APPENDIX The Injectable Medicines Guide (IMG)



The Injectable Medicines Guide (IMG)

Process Manual and Writing Guide (January 2017)

For medicines given by Intramuscular (IM) injections

A brief description of the Injectable Medicines Guide

The Injectable Medicines Guide (IMG) aims to provide:

• Guidance on the preparation and administration of injectable medicines in adult and paediatric clinical areas with links, if appropriate, to local practice guidelines.

• A reference source for organisations preparing an injectable medicines administration policy.

The IMG is a web-based resource, also known as Medusa. It is hosted by the NHS Wales Informatics Service and can be accessed via the internet or downloaded and made available through an organisation’s intranet.

The IMG contains in excess of 400 monographs for medicines given by the intravenous (IV) route with the exception of cytotoxic agents. Monographs are written for adult practice and for paediatric practice where appropriate. They cover both licensed and unlicensed medicines. As far as is achievable, information is relevant to all generic IV medicines currently on contract to the NHS in England and Scotland. The IMG also contains monographs on medicines commonly administered by intramuscular (IM) injection in mental health practice and on medicines given by the intraocular route. Monograph content is based on information from the literature and pharmaceutical companies, and also draws on clinical experience and current practice.

Monographs comprise a number of different sections detailing how the medicine is presented, how it should be reconstituted and/or diluted if appropriate, how it should be administered, information on adverse effects that may occur during administration, any monitoring required, plus technical details such as pH, osmolarity, sodium content and latex status. Risk assessments using the NPSA tool are also included. Each monograph links to the British National Formulary (BNF), BNF for Children, the Summary of Product Characteristics (SPCs) and Package insert/Patient Information Leaflet (PI).

Monographs are supported by user guides ‘Using the Injectable Medicines Guide in clinical areas’ and, within the monographs themselves, by information icons [pic] for each section, which, when selected, give advice on how to interpret the information in that section.

The IMG website is locally adaptable. For example, the website can be set up to show the full monograph, or a ‘condensed’ (short) version can be created based on specified criteria. The condensed version can be restricted to those sections absolutely essential for safe administration of the medicine, but access to the full monograph still easily obtained. The version shown initially is dictated by the password allocated. Some Trusts choose to omit technical details such as pH and osmolarity from monographs accessed at ward level, but have this detail accessible to pharmacy staff by using two separate passwords. Organisations can also link locally-produced injectable medicine-related guidelines to individual monographs. For organisations that produce their own monographs for specific medicines it is possible to add local monographs to the website in such a way they will be viewed preferentially, but a link to the IMG monograph is maintained.

Most trusts involved in the IMG customise the website to some extent and this makes the monographs more acceptable across the whole range of clinical practice within the NHS. The website is dm&d coded which makes it compatible with electronic prescribing systems.

The majority of trusts using the IMG gain access by writing monographs and keeping them updated. The number of monographs a trust contributes relates to the size of the organisation. Organisations can also gain access the website by subscription. From 2015, a facility has been introduced enabling organisations to pay for individual monographs to be updated on their behalf to overcome short-term staffing problems, but to continue to have access to the IMG through contribution.

The IMG project is led by Susan Keeling at Imperial College Healthcare Trust, working with Gill Bullock, the IMG administrator. Robin Burfield, NHS Wales Informatics Service, leads on website hosting and development. Other members of the IMG team are listed in appendix 1.

A number of pharmacy organisations are involved in the IMG. The Neonatal and Paediatric Pharmacist Group (NPPG) review all monographs for medicines used in children and/or neonates to ensure content reflects good practice in this clinical area. Separate adult and paediatric monographs were launched in 2014. Members of the College of Mental Health Pharmacists (CMHP) contribute monographs of IM medicines used in mental health; they will also be checked by an accredited member of the CMHP. The UK Ophthalmic Pharmacy Group is developing monographs on medicines given by intraocular injection.

All monographs are checked for accuracy and for consistency with IMG Writing Guidelines by a regional Medicines Information (UKMi) centre.

This document is intended for writers and in-house (internal) checkers of IMG monographs. The first part describes processes involved in writing and updating monographs. The second part comprises the IMG Writing Guidelines, which seek to ensure quality of content and uniformity of presentation.

Process Manual

Who can write, update and check a monograph?

Monographs must be prepared and/or checked by suitably experienced pharmacists (usually grade 8a or above).

Monograph authors have a ‘write access password’. This gives access to sections of the monograph (editor’s notes, previous UKMi checkers’ documentation and manufacturers’ comments) that are not accessible to those with user passwords (ward or pharmacy). This password also gives access to the draft monographs so that the author/checker can view them as they are being updated.

