Prescription of Megace to Nursing Home Residents Linked to Fraud and Horrific Corporate Irresponsibility

In one of the worst examples we have seen involving the abuse of the elderly, a company whose product was only approved to promote weight gain for HIV patients started to aggressively promote Megace to frail and elderly nursing home residents when the HIV population began to dwindle.  Knowing the dangerous side effects of this supplement (ie death), this represents a tragic example of profits over people.  To read more, click here.

Consumer Group Questions Risks of High Dosage of Popular Alzheimer's Drug

A recent article details a lawsuit by Public Citizen, a consumer rights and protection group, against the FDA to stop the sales of the popular Alzheimer’s drug Aricept in its highest dosage.  The group says that the FDAs testing shows that the drug benefits at that dosage are outweighed by the dangers posed.  

You can read the article here.

New Program Seeks to Reduce Anti-Psychotic Overuse in the Elderly with Dementia

A recent article details a new program launched by the Centers for Medicare and Medicaid Services (CMS) called the “Partnership to Improve Dementia Care in Nursing Homes” in order to address the problem of over medication of the elderly suffering from dementia in long term care.
 
The program seeks to reduce the use of antipsychotic drugs for nursing home residents by 15% by the end of this year.  A laudable goal given that a CMS study conducted in 2010 found that 17% of nursing home residents received daily anti-psychotic drugs exceeding recommended levels.
  
You can read the article here.
 

New Study Shows Many People Unknowingly Receiving Medications For "Off Label" Uses

Ask any family member caring for an elderly parent with dementia about the number of medications prescribed and it’s likely to be quite a few.  It is important to know what someone is prescribed and what for.  A new study shows that roughly 20% of medications are prescribed “off label”. You can read an article discussing the study here.

“Off label” refers to prescribing medications for uses other than what the FDA has approved a drug for.  Despite what the FDA approves a specific drug to treat, doctors may prescribe drugs for anything – approved or not.  This practice is obviously not a problem per se, however, it might be more difficult for a consumer to learn about a drug’s pros and cons if it is being prescribed “off label”. 

It is important to discuss medications with a doctor.  Learn what risks, if any, a drug’s use entails. 
 

New Law Proposed to Curb Off-Label Use of Antipsychotic Drugs

Despite the fact that antipsychotic drugs are approved by the FDA for specific uses, these drugs really may be prescribed for anything. When a drug is prescribed for something it is not approved or labeled for, this is called “off-label” use. 

Off-label use of anti-psychotics among the elderly is not uncommon. These medications are prescribed to residents who may suffer from Alzheimer’s or dementia, but who do not suffer from psychosis. This is concerning because several antipsychotics frequently prescribed “off-label” can have significant side effects for the elderly, including death. In fact, some of these drugs have received “black box” warning from the FDA – the most severe warning that can be given.

Always of concern to us is when medications are given solely for the convenience of the nursing home. In these cases, medications are given simply to make residents quiet and immobile. You see this in cases where staffing is cut to minimum levels and there are not enough people to adequately supervise the resident population.   

A new law has been proposed in an attempt to curb off-label use of powerful antipsychotics. The new law “will require the Health and Human Services Secretary to issue standardized protocols for obtaining informed consent, or authorization from patients or their designated health care agents or legal representatives, acknowledging possible risks and side effects associated with the antipsychotic, as well as alternative treatment options, before administering the drug for off-label use.” 

You can read the full article here, which includes a link to the amendment.

Triad Tangles with FDA on Recall

Earlier this year, I reported about the potential dangers posed to senior citizens (and others) who were potentially exposed to bacteria from antiseptic wipes. Reports indicate that a child may have died from such exposure and we are aware of seniors who appear to have potentially met the same fate.  Now, Federal regulators say that although Professional Disposables International (PDI) of Orangeburg, New York promised to recall the product this past June, it has since failed to launch that recall nearly four months later.

 

The U.S. Food and Drug Administration issued a second statement last Wednesday saying the agency was not backing down on its assertion that PDI failed to follow through on its promise to conduct a recall in June. A follow up story from the Journal Sentinel Online addresses some of the recent developments in the enforcement action.
 

