The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) convened a Roundtable Meeting in October 2005 entitled, Drug Name Suffixes and Medication Errors: Exploring the Relationship and Minimizing the Risk, to understand and explore the issues associated with the non-standardized use of suffixes in drug names.
Patient safety, pharmaceutical industry, practitioner, provider, regulatory and standards setting perspectives were presented and potential contributing factors and solutions were identified and discussed in service of the following meeting objectives:
Describe the wide array of issues associated with the use of non-standardized drug name suffixes from various stakeholder perspectives. Quantify and specify, to the extent possible, the underlying causes of medication errors arising from non-standardized use of drug name suffixes. Describe short and long-term solutions that will be encompassed in NCC MERP recommendations to reduce medication errors related to the non-standardized use of drug name suffixes.
Errors resulting in patient injury and death continue to occur at a significantly high rate. In 1999, the Institute of Medicine (IOM) published a report, To Err is Human: Building a Safer Health System, calling public attention to the important issue of patient safety. According to the IOM, as many as 98,000 Americans may die annually because of medical mistakes and a significant number of these deaths can be attributed to medication errors. In its 2006 report Preventing Medication Errors, the IOM estimates that more than 1.5 million people are injured by various types of medication errors each year. The 2006 IOM Report also specifically addresses concerns with medication errors and suffixes used in prescription drug names.
Numerous medication errors associated with the use of suffixes in drug names have been reported through various reporting programs including the Food and Drug Administration's (FDA) MedWatch Reporting Program, the United States Pharmacopeia-Institute for Safe Medication Practices' (USP-ISMP) Medication Errors Reporting Program, and the USP's MEDMARX Reporting Program.
Addressing this issue requires a balance between preserving the benefits associated with the use of suffixes (e.g., differentiation of product strength, identification of therapy duration and dosing interval, identification of product characteristics, etc), while minimizing errors associated with confusion, knowledge deficit, and lack of standardized meanings. Medication errors associated with the use of drug-name suffixes have been caused by:
- Confusion resulting from the introduction of a new dosage formulation whose name and strength overlap with an existing drug product's name and or strength (e.g., Drug Name 120mg vs. Drug Name SR 120mg)
Knowledge deficit with respect to the introduction of a modified-release product. Thus, prescriptions are being written with:
- Incorrect dosing interval
- Incorrect dosing frequency
- Incorrect or non-existent suffix
- Omission of a suffix
- Incorrect spelling of the suffix
- Using the suffix alone rather than the complete drug name including the suffix
- Numerous extended-release suffixes and terms used to describe the same dosing frequency or release rate
- Lack of uniformity and proliferation of different suffixes resulting in confusion in identifying the correct drug product.
- Suffixes LA, CR, CD, ER, XL and SR have no standard interpretation that would give a clear meaning to indicate release properties or dosing frequency. In addition, USP defines two categories of modified-release formulations; delayed and extended release. Delayed release denotes a formulation that has a coating to delay release of the drug until the product has passed through the stomach. Extended release denotes any formulation designed to deliver the dose over a longer interval than what is seen in immediate release products.
The following recommendations were developed by the Council based on the input and information derived from the above referenced October, 2005 Roundtable meeting. The Council urges expeditious implementation of these recommendations to promote the safe use of drug-name suffixes.
- Whether in writing or orally, prescribers should always indicate the complete drug name, including the suffix when ordering such medications.
- Pharmacists should call prescribers to clarify prescriptions where the presence or absence of a suffix fails to agree with the prescribed dosing schedule.
- Regulators, standards-setters, and the pharmaceutical industry should encourage practitioners and consumers to report actual and potential medication errors associated with drug-name suffixes.
- Regulators, standards-setters, the pharmaceutical industry, practitioners and consumers should immediately begin work toward developing and disseminating educational tools designed to obviate or minimize the potential for errors associated with drug-name suffixes. Several education-related actions suggested by Roundtable Meeting participants to address this recommendation may be found in Attachment A.
- USP, FDA, and the pharmaceutical industry should collaborate to evaluate the advantages and disadvantages of standardizing the use of drug-name suffixes and define a strategy to address this issue as it applies to prescription and over-the-counter drugs.
- Practitioners should proactively employ processes to evaluate drug products that contain suffixes in the name to determine the potential for errors that could occur in any phase of the medication use process. This evaluation should be completed before these drug products are added to an organization's inventory or formulary.
- FDA and the pharmaceutical industry should systematically evaluate proposed drug product names that contain suffixes to determine the potential for errors that could occur in any phase of the medication use process. This process should be done before these medications are approved for marketing.
