Specials Prescribing Optimisation Tool (SPOT)
|
|
- Eustace Perry
- 7 years ago
- Views:
Transcription
1 Bulletin 97 April 2015 Specials Prescribing Optimisation Tool (SPOT) Products which are un and are prescribed for individuals are called specials. A pharmaceutical special as defined by law is a medicine made to satisfy an individual patient need. The Medicines Act allows appropriate prescribers to prescribe medicines without a licence providing they are happy to assume full liability for the prescription. The Specials Prescribing Optimisation Tool (SPOT) is based on the national specials prescribing data. This list includes specials that appear regularly in the top ten specials prescribed list, those where there has been a significant growth in prescribing and those that may not appear very often but when they do pose significant cost pressure due to their expense. This bulletin aims to provide information on how to optimise prescribing either by offering alternatives or by suggesting how to contain prescribing of the particular special. Further supporting resources and bulletins will be developed to support implementation of the recommendations within this bulletin. However, as with all prescribing, these bulletins are general recommendations and any decisions on what to prescribe should be tailored to the individual patient. The prescriber is directly responsible for the prescribing of these products and will be liable for adverse effects or harm resulting from the use of that product. 1 Background There are several issues that are associated with specials, which affect both prescribers and pharmacists. Licensing Specials are un medicines, and so will not have been assessed by the licensing authority for safety, quality and efficacy. Usually they are specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned. Legal If a prescriber uses a medicine within the terms of the licence as specified in the Summary of Product Characteristics (SPC) any untoward effects are the legal responsibility of the manufacturer. If a patient experiences a side effect (even one not specified in the SPC) then the patient would have grounds to prosecute the manufacturer. This is not the case for a pharmaceutical special. As there is no SPC the prescriber takes full responsibility in law for any adverse effect caused by the medicine unless it can be demonstrated that the medicine was faulty. Given the uncertainties explained above this should not be underestimated. The prescriber should be able to justify and feel competent in using such medicines. 1 The prescriber is responsible because the medicine is un and has been made to their specifications. 1 of 11
2 Professional responsibility and accountability The primary professional responsibility of a prescriber and pharmacist is to ensure the safety of the patient. It is the pharmacist s professional responsibility to assist prescribers and ensure that when a special is prescribed that: There is no alternative It is safe and efficacious It is cost-effective It meets the prescriber s specification and the patients needs. It is the prescriber s responsibility to ensure the patient is aware of, and consents to, taking an un medication. The patient should also to be made aware of the risks associated with taking that un medicine. 1-3 The General Medical Council has prescribing guidance for un medicines it can be accessed via Quality and efficacy Specials are sourced from a variety of suppliers and consequently the quality and consistency of the product can vary considerably, this can lead to potential differences in pharmacokinetics and clinical responses which may have a negative impact on patient safety. This is particularly important for drugs with narrow therapeutic windows. Cost There is no set pricing for pharmaceutical specials, and there is no national pricing structure governing these products or local regulation of the cost of products to the NHS. As use of specials increases, there is a growing financial burden on the NHS. Part VIIIB of the Tariff (the Specials Tariff ) is a tariff of high volume and high cost un specials and imports, with set reimbursement prices on a selection of specials. The prices are set by analysis of a selection of un specials manufacturer s prices, with a margin included for pharmacy purchase profit. 1,2 Considerations When choosing suitable preparations for a patient the prescriber must consider: Clinical appropriateness for the patient Product quality and status Cost. When considering whether to prescribe an un product, the first consideration should be to determine if a medicine is needed at all. Any unnecessary medicines should be stopped. If a liquid formulation of a medication is required, consider agents with a prolonged therapeutic effect (but not modified or slow-release preparations) to reduce the frequency of dose administration. 4 These can be crushed and dispersed in a compatible liquid before administration. In some cases, modified release or slow release preparations may be used in this way, but the manufacturer would need to be contacted on a case by case basis to ensure this is appropriate. If the patient requires an oral dosage form, it is important to consider the hierarchy of risk on the basis of product origin (chart 1, adapted from MHRA guidance). 2 Enteral feeding is outside the scope of this bulletin. For detailed information about specific drugs, please refer to the Handbook of Administration via Enteral Feeding Tubes. 2 of 11
3 Chart 1. Hierarchy of risk, adapted from MHRA guidance PREFERRED CHOICE Hierachy of risk on basis of product origin Adapted from MHRA guidance LOWEST NET RISK A UK- medicine B Off-label use of a UK- medicine C An imported product in the country of origin D A UK manufactured special made in MHRA facilities E An extemporaneously dispensed medicine F An imported product not in the country of origin G A non-uk made un medicine or food supplement LAST CHOICE HIGHEST NET RISK The ideal situation is to switch the patient to an appropriate UK medication. If this is not possible then other options need to be considered. The hierarchy of risk diagram shows the preferred choice with the lowest risk at the top of the chart. If a product is not suitable; consider off-label use of a UK medication, e.g.by crushing and dispersing the tablet or opening the capsule. Consult product literature to see if this is a option. This may not be suitable option for all patients; consideration should be given to whether the patient or carer is able to administer medication in this manner and the dose required as drawing off aliquots from a dispersed product is not ideal but may sometimes be necessary. Where healthcare staff are administering these medicines, consideration should be given to providing written information or a protocol for the administration of medicines by un methods of administration. Individuals may require training and may need advice on health and safety issues particularly if medication is to be crushed or capsules opened. It is important that the prescriber writes brief instructions for administration on the prescription, e.g. via PEG Useful resources to identify the ability of crushing, dispersing tablets/ capsules for nasogastric (NG) feeding are: Handbook of Administration via Enteral Feeding Tubes The NEWT Guidelines The MHRA published guidance in May 2014 on the supply of un medicinal products ( specials ) which can be found at: 3 of 11
