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

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Contents

A brief description of the Injectable Medicines Guide 1

Process Manual

Writing Guidelines

Appendix 1: IMG team contact details

Appendix 2: Internal quality assurance checklist

Appendix 3: Obtaining Word copy of draft monograph from the website

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 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.

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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.

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

Action Who1 Main pharmacy contact notified that annual review of monograph due.

Word version (track changes activated) of current monograph sent as a draft. IMG team

2 Use draft sent or download template from IMG website for updating. Author3. Collect information to update monograph

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.

Author

4 Draft or update monograph Follow current Writing Guidelines

Author

5 Internal check Reference checked and proof read by second pharmacist. Checked by specialist paediatric pharmacist; local or NPPG identified. New monographs (or those new to the organisation) should be

checked by Trust nursing and medical staff for clarity.

Internal &paediatric checkers, Ward checkers

6 Finalise draft Send to IMG team with accompanying documents (eg SPCs not on

eMC, correspondence from manufacturer).

Author

7. Draft uploaded onto website With any accompanying documents. Author notified.

IMG team

8. Uploaded document checked Author confirms draft updated correctly.

Author

9. Draft released for external QA Sent to UKMi. Sent to company/ies.

IMG team

10. QA check by UKMi RMIC Standard QA form completed. Send completed QA form to NPPG team.

UKMi

11 QA check by NPPG Return form to UKMi RMIC with additional comments.

NPPG

12 UKMi RMIC finalises QA form Send completed QA form to author.

UKMi

13 QA check by company Comments sent to IMG team and forwarded to author. Comments uploaded to manufacturer’s section of monograph.

Company/IMG team

14. Draft finalised Comments reviewed and incorporated if agreed. Finalised document sent to IMG team.

Author

15. Monograph updated on website QA document added to QA section of monograph. Author notified when ready.

IMG team

16 Final check by author Checks content and all links. Sends signed copy to release ‘live’ monograph.

Author

17 Monograph made live IMG teamStage 1: Main contact is notified of new monograph or that the annual review of existing monograph is due.

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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 http://medusa.wales.nhs.uk/.

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 Character-istics

Access via: www.medicines.org.uk/emcIf the SPC is not on the eMC, check the company’s website and MHRA website.

Save hyperlinks to e-SPCs that have been obtained from websites other than the eMC, so they can be added to the monograph.

If an SPC is not available from an accessible website, send an e-copy (scanned if necessary) to the IMG team, to be added to the monograph.

Summary of Product Characteristics. Olanzapine (ZypAdhera). Eli Lilly. Last revised 25/4/14

Use the date of last revision (at the bottom of the SPC), not the date last updated on the eMC.

For multiple SPCs, reference each as 1a) 1b), etc.

Summary of Product Characteristics 1a) Depixol Injection, Depixol Conc Injection and Depixol Low 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: Martindale, The Complete Drug April 2015 5

No. Resource Comments Reference as:

www.medicinescomplete.com/mc/ if subscription available and record date accessed.

Use the current print copy only if electronic access is not available.

Reference, accessed via MedicinesComplete on 1/5/13.

Or if another platform used, for exampleMartindale, 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 Information’

Access via: www.medicinescomplete.com/mc/ if subscription available and record date accessed.

Use the current print copy only if electronic access is not available.

AHFS Drug Information, accessed via MedicinesComplete on 1/5/13.

Or if another platform used, e.g.

AHFS Drug Information, accessed via Lexicomp, on 1/5/13

Or if print copy used

AHFS Drug Information 2013, p456

4. ASHP‘Handbook on Injectable Drugs’

Access via: www.medicinescomplete.com/mc/ if subscription available and record date accessed.

Use the current print copy only if electronic access is not available.

ASHP, Handbook on Injectable Drugs, accessed via MedicinesComplete on 1/5/13.

Or if print copy used

ASHPl, Handbook on Injectable Drugs, 17th Ed, 2012, p456

5. British National Formulary

Access via: www.medicinescomplete.com/mc/ or NICE Evidence Search

Use the current print copy only if electronic access is not available.

British National Formulary Online, accessed on 1/5/13

Or if print copy used

British National Formulary No 65, March-September 2013, p456

6 BNF for Children

Access via: www.medicinescomplete.com/mc/ or NICE Evidence Search

Use the current print copy only if electronic access is not available.

