Progress with preventing name confusion errors
From the August 9, 2007 issue
The August 9, 2007, issue of the New England Journal of Medicine contains a book review of Medication Errors, a 2007 American Pharmacists Association publication written by ISMP staff and invited experts, and the 2006 Institute of Medicine (IOM) report, Preventing Medication Errors. The reviewer wrote: "...filling a handwritten prescription could be the most dangerous of all medical procedures."
It's a timely message, as ISMP knows well that handwritten prescriptions combined with look-alike drug names are among the most risky conditions associated with medication use. Running closely behind is the combination of verbal orders and sound-alike drug names. In Pennsylvania, one in ten medication errors submitted to the state's reporting program is associated with providing the wrong drug to a patient; of those, one in three is due to confusion between medications with similar names.(1) The same findings have been reported for errors submitted to the United States Pharmacopoeia (USP)-ISMP Medication Errors Reporting Program.(2) With thousands of medications—most with both generic and brand names—on the market in the United States (US), it is easy to understand why mix-ups occur. The challenge to create new drug names that are not similar to existing drug names is great. Factor in handwritten orders—unfortunately still the norm in healthcare—and suddenly, the ability to differentiate between similar drug names poses an enormous challenge to the healthcare practitioner.
Managing the risks associated with name similarity is an industry wide obligation. It begins with the regulatory agencies and pharmaceutical companies when generic and/or brand names are selected, and spans the entire healthcare continuum, from practitioners to consumers. Below we offer a brief glimpse at what is being done in the US to reduce the risk of look- and sound-alike drug names, along with additional steps that regulatory agencies, pharmaceutical companies, healthcare organizations, practitioners, and consumers should take to continue our efforts.
Regulatory agencies and pharmaceutical companies
When a newly marketed product turns out to have a name that is confused with an existing drug with a similar name, it may be tempting to believe that FDA and pharmaceutical companies are not doing enough to prevent drug name mix-ups. But, in recent years, there has been an increasing effort on the part of FDA and manufacturers to select and approve drug names that have been evaluated for safety. For instance, most major pharmaceutical companies currently use external safety testing companies to evaluate risks associated with potential trademarks (brand names) before launching new drugs. Unfortunately, many of the smaller pharmaceutical and biotech companies, and generic manufacturers and distributors have not yet adopted this practice. Occasionally, some of the larger companies that have had their trademarks evaluated do not follow the recommendations of a safety evaluation, downplaying the potential risk of an error and patient harm. Still, FDA evaluates all drug names presented for approval using an internal advisory committee and a computer software program known as POCA (phonetic and orthographic computer analysis).
Following a 2003 public meeting on drug name similarities jointly sponsored by FDA, ISMP, and the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry drafted Good Naming Practices. This effort, which has not yet been formally presented to FDA for endorsement, represents an industry commitment to drug name safety, and promising results are expected. PhRMA has also funded a current project headed by ISMP to catalog all drug name suffixes and associated meanings, which will be widely available as a reference for healthcare practitioners and consumers.
Additional steps for regulatory agencies and pharmaceutical companies
- FDA should require all pharmaceutical companies to use an external, unbiased source for evaluating new trademarks, which includes input from practitioners who work in the areas where the drug will most likely be prescribed, stored, dispensed, and administered. The drug name evaluation report should be provided to FDA when the company requests trademark approval.
- Companies should consistently accept the findings from external name evaluation companies to avoid potentially harmful mix-ups. Likewise, FDA authorities that grant final market approval to a new drug should give serious consideration to the recommendations from external name evaluation companies as well as the FDA’s own internal advisory committee.
- FDA, USP, and the United States Adopted Names (USAN) Council should work with PhRMA and other stakeholders to develop a standard evaluation method for nonproprietary names, to be employed at a specified point in their development.
- FDA approval should be required for all new trademarks for drugs, including trademarks used for over-the-counter (OTC) products. (A loophole in the Code of Federal Regulations allows companies to market some designated products without FDA approval of the product names.)
- The USP should provide a basis for some level of standardization of drug-name suffixes and associated drug release rates.
FDA should require companies to develop a risk management program that includes a name change provision for newer trademarks if post-marketing surveillance (including error reports) shows harmful or potentially harmful confusion with an existing brand or generic name.
- The USAN Council should remain open to changing the generic name of a product if post-marketing surveillance (including error reports) shows harmful or potentially harmful confusion with another generic drug name.
