Antipsychotics overused in LTC setting, OIG says

Key Points

Long-term-care (LTC) facilities are overusing antipsychotic drugs. One of every 7 elderly nursing home residents is receiving at least 1 atypical antipsychotic; in 83% of these cases, the drug is associated with a dementia diagnosis, yet the use of atypical antipsychotics in dementia increases the risk of death and is not approved by FDA, according to a report from the Office of the Inspector General (OIG).

Erroneous claims

"Government, taxpayers, nursing home residents, as well as their families and caregivers, should be outraged - and seek solutions," said Daniel R. Levinson, Inspector General, Department of Health and Human Services (HHS), in a statement. "Despite the fact that it is potentially lethal to prescribe antipsychotics to patients with dementia, there's ample evidence that some drug companies aggressively marketed their products toward such populations, putting profits before safety."

Unmet standards

OIG also found that 22% of atypical antipsychotics used in LTC were not administered according to Medicare standards regarding unnecessary drug use in nursing homes. The standards are designed to reduce excessive dosage, excessive duration of therapy, inappropriate use, and lack of appropriate monitoring. Noting that violation of unnecessary drug-use rules may affect nursing homes' participation in Medicare, OIG recommended that HHS act to reduce unnecessary drug use in LTC.

The report included aripiprazole (Abilify, Bristol-Myers Squibb), clozapine (Clozaril, Novartis), olanzapine (Zyprexa, Eli Lilly), olanzapine/fluoxetine (Symbyax, Eli Lilly), paliperidone (Invega, Janssen), quetiapine (Seroquel, AstraZeneca), risperidone (Risperdal, Janssen), and ziprasidone HCl (Geodon, Pfizer).

Implications for pharmacists

Where do the findings leave consultant pharmacists? The American Society of Consultant Pharmacists declined comment. Director of Policy and Advocacy Lynne Batshon told Drug Topics that the society was still discussing the report internally.

Spokesman John Norton of the National Community Pharmacists Association (NCPA) said that NCPA supports the government's interests in ensuring that that Medicare pays correctly for atypical antipsychotics and that elderly nursing home residents are free from treatment with unnecessary drugs.

"Atypical antipsychotics should only be prescribed for elderly nursing home residents when clinically indicated, as determined by the prescriber and consulting pharmacist, and should be provided in the lowest effective dose to achieve the clinical outcomes desired," he said in an e-mailed statement.

Drugmakers all in a row

This isn't the first time investigators have uncovered problems with atypical antipsychotic use in LTC. In 2009, Omnicare paid $98 million to settle government claims that it accepted kickbacks from drugmakers to increase the use of atypicals. In 2010, the Department of Justice sued Johnson & Johnson and subsidiaries over kickbacks paid to Omnicare to boost sales of Risperdal and other drugs. AstraZeneca, BMS, Lilly, and Pfizer have either pled guilty or settled allegations of marketing abuses to boost sales of their atypical agents.

"Drug companies have paid billions to resolve these civil and criminal liabilities," Levinson said. "But money can't make up for years of corporate campaigns that market drugs with questionable benefits and potentially deadly side effects for vulnerable elderly patients."

OIG recommended that the Centers for Medicare and Medicaid Services (CMS) collect diagnosis and other data to ensure that atypicals and other agents actually qualify for Medicare reimbursement. Medicare has never employed such oversight, typical of private sector plans, and isn't likely to try it soon.

HHS responded that diagnosis is not a required data element and is generally not included in prescriptions. CMS will not require diagnosis codes, the agency said, until state boards of pharmacy require the inclusion of diagnosis data in prescriptions and the industry develops a common data reporting format.