Commissione del Farmaco dell'Area Vasta Emilia Nord Modena 20 giugno 2011 Alla c.a. Componenti della Commissione del farmaco dell'Area Vasta Emilia Nord Loro Sedi OGGETTO: Verbale riunione 24/05/2011 della Commissione del Farmaco dell'Area Vasta Emilia Nord Presenti: Claudio Andreoli, Angelo Benedetti, Lina Bianconi, Giovanni Bologna, Corrado Busani, Giovanni Maria Centenaro, Giorgio Cioni, Carlo Coscelli, Mauro De Rosa, Roberto Esposito, Anna Maria Gazzola, Sergio Maccari, Anna Maria Marata, Mauro Miselli, Carlo Missorini, Enrico Montanari, Alessandro Navazio, Giovanni Pinelli, Italo Portioli, Daniela Riccò, Nilla Viani. Assenti: Diego Ardissino, Maria Barbagallo, Carlo Cagnoni, Fabio Caliumi, Marilena Castellana, Luigi Cavanna, Silvia Chiesa, Giuseppe Longo, Nicola Magrini, Giovanni Pedretti, Nilla Poncemmi, Saverio Santachiara.
Theaftd.orga quarterly newsletter for healthcare professionals Spring 2014
Why Does He Act Like That? Aggressive Behaviors in FTD
Partners in FTD Care Do you have questions about how to Because many individuals with frontotemporal degeneration (FTD) are not aware of serve individuals with FTD? Partners
their illness, they may become frustrated at limitations or constraints they do not in FTD Care can help. Clinical experts
understand and consider to be unfair. Aggression may include shouting, name-calling and experienced caregivers collaborate or physical abuse actions such as hitting, pushing, biting, pinching, scratching or grabbing to offer case-based studies and practical interventions you can use. Sign up today! (O'Hara, et al., 2009 in AFTD Partners in FTD Care Changes Behavior chart). In a person with FTD these behaviors can result from a frustrating situation, start for no apparent reason or can occur suddenly. When behavior becomes aggressive the immediate approach includes to stay out of the The Association for Frontotemporal person's way if they are combative; and never point out the problem to the person, try Degeneration (AFTD) provides to reason about the behavior, or argue about the ‘logical' solution. Developing a manage- information and resources for FTD ment approach to ensure the well-being and safety of the person with FTD and safety of patients, their families and health residents and staff requires understanding of the disease and careful planning. The fol- professionals. Check out: lowing case study demonstrates the challenges and best practices for assisting individuals •NEW website
with FTD and aggressive behavior. Effective management requires close collaboration just for children and teens who have a among the family, staff and primary care provider to develop and implement a highly parent with FTD. individualized Plan of Care. • An extensive website (www.theaftd.org) chock full of information and archived The case of Jake McKnight
A call comes into the nurse's center at the memory care community: "Jake just punched • Free publications on important issues in Mary (one of the caregivers) and is grabbing two of the residents. We can't settle him down. We need help right away." The nurses rush to the dining room. When they try • FTD-specific support for caregivers and redirecting Jake from the dining room, he starts to yell. He tries to hit one of the nurses diagnosed persons.
with a chair. The other nurse is finally able to calm and escort him to the living room. • Respite grants for family caregivers.
• It Is What It Is, a powerful short The residents and nurse have a few bruises; Mary has a broken nose. Mary asks, "Why documentary introducing people to FTD. does he act like that?" • Archived training presentations on History and diagnosis
clinical trials, approaches to self-care, Jake McKnight is a 59-year-old retired engineer. He married Helen after graduate school, advocacy, and a series on primary has two married daughters and one grandson. His family describes him as a kind, dedicated and loving husband and father. He was a well-respected vice president at a • An annual FTD education conference—April 24, 2015 in San Diego. major aircraft manufacturer for 25 years. Jake played guitar with a local band on weekends and enjoyed playing and coaching soccer. His friends describe him as loyal, fun-loving and dependable. Partners Yahoo Group His family, close friends and business associates noticed some changes in his personality The Partners in FTD Care YahooGroup
about five years ago. If he had trouble being understood or had to wait at all, he became is an on-line space to ask questions frustrated. These incidents were sporadic and most of the time he retained his usual and share practical interventions that personality. Around the same time he began missing meetings and project deadlines at work. The group is moderated by the team that develops the Partners in FTD work. Jake's response was always the same, "I'll get to it." Eventually, he was encouraged Care materials. Join the conversation to take early retirement. His family thought his behaviors were the result of work-related and learn from the pros. Sign up at: stress. He was prescribed Ativan for his stress, which actually increased his anxiety. He continued to play in the band and watch soccer. Jake could no longer coach or play soccer due to his anxiety.
