№ lp_1_14292
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This is a medical form used for monitoring patients prescribed high dose antipsychotics to ensure safety and adherence to guidelines.
Note:
Year
Subject:
High Dose Antipsychotic Monitoring
Document Type:
Medical Form
Institution:
Oxford Health
Target Audience:
Healthcare professionals
Price: 8 / 10 USD
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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
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
Year:
2006
Region / City:
Australia
Topic:
Medication management, disability services
Document Type:
Legal / Regulatory
Organization:
Disability Services
Author:
Not specified
Target Audience:
Healthcare providers, professionals in disability services
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Chronic migraine, medicinal product submission
Document type:
Submission for PBS listing
Organization:
Novartis Pharmaceuticals Australia Pty. Limited
Author:
Not specified
Target audience:
Health professionals, pharmaceutical regulatory bodies
Period of validity:
Not specified
Date of approval:
2 July 2018
Date of amendments:
November 2023
Year:
2024
Regulatory authority:
Therapeutic Goods Administration (TGA)
Medicine:
MACITENTAN 10 mg with TADALAFIL 40 mg (Opsynvi®)
Indication:
Pulmonary arterial hypertension (PAH), WHO Group 1, functional class II and III
Therapy type:
Dual or triple combination therapy
Dosage form:
Tablet, fixed dose combination (FDC)
Prescriber type:
Medical practitioners
Restriction type:
Authority Required (Written, Complex Authority Required)
Clinical criteria:
Treatment as dual therapy (MAC+TAD) or triple therapy with prostanoid
Population:
Adult patients with stable PAH on separate doses of macitentan and tadalafil
Previous considerations:
PBAC recommendations for macitentan and tadalafil since 2011–2014
Approval date:
16 September 2024
Source documents:
TGA registration, PBAC meeting minutes, ACM minutes August 2024, FDA, EMA, CDA references
Year:
2024
Region / city:
United Kingdom
Subject:
Radiological Protection, Transport of Radioactive Materials
Document Type:
Technical Assessment Guide
Organization:
Office for Nuclear Regulation (ONR)
Author:
Inspector - Nuclear Safety
Target Audience:
ONR safety inspectors
Validity Period:
October 2024 - October 2029
Approval Date:
October 2024
Revision Date:
Not applicable
Document Reference:
NS-TAST-GD-100
Record Reference:
2020/281169
Issue:
2.1
Purpose:
Guidance for assessing shielding designs and dose rates of transport packages for radioactive materials.
Scope:
Focuses on shielding and dose rate assessments in accordance with IAEA regulations for transport safety.
Related Legislation:
IAEA SSR-6 (2018), UK regulations for radioactive materials transport
Note:
Contextual Description
Year:
Not specified
Region / City:
Not specified
Topic:
Infliximab dose escalation in Crohn’s disease treatment
Document type:
Medical request letter
Institution / Organization:
Not specified
Author:
Not specified
Target audience:
Insurance company
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
Note:
Year
Topic:
Lung disease, steroid treatment
Document type:
Information sheet
Organization / institution:
Sheffield Teaching Hospitals NHS Foundation Trust
Author:
Respiratory and endocrinology teams
Target audience:
People with lung disease on high dose inhaled steroids
Year:
2023
Region / city:
Canberra, Australia
Topic:
Obstetrics, Pre-eclampsia, Pregnancy Care
Document type:
Guideline
Organization / institution:
Canberra Health Services
Author:
Society of Obstetric Medicine Australia and New Zealand (SOMANZ)
Target audience:
Medical Officers, Registered Nurses, Registered Midwives, Students, Pharmacists
Period of validity:
Not specified
Approval date:
2023
Date of amendments:
Not specified
Year:
2022
Region / City:
Australia
Subject:
Pharmacology, Pharmaceutical Benefits Scheme (PBS)
Document Type:
Submission
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Not specified
Target Audience:
Medical practitioners, healthcare professionals
Period of validity:
Not specified
Approval Date:
3 June 2022
Date of Changes:
Not specified
Contextual Description:
A regulatory submission detailing the request for listing of dupilumab in new forms for treating severe atopic dermatitis and uncontrolled severe asthma in pediatric patients under the PBS.