Organizations, practitioners, and consumers
The Joint Commission's National Patient Safety Goal (NPSG) 3(c) requires accredited organizations to identify a list of look- and sound-alike drugs and to take action to prevent mix-ups among these drugs. While the latest Joint Commission statistics for this goal cite a 92% compliance rate, data from error-reporting programs indicate that drug name mix-ups are still common, even in accredited facilities. This may indicate that practitioners and organizations are not implementing the most effective risk-reduction strategies. One observer recently expressed concern that many organizations seem to simply rely on warning stickers to reduce the risk of mix-ups, when more effective measures are available and needed.
Healthcare providers without Joint Commission accreditation, such as community pharmacies, may not be familiar with risk-reduction strategies related to look- and sound-alike drug names. Additionally, managing risks associated with look- and sound-alike drug names proved to be a low-scoring category in both the 2000 and 2004 ISMP Medication Safety Self Assessment for Hospitals. Similar results were found with an ISMP community pharmacy self-assessment tool.
Additional steps for organizations, practitioners, and patients
- Maintain awareness of look- and sound-alike drug names as published by safety agencies, and provide updated information to professional staff regularly.
- Identify a discrete list of look- and sound-alike drug names that may be problematic in your organization. A list of potentially harmful, problematic name pairs specific to different healthcare settings can be found at: www.jointcommission.org/NR/rdonlyres/C92AAB3F-A9BD-431C-8628-11DD2D1D53CC/0/LASA.pdf. ISMP Quarterly Action Agendas, internal error reports, and staff brainstorming sessions may also yield examples of similar drug name pairs that should be targeted for action. Ensure that clinicians are aware of the name pairs targeted for action and the steps that should be taken to reduce confusion.
- The Joint Commission should further specify in its NPSG 3(c) how organizations should choose targeted name pairs, update the list, and monitor the medication-use process to determine if their risk-reduction efforts are successful.
- Prescribers should specify the dosage form, drug strength, complete directions, and purpose of medications on prescriptions and orders to help differentiate drugs with look-alike names. Pharmacists and nurses should match the drug’s indication to the patient’s condition before dispensing or administering it.
- Implement electronic prescribing to reduce the risk of mix-ups stemming from handwritten orders. When warranted for a particularly problematic drug name pair, install a computerized alert as a reminder during prescription processing.
- Use preprinted orders or prescriptions if electronic prescribing is not available.
- Use verbal or telephone orders only when absolutely necessary and never for chemotherapy. If used, verbal or telephone orders should be documented on the patient's record and read back, spelling the drug name and stating its indication.
- Use both brand and generic names when prescribing drug name pairs known to be similar. Also, list brand and generic names for problematic name pairs on medication administration records (MARs) and automated dispensing cabinet (ADC) computer screens.
- Change the appearance of look-alike product names on computer screens, storage areas (including ADCs), pharmacy product labels, and MARs using bold face, color, or tall man letters for the parts of the names that are different (e.g., hydrOXYzine, hydrALAzine). Configure all computer screens to prevent look-alike drug name pairs from appearing consecutively.
- Store products with look-alike names in different locations. Use shelf stickers to help locate products that have been moved.
- Alert patients to the potential for mix-ups with known, problematic drug names.
- Encourage patients to question nurses or pharmacists about medications that look or sound different than expected.
- Require mandatory counseling in outpatient settings before dispensing one of the drugs from a problematic name pair.
- Explore and implement drug-specific risk-reduction strategies for problematic name pairs. For example, stock a different strength of morphine (2 mg/mL) and hydromorphone (1 mg/mL) to reduce the risk of confusion. (Visit the URL in the first bulleted item in this section for more examples.)
- Consider the risk of name confusion when adding a new drug to the formulary.
- Encourage reporting of actual and potential errors with look- and sound-alike product names, and use the information to establish error-reduction strategies.
To further national efforts to manage drug name confusion, ISMP will be hosting an invitational summit on October 9-10, 2007, in Philadelphia. This meeting will bring together a full range of pharmacy professionals and representatives from standard-setting organizations, regulatory agencies, the pharmaceutical industry, and the payer community. During the meeting, ISMP will discuss post-marketing strategies to identify and reduce name confusion and ways to improve upon their scope and effectiveness. ISMP believes that the healthcare industry can significantly reduce the risk to patients from otherwise preventable product mix-ups due to look- and sound-alike names.
References: 1) Pennsylvania Patient Safety Authority. Medication errors linked to drug name confusion. Patient Safety Advisory 2004; 1(4):1-3. 2) Smetzer JL, Cohen MR. Medication error reporting systems. In Cohen MR, ed. Medication Errors, 2nd ed. 2007; Washington, DC: American Pharmacists Association.