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Nursing Home Investigation Finds Errors by Druggists

Original source:

The New York Times, THE BAY CITIZEN
January 27, 2012

A woman with a medical history of seizures was prescribed the antipsychotic drug Seroquel, despite research showing that elderly people who take antipsychotic drugs are more likely to experience seizures. She was also given the antidepressant Trazodone, which has been linked to an increase in seizures among older patients. And then, according to a recent investigation by the California Department of Public Health, the woman was given a second antipsychotic drug, Risperdal. The combination of the two antipsychotic medications, the investigators said, could cause “life-threatening arrhythmias (irregular heartbeats).”

Despite these potentially dangerous side effects, the pharmacist responsible for reviewing the prescriptions of the woman, a resident of the Greenhills Manor nursing home in Campbell, told state investigators that he had not noted these irregularities or addressed them in the patient’s chart. Pharmacists responsible for reviewing the medication of patients in California nursing homes routinely allowed inappropriate and potentially lethal prescriptions of antipsychotic medications, and failed to correct other potentially dangerous drug irregularities, according to recent state investigations.

In reports obtained by The Bay Citizen, the department found that in 18 of the 32 investigations conducted in California nursing homes between May 2010 and June 2011 — 17 of the 32 were in the Bay Area — pharmacists failed to red-flag cases in which residents were inappropriately prescribed powerful antipsychotic medications like Seroquel, a drug used to treat schizophrenia. Pharmacists also overlooked or approved cases in which medications were prescribed at questionable levels or in unsafe combinations that could put patients at risk of seizures, accidents or even death, according to the public health department.

“The consultant pharmacists’ review, which is intended to identify unnecessary or potentially inappropriate drugs among nursing home residents, is defective in the state of California,” said Dr. Jonathan Evans, a geriatrician and the vice president of the American Medical Directors Association. He called the problem “widespread.”

The state investigations also suggested a “probable correlation” between the inadequate review of nursing home patients’ medications by pharmacists and the failure of those nursing homes to pay a fair market rate for the pharmacists’ services. A 1982 anti-kickback law requires nursing homes to pay a fair rate for pharmacy services to discourage consulting pharmacists from endorsing or extending the prescriptions of expensive, and potentially dangerous, drugs. A majority of the nursing homes where the state found patients who were inappropriately prescribed antipsychotic medications were paying below-average fees for pharmacy services.

The California investigations come in the wake of a report last year by the United States Department of Health and Human Services. The report revealed that, in nursing homes nationwide, at least 40 percent of all Medicareclaims for so-called atypical antipsychotics, like Risperdal, are inappropriate, given in excessive doses, given for too long, given without the need for use, without adequate monitoring or “in the presence of adverse consequences” and should be reduced or discontinued.

By California state law, consulting pharmacists who work for nursing homes are required to review residents’ charts monthly, and recommend to prescribing doctors that medications be stopped, reduced or changed if they pose potential dangers or are causing harmful side effects. The state health department found in its investigations that pharmacists failed to identify the misuse of antipsychotic medications in 90 percent of cases. In 59 percent of those cases, violations occurred in nursing facilities that were cited for accepting pharmacy services below cost.

The average pay rate for California pharmacists is $56.29 an hour, according to the Bureau of Labor Statistics. But a review of nursing home records indicated that some were billed much less, in some cases as low as $11 an hour. The state anti-kickback law bans nursing homes from accepting below-market rates “from any pharmacist or pharmacy as compensation or inducement for referral of business to any pharmacy.”

“When pharmacy services are provided below cost, the pharmacist may be recouping the losses by making drug recommendations according to financial incentives instead of the best interests of the residents,” said Anthony Chicotel, a lawyer with the California Advocates for Nursing Home Reform, which plans to release a report on the state investigations. “When their independence is compromised, the integrity of their protective function is eviscerated.”

The state investigations yielded a number of examples where the pharmacists’ protective function appeared to be compromised.

At Hillside Senior Care nursing home in Fremont, for example, a consulting pharmacist was billed at a rate as low as $16.24 an hour, and no more than $19.16 an hour, between January and May 2011. In the same period, according to state investigators, a pharmacist at Hillside contradicted a doctor’s request to cut back antipsychotic medication.

“We have corrected this already with the department,” said Vilmar Agustin, Hillside’s director of nursing.

At the Herman Health Care Center in San Jose, investigators found that between August 2010 and January 2011, pharmacist services were billed for as little as $23.75 an hour and not more than $29.75. The state also found prescription irregularities.

Mandy Sollis, Herman Health’s business office director, wrote in an e-mail: “We did increase our rate of pay to the pharmacy per regulations.” She would not specify the amount, saying it was private.

In the case of the elderly woman in Campbell who was prescribed drugs that the state investigators said were potentially life-threatening, “With regard to the investigation, I know there was a deficiency and a plan of correction,” said Ed Basa, who had been the administrator at Greenhills Manor at the time of the investigation last June.

At the Empress Care Center in San Jose, investigators found that a resident was kept on Risperdal and that the dosage was increased “without evidence of effectiveness over an eight-month period.” Another patient was on the antipsychotics Seroquel and Haldol, despite side effects that included “continuous lip smacking and shaking of the arms and legs.”

The resident told investigators “he had been like that for a very long time.” But the state found nothing in the resident’s chart to indicate that he suffered from side effects.

In another case at Empress, the state found that a resident with dementia who “refused to shower, dress and be groomed” was prescribed Zyprexa, one of a group of medications called “atypical” antipsychotics, which the Food and Drug Administration warned in 2005 were not approved for use in elderly people with dementia because they increase their risk of dying. That warning was extended in 2008 to include older antipsychotic drugs like Haldol.

Administrators at the Empress Care Center did not return calls asking for comment.

Anita Gore, a spokeswoman for the California Department of Public Health, said the recent investigations prompted her agency to pass a regulation limiting the prescription of antipsychotics for Medi-Cal recipients in nursing homes to uses approved by the federal Food and Drug Administration.

As a matter of routine, Ms. Gore said, nursing homes found by the state to be deficient have 10 days to submit plans of correction, but they can request an extension. “There is no set deadline for submitting a plan of correction,” she said.

Mr. Chicotel of California Advocates for Nursing Home Reform said he was disappointed with the state’s response to its own findings. Mr. Chicotel said he was concerned that “not a single facility was issued a citation or fined.”