A Third Pharma Settlement

The U.S. Attorney General recently announced that Johnson & Johnson has agreed to pay $2.2 billion for false marketing, principally for its antipsychotic medication risperidone. This is the third settlement in recent years; Pfizer and GlaxoSmithKline (GSK) also paid out similar settlements.

Risperidone has been FDA approved for many years for treating psychotic symptoms such as hallucinations and delusions. But there has been false marketing to doctors and kickbacks to pharmacies to promote non-FDA use in the elderly, children and people with developmental disabilities (such as mental retardation). Treating dementia in elderly patients; controlling disruptive behaviors in children; and managing a variety of non-psychotic problems in people with developmental disorders are not FDA-approved indications for risperidone.

Risperidone has generated multibillion dollar annual sales for many years, making it a very valuable product. The recent settlement included payments for the improper marketing to doctors to promote prescribing of these drugs, kickbacks to pharmacy suppliers tied to sales and forfeited profits.

But these practices are not new. The incentives to promote wide use of this drug, and many other agents, despite limited FDA approval, are huge. That means either the government or consumers, namely patients and families, are necessary checks against improper practices.

What can government do?

Court cases are after the fact. While they may have some deterrent effect the damage has already been done.

In New York State, where I work as medical director of a state agency, we have implemented two ongoing methods of improving prescribing practices and promoting patient safety.

The first is a checklist that doctors and prescribing nurses at the NYS Office of Mental Health must regularly complete on patients receiving antipsychotic agents. In 2010, after reports of cardiac complications of antipsychotic medications in the elderly as well as inescapable evidence of the health risks of these drugs in patients of all ages, we introduced and still use a checklist called SHAPEMEDs, "Is Your Doctor Using A Checklist?" It does not tell the clinician what to do, but engages him or her in critical thinking about his or her practices.

SHAPEMEDs (an acronym) asks eight questions about each patient:

1. Are you currently prescribing antipsychotic medications for this patient?

2. What is the patient's primary psychiatric diagnosis?

3. Please list each of the antipsychotic medications the patient is being prescribed.

4. Please list the primary targeted symptoms or behaviors for which these antipsychotic medications are being used.

5. Is the patient currently experiencing any of the following side effects or health issues? (A list then appears to choose from.)

6. Is adherence to antipsychotic medications a problem?

7. Has the preference of the patient and the patient's parent or guardian been a strong consideration in the choice of antipsychotic medication?

8. Is the current antipsychotic medication regimen expensive (a table with drug costs relative to one another then appears).

a) For the patient or the patient's family: e.g., insurance copays, out-of-pocket costs?

b) To the health-care system as a whole: e.g., Medicaid, OMH, DOCS, other payers?

The second is a NYS government database on medications and other treatments that patients have received in the past five years. OMH calls this data system PSYCKES (another acronym, you can Google if you wish). We have built in a number of quality monitors that include flagging instances of polypharmacy (the use of multiple medications of the same class, such as antipsychotics), as well as medications known to increase health risks, especially for diabetes and heart disease. PSYCKES is being progressively made available to clinicians and hospitals beyond OMH-operated facilities throughout the state.

Both SHAPEMEDs and PSYCKES are government created and implemented quality monitoring and improvement tools. They foster prudent prescribing practices in the interest of patients—and their caregiving families and loved ones.

What can patients and families do?

Some time ago, I asked in a HuffPost blog, "Can You Trust Your Psychiatrist?" That question arises again in light of this recent settlement.

More than ever, patients and families must be vocal advocates for their interests. In my recent book, A Family Guide to Mental Health Care (Norton, 2013), I write about the questions that recipients of medications should ask of the prescribing clinician. Some of these are: Why did you select the medication you did? What symptoms do you think this will help, and by when? What are the risks as well as benefits? What alternatives exist? What does it cost? When will we next review this treatment plan? What are the risks of no treatment?

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Given the rush and complexity of medical services, the known risks of all treatments, and the influence on prescribers that these cases reveal, there are just too many ways that care can go awry. It is thus essential—it may not feel fair or right—but it is essential that patients and families become informed and vocal advocates for their care.

Good doctors know that patients (and families) need to represent their self-interests. Good doctors welcome good questions—they ask questions when they are patients. Keep that in mind when you gather your courage to ask them. You can reasonably expect clear and understandable answers in everyday English. That is what is meant by "patient-centered care."

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This article originally appeared in the Huffington Post . Copyright Lloyd Sederer, MD