In May of 2003, MDH issued deficiencies at F329 (unnecessary drug tag) related to the potential for residents to receive more than the recommended daily dose of acetaminophen. In cases sited, patients were at risk for receiving up to 7or 8 grams/day when scheduled medications containing acetaminophen were combined with standing orders for acetaminophen given on an “as needed” (prn) basis. Although the recommended maximum total daily dose for this medication has been 4 grams, these deficiencies have caused confusion and turmoil among providers. This “Window” is dedicated to reviewing the basis for the deficiencies from clinical and regulatory standpoints.
In January/February, 2003, the FDA distributed an “Alert1” to the public regarding the importance of knowing the components of pain medications. In the “Alert”, consumers were cautioned about the presence of acetaminophen in many pain preparations, over-the-counter (OTC) and prescription preparations, and the importance of not exceeding recommended doses. It highlighted the possibility of liver injury associated with excessive doses. Based on this “Alert” and in the context of increasing attention to adequate pain control among medical practitioners who commonly use combination analgesics, it seemed prudent to have an explicit limit on the administration of total daily dose of acetaminophen to avoid unintended liver toxicity. This seemed especially important in the nursing home setting in view of the medically complicated and frail residents living in nursing homes, many of whom receive other medications which are primarily metabolized in the liver.
In December 2002, the Annals of Internal Medicine2 published a study which found acetaminophen to be the most common cause of acute liver failure, replacing viral hepatitis which was identified as the most common cause for the past 30 years. Of the individuals with acute hepatitis due to acetaminophen, 57% had accidental toxicity due to ingestion of the medication for pain control. These investigators used the 4 grams/day as the upper limit of the recommended daily dose.
Acetaminophen today daily dose limit of 4 grams appears commonly in reference materials3,4,5. USPDI goes farther in its recommendation by breaking it down to short use ( < 10 days): 4 grams/day and long-term use: 2.6 grams/day 6.
Surveyors look at medication compliance predominantly under 2 tags: F329 (unnecessary drugs) and F4297 (drug regimen review). Unnecessary drugs are defined as those used in excessive dose, for excessive duration, without adequate monitoring, without adequate indications or used in the presence of adverse consequences. F429 requires the consulting pharmacist to report medication irregularities to the attending physician and the director of nursing. The regulations are designed to identify irregularities whether or not there is resulting harm to residents. In the case of acetaminophen, deficiencies have typically been written when there are several sources of the medication on routine, prn or standing orders and no accompanying dose limitation.
When deficiencies have been identified related to acetaminophen use, the surveyors must determine a scope and severity level. Scope and severity levels reflect the relative number of residents affected by a deficient practice and the likely impact of the deficient practice. To date, these deficiencies have typically been written at “D” or “E” levels indicating that the scope involves an effect on a few to a group of residents, but not all residents in the facility and that there is a potential for more than minimal harm resulting from the deficient practice.
When a deficiency has been issued, the facility generally must provide a plan of correction. With regard to the acetaminophen issue, plans of correction quite simply must indicate how the facility will insure that residents receiving the medication will not be given inadvertent excessive doses. For example, facilities may decide to include a cautionary statement in the standing orders indicating a total daily dose limitation or may ask prescribers to indicate a total daily dose limitation when writing orders for known acetaminophen containing medications.
The regulatory activity surrounding acetaminophen is not because of a new regulation or even new information about the medication. It arises out of new awareness about the potential hazards of using the medication in excessive doses especially in frail, medically complicated patients who may already be receiving medications that are extensively metabolized in the liver or may have comorbid conditions that compromise liver function. It is also important to be reminded of the chance of excessive acetaminophen from “hidden” sources such as commonly used combination analgesics.
The identification of this issue during survey is not intended to signal a move toward writing deficiencies about every possible adverse drug reaction that can occur, however uncommonly. It was identified as a potential problem because it is commonly used for analgesia in the long-term care population and because the avoidance of acute liver failure, even one case, is beneficial. In the context of a general alert to the public9 and a recently published article by CNN8, it is prudent to exercise similar caution in our health care facilities.
|1.||FDA. Use Caution with Pain Relievers. “FDA Consumer Magazine,” January-February, 2003.|
|2.||Ostapowicz, G et al. Results of a Prospective Study of Acute Liver Failure in 17 Tertiary Care Centers in the United States. Annals of Internal Medicine 2002;137(12):947-54.|
|3.||Hazard, WR et al (eds): Principles of Geriatric Medicine and Gerontology, 4th ed, McGraw-Hill, 1999.|
|4.||Braunwald et al (eds): Harrison's Principles of Internal Medicine , 15th ed, McGraw-Hill, 2001.|
|5.||McEvoy et al (eds): Drug Information 2003. American Hospital Formulary Service, 2003.|
|6.||USPDI, Drug Information for the Health Care Professional, 19th ed, Taunton, Massachusetts, Rand McNally, 1999.|
|7.||CMS. Appendix PP, Guidance to Surveyors. Department of Health and Human Services.|
|8.||Neergaard, L. FDA: Misusing Painkillers Can Be Deadly. CNN News (Netscape), January, 2004.|
|9.||FDA. FDA Launches Consumer Campaign on Safe Use of OTC Pain Products.
( www.fda.gov/bbs/topics/NEWS/2004/NEW01008.html ), January 22, 2004.
February 6, 2004