PHARMACY

NABP implements nationwide effort to oversee compounding pharmacies

BY Alaric DeArment

MOUNT PROSPECT, Ill. — A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.

The National Association of Boards of Pharmacy said Wednesday that it would implement a four-part action plan centered around inspection of compounding pharmacies and sharing data from the inspections among boards of pharmacies around the country.

The announcement comes in the wake of a nationwide meningitis outbreak linked to contaminated injectable steroid drugs prepared at the New England Compounding Center, in Framingham, Mass., which had sickened 590 and led to 37 deaths in 19 states as of Monday, according to the Centers for Disease Control and Prevention. The outbreak has led to calls by legislators and the Food and Drug Administration for stronger regulations of pharmacy compounding, particularly after an FDA inspection of the NECC found widespread contamination and unsanitary conditions.

The NABP’s four-part plan consists of sharing a list of compounding pharmacies provided by the Iowa Board of Pharmacy with other NABP member boards and coordinating the collection of information on them; the second part involves implementing the inspection program to ensure they are doing business according to regulations and taking action against pharmacies that refuse inspection; the third part includes collection and maintaining of data on the pharmacies and storing it in an electronic profile; the fourth part involves training board of pharmacy inspectors and compliance officers, as well as cooperation with the FDA and legislators.

"Creating an information sharing network of verifiable data on compounding pharmacies, including information on the scope of operations, results of the Iowa inspection program and any disciplinary actions will provide a vital resource to support the boards’ regulatory efforts in this area," NABP president Michael Burleson said. "The network will be made available at no cost to boards for use in making licensure and registration determinations for pharmacies and may also help to identify pharmacies whose operations are more akin to manufacturing than compounding."


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J.MONTAGUE says:
May-06-2013 02:52 am

Third party inspections are gladly available in country like India and China. The quality and professionalism are all extremely changeable. Meet the local director of the company you select, and also attempt to meet the inspector. Third Party Inspection in India

J.CENA says:
Mar-21-2013 03:04 am

That's the motive for a final pre-shipment Inspection, you or your excellence inspection team visit the factory site and verify the quality of the over products and their wrapping. A final pre-shipment inspection for clear reasons takes place at the end of or close to the end of the manufacturing process. pre shipment inspection india approvals

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PHARMACY

FDA accepts application for Takeda, Lundbeck antidepressant

BY Alaric DeArment

DEERFIELD, Ill. — The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

The FDA will review the companies’ application for vortioxetine for the treatment of major depressive disorder in adults. The agency expects to finish reviewing the application by Oct. 2, 2013.

The application includes data from seven studies that included more than 7,500 patients ages 18 to 88 years. The companies have proposed marketing the drug under the name Brintellix if it wins approval.


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PHARMACY

Survey indicates growing importance of mobile health apps

BY Alaric DeArment

ANDOVER, Mass. — More than 10% of Americans consider Web-enabled, mobile health apps a part of their health care and key to living long lives, according to a new survey by a division of electronics manufacturer Philips.

Royal Philips Electronics commissioned Opinion Research to conduct a survey of 1,003 adults, finding that 11% said that were it not for Web-based health information, they might already be "dead or severely incapacitated."

"We are in the early stages of the Web-enabled, mHealth, mobile app world of healthcare delivery," Philips Healthcare chief medical officer Eric Silfen said. "Near-future apps will focus on tying together health information technologies, connecting with doctors, nurses, healthcare professionals and patients, all within a social context that facilitates shared medical decision making. This evolution will harken the new vital signs of the clinical times with technologies that help prevent medical errors, lower the financial and social cost of care, sustain a higher quality of medical practice and support an evidence-based standard for medicine in general."

The survey also found that a quarter of respondents use symptom-checker websites or home-based diagnosis technology as much as they visit the doctor, while another 27% use such applications instead of going to the doctor, and 41% said they were comfortable using websites to check their health symptoms. While 49% were comfortable with symptom checker technologies or home-based vital sign monitors automatically sharing information with their doctors, more than one-third believe technology that allows one to monitor personal health is now the key to living a long life.


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S.ALAM says:
Jul-03-2013 12:10 pm

More such apps should be created specially indicating basic primary health care including general guidelines of diabetes as well as food poisoning.

L.ROSE says:
May-16-2013 02:09 am

Completely appreciated with your approaches that emphasizes on the reason behind the growing importance of mobile healths apps with its advantageous features which are easily accessible in nature for them people having smartphone and tablets.This type of survey indicates the huge uses of this mobile health apps which increases the health care practices.Popularity of this apps is booming day by day known through such interesting review.Medifast shakes

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