Patient killed by 'massive overdose' of anti-psychotic drug after nurse 'mistakenly gave him 21 times what he needed'

From a much longer report in the MIRROR.

A patient died from a massive overdose of anti-psychotic drugs after being given 21 times the medication he needed by a nurse, a court has heard.

Joshua Gafney was handed 4,200mg of clozapine instead of just 200mg by Amanda Young after the nurse visited him at his home.

Mr Gafney, 22, was handed a glass containing six bottles of the drug by 40-year-old Young when he needed just under a teaspoon-worth, just hours before he died on February 8 2012.

Bristol Crown Court heard how the nurse claimed she "did not see" crucial labels on Mr Gafney's medication, causing her to confuse the dosage.

She mistakenly believed each 14 ml bottle contained 50 mg of the powerful drug - when in fact this figure was per millilitre meaning there were actually 700 mg in the bottle.

His mother immediately raised concerns, which Young, from Summerlands Hospital, Somerset, attempted to resolve by putting some water in the solution.

Just two hours after the nurse left the family home in Yeovil, Somerset, Joshua was found unresponsive in bed by his mother, Tina Marren.

In spite of desperate attempts by his sister, Jasmine Gafney, and paramedics, to save Joshua, he was declared dead that evening.

A postmortem examination found Mr Gafney had died as a result of acute clozapine toxicity - an overdose.

Congressional hearing reveals 4 more deaths at Tomah, Wisconsin, VA Hospital

Selections from this report on the Reveal website

Four more veterans died under suspicious circumstances than previously reported at the U.S. Department of Veterans Affairs hospital in Tomah, Wisconsin, under the leadership of its chief of staff, psychiatrist Dr. David Houlihan. The deaths, revealed in a rare congressional field hearing today in the small Wisconsin town, bring to 33 the number of unexpected deaths The Center for Investigative Reporting has found occurred during Houlihan’s decade at the helm. The medical center became known as “Candy Land” for the ease with which narcotic painkillers were prescribed.

They include Kraig Ferrington, a 45-year-old Army veteran and union plasterer who died of an overdose of seven medications prescribed by Houlihan in 2007, and three veterans that a VA pharmacist told lawmakers died in the VA parking lot in 2008 and 2009.

“We are doing everything we can to make sure these tragedies don’t happen to others,” Sen. Ron Johnson, chairman of the Senate Committee on Homeland Security and Governmental Affairs, told a packed audience of 400 veterans and family members at the Cranberry Country Lodge. The hearing brought together many of the people who had suffered and complained for years about Houlihan’s practices to no avail. Members of Congress from both parties made the trip to the rural community, which had until recently been more famous for cranberries and cheddar cheese than notorious for narcotic painkillers.

[...]

Today’s hearing marked the sixth congressional hearing where overmedication and abuse of authority at the Tomah VA have been discussed since CIR revealed the problems in a story published Jan. 8.

[...]

Within a week of that story’s publication, Houlihan and Frasher were removed from their positions pending the completion of an internal investigation.

On March 10, they were placed on administrative leave after a preliminary review found that Tomah patients were 2.5 times more likely than the national average to receive high doses of opiates. On March 20, the VA told Congress that Houlihan’s boss, Tomah hospital Director Mario DeSanctis, had been “reassigned to a position at the Great Lakes Health Care System network office, a position outside of the medical center.”

The VA Office of Inspector General, the Wisconsin Department of Safety and Professional Services and the U.S. Drug Enforcement Administration also have opened fresh investigations of Houlihan and the Tomah VA.

Throughout the three-hour hearing, lawmakers expressed exasperation that few alternatives to narcotics are being offered. Rep. Tim Walz, D-Minn., an Army veteran, said he had been pressing the VA to adopt a more nuanced approach to pain management since 2008. [...]