4 SPOT-List The SPOT-List contains the top ten medicines (all formulations and strengths) supplied as specials ranked by total spend nationally. The total national annual spend on these ten specials is approximately 44.1 million (based on April 14 to Jan 15 epact). For some of the items listed in the top ten, there are several formulations and strengths within the indicator. The chemical substances covered in the SPOT-List are: Acetylcysteine Diltiazem Glycopyrronium bromide Magnesium glycerophosphate/ magnesium oxide Melatonin Midodrine Midazolam buccal Omeprazole Sodium chloride (including eye preparations) Vitamin D prescribed as cholecalciferol or ergocalciferol SPOT-List supporting information The supporting information provided in the tables on the following pages is intended as a guide for healthcare professionals reviewing prescribing of specials. Please note this is not an exhaustive list of products available. Prices of medicines may vary depending on handling fees and changes in Tariff price. The use of the potential alternative product may be outside of its license, but a preferred option based on the hierarchy of risk. Please refer to the SPC or manufacturer for licensing information. For all the specials listed, the continued need for the special should be the first consideration when reviewing treatment. See the PrescQIPP optimising safe and appropriate medicines use bulletin for further guidance available at 4 of 11
5 Information for oral use (for enteral feeding please consult The Handbook of Administration via Enteral Feeding Tubes) Average cost per item (based on April 14 to Jan 15) Total spend in England (across all strengths and quantities, based on April 14 to Jan 15) Hierarchy of risk on basis of product origin (adapted from MHRA guidance code A-G) Review use, limited evidence to support usage. If patient can swallow, consider off-label use of Circadin. B Melatonin Circadin 2mg MR tablets Circadin tablets can be crushed; the release characteristics are similar to an immediate release dose form ,597,859 (If used in children it would be Consider discussion with secondary care specialist, consider shared care. Price in Tariff for liquid specials. Glycopyrronium bromide 1mg & 2mg tablets are in UK 200mcg/ml injection Licensed liquid in USA The BNF for Children states for administration by mouth, injection solution may be given or crushed tablets suspended in water. 6 This is outside the indication, so would be considered un use. 1mg/5ml oral solution (Cuvposa ) has been approved for use in the United States to reduce chronic severe drooling in patients aged 3-16 years with neurological disorders. 7 This will vary in cost as it needs to be imported ,704,753 Tablets: B (Tablets only for adults for add on therapy in the treatment of peptic ulcer.) Injection: B Liquid: C 5 of 11
6 Information for oral use (for enteral feeding please consult The Handbook of Administration via Enteral Feeding Tubes) Average cost per item (based on April 14 to Jan 15) Total spend in England (across all strengths and quantities, based on April 14 to Jan 15) Hierarchy of risk on basis of product origin (adapted from MHRA guidance code A-G) Magnesium glycerophosphate/ oxide No A summary of magnesium preparations available in the UK for the treatment and prevention of hypomagnesaemia did not find any significant difference in the efficacy or safety of the different oral magnesium preparations although there might be differences in bioavailability. Factors that could affect choice include local availability, patient tolerability, and price. 8 Magnaphate 4mmol tablets (Arjun Products Limited): for 50 tablets (magnesium glycerophosphate) (magnesium oxide) 3,461,911 (magnesium glycerophosphate) 634,236 (magnesium oxide) D Price in Tariff. Omeprazole Omeprazole orodispersible tablets. Some capsules can be opened and contents sprinkled on food (see PIL) Dispersible tablets (Losec MUPS) disintegrate to give a dispersion of small granules. 9 Generic dispersible tablets are also available. Losec MUPS/orodispersible tablets can also be dispersed in water or suspended in a small amount of yoghurt or fruit juice after gentle mixing. 9 It is important that the tablets shouldn t be crushed or chewed. 9 Price in Tariff is available for un oral solution ,280,059 Losec MUPS: A Dispersible tablets: A Capsules : B 6 of 11
7 Vitamin D (prescribed as colecalciferol (D3) and ergocalciferol (D2)) Desunin tablets Fultium-D3 capsules Invita oral solution Aviticol capsules Information for oral use (for enteral feeding please consult The Handbook of Administration via Enteral Feeding Tubes) High dose: InVita D3 25,000 IU oral solution, Fultium D3 20,000 IU capsules, Avitcol (D3) 20,000 IU capsules. 10 Maintenance dose: Fultium-D IU & 800 IU capsules, Desunin (D3) 800 IU tablets, InVita D3 25,000 IU oral solution, 10 the high dose products listed above can also be taken at longer intervals, see product details. Average cost per item (based on April 14 to Jan 15) (colecalciferol) (ergocalciferol) Total spend in England (across all strengths and quantities, based on April 14 to Jan 15) 3,142,606 (colecalciferol) 863,252 (ergocalciferol) Hierarchy of risk on basis of product origin (adapted from MHRA guidance code A-G) A Prices in Tariff for un variations. Midodrine Imported product in country of origin, un in UK. In the USA, midodrine is by the Food and Administration (FDA) for the treatment of symptomatic postural hypotension. It is also for use in several EU countries, such as Germany, France, Ireland, Italy and Spain. 11 Can be crushed and mixed with water for administration, this is considered off-label use ,343,985 B 7 of 11
8 Information for oral use (for enteral feeding please consult The Handbook of Administration via Enteral Feeding Tubes) Average cost per item (based on April 14 to Jan 15) Total spend in England (across all strengths and quantities, based on April 14 to Jan 15) Hierarchy of risk on basis of product origin (adapted from MHRA guidance code A-G) Acetylcysteine Not available Self care suggested Holland and Barrett 8.19 (for 30 capsules). This is a food supplement, and has not undergone a quality assurance assessment as medicines do. Patient to buy. product/holland-barrett-n-acetyl-cysteinenac-capsules-600mg IDIS are able to order as a special if prescribed ,034,135 G Some NHS hospitals may manufacturer this product. Oronac is also available via Fontus Health in various formulations. 8 of 11
