Articles Posted in medication problems

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More than a year ago, I blogged about a major lawsuit against pharmaceutical company Johnson & Johnson. The issue is interesting to me as a Pennsylvania nursing home lawyer because J&J was accused of paying kickbacks to Omnicare, the nation’s largest provider of drugs to nursing homes, for using its products. Among those products is Risperdal, an antipsychotic that was widely used to control dementia patients’ behavior until scientists realized it actually hastens death in the elderly. Last week, a federal judge declined to dismiss the lawsuit, which is being pursued by the U.S. Justice Department because the fraud allegations affect Medicare. Also in late February, a former J&J employee filed a related whistleblower lawsuit alleging that the company also defrauded Medicaid by concealing discounts the government should have been entitled to receive.

The new lawsuit was filed by Scott Bartz, a former sales employee of the pharmaceutical company. Drug manufacturers are required to give Medicaid the same price as the lowest price given to private companies. Bartz alleges that J&J intentionally concealed discounts to others in order to inflate its prices to Medicaid for drugs including Risperdal and others given to nursing home patients. In this, he claims, J&J was aided by Omnicare and distributor McKesson. Meanwhile, the decision in the earlier whistleblower suit means J&J must defend itself in court against allegations that it paid Omnicare to increase the sales of antipsychotics in nursing homes. Omnicare has already paid $98 million to settle its portion of the Justice Department lawsuit.

As a Philadelphia injury lawyer, I’m pleased that so many of these allegations are getting their day in court. Science has shown that Risperdal and other atypical antipsychotics are dangerous for elderly people, yet those antipsychotics were prescribed heavily until the FDA took action. To make matters worse, all of those prescriptions were off-label, which means the drug was never approved to control dementia patients — it was only ever approved for use in psychotic patients. That means safety studies focused on safety in those patients, not in the elderly or demented. Using drugs off-label in this manner as “chemical restraints” can be considered a form of Pennsylvania nursing home abuse. If you believe your loved one suffered or died because of this practice, don’t hesitate to contact a Philadelphia medical malpractice lawyer to learn about your rights and legal options.
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As a Pennsylvania nursing home lawyer, I’ve written here several times before about the controversial practice of using psychiatric medications to control the behavior of dementia patients. Dementia can make patients argumentative or violent towards others, and it can also cause them to put themselves in danger. As a result, it’s become a common practice to prescribe antipsychotic medications to these patients “off label,” which means the drugs aren’t approved for controlling dementia symptoms. I and many other Philadelphia medical malpractice lawyers have criticized the practice as unsafe, especially after studies began showing that certain atypical antipsychotics actually increased the rate of death in dementia patients. Now, a New York Times Well blog entry dated Feb. 15 suggests an alternative: a pilot project at Minnesota nursing homes that seeks to replace drugs whenever possible with behavioral interventions.

The Awakenings project trained the entire staff of one nursing home in how to calm and reassure patients, and talk to them without insisting on facts that the patients won’t accept as true anymore. The home’s director of nursing said just holding the patients’ hands is sometimes enough to calm them down. When those steps were in place, the home began to reduce or eliminate psychiatric medications whenever possible and agreed to by the families. In the end, all of the residents taking antipsychotics and 30 to 50 percent of those taking antidepressants were able to stop the medications. The post said the behavioral interventions were expensive because they required two additional staff members, but the results were so strong that the program has been expanded to all of the homes owned by this home’s parent company.

The experiment also uncovered the reasons for the outbursts from one patient, an unnamed woman in her 90s. The woman would grimace and cry out, had never spoken once since she entered the home and showed no clear signs of recognition when her children visited. At the beginning of the project, she was on the antipsychotic Risperdal, the anxiolytic Ativan and an antidepressant. But after Awakenings took her off most of her psychiatric medications, she was able to speak enough to tell caregivers that she was crying out in physical pain. She was also able to communicate with her family and even take part in games at the home before she eventually died of complications from the dementia.