Witnesses included Ryan Honl, a Gulf War veteran and West Point graduate; Noelle Johnson, a pharmacist who was fired in 2009 after she refused to fill prescriptions for high doses of morphine that she believed were unsafe; and family members of those who died, including Heather and Marvin Simcakoski, the widow and father of Jason Simcakoski, a 35-year-old former Marine who died of an overdose in the Tomah VA psychiatric ward in August.

GAO Finds Major Overuse of Antipsychotic Drugs by the Elderly

From the Illinois Nursing Home Abuse Blog

In late 2014 we blogged about the accusations levied against Dr. Michael J. Reinstein about his improper use of antipsychotic drugs prescribed to patients in abundance, as well as taking kickbacks from the drug maker to prescribe it, and making 140,000 or more false billing claims submitted to Medicare and Medicaid for those treatments. This activity landed him in both civil and criminal hot water, and in more recent news he pled guilty to criminal charges as well as settled civil claims with the Illinois and federal governments.

The companies accused of providing those kickbacks and receiving Medicare and Medicaid dollars from the business Reinstein generated by prescribing their antipsychotic drugs. Reinstein exemplifies a holdover of a slowly diminishing practice of using antipsychotic medications, which now is viewed more as the easy way out and a method of chemical restraint when there are other methods that could more humanely calm and care for a patient, particularly dementia and Alzheimer’s patients who have historically been the recipients of antipsychotic medications. Nursing homes historically used these especially when they kept low staffing levels and did not have the manpower to aid patients. Yet antipsychotic drugs can create a cycle of drug dependency, and can even lead to death.

Changing Tides?

While the movement to eliminate the use of antipsychotic medications has gained steam in recent years, the federal government reports that elderly Americans have been overusing psychiatric drugs such as clozapine (Dr. Reinstein’s apparent drug of choice), Abilify, and others. Such drugs are meant to calm down and sedate patients that are prone to violence or outbursts, which those suffering from dementia or psychosis may be particularly prone to exhibiting. The Government Accountability Office (GAO) has released a report stating that elderly adults who live outside of nursing homes and long-term care facilities overuse antipsychotic drugs which are prescribed to them by doctors, though residents in nursing homes also fell into such dependency and overuse, and efforts to curb over-prescription and overuse must continue there as well.

Notably, according to the report, about 86% of Medicare enrollees who suffer from dementia and live outside of nursing homes are prescribed antipsychotic medications, which is a staggering statistic. It is even more remarkable when considering that only approximately 6% of total Medicare enrollees living outside of nursing homes suffer from dementia. Thus the choice of treatment has predominantly been geared toward chemical intervention. For those in nursing homes, of the elderly dementia patients living in nursing homes for over 100 days in the year 2012, approximately a third of those patients were prescribed antipsychotic drugs (and 14% of those outside of nursing homes during 2012).

Part of the problem, according to the GAO report, is the lack of oversight by the government. Medicare and Medicaid specifically take responsibility for such oversight on behalf of the federal government, and states typically have Medicaid fraud units that look into not only financial fraud related to health care, but also investigate when issues include abuse or misuse of medications (which can result in unnecessary and excessive, and thus fraudulent, payments to providers and pharmaceuticals with federal dollars). Those agencies and offices, as well as the U.S. Department of Health and Human Services as the report notes, should be vital in promoting awareness of the dangers of antipsychotic drugs and reducing that use far more than the government has in the past.

California Lawmakers blast overuse of psychiatric drugs on foster kids

from this report in the Tribune in San Luis Obispo

California lawmakers on Tuesday blasted the overuse of psychiatric drugs on the state's foster children and pledged to improve the lives of thousands of vulnerable teens after more than a decade of government inaction.

"We can't let another decade go by without creating a system of care, a system of care that is capable of helping kids heal from the challenging experiences they have lived through or protecting them from further harm," said Sen. Mike McGuire, D-Healdsburg, in opening a joint Senate Human Services Committee and Senate Select Committee on Mental Health.

Advocates said the state's foster children are being prescribed psychiatric drugs at three times the rate of other youth. Since 2006, the use rate of psychotropic medications has nearly doubled, McGuire said. He noted that it's costing taxpayers millions of dollars through the state's low-income health program Medi-Cal.

