Karen M. Stockl, PharmD

: To examine the effect of a multiple sclerosis (MS) disease therapy management (DTM) program that incorporates a disease self-management component and a medication therapy management component within a structured 7-month program.

: Pharmacy claims were evaluated over an 8-month follow-up period to calculate injectable MS medication adherence and persistence among 156 continuously eligible patients who completed the DTM program compared with 156 patients in each of 2 propensity score—matched control groups (retail pharmacy patients and specialty pharmacy patients). For 283 patients completing the DTM program, the Short Form 12, Work Productivity Activity Impairment questionnaire, and MS relapses were assessed at month 0 and at month 6.

: Injectable MS medication adherence was significantly higher for DTM patients compared with retail pharmacy patients (0.92 vs 0.86,

 <.001) and was similar for DTM patients and specialty pharmacy patients (0.92 vs 0.90, 

 = .23). The DTM patients demonstrated significantly greater persistence on therapy (220 days) compared with the specialty pharmacy patients (188 days) (

 = .002) and the retail pharmacy patients (177 days) (

 <.01). The Short Form 12 and Work Productivity Activity Impairment results did not significantly change from month 0 to month 6. Multiple sclerosis relapses were reported by 14.0% of patients at month 0 and by 9.3% of patients at month 6 (

 = .03). Ninety-seven percent of patients at month 6 reported that the DTM

program was very helpful or somewhat helpful in enabling them to better manage their health. 

: An MS DTM program incorporating medication management resulted in increased adherence and persistence to injectable MS medications and decreased MS relapses. Quality of life and work productivity were not significantly changed. Patients reported improved ability to manage their health.

This study is the first to date to examine the effect of a multiple sclerosis (MS) disease therapy management (DTM) program that incorporates a disease self-management component and a medication therapy management component.

The MS DTM program increased adherence and persistence to injectable MS medications and decreased MS relapses.

No improvement to health-related quality of life or work productivity was demonstrated by the program.

Patients indicated that the program was helpful in enabling them to better manage their health.

Multiple sclerosis (MS) is a chronic inflammatory neurologic disease requiring lifelong adjustments and coping skills. Because of the chronic, disabling, and potentially progressive nature of MS, programs that promote symptom management, medication adherence, and health-promoting lifestyle are crucial in the management of MS. Self-management programs among patients with MS have been largely directed at improving physical activity, fatigue, or health-related quality of life (HRQOL).

In 2007, a national pharmacy benefit management (PBM) company implemented an MS disease therapy management (DTM) program that combines a disease self-management component and a medication therapy management component. The program is designed to improve patients’ knowledge of MS and treatment options, maximize therapeutic outcomes, promote self-management, and enhance HRQOL.

Eligible patients were identified on a weekly basis and were sent a DTM welcome packet. An outbound call was made to patients who returned a patient availability form indicating their preferred day and time for the telephone consultation. During the initial consultation (month 0), clinicians (registered nurse or pharmacist) used the INTERMED, a validated observer-rated instrument for assessing case complexity and healthcare needs using a biopsychosocial model,

 to stratify patients into the regular-intensity program (score, 0-20) or the high-intensity program (score, ≥21).

The DTM patients received telephone consultations, care plan mailings, and educational material mailings based on the predefined schedule for their level of intensity. For the regular-intensity program, consultations were conducted intermittently at enrollment (month 0), month 1, month 4, and month 6. For the high-intensity program, consultations were conducted monthly throughout the 7-month program. The initial consultation typically lasted 40 to 60 minutes, and follow-up consultations lasted 20 to 30 minutes. During each consultation, the clinician assessed patient knowledge and health concerns and provided education on core topics (

). Each clinician developed a personalized care plan that summarized the telephone consultation and sent it to the patient and to the prescriber of the injectable MS medication. Patients also received monthly educational mailings specific to MS for 6 months.

To evaluate the MS DTM program, data were obtained from the DTM program database and from electronic pharmacy claims for patients participating in Medicare Advantage Prescription Drug Plan, prescription drug plan, or commercial health plans that use the PBM’s specialty pharmacy. Exemption certification was obtained from an external institutional review board. 

