M. Ruano Encinar

OHP-042 Impact of the Paediatric Regulation on the environment of paediatric medicines use: paediatric investigation versus off-label drug use

Background In 2006, the European Parliament approved paediatric standards (Paediatric Regulation 1901/2006) in order to stimulate the development of paediatric clinical trials (PCT) reducing off-label drug use (ODU). Purpose To evaluate the variation in PCT and ODU in children over the last 6 years since this paediatric regulation came into force. We also analysed the type of PCT and characteristics of drugs involved in PCTs or prescribed in conditions that they are not approved (off label). Materials and methods Observational retrospective study in a 252-bed children’s hospital which forms part of a tertiary hospital. The main outcome measured was the number of PCT carried out per year and ODU per year (from 2007 to 2012). Furthermore, PCT design, type of drugs used in both conditions (experimental and off-label), and reasons for off-label use according to the summary of product characteristics were assessed as well. Results We analysed 87 drugs involved in PCT and 449 non-investigational drugs, of which 117 (26%) were considered off-label prescriptions. We observed an increase in PCT carried out per year from 9 in 2007 to 23 in 2011, reaching 19.3% of total clinical trials performed in our centre. Off-label drug use remained stable over the study period. The most common type of PCT design was phase III non-randomised open-label (27.6%). Concerning the drugs involved, antibiotics and antineoplastic-immunosuppressant agents were the most common drugs investigated in PCT, while off-label prescriptions mainly involved hypnotics-sedatives and anticoagulants. Most cases of these off-label prescriptions were related to the lack of studies. Conclusions Since January 2007 when the paediatric regulations came into force in the European Union, an increase of PCT performed has been detected in our centre. However, this fact has not affected off-label drug use which has not changed mainly due to a lack of research into drugs in children. No conflict of interest.

GRP-143 Potassium Monitoring: Do We Give It the Attention It Deserves?

Background Potassium (K+) is the principal intracellular cation and is essential to maintain the function of multiple organs. It is a critical component of cardiac conduction and has a narrow therapeutic/toxic range. Purpose To investigate the effect of pharmaceutical intervention through computerised prescription order entry (CPOE) in hospitalised patients with K+ disorders. Materials and Methods Prospective study carried out over 7 weeks. Pharmacists first added information about drugs that affect the K+ level as a support in the prescription programme. We then identified patients with abnormal K+ levels using a link with laboratory data (<3.1 and >5.3 mmol/l). Pharmacists reviewed the pharmacotherapy daily in order to detect possible medication errors related to K+ disorders. Lastly we analysed the effect of pharmaceutical recommendations and physician acceptance rate. Results 183 patients were included (67 ± 17 years old on average), 128 patients (69.9%) with hypokalaemia and 55 (30.1%) with hyperkalaemia. A total of 3,380 electronic prescriptions were selected. Of them, 540 (16.0%) could affect K+ levels mainly through furosemide, piperacillin-tazobactam and meropenem; pharmacists checked 383 orders thoroughly to prevent possible medication errors. 232 (60.6%) required pharmaceutical recommendations, 130 of them (56.0%) were related to optimising K+ therapy in hypokalaemic patients and 35 (15.0%) were safety recommendations for closer monitoring. Clinicians accepted 72.4% of recommendations. Conclusions There is a high rate of prescription errors related to K+ disorders that could jeopardise patient safety. Pharmaceutical intervention through CPOE helps to minimise them and increases physician awareness of the necessity of closer K+ monitoring in these patients. No conflict of interest.