Iris Hoffman, a member of the California Youth Connection in Sonoma County, told lawmakers how she spent her childhood in juvenile homes, group homes and treatment centers while heavily medicated on the anti-psychotic drugs Abilify and Seroquel. She and other foster children were fearful of retribution if they refused drugs that made them drowsy in class, Hoffman said.

"When you're in those situations, there's all kinds of punishments and things you have to be fearful of if you are to refuse medications prescribed to you by a psychiatrist that only meets with you for an hour a month," she said.

Democratic lawmakers are proposing several pieces of legislation to improve oversight after an investigation by the Bay Area News Group found that thousands of vulnerable teens in foster care are being prescribed antipsychotics that could trigger diabetes, tics, weight gain and drowsiness.

Sen. Jim Beall, D-San Jose, said Tuesday that the hearing at the Capitol is only a step in determining whether the drugs are being administered as part of a therapeutic regimen or "being used as a chemical straitjacket solely to control their behavior."

Beall and Sen. Holly Mitchell, D-Los Angeles, have proposed SB238, which would alert caretakers when drugs are overprescribed and warn of dangerous drug interactions.

Beall also plans to introduce two other bills — one calling for public health nurses to oversee the medical monitoring of children's medication, and the other to establish treatment protocols and oversight in group homes.

Lawmakers on Tuesday heard from medical professionals, child welfare directors, family service advocates, foster youth and officials from California's health and social services agencies.

The use of psychiatric drugs has increased even though the state's foster care population has dropped. As a result of reforms that emphasize keeping children with their families whenever possible, the number of children in foster care has dropped from 103,000 in 2000 to about 55,000 in 2013.

Lawmakers say nearly a quarter of adolescents in California's foster care youth system are prescribed powerful psychotropic drugs. According to the National Center for Youth Law with data provided by the state, 36 percent of them are taking multiple medications that carry harmful side effects.

Antipsychotics, antidepressants, ADHD drugs, anti-anxiety medications and mood stabilizers are some of the psychotropic drugs.

Choosing Wisely: Five Things Physicians, Psychiatrists, and Patients Should Question

As seen on the Choosing Wisely website

Available also as a PDF

1 Don’t prescribe antipsychotic medications to patients for any indication without appropriate initial evaluation and appropriate ongoing monitoring.

Metabolic, neuromuscular and cardiovascular side effects are common in patients receiving antipsychotic medications for any indication, so thorough initial evaluation to ensure that their use is clinically warranted, and ongoing monitoring to ensure that side effects are identified, are essential. “Appropriate initial evaluation” includes the following: (a) thorough assessment of possible underlying causes of target symptoms including general medical, psychiatric, environmental or psychosocial problems; (b) consideration of general medical conditions; and (c) assessment of family history of general medical conditions, especially of metabolic and cardiovascular disorders. “Appropriate ongoing monitoring” includes re-evaluation and documentation of dose, efficacy and adverse effects; and targeted assessment, including assessment of movement disorder or neurological symptoms; weight, waist circumference and/or BMI; blood pressure; heart rate; blood glucose level; and lipid profile at periodic intervals.

2 Don’t routinely prescribe two or more antipsychotic medications concurrently.

Research shows that use of two or more antipsychotic medications occurs in 4 to 35% of outpatients and 30 to 50% of inpatients. However, evidence for the efficacy and safety of using multiple antipsychotic medications is limited, and risk for drug interactions, noncompliance and medication errors is increased. Generally, the use of two or more antipsychotic medications concurrently should be avoided except in cases of three failed trials of monotherapy, which included one failed trial of Clozapine where possible, or where a second antipsychotic medication is added with a plan to cross-taper to monotherapy.