There were 2 analysis populations, a claims data population and a  patient-reported population (patients enrolled in the DTM program who completed the month 0 and month 6 consultations). Patients were eligible for the claims data population if they were enrolled in the DTM program and completed the month 0 and month 6 consultations, filled a prescription for an injectable MS medication at the PBM’s specialty pharmacy during the identification period (March through November 2007), and were continuously enrolled in the health plan for 4 months before (preperiod) and 8 months after (postperiod) the identification date.

Two control groups (retail pharmacy patients and specialty pharmacy patients) were compared with the claims data population. Retail pharmacy patients were those who filled a prescription for an injectable MS medication at a retail pharmacy but who did not have any prescriptions for injectable MS medications filled through the PBM’s specialty pharmacy. Specialty pharmacy patients were those who filled a prescription for an injectable MS medication at the PBM’s specialty pharmacy but who did not participate in the DTM program. Patients in both control groups had to be continuously enrolled during the preperiod and the postperiod.

To be included in the control groups, a patient also had to be matched 1:1 with a patient in the DTM group. Matching was performed using the propensity score method.

 Logistic regression analysis was used to calculate a propensity score, which represents each patient’s likelihood of participating in the DTM program. Variables included in the propensity score were age, sex, health plan type, Chronic Disease Score

 during the preperiod, and index injectable MS medication. Variables that were unavailable in claims data such as type or duration of MS and duration of injectable MS medication use (unable to determine history before plan enrollment) were not included in the propensity score model. Patients in the retail pharmacy group were first matched to a patient in the DTM group, and then patients meeting the criteria for the specialty pharmacy group were matched to each patient in this DTM and retail pharmacy—matched population.

The primary outcome was adherence to injectable MS medications for DTM patients versus retail pharmacy patients. Adherence to injectable MS medications was measured using the medication possession ratio (MPR), which was defined as the sum of days’ supply for all fills during the postperiod, divided by the number of days of therapy between the first fill and the last fill during the postperiod plus the days’ supply for the last fill. 

Additional medication utilization outcomes evaluated during the postperiod among the claims data population included the following: duration of therapy (number of days of therapy between the first fill and the last fill plus the days’ supply for the last fill), medication persistence (number of days on therapy until a gap of ≥30 days), medication discontinuation (gap of ≥30 days past the end of supply date for the last filled prescription and the end of the postperiod), medication switching (prescription fill of an injectable MS medication other than the index medication), and pharmacy ingredient costs.

Secondary outcome measures of changes in HRQOL, work productivity, and MS relapse rates from month 0 to month 6 were determined for the patient-reported population. The HRQOL was measured using the Short Form 12 (SF-12) (version 2; Quality Metric, Lincoln, RI), as the performance of this instrument has been previously evaluated in patients with MS.

 Work productivity was measured using the Work Productivity and Activity Impairment (WPAI) questionnaire (general health version 2.0; Reilly Associates, New York, NY).

 Multiple sclerosis relapses were evaluated by asking the patient, “During the last month, have you had exacerbation(s) or relapse(s) of your MS that interfered with your daily life?”

Data extraction and statistical analysis were performed using SAS (version 9.1; SAS Institute, Cary, NC). Comparisons were performed using 

 test for percentages. Multiple sclerosis relapse rates were evaluated using McNemar test (patients who were unsure if they had a relapse were categorized as having had a relapse) and conditional logistic regression analysis (assigning a score of 0, 1, and 2 for no relapse, unsure if had relapse, and had relapse, respectively). All comparisons were 2-sided and were performed at a .05 level of significance.

