Reuters) – The Canadian dollar weakened below parity against the U.S. currency before clawing back to end little changed on Wednesday after data showed the Canadian economy contracted unexpectedly in August.

The currency weakened to a session low shortly after the gross domestic product data pointed to slower growth in the third quarter and supported the Bank of Canada‘s message that interest rate hikes are not imminent. It later pared those losses.

“We are pretty much ending unchanged from where we started the day, but we saw a 50-point range and that’s the largest we’ve seen in a week,” said Dave Bradley, director of foreign exchange trading at Scotiabank.

The Canadian dollar ended the North American session at C$ 0.9990 to the greenback, or $ 1.0010, compared with C$ 0.9993, or $ 1.0007, at Tuesday’s close.

Bradley said the market was still suffering from poor liquidity due to the absence of many U.S. traders recovering from monster storm Sandy.

“Despite the U.S. equity markets opening again, a lot of New York based participants are out of the market … I think liquidity and general flow is at a minimum,” Bradley said.

With October 31 marking the end of the financial reporting year for Canadian banks, Bradley noted the Canadian currency was virtually unchanged from a year ago within a few basis points of parity.

Mark Chandler, head of Canadian fixed income and currency strategy at Royal Bank of Canada, said the currency could be weighed down by the August GDP numbers, which showed a 0.1 percent contraction, through to the end of the week.

“It’ll linger for a little bit, the only thing that could change the tune on this is we have payrolls,” he said.

Canada and the United States are set to release monthly employment data on Friday.

U.S. equity markets were mostly flat on Wednesday, opening for the first time this week after shutting their doors ahead of Hurricane Sandy. <.N>

With the GDP data backing up recent Bank of Canada comments that rate rises are “less imminent”, the price of Canadian government debt turned positive after the data, especially at the front end of the curve, and outperformed U.S. Treasuries.

The two-year bond was up 5 Canadian cents to yield 1.076 percent, while the benchmark 10-year bond rose 20 Canadian cents to yield 1.788 percent.

Overnight index swaps, which trade based on expectations for the central bank’s key policy rate, showed that after the data traders pulled their bets on the possibility of a rate hike in late 2013.

(With additional reporting by Alastair Sharp; Editing by Jeffrey Hodgson and Chizu Nomiyama)

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RIM starts carrier testing on BlackBerry 10 devices

TORONTO (Reuters) – Research In Motion has started carrier testing of its new line of BlackBerry 10 devices ahead of the launch of the devices in the first quarter of 2013, the company said on Wednesday.

“In the last week, BlackBerry 10 achieved lab entry with more than 50 carriers, a key step in our preparedness for the launch of BlackBerry 10 in the first quarter of 2013,” said RIM’s Chief Executive Thorsten Heins, in a brief statement.

Waterloo, Ontario-based RIM is seeking to turn around its faded fortunes with the launch of the BB10 devices, as its aging line-up of BlackBerry devices loses ground to Apple’s iPhone and Samsung’s line of Galaxy products, especially in the key North American and European markets.

(Reporting by Euan Rocha; Editing by Janet Guttsman)

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Disney to make new ‘Star Wars’ films, buy Lucas co

LOS ANGELES (AP) — A decade after George Lucas said “Star Wars” was finished on the big screen, a new trilogy is destined for theaters after The Walt Disney Co. announced Tuesday that it was buying Lucasfilm Ltd. for $ 4.05 billion.

The seventh movie, with a working title of “Episode 7,” is set for release in 2015. Episodes 8 and 9 will follow. The new trilogy will carry the story of Luke Skywalker, Han Solo and Princess Leia beyond “Return of the Jedi,” the third film released and the sixth in the saga. After that, Disney plans a new “Star Wars” movie every two or three years. Lucas will serve as creative consultant in the new movies.

“For the past 35 years, one of my greatest pleasures has been to see Star Wars passed from one generation to the next,” said Lucas, chairman and CEO of Lucasfilm Ltd. “It’s now time for me to pass Star Wars on to a new generation of filmmakers. I’ve always believed that Star Wars could live beyond me, and I thought it was important to set up the transition during my lifetime.”

Disney CEO Bob Iger said Lucusfilm had already developed an extensive story line on the next trilogy, and Episode 7 was now in early-stage development.

The Walt Disney Co. announced the blockbuster agreement to buy Lucasfilm in cash and stock Tuesday. The deal includes Lucasfilm’s prized high-tech production companies, Industrial Light & Magic and Skywalker Sound, as well as rights to the “Indiana Jones” franchise.

Iger said in a statement that the acquisition is a great fit and will help preserve and grow the “Star Wars” franchise.

“The last ‘Star Wars’ movie release was 2005′s ‘Revenge of the Sith’ — and we believe there’s substantial pent-up demand,” Iger said.

Kathleen Kennedy, the current co-chairman of Lucasfilm, will become the division’s president and report to Walt Disney Studios Chairman Alan Horn.

