Medication errors: Prescriptions for safety

A recent study published in the Journal of Patient Safety concluded that more than 400,000 hospital patients die each year as a result of preventable adverse events.^[1] That estimate is stunningly higher than the landmark Institute of Medicine (IOM) study, To Err is Human: Building a Safer Health System, which estimated that the annual number of hospital deaths due to adverse events is between 44,000 and 98,000. This article explores the weighty problem of adverse events in long-term care and suggests strategies to mitigate medication-related adverse events in long-term care settings.

In 2011, more than 1.4 million residents received care in the 15,671 facilities that participate in the Medicare and Medicaid programs, according to the U.S. Department of Health and Human Services.^[2] Of those residents, almost half received nine or more medications per day. Polypharmacy and multiple chronic medical conditions combine to make frail and elderly residents especially susceptible to medication errors. Decreased renal function, impaired hearing and vision, and cognitive or functional limitations place older residents at an even greater risk for medication errors and adverse drug events. Faulty or sparse documentation of medication administration by the skilled nursing staff can add additional medical and legal risks.

Adverse drug events (ADE) are defined by the IOM as, “injuries resulting from a medical intervention related to a drug.” Multiple studies reveal that ADEs are common in the nursing home setting, with an estimated 135 ADEs per year for the average size nursing facility. As one of the most daunting problems facing nursing facilities, ADEs are credited for an estimated 93,000 deaths annually and additional healthcare costs of almost $4 billion.^[3]

ADEs occur most often at the ordering and monitoring stages.^[4] Some categories of drugs pose greater risks than others. Residents who receive antipsychotic agents, anticoagulants, diuretics and anti-epileptics are more likely to suffer from an ADE. Thus, emphasis should be placed on categories of drugs which pose a greater likelihood of serious harm as well as on the ordering and monitoring stages.

Much of the risk associated with medication errors and adverse drug events in long-term care environments can be mitigated through diligent attention to several high-risk situations that create fertile ground for such errors. Creating solid protocols surrounding prescription documentation, drug/treatment verification and proper monitoring after medication administration can help reduce health risks for residents and business risks for the facility.

TRANSITIONS OF CARE AND MEDICATION RECONCILIATION

One of the highest risks for medication errors happens at the front door—when residents transition from home or a hospital to a skilled nursing facility. That risk is magnified if the resident is cognitively impaired and may not be able to actively participate in his/her care or provide valuable information, such as what medications and what doses he/she has been taking previously. Medication discrepancies were found to occur in almost three out of four nursing home admissions and one in five medications prescribed on admission.^[5] Researchers also estimate that 75 percent of the transcription errors related to new admissions are preventable. ^[6]

Whenever a resident is admitted to a nursing facility, medication reconciliation should be documented at intake, and reviewed regularly. The Centers for Medicare and Medicaid Services requires a medication regimen review by a consultant pharmacist at least monthly. Separately, the Joint Commission has determined that medication reconciliation should occur on admission, and that it is important enough to be a National Patient Safety Goal for nursing facilities. All medications, including over-the-counter medications as well as complementary and alternative/herbal medicines should be included in the medication reconciliation. The following strategies can help improve the medication reconciliation process and reduce risk:

• Create policies and procedures that describe the roles, responsibilities and steps in the reconciliation process. Engage staff input in designing, monitoring and revising the process.
• Create or approve a standardized form for medication reconciliation and place it in a consistent place in each resident’s medical record.
• Determine who will resolve variances in the medication reconciliation process, and develop a process to identify and mitigate failures in the process.
• Establish a reasonable time-frame for completion. High risk medications such as antihypertensive agents, antibiotics, and anti-seizure medications may need to be prioritized and reconciled sooner than other medications.
• Enlist the compliance committee (mandatory since March 2013) as well as the QAPI committee to track compliance and report discrepancies, and seek their input on the process.
• Develop a list of “high-alert medications” and “easily confused drug names,” and engage clinical staff in learning the drugs involved.
• Monitor compliance weekly and/or monthly.
• Provide adequate and current drug information references for clinicians, and involve a pharmacist for consultative purposes.
• Provide sufficient training and education regarding medication reconciliation for all involved staff.
• Educate residents and family members/guardians to serve as resident advocates.
• Engage hospitals in the process and establish lines of communication to hospitals, clinics and physician offices.
• Incorporate an “alert protocol” to notify staff when a medication reconciliation not completed within a specified time after admission.
• Determine whether communication across settings and among clinicians is a problem and mitigate any communication barriers.

