Lilly takes bar coding to unit dose level for insulin
include individual vials of its insulin products, going beyond the
requirements of recent labelling legislation aimed at cutting
medication errors.
The move ties in with new regulations implemented by the US Food and Drug Administration (FDA) last year that pharmaceutical companies should bar code all drugs dispensed in hospitals, with the aim of reducing errors by 50 per cent. It estimated at the time that the move would result in 413,000 fewer adverse events over the next 20 years, and that the annual cost benefit from preventing adverse events due to medication errors would be $3.9bn (€3.2bn).
Lilly's action goes beyond the requirement for on-pack bar codes, as mandated by the FDA, as it is the first time that bar codes are being included on the individual vial labels.
This answers one of the primary criticisms of the US bar code legislation - that it does not tackle the issue of drugs being taken out of their original packaging before delivery to the patient e.g. tablets taken out of a stock bottle and brought to the patient's bedside in a plastic cup.
For insulin products, which have the highest rates of errors in a hospital setting according to a US Pharmacopeia study published in 2003, on-vial bar codes have the potential to be a real advance as the vials are usually removed from outer packaging. US patient groups, including the Senior Med Alliance, have been campaigning to require that all insulin products have on-vial bar codes by law.
"Insulin is a life-saving medication for so many patients, so it's disheartening to see that it can be involved in errors," said Scott Jacober, medical advisor at Lilly. "Much of this can be attributed to the high volume of insulin used in a hospital setting and the complexity of hospital medication orders for insulin."
The system is designed to work as follows: patients are given identification bracelets on which their personal bar codes are imprinted. When a nurse or other provider prepares to administer a medication, they scan both the drug and patient's bar code and compares them to verify dose, time, and route of administration. According to FDA, the Veterans Administration tested this system, and 5.7 million doses of medication were administered with no errors.
The FDA's legislation came into effect in April 2004 and required that all new pharmaceuticals to be bar coded upon launch in the marketplace and all existing medications be bar coded within two years of the ruling. Lilly completed its bar coding of insulin vials 18 months before the FDA's deadline.
The company said that meeting the FDA's targets on medication errors would save a massive $93 billion in additional health care costs, patient pain and suffering and lost wages.
