The Standardization of Expiration-Date Labels
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《新英格兰医药杂志》
To the Editor: Although the Food and Drug Administration (FDA) requires certain medical products to be labeled with expiration dates and important information about use, there are variations among the standards it endorses for the visual presentation of such details. In an industry in which safe and reliable patient care is paramount, compliance with guidelines for inventory management should be made as simple as possible; this not only will reduce administrative costs and burdens but also is likely to enhance the quality of patient care. The standardization of expiration-date labels will help facilitate compliance with the guidelines endorsed by governing or regulatory organizations such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Centers for Medicare and Medicaid Services (CMS). There needs to be a cohesive set of standards for product labels that spans governing bodies and serves to reinforce, rather than undermine, the safe provision of patient care.
In comparing a variety of medical products, one could easily identify discrepancies in expiration-date labels. Dates are represented in different formats — mm/dd/yyyy, yyyy/mm, mm/yy/dd — or with "N/A" (not applicable). Manufacture dates and expiration dates are sometimes indistinguishable, even when supplemented with symbols or words. Manufacturers producing the same product, such as syringes, vary in whether they include expiration dates on that product and in whether they indicate that there is no expiration date, if that is the case. Finally, dates can appear anywhere on the product, making it burdensome for people to oversee inventory or to administer medication. Such challenges create opportunities for error that could be mitigated if standard labeling requirements were in place.
In 1999, recognizing the prevalence of medication errors and the importance of comprehensible labels, the FDA instituted a new "drug facts" label, which presents product information in a uniform fashion. Although the FDA has applied the drug facts label to over-the-counter medications, the label has not yet been applied to prescription drugs, biologic products, devices, and general medical and surgical supplies.
One longer-term solution may be bar-code technology, which could result in tighter control over inventory and help to prevent the distribution and usage of expired medications. However, the FDA's current ruling requires bar codes to include the national drug code but not necessarily expiration dates.
In the spirit of facilitating compliance, the FDA and other influential organizations such as CMS and JCAHO should collaborate to standardize product labels. Doing so will aid the effective and efficient management of inventory, which is essential for reinforcing the safe provision of patient care.
Sharon Itzchaki, B.A.
New York–Presbyterian Hospital
New York, NY 10032
Eliot Lazar, M.D., M.B.A.
New York–Presbyterian Healthcare Systems
New York, NY 10021
Emme Deland, M.B.A.
New York–Presbyterian Hospital
New York, NY 10032
In comparing a variety of medical products, one could easily identify discrepancies in expiration-date labels. Dates are represented in different formats — mm/dd/yyyy, yyyy/mm, mm/yy/dd — or with "N/A" (not applicable). Manufacture dates and expiration dates are sometimes indistinguishable, even when supplemented with symbols or words. Manufacturers producing the same product, such as syringes, vary in whether they include expiration dates on that product and in whether they indicate that there is no expiration date, if that is the case. Finally, dates can appear anywhere on the product, making it burdensome for people to oversee inventory or to administer medication. Such challenges create opportunities for error that could be mitigated if standard labeling requirements were in place.
In 1999, recognizing the prevalence of medication errors and the importance of comprehensible labels, the FDA instituted a new "drug facts" label, which presents product information in a uniform fashion. Although the FDA has applied the drug facts label to over-the-counter medications, the label has not yet been applied to prescription drugs, biologic products, devices, and general medical and surgical supplies.
One longer-term solution may be bar-code technology, which could result in tighter control over inventory and help to prevent the distribution and usage of expired medications. However, the FDA's current ruling requires bar codes to include the national drug code but not necessarily expiration dates.
In the spirit of facilitating compliance, the FDA and other influential organizations such as CMS and JCAHO should collaborate to standardize product labels. Doing so will aid the effective and efficient management of inventory, which is essential for reinforcing the safe provision of patient care.
Sharon Itzchaki, B.A.
New York–Presbyterian Hospital
New York, NY 10032
Eliot Lazar, M.D., M.B.A.
New York–Presbyterian Healthcare Systems
New York, NY 10021
Emme Deland, M.B.A.
New York–Presbyterian Hospital
New York, NY 10032