9 Information for oral use (for enteral feeding please consult The Handbook of Administration via Enteral Feeding Tubes) Average cost per item (based on April 14 to Jan 15) Total spend in England (across all strengths and quantities, based on April 14 to Jan 15) Hierarchy of risk on basis of product origin (adapted from MHRA guidance code A-G) Licensed for the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to <18 years). 13 Buccolam must only be used by parents/carers where the patient has been diagnosed to have epilepsy. 13 For infants between 3-6 months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available. 13 Buccal midazolam may be considered as an alternative to rectal diazepam for the treatment of prolonged seizures. Various buccal midazolam preparations have been used in children as un medicines, including Buccolam prior to receiving market authorisation. 15 Doses available as 2.5mg, 5mg, 7.5mg & 10mg pre-filled syringes. 14 Buccolam is half the strength of some other un preparations. It contains the hydrochloride salt. Some other preparations contain the maleate salt of midazolam. Although there is some suggestion that the maleate salt may be better absorbed in the buccal cavity, there are adequate studies with midazolam hydrochloride to support the dosing schedule authorised for Buccolam. 15 A hospital paediatric unit has recently published its experience of transferring patients to Buccolam. One of the key points raised was the requirement to have only one product (specifically only one strength of product available for use). 16 This would be to ensure no confusion during dosing, and should be considered prior to switching patients to product. Price in Tariff. Midazolam maleate Buccolam Oromucosal solution ,981,814 A 9 of 11
10 Information for oral use (for enteral feeding please consult The Handbook of Administration via Enteral Feeding Tubes) Most of the spend on diltiazem is for topical preparations, so the recommendations are for topical products only. Average cost per item (based on April 14 to Jan 15) Total spend in England (across all strengths and quantities, based on April 14 to Jan 15) Hierarchy of risk on basis of product origin (adapted from MHRA guidance code A-G) Diltiazem hydrochloride Rectogesic (GTN 0.4% Cream) Rectogesic 4mg/g rectal ointment can be used as a alternative, a finger cap should be used when applying. 17 Please note that topical glyceryl trinitrate 2mg/g (0.2%) ointment does not currently have a UK licence for treating chronic anal fissures, or for any other indication. Therefore, its use is un. 18 Un 2% diltiazem hydrochloride cream (Anoheal ) is available on a named-patient basis from S.L.A. Pharma (UK) Ltd at plus VAT per 30 g tube. Costs of products obtained from other sources may differ ,369,580 Rectogesic : A Anoheal : D Price in Tariff. For oral preparations Sodium chloride No Sodium chloride 5%w/v eye drops and sodium chloride 5%w/w eye ointment available medical devices. 20 Liquid is not available, consider if the tablet formulation is an option. Licensed tablets available as Slow Sodium 600mg (approx. 10 mmol each of Na+ and Cl-). 14 For eye preparations UK Ophthalmic Pharmacy Group suggest that other strengths such as 0.45% w/v likely to be an error in strength. 20 Check if 5% w/v or other strength intended - if other strength, suggest 5% w/v as licenced products should be prescribed in preference to un medicines. 20 Price in Tariff ,347,240 Tablets: A Liquid: D Eye preparations: D 10 of 11
11 References 1. PrescQIPP NHS programme and the NHS East of England Collaborative Procurement Hub. Information and Guidance on the Prescribing and Use of Un Specials v3.1. March 2013 available at 2. Royal Pharmaceutical Society of Great Britain. Dealing with Specials. Pharmacy Professional June 2010, updated June 2011 available at 3. General Medical Council. Good Practice in Prescribing Medicines and Devices: Unlicenced Medicines. 2013, Updated April Available at 4. UKMI Q&A What are the therapeutic options for patients unable to take solid oral dosage forms? Date prepared: July correspondence. Flynn Pharma, August British National Formulary for Children. British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary.BMJ Group and RPS Publishing. London; December Accessed via: BNF for Children, December National Institute of Health and Care Excellence. ESUOM15 Hypersalivation: Oral glycopyrronium bromide. July 2013 available at 8. UKMI Q&A What oral magnesium preparations are available in the UK and which preparation is preferred for the treatment and prevention of hypomagnesaemia. Date prepared: 22nd April White, R. Bradnam, V. Handbook of Administration via Enteral Feeding Tubes, Second edition. The Pharmaceutical Press. November Monthly Index of Medical Specialities (MIMS ). Accessed online via: on 23rd Feburary National Institute of Health and Care Excellence. ESUOM5Postural hypotension in adults: midodrine. February 2013 available at Wrexham Maelor Hospital Pharmacy Department. The NEWT Guidelines for Administration of Medication to Patients with Enteral Feeding Tubes or Swallowing Difficulties. April Summary Product Characteristics; Buccolam Oromucosal Solution. ViroPharma Ltd. Last revised on the emc 03 October Accessed via on 17th March British National Formulary. British Medical Association and Royal Pharmaceutical Society of Great Britain. BMJ Group and RPS Publishing. London; December Accessed via mc/bnf/current 15. Safety Update: Buccal midazolam (Buccolamq): new authorised medicine for paediatric use. October Accessed via: Tomlin, S. Medicines Tailored for Children: The Introduction of Buccal Midazolam. The Pharmaceutical Journal. 4 August 2011; 287: Summary Product Characteristics. Rectogesic 4 mg/g Rectal Ointment. ProStrakan. Last revised 07/2017. Accessed 24/04/2015 available at National Institute of Health and Care Excellence. ESUOM3 Chronic anal fissure: 2% topical diltiazem hydrochloride. Published date: January Accessed via National Institute of Health and Care Excellence. ESUOM07 Chronic anal fissure: 0.2% topical glyceryl trinitrate ointment. Published date:march Accessed via Ophthalmic Special Order Products, General Principles. The Royal Collage Ophthalmologists,.UK Ophthalmic Pharmacy Group. April 2014 Additional PrescQIPP resources There aren t any other resources available yet but further SPOT-List bulletins and resources will be following this introductory bulletin very soon. Information compiled by Rakhi Aggarwal PrescQIPP Programme, March 2015 and reviewed by Katie Smith, East Anglia Medicines Information Service, April Non-subscriber publication August of 11
June 2010 Pharmacy Professional
f e at u r e s p e c i a l s Dealing with specials Responding to members requests the Society presents practical guidance for pharmacists on professional responsibilities when dealing with the supply of
More informationNHS GGC Vitamin D Supplementation Frequently asked Questions
Pharmacy & Prescribing Support Unit NHS GGC Vitamin D Supplementation Frequently asked Questions In February 2012 the Scottish Government issued advice on supplements for groups at risk of vitamin D deficiency.
