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back (Cases of ECT) forward (References) Table of Contents 32 CONCLUSION This report is the culmination of a one-year review of the practice of ECT in the State of New York. Proponents and opponents of ECT passionately debate and defend their perspectives. Literature can be found supporting the contentions of both sides of this debate. The Committee received testimony and written communications from individuals who had benefited from ECT and from individuals who had suffered permanent damage. Based on its review, the Committee is not prepared to call for a ban on ECT use in the State. However, the Committee identified several issues of concern and has proposed legislation to address these concerns. Much of the argument that swirls around ECT relates to its safety. The federal Food and Drug Administration (FDA) considers ECT devices to be experimental, Class III medical devices. Such a classification is used for pre-market approval for devices that show an unreasonable risk of illness or injury. The FDA has never tested ECT devices to ensure their safety. The American Psychiatric Association (APA) has identified certain devices that should no longer be used for ECT, yet it is apparent that these devices continue to be used. In order to render the safety argument moot, the federal government needs to test all ECT devices for safety and to promulgate protocols that will maximize the benefits and minimize associated risks. Accordingly, the Committee calls upon the Legislature to pass a resolution urging the U.S. Congress to require the FDA to test ECT equipment for safety. The lack of minimum federally approved standards and protocols have exacerbated the problem. The American Psychiatric Association (APA) has recognized and promulgated standards and protocols in 1990 and again in 2001. However, these are voluntary standards and are not being implemented in all facilities that provide ECT. The Committee's review found several instances in both state operated and private sector facilities where protocols recommended by the APA were not being followed. For this reason. the Committee also calls on the Legislature to pass a resolution urging the U.S. Congress to enact legislation establishing proper protocols for the administration of ECT. The Committee recognizes that the federal government may take some time to act. In the interim, there are steps the Legislature can take now to improve the safety of ECT use in the State. Currently, there is no effective reporting mechanism regarding ECT use in the State. The Committee finds there is little information regarding how ECT is practiced in the State. Based upon existing information, there is considerable variation in the nature of ECT practices. Moreover, patients are being treated in a fashion that markedly departs from professional standards of practice recommended by the APA. Assembly bill A. 9083 requires mandatory reporting of information regarding ECT to enable the OMH Commissioner to better regulate the use of ECT and help ensure that the Legislature can effectively exercise its constitutional function. The report will include: The number of patients who receive ECT, both inpatient and outpatient. The number of patients for whom a court order was sought, including the results of such action. The age, sex, race and diagnosis of patients who receive ECT. Injuries reported and autopsy findings if the patient died within fourteen days of the administration of ECT. 33 Assembly bill A. 9082 establishes a temporary advisory council to address issues related to ECT, including but not limited to: Education and training of ECT practitioners and standards for ECT administration Safety of equipment. An analysis of the efficacy of ECT on special populations. Resources to be given to patients to help them learn more about ECT Assembly bill A. 9084 requires all facilities practicing ECT be accessible to emergency treatment. As the NIH and the APA have pointed out. ECT can have serious adverse physical consequences. It is prudent to require such access in order to avoid life-threatening situations that may be associated with the use of ECT. Protecting the mental health of the people of the state by providing appropriate care and treatment to persons afflicted with mental illness and ensuring that such persons are treated with dignity and respect are matters of public concern. Protecting the rights of patients and ensuring the appropriateness of medical interventions are based on proper diagnoses and are therefore also matters of public concern. The Committee identified weaknesses regarding the determination of the capacity of a patient to make an informed decision regarding the use of ECT. The Committee also identified weaknesses in the informed consent process. Assembly bill A. 9081 requires: In addition to the treating physician, a licensed psychologist who is not an employee of the facility will provide a written opinion regarding the patient's capacity to consent to ECT. If a patient is determined to possess capacity to consent, the patient will be: 1. Given written disclosure of the benefits and risks, and any less intrusive alternative treatments. 2. Provided with a list of resources to learn more about ECT. 3. Given a minimum of five business days to decide whether to consent. 4. Asked to sign a consent to treatment form which, with the written disclosure will be included in the patient's clinical record. 5. Informed, in writing, that the patient may withdraw consent to the treatment at any time. If the patient is determined to lack capacity and that ECT is appropriate, the clinical director may apply for court authorization. The determination of incapacity and the determination that the proposed treatment is in the best interests of the patient will be based on clear and convincing evidence. The burden of proof will rest with the clinical director of the facility. The Legislature has a constitutional obligation to protect and promote the health including, specifically, the mental health of the residents of the State. The federal government also has an obligation to protect and promote the health and well being of its residents. 34 The Committee has identified areas of concern and proposed the aforementioned legislative initiatives to address issues in need of attention. The Committee recognizes that these legislative Initiatives will satisfy neither proponents nor opponents of ECT. Proponents will argue that the legislation goes too far in regulating the use of ECT and that voluntary compliance with standards and protocols developed by the American Psychiatric Association are sufficient. Opponents will argue the legislation does not go far enough and have called for, at the very least, a ban on involuntary, court ordered ECT. Simply, adversaries would prefer a total ban on the use of ECT. The Committee finds that the proposed legislative initiatives are prudent, given the present state of information regarding the safety of ECT equipment, protocols, capacity and informed consent determination procedures, and risks/benefits associated with ECT, based on diagnoses, age and other factors. |
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