British National Formulary for Children Online, accessed on 1/5/13

Or if print copy used

British National Formulary for Children 2012- 2013, p456

6a Evelina Paediatric Formulary

Access via: http://cms.ubqo.com/public/d2595446-ce3c-47ff-9dcc-63167d9f4b80

Paediatric Formulary. Guys and St Thomas, Kings College and University Lewisham hospitals accessed via: http://cms.ubqo.com/public/d2595446-ce3c-47ff-9dcc-63167d9f4b80

7. Supplier/manufacturer

Contact the company for information on the following, if not available elsewhere:

SPC (or preferably, an accessible URL)

Latex content (see next column) Package insert if different to the

SPC/PIL. Suitability of the following as

Drug company name, Date of contact (give as the date of reply).

If multiple suppliers have been contacted, reference each as 9a) 9b), etc.

If the response is in writing (preferable) send an e-copy to the

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No. Resource Comments Reference as:

diluents:Sodium chloride 0.45% and 0.9%, glucose 5% and10%, glucose/sodium chloride mixtures, sodium lactate, compound (Hartmann’s solution), Ringer’s Solution for injection, sodium chloride 0.9% and glucose 5% infusions containing 20mmol or 40mmol potassium chloride) and Plasmalyte 148

Availability of educational/training aids relevant to preparation and administration of the product.

Presentations marketed in the UK if the SPC indicates that some may not be.

Don’t delay sending updates to the IMG team while waiting for a reply from the company. Information can be added at a later date.

IMG team, so it can be attached to the monograph for writers/QA checkers to view.

Latex status:The IMG uses three standard statements to describe this. Ask the manufacturer which of these statements best matches the status of their product:

Natural rubber latex is not used as a material in the manufacture of this product/these products or in the container(s) or packaging. Contact with latex during or after manufacture cannot be excluded.

This product/these products contain(s) natural rubber latex.

Other resources Resource CommentsLocal 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: http://nww.cmu.nhs.uk/PharmaQC. 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.

http://nww.cmu.nhs.uk/security/login.asp?redirect=/PharmaQC

Pro-file www.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 www.micromedexsolutions.com/ (subscription required).

MHRA Drug Safety Update

http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/index.htm

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

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Resource CommentsNICE evidence www.evidence.nhs.uk

or search the NICE Evidence link from the draft monograph’s ‘links’ section.UK Resuscitation Council

www.resus.org.uk (link on Injectable medicines guide ‘documents and links’ page)Guidelines on resuscitation.

Toxbase www.toxbase.org (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

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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.

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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

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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.

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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 in tables.

3mg not 3.0mg1mL 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 full.

Abbreviation of mmols is acceptable

Abbreviation mOsmol is acceptable

Use mL (not ml or mLs)Use L for litres5mmols/L

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 administration

Use ‘IV’ and ‘IM’

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 normal sentence convention)

‘Zovirax’ but ‘aciclovir’

Cite references in the text as superscript numbers within brackets. Reference numbers should be cited after a full stop or coma.

Injection.(1) aciclovir,(1)

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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).

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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.

April 2015 14

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 overCHILD 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.

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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 <5% an average DV can be used. The mean of the two DVs is 0.45mL, but an average DV of 0.5mL is easier to measure and is appropriate in this example.

For a small number of medicines (e.g. ceftazidime, vancomycin) use of an average DV is not appropriate because the dosing difference is greater the 5%. In other instances an average DV is applicable for one vial size but not for another. For these two circumstances the monograph should refer the user to the linked table giving individual displacement values. Suggested text to use in this situation: Displacement values may be significant. Use the LINKED TABLE below to find the reconstitution volume required for individual brands. When updating monographs, any previous links must be reviewed for currency

Some powder presentations contain an amount of medicine in excess of that specified on the label (an overage) so that the final concentration contains the defined

April 2015 16

strength/mL when reconstituted as directed. For these preparations the displacement value can be ignored. Specify in the monograph that the product contains an overage.

Displacement value:

This displacement value information is now displayed in the reconstitution information of the monograph.

Do not complete this section – it will disappear when monograph is made ‘live’ on the website.