More informationMELATONIN FOR SLEEP DISORDERS IN CHILDREN AND ADOLESCENTS WITH NEURODEVELOPMENTAL DISORDERS SHARED CARE GUIDELINES
MELATONIN FOR SLEEP DISORDERS IN CHILDREN AND ADOLESCENTS WITH NEURODEVELOPMENTAL DISORDERS SHARED CARE GUIDELINES Version control: Version Date Main changes/comments V1 4 June 2013 First draft circulated
More informationVITAMIN D PRODUCTS -WHAT AND WHEN TO PRESCRIBE. Claudette Allerdyce Principal Pharmacist Croydon CCG Pharmacy Team
VITAMIN D PRODUCTS -WHAT AND WHEN TO PRESCRIBE Claudette Allerdyce Principal Pharmacist Croydon CCG Pharmacy Team WHAT ARE THE ISSUES? A lack of suitable licensed vitamin D products in the UK for treating
More informationAll Wales Prescription Writing Standards
All Wales Prescription Writing Standards These standards should be read in conjunction with completing the All Wales Medication Chart e- learning package, available on the Learning@NHSWales internet site
More informationPL 17871/0208 UKPAR TABLE OF CONTENTS
Fultium-D 3 3,200 IU Capsules PL 17871/0208 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient
More informationPrompting, assisting and administration of medication in a care setting: guidance for professionals
Prompting, assisting and administration of medication in a care setting: guidance for professionals Publication date: March 2015 Publication code HCR-0315-092 Page 1 of 6 Background Any care service provision
More informationUse of medicines outside of their UK marketing authorisation in pain management and palliative medicine
The British Pain Society Use of medicines outside of their UK marketing authorisation in pain management and palliative medicine This is a consensus document prepared on behalf of the British Pain Society
More informationGUIDELINES FOR THE USE OF PALIPERIDONE PALMITATE (Xeplion ) Version: 2
SH CP 29 GUIDELINES FOR THE USE OF PALIPERIDONE PALMITATE (Xeplion ) Summary: Guidelines for the use of paliperidone palmitate (Xeplion ) Keywords (minimum of 5): (To assist policy search engine) Target
More informationPharmacists improving care in care homes
The Royal Pharmaceutical Society believes that better utilisation of pharmacists skills in care homes will bring significant benefits to care home residents, care homes providers and the NHS. Introduction
More informationGood practice for drug calculations
Good practice for drug calculations A step-by-step guide for nurses, doctors and all other healthcare professionals Pharmacyservices 7048 Drug Cal Guide A6 Update_AW.indd 1 22/07/2014 09:55 2 Contents
More informationTHE USE OF DRUGS BEYOND (OFF-LABEL) AND WITHOUT (UNLICENSED) MARKETING AUTHORIZATION
THE USE OF DRUGS BEYOND (OFF-LABEL) AND WITHOUT (UNLICENSED) MARKETING AUTHORIZATION The use of drugs for off-label purposes is widespread. Surveys suggest that up to 1/4 of all prescriptions in palliative
More informationNational Chlamydia Screening Programme September 2012 PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF AZITHROMYCIN FOR CHLAMYDIA TRACHOMATIS
PATIENT GROUP DIRECTION FOR THE ADMINISTRATION OF AZITHROMYCIN FOR CHLAMYDIA TRACHOMATIS Below is a template that can be used to produce a local patient group direction (PGD) for the administration of
More informationPublic Assessment Report. UK National Procedure. (colecalciferol) PL 16508/0047 PL 16508/0048. ProStrakan Ltd.
Public Assessment Report UK National Procedure STEXEROL-D 3 1,000 IU FILM-COATED TABLETS STEXEROL-D 3 25,000 IU FILM-COATED TABLETS (colecalciferol) PL 16508/0047 PL 16508/0048 ProStrakan Ltd. 1 LAY SUMMARY
More informationHumulin R (U500) insulin: Prescribing Guidance
Leeds Humulin R (U500) insulin: Prescribing Guidance Amber Drug Level 2 We have started your patient on Humulin R (U500) insulin for the treatment of diabetic patients with marked insulin resistance requiring
More informationPHARMACISTS AMENDMENTS TO PRESCRIPTIONS
PHARMACISTS AMENDMENTS TO PRESCRIPTIONS May 2016 Version 2.3 Table of Contents 1. Introduction... 3 2. Purpose of this Policy... 3 3. Scope... 3 4. Definitions/Glossary... 3 5. Ownership and Responsibilities...
More informationInformation and Guidance on the Prescribing and Use of Unlicensed Pharmaceutical Specials
Information and Guidance on the Prescribing and Use of Unlicensed Pharmaceutical Specials Contents Introduction 3 Scope 3 What is a pharmaceutical special? 3 The clinical and legal differences 5 Processes
More informationOn Demand Availability of Palliative Care Drugs Service
On Demand Availability of Palliative Care Drugs Service Locally Enhanced Service Author: Peer Review: Produced For review April 2013 Ruth Buchan, Senior Pharmacist Julie Landale, HoMM NHS Calderdale 4th
More informationA competency framework for all prescribers updated draft for consultation
A competency framework for all prescribers updated draft for consultation Consultation closes 15 April 2016 Contents 1 Introduction... 3 2 Uses of the framework... 4 3 Scope of the competency framework...