The monograph author and checker must be familiar with the following documents, which can be found on the ‘Documents and links’ page of the IMG website:

• National Patient Safety Agency’s document: ‘Promoting safer use of injectable medicines. A template standard operating procedure for prescribing, preparing and administering injectable medicines in clinical areas’. The monograph must be written in accordance with its content.

• Use of the Injectable Medicines Guide Website (Medusa) in Clinical Areas IntraMUSCULAR (IM) monographs – September 2016

What are the responsibilities of organisations contributing to the IMG?

Contributing organisations must provide the IMG team with a main contact who will be responsible for ensuring that the organisation’s commitment to the IMG is delivered. The main contact will be included in any communication between the IMG team and the organisation.

Monographs must be written in line with the Writing Guidelines. The contributing organisation takes full responsibility for the quality and accuracy of their monographs.

All monographs must be reviewed once a year and updated if required. If significant new information becomes available between annual updates, it should be incorporated into the monograph by the contributing organisation as soon as possible. Organisations can monitor the status of monographs they are responsible for (plus a list of the organisation’s contact names and passwords) by accessing the progress table on the IMG website (go to ‘injguide’ and ‘progress table’). A ‘write access password’ is required to do this.

Organisations must store copies of current and previous monographs for which they are responsible, together with the references used to prepare the monographs and the relevant quality assurance sheets, for ten years. They should also send a representative to IMG Group meetings, usually held annually.

Outline process of stages involved in writing/updating an IMG monograph

| |Action |Who |

|1 |Main pharmacy contact notified that annual review of monograph due. Word version (track changes activated) of |IMG team |

| |current monograph sent as a draft. | |

|2 |Use draft sent or download template from IMG website for updating. |Author |

|3. |Collect information to update monograph |Author |

| |Ensure all information in draft is relevant. Search standard references & other literature as required. | |

| |View PharmaQC for packaging/contract information. | |

| |View Profile for relevant specials. | |

| |View local guides on IMG website. | |

| |Contact company for specific information. | |

| |Ensure URL links available for each SPC. If not, acquire e- or hard-copy. | |

|4 |Draft or update monograph |Author |

| |Follow current Writing Guidelines | |

|5 |Internal check |Internal & |

| |Reference checked and proof read by second pharmacist. |paediatric |

| |Checked by specialist paediatric pharmacist; local or NPPG identified. |checkers, |

| |New monographs (or those new to the organisation) should be checked by Trust nursing and medical staff for clarity.|Ward checkers |

|6 |Finalise draft |Author |

| |Send to IMG team with accompanying documents (eg SPCs not on eMC, correspondence from manufacturer). | |

|7. |Draft uploaded onto website |IMG team |

| |With any accompanying documents. | |

| |Author notified. | |

|8. |Uploaded document checked |Author |

| |Author confirms draft updated correctly. | |

|9. |Draft released for external QA |IMG team |

| |Sent to UKMi. | |

| |Sent to company/ies. | |

|10. |QA check by UKMi RMIC |UKMi |

| |Standard QA form completed. | |

| |Send completed QA form to NPPG team. | |

|11 |QA check by NPPG |NPPG |

| |Return form to UKMi RMIC with additional comments. | |

|12 |UKMi RMIC finalises QA form |UKMi |

| |Send completed QA form to author. | |

|13 |QA check by company |Company/ |

| |Comments sent to IMG team and forwarded to author. |IMG team |

| |Comments uploaded to manufacturer’s section of monograph. | |

|14. |Draft finalised |Author |

| |Comments reviewed and incorporated if agreed. | |

| |Finalised document sent to IMG team. | |

|15. |Monograph updated on website |IMG team |

| |QA document added to QA section of monograph. | |

| |Author notified when ready. | |

|16 |Final check by author |Author |

| |Checks content and all links. | |

| |Sends signed copy to release ‘live’ monograph. | |

|17 |Monograph made live |IMG team |

Stage 1: Main contact is notified of new monograph or that the annual review of existing monograph is due.

• The website generates an automatic email to the main contact when the review date of a monograph is reached. You must review the monograph within two months of the review date. Emails alerts will continue automatically until the new monograph is released on the website.

• The IMG team set up a new draft monograph on the website. At this stage the draft is the content of the current ‘live’ monograph on the website. A Word version of the draft is sent to the main contact along with a copy of the most recent edition of the monograph Writing Guidelines.

• The Word document will include all available monograph headings, not just those apparent in the current ‘live’ version.

