Version 4.0 Revised March 2007

Guide to Writing Medicines Q&As

Kate Pickett

Wessex Drug & Medicines Information Centre, Southampton

This guide is intended for use by anyone writing a new Medicines Q&A (previously known as FAQs), or updating an existing one. Following this guide will help ensure uniformity of presentation and quality of content, and save time in the editing and checking process.

1.0  Objectives

(a)  The purpose of the Medicines Q&A database is to answer common questions that MI centres are asked, or questions which are difficult or time-consuming to answer. The audience was originally mainly MI pharmacists, but now includes doctors, nurses and pharmacists in primary and secondary care. Please be aware that the database is NOT password protected, and is therefore open to the general public.

(b)  Having a concise standard answer in a standardised format will save time, avoid duplication of work, and maintain the quality and consistency of answers given.

(c)  It is important to remember to answer the question if it is possible to do so, stating any qualifiers to the answer. The answer must be specific about the exact scenario being considered. If you can’t answer the question, then say so and explain why, or reconsider re-wording of the question.

(d)  The answer to the question is expected to contain an evaluation of the evidence, not just information. It should be directive, where possible, and offer advice on the basis of the available evidence.

(e)  Remember that the answer must be generic, so don’t miss out any key points.

2.0 Style Guide

2.1 General

(a)  Authors are expected to conduct a full and thorough literature search to support their answer, and should not rely on a single review or paper unless this is all that is available. (‘Shell’ Q&As can be an exception to this – since they serve mainly to direct users to specific web sources).

(b)  Ensure that you have critically evaluated all of the articles used to compile your answer. Original papers cited in review articles should be obtained, unless this is a systematic review or meta analysis. Give details of the number of patients included in the cited studies.

(c)  Present your arguments and facts in a concise and logical order. Use sub-headings and/or bullet points, if necessary, to sub-divide sections of text.

(d)  There must be no misleading or ambiguous statements and no unreferenced key statements.

(e)  The summary must accurately and completely reflect the key points in the text. It should not introduce any new information.

(f)  Use italics for species’ names (eg E.coli), words in a foreign language, and journal and book titles within the text.

(g)  Use UK rather than American English.

(h)  Always use SI units unless there is a good reason not to. The unnecessary use of decimal points should be avoided. Quantities less than 1 gram should be written in milligrams. Quantities less than one milligram should be written in micrograms. Milligrams can be abbreviated to mg, but micrograms, nanograms and units should be written out in full. Be consistent in your use of units.

(i)  Apart from those that are most commonly used, all abbreviated words should be given in full when first used, with the abbreviation in brackets. Decide whether or not to abbreviate and then stick to the decision throughout the text.

(j)  Do not use abbreviations in the title.

(k)  Avoid using underlining or exclamation marks.

(l)  All indications stated should correspond to the current SPC unless the text states otherwise. A specific statement on the use of medicines outside their product licence must be included in the answer and the summary sections if appropriate.

(m)  Where relevant, costs should be calculated using the current MIMS and Drug Tariff. State whether VAT is included or not.

2.2 Template

To ensure consistency of presentation it is essential to use the standard template (Appendix 1), except where agreed with Wessex MI in exceptional circumstances.

(a)  The Medicines Q&A will be assigned a number by Wessex MI.

(b)  The main heading should be a question in font size 14 arial bold blue centred.

(c)  Main headings should be font size 12 arial bold blue left-hand rectified, with a one-line space underneath.

(d)  Subheadings should be font size 10 arial bold blue left-hand rectified, with no space underneath.

(e)  For the main text use arial font size 10 black, left rectified throughout.

(f)  Bullet points should be diamonds (¨).

(g)  The Medicines Q&A should normally be given a 2 year expiry (from the end of the month of writing). In situations where clinical practice changes more frequently, an expiry of less than 2 years will be necessary at the discretion of the author.

(h)  The exact date of writing should be stated as this is required for addition to the NeLM website.

