Drug Use Evaluation: Antipsychotic Utilization in Schizophrenia Patients
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Schizophrenia Care Guide
August 2015 CCHCS/DHCS Care Guide: Schizophrenia SUMMARY DECISION SUPPORT PATIENT EDUCATION/SELF MANAGEMENT GOALS ALERTS Minimize frequency and severity of psychotic episodes Suicidal ideation or gestures Encourage medication adherence Abnormal movements Manage medication side effects Delusions Monitor as clinically appropriate Neuroleptic Malignant Syndrome Danger to self or others DIAGNOSTIC CRITERIA/EVALUATION (PER DSM V) 1. Rule out delirium or other medical illnesses mimicking schizophrenia (see page 5), medications or drugs of abuse causing psychosis (see page 6), other mental illness causes of psychosis, e.g., Bipolar Mania or Depression, Major Depression, PTSD, borderline personality disorder (see page 4). Ideas in patients (even odd ideas) that we disagree with can be learned and are therefore not necessarily signs of schizophrenia. Schizophrenia is a world-wide phenomenon that can occur in cultures with widely differing ideas. 2. Diagnosis is made based on the following: (Criteria A and B must be met) A. Two of the following symptoms/signs must be present over much of at least one month (unless treated), with a significant impact on social or occupational functioning, over at least a 6-month period of time: Delusions, Hallucinations, Disorganized Speech, Negative symptoms (social withdrawal, poverty of thought, etc.), severely disorganized or catatonic behavior. B. At least one of the symptoms/signs should be Delusions, Hallucinations, or Disorganized Speech. TREATMENT OPTIONS MEDICATIONS Informed consent for psychotropic -
Management of Major Depressive Disorder Clinical Practice Guidelines May 2014
Federal Bureau of Prisons Management of Major Depressive Disorder Clinical Practice Guidelines May 2014 Table of Contents 1. Purpose ............................................................................................................................................. 1 2. Introduction ...................................................................................................................................... 1 Natural History ................................................................................................................................. 2 Special Considerations ...................................................................................................................... 2 3. Screening ........................................................................................................................................... 3 Screening Questions .......................................................................................................................... 3 Further Screening Methods................................................................................................................ 4 4. Diagnosis ........................................................................................................................................... 4 Depression: Three Levels of Severity ............................................................................................... 4 Clinical Interview and Documentation of Risk Assessment............................................................... -
Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment for Schizophrenia in Adult Patients? Kyle J
Philadelphia College of Osteopathic Medicine DigitalCommons@PCOM PCOM Physician Assistant Studies Student Student Dissertations, Theses and Papers Scholarship 2017 Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles Philadelphia College of Osteopathic Medicine Follow this and additional works at: https://digitalcommons.pcom.edu/pa_systematic_reviews Part of the Psychiatry Commons Recommended Citation Knowles, Kyle J., "Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients?" (2017). PCOM Physician Assistant Studies Student Scholarship. 381. https://digitalcommons.pcom.edu/pa_systematic_reviews/381 This Selective Evidence-Based Medicine Review is brought to you for free and open access by the Student Dissertations, Theses and Papers at DigitalCommons@PCOM. It has been accepted for inclusion in PCOM Physician Assistant Studies Student Scholarship by an authorized administrator of DigitalCommons@PCOM. For more information, please contact [email protected]. Is Aristada (Aripiprazole Lauroxil) a Safe and Effective Treatment For Schizophrenia In Adult Patients? Kyle J. Knowles, PA-S A SELECTIVE EVIDENCE BASED MEDICINE REVIEW In Partial Fulfillment of the Requirements For The Degree of Master of Science In Health Sciences- Physician Assistant Department of Physician Assistant Studies Philadelphia College of Osteopathic Medicine Philadelphia, Pennsylvania December 16, 2016 ABSTRACT OBJECTIVE: The objective of this selective EBM review is to determine whether or not “Is Aristada (aripiprazole lauroxil) a safe and effective treatment for schizophrenia in adult patients?” STUDY DESIGN: Review of three randomized controlled studies. All three trials were conducted between 2014 and 2015. DATA SOURCES: One randomized, controlled trial and two randomized, controlled, double- blind trials found via Cochrane Library and PubMed. -