3 Don’t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia.

Behavioral and psychological symptoms of dementia are defined as the non-cognitive symptoms and behaviors, including agitation or aggression, anxiety, irritability, depression, apathy and psychosis. Evidence shows that risks (e.g., cerebrovascular effects, mortality, parkinsonism or extrapyramidal signs, sedation, confusion and other cognitive disturbances, and increased body weight) tend to outweigh the potential benefits of antipsychotic medications in this population. Clinicians should limit the use of antipsychotic medications to cases where non-pharmacologic measures have failed and the patients’ symptoms may create a threat to themselves or others. This item is also included in the American Geriatric Society’s list of recommendations for “Choosing Wisely.”

4 Don’t routinely prescribe antipsychotic medications as a first-line intervention for insomnia in adults.

There is inadequate evidence for the efficacy of antipsychotic medications to treat insomnia (primary or due to another psychiatric or medical condition), with the few studies that do exist showing mixed results.

5 Don’t routinely prescribe an antipsychotic medication to treat behavioral and emotional symptoms of childhood mental disorders in the absence of approved or evidence supported indications.

There are both on and off label clinical indications for antipsychotic use in children and adolescents. FDA approved and/or evidence supported indications for antipsychotic medications in children and adolescents include psychotic disorders, bipolar disorder, tic disorders, and severe irritability in children with autism spectrum disorders; there is increasing evidence that antipsychotic medication may be useful for some disruptive behavior disorders. Children and adolescents should be prescribed antipsychotic medications only after having had a careful diagnostic assessment with attention to comorbid medical conditions and a review of the patient’s prior treatments. Efforts should be made to combine both evidence-based pharmacological and psychosocial interventions and support. Limited availability of evidence based psychosocial interventions may make it difficult for every child to receive this ideal combination. Discussion of potential risks and benefits of medication treatment with the child and their guardian is critical. A short and long term treatment and monitoring plan to assess outcome, side effects, metabolic status and discontinuation, if appropriate, is also critical. The evidence base for use of atypical antipsychotics in preschool and younger children is limited and therefore further caution is warranted in prescribing in this population.

These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items on this list or their individual situation should consult their physician.

Sources

1.

American Psychiatric Association. Practice guideline for the psychiatric evaluation of adults, second edition. Am J Psychiatry. 2006 Jun;163(Suppl):3–36. Available from: http://psychiatryonline.org/content.aspx?bookid=28§ionid=2021669.

American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27(2):596-601.

Dixon L, Perkins D, Calmes C. Guideline watch (September 2009): practice guideline for the treatment of patients with schizophrenia [Internet]. Psychiatry Online. [cited 2013 Mar 8] Available from: http://psychiatryonline.org/content.aspx?bookid=28§ionid=1682213.

Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T; Southern California Evidence-Based Practice Center. Off-label use of atypical antipsychotics: an update. Rockville, MD: Agency for Healthcare Research and Quality; 2011 Sep 437 p. Report No.: HHSA290-2007-10062-1.

Nasrallah HA. Atypical antipsychotic-induced metabolic side effects: insights from receptor-binding profiles. Mol Psychiatry. 2008 Jan;13(1):27-35.

2.

American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl):1-56. Available from: http://psychiatryonline.org/content.aspx?bookid=28§ionid=1682213.

Kane J, Honigfeld G, Singer J, Meltzer H. Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine. Arch Gen Psychiatry. 1988;45(9):789-96.

McEvoy JP, Lieberman JA, Stroup TS, Davis SM, Meltzer HY, Rosenheck RA, Swartz MS, Perkins DO, Keefe RS, Davis CE, Severe J, Hsiao JK, CATIE Investigators. Effectiveness of clozapine versus olanzapine, quetiapine, and risperidone in patients with chronic schizophrenia who did not respond to prior atypical antipsychotic treatment. Am J Psychiatry. 2006;163(4):600-10.

Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T; Southern California Evidence-Based Practice Center. Off-label use of atypical antipsychotics: an update. Rockville, MD: Agency for Healthcare Research and Quality; 2011 Sep 437 p. Report No.: HHSA290-2007-10062-1.

