CERTs.About.Annual Reports.Year 6.CERTs Progress.Improving.System

CERTs researchers continue to seek new ways to improve the health care system related to therapeutics. Research in this area includes examination of the cost effectiveness of treatments as well as ways to address medical errors and improve patient safety.

One of the most common forms of medical errors in children involves medications. In medication therapy for infants and children, it is especially important to take weight and age into account when determining appropriate formulations and dosages. Careful attention to these factors is crucial because if negative reactions occur, children cannot always communicate symptoms to their parents or caregivers.

Although knowledge about medication errors has increased substantially, not enough is known about medication errors in children. CERTs researchers undertook an analysis of such errors over a 5-year period. They found that the older, commonly used agents (such as insulin, morphine, fentanyl, vancomycin, and gentamicin) still were associated with a substantial number of harmful errors in children. Dosing errors resulted from confusion between drug weight or volumes and drug dosage, flawed programming of infusion pumps to deliver drug dosages per minute rather than per hour, and inappropriate recording of patient weights in pounds instead of kilograms.

Researchers pinpointed several problem areas, such as the inappropriate use of abbreviations on order forms and the omission of a leading zero before the decimal point. Drug storage also presented problems, given that many products have brand or generic names that are similar to other products, leading to mix-ups. Ready-to-use doses for children could reduce the risk of dosing errors. The use of patient-controlled medication pumps or other complex delivery systems needs particular attention. Independent double-checks of the medication and of the infusion-pump settings are highly recommended.

One major responsibility of the FDA is monitoring the safety of drugs currently on the U.S. market. The Adverse Event Reporting System is its principal resource for surveillance, and it depends largely on health care professionals and consumers voluntarily reporting cases where medications may have caused a negative side effect. Unfortunately, the system is limited by underreporting, incomplete data about those who have been affected, biases in reporting, and limited information about the population in which the drug is being used.

In order to improve the current surveillance system, two CERTs research studies are taking place in collaboration with the FDA. Using data from eight managedcare organizations in the HMO Research Network, researchers are testing several possible ways to improve the detection of adverse drug reactions. Study results should be available in 2006.

In order to understand which risk factors can lead to adverse drug reactions in outpatient settings, a CERTs team conducted interviews with primary care patients taking medications at home. They found numerous factors that patients believe contribute to adverse drug events, many of which could be prevented through patient and provider education.

While extensive research in health literacy, medication adherence, and provider-patient communication has examined many important factors that lead to adverse drug events at home, results suggest that additional psychological and practical issues in patients' lives play important roles in medication safety. Such factors range from communication problems during office visits- stemming from distractions, time constraints, and patients' beliefs or emotions-to barriers at home, including lack of motivation or ability to fill prescriptions or follow instructions, forgetting, limited resources, and choices to deviate from prescribed regimens due to personal and pragmatic reasons. Thus, health care providers and patients should consider these multiple potential obstacles when making decisions about prescribing and taking medications safely at home.

Another area of importance is the prescription and dispensing of drugs in combinations that can have dangerous interactions. Despite the computerized alert mechanisms for pharmacies and pharmacy benefit managers, large numbers of patients are exposed to potentially harmful interactions. CERTs researchers have been trying to quantify the harm of such "drugdrug" interactions and are beginning to look for ways to prevent them. These investigators found that during a 25-month period, an estimated 2.5 million Americans were exposed to a potential clinically significant drug-drug interaction. A companion study observed how pharmacists respond to automated alert warnings about certain dangerous drug-drug combinations. Researchers found that pharmacists frequently override alert messages, spending 1 minute or less evaluating the alerts.

Experts often suggest computerized physician order entry (CPOE) as one way to reduce errors. CERTs researchers are completing a study of the alert system used by the Department of Veterans Affairs. Data from this study will be used to improve CPOE and pharmacy systems with respect to drug-drug interaction alerts.

As pressure mounts on Medicaid budgets, it is increasingly important that the dollars available for medical care be put to the best use. CERTs researchers designed a study to assess the cost effectiveness of palivizumab, an expensive medication used to prevent serious lower respiratory tract infections in premature infants. The North Carolina Medicaid Program spent more than $12 million on palivizumab in 2003.