Haloperidol Injection, USP and 3) Treatment of Any Concomitant Serious Medical Problems for Which Specific Treatments Are Available
drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, Haloperidol Injection, USP and 3) treatment of any concomitant serious medical problems for which specific treatments are available. (For Immediate Release) There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Rx only If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences WARNING of NMS have been reported. Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Hyperpyrexia and heat stroke, not associated with the above symptom complex, have also been reported Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an in- with haloperidol. creased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), Usage in Pregnancy largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated pa- Rodents given 2 to 20 times the usual maximum human dose of haloperidol by oral or parenteral routes tients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, com- teratogenic effect has been reported in rats, rabbits or dogs at dosages within this range, but cleft palate pared to a rate of about 2.6% in the placebo group. -
Second-Generation Long-Acting Injectable Antipsychotics: a PRACTICAL GUIDE Understanding Each of These Medications’ Unique Properties Can Optimize Patient Care
Second-generation long-acting injectable antipsychotics: A PRACTICAL GUIDE Understanding each of these medications’ unique properties can optimize patient care Brittany L. Parmentier, PharmD, MPH, here are currently 7 FDA-approved second-generation long-acting BCPS, BCPP 1-7 Clinical Assistant Professor injectable antipsychotics (LAIAs). These LAIAs provide a Department of Pharmacy Practice Tunique dosage form that allows patients to receive an antipsy- The University of Texas at Tyler Fisch College of Pharmacy chotic without taking oral medications every day, or multiple times per Tyler, Texas day. This may be an appealing option for patients and clinicians, but Disclosure The author reports no financial relationships with any because there are several types of LAIAs available, it may be difficult to companies whose products are mentioned in this article, or with determine which LAIA characteristics are best for a given patient. manufacturers of competing products. Since the FDA approved the first second-generation LAIA, risperidone long-acting injectable (LAI),1 in 2003, 6 additional second-generation LAIAs have been approved: • aripiprazole LAI • aripiprazole lauroxil LAI • olanzapine pamoate LAI • paliperidone palmitate monthly injection • paliperidone palmitate 3-month LAI • risperidone LAI for subcutaneous (SQ) injection. When discussing medication options with patients, clinicians need to consider factors that are unique to each LAIA. In this article, I describe the similarities and differences among the second-generation LAIAs, and address common questions about these medications. A major potential benefit: Increased adherence One potential benefit of all LAIAs is increased medication adherence com- pared with oral antipsychotics. One meta-analysis of 21 randomized con- trolled trials (RCTs) that compared LAIAs with oral antipsychotics and Current Psychiatry GEORGE MATTEI/SCIENCE SOURCE GEORGE MATTEI/SCIENCE Vol. -
Rapid Tranquillisation of Violent Or Agitated Patients in a Psychiatric
BRITISH JOURNAL OF PSYCHIATRY (2004), 185, 63^69 Rapid tranquillisation of violent or agitated patients Department of Psychiatry at the Christian Medical College, in Vellore in the southern in a psychiatric emergency setting Indian state of Tamil Nadu. The majority of patients presenting to the psychiatric emergency services of this 1800-bed teach- Pragmatic randomised trial of intramuscular lorazepam v. ing hospital were accompanied by family haloperidol plus promethazine members and were either brought directly, or were referred by general practitioners in the town or adjoining towns and villages JACOB ALEXANDER, PRATHAP THARYAN, CLIVE ADAMS, THOMAS JOHN, and from emergency services of this and CARINA MOL and JONCY PHILIP other hospitals. Background The pharmacological Violent or aggressive behaviour is a Patient selection management of violence in people with common reason for emergency psychiatric presentations, with assaultive behaviour Consecutive patients were assessed and psychiatric disordersis under-researched. seen in 3–10% of psychiatric patients were eligible for trial entry if the attending physician felt that intramuscular sedation Aims To compare interventions (Tardiff & Sweillam, 1982; Tardiff & Koenigsberg, 1985). A haloperidol– was clearly indicated because of agitation, commonly used for controlling agitation or promethazine mix is commonly used for aggression or violent behaviour, and if the violence in people with serious psychiatric rapid tranquillisation of agitated or violent physician did not feel that either -
