Medical device software: regulation remains challenging
Health apps as well as digital tools with a medical purpose are on the rise. Ever since the EU launched the Medical Devices Regulation, medical device software has been under scrutiny because many manufacturers do not meet the regulatory requirements. The professional associations FMH, pharmaSuisse and "H+ Die Spitäler der Schweiz" has had an expert opinion drawn up for Switzerland.
Administration of extemporaneous preparations despite authorised drugs
Data from Germany show that despite authorised drugs for indications in infants (propranolol for haemangioma, ibuprofen for ductus arteriosus occlusion and caffeine citrate for the treatment of primary apnoea), these are not used in one out of three cases. Instead, extemporaneous preparations are administered. In the discussion, the question is raised how much - if any - new knowledge is generated by an authorisation process when clinical data from large academic trials are already available? It is clear that the authorised products cost up to 1,700 times more and that the costs probably represent the main reason for further prescribing in the unlicensed area.
The question may be asked whether there is a need for completely new ways of dealing with medicines for children that are currently not authorised?
Harmonisation of drug dosages moves forward
The Federal Office of Public Health wants to continue to financially support the harmonisation of drug dosages for children. The Office is taking positive stock of the establishment of the SwissPedDose database. It now contains 134 active ingredients and will be continuously expanded. We too support the safe use of medications for children. For this reason, we have been the first eHealth provider to include the dosages from SwissPedDose in our intelligent tool PEDeDose. In addition, our tool contains further dosage recommendations based on clinical studies and the experience of children's hospitals. Health professionals use PEDeDose primarily to calculate patient-specific dosages rapidly with just a few clicks.
Pediatric drug calculators - lack of regulatory compliance
In a recently published systematic review Koldeweij et al. showed that out of 74 of mobile pediatric drug dosing calculators not even one was certified according to the Medical Device Regulation (MDR), while only one was notified according to the outdated Medical Device Directive (MDD). The authors state the following in the conclusion: "This lack of regulatory compliance puts both clinicians and patients at risk of medical errors resulting from the use of uncertified and, in some cases, potentially unsafe pediatric dosing calculators."
At PEDeus, we take on the effort of MDR (re-)certification every year in order to keep PEDeDose a safe and userfriendly clinical decision support tool that provides our young patients with appropriately dosed medications.
Pharmacists: on their own
In the recently published article in pharmaJournal (Oct 2021, in German), we report on drug safety in pediatric medicine and on the responsibility of pharmacists. Thanks to intelligent clinical decision support tools, errors in the validation of prescriptions can be prevented.
(article in French)
Description of a clinical decision support tool in the "European Journal of Pediatrics"
Have you ever wondered how the medication prescribing process may be supported by a Clinical Decision Support tool in pediatrics? And how it is integrated into the existing ICT infrastructure? We proudly present to you our newly published article in the well-respected European Journal of Pediatrics " Description of a clinical decision support tool with integrated dose calculator for paediatrics”.
Smarter medicine in pediatrics
pädiatrie schweiz (Swiss Society of Pediatrics) has published recommendations under the title "choosing wisely" on five measures that are usually unnecessary and have potential for adverse effects. All of these "Top 5" concern drug therapy - the benefit-risk ratio for the corresponding use is unfavourable, and therefore it is indicated to forgo treatment. We strongly support these Top 5, congratulate pädiatrie Schweiz for their valuable work and wish them every success in their implementation!
Potentially harmful excipients in neonatal medications
Data from Japan show that 40% of all neonates in neonatal intensive care units received doses exceeding the acceptable daily intake of potentially harmful excipients. Exposure could be reduced by replacing these medicines with available alternatives. In our database, the data on excipients and suitability by age group, especially for premature and newborn infants, are available with just a few clicks.
The need for a pediatric Clinical Decision Support tool is highlighted
An interesting study regarding the implementation of a pediatric CPOE (Computerised Physician Order Entry) shows: "The vulnerability analysis highlighted the need to configure a Clinical Decision Support system that can identify inappropriate dosing instructions for pediatric patients." The results of the study clearly point out that the implementation of a CPOE without a Clinical Decision Support tool for pediatric dosages does not improve the number of 'inappropriate orders'.
PEDeDose meets the highest quality requirements
The new year starts with good news for pediatrics: The software behind PEDeDose has recently been certified as a Class IIa medical device. This means that we fulfil the mandatory conditions of the Medical Device Regulation as of May 2021. After meticulous testing, the conformity assessment body TÜV SÜD has confirmed that PEDeDose meets the highest requirements. To our knowledge, this makes us the only European provider of a clinical decision support tool for dosing drugs for children which meets all regulatory requirements.
Dosing errors in pediatrics - analysis of CIRS data
The results of a recently published analysis of medication errors in pediatrics - reported via CIRS - show an already well-known picture: dosing errors are by far the most common cause of critical incidents. In their recommendations for preventing medication errors, the authors particularly emphasise the correct dosage calculation and the identification of high-risk situations.
Use of CDS tools in pediatrics to be enshrined in law
A few days ago, the Swiss National Council unanimously voted in favour of legislating the use of "Clinical Decision Support" tools in pediatric clinics and in public pharmacies. This follows last year's recommendation by the Federal Council and the Council of States to approve the motion of Councillor Stöckli. Politicians are thus sending a clear signal and setting the target: Drug safety for children must be increased in Switzerland.