Baseline characteristics were similar for the DTM, specialty pharmacy, and retail pharmacy groups (n = 156 each) except for the geographic state distribution for the DTM and retail pharmacy groups (

 <.001). These results are summarized in 

During the postperiod, the DTM group had the highest medication adherence (MPR, 0.92), followed by the specialty pharmacy group (MPR, 0.90) and the retail pharmacy group (MPR, 0.86) (

). Adherence to injectable MS medications was statistically significantly better in DTM patients versus retail pharmacy patients (

 <.001). Compared with the specialty pharmacy group or the retail pharmacy group, the DTM group demonstrated a significantly longer duration of therapy, greater medication persistence, and a lower medication discontinuation rate. The improved medication utilization patterns demonstrated by the DTM group resulted in significantly higher pharmacy ingredient costs.

Among the patient-reported population (n = 283), 68.9% of patients reported having the relapsing-remitting form of MS. The mean (SD) duration of MS was 11.7 (8.8) years, and 80.6% patients were not working outside of the home.

At month 0, the mean (SD) SF-12 physical and mental component scores were 37.7 (10.1) and 48.4 (10.4), respectively; at month 6, the scores were 37.9 (10.0) and 49.9 (11.1), respectively, which were not significantly changed. The mean (SD) work productivity loss on the WPAI for patients working outside of the home was 17.3% (26.4%) at month 0 and was similar at 20.4% (25.5%) at month 6. Multiple sclerosis relapses were reported by 14.0% of patients at month 0 and by 9.3% of patients at month 6 (

Ninety-seven percent of patients at month 6 reported that the program was very helpful or somewhat helpful when they were asked, “Overall, how helpful was the program in better managing your health?” The program was rated as very good or excellent by 91.5% of patients.

An MS DTM program focusing on medication management was successful in improving adherence and persistence to injectable MS medications. The percentage of DTM patients reporting an MS relapse decreased by 33.6% from month 0 to month 6. The SF-12 and WPAI results did not change significantly from month 0 to month 6. Most DTM patients indicated that the program was helpful in enabling them to better manage their health.

Previous studies have shown that approximately 80% of patients with MS adhere 80% of the time to injectable MS therapy for 6 months

 and that 60% to 76% of patients with MS adhere to therapy for 2 to 5 years.

 However, 43% of patients initiating therapy become nonpersistent within 14 months.

 Problems with injections, perceived lack of efficacy, and adverse events are considered major barriers to sustained adherence among patients with MS.

 The higher medication adherence and persistence rates observed with our MS DTM program may indicate a positive influence of the program on patients’ behavior.

Considering that previous research evaluating the effect of injectable MS medications on HRQOL has had varying results,

 it is not surprising that patients described herein who participated in the program did not experience improvements on the SF-12. In the present study, patients were not necessarily new to therapy, which may have reduced the ability to demonstrate a change in HRQOL among patients participating in the program. Because of a lack of published information on the WPAI in patients with MS, it is possible that the WPAI is not sensitive enough to detect changes in work productivity that may have occurred as the result of increased adherence to injectable MS medication therapy. Because only 19.4% of study patients worked outside of the home, the WPAI results are further complicated by the small sample size.

With previously published findings indicating that insured patients with MS incur 2 to 3 times more expense than average insured patients,

 managed care organizations may be interested in clinical programs that reduce additional medical expenditures incurred by patients with MS. Based on a 33.6% reduction in patients experiencing an MS relapse, a DTM intervention targeting 283 patients would be estimated to result in 13.3 fewer patients with an MS relapse. Using the mean cost of an MS relapse of $13,026 from a previous study,

the MS DTM intervention can be estimated to avoid $173,246 in relapse costs (about $612 per participating patient).

Although variables available in pharmacy claims were included in the propensity score—matching process to control for potential differences between groups, we were unable to match on additional clinical variables such as type and duration of MS that are unobservable in the pharmacy claims database. The consequence of this potential bias is unknown.

Because the DTM group consisted of patients who participated in and completed the DTM program, there was a potential selection bias favoring the more compliant patients to be included in this group. Because this potential limitation is inherent to all clinical programs that require patient participation, managed care organizations have a role in promoting and encouraging patient participation in their clinical programs by increasing patient understanding of the value that such programs can provide.

