1ErasmuMC, ROTTERDAM, Nederland2Radboud University, NIJMEGEN, Nederland3University Medical Centre Utrecht-Wilhelmina Children’s Hospital, UTRECHT, Nederland4The Hospital for Sick Children, TORONTO, Canada
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BackgroundAs many drugs in paediatrics are used of off-label, prescribers face a lack of evidence-based dosing guidelines. Current knowledge on paediatric pharmacotherapy is empirical, practice based, and seldom systematically collected and disseminated.The overall aim was to develop an openly accessible, web based formulary con-taining best evidence based, referenced and up-to-date drug-specific information, which was acceptable to paediatricians, hospital pharmacists and general practitioners.MethodsThe work was done by a team of a coordinat-ing paediatrician (0.2 fulltime equivalent (fte)), project manager (0.8 fte) and pharmacist (1.0 fte) and the multidisciplanary editorial board of 35 members. The overall budget on an annual basis was € 250 000 in the first 2 years, and currently € 220 000. The formulary started as a consensus-based formulary. From this point onwards, a dedicated pharmacist searched the available scientific literature following and assessed the risks and benefits of use in the paediatric population. The evidence is de-scribed in a risk analysis document and summarised in a drug monograph and reviewed by the editorial board before publication.ResultsA framework was developed to provide dosing guidelines based on best available evidence from reg-istration data, published investigator-initiated research, guidelines, clinical experience and consensus. Dissem-ination of these dosing guidelines was established by developing an open-access online database (http://http://www.kinderformularium.nl/). The development has resulted in the revision of many earlier consensus-based dose rec-ommendations, clarified the scientific grounds of drug use for children and ensured uniformity in prescribing habits in the Netherlands. Also, additional projects to fur-ther improve the information and usability of the formu-lary were initiated, including dosing guidelines for renal dysfunction, a dosing calculator and parent/patient drug information leaflets.DiscussionIt is almost impossible to make a paediatric risk-benefit assessment based on the same standards that are mandatory when assessing adult drug use. We are aware that many of our dosing recommendations there-fore still bear a varying degree of uncertainty. ‘Best-evidence’ means that we do know the scientific background that supports paediatric use. This also implies that, in the face of low-quality evidence, expert opinion or a consen-sus of a group of experts is important. It is a common misconception that a recommendation supported by low-quality evidence implies a recommendation against use. The Dutch Paediatric Formulary deliberately chose to give insights in the limited amount of evidence available and create awareness rather than to reject paediatric use because of limited evidence.ConclusionThe Dutch Paediatric Formulary is a proof of concept in creating a knowledge-based paediatric formulary. The formulary has also been of great value in timely translating scientific research knowledge to daily practice. We believe that the Dutch approach in creating a knowledge-based paediatric formulary was successful and could be used as basis for similar initiatives world-wide, preferably in a concerted effort to ultimately pro-vide children with effective and safe drug therapy.