Dosage Mistakes, a Global Safety Stake
Figures explanations about dosage mistakes
Every year the ANSM, the French National Agency for Medicines and Health Product Safety, evaluates incidents and risks of incidents involving a medical device with its vigilance system.
In 2016, the medical device vigilance system regroups around 44% of reports coming from healthcare institutions, 47% from manufacturers and 9% from other as associations delivering devices to patients’ homes, private individuals, non-hospital healthcare professionals, and French and European institutions.
From that, 15 961 reports were registered wherein 749 declared as serious and 129 submitted by patients and patient association.
Also, 2 414 reports of medication errors or risk of medication errors have been reported to the ANSM.
According to a 2012 study from NYU School of Medicine, 1 parent over 6 uses the spoon instead of the appropriate medical device required for the child treatment.
- Double dosage mistakes
- 40% of parents make dosage mistakes
Two manuals as a potential solution
To inform about the struggle of dosage mistakes, 2 major manuals have been identified:
- The FDA’s Guidance for Industry “Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products”
- The European Medicines Agency’s “Guideline on the pharmaceutical development of medicines for pediatric use“
But is it enough?…
Today ercé médical is developing an innovative medical device as a solution to the dosage mistake problem.