Medical Device Link.

Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published October 2000

OUR VIEW

Using Packaging and Labeling to Reduce Errors

Medication errors linked to poor labeling and packaging can be controlled through the use of error potential analysis.

Daily, physicians, nurses, and pharmacists base medical decisions on the information provided by a drug product's labeling and packaging. Unfortunately, poor labeling and packaging have been linked all too often to possible causes of medication errors. To help practitioners avoid errors, drug manufacturers should present information in a clear manner that can be grasped quickly and easily.

To determine what presentation is most clear, manufacturers should invite and consider the input of physicians, nurses, and pharmacists, because they work with these products every day and are more likely than label and package designers to discover potential problems. Such input provides the basis for failure modes and effects analysis (FMEA), also known as error potential analysis or error prevention analysis.

FMEA is a systematic process that can predict how and where systems might fail. Using FMEA, healthcare practitioners examine a product's packaging or labeling in order to identify all the ways in which it might fail. Drug manufacturers can then craft product tests based on the practitioners' opinions and answers to questionnaires, direct observation, and open discussion.

A number of steps to reduce confusion and improve the readability of a drug product's label have already been determined through the use of FMEA.

The first step is to reduce label clutter. Bars, stripes and other visual devices hinder the readability of important product information. Only essential information, such as the brand and generic names, strength or concentration, and warnings, should appear prominently on the front label. Nonessential information should be placed on the label's side panel or bottom.

Adding reminders and warnings to a drug product's label is the next step. Numerous deaths have been prevented through the addition of a warning to concentrated vials of injectable potassium chloride, for example. Its label contains a boxed warning that reinforces the need for dilution.

Another step includes the use of typeface to enhance distinctive portions of look-alike drug names on look-alike packaging. For example, Bristol-Myers Squibb's Platinol-AQ (cisplatin injection) was easily confused with Paraplatin (carboplatin) because of their similar drug names. This posed a significant problem because appropriate doses of carboplatin usually exceed the maximum dose of cisplatin, and severe toxicity and death are associated with a cisplatin overdose. As a result, several changes in the labeling and packaging of cisplatin were approved by FDA.

Medication errors are also associated with poor product packaging design. Manufacturers should use FMEA during the design process to prevent such tragic mistakes as the overdoses (at least 29 cases) of Brevibloc (esmolol) that have been reported since the drug became available in the mid-1980s. These overdoses occurred because of the use of a 2.5-g ampule instead of a 100-mg vial in preparation of a loading dose. Ampules are usually used in the preparation of loading doses of drugs because they are single-use containers, while vials are typically used to hold multiple doses. However, this is opposite to the way Brevibloc is packaged. To help prevent confusion, the company sends warning stickers, for adherence to the ampule, which warn practitioners that the 2.5 g contained in the ampule must be diluted before administration.

Unfortunately, medication errors linked to poor labeling and packaging are quite common. Manufacturers should consider how drug packaging and labeling will be used in the healthcare environment and seek the expertise of healthcare practitioners during the design phase.

Medical Error Recognition and Revision Strategies (Med-E.R.R.S.) is a for-profit subsidiary that is wholly owned by the Institute for Safe Medication Practices, a nonprofit organization. Med-E.R.R.S. provides a way for pharmaceutical companies to reveal possible design flaws in product labeling, packaging, and nomenclature. The methods incorporate confidential assessments by healthcare practitioners and experts in medication error prevention. For more information, contact Med-E.R.R.S. at 1800 Byberry Rd., Ste. 810, Huntingdon Valley, PA 19006; phone: 215/947-7797; fax: 215/914-1492; e-mail:sproulx@ismp.org; Web site: http://www.ismp.org.