More informationNational Centre for Pharmacoeconomics. Guidelines for Inclusion of Drug Costs in Pharmacoeconomic Evaluations
National Centre for Pharmacoeconomics Guidelines for Inclusion of Drug Costs in Pharmacoeconomic Evaluations Version 1.10 Please Note: This document may be updated periodically, therefore please refer
More informationMedicines & Enteral Feeding Tubes A DELA V IDICKI-MASTILOVICH C LINICAL P HARMACIST R OYAL C HILDREN S H OSPITAL
Medicines & Enteral Feeding Tubes A DELA V IDICKI-MASTILOVICH C LINICAL P HARMACIST R OYAL C HILDREN S H OSPITAL Introduction Types of Tubes Choosing a formulation Crushing tablets/opening capsules Administration
More informationBerkshire Healthcare NHS Foundation Trust Becky White CHS Pharmacist April 2013
Berkshire Healthcare NHS Foundation Trust Becky White CHS Pharmacist April 2013 Access to palliative care drugs out of hours Agreement set up with local community pharmacy s to hold stock of commonly prescribed
More informationIN-USE PRODUCT SAFETY ASSESSMENT REPORT BENEPALI (ETANERCEPT BIOSIMILAR)
IN-USE PRODUCT SAFETY ASSESSMENT REPORT BENEPALI (ETANERCEPT BIOSIMILAR) SUMMARY OF ASSESSMENT AND ITS FINDINGS BACKGROUND A UK marketing authorisation has been granted to an etanercept biosimilar (SB4,
More informationPatient Group Directions. Guidance and information for nurses
Patient Group Directions Guidance and information for nurses Patient Group Directions Guidance and information for nurses Contents Introduction 4 What is a patient group direction (PGD)? 4 When can PGDs
More informationMedication Management Guidelines for Nurses and Midwives
Medication Management Guidelines for Nurses and Midwives 1. Introduction As the statutory body responsible for the regulation of nursing and midwifery practice in Western Australia (WA), the Nurses & Midwives
More informationHOSPITAL PHARMACY PRACTICE IN THE UK AND THE RESPONSIBLE PHARMACIST REQUIREMENTS
HOSPITAL PHARMACY PRACTICE IN THE UK AND THE RESPONSIBLE PHARMACIST REQUIREMENTS ROYAL PHARMACEUTICAL SOCIETY OF GREAT BRITAIN AND THE PHARMACEUTICAL SOCIETY OF NORTHERN IRELAND STATUS OF THIS DOCUMENT
More informationIncluding Me, Managing Complex Health Needs in Schools and Early Years Settings
Model Policy for The Administration of Medicines in Schools Evelyn Green Steph King Moira Young Jo Howcroft Scott Lisa Maidment Jenny Tapply John Studley Liz Foster Sarah Fletcher Sally Anne Clark Manager
More informationGood Practice Guidance: The administration of medicines in domiciliary care
Good Practice Guidance: The administration of medicines in domiciliary care Medicines Management Social Care Support Team Reviewed February 2014 This guidance is based on documents that were on CQC s website
More informationPHARMACEUTICAL MANAGEMENT PROCEDURES
PHARMACEUTICAL MANAGEMENT PROCEDURES THE FORMULARY The purpose of Coventry Health Care s formulary is to encourage use of the most cost-effective drugs. The formulary is necessary because the cost of prescription
More information1. What are anti-epileptic drugs? Anti-epileptic drugs (AEDs) are prescribed to control seizures. They do not cure epilepsy.
14 FREQUENTLY ASKED QUESTIONS ON ANTI- EPILEPTIC DRUGS 1. What are anti-epileptic drugs? Anti-epileptic drugs (AEDs) are prescribed to control seizures. They do not cure epilepsy. 2. When should treatment
More informationGUIDELINES FOR THE CONTROL AND ADMINISTRATION OF MEDICINES DOMICILIARY CARE AGENCIES
GUIDELINES FOR THE CONTROL AND ADMINISTRATION OF MEDICINES DOMICILIARY CARE AGENCIES January 2009 Contents Page Number 1.0 Introduction 3 2.0 Background 4 3.0 Criteria 5 3.1 Referral 5 3.2 Levels of assistance/consent
More informationOmeprazole 20 mg gastro-resistant tablets PL 14017/0277
Omeprazole 20 mg gastro-resistant tablets PL 14017/0277 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Steps Taken After Initial Authorisation
More informationLocal Enhanced Service Specification for the Supply of Pharmaceutical Services to Care Homes through Community Pharmacy
Local Enhanced Service Specification for the Supply of Pharmaceutical Services to Care Homes through Community Pharmacy Contents: 1. Introduction and purpose 2. Period of Service 3. Aim of the Service
More informationDonepezil hydrochloride 10 mg film-coated tablets PL 19156/0130
Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics
More informationMemantine (Ebixa) Drug treatment for Alzheimer s disease
IS 20 October 2011 Information sheet Memantine (Ebixa) Drug treatment for Alzheimer s disease Introduction... 1 How does Ebixa work?... 1 Who might benefit?... 2 What effect might Ebixa have?... 2 How
More informationService Specification for NHS Community Pharmacy Palliative Care Drugs Stockist Scheme
Service Specification for NHS Community Pharmacy Palliative Care Drugs Stockist Scheme 1. This agreement is between NHS England North Midlands (Derbyshire/ Nottinghamshire only) (the Commissioner) Birch
More informationDonepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa )
Donepezil (Aricept ), Galantamine (Reminyl XL ), Rivastigmine (Exelon ) and Memantine (Ebixa ) ESCA: For the treatment of Alzheimer s disease. SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
More information**Form 1: - Consultant Copy** Telephone Number: Fax Number: Email: Author: Dr Bernard Udeze Pharmacist: Claire Ault Date of issue July 2011
Effective Shared Care Agreement for the treatment of Dementia in Alzheimer s Disease Donepezil tablets / orodispersible tablets (Aricept / Aricept Evess ) These forms (1 and 2) are to be completed by both
More informationPharmacist independent prescribing programme learning outcomes and indicative content
Pharmacist independent prescribing programme learning outcomes and indicative content Learning outcomes All providers of GPhC accredited independent prescribing programmes need to ensure that following
More informationIQ Level 2 Certificate in Understanding the Safe Handling of Medicines (QCF) Specification
IQ Level 2 Certificate in Understanding the Safe Handling of Medicines (QCF) Specification Regulation No: 601/2010/1 Page 1 of 25 IQB/0.2/211 Version 1.0 13/01/2014 Author AW Contents Page Industry Qualifications...
