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Background: In 2004, the US Food and Drug Administration issued a new rule requiring most prescription and some over-the-counter pharmaceutical products to carry bar codes down to the level of individual doses, with the intent of reducing the number of medication errors. Despite these regulatory changes in the United States, Health Canada has not yet adopted any mandatory bar-coding of drugs. Objective: To evaluate the feasibility of using commercial bar codes for receipt and preparation of drug products and to evaluate the readability of the bar codes printed on various levels of drug packaging. Methods: This cross-sectional observational pilot study was conducted in the Pharmacy Department of a Canadian mother–child university hospital centre in July 2010. For the purposes of the study, research drugs and cytotoxic drugs in various storage areas, as well as locally compounded medications with bar codes generated in house, were excluded. For all other drug products, the presence or absence of bar codes was documented for each level of packaging, along with the trade and generic names, content (i.e., drug product), quantity of doses or level of packaging, therapeutic class (if applicable), type of bar code (1- or 2-dimensional symbology), alphanumeric value contained in the bar code, standard of reference used to generate the alphanumeric value (Universal Product Code [UPC], Global Trade Item Number [GTIN], or unknown), and readability of the bar codes by 2 scanners. Only 33 (1.9%) of the 1734 products evaluated had no bar codes on any level of packaging. Of the 2875 levels of packaging evaluated, 2021 (70.3%) had at least one bar code. Of the 2384 bar codes evaluated, 2353 (98.7%) were linear (1-dimensional) and 31 (1.3%) were 2- dimensional. Well over three-quarters (2112 or 88.6%) of the evaluated bar codes were readable by at least 1 of the 2 scanners used in the study. On the basis of these results, bar-coding could be used for receipt of 80.9% of the drug products at this Canadian hospital and for the preparation and dispensing of 70.1% of the products. Results: O nly 33 (1.9%) of the 1734 products evaluated had no bar codes on any level of packaging. Of the 2875 levels of packaging evaluated, 2021 (70.3%) had at least one bar code. Of the 2384 bar codes evaluated, 2353 (98.7%) were linear (1-dimensional) and 31 (1.3%) were 2- dimensional. Well over three-quarters (2112 or 88.6%) of the evaluated bar codes were readable by at least 1 of the 2 scanners used in the study. Conclusions: On the basis of these results, bar-coding could be used for receipt of 80.9% of the drug products at this Canadian hospital and for the preparation and dispensing of 70.1% of the products. RESUME Contexte : En 2004, la US Food and Drug Administration a mis de l’avant un nouveau reglement exigeant que la plupart des produits pharmaceutiques d’ordonnance et certains produits pharmaceutiques en vente libre portent des codes-barres, y compris les emballages unitaires, dans le but de reduire le nombre d’erreurs de medication. Malgre cette nouvelle reglementation aux Etats-Unis, Sante Canada n’a pas encore adopte un tel reglement au pays. Objectif : Evaluer la faisabilite de l’utilisation de codes-barres commerciaux pour la reception et la preparation des produits pharmaceutiques et la lisibilite des codes-barres imprimes sur differents niveaux de conditionnement. Methodes : Il s’agit d’une etude pilote d’observation transversale menee dans le service de pharmacie d’un centre hospitalier universitaire mere-enfant canadien en juillet 2010. Aux fins de l’etude, les medicaments de recherche et les medicaments cytotoxiques dans diverses aires d’entreposage, de meme que les medicaments prepares sur place, portant des codes-barres maison, ont ete exclus. Pour tous les autres produits pharmaceutiques, la presence ou l’absence de codes-barres a ete constatee pour chaque niveau de conditionnement, de meme que les denominations commerciale et commune, le contenu (c.-a-d. le produit pharmaceutique), la quantite de doses ou le niveau de conditionnement, la classe therapeutique (le cas echeant), le type de code-barres (unidimensionnel ou bidimensionnel), la valeur alphanumerique du code-barres, la norme de reference utilisee pour generer la valeur alphanumerique (code universel des produits [CUP], code article international [ GTIN ] ou inconnue) et la lisibilite des codes-barres au moyen de deux lecteurs differents. Resultats : Seulement 33 (1,9 %) des 1734 produits evalues ne portaient pas de code-barres peu importe le niveau de conditionnement. Des 2875 niveaux de conditionnement evalues, 2021 (70,3 %) portaient au moins un code-barres. Des 2384 codes-barres evalues, 2353 (98,7 %) etaient lineaires (unidimensionnels) et 31 (1,3 %) etaient bidimensionnels. Bien au-dela des trois-quarts (2112 ou 88,6 %) des codes-barres evalues ont pu etre decodes par au moins un des deux lecteurs utilises. Conclusions : Ces resultats montrent que les codes-barres pourraient etre utilises pour la reception de 80,9 % des produits pharmaceutiques dans cet etablissement de sante canadien ainsi que pour la preparation et la distribution de 70,1 % des produits pharmaceutiques. |
