1. Aschenbrenner, Diane S. MS, RN, CS

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A new analgesic.

An extended-release formulation of hydromorphone, called Palladone, was recently approved by the Food and Drug Administration (FDA) to treat persistent, moderate-to-severe pain in patients who require around-the-clock analgesia. The drug is available in 12-mg, 16-mg, 24-mg, and 32-mg capsules and is to be taken once every 24 hours. It should be used only in opioid-tolerant patients taking daily doses of at least 60 mg of oral morphine, 30 mg of oral oxycodone, 8 mg of oral hydromorphone, or an equianalgesic dose of another opioid. The risk of respiratory depression, which can be a serious adverse effect of any opioid, is greater in opioid naive patients, older adults, or debilitated patients. The safety and effectiveness of Palladone has not been established in patients younger than 18 years old. An FDA medication guide is dispensed with each prescription to help alert patients to the potential risks involved in inappropriate use of this extended-release opioid. Patients should read the guide each time they have a prescription refilled because information may change. Nurses who work with patients who are prescribed Palladone should teach the patient and family about the importance of swallowing the medication whole.


U.S. Food and Drug Administration. FDA talk paper: FDA approves new extended release pain medication: agency works with sponsor to develop an effective plan to reduce inappropriate use. 2004.



An increased risk of sudden cardiac death.

A study recently published in the New England Journal of Medicine showed that when oral erythromycin is coadministered with another drug that's a cytochrome P-450 (CYP) 3A inhibitor-specifically, the azole antifungals, diltiazem, verapamil, or troleandomycin-the risk of sudden death from cardiac causes is higher than it is when either is used alone. In comparison, there was no increased risk of cardiac death in those receiving amoxicillin and CYP3A inhibitors.


Erythromycin is metabolized by the CYP3A isoenzyme system. It has been known for some time that it prolongs cardiac repolarization; torsades de pointes has been reported. There has also been concern that drugs that inhibit this isoenzyme will slow down erythromycin metabolism, increasing the available circulating levels of the antibiotic and increasing the risks of adverse effects from it. That concern was justified by the study.


Based on the strength of the findings the authors recommend that clinicians avoid coadminstration of erythromycin and the CYP3A inhibitors examined in the study.


Ray WA, et al. N Engl J Med 2004;351(11):1089-96.



A new study reveals the prevalence of inappropriate prescribing practices.

A large, national, retrospective study of outpatient prescriptions filled by older adults has revealed that drugs generally recognized as inappropriate for use by them are commonly prescribed to them.


The study, conducted by Curtis and colleagues and recently published in the Archives of Internal Medicine, examined the outpatient prescription claims made in 1999, as found in a database of a large, national pharmaceutical benefit manager. Among the 765,423 patients 65 years of age or older, 21% had filled a prescription for one or more drugs considered inappropriate because they can cause greater adverse effects in older adults. More than 15% of the older adults in the study filled two or more such prescriptions, and 4% filled three or more inappropriate prescriptions within the same year. Drugs generally considered inappropriate for use in that population are those identified in the Beers criteria for potentially inappropriate medication use in older adults.


Older adults are at greater risk for adverse effects---ones that possibly can be serious because of the decreases in metabolism and in the elimination of drugs characteristic of that population. The study findings do not indicate that all of the inappropriate prescriptions were of concern, only that they had the potential to be. The most commonly prescribed drugs of concern were amitriptyline (Elavil) and doxepin (Sinequan), both tricyclic antidepressants. One of the most disturbing of the authors' comments is that their findings are consistent with those of several studies that date as far back as 1987.


Nurses should closely monitor older adults for adverse effects of drug therapy when medications considered potentially inappropriate to a patient's age have been prescribed.


Curtis, LH, et al. Arch Intern Med 2004; 164(15):1621-25.


Fick, DM, et al. Arch Intern Med 2003;163(22):2716-24.