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Malpractice Rx


Should you restrain yourself from ordering restraints?

Vol. 9, No. 9 / September 2010

Dear Dr. Mossman:
We often have to administer sedating medications to aggressive patients who pose an immediate threat of harm to themselves or others. But I am unsure about whether these “chemical restraints” create more liability problems than “physical restraints”—or vice versa. Does one type of restraint carry more legal risk than the other?—Submitted by “Dr. L”

Mental health professionals view “mechanical” or “physical” restraints in a way that really differs from how they felt 2 decades ago. In the 1980s, physical restraint use was a common response when patients seemed to be immediately dangerous to themselves or others. But recent practice guidelines say physical restraints are a “last resort,” to be used only when other treatment measures to prevent aggression fail to work.

What should psychiatrists do? Is use of physical restraints malpractice? Are “chemical” restraints better?

This article looks at:

  • definitions of restraint
  • medical risks of restraint
  • evolution and status of restraint policy
  • what you can do about legal risks of restraint.

DO YOU HAVE A QUESTION ABOUT POSSIBLE LIABILITY?

  • Submit your malpractice-related questions to Dr. Mossman at douglas.mossman@qhc.com.
  • Include your name, address, and practice location. If your question is chosen for publication, your name can be withheld by request.

Definitions

In medical contexts, restraint typically refers to “any device or medication used to restrict a patient’s movement.”1 The longer, official US regulatory definitions of physical and chemical restraints appear in Table 1.2 Two important notes:

  • Neither regulatory definition of restraint is limited to psychiatric patients; both definitions and the accompanying regulations on restraint apply to any patient in a hospital eligible for federal reimbursement.
  • The definition of physical restraint would include holding a patient still while administering an injection.

The detailed interpretive rules (“Conditions of Participation for Hospitals”)3 for these regulations require hospitals to document conditions surrounding and reasons related to restraint incidents and to make this documentation available to federal surveyors.

Table 1

Federal regulatory definitions of ‘restraint’

Physical restraint

Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely

Chemical restraint

A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition

Source: Reference 2

Medical risks of restraint

In 1998, the Hartford Courant investigative series “Deadly restraint”4 reported on 142 deaths of psychiatric patients and alerted the public to the potentially fatal consequences of physical restraint. Often, restraint deaths result from asphyxia when patients try to free themselves and get caught in positions that restrict breathing.5 Other injuries—particularly those produced by falls—can result from well-intentioned efforts to protect confused patients by restraining them.6

Evolution of restraint policy

Although restraining patients might inadvertently cause harm, isn’t it better to restrain someone, which prevents harm from aggression and accidents? Mental health professionals once thought the answer to this question was, “Of course!” But scientific data say, “Often not.”

Studies conducted when physical restraint was more common found order-of-magnitude disparities in restraint rates at sites with similar patient populations. This suggested that institutional norms and practice styles—not patients’ problems or dangerousness—explained why much restraint occurred.7-9

Reacting to these kinds of findings, psychiatric hospitals in the United States and abroad implemented various methods and policy changes to reduce restraint. Follow-up studies typically showed that episodes of restraint and total time spent in restraints could decrease markedly without any increase in events that harmed patients or staff members.10 In addition, mental health professionals now recognize that being restrained is psychologically traumatic for patients, even when restraint causes no physical injury.11

Patients in psychiatric settings represent a minority of persons who get restrained. On inpatient medical/surgical units, patient confusion and wandering, fall prevention, and perceived medical necessity can lead to physical restraint use.12 Yet physical restraints as innocent-seeming as bed rails can lead to deaths and injuries.13

Nursing homes are another environment where restraints may be common but sometimes detrimental. A recent study found that in all aspects of nursing home patients’ health and functioning—behavior, cognitive performance, falls, walking, activities of daily living, pressure sores, and contractures—physical restraints lead to worse outcomes than leaving patients unrestrained.14

For all these reasons, restraining patients is often viewed as “poor practice”14 and a response of last resort for behavioral problems.15-17

Federal regulations

Publication of the Courant article spurred Congress to develop standards18 that, a decade later, permit restraint or seclusion only when less restrictive interventions will not prevent harm, only for limited periods, and only with careful medical monitoring. Restraint is permissible when no alternative exists, but facilities that use restraint must train staff members to recognize and avert situations that might lead to physical interventions and must generate proper documentation each time restraint is used.2

Federal regulations also apply to “chemical restraints” and aim to restrict their use. This doesn’t mean you can’t use drugs to treat patients, however. Regulations explicitly allow you to prescribe “standard treatment” (Table 2)3 to help your patients function or sleep better, to alleviate pain, or to reduce agitation—and such uses of medication are not “chemical restraint.” Rather, you’re using “chemical restraint” if you prescribe a drug to control bothersome behavior—for example, to “knock out” a patient with dementia whose “sundowning” bothers staff members.19 Psychiatrists should be familiar with the risks of medications used for behavioral control, particularly in elderly patients.20

Table 2

Federal criteria for ‘standard treatment‘

Medication is used within FDA-approved pharmaceutical parameters and manufacturer indications

Medication use follows standards recognized by the medical community

Choice of medication is based on patient’s symptoms, overall clinical situation, and prescriber’s knowledge of the patient’s treatment response

Source: Reference 3

Avoiding legal risks

No study or systematic data will ever tell us whether physical or chemical restraints create a greater liability risk. Obviously, the best way to avoid legal liability for restraints is to minimize use of physical restraints and to avoid using medications as chemical restraints. Psychiatrists who work in hospitals or other institutional settings can politely but firmly decline to prescribe medications or to order physical restraints when staff members request these measures for non-therapeutic reasons—ie, for a patient who has calmed down but whom staff members believe “needs to learn a lesson” or “get some consequences” for throwing a chair. When restraints are necessary, psychiatrists (along with other staff members) should document the reasons why, including what other interventions were tried first.

