Monday, September 29, 2014

Clinigen Group plc Receives FDA’s First Ever Drug Shortage Assistance Award

URTON-ON-TRENT, England, Sep 29, 2014 (BUSINESS WIRE) -- Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM:CLIN) the global specialty pharmaceutical company, today announces that it has received the first Drug Shortage Assistance Award from the US Food and Drug Administration (FDA)in recognition of its contribution in addressing a US shortage of Foscavir® (foscarnet sodium) injection.
Clinigen’s efforts related to the US shortage included making Foscavir® available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records. These actions by Clinigen resolved a critical drug shortage affecting patients.
This award also recognizes companies for their commitment to public health, as well as to quality manufacturing and is the first time the award has been made by the FDA.
Peter George, Chief Executive Officer, Clinigen Group, said: “To be the recipient of this new award from the FDA is a great honor and absolutely reflects Clinigen’s mission to ensure that the right drug reaches the right patient at the right time. Since acquiring Foscavir® from AstraZeneca in 2010, we have worked hard to expand the indications and markets for the drug to increase the number of patients who can benefit. It is a real compliment that the FDA is committed to working with companies, like Clinigen, to prevent and mitigate drug shortages.”
Drug shortages pose a substantial public health threat, delaying, and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent over 280 drug shortages in 2012 and 170 in 2013. There were 44 new drug shortages in 2013, down from 117 new drug shortages in 2012. Two key prevention strategies have helped drive this significant decrease in new shortages: 1) early notification and 2) a focus on quality manufacturing.

FDA: Eye drops recalled over flawed production

THE Food and Drug Administration (FDA) announced Thursday the voluntary recall of a particular batch of Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) 500mcg/400mcg/ per mL Ophthalmic Solution (Drops) owing to its supposed failure to meet Good Manufacturing Practice (GMP).
According to FDA Advisory No. 2014-071, Novartis Healthcare Philippines Inc. ordered the recall of the product's Batch No. 420548 with Registration No. DR-X473.
This, it said, is in response to the statement of non-compliance with GMP that was issued by the Italian Medicines Agency (AIFA) to Societa ltaliana Medicinali Scandicci, srl. (SIMS), which is the manufacturer of the active pharmaceutical ingredient, Tetryzoline Hydrochloride.

Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) Ophthalmic Solution (Drops) is being used for the treatment of irritant conjunctivitis, allergic inflammatory conditions of the conjunctiva particularly hay fever conjunctivitis and vernal conjunctivitis.Hydrochloride was used in the manufacture of the specific batch of Spersallerg Ophthalmic Solution (Drops)," said the FDA.
Failing to meet the GMP, the FDA said, may pose threats to consumers, thus making a recall order necessary.
"The affected product presents safety risk and potential adverse health consequences," said the FDA.
With the recall order, all distributors, retailers. hospitals, pharmacies, or clinics that have the affected batches of Antazoline Hydrochloride/Tetryzoline Hydrochloride (Spersallerg) 500mcg/400mcg/ per mL Ophthalmic Solution (Drops) are instructed to discontinue further distribution, sale and use.
Similarly, all field FDA Regulation Officers have been ordered to monitor the availability of the product batches in the market.
The product, the FDA noted, is packed in a LDPE Transparent Bottle containing l0 ml solution (box of 1's).

Wednesday, September 24, 2014

Tuesday, September 23, 2014

Are Generic Drugs Dangerous?

Generic drugs have long been pushed on American consumers as cost-effective alternatives to brand-name prescription medicines. But widespread manufacturing irregularities at drug factories overseas are raising troubling new questions about the safety of generics and whether they are putting Americans’ health at risk. 

A new analysis by the U.S. National Bureau of Economic Research reveals extensive problems with the quality of generics produced by Indian pharmaceutical companies, which supply about 40 percent of the generic drugs sold in the U.S. Bureau investigators examined nearly 1,500 India-made drug samples collected from 22 cities and found that up to 10 percent of some medications contained insufficient levels of the key active ingredients — concentrations so low, in fact, that they would not be effective against the diseases they’re designed to treat.
This new research adds to a growing body of evidence that the generic drug industry, which supplies 85 percent of the drugs sold in the U.S., routinely violates basic quality control standards and ships sub-par medicines to the U.S. and other countries. 
What that means is that many patients prescribed generic drugs are not only getting ripped off, but may not be at risk because their medications are not treating the conditions they have, says renowned cardiologist Chauncey Crandall, M.D.

