Content of educational materials for patients

The reason for developing and distributing EM for patientsis to communicate important safety information in order to increase the patient and patient carer awareness of these facts, and thus ensure the safe use of medicinal products, protection of the health of the patient and other persons coming into direct contact with the product, and to minimise risks.

The EM form must be adequate to the intended message.

When drafting the EM, it is always necessary to rely on the currently effective version of the PIL. EM may address several important safety concerns.

The message of EM for patients should be clear, brief, and as apt as possible, and their content should not exceed the basic scope of the topic and purpose of the EM and must not be confounded by additional, indirect information already contained in the PIL.

The language used must be comprehensible for lay persons and the use of specialised terms and foreign words must be reduced to a minimum in order to convey as straightforward a message as possible.

Any messages should be worded appropriately with a view to possible sensitive information and their impact upon the patient (e.g. further disease progression, pregnancy, adverse reactions, etc.).

The content may, for example, include recommendations pertaining to the administration of the medicinal product (dosage, quantity, application site, etc.), contraindications, adverse drug reactions, early recognition of (potentially) arising adverse reactions, and a description of recommended procedure to resolve these situations, including a clear recommendation on the situation under which it is necessary to immediately seek urgent medical assistance. Furthermore, the EM should contain important information to be discussed with the doctor before, during or after completion of the treatment.

If appropriate, a diary for posology or diary of other scheduled check-ups with the doctor or other diagnostic procedures could form an appropriate and important part of the patient’s educational materials to ensure and emphasise the necessary cooperation on the part of the patient throughout the entire therapeutic process.

EM should not be a duplicate of the currently effective PIL. They shall always include an invitation to study the PIL and emphasise the necessity to consult the treating doctor or pharmacists in case of any doubt or concerns regarding treatment.

It is advisable to include the following text:

<Tento přehled nežádoucích účinků není úplný a je třeba se seznámit i s možnými dalšími nežádoucími účinky, jejichž výčet naleznete v Příbalové Informaci pro pacienta. Příbalová Informace pro pacienta (PIL) je distribuována v každém balení léčivého přípravku a lze jí také vyhledat na https://www.olecich.cz po zadání názvu léčivého přípravku pod zkratkou PIL.>

<This overview of adverse drug reactions is not complete and it is necessary to familiarise with other potential adverse reactions the list of which is available from the Patient Information Leaflet. The Patient Information Leaflet (PIL) is distributed in each package of the medicinal product and it may be also found at https://www.olecich.cz under the abbreviation PIL if you enter the name of the medicinal product.>

The inclusion of this recommendation cannot be considered a fulfilment of the MA holder´s obligation to distribute the PIL to patients, where such condition has been stipulated by the marketing authorisation. In such a case the distributed EM shall include also the adequate number of copies of the currently effective PIL.

A description of the method of adverse drug reaction reporting shall form an integral part of any EM and shall be ideally worded as follows:

<Pokud se u Vás vyskytne kterýkoli z nežádoucích účinků, sdělte to svému lékaři nebo lékárníkovi. Stejně postupujte i v případě jakýchkoli nežádoucích účinků, které nejsou uvedeny v příbalové informaci. Nežádoucí účinky můžete hlásit také přímo prostřednictvím národního systému hlášení nežádoucích účinků.

Podrobnosti o hlášení najdete na https://www.olecich.cz/hlaseni-pro-sukl/nahlasit-nezadouci-ucinek.

Adresa pro zasílání je Státní ústav pro kontrolu léčiv, odbor farmakovigilance, Šrobárova 48, Praha 10, 100 41, email: farmakovigilance@sukl.cz>

<Should you experience any of the adverse reactions, please tell your doctor or pharmacist, and do so also in case of any adverse reactions that are not described in the Patient Information Leaflet. You can also report adverse reactions directly, via the national adverse drug reaction reporting system.

For details regarding reporting, please refer to: https://www.olecich.cz/hlaseni-pro-sukl/nahlasit-nezadouci-ucinek.

The mailing address is: 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 specified prior to other reporting methods, such as a request to report to the MA holder:

<Tato informace může být také hlášena společnosti…>

<This information may be also reported to (company)…>

In case EM on medicinal products under additional monitoring are distributed to patients, this fact shall be stated on the title page, in a distinct manner and worded as follows:

< Tento přípravek podléhá dalšímu sledování. To umožní rychlé získání nových informací o bezpečnosti. Můžete přispět tím, že nahlásíte jakékoli nežádoucí účinky, které se u Vás vyskytnou. >

< This product is under additional monitoring. This will facilitate rapid collection of new safety information. You can contribute by reporting any adverse reactions that you experience. >

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

Where the report concerns a biological product, the following warning on the necessity to report also the batch identification number shall be also included, ideally worded as follows:

<Je třeba doplnit i přesný obchodní název a číslo šarže. Nahlášením nežádoucích účinků můžete přispět k získání více informací o bezpečnosti tohoto přípravku.>

<It is necessary to provide also the exact trade name and batch number. By reporting adverse drug reactions you can contribute to the collection of further information on the safety of this product.>

Each EM version should be identified as appropriate 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>

<Approved by SÚKL: xx/20xx>