• You can also produce a Word draft from the website – see appendix 3.

• Any linked tables (e.g. table of rates of administration, displacement values) must be downloaded from the website and updated at the same time as the monograph.

Stage 2: Use draft sent or download template from IMG website for updating.

• Use your ‘write access’ password to login at .

• This gives you access to your draft, and to restricted documents in the ‘documents and links’ section and to the ‘local guide’ section.

• To view (and print) a draft monograph, click on ‘Inj Med Guide’ and select ‘Edit Inj Med Guide’. Click the ‘down’ arrow to the right of the ‘drug name’ box to show the drafts of all the drugs you are responsible for updating. The titles of draft monographs have a blue typeface. See appendix 3 for more details.

• To view a list of monographs your organisation is responsible for and their current status, click on ‘Inj Med Guide’ and select ‘Progress table’. The table also lists user names and passwords allocated to your organisation.

Stage 3: Collect information to write / update monograph

• Search standard references (cited as references 1-7 on all monographs) and other literature as required. See table below.

• Ensure URL links are available for each SPC. If not, acquire e- or hard-copy.

• Contact the company for specific information (see table below).

Standard IMG resources number 1- 7

|No. |Resource |Comments |Reference as: |

|1. |Summary of Product |Access via: .uk/emc |Summary of Product Characteristics. Olanzapine |

| |Character-istics |If the SPC is not on the eMC, check the company’s |(ZypAdhera). Eli Lilly. Last revised 25/4/14 |

| | |website and MHRA website. |Use the date of last revision (at the bottom of the |

| | |Save hyperlinks to e-SPCs that have been obtained from|SPC), not the date last updated on the eMC. |

| | |websites other than the eMC, so they can be added to |For multiple SPCs, reference each as 1a) 1b), etc. |

| | |the monograph. | |

| | |If an SPC is not available from an accessible website,|Summary of Product Characteristics 1a) Depixol |

| | |send an e-copy (scanned if necessary) to the IMG team,|Injection, Depixol Conc Injection and Depixol Low |

| | |to be added to the monograph. |Volume Injection. Lundbeck. Last revised 16/4/15. |

| | | |1b) Psytixol Injection 20mg in 1mL, 100mg in 1mL, |

| | | |200mg in 1mL. Mylan. Last revised 1/9/14 |

|2. |Martindale |Access via: mc/ if |Martindale, The Complete Drug Reference, accessed |

| | |subscription available and record date accessed. |via MedicinesComplete on 1/5/13. |

| | |Use the current print copy only if electronic access |Or if another platform used, for example |

| | |is not available. |Martindale, The Complete Drug Reference, accessed |

| | | |via Micromedex, on 1/5/13 |

| | | |Or if print copy used |

| | | |Martindale The Complete Drug Reference, 37th ed. |

| | | |2011, p456 |

|3. |AHFS ‘Drug |Access via: mc/ if |AHFS Drug Information, accessed via |

| |Information’ |subscription available and record date accessed. |MedicinesComplete on 1/5/13. |

| | |Use the current print copy only if electronic access |Or if another platform used, e.g. |

| | |is not available. |AHFS Drug Information, accessed via Lexicomp, on |

| | | |1/5/13 |

| | | |Or if print copy used |

| | | |AHFS Drug Information 2013, p456 |

|4. |ASHP |Access via: mc/ if |ASHP, Handbook on Injectable Drugs, accessed via |

| |‘Handbook on |subscription available and record date accessed. |MedicinesComplete on 1/5/13. |

| |Injectable Drugs’ |Use the current print copy only if electronic access |Or if print copy used |

| | |is not available. |ASHPl, Handbook on Injectable Drugs, 17th Ed, 2012, |

| | | |p456 |

|5. |British National |Access via: mc/ or NICE |British National Formulary Online, accessed on |

| |Formulary |Evidence Search |1/5/13 |

| | |Use the current print copy only if electronic access |Or if print copy used |

| | |is not available. |British National Formulary No 65, March-September |

| | | |2013, p456 |

|6 |BNF for Children |Access via: mc/ or NICE |British National Formulary for Children Online, |

| | |Evidence Search |accessed on 1/5/13 |

| | |Use the current print copy only if electronic access |Or if print copy used |

| | |is not available. |British National Formulary for Children 2012- 2013, |

| | | |p456 |

|6a |Evelina Paediatric |Access via: |Paediatric Formulary. Guys and St Thomas, Kings |

