Challenges in the Pharmacologic Management of Nursing Home Residents (NHR) With Overactive Bladder (OAB) and/or Urinary Incontinence (UI)

Barbara J. Zarowitz1, Terrence O’Shea1, Carrie Allen1, Eric G. Tangalos2, Todd Berner3, Joseph G. Ouslander4

1Omnicare, Inc.; 2Mayo Clinic, Rochester, MN; 3Formerly of Medical Affairs, Americas, Astellas Pharmaceutical Global Development, Northbrook, IL, USA; 4Florida Atlantic Univ.

The research reported on this poster was supported by Astellas. The investigators retained full independence in the conduct of this research

OBJECTIVESOBJECTIVES

METHODSMETHODS

DISCUSSIONDISCUSSION

The purpose of this descriptive, retrospective study was to determine the clinical profile and treatment patterns of NHR with OAB and/or UI through analysis of Minimum Data Set (MDS) [version 3.0] and prescription claims records. Specific aims included identification of NHR who had potential:

relative pharmacologic contraindications to antimuscarinic treatment due to concomitant anticholinergic medications and/or acetylcholinesterase inhibitors (AChEIs); and

non-pharmacologic limitations to treatment with antimuscarinics [i.e., severe mobility impairment (SMI) and/or moderate-to-severe cognitive impairment (MSCI)].

LIMITATIONSLIMITATIONS

CONCLUSIONSCONCLUSIONS

• After receiving IRB approval, a data extract was obtained from the Omnicare Senior Health Outcomes data repository of linked and de-identified MDS and prescription claims records from 9/2010 to10/2012

• UI identified by ICD-9 codes or MDS documentation; OAB by ICD-9 codes only

• Cognition assessed by MDS Brief Interview for Mental Status (BIMS) Summary Scores, calculated Cognitive Performance Scale (CPS) scores, or Cognitive Skills for Daily Decision Making; Severe Mobility Impairment identified in MDS Section G (Functional Status)

• A subset of these NHR with prescription claims data was identified and analyzed for medication utilization. Anticholinergic medications were identified from an accepted list published in Omnicare’s Geriatric Pharmaceutical Care Guidelines®

• For the purposes of defining potential antimuscarinic treatment candidates, we applied two definitions. To define those who would most likely benefit from treatment (Definition 1), we excluded NHR with MSCI, severe mobility impairment, and those receiving anticholinergic, AChEI and antimuscarinic medications at the time of evaluation. A less restrictive candidate antimuscarinic treatment population (Definition 2) was defined by excluding only NHR with MSCI and SMI, and those receiving antimuscarinic therapy, without concomitant interfering medications, at the time of evaluation.

• The derivation of the study sample is depicted in Figure 1.

• Identifying and excluding NHR with characteristics that precluded treatment with an antimuscarinic, or potentially contributed to drug-drug and/or drug-disease interactions that may worsen their underlying conditions, allowed us to characterize a small cohort who may benefit from treatment, and in whom no obvious contraindications to treatment existed.

• Among NHR not currently treated with an antimuscarinic, few met eligibility criteria for treatment established a priori, (i.e., absence of MSCI, severe mobility impairment, anticholinergic, antimuscarinic and AChEI therapy).

• Using the more rigorous definition of eligibility for treatment, as few as 6.6% of NHR with OAB and/or UI were considered treatment candidates. Even when only NHR with MSCI and severe mobility impairment were excluded (Definition 2), just 20.4% were considered treatment candidates for antimuscarinic therapy;

• When we explored antimuscarinic treatment of residents with OAB and/or UI and UI alone, we found that 77% of those treated with antimuscarinics had medications with anticholinergic properties prescribed concurrently.

• Prescription of anticholinergic drugs in older persons has been shown to reduce performance in tasks that assessed verbal memory, higher rates of global cognitive dysfunction, delirium, falls, poor physical performance and loss of independence;

• Despite a well-documented pharmacodynamic interaction between antimuscarinic agents and AChEI, we found 24% of NHR with OAB and/or UI received these concurrently.

• A 50% faster rate of functional decline has been documented for NHR with higher levels of functioning when antimuscarinics and AChEIs are administered concomitantly.2

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BACKGROUNDBACKGROUNDThere is a paucity of recent data regarding the identification, clinical profile, and treatment patterns of NHR with OAB and/or UI. As many as 36.7% of short-stay, and 70.3% of long-stay NHR are not in complete control of their bladder function1. Non-pharmacologic approaches such as pelvic floor exercises, prompted voiding, and other assistive toileting programs can be effective for a substantial proportion of NHR with UI. However, the success of such interventions may be diminished by the cognitive and/or functional impairments commonly seen in NHR. Studies have suggested that a subgroup of NHR who do not respond to prompted voiding alone do improve with antimuscarinic treatment , however, relatively few NHR may be candidates for such pharmacologic therapy.

I

RESULTS

• The study may have been subject to under-identification of NHR with OAB given that there is not an MDS- specific item dedicated to the diagnosis for OAB.

• There are potential inaccuracies in coding of MDS data due to poor medical historical data and inter-rater variability.

• Our design was not longitudinal and did not evaluate changes in cognitive or functional status over time. Therefore, we were unable to draw any conclusions about the contribution of drug-drug and drug-disease interactions to the status of the NHR.

• This study advances our understanding of the challenges in prescribing treatment safely and appropriately in elderly NHR with a high prevalence of underlying cognitive and functional impairment.

• Many NHR are poor candidates to proven non-pharmacological interventions to address UI.

• Relatively few NHR are candidates for antimuscarinic therapy.• Alternate drug classes for treatment of comorbid conditions in older

persons with OAB and/or UI should be considered.

REFERENCESREFERENCES1. Landefeld CS et al. NIH state-of-the-science conference statement: prevention of

fecal and urinary incontinence in adults. Ann Intern Med 2008;148:449-58.2. Sink KM, Thomas J, Xu H et al. Dual use of bladder anticholinergics and

cholinesterase inhibitors: long-term functional and cognitive outcomes. J Am Geriatr Soc 2008; 56:847-53.