Safety Implications of JCAHO Standards Raise Concerns

Robert S. Weller, MD

Patient safety is an issue that has received widespread national attention following the Institute of Medicine’s (IOM) report in 1999: To Err is Human: Building a Safer Health System, in which the risk of patient harm from medical errors was identified.1 Included in this report was Recommendation 8.2: “Health care organizations should implement proven medication safety practices.”

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) has included improving the safety of medication administration in its “National Patient Safety Goals” for both 2004 and 2005, and will be looking closely at compliance with Medication Administration Standards. Three specific line-items in the Patient Safety Goals are to remove concentrated electrolyte solutions from patient care units, to standardize and limit the number of drug concentrations available, and to identify and annually review a list of look-alike/sound-alike drugs and take action to prevent errors involving the interchange of these drugs.

JCAHO Standards Are Detailed and Sweeping

The actual JCAHO Medication Management Standards for January 2004 are far more detailed and sweeping than the “Goals,” and directly impact anesthesia providers. The 2004 Standards include Medication Management Standard MM 4.20: “When an on-site, licensed pharmacy is available, only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, or other drugs except in emergencies or when not feasible (for example, when the product’s stability is short).” Intravenous admixture is defined as “the preparation of pharmaceutical product which requires the measured addition of a medication to a 50 ml or greater bag or bottle of IV fluid. It does not include the drawing-up of medications into a syringe, adding medication to a buretrol, or the assembly and activation of an IV system that does not involve the measurement of an additive. This Standard 4.20 specifies that preparation of such an IV admixture must be performed in a Class 100 environment (airborne >0.5 micron particulate count of <100 per cubic foot).

Where did this requirement originate? It appears that the JCAHO has adopted, word-for-word, the compounding standard from the United States Pharmacopeia (USP), which went into effect in January 2004. Although the USP might not meet the definition of “proven medication safety practice” as recommended by the IOM report, the standard was subject to a period of national review and public comment and was promulgated with the requirement that it be enforced by state boards of pharmacy and subjected to survey by accrediting organizations. Of course, the pharmacy licensing boards only have jurisdiction over pharmacies and pharmacists, but the USP and JCAHO requirements resulting from this standard apply to practitioners of all types, in all health care settings where medications are compounded, including anesthesia providers in the operating room (OR).

USP Standard Has Long History

To go back a step further, what was the background for this new USP Standard on medication compounding? For the past 3 decades, published cases or series of cases of infections in patients resulting from contaminated medications elevated the concern for the safety of compounded medications, including parenteral nutrition, cardioplegia, steroids, and analgesics. This history included 4 cases of fungal meningitis in North Carolina, one fatal, following epidural methylprednisolone injection contaminated at the same compounding pharmacy.2 Additional cases of meningitis from epidural injection of contaminated steroids were reported in California and Michigan. A series of 11 patients receiving cardioplegia contaminated by Enterobacter was reported in 1986, with 8 patients rebleeding after surgery and 5 patients dying.3 Over this long history of safety concerns, particularly for drug contamination by compounding pharmacies, the American Society of Health-System Pharmacists (ASHP), the National Association of Boards of Pharmacy (NABP), and the USP have performed practice surveys and made recommendations to pharmacists and pharmacy technicians to try to improve medication safety. In 1991, the first national survey of compounding practices was performed by the ASHP,4 and that organization published voluntary practice guidelines in 1993. Another survey was performed in 1995, the guidelines were revised in 2000, and a third survey was performed in 2002. None of these surveys showed significant improvement or compliance with the voluntary (and expensive) ASHP guidelines, and therefore national standards were promulgated in 2004 (USP 797).

How does the United States Pharmacopeia develop such standards? The USP “is a nonprofit, nongovernmental, standard-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations.” The details of the new, 2004, USP Standard (797) include its goal “to prevent harm and fatality to patients” as a result of microbial contamination, content errors, or ingredient errors in the compounding of sterile preparations. The definition of a “compounded sterile preparation” from USP is quite broad, and includes any of the following:

a) Preparations prepared according to manufacturer’s labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination.

b) Preparations containing non-sterile ingredients or employing non-sterile components and devices that must be sterilized before administration.

c) Biologics, diagnostics, drugs, nutrients, or radiopharmaceuticals that possess either of the 2 previous characteristics and which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, powder for injection, irrigations, metered sprays, and ophthalmic and otic preparations.