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Helen had to continue working which left Jake at home alone. asked him about it, he would become upset and yell. One day Jake began to have outbursts of verbal agitation. He would she asked the question and he chased her throughout the house. yell at Helen if she did not come home at the exact time every She locked herself in the bedroom. Jake punched a hole in the day. Their children convinced Helen to schedule a complete door, and continued to scream. Helen called the police, and diagnostic work-up for Jake. Based on his history of behavior Jake was admitted to the psychiatric unit. The psychiatrist at the changes, physical and neurological examinations, neuropsycho- hospital adjusted his medications. The incidence of outbursts logical testing, and brain imaging results, a diagnosis of prob- decreased with medication and the structured setting. He able behavior variant FTD (bvFTD) was made. Jake's most recommended that Jake be placed in a specialized care facility. prominent symptoms and the most disruptive symptoms for his After encouragement from their daughters, Helen moved Jake family were related to his anxiety and agitation in interpersonal into a memory care community. Upon move in, his family and the attending physician at the facility met with the staff. Helen His family also noted that Jake appeared emotionally withdrawn had completed and discussed AFTD's Daily Care Snapshot and ignored his grandson. He began getting up during the Tool, and together the team developed a Plan of Care, with night, roamed the house, and constantly rearranged items in specific behaviors that might be anticipated, possible triggers the cupboards, refrigerator, and closets. He, also, took appli- and approaches. The Plan of Care was reviewed with all staff. ances apart which caused safety issues. He had verbal outbursts Jake would occasionally grab residents and not easily release when Helen tried to redirect him. Without warning, he shouted them. Staff observed that his behaviors increased when resi- during soccer games or just left. Also, his personal hygiene dents were in close proximity, when he had to wait for meals, or decreased and he was resistant to help from Helen. He was when there was a loud noise. He resisted attempts at personal prescribed a sleeping medication and restarted on Ativan which care. Trying to shake his hand or touch his shoulder made did not help. He was, then, prescribed Seroquel, an atypical Jake anxious. He appeared to understand the staff but he had antipsychotic medication, which decreased some of his anxiety trouble following through with tasks independently. He could not sit down on a chair, for example, without specific verbal Episodic aggressive behavior
instructions. While triggers were identified for many of Jake's On several occasions, Helen came home to find Jake had bro- behaviors, there were also random, spontaneous behaviors. ken dining room chairs and other home furnishings. When she The staff worked closely with Helen and the facility Troubles & Tips
Q. Our staff implemented behavioral strategies and the resident • Carefully assess unsafe behavior by identifying what triggered the
continues to be resistant to care. Many think medication is the only event. Describe the actual behavior and the effect of the behavior
way to effectively address the resident's frequent agitation.
on the resident and others. Write a note that tracks the timing and frequency of events to identify clues for possible interventions. For A. Resistance to personal care is common in persons with FTD and example, a resident pushed anyone in his way when walking to the may contribute to increased agitated behavior. These behaviors are dining room. Staff reported this aggressive behavior and when they associated with decreased ability to function and increase the risk looked closer at the behavior in the context of his history, it became of falls. The behaviors may also result in harm to other residents, evident that he was anxious there would be no food left. When he family members or care providers; therefore, they require effective was allowed to go to the dining room before everyone else, the behavior stopped. One of the barriers to using behavior management strategies • Use proven behavior management approaches including: follow effectively is that staff lack confidence that they work. Referral to the set routines, speak in a soft/pleasant voice, give the resident enough primary care provider often occurs before behavioral interventions room to respect their personal space, redirect to another activity if have been maximized. possible, reduce stimulation, involve family members, and assign Studies demonstrate the effectiveness of these interventions in consistent care providers. Avoid arguing with the person, as it will minimizing the need for medications. Behavioral treatment includes worsen agitation.
vital first-line strategies of 1) careful assessment, 2) creative problem • Assign enough staff to carefully observe behaviors and evaluate solving, and 3) addressing underlying causes of the person's behavior. results of interventions. Clearly communicate what does and does not work with all facility staff.