More informationNarcotic drugs used for pain treatment Version 4.3
Narcotic drugs used for pain treatment Version 4.3 Strategy to restrict the pack sizes or the type of packaging available in public pharmacies. 1. Introduction The document describing the strategy of the
More informationAlcohol use disorders: sample chlordiazepoxide dosing regimens for use in managing alcohol withdrawal
Alcohol use disorders: sample chlordiazepoxide dosing regimens for use in managing alcohol withdrawal February 2010 NICE clinical guidelines 100 and 115 1 These sample chlordiazepoxide dosing regimens
More informationPHARMACEUTICAL EXCIPIENTS
PHARMACEUTICAL EXCIPIENTS Brian R Matthews PDA Bethesda, MD, USA DHI Publishing, LLC River Grove, IL, USA 10 9 8 7 6 5 4 3 2 1 ISBN: x-xxxxxx-xx-x Copyright 2005 Brian R Matthews. All rights reserved.
More informationGUIDELINES ON PREVENTING MEDICATION ERRORS IN PHARMACIES AND LONG-TERM CARE FACILITIES THROUGH REPORTING AND EVALUATION
GUIDELINES GUIDELINES ON PREVENTING MEDICATION ERRORS IN PHARMACIES AND LONG-TERM CARE FACILITIES THROUGH REPORTING AND EVALUATION Preamble The purpose of this document is to provide guidance for the pharmacist
More informationVolume 9; Number 13 September 2015 TREATMENT OF VITAMIN D DEFICIENCY IN AT-RISK ADULTS (SECOND EDITION)
Arden and Greater East Midlands Commissioning Support Unit in association with Lincolnshire Clinical Commissioning Groups, Lincolnshire Community Health Services, United Lincolnshire Hospitals Trust and
More informationFexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS
Fexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps
More informationFormulary notes for the List of Approved Medicines
Formulary notes for the List of Approved Medicines Last updated May 2016 Contents Introduction... 2 Formulary notes... 2 Generic listing of medicines... 2 PBS items... 2 Restrictions... 3 Applications
More informationCoventry Health Care of Georgia, Inc. Coventry Health and Life Insurance Company
Coventry Health Care of Georgia, Inc. Coventry Health and Life Insurance Company PRESCRIPTION DRUG RIDER This Prescription Drug Rider is an attachment to the Coventry Health Care of Georgia, Inc. ( Health
More informationIssue: June 2009 PROFESSIONAL STANDARDS AND GUIDANCE FOR THE SALE AND SUPPLY OF MEDICINES
Issue: June 2009 PROFESSIONAL AND GUIDANCE FOR THE SALE AND SUPPLY OF MEDICINES PROFESSIONAL AND GUIDANCE FOR THE SALE AND SUPPLY OF MEDICINES CONTENTS Status of this document About this document 1 Pharmaceutical
More informationARRANGEMENTS FOR THE FUTURE SUPPLY AND REIMBURSEMENT OF GENERIC MEDICINES FOR NHS SCOTLAND. Consultation Document
ARRANGEMENTS FOR THE FUTURE SUPPLY AND REIMBURSEMENT OF GENERIC MEDICINES FOR NHS SCOTLAND Consultation Document Scottish Executive Health Department October 2003 Arrangements For The Future Supply And
More informationMedicines reconciliation on admission and discharge from hospital policy April 2013. WHSCT medicines reconciliation policy 1
Medicines reconciliation on admission and discharge from hospital policy April 2013 WHSCT medicines reconciliation policy 1 Policy Title Policy Reference Number Medicines reconciliation on admission and
More informationProfessional Standards and Guidance for the Sale and Supply of Medicines
Professional Standards and Guidance for the Sale and Supply of Medicines About this document The Code of Ethics sets out seven principles of ethical practice that you must follow as a pharmacist or pharmacy
More informationNHS Professionals. Guidelines for the Administration of Medicines
NHS Professionals Guidelines for the Administration of Medicines Introduction The control of medicines in the United Kingdom is primarily through the Medicines Act (1968) and associated British and European
More informationHypromellose Eye Drops BP 0.3% w/v PL 23097/0006
Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Summary of product characteristics Page 10 Patient
More informationMEDICATION GUIDE. Tranxene* (TRAN-zeen) T-TAB (clorazepate dipotassium) tablets
MEDICATION GUIDE Tranxene* (TRAN-zeen) T-TAB (clorazepate dipotassium) tablets Read this Medication Guide before you start taking TRANXENE and each time you get a refill. There may be new information.
