XVI.App2.4. Patient card

Location:
XVI.Appendix 2

A patient card may be intended to be carried by the patient at all times to:

  • Facilitate (during the hand-over of the card to the patient or the raising awareness of the patient about the card, and/or the personalisation of the card by adding the patient’s name on a dedicated field) that the healthcare professional informs the patient at the intended point of care, e.g. during prescribing or dispensing, about the risk and the intended actions for risk minimisation;
  • Remind the patient of the risks and the actions to minimise them during treatment, including, if applicable, to inform healthcare professionals that this medicinal product is used and to seek (urgent) medical attention if signs and symptoms of a possible adverse reaction occur;
  • Note as a reminder, if applicable, in a dedicated field on the card the dates for regular medication reviews or conducting tests, or for removing the related medical device, and/or the results of a test; and/or
  • Inform healthcare professionals during emergency care that the patient is using this medicinal product, possibly with contact details of the prescribing healthcare professional noted in a dedicated field on the card.

The card may carry an instruction for the patient “Carry with you at all times”, and as appropriate for the given intended actions for risk minimisation, the card may carry further instructions, e.g. “Show to your healthcare professional before starting a new treatment” or “Keep easily accessible for emergency care”.

For tailoring RMM materials (see XVI.B.4.1.), the purpose of the patient card (e.g. addressing patients using the medicinal product for a specific indication or belonging to a specific sex or age group) may be specified in a sub-heading of the patient card, below the name of the RMM tool as the main heading (see XVI.B.4.1.1.).

In the rare cases where a risk has different intended actions for risk minimisation for different patient groups, one patient card may address all concerned patient groups or more than one patient card for the same medicinal product may be appropriate.

For its purpose, a patient card should have the following features:

  • Format: single or folded (one-fold or Z-fold) card which is independent of the PL (i.e. not as a tearoff part of the PL);
  • Size: at minimum the size of half a credit card and at maximum the size of a credit card, to fit inside a pocket/wallet/card holder (if more space is needed, folds can be used, see above);
  • Material: carton of durable thickness and possibly laminated, to sustain wear and tear over time;
  • Design: striking (e.g. clean layout, shapes and/or colours), to be visible and immediately identifiable as important, and notably different from the PL (i.e. not resembling a PL);
  • Writable fields: a field for the patient’s name and, if applicable, for the prescriber’s name and contact details;
  • Multiple language versions if applicable: can be bundled, but it should be obvious for the patient how to take out from the bundle a complete card in the preferred language.

A patient card can be placed inside the package, be affixed to the outer side of the package as finished by the manufacturer, or be separate from the package. Cards placed inside the package or affixed to the outer side of the package should usually be preferred. Cards separate from the package may (additionally) be needed for hand-over to the patient, e.g. when the given medicinal product may be used in a setting where one package is used for more than one patient, or when the intended action for risk minimisation involves the prescriber handing over the patient card as part of a risk minimisation control programme.

Cards placed inside the package or affixed to the outer side of the package are considered part of the product information and hence their text should be included in the respective part of the marketing authorisation.

In the case when an existing patient card inside the package or affixed to the package outside is amended or newly required in the post-authorisation phase, the marketing authorisation holder should provide dissemination plan proposals to the competent authorities in Member States for interim measures to be provided as long as packages without the up-to-date patient card are in distribution (see XVI.B.4.2.).