• Check for new medical conditions, recent change in medication, • Recognize increased distress among staff working with agitated or unmet needs, such as hunger or the urge to urinate. Make sure individuals. Provide opportunities for staff to talk about their concerns that even "mild" pain associated with chronic conditions, such and feelings when confronted with unsafe situations. as arthritis or back pain is managed with physical therapy and/or pain medication. www.theaftd.org // 267.514.7221
psychiatrist concerning approaches and medication adjustments. room, where the cook had set up his breakfast. While Ativan and Haldol increased Jake's negative behaviors, Jake was re-admitted to the Geriatric Behavioral Unit for medi- Depakote and Seroquel decreased them. Behavioral approaches cation adjustment. He was also evaluated and treated for pain, included establishing a predictable daily routine, encouraging him secondary to prior soccer injuries. The staff met with Helen to walk in the secured courtyard and providing a soccer ball to and Jake's physician, and all agreed upon increased dosages of kick; permitting him to nap wherever he felt comfortable; and Depakote and Seroquel. Two approaches were added to his Plan providing immediate assistance for meals and the bathroom. of Care: serving Jake's meals in the living room if he is anxious Challenges included keeping residents away from him when his and administering a pain medication prior to personal care. Jake anxiety or aggression increased and the inability to provide Jake was, also, seen by Physical Therapy for pain management. The immediate attention when other residents needed help. Several revised Plan of Care was reviewed with all staff and a process staff remarked that Jake was different from the other residents. was implemented to review the Plan with new staff. With these He was younger, stronger, and gave that "blank, scary look" at changes and ongoing review, Jake's anxiety has decreased and he times. Staff expressed concern and some fear that they did not has not had any physically aggressive behaviors this quarter. know what he was going to do next. Due to incidents of physi-cal aggression and safety concerns, Jake was re-admitted to the Questions for discussion (Use for staff in-service training or in
Geriatric Behavioral Unit several times for observation and medi- resident-specific situations.)cation adjustment. 1) What are examples of Jake's aggression? He screamed at
Helen was conflicted about some of Jake's behaviors; she saw Helen; broke the dining room chairs and other home furnishings; them differently from staff. Since they were inconsistent, she punched a hole in the door; caused physical injuries by grabbing and remarked that she thought Jake was "acting like that just so he bruising other residents and punched Mary; physically threatened could come home." She also thought the medications caused Helen by chasing her around the house; tried to hit the nurse some of his problems. Helen took Jake to a different psychiatrist with a chair; and resisted care with verbal and physical outbursts.
who wrote an order to decrease his Seroquel and Depakote. This 2) Were there any triggers to Jake's aggressive behaviors?
was presented to his attending physician at the facility who did Jake became visibly frustrated when he had to wait for meals or not want to decrease the medications. However, he eventually did receive attention/responses from staff or residents; when he decrease the dosages based on the psychiatrist's recommendation could not complete a verbal request, such as sitting on a chair; and Helen's insistence. loud noises, such as residents talking or yelling; too much "Why does he act like that?" Reviewing the incident
stimulation from meal time and group activities; and people On the morning the caregivers called the nurses for assistance, getting too close to him, or touching him was overwhelming. Jake appeared more anxious. Nighttime staff reported that He was resistant to personal care. He did not want to move from he had not slept well. Breakfast was served a few minutes late. the living room to his room if he was sleeping. Jake was pacing in the dining room, approaching residents, and 3) What approaches were the most beneficial to Jake's
demanding food. He grabbed one resident who yelled at him and family and the staff ? Jake responded best in a quiet setting with
another who did not respond. When Mary, the caregiver, took his little stimulation; calm and single verbal instructions; hand to redirect from one of the residents, he turned around and no/minimal touching; an established routine; an opportunity to walk and kick the soccer ball in the courtyard; pain medication Upon review of the preceding incident, the staff identified prior to personal care; Physical Therapy, and sleeping in the behavioral triggers that included Jake not sleeping well and living room, or his room, with music. increased anxiety. A reason for his sleeplessness could have been 4) What were the keys to the success of Jake's
that a new caregiver encouraged him to sleep in his room versus Plan of Care? Jake's family, physician, and staff discussed his
the chair in the living room. Breakfast was slightly late as well, history, diagnosis, symptoms, medication regiment, and ap- and the caregivers did not have a chance to serve him cereal and proaches, and agreed upon a Plan of Care that addressed Jake's juice until the full breakfast arrived (not his usual routine). Also, need for supervised care, Helen's desire to have him in the pro- Jake recently had a decrease in several medications. gram, and the concerns of the facility. This occurred upon move- Mary was concerned for the safety of other residents, so she in, quarterly, and whenever there was a change in his condition. took his hand to redirect him. Since touching triggered Jake's ag- Developing interventions that were person and family centered gressive behaviors, he turned around and reflexively punched her. was critical to address all concerns. The Plan of Care was One nurse rushed into the dining room to assist, and this could reviewed and discussed with all staff.
have overwhelmed Jake; he then tried to hit her with a chair. The other nurse took over, using a calm, directing voice, and provided single phrases to escort Jake from the dining room to the living www.theaftd.org // 267.514.7221
Medications for Agitated Behaviors
Medications may be necessary when behavioral strategies are The following medications are listed by generic
not effective in managing unsafe behaviors in FTD. The same careful observation and creative thinking used for behavioral • The selective serotonin reuptake inhibitors (SSRIs) can interventions should be applied for effective use of medications. reduce disinhibition, repetitive/compulsive behaviors, The following are general approaches for medication use. This sexually inappropriate behaviors, and carbohydrate craving/ information should not be considered medical advice. Medications overeating. Examples of these medications include: should be prescribed only through careful consultation with the fluoxetine/Prozac, sertraline/Zoloft, paroxetine/Paxil, family caregiver, the care team and the primary care provider. fluvoxamine/Luvox, and citalopram/Celexa. It will take several weeks to fully evaluate the effectiveness of these medications.