- USP, FDA, and the pharmaceutical industry should collaborate to create a current listing of drug names using suffixes and their meanings. The list should be broadly disseminated to stakeholders including government, industry and healthcare providers and routinely updated.
- USP should evaluate the terms immediate release, extended release and delayed release as they apply to marketed products and, through public comment, solicit feedback about ways products could be differentiated for practitioners through naming and labeling..
- USP, FDA and the pharmaceutical industry should collaborate to establish "good naming practices" to improve the safe use of suffixes in drug names. Attachment B. summarizes several points identified by Roundtable meeting participants as important considerations in efforts to establish good naming practices.
The recommendations contained in this report are not a mandate to the healthcare community. It is a first step toward minimizing and perhaps eventually obviating the potential for error when using suffixes in drug names. Hopefully, subsequent efforts will drive toward an ideal future state where drug name suffixes are readily recognized and understood by prescribers and consumers.
The Council acknowledges that there are many benefits associated with using suffixes in drug names and that much work is needed before the issue can be fully addressed and resolved. Many of the suggestions offered above provide a basis for immediate action while others constitute a "call to action" for key stakeholders to collaborate to develop and implement longer term solutions. While prescription drug names were the primary subject of the Roundtable Meeting, the Council recommends that the use of suffixes among over-the-counter medications also be reviewed and considered.
Roundtable Suggestions to Initiate Efforts Associated with Recommendation # 4
Recommendation #4 - "Regulators, standards-setters, the pharmaceutical industry, practitioners and consumers should immediately begin work toward developing and disseminating educational tools designed to obviate or minimize the potential for errors associated with drug-name suffixes."
- The pharmaceutical industry should work with key stakeholders to develop and implement an efficient and effective approach for disseminating and communicating critical information to practitioners when a new dosage form is introduced.
- The FDA, USP and The Joint Commission should immediately disseminate an "Alert" to practitioners and healthcare organizations about the issues associated with the use of suffixes in drug names to raise awareness about suffix related error. Drug-name suffixes that pose a higher risk for patient harm should be emphasized.
- A "drug suffix quick reference tool" should be developed so providers can obtain needed information quickly.
- On-line modules should be designed to educate providers about drug-name suffixes and their meanings.
- Pharmacists should take the lead to educate all practitioner groups (pharmacists, physicians, nurses) to the potential of drug-name suffix confusion.
- Practitioners should proactively educate patients about the use and meaning of drug-name suffixes in order to reduce medication errors.
- FDA should add a column in the "Orange Book" to include the drug-name suffix's intended meaning.
- Professional associations should develop safe practices guidelines relating to medications that incorporate the use of suffixes for use/implementation by healthcare organizations (e.g., through the pharmacy and therapeutics committee) to help prevent associated errors.
Roundtable Suggestions to Initiate Efforts Associated with Recommendation # 10
Recommendation #10 - "USP, FDA and the pharmaceutical industry should collaborate to establish "good naming practices" to improve the safe use of suffixes in drug names. Attachment B summarizes several points identified by Roundtable meeting participants as important considerations in efforts to establish good naming practices."
- A description should be provided that clearly conveys the meaning of the suffix to healthcare practitioners and patients.
- The intended meaning of the suffix should be explained in the package insert and/or on the drug label.
- Consideration should be given to the types of errors that may occur if the suffix was omitted from the prescription.
- The suffix should be easily understood whether communicated verbally or in writing.
- The suffix meaning should be evaluated as appropriate.
- For potential new drug products in development, consideration should be given to the existing products of its kind. Where names and/or strengths overlap, the potential for confusion and error should be considered and addressed---confusion cannot be minimized if these characteristics overlap.
- Consideration should be given to the existing product line and where names and/or strengths overlap (e.g., Drug Name 5mg vs. Drug Name SR 5mg), the potential for confusion and error be considered and addressed.
- The suffix should not contribute to medication errors (e.g., sound-alike and look-alike errors) and may warrant careful evaluation with the intended audiences, including healthcare practitioners and consumers, during the drug name development phase.
- The suffix should be clear, distinctive and not easily confused with medical abbreviations, acronyms, dosing intervals, etc.
- The suffix should not have more than one meaning (i.e., each suffix should have a single and unique meaning).
- Complex suffixes (e.g., Depo-subq Provera 104) should be avoided where possible.
- A standard nomenclature about release rates should be defined.
- Electronic health records systems, (e.g., Medication administrations systems, pharmacy systems, computerized prescriber order entry systems, etc.) should include specific definitions, prompts and/or warnings about suffixes on a drug-specific basis.
Actions/Decisions are those of the Council as a whole and may not reflect the views/positions of individual member organizations.