Producing National Drug and Therapeutic Information - The Malawi Approach to Developing Standard Treatment Guidelines
(1994; 49 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
Open this folder and view contentsIntroduction
Close this folderMSTG 1 (First edition)
View the documentActivities prior to development of MSTG 1
View the documentDecision to develop MSTG
View the documentPreparation
View the documentPrinting
Open this folder and view contentsDistribution
View the documentIntroducing the guidelines
Open this folder and view contentsMSTG 2 (Second edition)
Open this folder and view contentsAppendices
 

Preparation

The actual development of the MSTG as a ready reference, therapeutic guidelines booklet, covering around 100 of the most common presentations, commenced in late 1988. The starting point for this was QUANTED (see above). Background publications used are listed in Appendix 1.

This first draft, which was still in tabular form (see Appendix 2), was sent out in December 1988 to all 74 public sector medical practitioners in the country. A covering letter requested comments on the treatment regimes, document design, presentation of dosage information and suggestions on other conditions to be included.

The 103 conditions covered were each subdivided according to adults/children and to level of severity. Information given was the name of the drug(s), the dose form and the dose regime. A rather low (approximately 30%) response rate was obtained.

Tip #1:

Steps should be taken to stimulate the maximum response to material distributed for comment

These may include:

active written or telephone follow-up of respondents;

inclusion of a stamped addressed return envelope with mailed material sent for review;

workshops to discuss the material developed for review;

requesting key specialists to develop or review specific areas. If necessary this could be done on a contract basis.

Comments centred around:

• clarification of the classification of conditions into severities;

• non-acceptance of the ICD9 (International Classification of Diseases) coding system used for the diseases covered;

• addition of obstetric conditions;

• dosage for children by weight and not age (range).

By May 1989, comments were incorporated into a revised (second) draft which was in non-tabular form (see Appendix 3). For this the files had been converted from spreadsheet format into a database using dBase IV®. In this version the now 98 conditions covered were listed alphabetically.

Instead of using the term “severities”, “recommended treatment” was used to indicate the normal (i.e. 1st line) treatment. When appropriate, an “alternative treatment” was given in case the recommended treatment failed to show results or was justified by the gravity of the case.

For example:


Asthma

Recommended treatment in adults:

aminophylline tabs 100 mg: 1 x 3 x 30 days



** Alternative **:

aminophylline amp 25 mg/ml, 10 ml: 1 amp IV


salbutamol inhaler: two puffs every 6 hours

A table of contents listed conditions alphabetically. For a few conditions, a brief (one line) treatment guidance note was given. For example:

Animal bites:

“Never suture a bite wound of any kind”;

Caries, Toothache:

“The only definitive treatment is surgical intervention”;

Convulsions:

“Protect patient from injury in side position and prevent tongue bite”.

The second draft was sent out for further comments to a group of 33 senior clinicians and health professionals. A covering letter included with the draft summarised the work done so far and proposed that the final document be produced in a smaller format so that it could easily fit into the pocket and thus be readily available for routine reference during daily clinical work.

A third draft, incorporating any comments received, was reviewed by the National Drugs Committee (NDC) in July 1989 (see Appendix 4). Several further amendments were made, such as addition of new conditions.

Approval in principle was given by the NDC and MOH to the editor to proceed with arrangements for printing, subject to incorporation of the agreed changes and verification of paediatric doses with the relevant specialists. Further editing and formatting was done to prepare the camera-ready material for printing. MultiMate Advantage II® was used to prepare text which was then transferred into Aldus Pagemaker® (desk-top publisher) for final enhancement. Microsoft Excel® was used for tables.

Tip #2:

Decide as early as possible, whether to prepare a camera-ready publication yourself and if so, on the computer software to be used

If possible it is much better to produce a camera-ready (i.e. in a form ready for printing) final product yourself, using a word-processor, spread-sheet and if required desk-top publishing programmes. This allows total control over the design and layout of the publication, and significantly reduces direct publication costs.

