PSYCHOTROPIC / PSYCHOACTIVE DRUGS Presented by: Jun Hernandez, R.N. Prepared by: Rhonda Anderson, RHIA

PSYCHOTROPIC DRUGS The 2008 Supplemental Guidance highlighted several quality of care areas: Pharmaceutical services – A failure to manage pharmaceutical services properly can seriously jeopardize resident safety and even result in resident deaths. Medication management and psychotropic medications with an emphasis on unnecessary drugs figured prominently. Comprehensive care plans – OIG Supplemental Compliance Program Guidance for Nursing Facilities, Federal Register, Volume 73, No. 190 (September 30, 2008). (

MEDICATION MANAGEMENT Are there medication management processes in place to: Ensure the safe and effective use of medication? Minimize adverse drug interactions and effects? Ensure that irregularities in a resident's drug regimen are promptly discovered and addressed?

MEDICATION MANAGEMENT -2 The key here is to look at the medications and the interactions; not just a statement that the pharmacist and/or Dr. says they were ordered; but the focus is really looking at the interactions, black box warnings; and assessment of the resident by physician and nursing.

PSYCHOTROPIC MEDICATIONS Nursing facilities should ensure that there is an adequate indication for the use of the medication and carefully monitor, document, and review the use of each resident's psychotropic drug. Are the attending physicians, the medical director, the consultant pharmacist, or other care providers within the facility collaborating to evaluate the outcomes of such care? Have you involved family members?

CARE PLANS Are your attending physicians and the consultant pharmacist involved in the development of these care plans? Do your care plans address the medical, nursing, mental and psychosocial needs for each resident? Do they include reasonable objectives and timetables? Do they address medication use – including behavioral indications for use, side effects, boxed warnings (Black Box Warnings)? Are these care plans fully implemented?

POLYPHARMACY… WHAT IS IT? Polypharmacy refers to the concurrent use of multiple medications in a single patient. Traditionally, polypharmacy has a negative connotation. ??? AND REVIEW THE use of multiple medications.

CONCERNS: ANTIPSYCHOTIC POLYPHARMACY The possibility of a higher than necessary numbers of medications; Greater than necessary total dosages and potential for increased short and long-term adverse effects (total side effect burden); Drug-drug interactions; Difficulties in determining the effect of each treatment; Substantially higher costs; A risk for higher morbidity and mortality; and The general lack of evidence for the effectiveness and safety of antipsychotic polypharmacy.

INFORMED CONSENT & PSYCHOTHERAPEUTIC DRUGS "Informed" implies the sharing of information; Similarly, "consent" means agreeing to do something or to allow something to happen. Legal definition of "Informed Consent" at §72052 of CCR, Title 22: Informed consent means the voluntary agreement of a patient, or a representative of an incapacitated patient, to accept a treatment or procedure after receiving information in accordance with Sections 72527(a)(5) and

INFORMED CONSENT -2 This means documentation of the informed consent; either by the physician’s documentation or delegated for a key nursing staff to explain and obtain the written consent when the Dr. is not there – does not mean delegation of the Dr. responsibility. Get the consent when continuing a medication WHEN A RESIDENT IS ADMITTED!

INFORMED CONSENT -3 WHEN A RESIDENT IS ADMITTED FROM AN ACUTE HOSPITAL Obtain a new consent ( after evaluation of the resident – DO NOT discontinue the medication until evaluation and time to titrate the medication – get informed consent and go from there based on the needs of the resident). The physicians is not there – the facility designee must get the consent.

OBTAIN INFORMED CONSENT Try to obtain the consent of the resident to notify the resident’s interested family member, as designated in the medical record. If the resident consents to the notice, the physician shall make reasonable attempts, either personally or through a designee, to notify the interested family member, as designated in the medical record.

ALL FACILITY LETTER INFORMED CONSENT Purpose of this letter was to notify all SNFs of a change in guidance at CCR, Title 22, Section 72528(c) Before initiating the administration of psychotherapeutic drugs, or physical restraints, facility staff shall verify that the patient's health record contains documentation that the patient has given informed consent to the proposed treatment or procedure. The facility shall also ensure that all decisions concerning the withdrawal or withholding of life sustaining treatment are documented in the patient's health record.

