"Nursing home used outdated consent forms in Risperdal case"
The Lakeland Times
A look at state’s inquiry of Taylor Park
5/12/2009 3:03:00 PM
Richard Moore |
When 71-year-old Bruce Bowman died in June 2008 with MRSA pneumonia, the Rhinelander resident was exhibiting the classic symptoms of the side effects of risperidone, an atypical antipsychotic drug he had been periodically treated with since December 2007.
He had suffered a severe dystonic reaction. He could not swallow. He coughed and choked on food. He engaged in tongue pumping, which is an involuntary movement caused by the drug. His upper body became rigid in a profound and pronounced way.
All of those conditions are the signature manifestations of an adverse reaction to an atypical antipsychotic. That was true, too, of Bowman's pneumonia, so much an indication of the drug's side effects in elderly patients that the federal government issued a black-box warning about it in April 2005.
"Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo," the 2005 FDA warning stated. "Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Risperidone is not approved for the treatment of patients with dementia-related psychosis."
But, says Bowman's daughter, Lisa MaKarrall, she and her family never received that warning when Taylor Park Nursing Home in Rhinelander, where Bowman had resided since November 2007, put him on the medication.
Neither did they receive a 2003 FDA warning that Risperdal could increase risks for diabetes and stroke, nor, for that matter, she says, did they receive any other warning of Risperdal's potentially fatal risks when the facility asked the family for permission to use the drug to treat aggression.
For example, the Informed Consent for Medication form signed by Bowman's son, Martin, on Dec. 12, 2007 - the first day risperidone was prescribed for Bowman - never mentions any black-box warning or increased risk of death among the elderly associated with the drug.
Indeed, the form states, the side effects include stomach pain and gas, difficulty swallowing, trembling hands, muscle spasms and other non-lethal conditions. Rarely, the form states, a patient might develop tardive dyskinesia (lip smacking, puckering and other involuntary movements).
No risk of death appears anywhere on the document. The only serious warning was that the medication could be "very dangerous" if taken in "large doses."
The form, though, was severely out of date, having been fashioned by the state Department of Health and Family Services in May 2003, almost two years before the FDA issued its black-box warning.
Indeed, MaKarrall says, it was only by accident the family ever found out about the negative consequences of taking Risperdal.
That happened when MaKarrall's mother - and Bowman's former wife - happened to hear he was taking the medication. She knew about it, having worked in the mental health field.
"In early April, my mom goes to the Taylor Park administrator and meets with her and the head nurse," MaKarrall says in describing a timeline of events. "She voices her concern over my dad's care and relays what we have told her. She also questions the use of Risperdal since she knows this is a drug given to schizophrenics and bi-polar patients. My mother has a medical background and worked with the mentally ill for 16 years."
Still, MaKarrall said, the family remained unaware of the black box warning until they researched the drug in late May after Bowman sustained a severe dystonic reaction on May 29.
"Called my mom that night after she finished work and told her what had happened and she knew it was from the Risperdal," MaKarrall relates. "She could not find her medication book so called the psych ward and was given a name of a drug to be given to counteract the side effects. The psych nurse also stated that what was described was from Risperdal and that they do not administer it to elderly patients since they don't tolerate it well. My mother relayed this to me, whereupon I called the RN in charge at Taylor Park on my dad's wing. I told (him) not to give my dad any more."
However, by May 29, it was way too late. Bowman was battling not only his acute dystonia but pneumonia, from which he would not recover. MaKarrall says she wished she had researched the issue earlier, but she blamed Taylor Park for using outdated medical consent forms.
"Did anyone ever check on the medication consent forms being current?" she asks. "Why wouldn't any medical facility be required to make sure those forms were updated. I mean, why would there even be a question? No other profession that was responsible for other peoples' lives could keep using outdated information. I have certainly had to update policy and procedure manuals, often on a weekly or daily basis, in the positions I have held over the years."
After Bowman died, MaKarrall filed a complaint with the state on June 27 against Taylor Park, but, when she did, she ran into another surprise: Nursing homes aren't required to use the state's informed medical consent forms.
"The laws for nursing homes are not prescriptive to what form must or must not be used to communicate this information (the dosage, the drug being used, side effects)," wrote Paul Peshek, the director of the state's Bureau of Nursing Home Resident Care, in his reply to MaKarrall's complaint. "They state that it must be reviewed and documented. Again, it states that it is reviewed and approved by the legal decision maker, and this requirement was met."
In other words, according to Peshek, conveying information about a drug's side effects that is inaccurate by omission is legal so long as the drug's name and the prescribed dosage is transmitted and the legal decision maker signs off on the prescription.
