english.prescrire.org > Spotlight > Archives : 2017 > French drug agency's recommendations on dosing devices: a step forward

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French drug agency's recommendations on dosing devices: a step forward

In 2016, the French drug regulatory agency (ANSM) published recommendations for companies regarding dosing devices. These recommendations are welcome, and should be extended.

Multi-dose oral liquid formulations allow different doses of a medicine to be dispensed, a situation frequently encountered with children for whom the dose needs to be adapted to body weight. They involve the use of a dosing device. The analyses of drug packaging carried out by Prescrire highlight the dangers posed by many dosing devices. In 2016, the French drug regulatory agency (ANSM) published recommendations for companies regarding dosing devices. Prescrire had taken part in the 2013 public consultation on these recommendations.

The ANSM recommendations are consistent with the dangers pointed out following our analysis of hundreds of dosing devices. These include:

  • absence of a dosing device;
  • lack of precision of droppers and cups;
  • illegible or superfluous graduations;
  • risk of error in converting milligrams of the prescribed dose into millilitres of volume to be measured;
  • provision of several dosing devices in the same box.

Recommendations which should be extended. The ANSM recommendations on dosing devices adopted in 2016 are to be welcomed. As we had suggested to ANSM, a few additional points could have been useful for completion: developing drug packaging well ahead of market authorisation, so that it can be evaluated; and, as far as possible, encouraging the use of unit-dose packaging (e.g. tablets, capsules, sachets) as first-choice options in order to guarantee the precision of dosing and reduce the risk of errors arising during preparation.

©Prescrire 1 September 2017

"French drug agency's recommendations on dosing devices: a step forward" Prescrire Int 2017; 26 (185): 221. (Pdf, free).
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