From the November 2004 Issue

Most error reduction efforts generally begin in response to a serious error. Individuals and practice sites have become accustomed to reacting to an error after it has occurred. Unfortunately, only then do they consider how to prevent the same error from being repeated. Wouldn't it be useful to be able to predict the types of errors that could occur and proactively institute preventative measures? All too often, error potential is not included in decisions about which medications, devices, or technology to purchase. Instead, decisions are guided by cost, third party formulary restrictions, contractual agreements with purchasing groups or vendors, and pharmaceutical marketing efforts. Input and evaluation from those who will be using the products may not be sought and error potential may not be considered ahead of time. The ultimate result…unforeseen safety issues and errors once the product is in the hands of clinical users or healthcare consumers.

In our September 2004 issue, we recommended the use of FMEA as a risk-reduction strategy. The goal of FMEA is to systematically identify areas of potential failure and gauge what the effects would be - before an error actually takes place. This proactive process can be used to examine the use of new medications, products, as well as the design of new services and processes that may affect workflow. FMEA is best employed prior to purchase and implementation so that preemptive action can be taken to eliminate or mitigate patient harm. Additionally, best results are achieved when several staff members are involved in the FMEA process.

So how can FMEA be used to reduce the risk of medication errors within your practice? To cite just one example, FMEA could be used to assess the potential for error with new medications when they are first marketed or before they are prescribed or added to your inventory. Here's how the process would work:

• Step 1: Design a process flow diagram. Then explore how the intended product would be prescribed. Who would prescribe it and for which patients? What clinical patient information will be important before it is prescribed? How would it be procured, stored, and used, from acquisition through dispensing and administration? Who would prepare and dispense it? What information will need to be given to the patient or caregiver? How would it be administered?
  
  
• Step 2: Potential failure modes (i.e., how and where systems and processes may fail and what can go wrong) would be identified while considering how the product would be used. Questions to be asked would include: Does the drug name (brand or generic) look or sound like another drug name? Would a similarly spelled drug name be listed in close proximity to the intended product on prescriber, wholesaler, or pharmacy computer order entry screens? Does the package label clearly express the strength or concentration? Would it be stored near or could it be mistaken for another similarly packaged product? Are dosing parameters complex? Is the administration process error prone?
  
  For example, an FMEA performed on SEROQUEL (quetiapine), by the drug manufacturer prior to its release or by practitioners before it became widely used, may have predicted a high likelihood of mix-ups with SERZONE (nefazodone). This process would have revealed many overlapping characteristics, which have contributed and continue to contribute to errors involving these medications. These two medications are: likely to be prescribed by the same type of physician; prescribed for patients with similar diagnoses; available in overlapping dosage strengths (i.e., 100 mg, 200 mg); often administered at the same frequency; and are likely to be stored together and appear on computerized lists in close proximity when inventory is organized alphabetically by brand name. Although Serzone is no longer marketed, these types of errors are still likely since generic formulations of nefazodone are available, and may be prescribed as "Serzone."
• Step 3: For each failure mode, staff would then determine the likelihood of making an error as well as the potential consequences. What would happen to the patient if the drug were given at the wrong dose, at the wrong time, or by the wrong route? What would happen if a patient received the wrong medication or if the wrong patient received the medication?
• Step 4: Staff would consider the severity of the outcome and identify any preexisting processes in place that could help eliminate or detect the error before it reaches the patient. Each process would then be evaluated for its effectiveness based upon what was learned in previous steps. For example, would obtaining additional patient information, using computer alerts, bar coding, or a double-check process catch these errors every time? Numerical values can be assigned to determine the likelihood of the occurrence, its severity, and the chance that it would be detected before causing patient harm.
• Step 5: If failure modes reveal errors with significant consequences, actions would be taken to prevent the error, detect it before it reaches the patient, or minimize its consequences. Such actions may include improved communication of orders by including indication on prescriptions or differentiating look-alike products by ordering from different manufacturers or by storing products separately.
  
  Although industries outside of medicine have developed elaborate FMEA scoring systems to rank items for action, a simplified FMEA process as described above can be an efficient, proactive risk management tool, especially when practice sites consider what is already known about error potential from past experiences or information available in publications such as the ISMP Medication Safety Alert!
  

• Cohen MR, Davis NM, Senders J. Failure mode and effects analysis: a novel approach to avoiding dangerous medication errors and accidents. Hosp Pharm 1994;29:319-24.
  
• Williams E, Talley R. The use of failure mode effect and criticality analysis in a medication error subcommittee. Hosp Pharm 1994;29:331-7.
  
• Senders JW, Senders SJ. Failure mode and effects analysis in medicine. In Cohen MR ed. Medication Errors: Causes, Prevention and Risk Management. Am Pharm Assoc. Washington, DC 1999.
  
• DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using Health Care Failure Mode and Effect Analysis™: The VA National Center for Patient Safety's Prospective Risk Analysis System. The Joint Commission Journal on Quality Improvement 2002;27(5):248-267.