| |Formulary | and University Lewisham hospitals accessed |

| | |67d9f4b80 |via: |

| | | |

| | | |3167d9f4b80 |

|7. |Supplier/ |Contact the company for information on the following, |Drug company name, Date of contact (give as the date|

| |manufacturer |if not available elsewhere: |of reply). |

| | |SPC (or preferably, an accessible URL) |If multiple suppliers have been contacted, reference|

| | |Latex content (see next column) |each as 9a) 9b), etc. |

| | |Package insert if different to the SPC/PIL. | |

| | |Suitability of the following as diluents: |If the response is in writing (preferable) send an |

| | |Sodium chloride 0.45% and 0.9%, glucose 5% and10%, |e-copy to the IMG team, so it can be attached to the|

| | |glucose/sodium chloride mixtures, sodium lactate, |monograph for writers/QA checkers to view. |

| | |compound (Hartmann’s solution), Ringer’s Solution for | |

| | |injection, sodium chloride 0.9% and glucose 5% |Latex status: |

| | |infusions containing 20mmol or 40mmol potassium |The IMG uses three standard statements to describe |

| | |chloride) and Plasmalyte 148 |this. Ask the manufacturer which of these statements|

| | |Availability of educational/training aids relevant to |best matches the status of their product: |

| | |preparation and administration of the product. |Natural rubber latex is not used as a material in |

| | |Presentations marketed in the UK if the SPC indicates |the manufacture of this product/these products or in|

| | |that some may not be. |the container(s) or packaging. Contact with latex |

| | |Don’t delay sending updates to the IMG team while |during or after manufacture cannot be excluded. |

| | |waiting for a reply from the company. Information can|This product/these products contain(s) natural |

| | |be added at a later date. |rubber latex. |

Other resources

|Resource |Comments |

|Local IV policies |The IMG website contains a selection of locally used injectable medicine administration policies accessible |

| |using your ‘write access’ password. These can help identify differences in local practice. |

| |Information from a local policy used to prepare a monograph that cannot be supported using standard references |

| |should be referenced as ‘local practice xxx organisation’ after permission has been obtained. Do not circulate |

| |these local policies in your organisation without first obtaining permission. |

|PharmaQC website |Register to access the database at: . |

| |PharmaQC provides information on products on NHS contract. Some suppliers provide technical data and SPC/PILs, |

| |and if they have, you can access them on the website. Products currently on contract will also be listed in the|

| |draft monograph you have been sent. |

| |Photos of packaging and containers are available for many products; these are particularly useful for |

| |determining the name of the manufacturer/supplier of a generic product given on the packaging. This is the name|

| |that should be included in the ‘Trade name’ section of an IMG monograph and may differ from that of the Market |

| |Authorisation Holder. |

| | |

|Pro-file |pro-file.nhs.uk. |

| |Registration requires confirmation from your Chief Pharmacist before registration can be completed. Your |

| |purchasing or Chief Pharmacist may have access. |

| |Pro-file lists unlicensed specials available from NHS manufacturing units. Check that the information is |

| |current with the manufacturing unit before adding to an IMG monograph. |

|DrugDex | (subscription required). |

|MHRA Drug Safety Update | |

| |DrugSafetyUpdate/index.htm |

|UKMi Medicines Q&As | |

| |Arrange with IMG team to add relevant Q&As as a ‘link’ to the website monograph |

|NICE evidence |evidence.nhs.uk |

| |or search the NICE Evidence link from the draft monograph’s ‘links’ section. |

|UK Resuscitation Council |.uk (link on Injectable medicines guide ‘documents and links’ page) |

| |Guidelines on resuscitation. |

|Toxbase | (password required) |

Stage 4. Draft or update monograph

• Follow the current Writing guidelines when writing or updating a monograph. The Writing Guidelines are reviewed annually and reflect developments such as inclusion of paediatric information.

• When updating a monograph, review the information under each heading both in terms of currency and whether it complies with the latest version of the Writing Guidelines.

• Check the monograph includes all generics listed as ‘on national contract’ (see the ‘contract details’ section of the monograph and PharmaQC). Also include all generic and branded products that have SPCs available through the eMC. If a generic described on the current monograph is no longer ‘on contract’ check with the supplier if it is still being marketed in the UK and delete if not. Inform editorial team if no longer required so that they can add a note to the ‘Suppliers’ section of the monograph.

• Check all SPCs and PILs (including the package insert if different to the PIL) for every product included in the monograph.

• Check whether documents linked to the website draft (e.g. example calculations) the version number will need to be changed as a minimum to reflect the same version as the monograph.

