OFF-LABEL PRESCRIPTIONS IN THE NEONATAL INTENSIVE CARE UNIT AT MARSEILLES NORTH HOSPITAL

AE Fagour, M Desbourdes, N Colombini, R Vialet, M Buès-Charbit.
Hôpital Nord, Pharmacy, Marseilles, France; Hôpital Nord, Pediatric ICU, Marseilles, France

Background: the availability of drugs specifi cally assessed for use in neonates is limited as evaluation is more diffi cult in neonates than in adults. The result is a widespread off-label use of drugs, especially in neonatal intensive care units. Such practise is an essential part of their care and should be based on the best available evidence.

Purpose: to describe and analyse the off-label use of medicines in a neonatal intensive care unit.

Materials and methods: prospective observational study conducted over three months, from 27 February 2012 to 27 May 2012. All the drugs prescribed were analysed with regard to their licence status for the: indication, dose, route of administration, mode of administration, age category, formulation (compounding of capsules, oral suspensions, eye drops), contraindications and warnings specified in the summary of product characteristics of the marketing authorization.

Results: in total, 638 prescriptions, comprising 59 different medicines were written, 107 newborn babies were admitted (60 male, 47 female). Their age varied from 0 to 27 days (average: 2 days), their mean gestational age was of 34 weeks of amenorrhea (65% premature), their weight ranged from 630 g to 4700 g (average: 2230 g). A total of 487 prescriptions were written offlabel (76%), with 101 patients (94%) receiving at least one drug used off-label. Drugs were prescribed off-label mostly concerning the indication (48%), then came off-label use for the dose and the age category. The medicine most often prescribed off-label was caffeine citrate.

Conclusions: critically ill neonates are exposed to numerous medicines, a signifi cant proportion of which are not yet approved for use in this vulnerable group of patients. Despite European initiatives aiming to promote greater awareness and research in the paediatric population, there is still a high percentage of unlicensed or off-label drug use in neonatal intensive care. This study underlines the need for clinical research and approval of the clinical data acquired within the neonatal population.

No confl ict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

UNLICENSED AND OFF-LABEL DRUG PRESCRIPTION AT DISCHARGE FROM A SWISS CHILDREN’S HOSPITAL

C Zaugg, J Behringer, M Walther, M Köhler.
Spitalapotheke, Kantonsspital Aarau; Klinik für Kinder und Jugendliche, Kantonsspital Aarau

Introduction: for children, many drugs are used without marketing authorization (“unlicensed”, e.g. imported drugs, drugs prepared by a pharmacy) or outside the terms of marketing authorization (“off-label”). In Switzerland, around half of all prescriptions for paediatric inpatients were either off-label or unlicensed [1].

Purpose: to determine the proportion of unlicensed and off-label prescriptions at discharge, which has not been investigated previously, and the proportion of parents informed about such a prescription.

Materials and methods: prospective study including all discharge prescriptions of inpatients over a two-month period at the Children’s Hospital of Aarau. Exclusion criteria: hospitalisation for chemotherapy only, age over 18, re-entry during study period, no informed consent of parents. At discharge parents were asked to fill in a questionnaire about the information they got on discharge medicines as well as about their satisfaction with this information. This questionnaire was available in German, French, Croatian, Turkish, Albanian, Spanish and English.

Results: during the study period 503 children were discharged, 231 children could be included. Discharge prescriptions were written for 140 children (61%). A total of 227 drugs were prescribed, especially anti-infl ammatory/analgesic, anti-asthmatic and anti-infective drugs. 38.5% of all prescriptions were off-label, regarding dosage in 51%, age in 40% and indication in 9% of all cases. Only 0.5% of drugs were unlicensed. Discharge questionnaires were returned by 103 of 140 children. Most parents (>80%) were informed about purpose, dosage and use of the drugs for their child, and satisfi ed with obtained information, but only 9% of parents getting an off-label/unlicensed prescription for their child were informed about the off-label/unlicensed use.

Conclusions: there is a high percentage of drugs prescribed offlabel at hospital discharge. Most drugs are well known substances and regularly prescribed for children. This emphasises the need toupdate marketing information for older substances, or the need for a national database for drug use and dosage in children.

Reference: 1. Paolo, E et al, 2006. Swiss. Med. WKLY. 136, 218–222.

No conflict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238