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FDA Finds Penicillin Drug Abuse in NY Farm Animals


The FDA has issued letters of warning to two New York food production operations suspected in violation of adulterated food brought about by misuse of animal medications.

Potsdam-based Adon Farms and Lloyd T. Smith & Sons in Canton are dairy farms, and Francis J. Szarek of Westmoreland, NY runs a veal operation.

The Adon dairy was inspected on April 2 and 9, 2009 and the “Warning Letter” mailed on Aug. 5, 2009. the Smith & Sons dairy was inspected in June 2009, and received the issued letter on September 9, 2009.

FDA says that both dairy farms offered animals for slaughter and sale as food that were held under insanitary conditions that may have rendered it injurious to health if brought into the food supply. Tests by the U.S. Department of Agriculture’s Food Safety & Inspection Service (FSIS) showed uncooked edible tissues exceeded the allowable levels for penicillin, an antibiotic used to prevent or destroy an infection in the animal. the FDA was also issued warnings to the dairies for inadequate record-keeping and not following federal instructions for the animal drugs, which requires that the animals be held back from sale until the drug residues clear the animals tissue. the penicillin was also used inappropriately and off-label, and not under the supervision of a veterinarian.

The Szarek veal facility was inspected on April 8 and 10, 2009, and its warning letter” also went out on Sept. 9, 2009. FSIS testing showed 0.134 parts per million of flunixin in the liver tissue of a veal calf sold for slaughter. FDA has not established any tolerance level for residues of flunixin and the presence of the drug in edible tissue means the food is adulterated. Like the dairies, it was charged with using animal drugs for “extra label” purposes without the benefit of a veterinarian and without keeping adequate records.

Flunixin is a non-steroidal anti-inflammatory drug used in animals for muscle pain, to alleviate fevers, and to prevent endotoxemia. it is only registered for use in horses and cattle.

It is estimated that 70% of the antibiotics used in the United States are fed to farm animals for non-therapeutic purposes such as growth promotion and to compensate for unsanitary farming conditions. Medical experts fear that the residue of antibiotics that end up in the food supply contribute to human development of bacterial resistance. many health organizations, such as the American Medical Association and the American Public Health Association urge for the regulation of antibiotics used for animals designated for slaughter for food.

The farms have 15 working days to respond to FDA.

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Electronic health records could be a deadly target during a cyberwar


Most health officials worry about hackers stealing sensitive information such as an AIDS diagnosis from someone’s electronic medical record, but a technology manager for a health care system in the Pacific Northwest said it’s just as likely the digital files could be a target of terrorists or a nation state during war.

Countries have invested millions of dollars in computer systems to conduct a cyberwar against the United States “and the best way to do that is to destabilize the population,” said Chad Skidmore, director of network services for Inland Northwest Health Services, a network of 34 hospitals in Spokane, Wash. To do that, hackers could infiltrate health systems to change patient records so misinformation will lead to deadly consequences.

Skidmore, speaking on Friday before a health IT standards committee organized by the Health and Human Services Department, said what “keeps me up night and fairly scared” is that an attacker could get into a system and, for example, change data fields that indicate patients who have an allergy to penicillin do not have an allergic reaction to the antibiotic. About 400 patients in the United States die each year from penicillin allergies, according to the Web site Wrong Diagnosis.

Skidmore said an adversary could manipulate other patient information such as blood types. Compounding his fears are findings that show health care organizations are more vulnerable to cyberattacks than other groups because the health care industry invests less in information security than other sectors of the economy, he said.

About 60 percent of hospitals and health care systems spend 3 percent or less of their IT budget on information security, according to a survey conducted in August and September by the Healthcare Information and Management Systems Society. The financial sector by comparison averages spending 10 percent of an IT budget on security.

Less than half the health organizations surveyed had a chief information security officer or a chief security officer on staff and less than half encrypted stored data, according to the survey, which Lisa Gallagher, senior director of privacy and security for the society, presented to the committee. Only two-thirds of the organizations encrypted data before electronically sending it to other parties. The group surveyed 196 hospitals and health care systems.

The survey also revealed that half of health organizations did not have a formal plan in place for responding to a data breach and nearly a third had at least one known case of medical identity theft.

Ryan Smith, assistant vice president of eBusiness, part of Intermountain Health Care in Salt Lake City, which operates 23 hospitals in Utah, told the panel that health care organizations that use cloud computing to store patient records remotely will make it increasingly difficult for hospitals to monitor and track who accesses patient records. Cloud computing also makes it difficult to fix records when the service goes offline, he said. “Who do you call when the cloud is down?” Smith asked.

Stephen Warren, deputy chief information officer for the Veterans Affairs Department, told the hearing that networked biomedical devices such as blood monitors, X-ray machines and CT scanners pose security challenges as well. he said VA recently issued a new policy that requires health care institutions to operate medical devices that run on virtual local area networks separate from other department computer systems.

Of VA’s 7,300 employees on its IT staff, 450, or 6 percent, are information security officers.

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