Posts Tagged ‘drug-safety’

Grassley Investigates Drugging of Elderly with Antipsychotics

Wednesday, June 1st, 2011

DesMoines Register
May 31, 2011

Sen. Charles Grassley recently sent a letter to the administrator of the U.S. Centers for Medicare and Medicaid Services. He wants some answers after a federal report Grassley requested found many nursing home residents with dementia are given antipsychotic drugs. These drugs are not approved to treat dementia. They can be lethal for those afflicted with it, and Medicare has been paying for them.

Grassley is right to ask questions of the agency. But keeping seniors safe is a responsibility that extends far beyond CMS — from the halls of Congress to state legislatures to nursing home workers in rural Iowa.

Washington

Politicians talk out of both sides of their mouths. They say they want to cut federal spending. They say there should be less government regulation. Then when something goes wrong, they demand federal agencies solve the problems or they take them to task for not doing what they were supposed to do.

Drug safety, nursing home oversight, and ferreting out problems in government programs like Medicare requires staff and resources. That takes money – some of the same money lawmakers propose cutting from the federal budget.

State legislatures

The “cut government but still expect it to keep everyone safe” attitude is prevalent at the state level, too. Shortly after Gov. Terry Branstad took office, one of his appointees cut positions for nursing home inspectors. It underscored a lack of understanding about the important and complicated work of making sure homes meet more than 150 regulatory standards.

In addition to observing care, talking to staff, interviewing residents and other tasks, an inspection team reviews medical records. It is frequently a registered nurse employed by the state who finds problems with medications. Having too few state inspectors puts seniors at risk.

Nursing homes and staff

Improving the quality of life for patients with dementia is difficult — and there are too few drugs approved specifically to do so. Even if doctors are aware of the risks, they may prescribe specific drugs to make patients more comfortable or less agitated. Also, drug companies benefit when more people take their drugs, and they want doctors to prescribe their drugs to, well, as many people as possible. In fact, several drug companies have faced criminal charges for promoting antipsychotic drugs for unapproved uses.

It’s up to nursing home staff and physicians to ensure that drugs prescribed are safe for specific patients.

* * *

Every day about 10,000 Americans become eligible for Medicare. An aging population means more people will be diagnosed with dementia. More will need care in facilities. Everyone — from doctors prescribing drugs to the government paying for them — must do more to keep older people safe.

Read article here:  http://www.desmoinesregister.com/article/20110601/OPINION03/106010328/-1/GETPUBLISHED03wp-rss2.php/More-need-help-protect-our-elderly

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AstraZeneca, UKs 2nd biggest drug maker, said to pay $55 million to settle about 5,500 lawsuits over antipsychotic drug

Wednesday, August 4th, 2010

Bloomberg News
By Jef Feeley and Phil Milford
August 4, 2010

AstraZeneca Plc, the U.K.’s second- biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel, people familiar with the accords said.

The settlements, with an average payout of about $10,000 per case, resulted from mediation involving 26,000 suits filed over Seroquel, the people said. The London-based company previously agreed to pay $2 million to resolve more than 200 allegations that Seroquel causes diabetes in some users, people familiar with those accords said last month.

“It implies that the overall exposure is very low” for AstraZeneca, Navid Malik, an analyst at Matrix Corporate Capital in London, said today in an interview. “$10,000 per patient doesn’t seem high” to settle drug-safety suits.

AstraZeneca is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium in the next four years. Seroquel, the company’s second- biggest seller after Nexium, generated sales of $4.87 billion last year, or 15 percent of AstraZeneca’s total revenue.

The 5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing, the people said. The company hasn’t disclosed terms of the accords and wouldn’t comment on them yesterday. The settlements stemmed from mediation ordered by the judge in Orlando, Florida, who was overseeing all federal-court litigation over the drug.

Read entire article here:  http://www.businessweek.com/news/2010-08-04/astrazeneca-said-to-pay-55-million-over-seroquel.html

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