Should Inverse Agonists Be Defined by Pharmacological Mechanism Or
CNS Spectrums,(2019), 24 419 – 425. © Cambridge University Press 2018. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. doi:10.1017/S1092852918000986 ORIGINAL RESEARCH Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period Peter J. Weiden,1* Yangchun Du,2 Chih-Chin Liu,2 and Arielle D. Stanford3 1 Medical Affairs, Alkermes, Inc., Waltham, Massachusetts, USA 2 Clinical Development, Alkermes, Inc., Waltham, Massachusetts, USA 3 Clinical Science, Alkermes, Inc., Waltham, Massachusetts, USA Objective. Switching antipsychotic medications is common in patients with schizophrenia who are experiencing persistent symptoms or tolerability issues associated with their current drug regimen. This analysis assessed the safety of switching from an oral antipsychotic to the long-acting injectable antipsychotic aripiprazole lauroxil (AL). Methods. This was a post hoc analysis of outpatients with schizophrenia who were prescribed an oral antipsychotic and who enrolled in an international, open-label, long-term (52-week) safety study of AL. The analysis focused on the first 3 injections of AL 882 mg over 12 weeks, divided into the immediate 4-week crossover period between the first and second AL injections (initiation phase) and the subsequent 8 weeks (stabilization phase). Patients were grouped by preswitch oral antipsychotic medication, and safety and clinical symptoms were assessed. Results. In total, 190 patients had switched from one of the following oral antipsychotic medications: aripiprazole, conventional antipsychotics, risperidone/paliperidone, olanzapine, or quetiapine. -
Advice on Prescribing for Adults with Obsessive-Compulsive Disorder (OCD)
Advice on Prescribing for Adults with Obsessive-Compulsive Disorder (OCD) Dr Lynne M Drummond, Local and National OCD Services, Behavioural and Cognitive Psychotherapy Unit, South West London and St George’s Menat Health NHS Trust 9th April 2008 Introduction Obsessive-Compulsive Disorder (OCD) is a common psychiatric disorder which untreated has a chronic often deteriorating course. OCD does respond well to treatment with either psychological approaches involving Graded Exposure and Self-Imposed Ritual Prevention (ERP) or with specific pharmacological agents. This paper aims to outline the various psychopharmacological approaches. Psychopharmacological approaches Repeated trials have demonstrated that drugs which act of the serotonin system are effective in many patients with OCD (SRI and SSRIs) • The Selective Serotonin Reuptake Inhibitors (SSRIs) are generally used as first line rather than clomipramine (a Serotonin Reuptake Inhibitor- SRI) due to fewer side effects. • There is little evidence of any particular advantage of any of the SSRIs apart from some evidence that Escitalopram* may reduce relapse of OCD. • In general if there is no response to the SRI on maximal doses for 12 weeks it is worthwhile switching to an alternative. • However there is evidence that benefit from SRI can accrue over as long as 2 years Drug Dose Major side effects Any special features Seizures in a small number of patients The first SRI to and less likely if demonstrate Clomipramine Up to 225mg at <250mg effectiveness in night (increase reducing OCD slowly as tolerated) Sexual Dysfunction symptoms in 80 % Dry mouth; blurred It is a tricyclic vision drowsiness; antidepressant weight gain and orthostatic hypotension 1 50 mg in evening Gastro-intestinal initially and upsets; anorexia and increased weight loss. -
Compatibility of Cholecalciferol, Haloperidol, Imipramine Hydrochlo
ORIGINAL ARTICLES Ortofarma – Quality Control Laboratories, Matias Barbosa, MG, Brazil Compatibility of cholecalciferol, haloperidol, imipramine hydrochlo- ride, levodopa/carbidopa, lorazepam, minocycline hydrochloride, tacro- limus monohydrate, terbinafine, tramadol hydrochloride and valsartan in SyrSpend® SF PH4 oral suspensions H. C. POLONINI, S. L. SILVA, C. N. CUNHA, M. A. F. BRANDÃO, A. O. FERREIRA Received October 21, 2015, accepted December 2, 2015 Ortofarma – Quality Control Laboratories, BR 040, n. 39, Empresarial Park Sul. 36120-000. Matias Barbosa – MG. Brazil [email protected] Pharmazie 71: 185–191 (2016) doi: 10.1691/ph.2016.5177 A challenge with compounding oral liquid formulations is the limited availability of data to support the physical, chemical and microbiological stability of the formulation. This poses a patient safety concern and a risk for medication errors. The objective of this study was to evaluate the compatibility of the following active pharma- ceutical ingredients (APIs) in 10 oral suspensions, using SyrSpend® SF PH4 (liquid) as the suspending vehicle: cholecalciferol 50,000 IU/mL, haloperidol 0.5 mg/mL, imipramine hydrochloride 5.0 mg/mL, levodopa/carbidopa 5.0/1.25 mg/mL, lorazepam 1.0 mg/mL, minocycline hydrochloride 10.0 mg/mL, tacrolimus monohydrate 1.0 mg/ mL, terbinafine 25.0 mg/mL, tramadol hydrochloride 10.0 mg/mL and valsartan 4.0 mg/mL. The suspensions were stored both refrigerated (2 - 8 °C) and at controlled room temperature (20 - 25 °C). This is the first stability study for these APIs in SyrSpend® SF PH4 (liquid). Further, the stability of haloperidol,iImipramine hydrochloride, minocycline, and valsartan in oral suspension has not been previously reported in the literature. -