As a Philadelphia injury lawyer, I’m pleased to see that nursing homes are considering alternatives to medicating dementia. As the post notes, medications are sometimes called “chemical restraints” because their purpose seems to be less to treat a medical problem than to make the caregiver’s life easier. This essentially robs the patient of his or her ability to live fully so that nursing homes don’t have to pay for the full amount of staff members they need (with Medicare, Medicaid or the family picking up the bill). As this blog post shows, it can also keep patients from communicating their actual medical or personal needs. And even worse, it’s now well established that atypical antipsychotics increase patients’ risk of stroke, diabetes and other serious health problems that are only exacerbated by age. Under these circumstances, using drugs as a substitute for adequate staffing could be considered a form of Pennsylvania nursing home abuse.
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As a Pennsylvania nursing home lawyer, I was very interested in a report of trouble at a Pittsburgh-area nursing home. As the Pittsburgh Business Times reported Feb. 9, Katera’s Kove in Beaver County has been cited and fined and had its license downgraded by the state for the second time in about six months. The 79-bed facility in Wampum, Penn. received a second provisional license Jan. 31, after receiving a first one last July. It was also cited for problems including inadequate staff training and re-using medical equipment, which raises sanitation issues. Katera’s Kove Inc. has until Feb. 17 to correct those problems or face fines of $1,704 a day. Its owner, Lynn Katekovich, said this would not be a problem.

Last year’s inspection of Katera’s Kove resulted in an admissions ban, fines and citations for problems including improper food storage and failure to document when medication was given. At that inspection, it had four repeat violations, including allowing smoking in unapproved areas, missing equipment from first-aid kits and burned out light bulbs in six rooms. Katekovich said at the time that she felt the DPW’s enforcement was selective and planned to appeal. That appeal did not happen, and the admissions ban was lifted. The late January inspection found more problems, including the re-use of a glucometer and its equipment with multiple patients. The devices test diabetics’ blood to monitor blood sugar, and use disposable lancets to pierce the skin for sanitary reasons. Katera’s Kove was cited for disinfecting this equipment with alcohol and re-using it. Katekovich said this had been approved by the DPW in the past, but “all of a sudden you get an inspector who doesn’t think it’s sanitary.”

As a Philadelphia medical malpractice lawyer, I agree with that inspector. In fact, so does the Pennsylvania Department of Public Welfare, which specifically warns against (PDF) using the same glucometer, lancets and test strips in multiple patients. This is an important part of basic sanitation for any medical facility, but it’s especially important at a nursing home, where the elderly and immune-compromised population lives in a close space that encourages the spread of disease. No doubt re-using a glucometer and equipment saves money, but an outbreak of disease spread in this way could harm the patients and eventually cost far more, in medical costs and costs related to a Pennsylvania nursing home abuse lawsuit. If this is typical of the home’s attitude toward sanitation, it’s no surprise that the DPW is keeping an eye on Katera’s Kove. As a Philadelphia injury lawyer, I hope the inspection and publicity improves policies at this home before a patient is harmed Continue reading →

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As a Philadelphia medical malpractice lawyer, I’m very concerned about the overuse of powerful antipsychotic medications in nursing homes. So I was pleased to see a MedPage Today article Dec. 9 showing that patient advocates have echoed those concerns in Congressional panel. The Senate Aging Committee invited leaders in the profession of nursing and a nursing home reform advocate to discuss this issue and how it could be affected by the aging of America’s population. As baby boomers move into retirement, the panelists said, over-medication of dementia patients is a growing issue. In fact, Dr. Patricia Grady of the National Institute of Nursing Research said people in her field felt “we’re headed in a very fast train toward the end of a cliff.”

Panelists agreed that dementia patients are at risk of over-medication because they can be verbally or physically difficult. These patients can’t express themselves clearly, however, which raises the risk of unnecessary medication. Christine Kovach, a professor of nursing at the University of Wisconsin at Milwaukee, talked about one patient who was given antipsychotics after she started resisting staff members who tried to move her. Almost four weeks later, staff members X-rayed the patient and discovered that her hip was broken. Patricia McGinnis, executive director of California Advocates for Nursing Home Reform, said her own mother had been given the powerful psychiatric medication Risperdal after being placed in a nursing home for the temporary care of a broken hip. Not only did her mother not need it, McGinnis said, but the home didn’t contact any her or any of her siblings for informed consent. She suggested several non-medication ways to address dementia patients’ behavior problems, including understanding the patient’s past and personality and ensuring that they consistently have the same caregivers.