Hopeful Report Indicates Reduction of Anti-Psychotic Medications in the Elderly

Many times I’ve written about the over-medication of the elderly – especially with anti-psychotics. Despite the fact that anti-psychotics are supposedly only for a small percentage of the elderly, many nursing home residents with dementia are given these drugs even though some have FDA warnings of an increased risk of death.  This overuse of anti-psychotics was confirmed in a recent government audit.

 

It appears that the message is finally being heard.  A recent article reports that nursing homes are beginning to reduce the use of anti-psychotic drugs. This is a positive development. Instead of chemically controlling people, nursing homes are beginning to use alternative methods to treat Alzheimer’s and dementia. These therapies are in many cases reported to be more effective.

 

Chemically controlling residents for the sake of convenience or punishment is illegal in New Jersey.  Knowing what medications a resident is taking is important. 

Anti-Psychotics Continue to be Administered to the Elderly for Parkinson's Disease Despite Known Dangers

According to The Wall Street Journal, new study published in Archives of Neurology, “showed that about half of elderly Parkinson's patients with psychosis were prescribed an antipsychotic.”  This is despite the fact that in 2005, the FDA issued a “black box” warning to antipsychotics due to an increase in risk of death in older dementia patients.  “Black box” warnings are the strongest warnings given by the FDA and are placed on drugs where medical studies indicate that a drug carries a significant risk of serious or life threatening adverse effects.

You can read the entire article here. Additionally, in some instances, side effects of some anti-psychotics actually worsen the shaking and stiffness that comes with Parkinson’s.  

According to New Jersey law, using medications for the convenience of the staff or in quantities that interfere with a resident’s normal living conditions is illegal. This is why knowing a resident’s medication regimen is important.  All medications a resident takes are located in the records and are available for review. 

Johnson & Johnson Investigated for Potential Illegal Promotion of Risperdol

It has been reported in Forbes Magazine that Johnson & Johnson has set funds aside for potential litigation relating to a probe which addresses whether or not the drug company engaged in illegal practices to promote this drug in nursing homes. Sadly, its use or over-use can be lethal for the elderly and vulnerable residents in nursing homes.


 
 

Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination

The Triad Group has initiated a voluntary recall for several of their products, including alcohol prep pads, alcohol swabs and alcohol swabsticks. The recall includes sterile and non-sterile products produced by Triad Group and was initiated due to concerns from a customer about potential contamination. The products are thought to contain an objectionable organism, Bacillus cereus. The Triad Group is issuing the recall in order to ensure that they are not the source of the contamination issues.

 

If consumers use the contaminated products, it could lead to life-threatening infections, especially in immune suppressed and surgical patients. To date, there have only been reports of a non-life-threatening skin infection.

 

The affected products were packaged by Triad Group, and third party companies including: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS and Conzellin. These products were distributed in the United States, Canada and Europe.
 

New Study Links Psychotropic Drugs to Increased Risk of Injuries and Death

Although psychotropic drugs are often used to control behavioral symptoms in nursing-home residents, recent data points out that these drugs are given to close to 2/3 of the dementia patients currently residing in nursing homes across the country and have devastating effects. The data states that prolonged use of these drugs leads to a greater risk of adverse effects and even death.
 
Patients who are treated with conventional antipsychotics increased the risk of death by 47% and increased the risk of suffering from a femur fracture by more than 61%. Additionally, other drugs, such as benzodiazepines, were associated with a 54% increase in the risk of heart failure, and patients who regularly took antidepressants had a 20%-30% increase in the risk of death.

You can find additional information on this study online here.

Drugs and Medication Use in the Nursing Home

People with a loved one in a nursing home often become drug experts.  Drugs such as Risperdal, Ativan, and Zyprexa are frequently used in nursing homes, and not always for the right reasons. 

Even though it is not allowed under Federal law or the New Jersey Responsibilities of Nursing Homes Statute, N.J.S.A. 30:13-3(f), nursing homes may use psychotropic drugs as “chemical restraints” simply to save time, make residents compliant, and for convenience of the staff.  This can be especially true in understaffed facilities. 

There are numerous risks involved with this practice, including drug dependency and side effects, not to mention the immorality of the practice. 

However, it does not have to be this way.  There are nursing homes where the owners and administrators have been moving to reduce the use of drugs in their facilities.  Here is a New York Times article discussing this problem and some alternative therapies getting excellent results - such as exercise, activities, music, massage, and aromatherapy.

