Senate Back and Forth on Psychoactive Medication Regs

Last week, Senators Kohl, Grassley and Blumenthal introduced an amendment to an existing FDA bill that would require the informed consent of nursing home patients or their legal surrogates before certain anti-psychotic/psychoactive medications were given.  The target of this legislative initiative is to reduce the use of certain types of drugs commonly used to treat serious, chronic mental illness such as Risperdal and Haldol.  Despite FDA black box warnings with regard to the side-effects of these types of drugs and their unwarranted use in patients suffering from dementia (Alzheimer’s and other forms), research and evidence supports that use in the elderly to chemically control behaviors remains widespread, particularly in nursing homes.  A 2011 Inspector General report illustrated wide-spread use as documented by Medicare claims for psychoactive medications not corollary to a specific mental illness; one that would typically be treated by anti-psychotic therapy (schizophrenia, bipolar disorder, etc.).  Extrapolating from Medicare claim data, the report found that 14% of nursing home patients were undergoing inappropriate anti-psychotic therapy for non mental illness purposes – defined by OIG as atypical drug therapy. Perhaps most troubling is that (per the report), 88% of the use fell within the FDA black box warnings or, use for diagnoses unrelated to mental illness.  The link to the full report is http://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf

Despite the appearance of wide-spread, bipartisan support for the amendment, the amendment was removed from the final bill.  Procedurally, the original legislation already had significant proposed amendments and to garner passage, the final bill was streamlined.  Indications are that the legislative effort to require additional safe-guards such as informed consent to limit psychoactive/anti-psychotic therapies in the elderly is possible.  Interesting to note is that Senator Kohl is from Wisconsin; a state that enacted its own law requiring informed consent for psychoactive medication therapy in nursing homes.

Apparently, CMS is still searching for vehicles to curb unnecessary drug use in nursing home patients, particularly psychoactive therapies.  Recall earlier in the year, CMS was about to promulgate rules requiring the separation of pharmacy duties, requiring that consultant pharmacists not be employed by the dispensing pharmacy.  The logic used to justify the proposed (since dead) rule is the wide-spread use of psychoactive medications.  Theoretically, separating consulting and dispensing duties would reduce inappropriate therapies.  Curiously, rules exist and survey instructions the same, to hold nursing homes accountable for unnecessary drug use and to enforce the requirement that every medication have a corresponding clinical justification.   Accordingly, if the CMS/OIG indicates that clinical justification for the majority of psychoactive medications is erroneous or non-existent, then targeted enforcement of existing regulation seems the logical next step; though I am on principle, in favor of informed consent for anti-psychotic use.