• Be specific about the behavior to be targeted with medication • Trazodone/Desyrel also increases the availability of serotonin (for example, unprovoked confrontation to other residents in the brain and may improve agitation, depression and eating and visitors). Careful observation by staff is critical to behaviors. Trazodone can cause sedation and may help sleep.
evaluate both the effectiveness and potential side effects of • Mirtazipine/Remeron stimulates appetite and may cause sedation and help with sleep.
• Start with a low dose of one medication and wait sufficient • Atypical antipsychotics (including risperidone/Risperdal, time before increasing it. Some medications take several arepiprazole/Abilify, olanzapine/Zyprexa, and quetiapine/ Seroquel)are prescribed for severe uninhibited behavior and weeks before their effectiveness can be measured.
verbal and physical outbursts in FTD. These medications carry • Medicines for mood and behaviors work slowly. It often takes an FDA ‘black box' warning for use with elderly dementia several weeks to see the true effect of the medication. For patients due to increased risk of stroke, heart attack, and death. While the risk to younger FTD individuals is unknown, that reason, giving single doses on an "as needed (PRN)" basis discussion of these possibilities with their families and them is is discouraged.
required. In addition, some persons with FTD have increased • Reevaluate periodically as the type of medication or dosage sensitivity to these medications and may be more likely to may need adjustment.
develop body rigidity, neck stiffness, swallowing difficulty, and falls. Careful monitoring is essential.
• Set realistic goals: reduced frequencies of the targeted • Mood stabilizers include the anticonvulsants carbamazepine/ behavior indicate the appropriateness of the prescribed class Tegretol, valproate/Depakote, gabapentin/Neurontin, Trileptal and lithium/Lithobid or Eskalith. These medications • Discuss possible side effects with the prescribing physician. may help manage compulsive and agitated behaviors.
• Family members may hesitate to medicate their loved ones. • Medications in the benzodiazepine family tend to decrease Communicate concerns about the safety of all residents and inhibitions and may cause rebound agitation once they wear staff in the facility while respecting the needs of individuals off. These medications are generally not recommended with agitated behaviors. Listen to families' suggestions for agitation: lorazepam/Ativan, alprazolam/Xanax, and about management strategies and encourage their active participation in care.
• Medications for Alzheimer's disease are generally avoided, as they may worsen cognition and behavior in FTD. These Categories of Medications
include the anticholinesterase inhibitors (donepezil/Aricept, galantamine/Razadyne, and rivistigmine/Exelon and There are currently no FDA-approved medications for treating FTD. Best practice guidelines for agitation come primarily from • Avoid stopping any of these medications suddenly. Taper studies in older individuals with Alzheimer's disease rather than each medication slowly.
the younger FTD population. There are several categories of • Notify the prescribing physician if there is no sign of the medications used for agitation associated with FTD. It is important specific agitated behavior for 3-6 months. A trial off the to carefully review potential side effects by referring to patient medication may be considered.
education materials available from the pharmacy. www.theaftd.org // 267.514.7221
A Clinical Plan for MDMA (Ecstasy) in the Treatment of Post-Traumatic Stress Disorder (PTSD): Partnering with the FDA Rick Doblin, Ph.D. The following article was originally published in the April-June 2002 special MDMA issue of theJournal of Psychoactive Drugs (www.hafci.org). The article presents the rationale behind MAPS'efforts to sponsor research in Spain, the US and Israel investigating MDMA's potential in treatingpatients suffering from posttraumatic stress disorder (PTSD). This document is the clearest expres-sion to date of MAPS' role as a membership-based non-profit pharmaceutical company, as distinctfrom MAPS' other research and educational functions. We are reprinting this article in order toexplain in detail to MAPS' membership the vision and strategy animating MAPS' MDMA/PTSD researchprojects and associated fundraising efforts. A mission statement in a way, this article should help toexplain why MAPS has chosen the ambitious goal of developing MDMA into an FDA-approved prescrip-tion medicine in the treatment of PTSD. Since this article was written, the Spain MDMA/PTSD re-search project has been halted (hopefully temporarily) due to political pressure, and it has takenlonger than expected to obtain DEA and IRB permission to start the US MDMA/PTSD project.