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Knoxville-area clinics say they aren't affected by injectable warning from state health department

CLEVELAND (WATE) - State health regulators are telling people not to use certain injectable medications produced by a Chattanooga-area compounding pharmacy. The state says two clinics in the Knoxville area received drugs from the pharmacy, but those clinics say the drugs they use are not the ones that have inspectors worried.
The pharmacy at the center of this is the Wellness Store Compounding Pharmacy in Cleveland, Tennessee.
A state investigation found violations like out-of-date ingredients, unsupervised production of sterile products and falsification of records.
The products in question include prescription eye drops, steroids, vitamin B12, amino acids and hormones.
The state sent out a list of clinics known to have received injectable medications from the Wellness Store, including East Tennessee Vein Clinic of Knoxville and Premier Weight Management of LaFollette.
6 News spoke with both of them Monday. Both told us that they do not use the sort of medications listed by the state in the notice.
East Tennessee Vein Clinic of Knoxville said:"Our patients were not affected by any of the injectable medications in question."
Melissa Justice, owner of Premier Weight Management, told 6 News: "Everything we do is to the letter of the law and the highest standards of health care. We do not use that company anymore."
The state health department says the warning was issued out of an abundance of caution, and that it is not aware of any patients harmed by those medications.
Affected clinics, according to the Tennessee Department of Health:
  • Associates in Spine and Joint Medicine, Cleveland, Tenn.
  • Cleveland Medical Associates, Cleveland, Tenn.
  • East Tennessee Vein Clinic, Knoxville, Tenn.
  • Hollywood Body Spa, Athens, Tenn.
  • Internal Medicine Group, Cleveland, Tenn.
  • Kennedy Clinic, Ooltewah, Tenn.
  • Lynn Garden Weight Loss, Kingsport, Tenn.
  • Premier Weight Management, LaFollete, Tenn.
  • Voytik Center for Orthopedics, Cleveland, Tenn

Study shows inconsistent dosages of widely used eye disease drug

Custom-made versions of a widely prescribed, low-cost drug used to prevent a leading cause of blindness in the elderly vary widely in their dosages, Weill Cornell Medical College scientists found in analyses of the eye injections. Investigators saw no evidence of impurities or contamination but found that many of the samples, which were prepared by pharmacists through a process called compounding, contained less medication than doses of the drug obtained directly from the manufacturer. The research, published today in JAMA Ophthalmology, is likely to increase scrutiny of compounding pharmacies, which tailor-mix drugs for individual patients, and to question whether eye-care specialists should continue to prescribe the cancer drug Avastin for age-related macular degeneration (AMD).

IACP Launches Partnership for Personalized Prescriptions International Academy of Compounding Pharmacists

The International Academy of Compounding Pharmacists (IACP) announced today that it has enhanced its support of the compounding pharmacy profession with the establishment of the Partnership for Personalized Prescriptions.
The Partnership for Personalized Prescriptions or P3 is a new advocacy society that brings together over 150000 patients and practitioners who share a passion for compounding and are concerned about changes in prescription reimbursement programs that are increasingly threatening patient access to customized medicines.
P3 launched with a new website and social media channels on Facebook and Twitter which provide a forum for patients and practitioners to voice their support for compounding pharmacy or learn more about its important role in health care.
IACP is building on the association’s rich heritage of advocacy that began many years ago with the foundation of Patients and Professionals for Customized Care or P2C2.
“With the creation of the Partnership for Personalized Prescriptions we are expanding our original advocacy efforts and sharpening our tools to provide a strong platform to help raise compounding awareness as well as to restore the outstanding reputation of our profession” said Pat Stephens PharmD President of IACP and owner of Medi-Fare Drug an FDA-registered drug compounding outsourcing facility in Blacksburg S.C. “We encourage patients practitioners and pharmacists to join our effort to ensure continued access to personalized medicines.”