Yvonnick Bezie

Off-label prescribing in a French hospital

ObjectiveIn contrast to paediatrics patients, data concerning the extent of off-label prescribing for adult patients are limited. The aim of our study was to investigate the frequency of off-label drug use for adult patients in a French general hospital.MethodThe study was conducted on a Wednesday in November 2004. Prescribing was prospectively assessed on the basis of conformity with the marketing authorizations.ResultsA total of 1341 prescriptions for 192 hospitalized patients were analysed. Twenty three per cent of the prescriptions were off-label. Among all patients, 70% received at least one off-label medicine. Most off-label prescriptions were related to an unapproved indication (75%). The main other reasons were dosage (14%) and dosing schedule (9%). Anti-thrombotic and anti-ulcer agents were found on more than 40% of the off-label prescriptions.ConclusionOff-label prescriptions occur frequently in the hospital and often alternatives with the proper marketing authorizations are available. An increased involvement of hospital pharmacists should reduce the incidence of off-label prescribing and thus contribute to patient safety and possibly cost reduction.

Surgery in a patient allergic to ethylene oxide

To the editor—Ethylene oxide (EO), an alkylating compound of high chemical reactivity, is widely used as a sterilisation gas for various medical devices (MD) that are heat-sensitive. This type of sterilisation can cause rare but severe allergic reactions in sensitive patients. Allergic manifestations such as hives/rash, asthma or anaphylactic shock have been noted among patients in repeated contact with EO-sterilised MD. Widespread hypersensitivity to EO has also been documented in numerous dialysis patients [1, 2]. Allergic reactions to EO-treated products have also been described in several children with spina bifida [3]. The high prevalence of sensitisation to EO, and the frequency, unpredictability, and potential danger of anaphylactic reactions to EO have led to the conclusion that EO sterilisation of dialyzers should be discontinued, since alternative modalities of sterilisation are currently available. However, in spite of the progressive desorption of EO after prolonged storage times, residual EO is still detectable in the milligram range. Even though intraoperative rinsing with physiological saline reduced the residual level of EO [4, 5], this approach has not been validated and so safety cannot be guaranteed for the sensitive/allergic patient. This account describes the case of a patient (born 1983) suffering from myelomeningocele (spina bifida cystica) with an Arnold–Chiari malformation; the patient underwent major surgery on several occasions. During minor surgery in 1996 to treat bedsores, the patient developed a rash with complications—Quincke’s oedema. RAST measurement of the specific IgE revealed a level-4 allergy to EO, and the absence of allergy to latex. In 1997 an operation to decompress the occipital hole was planned. Benzalkonium chloride was used to prepare the patient’s skin. Anaesthetic induction was performed with inhaled sevoflurane (Sevorane) followed by injections of thiopental (Nesdonal), sufentanyl (Sufenta) and vecuronium bromide (Norcuron). The anaesthetic was maintained by isoflurane (Isoflurane) and continual perfusion of sufentanyl. Perfusion of hydroxyethylamidon (Elohes) was commenced 15 min after anaesthetic induction to moderate hypotension. After 25 min a silicone urinary catheter was placed with latex gloves. A pubic rash then appeared; it became general, and was rapidly followed by cardiovascular collapse. Hemodynamics were restored by continuous adrenaline perfusion. Plasma measurements of histamine and tryptase confirmed anaphylactic shock. Specific IgE measurements of the products used during the induction and maintenance of the anaesthetic were undertaken. The results were negative and therefore did not favour allergic reactions to the anaesthetics and narcotics. Based on these results, and given the chronology of events, V. Demontoux E. Moreau I. Peyron V. Talon Y. Bézie (&) Pharmacy Department, Groupe Hospitalier Paris Saint-Joseph, 185 rue R Losserand, Paris 75014, France e-mail: ybezie@hpsj.fr

Complete Atrioventricular Block in an Elderly Patient Treated with Low-Dose Lacosamide

Lacosamide, one of the last antiepileptic drugs marketed, can cause extension of PR interval. Precautions are recommended when used in elderly and with other drugs extending PR interval. Cases of severe third-degree atrioventricular block have been reported only in post-marketing case reports when used at high-doses and remain rare. We report the case of an 88-year-old woman treated with bisoprolol, who experienced a complete atrioventricular block after initiation of lacosamide for epilepsy associated with neurodegenerative disease. This dramatic event required a pacemaker implementation. Not being dose-dependent (initiation dosage used), it seemed partially explained by drug–drug interaction with bisoprolol.