Note:
Year
Background:
The submission requested a General Schedule Authority Required (Telephone/Online) listing of a new form of adrenaline (epinephrine) acid tartrate 150 micrograms/0.15 mL autoinjector (AI) (Jext® Junior (Jr)) and 300 micrograms/0.3 mL AI (Jext®) under the same circumstances as the currently listed adrenaline (epinephrine) 150 microgram/0.3 mL AI (EpiPen® Jr and Anapen® Jr 150) and 300 microgram/0.3 mL AI (EpiPen® and Anapen® 300).
Year:
Not specified
Region / city:
Not specified
Theme:
Clinical Trials, Dose Escalation
Document type:
Protocol
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Clinical researchers, Principal Investigators
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Year:
2022
Region / City:
Australia
Topic:
Medicinal Product Submission
Document Type:
Submission for Pharmaceutical Listing
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Healthcare professionals, policy makers
Period of Validity:
Not specified
Approval Date:
10 August 2022
Date of Changes:
Not specified
Year:
2021
Region / City:
Australia
Topic:
Atopic dermatitis treatment, medication submission
Document Type:
Submission report
Organization / Institution:
Sanofi-Aventis Australia Pty Ltd
Author:
Sanofi-Aventis
Target Audience:
Medical professionals, regulatory authorities
Action Period:
Ongoing treatment evaluation
Approval Date:
17 August 2021
Modification Date:
Not specified
Background:
Dupilumab registration history
Clinical Claim:
Dupilumab has superior efficacy compared to standard care for children with severe atopic dermatitis
Episodicity:
Chronic
Severity:
Severe
Condition:
Atopic dermatitis
PBS Indication:
Chronic severe atopic dermatitis
Prescriber Type:
Medical practitioners, dermatologists, clinical immunologists
Treatment Phase:
Initial, continuing
Population Criteria:
Children aged 6 to 11 years, specific weight ranges
Comparator:
Placebo
Outcomes:
EASI-75, IGA 0 or 1 at Week 16, improvement in itch score
Dosing:
Tiered by body weight
Cost:
$1,754.28–$3,380.91
Price:
Published price for maximum quantity
Form:
Pre-filled syringe
Medical Information:
Dupilumab 300 mg/2 mL, 200 mg/1.14 mL
Note:
Comparator
Standard of care (Placebo)
Source:
PBAC submission
Year:
2016
Region / city:
United Kingdom
Topic:
Medical imaging, Radiation dose reduction
Document Type:
Guidelines
Organization / institution:
Royal College of Radiologists, British Association of Urological Surgeons
Author:
Dr. John Maguire, Nicola Spence, Dr. Karen Gray
Target Audience:
Radiologists, CT radiographers
Effective Period:
Ongoing
Approval Date:
28 January 2016
Last Reviewed:
8 April 2018
Year:
not specified
Country:
United Kingdom
Medication:
Zopiclone
Therapeutic class:
Hypnotic
Indication:
Insomnia
Licensed use duration:
Up to 4 weeks
Adult licensed dose:
7.5 mg at bedtime
Elderly licensed dose:
3.75–7.5 mg at bedtime
Off-licence use:
Yes
Primary topic:
Dose reduction and withdrawal
Withdrawal risks:
Physical and psychological withdrawal symptoms
Target population:
Adult patients using zopiclone long term
Recommended tapering pace:
No faster than one change per week
Dose forms:
3.75 mg tablets, 7.5 mg tablets
Reference bodies:
All Wales Medicines Strategy Group; NICE
Document components:
Clinical guidance; tapering schedule; patient reduction record
Note:
Year
Topic:
Medication Administration
Document Type:
Guidelines
Target Audience:
Staff in care homes