The article quotes outside medical experts who claim the overuse of psychiatric medication is not a serious problem. As a Pennsylvania nursing home abuse lawyer, I suspect neither of the people quoted are familiar with actual practices at nursing homes. While dementia patients can genuinely have psychotic symptoms, many homes start patients on antipsychotics as soon as they enter the home, or as soon as they show any sign of making staff members’ jobs more difficult. Because antipsychotics are powerful drugs that change patients’ brain chemistry, this is not just a waste. It can actually pose a risk to the patient, from drug interactions or serious side effects like diabetes and tardive dyskinesia. When this is done for the convenience of the staff, it’s a form of Pennsylvania nursing home abuse that patients and families should not permit.
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As a Philadelphia injury lawyer, I was interested to see that a nursing home in Luzerne County has kept its Medicare and Medicaid eligibility after an inspection showed improvements. The Standard Speaker of Hazelton reported Nov. 17 that Mountain City Nursing and Rehabilitation Center in Hazle Township will not lose its Medicare and Medicaid payments, thanks to a Nov. 15 inspection that showed improvements over an Oct. 13 inspection and survey. The inspections were undertaken by the Pennsylvania Department of Health, which collects information on behalf of the federal Medicare program as well as state-administered Medicaid. Losing eligibility for the two programs would likely have been a serious financial blow for Mountain City, as well as a vote of no confidence by federal regulators.

According to the article, Department of Health inspectors found four deficiencies at the home during the Oct. 13 inspection and survey. Unfortunately, the article did not specify what those deficiencies were. However, they were apparently enough to violate Medicare and Medicaid guidelines. If allowed to continue, those violations could have eliminated Mountain City’s eligibility to receive Medicare and Medicaid funding. The Nov. 15 reinspection found the deficiencies had been fixed. A spokesperson for the home’s parent company declined to comment on the deficiencies, but Department of Health records for Mountain City show problems with overuse of psychiatric medication to control unpleasant behavior. Drugs alleged to be used incorrectly include the powerful benzodiazepine drug Ativan and the antipsychotics Abilify, Haldol and Risperdal. State inspectors said the maximum dosage of the Haldol had been exceeded without any documented reason why that was necessary.

Overuse and misuse of medication is an ongoing issue in nursing homes, and one that I take seriously as a Philadelphia medical malpractice lawyer. Psychiatric drugs are powerful, and they have been known to injure or even kill people when overused. There are also potential addiction issues with certain drugs, including the family of drugs to which Ativan belongs. And particularly with newer drugs that are less well tested, there can be safety issues even with normal use, never mind overdoses. Risperdal, for example, is connected with an increased risk of diabetes, and most of the drugs named above can trigger a rare but serious neurological disorder. Given these risks, they should only be used when necessary — and they should never be overprescribed or used off-label in situations where they are not well tested. Using psychiatric drugs to sedate difficult patients for staff members’ convenience is absolutely a form of Pennsylvania nursing home abuse that families should not tolerate.
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As Pennsylvania nursing home abuse attorneys, we are keenly aware of the dangers of overmedicating nursing home patients and we are pleased to see pharmaceutical providers and nursing home companies held accountable for it. As we noted just over a month ago, federal regulators have pursued several companies over a kickbacks scandal involving nursing home medications.

McKnight’s Long Term Care News reported on March 2 that two large, Atlanta-based nursing home companies, Sava Senior Care, which operates two Pennsylvania nursing homes, and Mariner Health Care Inc., have agreed to pay a $14 million settlement for participating in some of the same pharmacy kickbacks that recently cost Omnicare $98 million in penalties. According to the U.S. Department of Justice, Omnicare, the nation’s largest specialized provider of pharmaceuticals to nursing home patients, took kickbacks for encouraging doctors to prescribe Risperdal, an anti-psychotic drug, to nursing home patients.

Commenting on the Omnicare settlement announced in November 2009, Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, pointed out that “Illegal conduct like this can… lead to patients being prescribed medications they do not need” and that such kickbacks put profits ahead of good medicine. As Philadelphia nursing home negligence attorneys, we are here to represent the victims of profit-seeking schemes such as this. Over-prescribing medication for nursing home patients costs them and their families money as well as potentially harming them physically, when many of them are already suffering from weakened health. Unnecessary side effects and interactions with other drugs are bad enough, but these patients’ dignity as human beings also suffers when they are overmedicated for the sake of nursing homes’ profits and convenience.
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