Safety of computerized drug management: a case report

A previously healthy French-born 13-month-old ethnically African girl, weighing 10 kg, travelled to Comoros (South-East Africa) on 10 July. Her family history was notable for an autistic brother and two other brothers in good health. Her parents are of African origin and are not related. She was prescribed pyrimethamine, 50 mg once daily (adult dosage), as an antimalaria chemoprophylaxis by her physician prior to this first visit to Comoros. Her parents supervised administration of this medication and stated that she missed no dose.

On 23 July, she presented to a clinic in Comoros with hyperthermia and generalized clonic seizures, continuous for the first 5–6 h and then intermittent for 24 h. She was admitted to the intensive care unit in Comoros where she was treated for presumed cerebral malaria with intravenous quinine despite a negative malaria test. During the next 15 days, she had many recurrent crises, with continued confusion and digestive problems. Her fever abated on 31 August. She was brought back to France and hospitalized in the Department of Paediatric Neurology (Hôpital Debrousse-Lyon-France). Search for Plasmodium and other microorganisms in the blood and in cerebral fluid were negative. She was discharged on 5 September with severe persistent neurological deficits. Cerebral magnetic resonance imaging performed on 6 September showed cortical and subcortical atrophy, and electroencephalograms showed the persistence of disturbed basic cortical activity.

This adverse event was reported to the Lyon Pharmacovigilance Centre. A computerized prescribing error was suspected because the prescription was not handwritten. The prescribing physician, interviewed by telephone, confirmed that she has used Medigest, a drug management software.

The principal indication for pyrimethamine in children is congenital toxoplasmosis, administered at a dose of 1 mg kg⁻¹ day⁻¹. Adverse effects occur with doses >20 mg kg⁻¹ or with a recurrent dose >5 mg kg⁻¹ day⁻¹[1]. Seizures, coma and blindness have been reported [1–5]. Because of the high risk of severe neurological consequences and also Plasmodium resistance, pyrimethamine is no longer appropriate for the chemoprophylaxis of malaria [6].

In this case, the prescribing physician searched the drug management software (Medigest) for the indication of malaria prophylaxis by entering ‘Mal’. When we searched the same computerized system for ‘Mal’, pyrimethamine and atovaquone-proguanil displayed next to each other. We first selected pyrimethamine with a default adult dosage. There was no alert indicating that pyrimethamine is no longer prescribed alone as a chemoprophlaxis for malaria. When the patient’s characteristics and the disease (presumed P. falciparum) were entered we were alerted that ‘the 50 mg tablet is only to be prescribed for adults’.

The use of information technology (IT) in routine clinical care has been promoted in Europe and the USA to improve patient safety and practice efficiency [7]. IT has been shown to reduce medical errors and improve the quality of healthcare in certain circumstances [8]. However, error reduction and improved patient safety cannot be achieved if prescribing errors are not addressed [9].

Many computerized order entry programs lack efficient alert systems to avoid overdoses, allergies, drug–drug interactions and contraindications or drugs unlaballed or unauthorized in children. IT solutions should provide physicians with reminders and alerts for evidence-based preventive care and disease management based on patient-specific drug, disease, and therapeutic information [9].