The DHS investigation
The bottom line was, DHS cleared Taylor Park of any malfeasance, both in a preliminary review and in a secondary review completed by Peshek in October 2008.
In an Oct. 28, 2008, letter to MaKarrall, Peshek observed that, while a black-box warning existed for Risperdal, doctors could still prescribe it.
"The prescriber must balance the benefits that are obtained by using the medication with the side effects that some individuals are known to have experienced," he wrote. "When your father was off of Risperdal, his physical aggression increased; for his safety and quality of life, and for the safety of others, the physician restarted your father on Risperdal. . . . . Review of your father's medical record found that the facility appropriately monitored him for side effects of the medication and tried several non-pharmacological interventions to diminish the behaviors being exhibited."
In fact, however, the nursing home's own documents, obtained later by MaKarrall, substantially contradict those findings.
For one thing, Bowman was initially started on Risperdal after he was thought to have kicked his roommate. In fact, an internal nursing home investigation found that Bowman had already been placed on Risperdal for non-physical aggression, and it was believed the kicking was an involuntary side effect of the risperidone.
In other words, the original rationale for prescribing the drug, and cited authoritatively by Peshek, seems not to have existed at the time. Yet the risperidone flowed on.
As for the non-pharmacological interventions, nursing home staff had employed those interventions simultaneously with the use of Risperdal, itself a violation of nursing home guidelines, which call for environmental solutions to be exhausted before trying the drugs.
Risperdal and other atypicals are supposed to be drugs of last resort, in other words, not of first resort.
The guidelines call for a facility to first identify or rule out environmental or psychosocial stressors, to try medical or environmental solutions, and, if those fail, to give the drug - but only if it is needed to maintain functionality. A February 2005 newsletter of the Wisconsin Association of Medical Directors, an association of nursing home directors, laid out those guidelines explicitly.
While it is true, as Peshek stated, that Bowman's aggression increased when the risperidone was stopped, it is also true that nursing home staff had returned Bowman to the two environments that had caused his aggression in the first place: a loud and noisy dining room, and to a loud and noisy roommate, according to the family.
Nurses' notes clearly indicate that Bowman's aggression subsided when he was moved to a private room and to a smaller quieter dining lounge. Yet he was returned to the original room "to be closer to the Nurses station" and inexplicably to the large dining room.
So, while Peshek's investigation emphasizes the facility's attempt to try nonpharmacological intervention, it omits both that the drug was administered before the failure of such efforts and that the efforts themselves were indeed deemed successful, only to be abandoned
What wasn't abandoned was Risperdal, and Peshek's investigation absolutely misstates the reason why it wasn't.
In the Oct. 28 letter, Peshek cites Bowman's physical aggression when not on risperidone, as well as a threat to the safety of himself and others. The records contradict that, too, on several levels.
First, in January 2008, Bowman's agitation had subsided, and so his dosage should have been appropriately reduced, as Peshek maintains the nursing home did.
The actual records tell a different story. Nursing home staff actually increased the dosage, admittedly using the drug to target his restlessness, which is not allowed under the guidelines. That 2005 newsletter of the Wisconsin Association of Medical Directors specifically cautioned that some behaviors, including restlessness, were "inappropriate target behaviors" for antipsychotic treatment.
That didn't stop the staff at Taylor Park, but Peshek did not question it in his probe.
"His physical aggression has not recurred, but he has daily marked restlessness and yelling that respond variably to meeting his needs and redirection," nurse practitioner Pam Thul-Immler wrote in her consultation report Jan. 15.
She recommended ramping up the dosage even more. The physician order sheet for that day shows an increase to .5 BID.
"Advance risperidone to .25 mg tid (from bid)," she wrote in the recommendations section of the report, meaning to three times a day. "In 1 week, if still restless and no significant orthastosis may increase risperidone to .5 bid."
Far from effectively using risperidone to control Bowman's aggressiveness, by Jan. 29, the medication was not working to control what outbursts he did have, according to Thul-Immler's January records. And in the lone instance when risperidone was restarted due to physical aggression - in May after it was stopped in late April - the physical aggression continued even with Risperdal.
Finally, Peshek's investigation misstates the doctor's own acknowledgment of Risperdal's role in Bowman's deterioration.
"I am aware that your father did have a change of condition in May 2008 when he displayed increased rigidity and hyperextension of the neck," Peshek wrote. "The nursing home responded appropriately to the change. This change was considered to be a progression of your father's illness and his underlying diagnosis of Machiafava Bignami, which was ultimately listed as the cause of his death. There is no evidence that it occurred because of misuse of Risperdal."