The study compared the health care costs in NC Medicaid over a 7-month period, including the winter months, of infants born 5 to 8 weeks prematurely. One group received palivizumab as a preventive measure, while the other group did not. Although the group receiving the medication had fewer hospitalizations during this period, the cost of the drug outweighed the money spent to treat respiratory infections in these children. Researchers suggested that the North Carolina Medicaid Program reconsider its budgetary allocation for this medication and look toward lessexpensive ways of preventing respiratory infections in babies at risk.

Recent clinical trials have suggested extending the length of time that patients receive an antiplatelet drug, clopidogrel, because it can help prevent cardiovascular events after angioplasty or stent placement. CERTs researchers studied whether it would be worth the added expense to extend therapy with clopidogrel from the usual practice of 1 month to 12 months after a coronary procedure.

Using clopidogrel for a full year, rather than for only 1 month, would extend the lives of enough people to make it an economically attractive option compared with currently accepted treatment. However, for patients without prescription drug insurance coverage, the cost of the medication must be taken into account and evaluated in the context of each patient's particular risks and other medications already prescribed.

Glucocorticoids are an affordable therapy for the treatment of rheumatoid arthritis (RA) and many other chronic inflammatory diseases. An estimated 1 million Americans use them on a regular basis. As noted previously, however, glucocorticoids can have serious adverse effects, including bone loss leading to fractures. In evaluating the cost effectiveness of these drugs, it is important to include not only their purchase price, which is relatively low compared with other medications used for RA, but also the cost of treating adverse events that result from taking the drugs.

CERTs researchers undertook a study to estimate the costs of adverse effects associated with glucocorticoid use. Although costs varied depending on specific adverse effects attributed to glucocorticoids, in general, glucocorticoid users spent more on treatment of adverse drug effects and had a higher mortality rate than other RA patients. Over a 2-year period, for every dollar spent on glucocorticoids for RA patients, an additional $0.20 to $0.70 was spent on the treatment of adverse events associated with these drugs. In the same 2-year period, there were 1 to 8 additional deaths for every 1,000 glucocorticoid users compared with people with RA who did not use these drugs. Researchers recommended that patients, providers, and policymakers take these factors into account when making decisions about treatment for RA.

Asthma is the most common chronic respiratory disease among children and adolescents, affecting between 3 percent and 7 percent of children in the United States. Certain groups of children are at high risk for complications from asthma, leading to emergency department visits, hospitalizations, or even death. These high-risk children include many who are served by Medicaid programs.

A CERTs study examined high-risk children with asthma who were enrolled in a Medicaid managedcare program to determine what effect gaps in insurance coverage might have on emergency-room visits or hospitalizations for asthma, respiratory illnesses, croup, and other disorders. Researchers found that children with asthma who had gaps in Medicaid coverage had no increase in asthma-related emergency department visits and hospitalizations. In fact, they had fewer nonrespiratory emergency visits and hospitalizations than did children who had no gaps in Medicaid coverage.

These results surprised researchers, who suggested several possible reasons for the unexpected outcomes. Families whose children had more severe illnesses might have worked harder to avoid gaps in coverage. Some families may have had access to private insurance during the enrollment gaps, or the gaps in coverage might have been too short to interfere significantly with a child's access to care. Families without Medicaid coverage also might have avoided seeking medical care because they could not afford to pay for it. These and other possible reasons need further study in order to detect and remove barriers to better care for children with asthma.

After the attacks of September 11, 2001, and the anthrax attacks that occurred in the ensuing weeks, the threat of bioterrorism put new demands on the health care system. Many people who feared anthrax exposure requested prophylactic doses of antibiotics. To better understand how such a situation can impact the health care system, CERTs researchers surveyed emergency physicians in Pennsylvania to find out whether they had received patient requests for antibiotics because of the fear of anthrax exposure and, if so, whether they had prescribed them.

Most of the respondents had received requests for antibiotics, and one-quarter had prescribed them in response to such a request. Although antibiotics are an important tool for responding to a true anthrax exposure, their inappropriate use causes concern. The overuse of antibiotics can have serious public-health ramifications, ranging from potential adverse effects on individual patients to the increased risk of antibiotic resistance, depletion of supplies, and increased costs to insurers and patients.

Health care providers and policymakers must carefully consider how to handle public demands for medications after perceived exposure to bioterrorist threats. Emergency physicians suggest that improving public communication to reduce fear could help. This study underscores conclusions drawn after the attacks of 2001-that cities with a strong working relationship between public-health officials and health care providers are better prepared to respond to demands for treatment for possible exposure after a bioterrorist incident.

About CERTs

Annual Report Year 5

CERTs Progress

Improving the System