Introduction In July 1999, CMS expanded drug use review protocols of nursing homes [NH] to include 41 inappropriate medications. Evaluation of National Drug Use Reviews to Improve Patient Safety in Nursing Homes Largest effort to codify standards of safe medication use in NHs since the 1987 OBRA to reduce antipsychotics. State surveyors and consultant pharmacists must evaluate medication records for: Becky Briesacher, PhD1 Rhona Limcangco, MPharm2 Linda Simoni-Wastila, PhD1,2 Jalpa Doshi, PhD3 Jerry Gurwitz, MD1 1University of Massachusetts of Maryland 3University of Pennsylvania use of inappropriate drugs, adverse medication reactions, or justification if exempted use. 2University For noncompliance, surveyors may cite facility as deficient in care and jeopardize CMS certification status. May 2004 Funded by Centers of Medicare and Medicaid Services (CMS) 1 Background and Study Objective Methods New drug criteria based on 1997 consensus list of risky medications for older adults (Beers criteria); Data Criteria apply to all adults 65+ and some relate to specific diseases. Highest use of Beers drugs occurs in NHs. (23%-40%). 1997-2000 Medicare Current Beneficiary Survey (MCBS), nationally representative dataset of community-dwelling and institutionalized Medicare beneficiaries Overlapping panel samples selected w/stratified probability design (n=12,000) Data contain surveys of health status and medical care linked to Medicare Part A and B claims. No agreement about best solutions to reduce use. Advocates for policy interventions believe unsafe medication use will continue unabated without drug reviews. Our study linked a restricted file of MCBS LTC medications. LTC medication file contains monthly chart abstracts of MARs. Critics argue prescribing habits will naturally decline as new practice patterns omit “archaic and offensive” drugs. Study sample To test if nationally-required drug use reviews reduce exposure to inappropriate medications in NHs. Medicare beneficiaries in NHs [unweighted n=2,242] and comparator group in Assisted Living Facilities (ALF) [unweighted n=664]. 2 Methods 3 Methods Criteria Analysis Study created measures for 38 of 41 CMS criteria Study constructed quarterly observations of medication use Estimated prevalent use and new exposures (3 drugs omitted due to ill-defined disorders such as insomnia) new drug use is preceded by three months’ without any use Did not apply CMS protocols for exceptions Criteria categorized by consensus classification of justifiable use (Zhan 2001): (e.g., some criteria do not apply if medication given intermittently) Plotted exposure rates in relation to policy implementation (11 quarters prior and 5 quarters post). always avoid (e.g. Barbiturates such as Barbital) rarely appropriate (e.g., Valium), or some acceptable indications (e.g., Amitriptyline). Compared pre- and post-policy estimates between NHs and ALFs Medical claims/health surveys examined for disease criteria Statistical Approach: descriptive frequencies and multivariate analysis controlling for demographics and health status Diabetes, BPH, COPD, GERD/PUD, arrhythmia, or seizure/epilepsy. 4 5 1 Figure 1. to be avoided or rarely appropriate by medication use always Fig 1National US estimates of inappropriate institutional residence, 1997-2000 Table 1. Population Characteristics, 1997 and 2000 6 Nursing Home 1997 n=2,026,000 Average age 80.3 73.6 Female (%) 67.7 White race (%) 88.1 Fair-Poor Health (%) 65.8 ALF NH n=496,000 n=1,860, 000 n=585, 000 80.5 74.6 ALF 67.1 69.3 68.0 95.5 86.3 94.9 43.5 65.9 41.4 44.6 27.1 24.0 3.2 3.8 23.8 7.1 34.4 16.8 17.8 4.1 2.6 13.5 5.3 42.3 29.6 30.1 5.6 2.6 31.1 8.0 32.0 20.9 15.5 3.4 1.0 17.1 4.2 7.6 7.2 8.9 7.9 Average Monthly Rx Use July 1999 CMS Policy Expansion 5 4 Percent Prevalence NH Weighted total Select Conditions (%) Dementia/Alzheimer’s Diabetes Chronic lung disease BPH GERD/PUD Seizure/Epilepsy Arrhythmia Assisted Living 2000 Characteristics 3 2 1 0 Q1-1997 Unweighted unique n=928 (1997) n=843 (2000) NH; n=250 (1997) n=289 (2000) ALF Q2 Q3 Q4 Q1-1998 Q2 Q3 Source: MCBS, 1997-2000 Q4 Q1-1999 Q2 Q3 Q4 Q1-2000 Q2 Q3 7 Figure 2. National estimates of inappropriate medication use that may have some indications by institutional residence, 1997-2000 Fig 2 Nursing Homes Q4 Quarters 6 Figure 3. National US estimates of innapropriate medication use restricted with specific diagnoses, by institutional residence, 1997-2000 Fig 3 Assisted Living Nursing Home Assisted Living 20 25 July 1999 CMS Policy Expansion July 1999 CMS Policy Expansion 20 Perce nt Pre va len ce Percent Prevalence 15 15 10 10 5 5 0 0 Q1-1997 Q2 Q3 Q4 Q1-1998 Q2 Q3 Q4 Q1-1999 Q2 Q3 Q4 Q1-2000 Q2 Q3 Q4 Q1-1997 Q2 Q3 Q4 Q1-1998 Q2 Q3 Q4 Q1-1999 Q2 Q3 Q4 Q1-2000 Q2 Q3 Q4 Quarters Quarters 8 9 Results Caveats and Conclusion Descriptive analysis found evidence of general trend toward less Beers criteria prescribing in ALFs and NHs rather than policy impact. •Cross-over effects possible •Post-policy observation may have been too short Pre-policy and Post-policy prevalence rates: NH 28.8% (95% CI: 27.3-30.3) to 25.6% (CI: 24.1-27.1, p<.05) ALF 22.4% (CI: 19.8-25.0) to 19.0% (CI: 16.7-21.3). Study highlights unclear effectiveness of trying to improve patient safety in NH through nationally mandated drug use reviews. Prescriber disfavor did not include disease criteria. Our study is the first to evaluate CMS policy on inappropriate medications. Most prescribing in post-period is new use (16.4% in NH vs. 16.6% in ALFs) Study is among the first to use MCBS LTC drug files. Multivariate analysis detected no differences in post-policy use of inappropriate drugs between NHs and ALFs. 10 11 2