2.3 Tables

(a)  Tables should be single lined all around.

(b)  Supply a heading for each column.

(c)  Make sure each table is fully explanatory so that it can be understood without reference to the text.

(d)  The aim of a table should be to present information in a concise manner. Do not repeat the information in the text.

(e)  Be sure to state all units of measurement.

2.4 References

(a)  References must be cited in the Vancouver format, except that for papers with more than six authors, only the first three authors ‘et al’ should be listed. For example:

¨  Vega KJ, Piba I, Krevsky B et al. Heart transplantation is associated with an increased risk of pancreatobiliary disease. Ann Intern Med 1996; 124: 980-3.

¨  You can see other examples at e.g. http://www.nlm.nih.gov/bsd/uniform_requirements.html

(b) The references should be numbered in normal font size in their order of appearance in the

text, within brackets, not as superscripts. Please cite at the end of sentences where possible to avoid interrupting the flow of text. Reference numbers should be cited before

the full stop.

(b)  For references accessible via the web it is helpful to add a web link if you can, together with the date accessed. Links to PubMed abstracts are a helpful option.

(c)  SPCs should be referenced as follows: e.g. Summary of Product Characteristics – Cardura. Pfizer Ltd. Accessed via http://emc.medicines.org.uk/ on 13/03/07 [date of revision of the text February 2007]. If there is no date of revision then the date of first authorisation/renewal of the authorisation should be stated.

(d)  Books should be referenced as follows and should include the relevant page numbers: e.g. Mehta DK, editor. British National Formulary No 52.London: British Medical Association and The Royal Pharmaceutical Society of Great Britain; September 2006, p468.

(f) Individual documents in the Micromedex system should be referenced as follows: e.g. DRUGDEX®System: McLean W & Ariano R: Evening Primrose Oil - Therapy of Polyunsaturated Fat Deficiency (Drug Consult). In: Klasco RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com/(cited: month/day/year).

2.5 Common Problems

Please be wary of the following common problems:

(a)  Generic drug names do not have initial capital letters, but brand names do.

(b)  Make full use of forms of punctuation other than full stops, where appropriate.

(c)  The Latin abbreviation “i.e.” means “that is” and introduces a clarification of what has gone before. The abbreviation “e.g.” means “for example” and introduces examples. Examples should usually be included in brackets.

(d)  Keep the answer as concise as you can. Stick to the point and avoid wandering off into irrelevant areas. See section 2.6 below

(e)  Remember that the word “data” is plural.

(f)  There is nothing wrong with giving your own opinion, but if you do this please make clear that you are doing so and provide some support for it.

(g)  Please be consistent with your choice of indenting space, numbering systems etc.

2.6 Length of Medicines Q&As

Medicines Q&As must not exceed 3 pages in length including the summary (but excluding references and the administration section at the end) and all authors should aim for a maximum of 1-2 pages. Some of the existing Q&As on the site at the time of writing are longer than this but they will be reviewed when they near expiry. In exceptional circumstances, longer documents will be considered – for example if the quantity of data to be reviewed is extensive, or if an expansive table format precludes shortening.

Consider the following tips for reducing the word count:

(a)  Keep the background information section short. It is often not necessary to include information on aetiology or mechanisms of drug action.

(b)  Is there a recent reliable meta-analysis e.g. a Cochrane review that you could evaluate instead of the individual studies?

(c)  Make sure that you do not start a new paragraph for each sentence.

(d)  If you still find that your document is too long, could it be made into three or four separate Q&As? (e.g. see the management of hypersalivation quintet already on site). It is possible to include hyperlinks between documents to allow cross-referencing and avoid repetition.

(e)  You don’t need to describe the contents of every reference in detail. Include just enough to justify your answer.

3.0 Production Process for Medicines Q&As

3.1 Definitions

(a)  Q&A Author – Someone who conducts a literature search and writes a Q&A document.

(b)  Q&A Checker – Someone who checks that an author’s Q&A document is factually correct and is presented correctly. Q&A content is checked against original references.