Furthermore, because patient-reported data were unavailable for patients in the specialty pharmacy and retail pharmacy groups, patient-reported data for the DTM group had to be evaluated with a preperiod versus postperiod design, which is not ideal in a progressively disabling condition such as MS. In addition, more accurate measures of MS relapse rates and health plan costs would have been yielded if medical claims data had been available.

In conclusion, an MS DTM program focusing on medication management resulted in increased adherence and persistence to injectable MS medications and decreased MS relapses, but there were no significant changes in HRQOL or work productivity. Patients indicated that the program was helpful in enabling them to better manage their health.

We thank Jenni Stroup for managing the program operations and Gary Oakes for building the DTM database.

 From Prescription Solutions (KMS, JSS, SG, ASMH, BKS, HCL), Irvine, CA.

No outside funding was obtained for this study.

 Dr Stockl reports owning stock in United Healthcare, the parent company of Prescription Solutions. The other authors (JSS, SG, ASMH, BKS, HCL) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Articles

This study evaluated the effect of a multiple sclerosis disease therapy management program on medication adherence, therapy persistence, relapses, work productivity, and quality of life.

Improving Patient Self-Management of Multiple Sclerosis Through a Disease Therapy Management Program

: To evaluate the risk of adverse events (AEs) and the healthcare costs for elderly patients receiving specific potentially inappropriate medications (PIMs).

: Patients 65 years and older who started 1 of 23 PIMs were matched with control subjects who were not receiving PIMs. The following 4 AEs and PIMs were evaluated: delirium or hallucinations with Beers high-severity (BHS) anticholinergics, delirium or hallucinations with BHS narcotics (meperidine hydrochloride or pentazocine lactate or pentazocine hydrochloride), extrapyramidal effects with trimethobenzamide hydrochloride, and falls or fractures with BHS sedative hypnotics. The risk of having the AE of interest within 360 days and the annual healthcare costs were examined.

: Patients receiving BHS sedative hypnotics were significantly more likely to have a fall or fracture than controls (hazard ratio, 1.22; 95% confidence interval [CI], 1.10-1.35). Patients receiving BHS anticholinergics did not have higher risk of delirium or hallucinations than controls (hazard ratio, 1.03; 95% CI, 0.91-1.16). Delirium or hallucinations occurred at a higher rate among patients receiving BHS narcotics, and extrapyramidal effects occurred at a higher rate among patients receiving trimethobenzamide; however, too few events occurred to assess statistical significance. For all PIMs evaluated, annual adjusted medical and total healthcare costs were significantly higher for patients exposed to PIMs than for controls.

: The use of certain BHS PIMs in the elderly may increase AEs or healthcare costs.

	Despite widespread adoption of the Beers list of potentially inappropriate medications (PIMs) in the elderly, outcomes data are limited. Clinical and economic outcomes associated with the use of specific PIMs in the elderly were evaluated.

		Patients using Beers high-severity sedative hypnotics had increased risk of falls or fractures.

		Increased risk of delirium or hallucinations was not observed for patients using highseverity anticholinergics.

		Beers high-severity narcotics and trimethobenzamide hydrochloride may increase the rate of adverse events.

		For all PIMs evaluated, medical costs were significantly higher for patients exposed to PIMs than for control subjects.

	Developed in 1997 to improve the quality of pharmaceutical care, criteria by Beers

 have been widely used to identify potentially inappropriate medication (PIM) use in the elderly. In 2002, the Beers criteria were updated to incorporate new information from scientific literature.

 Severity ratings (high vs low) were assigned to each of the medications. Because some medications listed in the Beers criteria may be justified for certain patients, Zhan et al

 convened an expert panel to classify the Beers criteria into the following 3 categories: (1) drugs that should always be avoided by the elderly, (2) drugs that are rarely appropriate for the elderly, and (3) drugs that have some indications but are often misused.