INFORMED CONSENT -4 For the prolonged use of a device that may lead to the inability to regain use of a normal bodily function – also requires informed consent and risk/benefits provided and documentation in the record.

DPH L & C Informed consent must be obtained even when resident is admitted from an acute hospital with the preexisting orders for psychotherapeutic drugs, or physical restraints, or the prolonged use of a device that may lead to the inability to regain use of a normal bodily function. SNF MUST VERIFY informed consent and assure documentation in the patient’s medical record.

DPH L & C -2 Section 72528(c). The Department has determined that in order to verify compliance with Section 72528(c), surveyors must confirm that health records contain documentation that the patient gave informed consent for the treatments listed in the regulation for all residents, including those admitted with preexisting orders.

DPH L & C -3 Therefore, effective immediately, all SNF shall verify that the patient’s health record contains documentation that the patient has given informed consent to the proposed treatment or procedure as written in Section 72528(c).

DPH L & C -4 In order for SNF to be in full compliance with this regulation, the Department suggests a few methods that are permitted under current regulations and/or statutes. Obtain documentation that informed consent had been obtained from the patient for the proposed therapy and that it is in the patient’s clinical record. Obtain new informed consent as described in Section 72528(c) and place the informed consent documentation in the patient’s medical record. FL.aspx FL.aspx

WHAT TO DO NOW… At time of admission; when admission orders are obtained – obtain a signed consent from the appropriate person (resident if has the capacity to give consent); (same as signing admission consents; resident should sign). Contact physician to be sure the Physician wants medication continued, of course.

WHAT TO DO NOW… -2 Nursing staff will need to provide the informed consent to the resident (physician is not available); this does not delegate the Drs. Accountability for informed consent. All new psychotherapeutic drugs, either physician or delegated nursing staff must obtain informed consent. Recommend Dr. review with resident on next admission and sign the informed consent.

WHAT TO DO NOW… -3 Take all the resident’s psychotherapeutic medications and determine if you have a consent now (even for those residents admitted without a consent and one was not received ever in the facility). Obtain a new informed consent; recommend initiate ASAP and the physician review and discuss with resident and sign informed consent on next visit indicating review with the resident or designated or legal representative.

WHAT TO DO NOW… -4 Identify all residents with catheters or other devices that may be used that would alter the resident’s body function – identify those and obtain written consent to continue their use – same as with on admission. Either a form or have available the risks and benefits of devices available so nurses know what to say if ???

WHAT TO DO NOW… -5 Inform all nursing staff admitting residents about the need to get an informed consent and what that is meant in this new focus on consents on admission for INFORMED CONSENT.

POLICIES & PROCEDURES Administrative and Medical Record Manuals will be updated and provided to the facility. Administrative #4030 on consents; HIM/Record Manual – Admission audit, psychoactive drug audit and will add these and devices to Change of Condition reviews; Consents #5025 – Antipsychotic Consent/Notification, page 4; Other related policies and audits.

REGULATION REFERENCES SUPPORT FOR UPDATING POLICIES AND PROCEDURES for informed consent, psychotherapeutic / psychotropic / psychoactive drugs and regulatory grouping: CCR, Title 22, Division 5, Chapter 3 Skilled Nursing Facilities – §72319 Nursing Service—Restraints and Postural Supports – §72527 Patients’ Rights – §72528 Informed Consent Requirements

REGULATION REFERENCES -2 Regulations (continued): H&SC (a.k.a. the Epple Act) (focus on antipsychotic use), and (devolution of rights) 42 CFR State Operations Manual, Appendix PP F152 §483.10(a)(3) and (4) Rights of incompetent; rights designated to a surrogate; F154 §483.10(b)(3) Right to be fully informed; F155 §483.10(b)(4) Right to refuse treatment F222 §483.13(a) Restraints (chemical) F329 §483.25(l) Unnecessary Drugs F428 §483.60(c) Drug Regimen Review

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