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Effect of New York State Regulatory Action on Benzodiazepine Prescribing and Hip Fracture Rates

Anita K. Wagner, PharmD, MPH, DrPH; Dennis Ross-Degnan, ScD; Jerry H. Gurwitz, MD; Fang Zhang, MS, PhD; Daniel B. Gilden, MS; Leon Cosler, PhD; and Stephen B. Soumerai, ScD
[+] Article and Author Information

From Harvard Medical School and Harvard Pilgrim Health Care, Boston, Massachusetts; Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Foundation, and Fallon Community Health Plan, Worcester, Massachusetts; JEN Associates, Inc., Cambridge, Massachusetts; and Albany College of Pharmacy and Management Reports & Research Unit, Office of Medicaid Management, New York State Department of Health, Albany, New York.


Disclaimer: The conclusions derived in this manuscript are those of the authors and not of the New York State Department of Health.

Acknowledgments: The authors thank Dr. Woopill Hwang for facilitating the extract of New York Medicaid data; Joyce Cheatham, Robert LeCates, Mai Manchanda, and Ann Payson for administrative support; and Dr. Sebastian Schneeweiss for insightful comments on an earlier version of the manuscript.

Grant Support: From the National Institute on Aging (grant R01 AG19808-01A1; principal investigator, Stephen B. Soumerai) and the National Institute on Drug Abuse (grant R01DA10 371-01; principal investigator, Stephen B. Soumerai). Drs. Wagner, Soumerai, Ross-Degnan and Gurwitz were also investigators in the HMO Research Network Centers for Education and Research on Therapeutics Prescribing Safety Study (Agency for Health Care Research and Quality Cooperative Agreement U 18 HS 11843; principal investigator, Richard Platt).

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Stephen B. Soumerai, ScD, Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, 133 Brookline Avenue, 6th Floor, Boston, MA 02215; e-mail, ssoumerai@hms.harvard.edu.

Current Author Addresses: Drs. Wagner, Ross-Degnan, Zhang, and Soumerai: Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, 133 Brookline Avenue, 6th Floor, Boston, MA 02215.

Dr. Gurwitz: Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Foundation, and Fallon Community Health Plan, 630 Plantation Street, Worcester, MA 01605.

Mr. Gilden: JEN Associates, Inc., 5 Bigelow Street, Cambridge, MA 02139.

Dr. Cosler: Albany College of Pharmacy, 106 New Scotland Avenue, Albany, NY 12208.

Author Contributions: Conception and design: A.K. Wagner, J.H. Gurwitz, S.B. Soumerai.

Analysis and interpretation of the data: A.K. Wagner, D. Ross-Degnan, F. Zhang, D.B. Gilden, L. Cosler, S.B. Soumerai.

Drafting of the article: A.K. Wagner, D. Ross-Degnan, S.B. Soumerai.

Critical revision of the article for important intellectual content: A.K. Wagner, D. Ross-Degnan, J.H. Gurwitz, F. Zhang, D.B. Gilden, L. Cosler, S.B. Soumerai.

Final approval of the article: A.K. Wagner, D. Ross-Degnan, J.H. Gurwitz, F. Zhang, S.B. Soumerai.

Provision of study materials or patients: L. Cosler.

Statistical expertise: F. Zhang.

Obtaining of funding: A.K. Wagner, S.B. Soumerai.

Administrative, technical, or logistic support: S.B. Soumerai.

Collection and assembly of data: D. Ross-Degnan, D.B. Gilden, L. Cosler, S.B. Soumerai.


Ann Intern Med. 2007;146(2):96-103. doi:10.7326/0003-4819-146-2-200701160-00004
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Consistent with the limited data available on changes in rates of benzodiazepine-associated adverse events after the TPP in New York (10, 22), we found that the TPP substantially decreased rates of continued and new use of benzodiazepines but did not decrease the incidence of hip fracture. The only published uncontrolled ecological study of the effect of the TPP on the incidence of hip fracture (10) (which found no effect among elderly persons in New York overall) was not likely to detect an effect, because the investigators did not have access to data on benzodiazepine exposure and could not assess changes in hip fracture rates among subgroups at risk. Our controlled study shows a lack of effect of the TPP in the subgroups at highest risk for hip fractures, defined by female sex and pre-TPP use of benzodiazepines.

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Figures

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Figure 1.
Benzodiazepine use and cumulative incidence of hip fracture before and after the New York triplicate prescription policy (TPP) among women enrolled in Medicaid who did or did not receive at least 1 dispensed benzodiazepine before the policy was implemented.
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Grahic Jump Location
Figure 2.
Benzodiazepine use and cumulative incidence of hip fracture before and after the New York triplicate prescription policy (TPP) among men enrolled in Medicaid who did or did not receive at least 1 dispensed benzodiazepine before the policy was implemented.
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Benzodiazepines, Falls and Fractures
Posted on January 25, 2007
Gerson T. Lesser
Mount Sinai School of Medicine and The Jewish Home and Hospital, New York, NY
Conflict of Interest: None Declared

The use of hypnotics in general, and benzodiazepines in particular, have been largely proscribed in geriatric teaching and practice for some years. Wagner and co-workers (1) have served us well by showing definitively that intervention effecting major reduction of benzodiazepine use in a large, vulnerable population failed to lower the incidence of hip fractures. The authors sensibly conclude that discrepancies between their observations and earlier reports are likely explained by the existence of unmeasured confounders. In a 1999 review and meta-analysis of psychotropic drugs and falls, Leipzig, et al (2) similarly noted the need for further adjustment for potential confounders.