• Use the ‘tracked change’ facility to update the Word version of the draft monograph. If there are major changes use a new monograph template which you can obtain from the IMG team and the full monograph will be reloaded.

• Notify Jules Haste at julie.haste@wsht.nhs.uk if a medicine is discontinued, together with the date the medicine was discontinued and the expiry date of the last batch produced. This information will be added to the monograph which will be automatically removed from the website when the expiry date of the last batch is reached.

Stage 5. Internal check

• The local IMG main contact must sign-off the monograph (if not the author):

• for compliance with the Writing Guidelines,

• for clarity of information,

• that the information is correct for each cited reference,

• any included example calculation is correct,

• any dose calculator included works correctly.

Use the quality assurance checklist (Appendix 2) to facilitate this process. The checklist should be signed by you and your checker and retained with the information used to write/update the monograph.

• If a monograph is new to your organisation, ask two nurses, an experienced nurse and an inexperienced nurse, and a member of medical staff who routinely prescribes the drug, to review the monograph and confirm that it can be easily interpreted at ward level. These ‘user’ checks are not necessary if there are no significant changes to updates.

• Obtain a check from a specialist paediatric pharmacist. If this is not possible for your organisation, contact a NPPG Medusa representative (see Appendix 1).

Stage 6: Finalise draft

• Send the revised draft to Jules Haste at julie.haste@wsht.nhs.uk

• Electronic copies of any background information and difficult to access references (e.g. SPCs not on the eMC, correspondence from manufacturers) obtained while updating the monograph should be also sent and they will be added as a ‘link’ to the appropriate section of the monograph so they are available for the person doing the external QA report and for the next update.

• If the body of the monograph and any linked tables require no revision, advise Gill that this is the case. The reference section will always need to be updated; the names of those updating/checking the monograph may need to be changed.

Stage 7: Draft uploaded onto website

• The updated monograph will be uploaded onto the website by the IMG team.

Stage 8: Uploaded document checked

• You will be asked to confirm the draft has been updated on the website correctly.

• If amendments are required, print off the draft monograph from the website and fax or email the changes to Jules.

• Check that all the electronic ‘links’ (e.g. to the SPC, PIL, BNF, interactions section of BNF, example calculation, etc.) in the updated draft monograph are relevant, up to date and work correctly.

Stage 9: Draft released for external QA

• Once you have confirmed the draft on the website is correct, it will be released for external quality assurance. The IMG team send the draft to:

• UKMi. The draft is allocated to one of several regional MI centres who will also arrange for an external NPPG check. [External QA checks by UKMi/NPPG are usually carried out after every second monograph review, that is, every two years. During the process of producing separate paediatric monographs, your monograph may be sent for external QA check before that time.]

• Company/ies with products covered in the monograph.

Stages 10-13: The external QA check

• UKMi checking centres use a standard QA form to record any comments they have.

• The UKMi centre forwards the QA form to an NPPG checker who will ensure that the content of the draft monograph, and any suggestions made by the UKMi checker, are suitable for use in paediatric clinical areas. Comments from NPPG are incorporated into the form and returned to the UKMi checker,

• UKMi forward the completed QA form to the main contact for the Trust, you the author, and copy it to the IMG team who will link an electronic copy of the form to the draft monograph in the ‘QA report’ section. This section is only available to authors, QA checkers and the IMG team.

• Comments received from companies by the IMG team are added to the ‘manufacturers’ notes’ section of the monograph draft and forwarded to the author and QA checker. The ‘manufacturers’ notes’ section is only available to authors, QA checkers and the IMG team. Do not delay the updating process waiting for manufacturer’s comments.

Stage 14: Finalising the draft

• Consider the comments made by UKMi and NPPG checkers and, if available, by the company before finalising your monograph.

• The UKMi standard QA form comprises three columns.

• The first column contains the content of the draft monograph that you produced under individual section headings.

• Comments from the UKMi QA centre are added to the second column. The colour coded system used by QA checkers of marking text is outlined on the QA form.

• If, following consideration of the comments, you decide to alter the text in one or more sections of the monograph, enter into the final column the complete text that you now wish to be included in that section, and not just, for example, the sentence you want to be altered. For those sections where you are not revising the text, leave the final column empty.

• The QA form has the name and contact details of the UKMi checker. Contact the UKMi checker if you disagree with, or need clarity around, any of their comments. This helps authors and checkers learn from each other and any contentious areas of practice can be identified which can then be referred to the IMG team.

• Use your judgement about including manufacturers’ comments in the final version of the monograph as they are not always appropriate or reflect current practice.

