We continue to see people getting medicines dispensed in various anonymous pots and bottles, without essential information. This is unacceptable. People shouldn't have to use a magnifying glass and an online forum to find out what they have been given.
If you are in the position of getting given anything not in its full, original, unbroken packaging, please ask for, if necessary DEMAND (politely but firmly), the Patient Information Leaflet, the product code, the serial number which is a numeric or alphanumeric sequence, the batch number and the expiry date.
EVERY item dispensed should have:
Patient information leaflets (PILs)
Unless all the information is on the pack, all medicines must include a PIL, regardless of how patients get them. PILs must:
be easy to understand
not contain personal information that can identify an individual, including names of staff members or digital signatures
Each product authorised under a marketing authorisation must have its own leaflet as explained in our best practice guidance on patient information leaflets.
Further, the official packaging must have the information below. In my view, the fact that the pharmacy has decanted product into another container does not remove this requirement.
Safety features legislation
The European Parliament and Council has approved and published a Delegated Regulation (EU2016/161) in the Official Journal of the European Union. This supplements the Falsified Medicines Directive (FMD) and introduces two mandatory safety features that will allow medicines to be verified and authenticated.
These safety features are:
a unique identifier (a 2D data matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain
tamper evident features on the pack
The unique identifier comprises:
a product code which allows the identification of at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size, and the pack type
a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated
a batch number
an expiry date