HALDOL Decanoate 50 (Haloperidol)
HALDOL® Decanoate 50 (haloperidol) HALDOL® Decanoate 100 (haloperidol) For IM Injection Only WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. HALDOL Decanoate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). DESCRIPTION Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol). It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is: Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. -
For More Than Half a Century, Haloperidol Has Been Used As a First
Time to retire haloperidol? For emergency agitation, evidence suggests newer alternatives may be a better choice Joseph M. Pierre, MD or more than half a century, haloperidol has been used as a first- Health Sciences Clinical Professor Department of Psychiatry and line medication for psychiatric agitation constituting a “behav- Biobehavioral Sciences ioral emergency” when a patient cannot or will not take oral David Geffen School of Medicine at UCLA F medication. Today, haloperidol is most commonly administered as Los Angeles, California an IM injection along with an anticholinergic medication to minimize Disclosure The author reports no financial relationships with any extrapyramidal symptoms (EPS) and a benzodiazepine for additional companies whose products are mentioned in this article, sedation. The multiple-medication “cocktail” is often referred to by dou- or with manufacturers of competing products. ble-entendre nicknames, such as “B-52” or “5250” (ie, haloperidol, 5 mg; lorazepam, 2 mg; and diphenhydramine, 50 mg). In this article, I discuss whether haloperidol, a first-generation antipsychotic (FGA) medication developed in 1958, still deserves to be the IM “gold standard” for man- aging emergency psychiatric agitation. Earlier evidence of haloperidol’s efficacy The initial “discovery” of antipsychotic medications was made in 1951 based on the inadvertent observation that chlorpromazine had the potential to calm surgical patients with autonomic activation. This calm- ing effect, described as “désintéressment” (meaning a kind of “indiffer- ence to the world”),1 resulted in a new class of medications replacing barbiturates and bromides as go-to options to achieve “rapid tranquil- ization” of psychiatric agitation.2 Although the ability of antipsychotic medications to gradually reduce positive symptoms, such as delusions and hallucinations, has been attributed to dopamine (D2) antagonism, their more immediate sedating and anti-agitation effects are the result of broader effects as histamine (H1) and alpha-1 adrenergic antagonists. -
Aristada Initio (Aripiprazole Lauroxil), in Combination with Oral Aripiprazole for the Initiation of Aristada When Used for the Treatment of Schizophrenia in Adults
Aristada Initio™ (aripiprazole lauroxil) – New drug approval • On July 2, 2018, Alkermes announced the FDA approval of Aristada Initio (aripiprazole lauroxil), in combination with oral aripiprazole for the initiation of Aristada when used for the treatment of schizophrenia in adults. — The approval of Aristada Initio provides physicians with an alternative regimen to initiate patients onto any dose of Aristada injection on day 1. — Previously, the first Aristada injection was recommended in conjunction with oral aripiprazole for 21 consecutive days. • Oral aripiprazole is generically available as tablets, disintegrating tablets, and solution. Aripiprazole is also available as Abilify Maintena®, a brand extended-release injectable suspension. — The oral formulations are approved for the treatment of schizophrenia and other indications as outlined in the individual drug labels. — Abilify Maintena is indicated for the treatment of schizophrenia in adults and as maintenance monotherapy treatment of bipolar I disorder in adults. • Aristada Initio leverages Alkermes’ proprietary NanoCrystal® technology, which provides an extended-release formulation using a smaller particle size compared to Aristada, thereby enabling faster dissolution and more rapid achievement of relevant drug levels. • The effectiveness of Aristada Initio, in combination with oral aripiprazole and for the initiation of Aristada injection, was established by adequate and well-controlled studies of oral aripiprazole and Aristada injection in adult patients with schizophrenia.