• If a change in the text of the draft is required, send the QA form with the appropriate sections of the third column completed to Jules Haste at julie.haste@wsht.nhs.uk The QA form incorporating your changes will replace the prior copy of the same form on the website.

• If no changes are necessary to the draft, sign a copy of the completed monograph downloaded from the website and fax, or scan and email it to gill.bullock@imperial.nhs.uk with the instructions to make it ‘live’.

Stage 15-16: Monograph updated on website and final check by author

• Changes to the monograph will be made to the draft version of the monograph on the website by the IMG team. You will be informed when this has been done.

• You must then check the updated website draft of the monograph and fax or email Jules any other necessary changes. Before sending it to Jules, copy the website draft into a Word document (see appendix 3) and perform a spell check.

• Once you and the local checker are satisfied that the website draft is correct, you must both sign a copy of the completed monograph downloaded from the website and fax or email it to Gill at gill.bullock@imperial.nhs.uk with the instruction to make it ‘live’.

• The copy of the internal QA checklist (see appendix 2) should be signed as completed. Store the check list in your department along with copies of any background information obtained while updating the monograph.

Stage 17: The IMG team make the monograph live

Writing Guidelines

General rules

A single monograph for a particular medicine will usually cover all products on a national contract at the time of writing/updating, and/or, where relevant, unlicensed NHS specials. Important differences between products (e.g. a major difference in pH) should be highlighted within the monograph (see later). If a monograph including more than one product is too confusing, write a separate monograph for each preparation after confirming this with the IMG team.

Each monograph should include information for adults, and for children and neonates if appropriate.

Remember that the first language of the reader may not be English. Write in simple terms that other people can understand. Write in sentences rather than note form, but be clear and concise. Use active tense when describing how to prepare and administer a product. Interpret information from the SPC/package insert rather than copy out large sections of it which are often difficult for non-pharmacists to understand. Do not put in information that is unhelpful just because you have it! Keep the monographs short, but as practical as possible. Think of the IMG as a recipe book rather than an academic text.

Do not duplicate information in the monographs. Highlight important messages once only, in the most relevant section. If references give contradictory information, assess which is the most appropriate to use in the clinical area.

IMG style guidelines

|Instruction |Example |

|Do not insert a space between the figure and the units |3mg not 3 mg |

|Write quantities of 1 gram or more as 1g |1g |

|Write quantities of less than 1g as mg |500mg not 0.5g |

|Write quantities of less than 1mg as micrograms |100micrograms not 0.1mg |

|Do not abbreviate other measures of weight, etc. |Use micrograms, nanograms, units, etc. in full |

|Avoid unnecessary decimal places. Do not write a zero after a decimal point, even |3mg not 3.0mg |

|in tables. |1mL not 1.0mL |

|Always write a zero in front of a decimal place with a value less than1 |0.5mL not .5mL |

|Abbreviation of millilitres and litres is acceptable, but write other volumes in |Use mL (not ml or mLs) |

|full. |Use L for litres |

|Abbreviation of mmols is acceptable |5mmols/L |

|Abbreviation mOsmol is acceptable |290mOsmol/L |

|Write strengths in full |3mg in 5mL not 3mg/5mL |

|Write time in full |minutes, hours |

|Do not use symbols such as < and > |Use ‘less than’ or ‘greater than’ |

|Do not use abbreviations for elements such as Na, K |Use ‘sodium’ and ‘potassium’ |

|It is acceptable to use abbreviations for intravenous and intramuscular routes of |Use ‘IV’ and ‘IM’ |

|administration | |

|Write all other routes in full |e.g. Subcutaneous |

|It is acceptable to use abbreviation for electrocardiogram |Use ‘ECG’ |

|Write dates in UK format dd/mm/yy or write in full |28/09/14 or 29 September 2014 |

|Use UK rather than US spellings |‘Ischaemia’ not ‘ischemia’ |

|Use an initial capital letter for trade names but not generic drug names (excluding|‘Zovirax’ but ‘aciclovir’ |

|normal sentence convention) | |

|Cite references in the text as superscript numbers within brackets. Reference |Injection.(1) aciclovir,(1) |

|numbers should be cited after a full stop or coma. | |

What should be included under each monograph heading?

Monograph headings are standardised and cannot be altered by authors. Where there is no content under a section heading, the heading will not be visible to website users when the monograph is ‘live’ on the website. Not all headings need to be completed, e.g. displacement value for medicines presented as solutions.

When updating a monograph, make sure that you also update any linked tables (e.g. relating to displacement values, infusion rates etc). These tables are not included in the draft monograph sent to you by the IMG team; view the website draft to access them.