One nursing home, “eliminated anything considered potentially restraining, from deep-seated wheelchairs that hinder standing up to bedrails (some beds are lowered and protected by mats). It drastically reduced the need for antipsychotics and medications considered primarily for ‘staff convenience,’ focusing on relieving pain.”  You can find an enlightening and inspiring discussion about this home online here

This same nursing home, which looks “outdated” and “institutional,” is actually a top rated five-star facility.  This facility reported that fewer medications and restrictions, along with alternative therapies and caring staff in adequate numbers produced great outcomes with residents suffering from Alzheimer’s and dementia. 

Sterling Manor Staff Member Accused of Selling Drugs

Theresa Walters, of Pennsauken, New Jersey, has been charged with conspiracy, distribution and possession of drugs and distribution in a school zone after police learned that she had been selling prescription drugs to residents at Sterling Manor Nursing Home in Maple Shade, New Jersey. Walters worked at Sterling Manor where she sold and offered to sell drugs to several people at the facility. It is not clear how many residents were offered the drugs or how many bought them. This is just another example of why it is imperative that administration of nursing homes carefully monitor their stock of drugs in order to prevent incidents like this from happening. 
 

Fosamax Attorneys Investigate Possible Claims

We wanted to inform the readers of our blog that the Mass Tort Team of Stark & Stark is now reviewing possible claims against the popular osteoporosis drug, Fosamax. Patients who used Fosamax have reported serious side effects from the drug, including Osteonecrosis of the Jaw (also known as Fossy Jaw, Dead Jaw and Phossy Jaw), low-energy femur fractures and severe and painful injuries affecting bones, joints and muscles.

If you or a loved one have suffered a severe illness or injury after taking Fosamax, you can have an experienced Mass Tort attorney from our firm review your potential case.


 

Heparin Injury Attorneys Investigating Potential Claims

Lately there has been a lot of news about contaminated batches of the blood thinning drug Heparin injuring patients.  The injury attorneys of my firm are actively investigating potential Heparin injury claims on behalf of people across the country. 

After it came to light that contaminated Heparin was causing sever allergic reactions and death in certain patients, the FDA issued a recall of the drug which was manufactured in China. 

If you or a loved one were victim of a severe allergic reaction or death after being administered Heparin you can have an experienced injury lawyer from my firm investigate your potential case.

Digitek Injury Lawyers Investigate Possilbe Claims

We wanted to inform the readers of our blog of the recent recall for the drug Digitek. Digitek was initially prescribed to treat cardiac arrhythimas and heart failure, but more recently has been known to have devastating effects for those to have taken the medication.

The recall was announced after Digitek tablets were distributed with double the amount of the approved active ingredient. Several incidents of serious injury and death in patients who have taken the drug have already been reported. Some patients have reported toxicity, nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia.

If you or a loved one have suffered a severe illness, injury or death after taking Digitek, you can have an experienced injury attorney from our firm review your potential case.

Potential Treatment for Alzheimer's Disease

Below is an extraordinarily promising article involving a potential treatment for Alzheimer's disease.  A very significant component of nursing home and Assisted Living populations includes physically healthy individuals with developing Alzheimer's. 

The drug, Enbrel - commonly used to treat arthritis, in recent tests has shown to reverse the effects of Alzheimer's Disease in just minutes. Enbrel is believed to assist those with Alzheimer's by delivering the same relief the drug offers arthritis patients. The drug, which is used to relieve the inflammation in joints of people suffering from arthritis, researchers now believe can reduce the inflammation in the brain of people suffering from Alzheimer's.

This article offer some hope for the many families and patients suffering from this devastating illness.

Pharmacy Records Play Crucial Role in Administration of Medication

Pharmacy records are critically important in the evaluation of claims involving improper administration of medication.  They also provide a means by which advocates can effectively fact check whether medications that nursing homes claim are delivered actually are.
 
Our office has uncovered many instances wherein nursing home claim to have provided medications to our clients (and billed for them) when they weren't even in the facility.  It is only though careful review of detailed records that these deeds can be uncovered.
 
Attached is an interesting article which highlights the importance of proper monitoring of pharmaceuticals for our burgeoning nursing population, which is now approximately 1.8 million.  As the needs of the geriatric population increase, so must the support that we provide.

