Survey: Hospitals improving medication safety practices

America’s hospitals are making improvements in the area of medication safety practices, according to recently released data from a survey developed by the Institute for Safe Medication Practices (ISMP) in Huntingdon Valley, PA.

Results from the ISMP’s 2004 Medication Safety Self-Assessment show significant advances in many safety practices, when compared to the initial assessment, which was completed in 2000. The self-assessments, conducted by ISMP in partnership with the Health Research and Educational Trust (HRET) and the American Hospital Association (AHA) through a grant by the Commonwealth Fund, allow U.S. hospitals to gauge their use of nearly 200 practices that most significantly influence safe medication use and compare their current systems and practices to similar hospitals nationwide. More than 1,600 hospitals participated in the 2004 assessment, many of which were able to chart their progress over the last four years by comparing results with their responses to the 2000 survey.

The largest changes in medication safety have occurred in the areas of quality processes and risk management, drug order communication, staff education, and patient education:

Quality processes and risk management. Comparison of 2000 and 2004 data reveals a 43% increase in nonpunitive, system-based approaches to error reduction, including providing positive incentives for error reporting and incorporating specific medication safety objectives in strategic plans. Preliminary data in this area also show a 29% increase from 2000 scores in practitioners’ ability to detect, report, and analyze errors, and in the use of redundancies and independent double-checks to detect and correct serious errors before they reach patients.

• Methods of communicating drug orders. Methods of communicating drug orders are another area of significant improvement when compared to the 2000 self-assessment. The 2004 self-assessment results show a 30% increase in implementation of standardized automated methods of communication, including linking computer systems with pharmacies, establishing lists of error-prone drug abbreviations, and following specific policies for verbal or telephone medication orders.

• Patient education. There was a 23% increase over the last five years in the category of patient education — patients being involved as active partners in their hospital care by being provided with information about their medications and ways to prevent errors. Hospitals indicated that more patients are being encouraged to ask questions about their medications and are being provided written, up-to-date information about critical drugs prescribed at discharge.

In addition, the self-assessment revealed a 29% improvement from 2000 in efforts to minimize problems with look-/sound-alike drugs. Survey items queried to what extent hospitals were regularly reviewing current medical literature to identify potential problems, implementing computer alerts for problematic drug names, and using auxiliary warnings or other label enhancements.

FDA renews contamination alert on IV catheter flushes

The FDA has reissued a nationwide alert against the use of all lots of preloaded syringes containing either heparin or sodium chloride intravenous catheter flushes manufactured by IV Flush LLC, and distributed by Pinnacle Medical Supply of Rowlett, TX. New cases of Pseudomonas fluorescens infections associated with the use of these unapproved and possibly contaminated products have been reported.

The heparin and sodium chloride-containing intravenous flushes were sold to distributors who redistributed to other medical distributors and hospitals. Some of the intravenous flushes may have been provided to patients for home use. They can be identified by the syringe label, which reads in part: "IV Flush Dallas, TX."

IV Flush LLC is notifying its distributors by phone and letter and has requested those distributors contact their customers. The company is arranging for return of all recalled products.

P. fluorescens is an infrequent cause of infection, but has been reported to cause outbreaks of pseudobacteremia (i.e., presence in a blood culture in the absence of clinical evidence of bloodstream infection). P. fluorescens also has been reported as the cause of procedure-related infections and infections resulting from transfusion with contaminated blood components.

Those wanting to report anything to the FDA regarding either of these products may contact the FDA’s MedWatch office at (800) FDA-1088. Clinicians with patients possibly infected from these products should report cases to their state or local health department and the FDA.

Proposed regs will support e-prescribing for Medicare

The Department of Health and Human Services Secretary Mike Leavitt has announced new proposed regulations that will support electronic prescriptions for Medicare when the prescription drug benefit takes effect in January 2006.

