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Guidance for clinical prescribing and monitoring of long-acting antipsychotic injections, including typical and atypical depots, their selection criteria, administration protocols, and adverse event reporting.
Version number:
6.0
Approved by:
Medicines Committee
Ratified by:
Medicines Committee
Date ratified:
June 2023
Original author:
Luton & Bedfordshire Lead Pharmacist
Executive Director lead:
Chief Medical Officer
Implementation Date:
July 2023
Last Review Date:
June 2023
Next Review Date:
June 2026
Services:
Trustwide, Mental Health and LD, Community Health Services
Type of document:
Policy
Scope:
Long-acting antipsychotic injections, typical and atypical
Target audience:
Clinicians, pharmacists, mental health services staff
Document structure:
Includes guidance on initiation, choice, and monitoring of depot injections, adverse effect reporting, and appendices with forms and rating scales
Price: 8 / 10 USD
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Note:
Year
Subject:
High Dose Antipsychotic Monitoring
Document Type:
Medical Form
Institution:
Oxford Health
Target Audience:
Healthcare professionals
Year:
2010
Region / City:
Connecticut
Subject:
Pharmaceutical practice, Collaborative practice agreements, Antipsychotic therapy
Document Type:
Legal agreement, Clinical protocol
Organization / Institution:
Connecticut Department of Consumer Protection, University of Connecticut School of Pharmacy
Author:
C. Caley, PharmD, BCPP, Clinical Professor
Target Audience:
Pharmacists, Physicians, Healthcare providers in Connecticut
Effective Date:
October 1, 2010
Date of Approval:
Not specified
Date of Review:
Annual review completed
Date of Modification:
Not specified
Year:
2011-2014
Region / city:
Oxford, United Kingdom
Topic:
Aripiprazole treatment, antipsychotic induced hyperprolactinaemia
Document type:
Clinical trial report
Organization / institution:
University of Oxford
Author:
Guy Goodwin, Valeria Frighi, Matthew Stephenson, Alireza Morovat, Anthony James
Target audience:
Medical professionals, researchers, healthcare providers
Period of validity:
2011-2014
Approval date:
Not specified
Date of changes:
Not specified
Study initiation date:
27/4/2011
Date of termination:
31/12/2014
Date of current report:
4/8/2016
Principal Investigator:
Guy Goodwin
Clinical Coordinator and contact person:
Dr. Valeria Frighi
Study centers:
University of Oxford, Oxford Health NHS Foundation Trust, Oxfordshire Learning Disability NHS Trust
Diagnosis:
Severe mental illness and/or learning disability with antipsychotic induced hyperprolactinaemia
Test drug:
Aripiprazole (Abilify)
Study drug dose:
2.5-30 mg daily planned, 1.5-10 mg used
Follow-up duration:
Median 6.1 months
Evaluation criteria:
Efficacy (prolactin reduction, menses normalization, testosterone normalization), Safety (metabolic parameters, psychiatric/neurological symptoms)
Safety results:
No unexpected adverse reactions, known adverse reactions occurred in 2 patients
Efficacy results:
Significant reduction of prolactin in patients on risperidone or paliperidone, restoration of normal gonadal function
Statistical methods:
Mann-Whitney U test, paired t-tests
Context:
Clinical trial report on the efficacy and safety of adjunctive aripiprazole treatment for hyperprolactinaemia in patients with severe mental illness and learning disabilities
Year:
2024
Region / City:
Massachusetts
Topic:
Long-Acting Injectable Antipsychotic Medications
Document Type:
MassHealth Drug List Update
Institution:
MassHealth
Author:
MassHealth
Target Audience:
Healthcare providers, inpatient psychiatric service providers
Effective Period:
May 15, 2024
Approval Date:
May 15, 2024
Update Date:
Ongoing updates
Applicable Policy:
Long-Acting Injectable Antipsychotic Medication Payment and Reimbursement Policy
J-Codes:
J0401, J0402, J1631, J1943, J1944, J2358, J2426, J2427, J2428, J2680, J2794, J2798, J2799, J2801
Billing Instructions:
Available on the MassHealth website
Year:
2005-2015
Region:
The Netherlands
Topic:
Pediatric psychopharmacology
Document type:
Research article
Institution:
Erasmus Medical Centre, University of Groningen
Authors:
Sanne M. Kloosterboer, Catharina C.M. Schuiling-Veninga, Jens H.J. Bos, Luuk J. Kalverdijk, Birgit C.P. Koch, Gwen C. Dieleman, Manon H.J. Hillegers, Bram Dierckx
Funding:
The Netherlands Organisation for Health Research and Development (ZonMW), grant 836041011
Target audience:
Healthcare professionals, researchers
Data source:
IADB.nl community pharmacy prescription database
Study population:
Youths aged 0-19 years
Outcome measures:
Prevalence, incidence, dosages, duration of antipsychotic use, prior psychotropic medication
Key findings:
Stabilization of usage rates, decrease in dosages and duration, one in eight youths used antipsychotics ≥4 years, boys had longer median usage than girls
Type of source:
Peer-reviewed scientific article
Type of document:
Pharmaceutical Benefits Advisory Committee (PBAC) submission and assessment report
Medicine:
Aripiprazole long-acting injectable (AOM)
Dosage forms/strengths:
Powder for injection 300 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe; Powder for injection 400 mg (as monohydrate) with diluent in pre-filled dual-chamber syringe
Brand:
Abilify Maintena
Sponsor:
Lundbeck Australia Pty Ltd
Purpose of submission:
Request for General Schedule Authority Required (STREAMLINED) PBS listing of AOM pre-filled syringe dose form
Indication:
Treatment of schizophrenia
Comparator:
AOM modified release injection vial kit (therapeutic vial kits)
Regulatory status:
TGA registered 7 May 2018 for acute and maintenance treatment of schizophrenia in adults and maintenance treatment of bipolar I disorder (monotherapy)
Previous PBAC consideration:
400 mg AOM PFS recommended July 2018; recommendation rescinded March 2023
Pricing basis:
Cost-minimisation versus AOM vial kit with equivalent pricing (no price premium)
Price levels referenced:
DPMQ, PTP, AEMP (current as of 1 June 2025)
Estimated PBS usage:
400,000 to <500,000 scripts over first six years (Year 1 10,000–<20,000; Year 6 100,457)
Indication listing conditions:
Authority Required (Streamlined); prescriber types include medical practitioners and nurse practitioners; general schedule (Code GE)
Year:
2010
Region / City:
Connecticut
Subject:
Pharmaceutical practice, Collaborative practice agreements, Antipsychotic therapy
Document Type:
Legal agreement, Clinical protocol
Organization / Institution:
Connecticut Department of Consumer Protection, University of Connecticut School of Pharmacy
Author:
C. Caley, PharmD, BCPP, Clinical Professor
Target Audience:
Pharmacists, Physicians, Healthcare providers in Connecticut
Effective Date:
October 1, 2010
Date of Approval:
Not specified
Date of Review:
Annual review completed
Date of Modification:
Not specified
Document type:
Shared care protocol
Medicine:
Paliperidone palmitate long-acting injection
Indication:
Maintenance treatment of schizophrenia
Population:
Adults aged 18 years and over
Healthcare setting:
Secondary and primary care
Intended users:
NHS healthcare professionals
Initiation of treatment:
Secondary care mental health services
Shared care commencement:
After approximately 12 weeks when dose is optimised
Dosage forms:
1-monthly, 3-monthly and 6-monthly long-acting injections
Renal impairment restriction:
Not recommended in moderate or severe renal impairment (creatinine clearance <50 ml/min)
Version:
v4.0
Replaces version:
v3.0
Clinical content last reviewed:
January 2024
Next review date:
June 2026
Approving bodies:
GM CRG, GMMMG, CEGC
Approval dates:
14 May 2024; 13 June 2024; 20 June 2024
Geographical scope:
NHS Greater Manchester
Usage restriction:
Non-commercial, non-marketing use only
Year:
not specified
Language:
English
Topic:
HIV-1 treatment
Therapeutic regimen:
Long-acting injectable antiretroviral therapy
Medication:
Cabenuva (cabotegravir and rilpivirine)
Drug classes:
Integrase strand transfer inhibitor; non-nucleoside reverse transcriptase inhibitor
Route of administration:
Intramuscular gluteal injection
Dosing schedules:
Every 4 weeks; every 8 weeks
Target population:
Adults with HIV-1 infection
Eligibility criteria:
Virologically suppressed patients without relevant drug resistance
Exclusion criteria:
Pregnancy, breastfeeding, specific drug interactions, hypersensitivity
Monitoring requirements:
HIV viral load, CMP, CBC