If this is not possible, it may be necessary to pass on drafted material and requirements for tables, artwork, etc. to a publisher for preparation of the final document. This can be very expensive and time-consuming. It will also be necessary to liaise very closely with the publisher throughout the process in order to ensure that the layout, etc. are exactly as originally intended.

The MSTG started off as a spreadsheet, was converted to a database and finally transferred to desk-top publishing software. Each of these changes takes a significant amount of time and effort to complete. Preparation of the material at an early stage in a size and form similar to that ultimately intended probably leads to improvement in the presentation of the content and the overall design and layout of the document.

For the second edition (MSTG 2) a change was made from desk-top publishing to word processing software (Microsoft Word for Windows®). This provided equally good text enhancement features (e.g. bullets, boxes and shading) but was much easier to use and facilitated indexing.

However at this stage the MOH, guided by senior clinicians, had second thoughts about the development process followed thus far and called a further meeting to discuss the draft. Reasons for this were mainly related to the sensitivities of the medical community and included:

• lack of a wide enough consensus between clinicians, national health experts and MOH administrators regarding:

- the need for target groups and objectives of the prescriber training activities which would follow the publication of the MSTG;

- the content and format of the MSTG.

• harmonisation of the MSTG with other drug information documents including the Malawi National Formulary, a new edition of which was also being prepared.

Tip #3:

A wide consensus must be reached with all interested parties in the medical and pharmaceutical establishment.

This means involving representatives of a wide range of interest and expertise, including senior policy-makers, senior clinicians (especially at university level) and all levels of the intended target audience, in the development of the publication. These should be fully briefed, at a national workshop, on the aims of the publication and the benefits expected from its use.

It is important that all involved are clear from the beginning that treatment guidelines should be used together with clinical judgment, are not as restrictive as often perceived, and that while the treatment protocols should represent the best practice for most patients, individual patients may still require different treatment.

It was in this context that a special National Drugs Committee meeting was held in December 1989 to ensure final consensus among senior clinicians. Numerous, although mainly minor, changes were made to the draft of the STG. These included:

• standardisation of dose regime statements in the form: generic drug name, dose size, route of administration, dose frequency and duration of treatment;

• dose forms were deleted and the route of administration indicated instead;

• addition of prescriber guidance points to several treatments - these consisted of brief statements of advice on management of the condition.

The process of review simply involved starting with the first condition and working through each page in sequence asking for comments from the whole Committee. This was a comprehensive but rather lengthy and inefficient process.

Tip #4:

A systematic process of preparation and review of the document by the national drugs committee should be followed, making optimal use of the time and expertise available.

The first draft of the document should be prepared by an individual or small committee appointed by the NDC. Sections of this should be sent out for comment to the appropriate specialists. The draft, together with any comments received, should then be distributed to the members of the national drugs committee well before a special meeting called to review the material and agree on the final version. Additional members should be co-opted for the meeting, as necessary, to ensure that all the required expertise is available. This minimises the extent of any follow-up which may be needed after the meeting to seek advice or confirmation on specific issues.

It is recommended that the document be split into several sections to be reviewed by smaller working groups with specific expertise. These then report their findings and recommendations to a plenary meeting for further discussion and final agreement.

If confirmation of specific points with specialists is still required following the review meeting, the committee can mandate the subsequent inclusion of these in the final document without the need to call another meeting of the drugs committee. This will save time and additional expense.

Following the meeting, agreed amendments were incorporated, final formatting and layout completed, and remaining sections added. The latter included the cover page, table of contents, foreword, preface, modification form and paediatric weight/age conversion charts. Certain treatments were re-drafted following the meeting by nominated members of the Committee or identified specialists. Submission of these for incorporation in the final document took over six months. It became clear that, in some cases, getting draft new material was much more difficult than obtaining comments on existing material. It was not until November 1990, some 11 months after the NDC meeting, that the document was in camera-ready form for printing (see Appendix 5).

For technical notes on MSTG 1, see Appendix 6.

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