Instructions for dilution and suitable diluent:

Complete only for those preparations that need dilution. For preparations that do not require dilution. Do not complete this section – it will

disappear when monograph is made ‘live’ on the website. 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 overCHILD 4-18 years

If reconstitution is identical in adults and paediatrics still state both subheadings. In this section:

always describe as diluting to a concentration, not to a volume e.g. dilute to 1mg/mL by adding xxx to yyy

Only include sodium chloride 0.9% and/or glucose 5% as possible diluents in this section, using the terms:

Sodium chloride 0.9% Glucose 5%

Include other compatible infusion fluids in the ‘Compatibility Information’ section of the monograph.

Include information on colour following dilution if this is available.

Expiry time once prepared:

Do not complete this section – it will disappear when monograph is made ‘live’ on the website.

Example calculation: This will become a link to a table that can be printed separately. Give examples of calculations. The version number should always be the same as the version for the monograph

even if there are no changes at review.

April 2015 17

For example

Dose of aripirazole Volume of aripiprazole inj.(7.5mg/ml) required

5.25mg 0.7ml9.75mg 1.3ml (complete vial)15mg 2ml (2 vials needed)

Dose of flupentixoldecanoate required

Volume of 20mg/mLinjection required

Volume of 100mg/mLinjection required

Volume of 200mg/mLinjection required

20mg 1mL

40mg 2mL

50mg 0.5mL

100mg 1mL

200mg 1mL

400mg 2mL

If this medicine is given to children and neonates ensure the example calculation includes example doses for all age groups.

Flushing:

Do not complete this section – it will disappear when monograph is made ‘live’ on the website

Adverse effects relevant to the route of administration and suggested monitoring:

Only include details of adverse effects that may occur acutely as a result of the administration of a medicines by the intramuscular route e.g. anaphylaxis, injection site necrosis, tachycardia, hypotension or ECG changes (especially QTc changes).

Give brief details of any suggested monitoring for adverse effects under the heading. Monitoring: This information may not be included in the SPC or the BNF. Local policies (see IMG website) or clinical advice may be helpful when considering appropriate monitoring.

Emergency treatment of poisoning: Only complete for those medicine for which a specific parenteral antidote is available. Cross reference this section to the monograph for the antidote e.g.

Valproate toxicity: See levocarnitine monograph. The following statement 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).’

Inform the IMG team if the ‘Use as a poisoning antidote’ section in the cross referenced antidote monograph is not completed.

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Extravasation: Do not complete this section – it will disappear when monograph is made ‘live’ on the

website

Compatibility information useful in routine clinical practice:

Do not complete this section – it will disappear when monograph is made ‘live’ on the website

Other comments: Include storage temperature range of the original product and state if it should be

protected from light during storage (if light protection is needed during administration, put this information in the ‘Instructions for dilution section).

Include information on significant excipients. Always state if a product contains alcohol or propylene glycol and add a caution about their use in neonates.

A note will be added to this section ASAP by the website editor describing any SPC change or a significant NHS/MHRA alert which may become available since a monograph was last published. The author will be asked to review the monograph in light of the new information.

Includes information such as olanzapine and lorazepam IM injections not to be given at the same time.

Special handling precautions: Add any handling precautions relevant to clinical practice from the SPC that are in

addition to the standard ‘gloves and apron’ recommendations. Leave this section blank if no additional precautions, over and above wearing gloves

and an apron, are required. Do not include statements such as ‘toxic if swallowed’, or statements that relate to

industrial handling requirements such as ‘avoid inhalation’. Add the following statements if appropriate:

Do not handle if pregnant. Handle with care and minimum exposure: carcinogenic/teratogenic in animals,

potentially carcinogenic/teratogenic in humans.

Note: it is no longer necessary to request COSHH data from the manufacturer. This was previously standard reference 8, but has been removed.

Latex status Request information on the latex status of a product from the manufacturer/supplier

each time the monograph is updated. Check any equivalent IV monograph which may have this information already.

Choose one of the statements below to describe latex status. If the monograph covers more than one product, give the latex status of each product after the trade or manufacturer name and date each statement.

Natural rubber latex is not used as a material in the manufacture of this product, or in its container and packaging. Contact with latex during or after manufacture cannot be excluded. (date e.g. Jan 15).

This product contains natural rubber latex (date e.g. Jan 15).

Sodium content (mmol): Not clinically relevant for IM administration.

