New Study Confirms Inappropriate Use of Sedative Hypnotics By Elderly May Increase Adverse Events, Health Care Costs

  • Elderly Patients at Significantly Higher Risk of Falls and Fractures than Control Group
  • Patients Exposed To These Medications Experience Higher Medical And Total Health Care Costs
IRVINE, Calif. — 

A new study provides important evidence that the use of certain potentially inappropriate medications (PIMs) among the elderly may increase adverse events and health care costs.

Among the key study findings was that patients receiving sedative hypnotics (classified as Beers high-severity, or BHS) were significantly more likely (22 percent) to suffer a fall or fracture than control subjects. In addition, patients exposed to these medications had significantly higher adjusted medical and total health care costs than those in the control group ($20,537 vs. $15,835 for adjusted medical costs and $21,807 vs. $17,154 for adjusted total health care costs; P<.001 for both).

Clinicians and managed care organizations use specific measures, based on the Beers criteria1, to help identify and target elderly patients who may be at risk of adverse events due to their use of PIMs. While the Beers criteria are widely used, there has been very limited data on clinical outcomes associated with specific PIMs.

Sedative-hypnotics are drugs that depress or slow down the body's functions and are often prescribed to treat anxiety or promote sleep. Some well-known drugs in this category include diazepam (Valium) and secobarbital (Seconal).

The study, published in the January edition of The American Journal of Managed Care, is the first to examine clinical outcomes associated with specific so-called PIMs and is based on electronic pharmacy and medical claims data. It was conducted by Prescription Solutions, a leading pharmacy benefits management organization and a UnitedHealth Group (NYSE: UNH) company.

“These findings demonstrate that elderly patients who take certain PIMs are at increased risk of adverse events and higher health care costs,” said Karen Stockl, Pharm.D., Prescription Solutions, and lead author of the study. “This should be of great value to managed care organizations that are conducting, or deciding whether to conduct, clinical programs to reduce PIMs in this vulnerable patient population.”

Study Reveals Unexpected Finding
In an unexpected finding, patients receiving BHS anticholinergics did not have a higher risk of delirium or hallucinations than the control group. Anticholinergic medications are widely used to treat a variety of disorders commonly found in elderly populations, such as gastrointestinal disorders, respiratory disorders, motion sickness, muscular spasms and Parkinson’s disease, and as an aid to anesthesia.

Considering the large study sample size (37,358 pairs), the fact that there was no higher risk for the anticholinergic group was a surprising outcome. The researchers postulated that the way patients actually take these medications in a real-world setting (e.g., intermittently or at low doses) may minimize the number of observed events. Another possible explanation is that delirium and hallucinations may be overlooked by patients or their caregivers and may never be reported to the physician. Finally, delirium and hallucinations may be under-recognized or under-coded in the claims database.

Medical Costs Higher For Patients Exposed to PIMs
Whether adverse events were higher for exposed patients or not, one finding was the same for all PIM categories: medical costs were significantly higher for patients exposed to the PIMs than for control subjects.

“This study confirms that elderly patients who are prescribed PIMs tend to be higher utilizers of health care resources than patients who don’t take them,” said Dr. Joseph Addiego, chief medical officer, Prescription Solutions. “Studies such as this are critically important to the health care industry because they provide a real-world look at drug utilization and its impact on clinical outcomes and health care costs.”

Prescription Solutions routinely conducts scientific studies on various disease states as a way to use its clinical expertise to advance the practice of medicine and add to the scientific literature. This is a key element of Prescription Solutions' ongoing search for the most current, highest quality evidence available to enable it to provide the best, most cost-effective medications to patients.

Study Methodology
The study was designed as a retrospective cohort, using electronic pharmacy and medical claims from a managed care organization based in the western United States. The study group included patients 65 years and older who started one of 23 PIMs between January 2003 and June 2005; patients 65 years and older who were not receiving one of the same PIMs were selected as potential control subjects. The primary study outcome was the risk of having an “adverse event of interest” (AEI) during a period of up to 360 days for exposed patients vs. the control group. The AEIs were delirium and hallucinations for patients exposed to BHS anticholinergics, or BHS narcotics, and falls or fractures for those exposed to BHS sedative hypnotics. The study also looked at extrapyramidal side effects for those exposed to trimethobenzamide. Patients were designated as having an AEI if they had an inpatient hospitalization, an emergency department visit or two medical claims with a primary diagnosis code representing the AEI.

1The Beers criteria were used by NCQA to develop the HEDIS measures.

About Prescription Solutions
Prescription Solutions is an innovative pharmacy benefit management company managing the prescription drug benefit of commercial, Medicare and other governmental health plans, as well as those of employers and unions. A UnitedHealth Group company, Prescription Solutions serves patients through a national network of 64,000 community pharmacies and state-of-the-art mail service pharmacies in Carlsbad, Calif., and Overland Park, Kan., both of which have earned the prestigious Verified Internet Pharmacy Practice Sites™ (VIPPS®) accreditation by the National Association of Boards of Pharmacy® (NABP®). The company was recently named by WilsonRx® as the No. 1 National Top-Tier PBM and No. 1 National Mail Order Pharmacy for customer satisfaction two years in a row. Prescription Solutions also won two Silver Awards for URAC’s Best Practices for Consumer Empowerment and Protection Awards – Geriatric RxMonitor program (2008) and the Drug Interaction Alert Program (2009). Additional information can be found at www.prescriptionsolutions.com.

About UnitedHealth Group
UnitedHealth Group (NYSE:UNH) is a diversified health and well-being company dedicated to making health care work better. Headquartered in Minneapolis, Minn., UnitedHealth Group offers a broad spectrum of products and services through six operating businesses: UnitedHealth care, Ovations, AmeriChoice, OptumHealth, Ingenix, and Prescription Solutions. Through its family of businesses, UnitedHealth Group serves more than 70 million individuals nationwide. 

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New Study Confirms Inappropriate Use of Sedative Hypnotics By Elderly May Increase Adverse Events, Health Care Costs