(c)  Accredited Q&A Lead – Someone who can approve Q&A documents for addition to the national database. It is an individual and not the RMIC that becomes accredited.

3.2 Overview

3.3  Approval Process

There are two ways in which Medicines Q&As can be produced depending on whether or not the originating RMIC has an accredited Q&A Lead (who must either author or check documents). An RMIC can have more than one accredited Q&A Lead.


3.3.1 Method 1 – for RMICs without Accredited Q&A Leads

3.3.1.1 Role of Q&A Author

(a)  Inform Wessex MI that you are writing a Medicines Q&A via email to . Please provide details of the title and the expected date of completion. Wessex MI will ensure that someone else is not already writing on this subject, and then allocate it a unique Medicines Q&A number.

(b)  Contact an accredited Q&A Lead (not Wessex MI) and ensure that they are willing to provide an external check for your Medicines Q&A. As of March 2007 the following RMICs have accredited Q&A Leads: East Anglia, Guys, Liverpool, London MI, Trent, Wales.

(c)  Conduct a literature search of various sources such as: Embase, Medline, Pharmline, Cochrane Database, any in-house databases, and a general search of the Internet if appropriate. A primary literature search (including Embase/Medline) is necessary for all Q&As unless the author can justify otherwise. Details of all the information sources used should be included in the Medicines Q&A whether or not all of them yielded useful information. You may find it helpful to use the standard search pattern in Appendix 2.

(d)  Search strategy should include any relevant government websites.

(e)  The details of the search terms and any qualifiers should be recorded (e.g. “cut and paste” the whole Medline search strategy into the Q&A template).

(f)  Obtain references and store for any future referral, along with the search strategy and any communication relating to the Q&A document (including copies of emails).

(g)  Electronic copies of all draft versions, comments received and Quality Assurance Checklists must be stored for any future referral.

(h)  RMICs are responsible for storing all historical information about a Q&A while it remains active. The timescale for storing information after a Q&A has been deleted from NeLM should be the same length of time that enquiries are kept for within the Trust in which the author works (starting at expiry date) if these vary from standard NHS guidelines.

(i)  Ensure that any information from the industry is obtained in writing, and stored for future referral.

(j)  Evaluate the data and write the first draft of text.

(k)  Use the highest quality of evidence available and evaluate it in the context of the Medicines Q&A.

(l)  Involve a clinical expert where possible, and if appropriate.

(m)  Complete the Quality Assurance Checklist 1.

(n)  Make any corrections suggested by in-house checker (reasons for not incorporating their suggestions must be documented).

(o)  Send to the agreed accredited Q&A Lead for an external check (see (b) above).

(p)  Update the Q&A when it expires (responsibility for updating defaults to RMIC director or his/her nominee if the author is absent) and keep updated during the course of it being active if there are significant new developments. See section 7.0 for guidance on updating.

3.3.1.2  Role of Q&A Checker

(a)  This should be a suitably experienced MI pharmacist at the discretion of the RMIC Director.

(b)  Obtain evidence that a sufficiently comprehensive literature search was done and check that the search terms were appropriate. It is not necessary to repeat it.

(c)  Check that the right format and template has been used.

(d)  Compare the text against original sources/documents for accuracy.

(e)  The clinical acceptability of the answer should also be verified.

(f)  Check for typographical and grammatical errors.

(g)  Ensure that the question has been answered, if this is possible, and that the answer is generic.

(h)  Ensure the answer is complete: for example that no major clinical areas or drug groups have been omitted.

(i)  Comments should be incorporated into the text of the Medicines Q&A using the Word tracking function.

(j)  Liaise with the author concerning any changes.

(k)  Complete the Quality Assurance Checklist 1.

3.3.1.3  Role of Q&A Leads

(a)  Ensure that the template is used.

(b)  Look for grammatical errors, lack of clarity, typographical errors, good flow of English.

(c)  Ensure that it has been checked and the QA documented.