The deal brings Lucasfilm under the Disney banner with other brands including Pixar, Marvel, ESPN and ABC, all companies that Disney has acquired over the years. A former weatherman who rose through the ranks of ABC, Iger has orchestrated some of the company’s biggest acquisitions, including the $ 7.4 billion purchase of animated movie studio Pixar in 2006 and the $ 4.2 billion acquisition of comic book giant Marvel in 2009.

Disney shares were not trading with stock markets closed due to the impact of Superstorm Sandy in New York.

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Compounding Pharmacies Feeling the Effects of NECC’s Errors

Closing the barn door after the horse has escaped doesn’t help those it might encounter, but it does protect people from the many other horses that remain in the barn. This is analogous to what’s going on with compounding pharmacies in Florida and Massachusetts, now that the unsanitary conditions of the New England Compounding Center , NECC, have been linked to the current fungal meningitis outbreak.

Massachusetts Takes Action Against Compounding Pharmacies

The New York Times reported that after Massachusetts’ health officials performed surprise inspections at some of the compounding pharmacies located in the state, the Waltham, Massachusetts-based Infusion Resource voluntarily surrendered its license over the weekend. The license surrender followed an Oct. 23 inspection that found the environment in which medications were being made revealed sanitation issues and perhaps as importantly, this pharmacy had been administering intravenous medications to patients, a clear violation of their license.

Infusion Resource is the third compounding pharmacy in the state to have its license suspended.

Florida Takes Action Against Compounding Pharmacy

Rejuvi Pharmaceuticals was the first compounding pharmacy in Florida to have its operations suspended after an inspection of the facility by the Florida Department of Health, according to Reuters . State officials visited Rejuvi Pharmaceuticals on Oct. 26 as part of a routine inspection rotation and found a number of violations, ranging from cleanliness of areas related to medications to record keeping issues.

Role of Compounding Pharmacies

A compounding pharmacy’s main role is to make a drug or drugs as prescribed by a physician for a specific patient. These prescriptions may call for formulations or dosages of medications not available through the usual route from drug manufacturers.

As WebMD explained, perhaps a person is allergic to an ingredient in a manufactured medication. The compounding pharmacy would create the needed medication absent the allergy-causing ingredient. When a specific strength or dose is not available in manufactured medications, a compounding pharmacy is called upon to create what is necessary for that prescription, for that patient.

Where NECC Fell Short

In addition to the unsanitary conditions at NECC, in addition to the pharmacy violating its own regulations of awaiting test results on purity of product before that product is shipped, the NECC erred in manufacturing and distributing vials of medication that were not patient-specific in nature, such as the three lots of recalled methylprednisolone acetate linked to the fungal meningitis outbreak.

Bottom Line

No one is suggesting that compounding pharmacies shutter their doors, because the role their products play in health care is an important one. Compounding pharmacies have thus far escaped the same scrutiny and standards to which standard pharmaceutical companies are held. In Massachusetts, for instance, according to the Associated Press, a compounding pharmacy is inspected when it opens, if it moves, or if a complaint is received about it.

More inspections and improved regulations may prevent another public health dilemma, but improved vigilance will also cost more money. That may be the sore point with taxpayers/consumers.

Smack dab in the middle of the baby boomer generation, L.L. Woodard is a proud resident of “The Red Man” state. With what he hopes is an everyman’s view of life’s concerns both in his state and throughout the nation, Woodard presents facts and opinions based on common-sense solutions.

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Hurricane’s death toll rises to 65 in Caribbean

PORT-AU-PRINCE, Haiti (AP) — As Americans braced Sunday for Hurricane Sandy, Haiti was still suffering.

Officials raised the storm-related death toll across the Caribbean to 65, with 51 of those coming in Haiti, which was pelted by three days of constant rains that ended only on Friday.

As the rains stopped and rivers began to recede, authorities were getting a fuller idea of how much damage Sandy brought on Haiti. Bridges collapsed. Banana crops were ruined. Homes were underwater. Officials said the death toll might still rise.

“This is a disaster of major proportions,” Prime Minister Laurent Lamothe told The Associated Press, adding with a touch of hyperbole, “The whole south is under water.”

The country’s ramshackle housing and denuded hillsides are especially vulnerable to flooding. The bulk of the deaths were in the southern part of the country and the area around Port-au-Prince, the capital, which holds most of the 370,000 Haitians who are still living in flimsy shelters as a result of the devastating 2010 earthquake.

Santos Alexis, mayor of the southern city of Leogane, said Sunday that the rivers were receding and that people were beginning to dry their belongings in the sun.

“Things are back to being a little quiet,” Alexis said by telephone. “We have seen the end.”

Sandy also killed 11 in Cuba, where officials said it destroyed or damaged tens of thousands of houses. Deaths were also reported in Jamaica, the Bahamas and Puerto Rico. Authorities in the Dominican Republic said the storm destroyed several bridges and isolated at least 130 communities while damaging an estimated 3,500 homes.

Jamaica’s emergency management office on Sunday was airlifting supplies to marooned communities in remote areas of four badly impacted parishes.

In the Bahamas, Wolf Seyfert, operations director at local airline Western Air, said the domestic terminal of Grand Bahamas‘ airport received “substantial damage” from Sandy’s battering storm surge and would need to be rebuilt.

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