Monograph title:

• Include the medicine name, as used in the BNF monograph for the preparation.

• If two monographs are available for the same medicine, add the trade name in brackets so this is apparent in the IMG index e.g. flupentixol decanoate (Depixol) and flupentixol (Psytixol).

• Include the medicine name, as used in the BNF monograph for the preparation e.g. haloperidol - short action and haloperidol decanoate – long acting (depot).

Monograph ‘banner’:

• Use this section to highlight important notes, for example, that the product is an unlicensed medicine or there is a relevant MHRA/NPSA alert.

• For most medicines, this section will be left blank.

• Use the following standard phrases in the banner where appropriate:

➢ ‘Some information in this monograph is brand specific. Ensure you refer to the correct information for the brand used in your organisation.’ Only use this statement if the difference is important in practice.

➢ Preferred route of administration if this is different to the route described in the monograph.

➢ If IM is the preferred route of administration a statement such as ‘IM injection is the preferred route of administration’ should be added.

➢ State ‘For Intramuscular injection’ if there is more than one route available and ‘For intramuscular injection only’ if there are no other routes recommended.

➢ Include statements such as ‘IM route should only be used to treat opiate poisoning where the IV route is not practical or possible.

➢ For penicillins: ‘Contains a penicillin.’

➢ For cephalosporins and carbapenems: ‘Contains a penicillin-like structure.’

➢ Where an MHRA safety update has been issued giving information that conflicts with that in the current SPC add: Changes recommended by MHRA in month year are not necessarily reflected in manufacturer’s SPC and package insert.

➢ For discontinued products add: This product has been discontinued. The expiry date of the last manufactured batch is date.

➢ For unlicensed products: ‘Unlicensed’

• Product shortages that may result in substitution of, for example, an imported or unlicensed product, the preparation and administration of which could differ from that described, may be highlighted in the banner. Contact the IMG team if such a situation arises.

Medicine name:

• Include the medicine name, as used in the BNF monograph for the preparation.

• If two monographs are available for the same medicine, add the trade name in brackets so this is apparent in the IMG index e.g. flupentixol decanoate (Depixol) and flupentixol decanoate (Psytixol).

Include the medicine name, as used in the BNF monograph for the preparation e.g. haloperidol - short action and haloperidol decanoate – long acting (depot)

Trade name:

Include all trade names of preparations for which the information is relevant

• If generic preparations are available, just add ‘(non-proprietary)’ to the trade name section; don’t add the generic manufacturer name(s) as was previous practice.

• Note that despite this change in practice, the monograph should continue to include information on all generic preparations on contract (see the ‘Contract’ section of the monograph displayed when using an ‘author’ password). You will need to use the name of the manufacturer in the body of the monograph to identify information specific to a particular product (e.g. latex status). Where applicable, always use the name on the packaging; this may differ from the contracted supplier listed in the ‘Current suppliers’ section at the bottom of the monograph. Look at the packaging images on the PharmaQC database to determine the relevant information.

Presentation of medicine:

• Describe the container. For example

➢ Vials containing

➢ Ampoules containing

• Include the name of the medicine, give the strength of the medicine in the container and indicate whether the strength refers to the base or the salt. For example

➢ Ampoules containing flupentixol decanoate 100mg in 1mL

➢ Ampoules containing haloperidol 50mg in 1mL (as decanaote)

• List individual preparations separately, for example

➢ Pre-filled syringes containing paliperidone (as palmitate):

▪ 50mg

▪ 75mg

▪ 100mg

▪ 150mg

Each pack contains two safety needles (22G and 23G).

• Give a brief description of the presentation if appropriate, for example

➢ Ampoules containing lorazepam 4mg in 1mL. Concentrate for dilution.

➢ Vials containing risperidone 25mg powder for reconstitution

• Give details of the diluent if this is included in the pack

➢ Vials containing powder for reconstitution:

▪ Risperidone 25mg

▪ Risperidone 37.5mg

▪ Risperidone 50mg

Plus:

➢ A prefilled syringe containing 2 mL solvent.

➢ An Alaris SmartSite needle-free vial access device for reconstitution.

➢ Two Needle-Pro needle for intramuscular injection

▪ 20G TW 2-inch safety needle with needle protection device.

▪ 21G UTW 1-inch safety needle with needle protection device.

• Follow IMG style guidelines for instructions on how to cite strength and volume.

When writing an intramuscular monograph if there is a strength/volume that is not going to be used (i.e. over 3mL) then the information should not be displayed therefore reducing the risk of confusion. It can go into the Pharmacy section if felt the information should be displayed. For instance midazolam 10mL or 50mL vials.