Specifications Manual for Joint Commission National Quality Measures (v2013A1). Measure Set: Hospital Based Inpatient Psychiatric Services (HBIPS), Set Measure ID: HBIPS-4.

Stahl SM, Grady MM. A critical review of atypical antipsychotic utilization: comparing monotherapy with polypharmacy and augmentation. Curr Med Chem. 2004; 11(3):313-27.

3.

American Psychiatric Association: Practice guideline for the treatment of patients with Alzheimer’s disease and other dementias, second edition. Am J Psychiatry. 2007 Dec; 164(Dec suppl):5–56. Available from: http://psychiatryonline.org/content.aspx?bookid=28§ionid=1679489.

Ballard CG, Waite J, Birks J. Atypical antipsychotics for aggression and psychosis in Alzheimer’s disease. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD003476.

Gitlin LN, Kales HC, Lyketsos CG. Nonpharmacologic management of behavioral symptoms in dementia. JAMA. 2012 Nov 21; 308(19):2020-9.

Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T; Southern California Evidence-Based Practice Center. Off-label use of atypical antipsychotics: an update. Rockville, MD: Agency for Healthcare Research and Quality; 2011 Sep 437 p. Report No.: HHSA290-2007-10062-1.

Nasrallah HA. Atypical antipsychotic-induced metabolic side effects: insights from receptor-binding profiles. Mol Psychiatry. 2008 Jan;13(1):27-35.

Richter T, Meyer G, Möhler R, Köpke S. Psychosocial interventions for reducing antipsychotic medication in care home residents. Cochrane Database Syst Rev. 2012 Dec 12;12:CD008634.

Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease. N Engl J Med. 2006;355(15):1525-38.

4.

American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27(2):596-601.

Maglione M, Ruelaz Maher A, Hu J, Wang Z, Shanman R, Shekelle PG, Roth B, Hilton L, Suttorp MJ, Ewing BA, Motala A, Perry T; Southern California Evidence-Based Practice Center. Off-label use of atypical antipsychotics: an update. Rockville, MD: Agency for Healthcare Research and Quality; 2011 Sep 437 p. Report No.: HHSA290-2007-10062-1.

Nasrallah HA. Atypical antipsychotic-induced metabolic side effects: insights from receptor-binding profiles. Mol Psychiatry. 2008 Jan;13(1):27-35.

5.

Correll CU. Monitoring and management of antipsychotic-related metabolic and endocrine adverse events in pediatric patients. Int Rev Psychiatry. 2008; 20(2):195-201.

Findling RL, Drury SS, Jensen PS, Rapoport JL; AACAP Committee on Quality Issues. Practice parameter for the use of atypical antipsychotic medications in children and adolescents [Internet]. American Academy of Child and Adolescent Psychiatry. [cited 2013 Mar 3]. Available from: http://www.aacap.org/galleries/PracticeParameters/Atypical_Antipsychotic_ Medications_Web.pdf.

Loy JH, Merry SN, Hetrick SE, Stasiak K. Atypical antipsychotics for disruptive behaviour disorders in children and youths. Cochrane Database Syst Rev. 2012 Sep 12;9:CD008559.

Zito JM, Burcu M, Ibe A, Safer DJ, Magder LS: Antipsychotic use by Medicaid-insured youths: impact of eligibility and psychiatric diagnosis across a decade. Psychiatr Serv. 2013 Mar 1;64(3):223-9.

VA to look into overmedication reports at Tomah center

From an AP Report in the San Francisco Chronicle

The U.S. Department of Veterans Affairs is launching an investigation into reports of overmedication and retaliatory management practices at the VA Medical Center in Tomah, the agency said Thursday.

Veterans Health Administration specialists plan to visit the western Wisconsin facility within two weeks to review medication prescription practices, the federal agency said in a statement Thursday afternoon. They also plan to send representatives from the Office of Accountability Review to look into allegations of retaliatory behavior.

"My sense is that this isn't just unique to Tomah," U.S. Rep. Ron Kind, a Democrat whose district includes Tomah. "We have a system-wide issue that needs to be addressed when it comes to pain management with our veterans."

