Content of educational materials for healthcare professionals

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2. Content of educational materials for healthcare professionals

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In force from:

15.07.2019

The reason for EM development and distribution is to alert doctors or other healthcare professionals, as appropriate, of important safety information, and hence ensure the protection of the health of the patient as well as other persons coming into direct contact with the medicinal product and, furthermore, to minimise the risk implied by the nature, indication, and use of the active substance. The EM development should be always based upon the currently effective version of the SmPC. The form of the EM has to be adequate to the intended message.

The topic communicated through EM may be addressed to various recipients, i.e. doctors of various specialities, pharmacists, or other healthcare professionals, as appropriate, and may pertain to more than one safety problem.

The content may, for instance, include recommendations relevant to dosage, contraindications, managing critical situations and adverse reactions, measures relevant forspecific patient groups, description of treatment, including specifications regarding the method of use, medicinal product posology, and patient additional monitoring, or important information that the doctor has to communicate to the patient before, during, or after treatment.

Messages contained in the EM should be clear, brief, as apt as possible, and not exceeding the basic scope of the topic. The purpose of the EM must not be distorted by the addition of other, redundant information which already forms part of the SmPC.

The EM should not be a duplicate of the currently effective SmPC. They must always include an invitation to study the SmPC, which should be ideally worded as follows:

<Aktuálně platný SmPC lze vyhledat na webových stránkách Státního ústavu pro kontrolu léčiv v sekci Databáze léků na adrese https://www.sukl.cz/modules/medication/search.php.>

The inclusion of this recommendation cannot be considered a fulfilment of the MA holder´s obligation to distribute the SmPC to doctors, where such condition has been stipulated by the marketing authorisation.

To distinguish the EM from a number of other printed matter and promotional brochures, as a standard, the cover page of the EM has to show the words in the left upper corner, in a clearly visible format in red colour. The font size of these words has to be significantly bigger than the font size of the other text. These words have to be clearly and visibly distinguished from other texts, titles and other graphic elements. Where the EM are to be distributed in a form other than written text, it is necessary to place this indication on the label of the relevant media in a suitable manner.

This indication must be also shown on the envelope or packaging in which the EM is distributed.

This indication may be used solely for EM the form, content, and method of distribution of which have been approved by SÚKL.

Furthermore, the active substance/active substance combination to which the communication pertains, or the name of the medicinal product, if appropriate, must be specified. Below the name of the medicinal product, the EM title shall be provided, which shall effectively represent the content thereof.

A description of the method of adverse drug reaction reporting must form part of any EM, ideally worded as follows:

<Jakékoli podezření na závažný nebo neočekávaný nežádoucí účinek a jiné skutečnosti závažné pro zdraví léčených osob musí být hlášeno Státnímu ústavu pro kontrolu léčiv. Podrobnosti o hlášení najdete na: https://www.sukl.cz/nahlasit-nezadouci-ucinek. Adresa pro zasílání je Státní ústav pro kontrolu léčiv, odbor farmakovigilance, Šrobárova 48, Praha 10, 100 41, email: farmakovigilance@sukl.cz.>

This method of reporting to SÚKL must be always provided prior to other reporting methods, such as an invitation to report to the MA holder:

In case EM concerning a medicinal product under additional monitoring are distributed to healthcare professionals, this fact shall be distinctly shown on the title page, in the following manner:

< Tento léčivý přípravek podléhá dalšímu sledování. To umožní rychlé získání nových informací o bezpečnosti. Žádáme zdravotnické pracovníky, aby hlásili jakákoli podezření na nežádoucí účinky.>

< This medicinal product is under additional monitoring. This will facilitate rapid collection of new safety information. Healthcare professionals are kindly asked to report any suspected adverse reactions.>

One side of the printed black triangle must be 0.5 cm.

Where the EM concern a biological product, the following shall be also included:

a) Warning of the need to report the batch identification number and the trade name of the product in case an adverse reaction is reported, ideally worded as follows:
- <Je třeba doplnit i přesný obchodní název a číslo šarže. Tato informace může být také hlášena společnosti…>
- <It is necessary to provide also the exact trade name and batch number. This information may be also reported to (company)…>
b) Warning that the name of the medicinal product and batch number must be clearly noted in the patient´s documentation.

Where SÚKL does not require joint EM for an active substance, where the name(s) of medicinal products are not specified, then the EM developed for generic products must be, in terms of their purpose, content, form as well as graphic representation, as similar to the EM for the original product as practicable.

Each version of the EM should be appropriately identified in the bottom part of the title and last page of the EM, i.e. version number and date of approval by SÚKL, ideally in the following format:

<Verze: xx>

<Schváleno SÚKL: xx/20xx>

<Version: xx>

EM must not contain:

any direct or indirect elements of advertising nature (including logos, colour combinations associated with a logo or product, etc.);
photos or images not directly associated with the safe use of the product (images are allowed only if illustrating the content of the material, such as possible injection application sites, etc.);
graphs and tables which are not directly associated with the safe use of the product;
content not closely related to the intended message;
title or name of the product on the title page in red font;
references to any literature not directly associated with the content of the EM.

It is advisable to consult doctors of the respective speciality and professional societies when developing EM.

EM for healthcare professionals with professional and specialised qualification required for the performance of the medical profession of a doctor, dentist and pharmacist may, in exceptional cases, be approved solely in the English language. This shall be always assessed and approved by SÚKL with a view to the specific circumstances of the case in question.

EM for healthcare professionals defined by Act No 96/2004 Coll. on Non-Medical Healthcare Professions, should always be drafted in the Czech language.