More informationDrugs to consider prescribing by brand name or where brands should not be switched
Index Page Index Page Adrenaline (epinephrine) prefilled syringes 2 Hormone replacement therapy oral 3 Alprostadil injection 4 Human papillomavirus vaccine 5 Aminophylline modified release 2 Insulins 3
More information2. Characteristics of staff Qualifications required. Additional requirements. Continued education & training requirements
Patient Group Direction The supply of Azithromycin 1g as a single dose by accredited Community Pharmacists to patients in receipt of a positive test result to Chlamydia trachomatis, and treatment of their
More informationGalantamine hydrobromide (Reminyl) Drug treatment for Alzheimer s disease
IS 17 October 2011 Information sheet Galantamine hydrobromide (Reminyl) Drug treatment for Alzheimer s disease Introduction... 1 How does Reminyl work?... 1 Who might benefit?... 2 What effect might Reminyl
More informationLEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES. (paracetamol, caffeine and phenylephrine hydrochloride)
LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES (paracetamol, caffeine and phenylephrine hydrochloride) PL 00063/0529 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Summary of
More informationMEDICINES MANAGEMENT STANDARD OPERATING PROCEDURE (MMSOP018) Preparation of Medication Administration Record (MAR) Charts
MEDICINES MANAGEMENT STANDARD OPERATING PROCEDURE (MMSOP018) Preparation of Medication Administration Record (MAR) Charts Any deviation in practice from this procedure must be discussed with the Community
More informationSPECIFICATION FOR THE LOCAL COMMISSIONED SERVICE FOR THE MANAGEMENT ALCOHOL MISUSE
SPECIFICATION FOR THE LOCAL COMMISSIONED SERVICE FOR THE MANAGEMENT OF ALCOHOL MISUSE Date: March 2015 1 1. Introduction Alcohol misuse is a major public health problem in Camden with high rates of hospital
More informationSection II When you are finished with this section, you will be able to: Define medication (p 2) Describe how medications work (p 3)
Section II When you are finished with this section, you will be able to: Define medication (p 2) Describe how medications work (p 3) List the different medication effects (p5) List the ways that medications
More informationZOVIRAX Cold Sore Cream
Data Sheet ZOVIRAX Cold Sore Cream Aciclovir 5% w/w Presentation Topical cream Indications ZOVIRAX Cold Sore Cream is indicated for the treatment of Herpes simplex virus infections of the lips and face
More information1 Manipulation of formulae and dilutions
1 Manipulation of formulae and dilutions This first chapter of questions is specifically designed to cover a range of numeracy skills. It will give the user further experience in the skills of addition,
More informationRMIP Prescription Plan FAQ's
RMIP Prescription Plan FAQ's A new U.S. Pharmacy Benefit Manager has been selected for January 1, 2015 - CVS/caremark. 1) Why is the RMIP changing to CVS/caremark? The Express Scripts contract ends on
More informationPROPOSALS FOR AMENDMENTS TO THE HUMAN MEDICINES REGULATIONS 2012 TO ALLOW WIDER ACCESS TO NALOXONE FOR USE IN EMERGENCIES
To: Interested Organisations Our reference: MLX MLX 383 Date: 19 November 2013 Dear Sir/Madam PROPOSALS FOR AMENDMENTS TO THE HUMAN MEDICINES REGULATIONS 2012 TO ALLOW WIDER ACCESS TO NALOXONE FOR USE
More informationPrescription Drug Plan
Prescription Drug Plan The prescription drug plan helps you pay for prescribed medications using either a retail pharmacy or the mail order program. For More Information Administrative details and procedures
More informationPharmacy Policy (General)
WORKSAFE VICTORIA Pharmacy Policy (General) WorkSafe can pay the reasonable costs of medications and other pharmacy items required as a result of a work-related injury or illness in accordance with Victorian
More informationAppendix 9 Key Performance Indicators for Homecare Service Providers
Appendix 9 Key Performance Indicators for Homecare Service Providers These KPIs are currently under review by the National Homecare Medicines Committee and a final version of agreed KPIs is anticipated
More informationAnnex 7 Guidelines on pre-approval inspections
World Health Organization WHO Technical Report Series, No. 902, 2002 Annex 7 Guidelines on pre-approval inspections 1. General 94 2. Glossary 94 3. Objectives 95 4. Priorities 96 5. Preparation for the
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER. VITAMINE B12 STEROP 1mg/1ml Solution for injection / oral solution. Cyanocobalamin
PACKAGE LEAFLET: INFORMATION FOR THE USER VITAMINE B12 STEROP 1mg/1ml Solution for injection / oral solution Cyanocobalamin Read all of this leaflet carefully before you start using this medicine because
More informationReview Group: Mental Health Operational Medicines Management Group. Signature Signature Signature. Review Date: December 2014
Mental Health NHS Grampian Mental Health Service Staff Guidance For The Prescribing Of Vitamin Supplementation During In-Patient Admission (Mental Health) For Alcohol Withdrawal Co-ordinators: Consultant
More informationPolicy Document Control Page
Policy Document Control Page Title Title: Covert Administration of Medicines Version: Version 6 Reference Number: CL37 Supersedes Supersedes: Version 5 Description of amendment(s): Originator 3.5 Clarification
More informationOVERVIEW OF IPTR AND NON-FORMULARY PROCESS IN THE ACUTE SECTOR
5.2: POLICY FOR THE MANAGEMENT OF INDIVIDUAL PATIENT TREATMENT REQUESTS IMPORTANT NOTE: This policy document is subject to review pending the introduction of the Peer Approval Clinical System which will
More informationPART 14 CORE BUSINESS RULES FOR REIMBURSEMENT SCOTTISH DRUG TARIFF PART 14 CORE BUSINESS RULES FOR REIMBURSEMENT
SCOTTISH DRUG TARIFF PART 14 PREFACE The rules as set out below are the basic requirement for reimbursement of items presented on NHS primary care prescription in Scotland. These rules cover both printed
More informationShared Care Guideline-Use of Donepezil, Galantamine, Rivastigmine and Memantine in Dementia
Shared Care Guideline-Use of Donepezil, Galantamine, Rivastigmine and Memantine in Dementia Version: 3.0 Ratified by: Medicines Committee Date ratified: 16 th November 2011 Name of originator/author: James
More informationMucodyne-Clear 250 mg/5 ml Syrup PL 04425/0665
Mucodyne-Clear 250 mg/5 ml Syrup PL 04425/0665 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Summary of product characteristics Page 10 Patient
More informationGuidance notes. for Patient Safety and Pharmacovigilance in Patient Support Programmes
Guidance notes for Patient Safety and Pharmacovigilance in Patient Support Programmes 9 May 2011 Approval Status Authors The ABPI Pharmacovigilance Expert Network Change History N/A Approval Date 9 May
More informationMontelukast 10mg film-coated tablets PL 17907/0474
Montelukast 10mg film-coated tablets PL 17907/0474 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Steps Taken After Initial Authorisation Page
More informationKeeping patients safe when they transfer between care providers getting the medicines right
PART 1 Keeping patients safe when they transfer between care providers getting the medicines right Good practice guidance for healthcare professions July 2011 Endorsed by: Foreword Taking a medicine is
More informationMedication Administration Procedure
Medication Administration Procedure Procedure Name Medication Administration Approved by Category Work Practice Approval date April 2014 Version 1 Review date April 2016 Why do we need this procedure?
