Accuracy and availability of key information inpackage inserts of medicines used in Sri Lanka

Abstract

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Introduction Package inserts (Pis) provide information about medicines to health professionals. Incomplete or inaccurate information may lead to medication errors. Objectives Aim of the study was to assess the accuracy and availability of key information in Pis of medicines used in Sri Lanka. Method Two samples of 100 Pis each were used to assess availability and accuracy of information respectively. Pis were randomly selected from a government hospital and a private pharmacy. Availability of essential information was checked against criteria specified in the regulations of the Cosmetics, Devices and Drugs (CDDA) Act No. 27 of 1980.Clinical facts in Pis were matched against the British National Formulary and/or Australian Medicines Handbook for accuracy. Pis were categorized as 'compatible' when information was identical, 'partially compatible' if there was at least one mismatch, and 'not compatible' if completely unmatched against references. Results Nine types of clinical information (Indication/s, contraindications, precautions, adverse effects, drug interactions, average dose, dose regimen for adult/child, dosing interval and average duration of treatment) were matched with the reference in 100 Pis, resulting in 900 cross-matches. Among them, 61 incompatibilities and 179 partial compatibilities were identified. Contraindications (16%) and precautions (11%) had the highest percentage of incompatibilities. 82% of Pis had at least one deviation from the CDDA regulations. The most frequently missing information was pharmacokinetic data, duration of treatment, overdose, and dosage information in special situations. Conclusions Information provided in Pis is inadequate and not completely accurate. Regulatory authorities need to urgently and continuously review Pis prepared by drug manufacturers.