April 2015 19

Do not complete this section – it will disappear when monograph is made ‘live’ on the website

Osmolarity: Not clinically relevant for IM administration. Do not complete this section – it will disappear when monograph is made ‘live’ on the

website

pH Not clinically relevant for IM administration. Do not complete this section – it will disappear when monograph is made ‘live’ on the

website

Infusion pump to use according to therapy category: Not clinically relevant for IM administration. Do not complete this section – it will disappear when monograph is made ‘live’ on the

website

Error risk due to similar presentation, packaging or labelling: This section is completed by the IMG editorial team

If a medicine is included in the NHS Pharmaceutical QA Service Safe Medication Bulletin, the bulletin is added as a link with an expiry of two years from the contract start date. The monograph author should check that bulletin is still relevant when updating the monograph and whether it highlights any specific safety issues that could be usefully included in another section e.g. variations in the way strengths are cited (% or mg).

Product risk factors: This section is only accessible using a pharmacy password. This section is intended to provide an example product risk assessment only and is

not intended to replace a locally performed product risk assessment. Conduct a risk assessment of a commonly prepared dilution of the preparation as

required by the NPSA Safety Alert 20 (see ‘documents and links’ page). Example calculated product risk assessments are also available on this page.

In the monograph, the risk assessment is represented as a pictogram together with text indicating the total number of risk factors and the overall risk rating. e.g.

TOTAL RISK FACTORS: 1      OVERALL RISK RATING: Green

The number in the pictogram relates to the applicable risk factor; these are listed in the monograph heading ‘help’ menu. The risk factors are: 1. Therapeutic risk; 2. Use of a concentrate; 3. Complex calculation; 4. Complex method; 5. Reconstitution of powder; 6. Use of part vial or more than one vial; 7. Use of pump; 8. Use of a non-standard giving set. Green: 0-2, Amber: 3-5, Red: 6 or more.

Complete this section as below replacing italic text as appropriate:IM injection (adult): Risk factors for medicine (dose): list risk factorsIM injection (child): Risk factors for medicine (dose): list risk factors

The IMG team will convert this information into the pictogram format and ensure the adult and paediatric information appears in the relevant ‘age’ monographs.

April 2015

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20

Other injectable routes of administration: This section is only accessible using a pharmacy level password. Include unlicensed or off-label routes of administration, highlighting them as such, if they

are used in practice.

Pharmacy notes: This section is only accessible using a pharmacy level password. Include notes on identified inconsistencies e.g. rate of administration of digoxin differs

in BNF and SPC. Include information on how long the reconstituted/diluted preparation can be stored

before use if this information is available.

Contract details: This section is only accessible using a ‘write access level’ password. It is included as

guide for monograph authors and is not available when the monograph is made ‘live’ The section includes details of those preparations currently on national contract in

England and Scotland, and is added by the IMG team. As a minimum all generics listed must be included in the monograph. However, be aware that the information has been automatically generated from a spread sheet supplied by the CMU and may include products that are not specific to the monograph (e.g. lidocaine + adrenaline products are listed under the lidocaine monograph).

Current Suppliers: Check that all suppliers listed are current, that their details are correct and that there

is a link in place in the website draft to the most recent SPC and PIL/package insert. The eMC manufacturer’s Summary of Product Characteristics and Patient Information Leaflets are added to a monograph by the IMG team. If the SPC/PIL is not available via the eMC, send a link to the SPC/PIL on the manufacturer’s or the MHRA website if available to julie.haste@wsht.nhs.uk.

If the SPC is not readily accessible on a public facing website, send an electronic copy obtained from the Supplier to julie.haste@wsht.nhs.uk.

If the name of the manufacturer (given on the packaging, as checked on the Pharma QC database) and the current supplier, as given in this section, differ, ensure that this section links these two pieces of information. Add a note to the current supplier stating: ‘Supplies xxx product’ (xxx being the name of the manufacturer that appears on the packaging).

If a supplier has stopped supplying a product, their details will continue to appear on future drafts, visible to authors and QA checkers only, as a ‘discontinued supplier’ if they provided any information for previous versions of the monograph.

Links: Links to the BNF, BNFC, eMC and NICE evidence appear automatically in this

section. There is a facility for the authoring pharmacist at each participating organisation to

create a link from each monograph to another Internet page. This enables linking to local policies, guidance or formularies as required. Contact the IMG team or Robin.burfield@wales.nhs.uk for information.

Copies of UKMI external QA reports are included in this section as a link. Refer to these reports when updating a monograph.

Comments from manufacturers are also displayed as a link in this section.