	Clinicians and managed care organizations (MCOs) have adopted the Beers criteria to help identify and target elderly members who may be at risk of adverse events (AEs) due to their use of PIMs. Starting in 2006, the National Committee for Quality Assurance

 has included a Healthcare Effectiveness Data and Information Set (HEDIS) performance measure for MCOs to evaluate the percentage of elderly members who received PIMs. The specifications for this HEDIS measure are based on the Beers criteria.

	Despite the wide adoption of the Beers criteria within managed care, outcomes data associated with using these PIMs in the elderly are limited. While MCOs are tasked with developing clinical programs to decrease the use of PIMs in the elderly, it is unknown which specific PIMs are most beneficial to target to improve clinical outcomes and reduce healthcare costs. Because the Beers criteria were developed solely based on an expert consensus panel and have not been studied in controlled clinical trials, it has not been proven that reducing PIM use in the elderly prevents adverse clinical outcomes. Although retrospective claims analyses have examined healthcare expenditures or AEs among elderly patients receiving PIMs in the community setting,

 these studies grouped together patients with different types of PIMs and did not thoroughly examine outcomes associated with specific PIMs. Because outcomes may vary for different PIMs, studies evaluating specific PIMs are necessary to build stronger evidence that the use of PIMs leads to adverse outcomes in the elderly.

	We tested the hypothesis that the use of specific Beers high-severity (BHS) medications designated as “always avoid” or “rarely appropriate” in the elderly would result in increased AEs and healthcare costs. Using retrospective claims data, we evaluated the risk of selected AEs and healthcare costs for elderly patients receiving specific BHS PIMs versus comparable elderly patients not receiving PIMs.

	This was a retrospective cohort study using electronic pharmacy and medical claims from an MCO based in the western United States. To focus the analysis on a limited number of medications that would have a higher likelihood of causing AEs, medications were evaluated if they had a severity rating of “high” using the Beers criteria2 and were classified as “always avoid” or “rarely appropriate” by Zhan et al.

 Based on potential adverse outcomes that could occur in the elderly as reported in the Beers criteria

 these medications fell within the following 5 AE categories: delirium or hallucinations related to BHS anticholinergic use, delirium or hallucinations related to BHS narcotic use, extrapyramidal AEs related to trimethobenzamide hydrochloride use, falls or fractures related to BHS sedative hypnotic use, and hypoglycemia related to chlorpropamide use. Because only 40 patients receiving chlorpropamide were identified, the last category was not included in the evaluation. A total of 23 medications and 4 AE categories were evaluated (

	Patients 65 years and older were identified if they started 1 of 23 PIMs listed in Table 1 (with no prior use during the 180-day preperiod) during the identification period from January 2003 through June 2005. The date of the first prescription of the PIM during the identification period was defined as the index date. Patients 65 years and older who were not receiving the PIM or another PIM within the same AE category were selected as potential control subjects. For controls, an index date was randomly selected within the identification period. 

 gives additional inclusion and exclusion criteria that were applied for the different cohorts. The final cohorts were obtained by matching controls with patients exposed to a PIM on a 1:1 basis using the propensity score method.

 Independent variables used to calculate the propensity score for matching are given in 

. Matching was performed in a stepwise fashion; pairs were matched using the lowest window (propensity score, 0.0000001), and then the window was gradually extended by a factor of 10 until reaching 0.1.

	The primary outcome was the risk of having the AE of interest during a postperiod of up to 360 days for exposed patients versus controls. The AEs of interest were delirium or hallucinations for the BHS anticholinergics, delirium or hallucinations for the BHS narcotics, extrapyramidal effects for trimethobenzamide, and falls or fractures for the BHS sedative hypnotics. Patients were designated as having the AE of interest if they had an inpatient hospitalization, an emergency department visit, or 2 medical claims with a primary diagnosis code representing the AE (Table 1).

