PHARMACY

First MinuteClinic locations set to open in Massachusetts

BY Antoinette Alexander

BOSTON CVS Caremark has confirmed that its MinuteClinic business in about a month will open the state’s first retail-based convenient care clinics.

The clinics will open in the Medway and Tewksbury locations. The company has applied for licenses in 26 additional locations, with plans to open as many as 100 clinics across the state.

Walgreens’ Take Care Health Systems in June confirmed plans to launch multiple clinics in the Boston-metro area through a phased approach beginning this fall.

“Take Care Health Systems is looking forward to launching Take Care Health Clinics in the Boston-area this fall. We’ll open multiple clinics, located at Walgreens drugstores, through a phased approach this year. Access to care is a paramount issue in the United States, and Massachusetts is no different. Take Care Health Clinics offer access to high-quality, convenient and affordable healthcare. We’re excited to bring our model of patient-first care to the people of Massachusetts,” the company said in a prepared statement issued in June.

In January, the convenient care industry celebrated a victory in Massachusetts as state health officials approved regulations allowing for limited service medical clinics, marking the end of a long review process that included two public hearings and the submission of hundreds of pages of testimony regarding the regulations.

Sparking the move to create specialized regulations: CVS’ application to open a MinuteClinic in one of its stores in Weymouth.

According to the state Public Health Council, early in the application review process it became clear that Department of Public Health regulations governing medical clinics did not address the operation of medical clinics with limited scope of services. Rather than consider applications requiring numerous waivers from full-service clinic regulations, the department decided to create a specialized set of rules.

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PHARMACY

FDA increases drug warnings for TNF blockers

BY Alaric DeArment

WASHINGTON A risk of fungal infection has prompted the Food and Drug Administration to call on four drug makers to strengthen warnings on some of their products.

Johnson & Johnson’s Remicade (infliximab), Abbott Laboratories’ Humira (adalimumab), Amgen’s and Wyeth’s Enbrel (etanercept) and UCB’s Cimzia (certolizumab pegol) are the drugs affected after the FDA reviewed 240 reports of the respiratory fungal disease histoplasmosis in patients using the drugs. Of the 240 patients, 45 died from the disease, whose symptoms resemble those of the flu.

The drugs belong to a class of drugs that block tumor necrosis factor, which normally helps the body fight cancer but is sometimes overproduced, leading to diseases such as arthritis and Crohn’s disease.

“Amgen and Wyeth are committed to the safety of patients,” the companies said in a jointly released statement Friday. “Both companies maintain ongoing safety surveillance programs worldwide to analyze and evaluate safety reports from controlled and open-label clinical trials and patient registries, as well as reports received from health care professionals and patients. Both companies work with regulatory agencies to update the label periodically as appropriate based on emerging information.”

Amgen, they stated, will work with the FDA to finalize and communicate revised product labeling for Enbrel to both physicians and patients.

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FDA posts first quarterly drug safety report

BY Alaric DeArment

WASHINGTON The Food and Drug Administration has posted its first quarterly report on drugs under review for possible safety issues, the agency announced Friday.

The drugs are identified based on a review of reports in the FDA’s Adverse Event Reporting System and are listed under the Food and Drug Administration Amendments Act of 2007, which requires the FDA to inform the public of new safety information or potential signals of serious risk, based on reviews of AERS.

But, the FDA cautioned, a drug’s appearance on the list doesn’t mean it definitely carries the risk only because the FDA has identified a potential safety issue.

“My message to patients is this: Don’t stop taking your medicine,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”

Please click here to view the full list of drugs.

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