References: Where possible all information in monographs should be referenced. Cite references in

the text as superscript numbers within brackets e.g. (1) To avoid interrupting the flow of

April 2015 21

text, cite the reference at the end of the sentence or the paragraph, after the full stop if possible.

Do not reference every resource that contains a specific piece of information, as this makes the document difficult to read. For example, if the information is contained in the SPC, there is no need to indicate that it is also in the BNF and Martindale: reference as (1) and not as (1)(2)(5). However, it is useful for you to have this information in your in-house records.

Standard references 1 to 7 are included as per the checklist in the Process Manual. Do not change the order and associated numbers of these standard references. Number any additional references used from 7 onwards, in order of citation in the text.

All standard references must be checked when the monograph is written and at each annual update. Current editions must be used. It is preferable to use online editions of books where these are available as these are updated more frequently than print copies.

Cite standard references as in the table in the Process Manual, adding details of the edition or number used, or date of publication. Include the relevant page number/s. For example:

o British National Formulary No 65, March-September 2013, p468o British National Formulary Online. Accessed on 24/05/14

If using MedicinesComplete to access Martindale or other resources cite as: Martindale. Accessed via MedicinesComplete on 25/09/14.

Cite SPCs with date as in: Summary of Product Characteristics. Zovirax. Last revised September 2006. Use the date of last revision (at the bottom of the SPC), not the date last updated on the eMC. Do not put accessed via eMC

For monographs that include multiple products, reference the SPCs individually as 1a), 1b), etc. If all SPCs cited contain the same piece of information, just reference as (1)

within the body of the monograph, rather than (1a-d). If information has been obtained from a Supplier, reference as:

Drug company: Eli Lilly, date contacted: 05/06/2014.

Medicines name indices:This section is used to create the IMG index. Include:

Generic name as cited in the BNF. (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). All relevant trade names, Synonyms as cited in the BNF.

BNF class: The IMG currently uses the ‘old’ BNF classification system. Use the BNF Legacy

resource to find the principal BNF classification e.g. 5.3.2 and add it to this section.

Other BNF class: Include other BNF classes listed in the BNF.

Editor notes: This section is only visible to the monograph author, the IMG team and the UKMI QA

checker. It will be used by the IMG team to highlight points that they would like the monograph

author to consider while they are updating the monograph.

Manufacturer notes: This section is only visible to the monograph author, the IMG team, the UKMI QA

checker and the listed current supplier. Send copies of any correspondence received from the manufacturer to Gill Bullock

April 2015 22

who will add it to this section.

Date last edited:This is the date that the monograph draft is updated on the website. It is completed by the IMG team.

Date Published and Review DateThese dates are completed by the IMG team when the monograph is made ‘live’ on the website.

New Version notes: If there has been a major change between updates, add a note in this section. This will be seen on the opening page of the website under ‘What’s new’.The purpose of the note is to alert those organisations that provide paper copies of monographs to clinical areas, and to prompt them to remove the previous monograph from use. Examples of notes might include:

significant change in method of administration section significant change to method of preparation MHRA Drug Safety Update issued

Prepared by: This section is only accessible using a ‘write access level’ password. Include author’s name and organisation.

Checked by: This section is only accessible using a ‘write access level’ password. Include checker’s name and organisation. If the monograph has not prepared by the main contact then main contact must be

the checker.

Checked by accredited member of CMHP: Only complete for monographs used in the mental health setting. If the main author or checker is an accredited member they can also sign this section. This check is only to determine if the monograph is clinically accurate or if important

information is missing. Therefore the accredited member does not need to check all references (unless they are the second checker).

If there is no accredited member in the pharmacy team then it must be sent back to Jules Haste to be assigned to an accredited member of the CMHP.

April 2015 23

Appendix 1 IMG team contact details

Administrator:Gill Bullock

Pharmacy Department, Charing Cross Hospital, Fulham Palace RoadLondon W6 8RFTelephone Number: 020 3311 1142Fax Number: 020 3311 1342Email: gill.bullock@nhs.net

IMG pharmacist co-ordinators:

Susan KeelingTel: 020 3313 0239 or 020 3311 1142

Fax Number: 020 3311 1342Home: 01276 471830

Email: susan.keeling@nhs.netChristine ProudloveTel: 0151 794 8117Email: chris.proudlove@rlbuht.nhs.uk

Pharmacist co-ordinator for IM section

Jules HastePharmacy Department

Southlands Hospital PharmacyUpper Shoreham Road

Shoreham-By-SeaWest SussexBN43 6TQ.