The proposed e-prescribing regulations will adopt standards for:

  • Transactions between prescribers and dispensers for new prescriptions, prescription refill request and response, prescription change request and response, prescription cancellation request and response, and related messaging and administrative transactions.
  • Eligibility and benefits inquires and responses between drug prescribers and prescription drug plans.
  • Eligibility and benefits inquiries and responses between dispensers and Part D sponsors.
  • Formulary and benefit coverage information, including information on the availability of lower cost, therapeutically appropriate alternative drugs, if certain characteristics are met.

The Centers for Medicare & Medicaid Services (CMS) proposes to make the compliance date for these foundation standards Jan. 1, 2006, so they will be ready for immediate use when the Medicare drug benefit begins. Additional electronic information can be used in conjunction with these foundation standards, to provide more support for using drugs safely and effectively.

The proposed regulations, which now are available for public comment, are a part of the Medicare Modernization Act (MMA), signed into law by President Bush on Dec. 8, 2003. As part of the MMA, Medicare will require drug plans participating in the new prescription drug benefit to support electronic prescribing but it will be voluntary for physicians and pharmacies.

Additional standards will be tested through a pilot project and recommended for adoption in a final rule to be issued no later than April 1, 2008, which will take effect no later than one year from the date the standards are issued. Participation by physicians in e-prescribing will be optional, but the establishment of standards and steps to encourage the adoption of effective e-prescribing programs will make e-prescribing more attractive.

To view the proposed rule, see the Feb. 4, 2004, issue of the Federal Register. Public comments will be accepted through April 5, 2005.

Awareness of drug programs for lower-income Americans low

While nearly two-thirds (65%) of U.S. adults have heard of prescription drug discount cards for seniors that cover drugs from many different companies, there is relatively low awareness of prescription drug programs that assist lower income adults with the costs of medication. Only one-third (32%) of all adults have heard of patient assistance programs offered by some pharmaceutical companies to subsidize the costs of medications for lower income patients. Even fewer adults (20%) are aware of Together Rx, a drug discount card for lower-income people offered by a coalition of pharmaceutical companies.

The results are taken from a Harris Interactive poll of 2,441 U.S. adults conducted on-line between Jan. 18 and 20, 2005, for The Wall Street Journal Online’s Health Industry Edition.

Despite low awareness levels of discount drug programs for those with lower incomes, nearly one-quarter (24%) of adults ages 18 to 64 are interested in or have already signed up for a drug discount card. Response to discount drug programs for seniors has been somewhat similar with 26% of adults ages 65 and older being interested in or having already signed up for this benefit.

Of those respondents who have signed up for drug discount cards, 73% ages 18-64 and 66% age 65 and older report satisfaction with their experience using their card. However, most respondents age 65 and older who reported dissatisfaction, said they were "very dissatisfied" (23%) rather than only "somewhat dissatisfied"(3%) with their experience.

FDA issues safety notices

The FDA and Amgen have notified health care professionals of revisions to the warnings and precautions sections of the prescribing information for darbepoetin alfa (Aranesp), indicated for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. This safety information alerts physicians to the adverse effects observed with other products in this class in association with off-label dosing strategies.

Two recent investigational studies with other erythropoietic products permitted or required dosing to achieve hemoglobin levels of greater than 12 g/dL. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events, were reported in these studies. As indicated in the darbepoetin alfa prescribing information, the target hemoglobin level should not exceed 12 g/dL in men or women. For more information, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#aranesp.

The FDA also has issued a public health advisory to inform health care providers and patients about recent safety-related changes to the nevirapine (Viramune) label and about appropriate use of HIV triple combination therapy containing nevirapine. The indications and usage section now recommends against starting nevirapine treatment in women with CD4+ cell counts greater than 250 cells/mm3 unless benefits clearly outweigh risks.

This recommendation is based on a higher observed risk of serious liver toxicity in patients with higher CD4+ cell counts prior to initiation of therapy. In addition, the revised label now includes a medication guide to inform patients about risks associated with nevirapine when used for the treatment of HIV.

For the complete safety summary, see www.fda.gov/medwatch/SAFETY/2005/safety05.htm#viramune.