	Patients were followed up from the index date until the first date when one of the following conditions occurred: (1) the patient discontinued the index medication (defined as a gap of >30 days past the end of supply date for the last prescription for the index medication and the end of the postperiod), (2) the patient in the anticholinergic or narcotic medication evaluation filled a BHS anticholinergic or narcotic other than the index medication, (3) the patient in the control group for trimethobenzamide filled trimethobenzamide, (4) the patient in the sedative hypnotic evaluation filled a BHS sedative hypnotic other than the index medication, (5) the patient reached the end of the 360-day postperiod, or (6) the patient had an AE of interest.

	Pharmacy ingredient costs, medical charges, and total healthcare costs (pharmacy plus medical) were measured for exposed patients versus controls over the 360-day postperiod. Adjusted costs were estimated for the cohorts after controlling for potential confounding factors.

	Propensity scores were estimated using logistic regression analysis. Proportional hazards regression was used to analyze the relative risk of having the target AE for exposed patients versus controls. Patients who did not have the target AE were censored at their end of follow-up.

	Costs were evaluated using t tests for means, Wilcoxon rank sum tests for medians, and generalized linear models (GLMs) with a log link and gamma distribution for adjusted costs. Adjustment variables included in the GLMs were age, sex, health plan type, geographic state, Charlson Comorbidity Index

 (calculated during the preperiod using a method adapted for electronic claims databases

), and preperiod costs. Statistical analysis was performed using SAS version 9.1 (SAS Institute, Inc, Cary, NC). All comparisons were 2-sided with a .05 level of significance.

	Among 37,358 pairs of patients exposed to BHS anticholinergics and controls, baseline characteristics were similar except that exposed patients filled more days supply for anticholinergics during the preperiod (

). Exposed patients also had higher preperiod medical costs than

	Patients exposed to BHS anticholinergics experienced 15.60 cases of delirium or hallucinations per 1000 person-years compared with 15.18 cases per 1000 person-years for controls (

). The risk of delirium or hallucinations was not significantly different between patients exposed to BHS anticholinergics compared with controls (hazard ratio, 1.03; 95% confidence interval [CI], 0.91-1.16).

	Compared with controls, exposed patients had lower adjusted pharmacy costs ($773 vs $796) but higher adjusted medical costs ($17,154 vs $15,214) and higher adjusted total healthcare costs ($18,398 vs $16,482) during the postperiod (

 <.001 for all). These results are given in 

	The 395 patients who met the identification criteria for exposure to BHS narcotics were matched with controls having similar characteristics (Table 3). Exposed patients had higher preperiod medical costs than controls.

	Delirium or hallucinations occurred at a rate of 16.07 cases per 1000 person-years among exposed patients and 10.75 cases per 1000 person-years among controls (Table 4). However, the number of events (5 for exposed patients and 4 for controls) was too few to assess whether there were statistical differences between cohorts.

	While adjusted postperiod pharmacy costs were similar between cohorts, adjusted postperiod medical costs and adjusted postperiod total healthcare costs were significantly higher for exposed patients than for controls ($26,370 vs $20,952 for medical costs and $27,447 vs $22,471 for total healthcare costs; 

 = .03 for both). These results are given in Table 5.

	There were 1085 patients exposed to trimethobenzamide and 1085 controls. Clinical characteristics were well matched between the 2 cohorts (Table 3). Patients exposed to trimethobenzamide had higher preperiod medical costs than controls.

	Four patients exposed to trimethobenzamide and 1 control experienced extrapyramidal effects (4.09 vs 0.93 cases per 1000 person-years) (Table 4). Statistical testing and regression analysis were not performed because the number of events was too few to make meaningful comparisons.

	Compared with controls, exposed patients had similar adjusted pharmacy costs ($907 vs $916; 

 = .86) and significantly higher adjusted medical costs ($27,722 vs $16,647; 

 <.001) and adjusted total healthcare costs ($29,144 vs $18,034; 

	For 13,542 pairs of patients receiving BHS sedative hypnotics and controls, most of the clinical variables were similar; however, the exposed cohort had a higher percentage of patients with a medical condition that may increase the risk of falls or fractures than controls (17.3% vs 16.0%) (Table 3). Exposed patients also had higher preperiod medical costs than controls. Exposed patients had more cases of fall or fracture per 1000 person-years (69.10 vs 56.36) and were significantly more likely to have a fall or fracture than controls (hazard ratio, 1.22; 95% CI, 1.10-1.35; 

 <.001). These results are given in Table 4.

