Good Medical Care for the Elderly and How to Get It

The "Beers Criteria": Dangerous Drugs for the Elderly

It has been quite a long time since I have posted to this blog. It's difficult to believe that my mother passed away almost thirteen years ago. The cause of her death was, quite simply this: all of the medications she was prescribed accumulated in her body because she was dehydrated. Then her kidneys malfunctioned. As a result, she became toxic. Put another way, she was poisoned and died. During the course of my research to find out what had caused her death, I became very familiar with the work of Dr. Mark Beers, then the editor of the Merck Manual and the Merck Geriatric Manual.

FDA Warns About Unapproved Nitroglycerin Tablets

Patients who take nitroglycerin tablets may ask whether they are receiving an unapproved brand subject to recent FDA action, as reported in the New York Times on Friday. The FDA sent warning letters to two major manufacturers of unapproved nitroglycerin: Konec, Inc. and Glenmark Generics, Inc. The drugs are not being recalled; the manufacturers have 180 days to stop shipments.

According to the article, some manufacturers previously argued that they didn't need approval because nitroglycerin was available before the FDA was formed. The FDA says the drugs need prior approval and that some unapproved versions have "significant quality and efficacy problems." Only Pfizer has FDA approval to market nitroglycerin tablets.

Antipsychotics prescribed to elderly | Adverse event

Today, the Archives of Internal Medicine published a "retrospective cohort study" in which is is reported that the short-term use of antipsychotic therapy in older people with dementia is often followed by adverse events leading to hospitalization or death.

Shortly after my mother died in November 2000, I filed a report with the FDA's Med Watch --a reporting system for adverse medication reactions causing death and other serious complications. I told the FDA that risperidone, an atypical antipsychotic, prescribed for my mother when she was delirious was a likely contributing factor in her death. What did MedWatch do with this report?

Heparin contamination

If you or one of your loved ones takes heparin, a blood-thinner often prescribed for patients with heart conditions, you should be watchful for the following symptoms:

• difficulty breathing
• nausea
• vomiting
• excessive sweating and
• rapidly falling blood pressure

Avoiding an inappropriate psychiatric hospitalization

Recently, a caregiver complained that a hospital would not allow her to elect a transfer to a psychiatric unit for her parent suffering from dementia. The hospital’s position was that the health care power of attorney did not allow the patient advocate to make a psychiatric admission. They said that only the patient could make that choice. The patient was described as being “delusional.” What seemed probable was that this patient was delirious, not psychotic. If that were the case, then a psychiatric admission would potentially be very harmful to the patient.

Avoiding an inappropriate psychiatric hospitalization for an elderly person can be life-saving for that patient.

Commonly prescribed drugs cause most adverse drug events in elders

When I began my research to learn what had caused the death of my mother only 65 days after she had been diagnosed with a simple urinary tract infection, one of my first goals was to learn whether an antipsychotic medication that had been prescribed for her could possibly be linked to her death. I learned that this drug was frequently used in nursing homes to control “behavior problems,” that the drug was intended for use with schizophrenics and that use in the elderly was “off-label” – meaning that the FDA had not approved the drug for that use.

I also learned that research linked use of antipsychotics in the elderly with unacceptable risk of harm to the elderly. In fact, the FDA has since issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., “off-label”) use of certain drugs called “atypical antipsychotic drugs.” No research has demonstrated that antipsychotics are effective in “treating” behavioral problems in the elderly. The side effects of antipsychotics make them particularly dangerous to the elderly. These side effects include anorexia, drowsiness, dizziness, and dangerous “extrapyramidal side effects” such as dystonia (Involuntary movements and prolonged muscle contraction resulting in twisting body motions, tremor, and abnormal posture), Parkinsonism (motor stiffness, difficulty initiating movements, shuffling, stiff gait, resting tremors, and reduced facial movements), and others. EPSs can be life-threatening.

Merck announces plans for new Vioxx-like drug

The Boston Globe reported on March 30, 2007 that Merck is scheduled to appear before the FDA to seek approval for a new painkiller “that is just like Vioxx,” the drug Merck was forced with withdraw from the market in 2004 when research proved that it increased the risk of heart attacks substantially. Just so you know, the new drug is called Arcoxia. While some analysts doubt that the FDA will approve the drug, others are skeptical about the FDA. Legislation is pending that seeks to avoid another Vioxx mess by limiting the type of advertising that can be done with new drugs and to limit the number of doctors who can prescribe them when safety concerns arise after the FDA has already approved a drug.

