Category Archives: Pharmacy

BOSTON (AP) A company with the same founders as the specialty pharmacy linked to deadly meningitis outbreak said Wednesday that it's recalling all its products after federal inspectors said it must improve its sterility testing process. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said she could not be specific about the problem at Ameridose. She would only say: "We found there was not adequate assurance of sterility in their sterile products." Woodcock stressed the agency knows of no infections linked to the recalled products. In a statement, Westborough-based Ameridose said it issued the recall "out of an abundance of caution." "Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death," the company said. "We are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA's recommendations." The company posted a lengthy list of the recalled products, including painkillers, anesthetics and blood thinners, on its website Wednesday. Woodcock said the large recall could exacerbate some shortages for critically … Continue reading →

By Kay Lazar, Globe Staff The Patrick administration Thursday unveiled new emergency regulations to more tightly oversee compounding pharamacies like the Framingham facility linked to the national fungal meningitis outbreak. The new rules, approved by the Massachusetts Board of Registration in Pharmacy, will for the first time allow the state to track the volume and distribution of drugs made by compounding pharmacies to determine whether they are operating more like a manufacturing facility subject to licensing by the US Food and Drug Administration. Penalties are included for pharmacies that fail to comply with rules and regulations, and the rules give new powers to the pharmacy board to shut down operations of a compounding pharmacy and quarantine its products without having to first hold a hearing. The regulations also require pharmacies to report when they are the subject of an investigation by another state or federal authority. At the same time, Massachusetts Congressman Ed Markey unveiled federal legislation Thursday to address what he called a regulatory black hole currently governing these pharmacies by giving the FDA new oversight authority. At least 28 people have died and 377 have been sickened after receiving injections of a contaminated steroid medication linked to the … Continue reading →

BOSTON (AP) 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. She said the manager of record at the company was a former employee at Ameridose, which is owned by the same people who ran New England Compounding Center, the company linked to the meningitis outbreak. She would not identify the drugs or say what specific issues investigators found at Infusion Resource, but she said they were concerned about sterility. The company mixes sterile injectable drugs for people who have been released from hospitals. The company has agreed to contact its 40 patients and their doctors and ask them to return any unused medication. Biondolillo says there is no indication any medication the company compounded is unsafe. She said the company also had an area to … Continue reading →

By William Hudson, CNN updated 8:00 AM EDT, Wed October 31, 2012 State officials have found a second Massachusetts pharmacy in violation of state regulations. STORY HIGHLIGHTS (CNN) -- A second Massachusetts compounding pharmacy surrendered its license after state inspectors found "significant" issues that could affect sterility, state health officials said. The pharmacy, Infusion Resource, was also found to have a center for giving intravenous medications to patients in violation of state regulations, which require a clinic license, Dr. Madeleine Biondolillo, director of the Massachusetts Department of Public Health Bureau of Healthcare Safety and Quality, said Sunday. The state Board of Pharmacy immediately issued a cease and desist notice to Infusion Resource after the October 23 inspection revealed the violations, she said. Over the weekend, the Department of Public Health "secured the voluntary surrender of Infusion's pharmacy license." The company, which compounds antibiotic and nutritional IV medications for home use, said in a statement it has since recalled all compounded products dispensed in the past month, effecting 38 patients. "No issues were cited related to the integrity of our products nor to the quality of our compounding practices," said Bernard Lambrese, Infusion Resource CEO, in a statement. "It is correct … Continue reading →

WOONSOCKET, R.I., Nov. 1, 2012 /PRNewswire/ -- CVS/pharmacy is partnering with the American Diabetes Association (ADA) as the sponsor of "A Day in the Life of Diabetes" campaign a photo sharing campaign on the ADA's main Facebook page. The CVS/pharmacy ExtraCare Advantage for Diabetes program will donate $1 to the American Diabetes Association for every photo or image uploaded, up to $25,000. CVS/pharmacy will also co-host a Twitter Chat on November 15 with Dr. Elizabeth Seaquist, Vice President of Medicine & Science for the ADA. (Logo: http://photos.prnewswire.com/prnh/20100816/NE50800LOGO ) "With 26 million people afflicted with the disease in the U.S. and an additional 79 million Americans at risk for type 2 diabetes, this chronic condition has reached epic proportions," said Papatya Tankut, RPh, Vice President of Pharmacy Affairs, CVS Caremark. "By working together with the American Diabetes Association, we're able to cast a wider net to help more people on their path to better health by sharing educational resources and spreading awareness of programs that can help them to manage diabetes and save money." Additional activities happening during American Diabetes Month include: ExtraCare Advantage for Diabetes members earn ExtraBucks Rewards on more than 100 products used to manage diabetes, including testing … Continue reading →