	Adjusted pharmacy costs were similar for patients exposed to BHS sedative hypnotics compared with controls (Table 5). However, exposed patients had significantly higher adjusted medical and total healthcare costs than controls ($20,537 vs $15,835 for adjusted medical costs and $21,807 vs $17,154 for adjusted total healthcare costs; 

	In this evaluation of BHS PIMs categorized as “always avoid” or “rarely appropriate” for the elderly, the risk of developing an AE was different depending on the category of PIM. Patients receiving BHS sedative hypnotics were 22% more likely to have a fall or fracture than controls. In contrast, patients receiving BHS anticholinergics were not found to have a higher risk of delirium or hallucinations than controls. While delirium or hallucinations occurred at a higher rate among patients receiving BHS narcotics compared with controls and extrapyramidal effects occurred at a higher rate among patients receiving trimethobenzamide compared with controls, too few events occurred to assess statistical significance. For all 4 types of BHS PIMs, annual adjusted medical and total healthcare costs were significantly higher for exposed patients than for controls.

	While these results are consistent with other retrospective claims analyses that have shown an association between PIM use in the elderly and increased adverse clinical outcomes

 this study adds to the current literature because it examines patients receiving specific PIMs instead of a heterogeneous mix of patients receiving different types of PIMs. In an era of limited healthcare resources, these results may help MCOs prioritize which specific medications and patients to target for interventions designed to reduce the use of PIMs in the elderly.

	The fact that elderly patients receiving BHS sedative hypnotics had an increased risk of falls or fractures is not surprising because the use of sedative hypnotics has long been implicated as contributing to falls and fractures among the elderly.

 Additional analysis of 790 patients within this study who were exposed to a BHS sedative hypnotic and who had a fall or fracture found that the mean (SD) event-related medical costs per patient over the 3-month period was $10,339 ($22,406) (median, $1821). These findings lend support to the current Medicare Part D design in which certain sedative hypnotics (eg, benzodiazepines) are a benefit exclusion. For non—Part D plans, these results justify the need to conduct interventions to minimize the use of BHS sedative hypnotics among the elderly and help prevent high medical costs associated with falls or fractures.

	With such a large sample size (37,358 pairs), it is surprising that patients receiving BHS anticholinergics did not have increased risk of developing delirium or hallucinations. While delirium or hallucinations would be expected with BHS anticholinergics in theory, perhaps the way that patients actually take these medications in the real-world setting minimizes the number of observed events. Patients may take these medications intermittently or at low doses and, as a result, may never experience such events. Another possible explanation is that delirium or hallucinations may be overlooked by patients or caregivers and may never be reported to the patient’s physician. It is also possible that these events were reported but the provider did not code them in the encounter. Delirium and hallucinations may be underrecognized or undercoded in the claims database.

	Although patients receiving BHS anticholinergics did not seem to have an increased risk of delirium or hallucinations, they had higher total postperiod healthcare costs. The disparity between AEs and healthcare costs for the BHS anticholinergics may be owing to these medications causing other AEs that were not evaluated in this analysis. While this study focused on evaluating the risk of delirium and hallucinations, which was the primary AE of concern as reported in the literature,10 it is possible that BHS anticholinergics could increase the risk of other costly events (eg, falls and fractures) that were not studied within this analysis. Further evaluation of different AE outcomes among patients exposed and not exposed to BHS anticholinergics may help explain some of the factors contributing to increased healthcare costs.

Clinical and economic outcomes associated with the use of specific potentially inappropriate medications in the elderly were evaluated.

Karen M. Stockl, PharmD

Articles

Improving Patient Self-Management of Multiple Sclerosis Through a Disease Therapy Management Program

Clinical and Economic Outcomes Associated With Potentially Inappropriate Prescribing in the Elderly