More informationGuidelines for the Use of Controlled Substances in the Treatment of Pain Adopted by the New Hampshire Medical Society, July 1998
Guidelines for the Use of Controlled Substances in the Treatment of Pain Adopted by the New Hampshire Medical Society, July 1998 Section I: Preamble The New Hampshire Medical Society believes that principles
More informationFrequently Asked Questions (FAQs) Treatment Authorization Request (TAR) Restriction on Antipsychotic Medications for the 0-17 Population
Frequently Asked Questions (FAQs) Treatment Authorization Request (TAR) Restriction on Antipsychotic Medications for the 0-17 Population Prescriber FAQs Update January 22, 2015 1. What information is needed
More informationMULTI AGENCY POLICY FOR THE ADMINISTRATION OF MEDICATION AND HEALTH CARE PROCEDURES:
MULTI AGENCY POLICY FOR THE ADMINISTRATION OF MEDICATION AND HEALTH CARE PROCEDURES: Early years provision, Educational Establishments and Voluntary Services Document reference number: C O R P O L O 0
More informationFile No.: 20100701. Guidelines for the Administration of certain substances by aged-care workers in residential aged care services
File No.: 20100701 Guidelines for the Administration of certain substances by aged-care workers in residential aged care services 1 September 2010 Contents 1. Introduction...4 2. Regulation 95EA...5 3.
More informationAdministrative Policies and Procedures for MOH hospitals /PHC Centers. TITLE: Organization & Management Of Medication Use APPLIES TO: Hospital-wide
Administrative Policies and Procedures for MOH hospitals /PHC Centers TITLE: Organization & Management Of Medication Use APPLIES TO: Hospital-wide NO. OF PAGES: ORIGINAL DATE: REVISION DATE : السیاسات
More informationStowe School Medications Policy
INTRODUCTION Most pupils will need medication at some stage of their school life. Although this will mainly be for short periods there are a few pupils with chronic conditions who may require regular medication
More informationIntroduction. Background to this event. Raising awareness 09/11/2015
Introduction Primary Care Medicines Governance HSCB Background to this event New class of medicines Availability of training Increasing volume of prescriptions Reports of medication incidents Raising awareness
More informationPharmaCare is BC s public drug insurance program that assists BC residents in paying for eligible prescription drugs and designated medical supplies.
PHARMANET AND PHARMACARE DATA DICTIONARY Date Range: September 1, 1995 to present date, data is provided by calendar year Data Source: BC Ministry of Health Description The PharmaNet system is an online,
More informationGMMMG Interface Prescribing Subgroup. Shared Care Template
GMMMG Interface Prescribing Subgroup Shared Care Template Shared Care Guideline for Selective Serotonin Reuptake Inhibitors (SSRIs) for the treatment of Obsessive Compulsive Disorder (OCD) and Body Dysmorphic
More informationWorking together for healthier living
Working together for healthier living What is compounding? Compounding is the art and science of preparing custom medications to meet patients unique needs and prescribers exact specifications. The practice
More informationAscorbic Acid 50 mg Tablets. Ascorbic Acid 100 mg Tablets. Ascorbic Acid 200 mg Tablets. Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287
Ascorbic Acid 50 mg Tablets Ascorbic Acid 100 mg Tablets Ascorbic Acid 200 mg Tablets Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287 PL 20416/0288 PL 20416/0289 UKPAR TABLE OF CONTENTS Lay Summary
More informationPrescribing Framework for Donepezil in the Treatment and Management of Dementia
Hull & East Riding Prescribing Committee Prescribing Framework for Donepezil in the Treatment and Management of Dementia Patients Name:.. NHS Number: Patients Address:... (Use addressograph sticker) GP
More informationNational Patient Safety Agency. Risk Assessment of Injectable Medicines. STEP 1 Local Risk Factor Assessment. STEP 2 Product Risk Factor Assessment
NPSA Injectable Medicines Risk Assessment Tool National Patient Safety Agency Risk Assessment of Injectable Medicines STEP 1 Local Risk Factor Assessment. Carry out a baseline assessment in a near patient
More informationPublic Assessment Report. (Budesonide) PL 17901/0254. AstraZeneca UK Ltd
Public Assessment Report Rhinocort Hay Fever 64 micrograms, Nasal Spray (Budesonide) PL 17901/0254 AstraZeneca UK Ltd 1 LAY SUMMARY Rhinocort Hay Fever 64 micrograms, Nasal Spray (Budesonide) This is a
More informationProposals to simplify the reimbursement arrangements for NHS dispensing contractors: A consultation
Proposals to simplify the reimbursement arrangements for NHS dispensing contractors: A consultation 0 CONSULTATION PAPER PROPOSALS TO SIMPLIFY THE REIMBURSEMENT ARRANGEMENTS FOR NHS DISPENSING CONTRACTORS
More informationAcute management of Parkinson s
Acute management of Parkinson s Fife Parkinson s Service 2013 1 Contents 1. Introduction 2. On admission to hospital 3. If Patient has compromised swallow or is nil by mouth 4. Conversion charts if patient
More informationAlert. Patient safety alert. Actions that can make anticoagulant therapy safer. 28 March 2007. Action for the NHS and the independent sector
Patient safety alert 18 Alert 28 March 2007 Immediate action Action Update Information request Ref: NPSA/2007/18 4 Actions that can make anticoagulant therapy safer Anticoagulants are one of the classes
More informationGUIDANCE ON THE ADMINISTRATION OF DRUGS VIA ENTERAL FEEDING TUBES V 3.0
GUIDANCE ON THE ADMINISTRATION OF DRUGS VIA ENTERAL FEEDING TUBES V 3.0 1 st June 2013 Table of Contents Table of Contents... 2 1. Introduction... 3 2. Purpose of this Policy/Procedure... 3 3. Scope...
More informationNEW ZEALAND DATA SHEET NAPHCON-A Naphazoline hydrochloride and pheniramine maleate.
NEW ZEALAND DATA SHEET NAPHCON-A Naphazoline hydrochloride and pheniramine maleate. PRESENTATION Eye Drops: NAPHCON-A Eye Drops are a combination of an antihistamine (pheniramine maleate) and a decongestant
More information