U.S. Food and Drug Administration agents and local police searched the Framingham office of the New England Compounding Center, which made the medicine first implicated in the outbreak -- three lots of preservative-free methylprednisolone acetate. On Oct. 6, NECC recalled all products made at and distributed from the Framingham branch that are currently in circulation. I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center, U.S Attorney Carmen Ortiz said in a statement Tuesday. I think that it is entirely premature to suggest what the results of the investigation will be. NECC's lawyer, Paul Cirel of Collora LLP, said in a statement that the raid was unwarranted. "It is difficult to understand the purpose of this search, since we have been clear that [NECC] would provide, and has provided, anything requested. We've been clear that warrants weren't needed," Cirel said, according to Reuters. As of Wednesday, there have been 245 cases of fungal meningitis reported to the U.S. Centers for Disease Control and Prevention, along with two cases of joint infection. Nineteen people have died thus far. The CDC has confirmed that the fungus exserohilum rostratum was present in at … Continue reading →

BELLEVUE, Wash.--(BUSINESS WIRE)-- Wolters Kluwer Health, a leading global provider of information for healthcare professionals and students, announced today that Pharmacy OneSource, part of Wolters Kluwer Health, has released a new version of Simplifi 797, a web-based quality assurance software for USP Chapter 797 compounding compliance. USP Chapter 797 regulations calls for conscientious and skillful training of personnel who prepare compounded sterile products (CSPs), which should be completed and documented before any preparation of CSPs. These new features in Simplifi 797 will make it easier to demonstrate compliance with the chapter. Pharmacy managers will be able to track competencies easily with a redesigned dashboard that separates competencies for each staff member by completion, outstanding or soon expiration. An improved competency scheduler allows competency assignments for the entire clean room staff to be created or modified with just a few clicks. New scheduling options also allow easier tracking and reporting for USP 797-required initial employee competencies, such as the three successful gloved fingertip completions. Simplifi 797 includes CriticalPoints education program, which gives users unlimited access to 42 hours of ACPE-approved continuing education credits supporting compliance with USP Chapter 797. Lessons guide clean room employees through a series of interactive tests that … Continue reading →

Federal criminal investigators on Tuesday searched the New England Compounding Center, which supplied drugs tied to the deadly meningitis outbreak. A spokeswoman for the U.S. Food and Drug Administration said criminal investigators from the agency were at the NECC, based in Framingham, Mass., on Tuesday. U.S. Attorney Carmen M. Ortiz of Massachusetts said her office is investigating allegations concerning the compounding center but didn't provide further details. Paul R. Cirel, a lawyer for the New England Compounding Center said in a statement late Tuesday: "It is difficult to understand the purpose of this search, since we have been clear that New England Compounding Center would provide, and has provided, anything requested. We've been clear that warrants weren't needed; asking would have produced the same result. Nevertheless, we continue to offer our cooperation." Also on Tuesday, federal health officials updated treatment guidelines for doctors dealing with the outbreak, saying oral medicine can be used to treat mild cases of meningitis. The Centers for Disease Control and Prevention said there is growing evidence that the fungus Exserohilum rostratum, " a brown-black mold," is the predominant pathogen behind the fungal-meningitis outbreak associated with tainted steroid injections made by NECC. As of Tuesday, the … Continue reading →

This undated photo made available by the Centers for Disease Control and Prevention shows a branch of the fungus Aspergillus fumigatus. The fungus can also cause skin infections if it enters a break in the skin. The meningitis outbreak is linked to the fungus being accidentally injected into people as a contaminant in steroid treatments. It's not clear how the fungus got into the medicine. NEW YORK -- Two more drugs from a specialty pharmacy linked to a meningitis outbreak now are being investigated, U.S. health officials said, as they urged doctors to contact patients who got any kind of injection from the company. The New England Compounding Center of Framingham, Mass., has been under scrutiny since last month, when a rare fungal form of meningitis was linked to its steroid shots used mostly for back pain. Monday's step by the Food and Drug Administration followed two developments. One was a report of a meningitis illness in a patient who got another type of steroid made by the company. The agency also learned of two heart transplant patients who got fungal infections after being given a third product from the company during surgery. The illnesses are under investigation, and it's … Continue reading →

Home Business Loading Published: 10/16/2012 BY JON CHAVEZ BLADE BUSINESS WRITER It isnt that she prefers doing things the hard way, but its probably fair to say that Najwa Kassem, all 5-foot-2 of her, has never backed down from the many challenges that have come her way. Growing up in her native Lebanon, there was pressure to settle down and marry and not pursue a career. Instead, she went to school and became a pharmacist. Later, she wanted to start her own pharmacy in her town of Baalbeck, but everyone cautioned her that in Baalbeck a conservative, traditional city whose roots date back 9,000 years women do not own businesses. Its very unusual for a woman to own her own business there, Mrs. Kassem said. There were seven other pharmacies and all of them were run by males. I was told, This is a big challenge for you, a girl, in this area, with seven other guys. I dont think youre going to stand a chance. Undeterred, she started her own pharmacy, which became very successful and was destined to remain that way until 1995 when she met a visiting American, Jamil Kassem. A whirlwind romance ensued, and after a … Continue reading →