Method of administration:

If the medicine is used in Adult and paediatric or neonatal practice then sub headings should be written in this section.

• For IM monographs that are only used for adult state ‘ADULT:’

• When monographs are used for other age groups use the subheading ‘CHILD:’ and/or NEONATE as appropriate as subheading/s and define the relevant age group.

➢ For example

CHILD 1 year or over:

CHILD 4-18 years:

If administration is identical in adults and paediatrics state both subheadings i.e. ADULT and CHILD.

• Use bolded subheadings to highlight the IM administration route/s. For example:

➢ For IM injection only.

➢ Give by deep intramuscular deltoid or gluteal injection.

➢ Gluteal injection should be made into the upper-outer quadrant of the gluteal area.

➢ The full contents of the vial should be injected; giving partial contents of a vial may not deliver the intended dose.

• The Injectable medicines guide is not intended to be a prescribing guide. Do not give details of doses.

Use as a poisoning antidote:

• Complete only for those medicines that are used as poisoning antidotes.

• The following statement and appropriate link to Toxbase will be added where there is text in this section. ‘Information can be accessed online using the link to TOXBASE below. Serious cases of toxicity should be discussed with the National Poisons Information Service (tel: 0344 892 0111).’

Instructions for reconstitution:

If the medicine is used in Adult and paediatric and/or neonatal practice then sub headings should be written in this section.

• For IM monographs that are only used for adult state ‘ADULT:’

• When monographs are used for other age groups use the subheading ‘CHILD’ and/or NEONATE as appropriate as subheading/s and define the relevant age group.

➢ For example

CHILD 1 year or over

CHILD 4-18 years

If reconstitution is identical in adults and paediatrics still state both subheadings.

• Complete only for those medicines requiring reconstitution i.e. those presented as a powder.

• Include instructions such as:

➢ ‘shake until solution is clear’

➢ ‘Do not shake to avoid foam formation’

• Use the term water for injections (not water for injection).

• Include information on colour following reconstitution if this is available.

• State if the preparation requires further dilution following reconstitution, as

➢ ‘Requires further dilution before administration’

• State the strength of the preparation once reconstituted e.g. olanzapine (short action injection) is 11mg in 2.2mL i.e. 5mg in 1mL.

• Do not include information on how long the reconstituted medicine is stable in this section. Solutions reconstituted in the clinical area should be used immediately. This information, if available, should be added to the ‘Pharmacy notes’ section of the monograph.

• If there is a comprehensive instruction leaflet then the wording ‘Refer to the package insert or the Summary of Product Characteristics (link below) for detailed instructions on how to reconstitute the injection. ‘

• Do not include standard instructions such as, ‘remove flip top from the vial’, ‘inspect for particles’, ‘use aseptic technique’, ‘discard any unused portion’.

Extra information for CHILD and/or NEONATES

• Include information on displacement values, corrected to one decimal place, in this section (the ‘Displacement value’ section is to be removed from live monographs). Displacement values may only be available from the manufacturer. If the monograph only requires a single displacement value to be given for each vial size (e.g. there is only one supplier), present the displacement value as described below. NPPG has agreed that for medicines for which the average displacement value for the products covered in the monograph will result a less than 5% dosing difference, the average displacement value should be displayed in the body of the monograph, with individual product displacement values given in a linked table. In the future, it may be possible to add single/average displacement values to a table embedded in this section. Until then use the following convention where a single/average displacement value is quoted:

➢ 250mg vial: (average*) displacement value 0.2mL. Reconstitute with 2.3mL to give a final concentration of 100mg in 1mL.

750mg vial: (average*) displacement value 0.5mL. Reconstitute with 7mL to give a final concentration of 100mg in 1mL.

*see linked table for values for individual products. However, using the average displacement value is acceptable as the difference in final concentration achieved is minimal.

• Example of how to calculate an average displacement value. The displacement value (DV) for one brand of meropenem is 0.4mL. Reconstituting this brand with 10mL gives a concentration of 48.08mg/mL (500mg in 10.4mL). If 50mg/mL delivers 100% of the dose, 48.1mg/mL delivers 96.1% (48.08 divided by 50 multiplied by 100). Therefore, there is a 3.9% difference (100 – 96.1) in dose delivered where the DV has not been taken into account. A second brand of meropenem has a displacement value of 0.5mL, resulting in a difference in dose delivered of 4.8%. The range of the disparity between these two brands is 0.9% (4.8-3.9) and as this is ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download