Mobile: 07500 089688Email: Julie.haste@wsht.nhs.uk

Neonatal and Paediatric Pharmacy Group (NPPG) IMG co-ordinators

Lekha Shah Northwick Park Medicines Information Centre.Tel: 020 8869 2761/62Email: lekha.shah@nhs.net

Nanna Christiansen Tel: 020 3246 0133 Fax: 020 3246 0125Email: nanna.christiansen@bartshealth.nhs.uk

Ophthalmic project pharmacist Jacqueline Jones

Tel: 0115-9249924 ext 65954 (Monday only); Mobile: 07913420556Email (work):  jacqueline.jones@nuh.nhs.uk

UKMi QA co-ordinator:Kathryn Phillips

Tel: 0151 794 8117Email: kathryn.phillips@rlbuht.nhs.uk

April 2015 24

Website co-ordinators:

Robin BurfieldTel: 029 2050 3204Email: Robin.Burfield@wales.nhs.uk

Simon WatkinsTel: 029 2050 3206Email: Simon.watkins@wales.nhs.uk

Contact for technical, password and printing issues, including information on how to create a link from monographs to internet/intranet based local policies, guidance or formularies.

April 2015 25

Appendix 2Injectable Medicines Guide monographs - Quality Assurance Checklist (This document aims to help monograph authors ensure they have checked all relevant references – for in-house use only)

Monograph:

New monograph: Update: Version:

Author: Checker:

Section A – in-house draftCriteria Author

InitialsDate Checker

initialsDate

All relevant resources have been searched and the checklist of resources has been completedThe monograph has been written/updated according to the current guidelines: - the information is under the correct section headings - strength/volumes, etc. are cited as per style guidelines

The text can be verified from the references.References in the bibliography correspond to the appropriate number in the text.Text has been checked for: typographical errors (particular care with drug names), grammatical errorsclaritycorrect calculations Electronic calculator works correctlyText has been checked by a minimum of two nurses for clarity and comprehension, and amended if required.Date draft sent to the Injectable medicines guide team

Section B – external commentCriteria Author

InitialsDate Checker

initialsDate

Comments received from RMIC. Text amended or the reasons for not amending are recordedRMIC: Contact name:Any further comments received from Injectable medicines guide team. Text amended or the reasons for not amending are recorded

Section C – finalising the monographCriteria Author

InitialsDate Checker

initialsDate

Completed monograph emailed to g ill.bullock@nhs.net Web monograph checked against completed monograph and agreedPrinted copy of agreed monograph signed by author and checker and faxed or scanned and emailed to Gill Bullock (fax 020 3311 1342)A copy of the monograph, references used in compilation, resource checklist, external comments are stored for future reference (for 10 years).

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Appendix 3

Obtaining a Word copy of a draft monograph from the websiteGo to ‘Inj Med Guide’ top right screen, then select ‘Edit Inj Med Guide’.Select the required draft monograph (drafts have titles with a blue typeface)Select ‘Show monograph’ and press ‘Print Monograph’ button at the top of the page. Select ‘Print author monograph’.Go to ‘Edit’ on the top bar, ‘Select All’ and then ‘Copy’. Alternatively, highlight all text by using ControlA and copy using ControlC, or drag mouse across all text to highlight, right click and select ‘Copy’)Open a Word documentGo to ‘Edit’ and select ‘paste’. Alternatively, use Control V, or click on ‘Paste’, or right click and select ‘Paste’.

Remove any headings that are not required. Activate ‘track changes’ and save changes to the Word document.

April 2015 27

Appendix 4

Example email to manufacturer

Dear Medical Information.

I am writing a monograph on the injection for the NHS Injectable Medicine Guide (Medusa). This guide is intended to inform healthcare staff on the safe preparation and administration of injectable medicines and is used by a large number of acute hospital trusts across the UK.

EITHER:

I would be grateful if you could provide the following information to help me complete the monograph.

1. The latex content of the preparation. Please select from one of the two following standard statements the Guide uses:

Natural rubber latex is not used as a material in the manufacture of this product or in the container or packaging. Contact with latex during or after manufacture cannot be exclude.

This product contains natural rubber latex.

Thank you for your help.

April 2015 28