NJ Physician Magazine March 2013

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Van Drew, a dentist, said the Med Prep Consulting case underscored the need for tighter regulation of the industry. He expressed frustration that Congress has failed to pass legislation that would apply federal drug regulations to compounding pharmacies, whose operations are more similar to pharmaceutical manufacturers than they are to traditional pharmacies. “These pharmaceutical compounding companies have sprung up and they’re really manufacturing companies,” Van Drew said. “Most of them are good but some of them are not as good as they should be.” New Jersey has 41 pharmacies that perform sterile compounding, in addition to pharmacies located in hospitals, according to Neal Buccino, a spokesman for the Division of Consumer Affairs in the Department of Public Safety. State Board of Pharmacy regulations require regular training and testing of all personnel involved in sterile compounding, Buccino said. In addition, the state performs routine, unannounced inspections of compounding pharmacies, he said. Van Drew said he has heard from anesthesiologists in South Jersey about the potential danger of some compounding pharmacy products. Some compounding pharmacies have increased production to meet the need caused by shortages of some pharmaceuticals. Van Drew described federal regulation “as the real and best answer” to the need to regulate the industry. “We should deal with it,” he said. In the absence of federal action, he added, “All we can do is state-by-state, try to ensure that the live up to standards.” While the current version of the bill would require that all compounding pharmacies be accredited by the Pharmacy Compounding Accreditation Board, a national organization, Van Drew said he plans replace any reference to the organization with requirements that compounding pharmacies follow a set of regulations. Van Drew said he was “disgusted” by the negligence shown by the New England Compounding Center. “This is something that is very fixable,” he said. Michael R. Cohen, president of the Institute for Safe Medication Practices, a Pennsylvania-based pharmacy monitoring organization, said the lack of federal regulation has led to many questions about safety practices of compounding pharmacies. State inspections of compounding pharmacies can be costly, according to Cohen, speaking at the Association of Health Care Journalists annual convention on Friday in Boston. State and federal investigators are investigating the Med Prep Consulting products. The company has agreed to halt its operations at least through at Friday. It agreed with the state Board of Pharmacy to stop producing and shipping medications until more information about its products can be analyzed, Attorney General Jeffrey S. Chiesa said in a statement on Friday. State health authorities have recommended that healthcare facilities that received Med Prep products remove them from use. A woman who answered the phone at Med Prep Consulting declined to comment on the issue.

Massachusetts’ Pioneering Healthcare Reform Offers Early Look at What New Jersey May Face Six-year struggle to contain rising medical costs demonstrates unified front is key to success By Andrew Kitchenman What does Massachusetts have to teach New Jersey? Plenty -- at least when it comes to health reform. The Bay State was the first in the country to require residents to have health insurance. Its experience offers a number of lessons to the Garden State. Chief among them: government, health, and business leaders need to work together to contain healthcare costs. Under former Gov. Mitt Romney in 2006, Massachusetts instituted several of the key features of the Affordable Care Act, four years before the federal law was enacted. These included a mandate for every resident to purchase insurance, as well as public subsidies for low- to middle-income individuals and families to buy coverage. Today, only 2 percent to 3 percent of the state's population lacks health insurance. And with the entire country struggling to hold the line on healthcare costs, Massachusetts has gotten an early jump on this potentially divisive issue, according to officials who spoke to a gathering of healthcare reporters in Boston March 14 to 17. Still, it took until 2012, six years after the state's first healthcare law was passed, for the government to tackle the politically vexing issue of trying to contain costs. Current Massachusetts Gov. Deval Patrick told the Association of Health Care Journalists that rising costs led to a second healthcare reform law. This measure encouraged accountable care organizations (ACOs), a network of doctors, hospitals, and other healthcare providers that work together to coordinate quality care for the patients they serve. ACOs are compensated for how well they perform and keep costs down, rather than for each service they provide (as with the conventional medical model). The cost-containment bill also caps the rise of future healthcare costs to the increase in the size of the state’s economy, projected

10 New Jersey Physician


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