Best Evidence-Based Dosing Recommendations for Dexmedetomidine for Premedication and Procedural Sedation in Pediatrics: Outcome of a Risk-Benefit Analysis By the Dutch Pediatric Formulary.

BACKGROUND: Dexmedetomidine is currently off-label for use in pediatric clinical care worldwide. Nevertheless, it is frequently prescribed to pediatric patients as premedication prior to induction of anesthesia or for procedural sedation. There is ample literature on the pharmacokinetics, efficacy and safety of dexmedetomidine in this vulnerable patient population, but there is a general lack of consensus on dosing. In this project, we aimed to use the standardized workflow of the Dutch Pediatric Formulary to establish best evidence-based pediatric dosing guidelines for dexmedetomidine as premedication and for procedural sedation. METHOD: The available literature on dexmedetomidine in pediatrics was reviewed in order to address the following three questions: (1) What is the right dose? (2) What is known about efficacy? (3) What is known about safety? Relevant literature was compiled into a risk-benefit analysis document. A team of clinical experts critically appraised the analysis and the proposed dosing recommendations. RESULTS: Dexmedetomidine is most commonly administered via the intravenous or intranasal route. Clearance is age dependent, warranting higher doses in infants to reach similar exposure as in adults. Dexmedetomidine use results in satisfactory sedation at parent separation, adequate sedation and a favorable recovery profile. The safety profile is good and comparable to adults, with dose-related hemodynamic effects. CONCLUSION: Following the structured approach of the Dutch Pediatric Formulary, best evidence-based dosing recommendations were proposed for dexmedetomidine, used as premedication prior to induction of anesthesia (intranasal dose) and for procedural sedation (intranasal and intravenous dose) in pediatric patients.

Prescribing with indication: uptake of regulations in current practice and patients opinions in the Netherlands.

BACKGROUND: Since January 2012 the Dutch Medicines Act has been changed to enable medication monitoring and counselling for individual patients. Prescribers of medicines are now obliged to record the indication on the prescription of medicines mentioned in this law. OBJECTIVE: To assess patients' opinion about recording of the indication on prescription and to explore the uptake of alterations in the medicines act in clinical practice. METHODS: The study was conducted in a sample of 57 community pharmacies belonging to the Utrecht Pharmacy Practice Network for Education and Research. In total, 528 patients were interviewed in these pharmacies and automated dispensing records were obtained from 22 community pharmacies to check prescriptions for linking of diagnosis codes (indications). RESULTS: For 12.5 % of the prescriptions that required notification of the indication, a diagnosis code was mentioned. For all other medicines, 15.1 % of the prescriptions were provided with diagnosis codes. There was large variation between different drugs. Only 11.7 % of the interviewed patients were familiar with the law. The majority of patients (91.1 %) had no objections with mentioning the indication for use on the prescription. CONCLUSION: Indications are insufficiently mentioned on prescriptions while the majority of patients are generally positive about the law.