Kind and other Wisconsin lawmakers had sent requests to Veterans Affairs Secretary Robert McDonald this week seeking an investigation

Tomah VA spokesman Scott Farley said in a statement the medical center will fully cooperate with the investigation.

A recent story from The Center for Investigative Reporting noted the number of opiates prescribed at the Tomah VA had more than quintupled between 2004 and 2012, even as the number of veterans seeking treatment there has declined. Health care professionals have complained about the medical center's practices for several years.

Here is more info from The Center for Investigative Reporting Looks like the main culprite is, of course, another damn psychiatrist Dr. David Houlihan

Politicians from both parties and government bureaucrats are rushing to look into allegations of rampant overmedication, retaliatory management practices and preventable overdose deaths at the U.S. Department of Veterans Affairs Medical Center in Tomah, Wisconsin, that The Center for Investigative Reporting revealed last week.

In the story’s wake, the VA has begun “actively reviewing allegations of retaliatory behavior and overmedication at the Tomah VA Medical Center,” said agency spokesman James Hutton. He said the facility’s chief of staff, psychiatrist Dr. David Houlihan, has been temporarily reassigned to the VA regional office while an internal investigation takes place.

But the problems disclosed should not have surprised politicians or federal officials: Health care professionals at the hospital have complained for at least five years about Houlihan’s prescription practices and his retaliatory management style – filing numerous reports with those in charge of oversight.

“It’s about time,” said Robin Weeth, a former social worker at the hospital who wrote to the VA inspector general in 2012 with a long list of allegations, including that “veterans are overmedicated and have been driving while impaired, fallen asleep while smoking and set themselves on fire.”

Today, Weeth reports that he never heard back from the inspector general.

The CIR story reported that the number of opiates prescribed at the Tomah VA had more than quintupled between 2004 and 2012, even as the number of veterans seeking care at the hospital declined. It included details of the August death of a 35-year-old Marine Corps veteran, who overdosed while in the hospital’s inpatient psychiatric ward.

[...]

The VA inspector general had closed an investigation into the Tomah VA before Baldwin even got in touch, in March 2014. The inspector general’s report noted that Houlihan’s narcotic prescriptions were “at considerable variance compared to most opioid prescribers” and “raised potentially serious concerns” that should be brought to the attention of the federal agency’s leadership. But the report suggested no punishment.

Weeth said he believed that Jason Simcakoski, the 35-year-old former Marine who fatally overdosed in the Tomah VA psychiatric ward in August, still would be alive today if the inspector general had come down harder on Houlihan.

[...]

Much more information at the links

The Era of "Marketing-based Medicine"

From a much longer article by Melissa Sweet, published in Crikey Online

The tactics used by the pharma industry to entrench its influence – whether with politicians, health groups or prescribers – have been hitting the headlines lately.

A story on the cover of the SMHS’s Weekend Business section (beats me why it wasn’t on the paper’s main cover) examined how the industry buys influence in Canberra, and last week Sun Dunlevy splashed in The Daily Telegraph on pharma funding of patient and other health groups. (For more about this particular story, see the bottom of the post)

Meanwhile, Dr Peter Parry, a psychiatrist and senior lecturer at Flinders University, has been investigating internal pharma documents and has come to the conclusion that we live in a world of “marketing-based medicine”. He writes:

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data…”  AstraZeneca publications manager in internal email 6 Dec 1999.

In recent years doctors and other health professionals have been exhorted to practice “Evidence-based Medicine” or “EBM”. We should prescribe to our patients the right medication based on the best available medical science. Similarly surgeons should select the right implantable prosthesis according to EBM.

However there has been a growing tide of voices claiming EBM is not what it seems, that given the multi-billions of dollars involved, the medical science system has been distorted. The big pharmaceutical companies spend around 11% to 15% on research and development, but they spend around 36% of their budgets on marketing. This influence means much of what passes as EBM, may in fact be “MBM” – “Marketing-based Medicine”.