You can read the entire Globe article here.

Technorati tags: Merck, vioxx, fda, drug safety

Medication errors occur frequently with surgery

The Washington Post reported on March 6, 2007 that patients having surgery face a significant risk of medical error involving medication, citing a report prepared by U.S. Pharmacopeia, a private group that sets standards for the drug industry.

The report was based on data from more than 400 hospitals. Statistics were collected about medication errors occurring between 1998 and 2005 during outpatient surgery, in preparation for surgery, in the operating room and in recovery.

According to the Post, a total of 11,239 errors were reported, including giving the wrong drug or the wrong dose, or giving it at the wrong time. Five percent of the mistakes caused harm, making surgery one of the most dangerous times for medication mistakes.

The entire article may be read here.

Vioxx -- What did Merck know, when did Merck know it . . .

On February 18, 2007, the Boston Globe printed an Op-ed piece by Dr. Jerry Avorn. Dr. Avorn teaches at Harvard Medical School and Brigham and Women's Hospital in Boston. He is a leading expert on the topic of safe use of medications in the elderly. He’s also the author of "Powerful Medicines: the Benefits, Risks, and Costs of Prescription Drugs." [Available at local book stores]

Dr. Avorn recently testified pro bono on behalf of the plaintiffs in a class action suit against Merck & Co. in what is, for Merck, “a multi billion-dollar bet.” Merck is awaiting a jury verdict that will decide two important questions—questions that are part of what is called a “special verdict form.” Special verdict forms require the jury to make written findings on issues of fact and nothing more. The jury in Atlantic City is asked to decide whether Merck knew that its blockbuster Vioxx could cause heart attacks, but then minimized that risk in the information it gave to doctors and patients. The jury’s decision on these issues help to prevent future drug disasters.

According to Dr. Avorn, the judge will first ask the jury to decide these factual questions:

Amgen discloses risks in 'off-label' use

The New York Times reported on January 25, 2007 that Amgen, the manufacturer of the anti-anemia drug Aranesp, has acknowledged an increased risk of death when this drug is used to treat certain cancer patients. Aranesp, Epogen (also from Amgen), and Procrit (from Johnson & Johnson) are three anti-anemia drugs that have been used for what are called “off label” purposes. “Off-label” purpose means a use not approved by the FDA.

Recently an Amgen executive vice president estimated that about 10 percent to 12 percent of Aranesp sales are used for “anemia of cancer.”

Amgen’s disclosure related to recent clinical trials involving Aranesp. Amgen’s stated goal in these trials was to see whether Aranesp could reduce the need for blood transfusions to treat anemia caused by certain cancers.

Amgen now says that the company found that the drug did not reduce the need for transfusions compared with a placebo, but did increase the number of deaths by the end of 16 weeks by a statistically significant amount. While Amgen did not provide any numerical results from the trial, the company said in a news release that in this particular population the “risk/benefit ratio for Aranesp use is at best neutral and perhaps negative.”

According to today’s New York Times article, the sale of anti-anemia drugs is a $10 billion business for the drug companies. The drugs are marketed globally; about one million American patients receive prescriptions for this class of drug every year.

Earlier this fall, I wrote about the risks posed to dialysis patients when Epogen, Amgen’s other anti-anemia drug, was overused by dialysis patients. Responding to current research reports, I wrote that most dialysis clinics administer the anti-anemia drugs intravenously rather than by injection. As a result, each patient gets about one-third more drug than the patient would need if he/she received the drug by injection.

After the Epogen/dialysis story broke, on November 30, 2006, the New York Times reported that an expert panel of doctors for the National Kidney Foundation plans to study whether the intravenous administration of the anti-anemia drugs to hundreds of thousands of patients with kidney disease is subjecting the patients to unnecessary threat of harm. The purpose of the study is to determine whether to change guidelines for how patients should be treated.

You can read the entire New York Times article, here.