Many psychiatric facilities and care systems have reduced incidence of restraint and time spent by patients in restraint through programs that broadly address institutional practices. Such programs usually involve a multi-disciplinary, multi-strategy commitment to alternatives—to helping staff members see that restraints represent a failure in treatment rather than a form of treatment, and to developing other mechanisms for averting or responding to patients’ aggression before restraint becomes the only option.10,21 Individual psychiatrists can play an important role in advocating and supporting institutional policies, practices, and training that help staff members minimize restraint use.

References

1. Agens JE. Chemical and physical restraint use in the older person. BJMP. 2010;3:302.-

2. Code of Federal Regulations. Conditions of participation for hospitals: Condition of participation: Patient’s rights. Title 42, Part 482, § 482.13. Available at: http://edocket.access.gpo.gov/cfr_2004/octqtr/pdf/42cfr482.13.pdf. Accessed July 21, 2010.

3. Department of Health and Human Services, Centers for Medicare and Medicaid Services Pub. 100-07 State Operations (Provider Certification, Transmittal 37). Available at: https://146.123.140.205/transmittals/downloads/R37SOMA.pdf. Accessed July 20, 2010.

4. Weiss EM. Deadly restraint: a Hartford Courant investigative report. Hartford Courant. October 11-15, 1998.

5. Karger B, Fracasso T, Pfeiffer H. Fatalities related to medical restraint devices—asphyxia is a common finding. Forensic Sci Int. 2008;178:178-184.

6. Inouye SK, Brown CJ, Tinetti ME. Medicare nonpayment, hospital falls, and unintended consequences. N Engl J Med. 2009;360:2390-2393.

7. Betemps EJ, Somoza E, Buncher CR. Hospital characteristics, diagnoses, and staff reasons associated with use of seclusion and restraint. Hosp Community Psychiatry. 1993;44:367-371.

8. Crenshaw WB, Francis PS. A national survey on seclusion and restraint in state psychiatric hospitals. Psychiatr Serv. 1995;46:1026-1031.

9. Ray NK, Rappaport ME. Use of restraint and seclusion in psychiatric settings in New York State. Psychiatr Serv. 1995;46:1032-1037.

10. Smith GM, Davis RH, Bixler EO, et al. Pennsylvania State Hospital system’s seclusion and restraint reduction program. Psychiatr Serv. 2005;56:1115-1122.

11. Frueh BC, Knapp RG, Cusack KJ, et al. Patients’ reports of traumatic or harmful experiences within the psychiatric setting. Psychiatr Serv. 2005;56:1123-1133.

12. Forrester DA, McCabe-Bender J, Walsh N, et al. Physical restraint management of hospitalized adults and follow-up study. J Nurses Staff Dev. 2000;16:267-276.

13. The Joint Commission. Bed rail-related entrapment deaths. Available at: http://www.jointcommission.org/ sentinelevents/alert/sea_27.htm. Accessed July 20, 2010.

14. Castle NG, Engberg J. The health consequences of using physical restraints in nursing homes. Med Care. 2009;47:1164-1173.

15. Marder SR. A review of agitation in mental illness: treatment guidelines and current therapies. J Clin Psychiatry. 2006;67(suppl 10):13-21.

16. Borckardt JJ, Grubaugh AL, Pelic CG, et al. Enhancing patient safety in psychiatric settings. J Psychiatr Pract. 2007;13:355-361.

17. National Association of State Mental Health Program Directors. Position Statement on Seclusion and Restraint. Available at: http://www.nasmhpd.org/general_files/position_statement/posses1.htm. Accessed July 18, 2010.

18. Appelbaum P. Seclusion and restraint: Congress reacts to reports of abuse. Psychiatr Serv. 1999;50:881-882, 885.

19. Centers for Medicare and Medicaid Services. State operations manual: appendix A—survey protocol, regulations and interpretive guidelines for hospitals. Available at: http://www.cms.gov/manuals/downloads/som107ap_a_hospitals.pdf. Accessed July 20, 2010.

20. Salzman C, Jeste DV, Meyer RE, et al. Elderly patients with dementia-related symptoms of severe agitation and aggression: consensus statement on treatment options, clinical trials methodology, and policy. J Clin Psychiatry. 2008;69:889-898.

21. Gaskin CJ, Elsom SJ, Happell B. Interventions for reducing the use of seclusion in psychiatric facilities: review of the literature. Br J Psychiatry. 2007;191:298-303.

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