Clinical setting:
Clinic-administered therapy
Healthcare roles:
Provider, case manager, registered nurse, pharmacy
Regulatory reference:
FDA labeling
Source adaptation:
Ward 86 Long-Acting Injectable ARV Protocol
Year:
2021
Region / City:
United States
Subject:
Medicine, Pharmacology
Document Type:
Drug Information
Agency / Institution:
Food and Drug Administration (FDA)
Author:
FDA
Target Audience:
Healthcare professionals, physicians, pharmacists
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Revisions:
Not specified
Year:
2023
Region / City:
Global
Topic:
Pharmacology, Psychiatry
Document Type:
Medical Guidelines
Organization / Institution:
Unspecified
Author:
Unspecified
Target Audience:
Healthcare Professionals, Psychiatrists
Duration of Validity:
Indefinite
Approval Date:
Unspecified
Date of Changes:
Unspecified
Year:
2024
Region:
Massachusetts, USA
Subject:
Healthcare billing, Antipsychotic medications
Document Type:
Policy / Instruction
Organization:
MassHealth
Audience:
In-state acute inpatient hospital providers
Effective Date:
5/15/2024
Reference:
Sections 5.B.4.g of the MassHealth Acute Hospital Request for Applications
Medication Covered:
Long-Acting Injectable (LAI) Antipsychotics
Billing Codes:
National Drug Code (NDC), HCPCS
Submission Requirements:
Professional claims (Claim Types M and B), Direct Data Entry for IC drugs, invoice attachment from distributor/manufacturer
Payment Methodology:
Fee schedule in 101 CMR 317.00 or Individual Consideration (IC)
Documentation:
Attachments via Provider Online Service Center (POSC)
Compliance Notes:
Failure to follow instructions may result in inaccurate payment
Instruction Updates:
May be updated from time to time
Year:
2024
Region / City:
Massachusetts
Topic:
Long-Acting Injectable Antipsychotic Medications
Document Type:
MassHealth Drug List Update
Institution:
MassHealth
Author:
MassHealth
Target Audience:
Healthcare providers, inpatient psychiatric service providers
Effective Period:
May 15, 2024
Approval Date:
May 15, 2024
Update Date:
Ongoing updates
Applicable Policy:
Long-Acting Injectable Antipsychotic Medication Payment and Reimbursement Policy
J-Codes:
J0401, J0402, J1631, J1943, J1944, J2358, J2426, J2427, J2428, J2680, J2794, J2798, J2799, J2801
Billing Instructions:
Available on the MassHealth website
Year:
2020
Region / city:
Australia
Topic:
Biosimilar medicine submission
Document type:
Pharmaceutical submission
Organization / institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Maxx Pharma Pty Ltd
Target audience:
Healthcare professionals, regulatory bodies
Period of validity:
Ongoing
Approval date:
November 2022
Modification date:
November 2022
Note:
Year
Topic:
Lipid disorders, Cardiovascular Risk
Document Type:
Medical guideline
Target Audience:
Medical professionals, healthcare providers
Year:
2023
Region / city:
UK
Topic:
Medical procedures, Informed consent, Physiotherapy
Document type:
Guidelines
Author:
Chartered Society of Physiotherapists
Target audience:
Healthcare professionals, Physiotherapists
Date of approval:
2023
Date of changes:
N/A
Year:
2022
Region / City:
ACT and surrounding NSW
Topic:
Paediatric Diabetes Care, Insulin Pump Therapy
Document Type:
Clinical Guideline
Organization:
Canberra Health Services (CHS)
Author:
Canberra Health Services, Paediatric Endocrinology and Diabetes Service
Target Audience:
Paediatric Diabetes Healthcare Providers
Period of Validity:
N/A
Approval Date:
N/A
Date of Last Revision:
N/A
Year:
2016
Region / City:
United States
Topic:
Ophthalmology, Risk Management
Document Type:
Risk Management Recommendations
Organization / Institution:
OMIC
Author:
Anne M. Menke, Pauline Merrill, Trexler M. Topping, George Williams
Target Audience:
Ophthalmologists, Healthcare Providers
Period of Validity:
Not specified
Approval Date:
8/26/16
Date of Changes:
Not specified
Year:
2019
Region / City:
New Delhi, India
Sector:
Energy
Document Type:
Request for Qualification
Organization:
REC Transmission Projects Company Ltd.
Author:
REC Transmission Projects Company Ltd.
Target Audience:
Potential Bidders for Transmission Service Provider
Period of Validity:
Until 08.02.2019
Approval Date:
12th January 2019
Amendments Date:
Not provided