In fact, data presented in recent years have put forth several reasonable and pertinent confounders. In 2000, Brassington and co-workers (3) found that depression, "stress" and sleep difficulties were strongly associated with increased falling in an elderly community-based population. When adjusted for the various risk factors and for medication use, sleep problems were significantly related to falls, but with similar adjustments the use of psychotropic medication was not.

A more recent analysis based on over 34,000 Michigan nursing home residents (4) confirmed and extended Brassington's observations. With adjustment for confounders, falls were strongly related to insomnia, but the relationship of falls and hypnotics use was no longer significant. With the same statistical adjustments, their data did not show any association with hip fracture for either insomnia or hypnotics use.

Obviously, well designed, randomized prospective trials are necessary to establish firm conclusions in this area. Perhaps the ideal control subjects would be well matched elders with similar frequencies of insomnia and psychiatric disorders. In any case, the findings of Wagner and her colleagues suggest it is time to reconsider the use of sedatives and hypnotics. We may be needlessly depriving some older patients of comfort from the sufferings of chronic anxiety and severe insomnia. In addition, there are hints that insomniac nursing home residents not using hypnotics may have even slightly greater frequency of falls than insomniacs using hypnotics (4; Table 2). This may be one more instance in the history of medicine that a practice that seems quite rational proves to be adverse for overall patient care.

References:

1. Wagner AK, Ross-Degnan D, Gurwitz JH, Zhang F, Gilden DB, Cosler L, et al. Effect of New York State regulatory action on benodiazepine prescribing and hip fracture rates. Ann Intern Med. 2007;146:96-103.

2. Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis: I. Psychotropic drugs. J Am Geriatr Soc. 1999;47:30-39.

3. Brassington GS, King AC, Bliwise DL. Sleep problems as a risk factor for falls in a sample of community-dwelling adults aged 64 to 99 years. J Am Geriatr Soc. 2000;48:1234-1240.

4. Avidan AY, Fries BE, James ML, Szafara KL, Wright GT, Chervin RD. Insomnia and hypnotic use, recorded in the minimum data set, as predictors of falls and hip fractures in Michigan nursing homes. J Am Geriatr Soc. 2005;53:955-962.

Conflict of Interest:

None declared

Benzodiazepines and hip fractures
Posted on March 7, 2007
Anita K. Wagner
Department of Ambulatory Care and Prevention, Harvard Medical School and harvard Pilgrim Health Care
Conflict of Interest: None Declared

Dr. Lesser supports our conclusion (1) of the possible lack of a relationship between use of benzodiazepines and hip fractures in the elderly with additional data from the published literature. Since the landmark studies of 1987 (2) and 1989,(3) results of research on the benzodiazepine hip-fracture relationship have become increasingly contradictory. We concur with Dr. Lesser that differences in results are likely due to study design issues, such as benzodiazepine exposure misclassification in prospective cohort studies, (4) and the imperfect control for potential confounders in large claims data-based case-control studies.(5) Based on these results and our study, we believe that broad- based policies like the payment restrictions encompassed in Medicare Part D, which are in part based on these controversial results, are misdirected.

The ideal randomized controlled study of the benzodiazepine-hip fracture relationship is unlikely to ever be conducted, for at least two reasons: Benzodiazepines are inexpensive drugs which have been on the market for a long time, making funding of a costly randomized controlled trial unlikely; and benzodiazepines have proven efficacy; therefore the equipoise principle required for randomizing patients would not be met.

In the absence of a randomized trial, quasi-experimental studies like ours are the best research design option to assess the relationship. Potential confounders of a longitudinal quasi-experimental study would need to be related to the outcome of interest (hip fractures) and happen at the same time as the policy change that gave rise to the quasi- experiment. We believe that no such confounders could have explained our finding of stable rates of hip fractures at a time when use of benzodiazepines suddenly declined by about 60% after a state-wide policy restricting access to the drugs.

However, we also believe that clinicians should evaluate risks and benefits of all medications, including benzodiazepines, based on each patient's unique clinical circumstances and caution against over- interpreting the findings of our study in applying them to individual patient clinical decision-making.

(1) Wagner AK, Ross-Degnan D, Gurwitz JH, Zhang F, Gilden DB, Cosler L, et al. Effect of New York State regulatory action on benodiazepine prescribing and hip fracture rates. Ann Intern Med. 2007;146:96-103.

(2) Ray WA, Griffin MR, Schaffner W, Baugh DK, Melton LJ 3rd. Psychotropic drug use and the risk of hip fracture. N Engl J Med.1987;316:363-369.

(3) Ray WA, Griffin MR, Downey W. Benzodiazepines of long and short elimination half-life and the risk of hip fracture. JAMA.1989;262:3303- 3307.

(4) Ray WA, Thapa PB, Gideon P. Misclassification of current benzodiazepine exposure by use of a single baseline measurement and its effects upon studies of injuries. Pharmacoepidemiology and Drug Saf 2002;11:663-669.

(5) Schneeweiss S, Wang S. Claims data studies of sedative-hypnotics and hip fractures in older people: Exploring residual confounding using survey information. J Am Geriatr Soc.2005;53:948-954.

Conflict of Interest:

None declared

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