But in fact there was evidence of Risperdal's role.
On May 30, Dr. John Frost ordered all risperidone stopped and Bowman's primary care team acknowledged the drug's probable role, along with the underlying diagnosis, in Bowman's deteriorating situation.
"Mr. Bowman has developed an acute dystonia, likely multi-factorial - underlying disease and sensitivity to dopamine blockade of risperidone," Thul-Immler wrote of the team's May 30 assessment.
Peshek concluded his letter by attaching a link to an Alzheimer's Association Internet message board, where positive messages have been relayed about the use of the drug.
"What I am trying to communicate with this information is that different families and patients have different experiences with different drugs," he wrote. "You may want to share your experiences."
In fact, the Alzheimer's Association has come under fire as a non-profit organization with close ties to the pharmaceutical industry. It has received funding from Pfizer, Inc., Eli Lilly & Company, and Janssen Pharmaceutica, the makers of Risperdal, according to the group Integrity in Science.
In the end, MaKarrall, said, she considered the DHS investigation a whitewash.
"This is part of what eggs me on," she said. "It's just common sense. They take the most ridiculous things and send them to you and you're to take that for an answer."
The state's role
If the state seemed to go out of its way to absolve Taylor Park of any wrongdoing, one reason might be that DHS itself was not blameless in the incident.
MaKarrall has raised the issue of when the state updated its own medical forms. The DHS makes consent forms available on its website for use by state-run facilities but also for private institutions, and many nursing homes simply download the state's forms to use as their own consent form and guide to side effects
In this case the updated medical consent for Risperdal was posted on the state's website with a July 2008 date - meaning it was posted after MaKarrall filed her complaint about the nursing home. The use of an outdated consent form was part of that complaint.
The new state consent form for Risperdal indicates that new side effect information was inserted in May 2008.
The question is, what was updated?
Certainly the forms now carried the federal black-box warning, and the section on emergency side effects was expanded, but all of that information had been available for years.
In fact, the federal black box warning was issued in 2005, all of which means, MaKarrall says, the state failed to properly update its own form for three years after the black-box warning.
What MaKarrall wants
Her father's death and its link to risperidone - not to mention her frustration with state officials who decline to question the drug or the actions of individuals on the local level - have transformed MaKarrall into an advocate and an activist.
Her most urgent goal is to let people know about the dangers of atypical antipsychotics such as Risperdal and to pass reform legislation that will require nursing homes to both convey to families accurate information on medical consent forms and give training for nursing home staff.
In the latter effort, she has been working with state Rep. Dan Meyer's (R-Eagle River) office to develop legislation.
"No one is trained to even recognize the side effects," MaKarrall says. "They were handing this out like candy and no one knew what to look for."
Up-to-date and mandated consent forms are also critical, MaKarrall says.
"Look at the difference between the two consent forms," she said of the 2003 and 2008 DHS versions. "There are probably a gazillion other families who have signed the same thing, especially in the last three years. And if they are going to have consent forms, they need to be updated and they need to be reading this to people."
Meyer's aide, Jennifer Western, said last week a bill was in the drafting stage and would be ready soon.
"The legislation would ensure that nursing home residents who have degenerative brain disorders who are prescribed an antipsychotic with a black box warning are presented with a written informed consent form, or their legal guardians would be," Western said.
Western said she was unsure if the DHS form had also been outdated, but she believed the agency had acknowledged it was. In any event, it too should be required to post accurate information, she said.
"In the interest that people are getting up-to-date information, the form should be required and DHS should be required to have up-to-date forms on their website," Western said.
She said Meyer's goal in proposing legislation was to promote the ability of consumers to make wise choices.
"Dan's purpose is to make sure that the patients and the guardians have the information to make an informed choice," Western said. "Because in some cases, knowing the risks, that might be a choice they are going to take for one reason or another. It's not always the case that it (the drug) has the bad effects, and sometimes it can be helpful, especially if someone is a threat to another."
For her part, MaKarrall, too, wants more people to be cognizant of what is going on in nursing homes.
"I want people to be more aware of the fact that they have to make sure that everything they are taking is updated," she said. "They need to know what the side effects are, and they should be checking into their people's files more than they are. It wouldn't hurt people to go through all the files and not just listen to what other people are telling them. People have to be more aggressive and make sure of what they are getting."
As for Risperdal, she said, it's just a different kind of straightjacket.
"They outlawed actually strapping the residents down," she said. "Well, they just changed strapping them down for drugging them. They just reversed it. They just substituted the drugging for the physical straps."