Opioids, especially prolonged-release morphine (M-LONG RETARD, generics), are regarded as the treatment of choice for severe chronic pain. In addition, patients may need a non-prolonged-release opioid for the control of breakthrough pain, also primarily morphine (c.f. a-t 2005; 36: 19-22). We consider fentanyl for oral transmucosal administration (ACTIQ), which has been available for a few years and is a lozenge attached to a plastic stick, as a reserve drug for patients who have difficulty swallowing. According to an investigation by the French regulatory agency Afssaps, the manufacturer Cephalon documented 177 reports of accidental use of the fentanyl stick by children between 1998 and 2007 worldwide. 37 reports were classed as "severe". Three children aged one year, 18 months and ten years died after eating the lollipops prescribed for their grandmothers (1).

The ACTIQ package leaflet (2) states in several places that the stick must be kept out of the reach and sight of children. However, - and unlike on the American patient information leaflet (3) -, the statements are neither positioned in a prominent place, such as at the beginning of the document, nor made to stand out, which means that they are easy to overlook. Furthermore, patients in the USA are given information material and a special childproof storage system with different containers in which to keep packs of the medicinal product, a small supply of the fentanyl lollipops for use when on the move, and partially used sticks. In Germany, there is no such kit (4).

1

Prescrire International 2008; 17: 245

2

Cephalon: ACTIQ patient information leaflet, as at June 2007

3

Cephalon (USA): ACTIQ patient information leaflet (USA), as at Febr. 2007

4

Cephalon: letter dated 12 Jan. 2009