Serum zinc and pneumonia in nursing home elderly

Simin N Meydani, Junaidah B Barnett, Gerard E Dallal, Basil C Fine, Paul F Jacques, Lynette S Leka and Davidson H Hamer

1 From the Nutritional Immunology Laboratory (SNM, JBB, LSL, and DHH), the Biostatistics Unit (GED), and the Nutritional Epidemiology Program (PJF), Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, MA; the Department of Pathology, Sackler Graduate School of Biochemical Sciences, Tufts University, Boston, MA (SNM); the Friedman School of Nutrition Science and Policy at Tufts University (SNM, JBB, GED, PFJ, and DHH); the Nutrition/Infection Unit, Department of Public Health and Family Medicine, Tufts University School of Medicine, Boston, MA (JBB); the Travel and Tropical Medicine Practice, Boston, MA (BCF); the Department of Medicine, Boston University School of Medicine, Boston, MA (DHH); and the Center for International Health and Development, Boston University School of Public Health, Boston, MA (DHH)

Background: Zinc plays an important role in immune function. The association between serum zinc and pneumonia in the elderly has not been studied.

Objective: The objective was to determine whether serum zinc concentrations in nursing home elderly are associated with the incidence and duration of pneumonia, total and duration of antibiotic use, and pneumonia-associated and all-cause mortality.

Design: This observational study was conducted in residents from 33 nursing homes in Boston, MA, who participated in a 1-y randomized, double-blind, and placebo-controlled vitamin E supplementation trial; all were given daily doses of 50% of the recommended dietary allowance of essential vitamins and minerals, including zinc. Participants with baseline (n = 578) or final (n = 420) serum zinc concentrations were categorized as having low (<70 µg/dL) or normal serum zinc concentrations. Outcome measures included the incidence and number of days with pneumonia, number of new antibiotic prescriptions, days of antibiotic use, death due to pneumonia, and all-cause mortality.

Results: Compared with subjects with low zinc concentrations, subjects with normal final serum zinc concentrations had a lower incidence of pneumonia, fewer (by almost 50%) new antibiotic prescriptions, a shorter duration of pneumonia, and fewer days of antibiotic use. Normal baseline serum zinc concentrations were associated with a reduction in all-cause mortality (P = 0.049).

Conclusion: Normal serum zinc concentrations in nursing home elderly are associated with a decreased incidence and duration of pneumonia, a decreased number of new antibiotic prescriptions, and a decrease in the days of antibiotic use. Zinc supplementation to maintain normal serum zinc concentrations in the elderly may help reduce the incidence of pneumonia and associated morbidity.

The Use of Anti-Psychotic Drugs on Alzheimer's Patients

A recent study by the National Institute of Mental Health indicated that widely prescribed anti-psychotic drugs do not help most Alzheimer’s patients with delusions and aggression and are not worth the risk of sudden death and other side effects. The study tested Zyprexa, Risperdal and Seroquel - newer drugs developed for schizophrenia that doctors are free to prescribe for any use. These drugs are commonly administered to nursing home residents. All three of the drugs carry a strong warning that they increase the risk of death for elderly people with dementia related psychotic symptoms. Yet, roughly one-quarter of nursing home patients are on these drugs. Residents are often put on these types of medications and not particularly monitored and treated for indefinite periods of time. It is strongly advised that any family member with a loved one in a nursing home speak with the loved one’s physician at the nursing home and understand the pros and cons of administering these medications.

Dementia Medication

Dementia medication has become a new concern for nursing home residents and their caretakers. A recent study by the National Institute of Mental Health indicated that widely prescribed anti-psychotic drugs do not help most Alzheimer’s patients with delusions and aggression and are not worth the risk of sudden death and other side effects. The study tested Zyprexa, Risperdal and Seroquel - newer drugs developed for schizophrenia that doctors are free to prescribe for any use. These drugs are commonly administered to nursing home residents. All three of the drugs carry a strong warning that they increase the risk of death for elderly people with dementia related psychotic symptoms. Yet, roughly one-quarter of nursing home patients are on these drugs. Residents are often put on these types of medications and not particularly monitored and treated for indefinite periods of time. It is strongly advised that any family member with a loved one in a nursing home speak with the loved one’s physician at the nursing home and understand the pros and cons of administering these medications.