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Closing deadly loopholes

Pharmaceutical IndustryJustice SystemLocal GovernmentChemical IndustryU.S. Senate Committee on FinanceFood and Drug Administration

In July, authorities discovered that a radiology technician who had worked in Maryland and several other states had been injecting himself with narcotics-filled syringes, refilling them with saline and leaving them behind for use on patients. More than 1,700 Marylanders were exposed to hepatitis C as a result, and five contracted the disease. Dozens more were affected in other states.

In September, the Maryland health department shut down a Timonium cosmetic surgery center after three patients contracted a dangerous bacterial infection after liposuction. All three were hospitalized, and one, a 59-year-old Lochearn woman, died.

And last fall, hundreds of patients in 20 states became infected with fungal meningitis after taking an injectable steroid medication that had been produced by the New England Compounding Center in Framingham, Mass. Nearly 50 people died as a result, including three in Maryland.

What the three cases have in common is that each exposed loopholes in our health care regulatory structure, with deadly consequences. The Maryland Department of Health and Mental Hygiene is proposing legislation in response to all three incidents, and while none of the bills may offer a perfect solution, each would make Marylanders safer.

On Thursday, the Senate Finance Committee unanimously endorsed a bill that would require the health department to regulate the agencies that provide workers like the radiology technician in the hepatitis C case. The state currently regulates agencies that place nurses in hospitals and other settings and those that provide home health aides to ensure that they verify credentials of their personnel, act on complaints and report problems to state regulators, among other things. But the law does not cover the companies that refer a wide variety of other medical professionals to hospitals, doctors' offices and other medical settings. This legislation would authorize the health department to require that such agencies either be accredited by a national organization or take appropriate corrective action.

The health care staffing agencies in Maryland and other states that employed the radiology technician, David Kwiatkowski, weren't solely to blame, a new report from the state health department found. Hospital workers who suspected something was amiss were also reluctant to report him. He failed to disclose a DWI arrest and other possibly disqualifying infractions when he sought a radiographer license from the Maryland Board of Physicians, and a national registry that should have enabled the state to catch those omissions failed to list all of his faults. The report also suggests that the Board of Physicians conduct background checks as part of its licensure process. Nonetheless, the staffing agency legislation is an important part of the effort to prevent something like this from happening again.

In the case of the cosmetic surgery death, state and local inspectors found inadequate infection control procedures. A loophole in state law explains why they weren't discovered earlier. The state is authorized to regulate ambulatory surgery centers, but the definition of those centers under state law has to do not only with what procedures they perform but also with how they bill for their services. This legislation would base the requirement for state regulation solely on what invasive procedures a facility performs. The legislation also allows the health department to add to the list of procedures that trigger a registration requirement if it determines that they pose a potential risk.

Perhaps the trickiest of the three proposed regulations deals with compounding pharmacies. The term originally referred to facilities where pharmacists could reconstitute drugs on an individual basis — for example, turning a pill into a liquid medicine for a child. But in cases like the New England Compounding Center, they have become de facto drug manufacturers operating outside of federal Food and Drug Administration regulations. The health care system has, nonetheless, grown dependent on such facilities to supply certain medications, and simply outlawing them in Maryland and prohibiting ones from other states from selling drugs here could lead to drug shortages.

This bill would create a new kind of license for sterile compounding facilities in Maryland and would require out-of-state facilities to receive a permit from the Maryland Board of Pharmacy before selling drugs here. The licensing requirements include adherence to proper sanitary procedures and staff training. The health department and legislators are working on an amendment to the bill that would allow some kind of waiver process for facilities that have not received Maryland permits but which supply drugs for which there is a demonstrated need, though the details have not been finalized.

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