Proposed HCFA rule may cause increase in medication errors

From the January 28, 1998 issue

In the December 19, 1997, issue of the Federal Register, HCFA published a proposed rule for conditions of participation (COP) that hospitals must meet to participate in Medicare and Medicaid programs. Reducing adverse drug events (ADEs) is the predominant focus of the conditions specific to "Pharmaceutical Services," and at first glance, the underlying concepts are encouraging. Adopting "requirements that integrate drug therapy services and support a coordination of services by the various disciplines that provide them" is a powerful theme to support HCFA's goal of reducing ADEs. However, many of the requirements proposed for achieving this goal are flawed, and, in reality, may produce the opposite result: a potentially dangerous medication use process. We are concerned primarily with the standards for adverse drug event monitoring and some of the proposed deletions to the rule.

The proposed rule requires hospitals to establish a "safety net" that detects medication errors, provides comprehensive drug information, and relies on only one discipline, nursing, to assure accuracy through all phases of the medication use process. To measure the success of this "safety net," HCFA has proposed a 2% medication error rate with "zero tolerance" for significant medication errors. Hospitals that do not achieve this goal will be subjected to sanctions. How errors are detected and how error rates are calculated are not discussed in the rule. In long term care, HCFA surveyors perform observational studies to determine a medication error rate. This method yields little useful data because it is a static snapshot of medication use focused only on medication administration. Prescribing errors go undetected, as do significant errors that occur infrequently. The alternative is to determine error rates from voluntary reports. However, if hospitals use a voluntary reporting method to report their error rate to HCFA, fear of losing Medicare and Medicaid reimbursement could lead to underreporting of errors, especially significant errors. Also, setting a national standard for a medication error rate perpetuates the myth that quality and safety of the medication use process can be gauged by comparing error rates with other institutions; however, that is not possible as long as each institution defines, measures and reports errors differently.

In addition, HCFA proposes to "delete a number of narrowly focused, structure and process-oriented requirements." Requirements defining the pharmacists' role have been deleted, including drug preparation and dispensing oversight, thus removing all reference to pharmacists in the standards. By deleting these standards, HCFA implies that the pharmacist is not an important participant in the medication use process, and it places the burden of safe medication practices solely on nurses. Nurses may be required to compound and package drugs, and prepare complicated intravenous admixtures, such as total parenteral nutrition (TPN). Hospitals may be able to meet the COP without having a single pharmacist on staff or available on a consulting basis!

While ISMP supports HCFA's goal of reducing ADEs in hospitals, our concern is that the proposed rule will actually work in opposition to this goal, and even unravel successful ADE reduction efforts already in place. Obtain a copy of the December 19, 1997, issue of the Federal Register from your Medical Library and read the proposed revisions, specifically the COP for "Pharmaceutical Services" (pp. 66737-66740 and 66757). You can support our concerns by submitting your comments (one original and three copies) to the following address: HCFA, Department of Health and Human Services, Attn: HCFA-3745-P, P.O. Box 7517, Baltimore, MD 21207-0517. Comments must be received by HCFA no later than February 17, 1998. For reference, you can request by fax our detailed comments to HCFA on the proposed rule. We will mail you a copy if you fax your address to fax number 215 357 7024.