Obviously, nearly any manipulation of IV medications could expose the contents “to potential contamination,” and other medical specialties such as nuclear medicine have expressed concern for the effect of these far-reaching regulations on their practice.5

The Standards identify various risk levels for medication compounding, and anesthesia providers only prepare sterile solutions from sterile ingredients, for immediate administration or administration over a limited number of (but <24) hours. This would likely qualify as a “low-risk” level for microbial contamination6 in the professional judgment of pharmacy and anesthesiology practitioners, compared to preparation of IV admixtures for administration over several days (“medium risk”), or preparation from non-sterile components for later sterilization (“high risk”). Medication preparation by anesthesia providers also usually takes place in an OR with a required minimum of 15 air changes per hour (ACH), and usually by an individual wearing a mask and non-sterile gloves, but clearly not under a Class 100 hood. Having said this, anesthesia medication has been implicated (rarely) in the transmission of fungal and bacterial infection, most notably with the original propofol formulation with resultant sepsis and multiple organ failure.7 Heightened awareness of the risk,8,9 handling recommendations from the manufacturer, and reformulation of the solution have apparently reduced reports of patient infection, but other drugs have also been shown to be contaminated after anesthesia provider preparation, and 2 reported cases of hepatitis C transmission were linked to anesthesia medication. Still, these are rare reports, and the IOM report identified Anesthesiology and its Anesthesia Patient Safety Foundation (APSF) as a specialty that had dramatically improved patient safety over the last 20 years by collective action. Also, the American Society of Anesthesiologists specifically defines the anesthesiologist’s responsibilities in perianesthetic care as including the preparation and check of (equipment and) drugs.

Clearly, although pharmacy organizations have been struggling with these medication safety issues for many years, this new JCAHO MM 4.20 Standard has caught anesthesia providers by surprise, and we have had little direction in determining its scope. In a recent list-serve query, the interpretation of MM 4.20 by academic health centers was quite variable. Many institutions have adopted a practice that requires pharmacy preparation of all IV admixtures, while others consider the OR to be a unique site where infusions and other IV admixtures may continue to be prepared by anesthesia providers.

The careful consideration of the application of JCAHO Standard MM 4.20 to anesthesia providers suggests there may be a real and dangerous safety trade-off that has not been part of the discussion to date. Once again, the intent of USP (797) and MM 4.20 is to improve medication safety both from the standpoint of reducing microbial contamination and reducing the potential for errors in measurement or dilution. Since anesthesia is commonly provided in the emergency setting which is an exclusion for pharmacy preparation of solutions, anesthesia providers will be placed in the position of preparing IV admixtures only in crisis situations. The risk of measurement or contamination error is likely to be increased by lack of familiarity and experience previously gained by compounding such solutions on a daily basis. The emergency situation with a critically ill patient is already a time-pressured and risk-laden setting; this is the last place one would want to increase the potential for medication error.

It seems far more rational to adopt institutional practice guidelines that document safe practice and minimize the already low risk of microbial contamination of solutions, and allow anesthesia providers to continue to prepare all manner of medications in the OR environment. Such practices might include

  • Mandatory use of gloves and mask when preparing IV admixtures from sterile ingredients in an OR.
  • Annual training in aseptic medication preparation and written exam competence demonstration.
  • Labeling of preparations with medication name, concentration, and time of preparation or expiration date (Standard MM 4.30).
  • Discarding of preparations used in the OR within 24 hours, or when the patient leaves the OR or post-anesthesia care unit (PACU) and is transferred to another patient care area.

If adopting these simple safeguards could meet the requirements for safe compounding in a low-risk situation for contamination, one might avoid the potential for increasing the risk of medication measurement error.

Dr. Weller is an Associate Professor and Director of Orthopaedic Anesthesia at Wake Forest University School of Medicine, Winston-Salem, NC.


References

  1. Kohn LT, Corrigan JM, Donaldson MS. To Err is Human: Building a Safer Health System. Institute of Medicine, Washington, DC: National Academy Press, 1999.
  2. Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy–United States, July-November 2002. MMWR Morb Mortal Wkly Rep 2002;51:1109-12.
  3. Hughes CF, Grant AF, Leckie BD, Baird DK. Cardioplegic solution: a contamination crisis. J Thorac Cardiovasc Surg 1986;91:296-302.
  4. Crawford SY, Narducci WA, Augustine SC. National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals. Am J Hosp Pharm 1991;48:2398-413.
  5. Hung JC. USP general chapter <797> pharmaceutical compounding-sterile preparations. J Nucl Med 2004;45:20N,28N.
  6. Schubert A, Hyams KC, Longfield RN. Sterility of anesthetic multiple-dose vials after opening. Anesthesiology 1985;62:634-6.
  7. Postsurgical infections associated with an extrinsically contaminated intravenous anesthetic agent–California, Illinois, Maine, and Michigan, 1990. MMWR Morb Mortal Wkly Rep 1990;39:426-7, 433.
  8. Zacher AN, Zornow MH, Evans G. Drug contamination from opening glass ampules. Anesthesiology 1991;75:893-5.
  9. Magee L, Godsiff L, Matthews I, et al. Anaesthetic drugs and bacterial contamination. Eur J Anaesthesiol Suppl 1995;12:41-3.