TECHNOLOGICAL IMPROVEMENTS

As technologies continue to evolve, they find broader application in the prevention of ADEs. During a survey of 800 physicians at the 2010 annual American Medical Directors Association annual meeting, approximately 560 of surveyed physicians reported using a mobile device as an aid in prescribing medications within nursing facilities. Of those physicians who used their mobile devices, 98 percent reported that they used the drug-reference software on a daily basis, and 88 percent reported that it helped prevent one or more ADEs in the month prior to the survey.^[7]

     Computerized prescriber order entry (CPOE) is another area where technology has had a dramatic impact on reducing ADEs. Typically, CPOE screens orders for potential concerns such as a maximum daily dose, drug-drug interactions, resident allergies and contraindications based on reported laboratory values.

     Other technological advances, such as electronic health records (EHRs), electronic medication administration systems (eMARs), computerized medication carts and “smart” infusion pumps have also enhanced medication administration safety.

LOOK-ALIKE, SOUND-ALIKE MEDICATIONS

Providing educational and resource material on topics such as look-alike and sound-alike drugs is a useful strategy that underscores the need for vigilance when prescribing, dispensing or administering medications. For example, some of the hundreds of look-alike and sound-alike medications are: Alora- Aldara, amiloride-amlodipine, Amicar-Omacor, Avinza-Invanz, Diabeta-Zebeta, Dilocar XR-Pilocar, Humalog-Novolog, fluoxetine-duloxetine, Doxil-Paxil, lorazepam-alprazolam, lorazepam-clonazepam, prednisolone-prednisone, and Zyrtec-Zantac.^[8] Skilled nursing facilities should consider using both the brand name and the generic name to minimize the risk of confusion, and also include the medication’s intended purpose on the order.

HIGH-ALERT MEDICATIONS

High-alert medications are those that carry an increased risk of causing serious harm or death when associated with an ADE. Because the consequences are so serious, all staff involved with medication prescribing, dispensing, administering and monitoring should be familiar with high-alert medications. As noted above, anticoagulants, antipsychotics and insulin are among the medications most frequently associated with ADEs; they are also among the most dangerous when coupled with a medication error such as a wrong dose or a wrong resident. Useful strategies include using auxiliary labels and automated alerts for high-alert drugs.

In 2012, the American Geriatrics Society published an updated version of the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Essentially, a panel of geriatric and pharmacotherapy experts reviewed more than 2,000 research studies dealing with medications prescribed for elderly patients. Based on their review, they identified 34 medications and types of medications that are “potentially inappropriate” for elderly adults. The Beers Criteria suggests that when healthcare providers prescribe medications for adults 65 and older, they should consider avoiding drugs on the list due to the attendant risk of side-effects. For example, the Beers Criteria suggests avoiding sliding scale insulin as a method of dosing insulin as it may increase hypoglycemia.

VERBAL ORDERS

The Institute for Safe Medication Practices (ISMP) has identified verbal orders as a potential risk for medication errors, especially since verbal medication orders involving drugs that have similar sounding names can be a prescription for trouble. Verbal orders have become even more worrisome in today's increasingly mobile world, since a physician may call in a script order to a nursing facility from a cell phone while in a car or at a social event where poor (or interrupted) call quality is possible.

One example of a similar-sounding medication is Fluoxetine (Prozac, Sarafem) and duloxetine (Cymbalta). Compounding the problem, both medications are available in 20 mg capsules and both are used to treat depression. Likewise, Protonix (pantoprazole) and Lotronix (alosetron) have been confused with one another; the former is prescribed for GERD while the latter is prescribed for irritable bowel syndrome.

ISMP notes the magnitude of the problem of verbal orders: A physician gave a telephone verbal order for “Xanax point 125 mg,” by which the physician meant as 0.125 mg. The nurse transcribed the verbal order as “Xanax point one to five mg” and wrote the verbal order for “Xanax 0.1 – 0.5 mg.” In another ISMP example, a nurse transcribed a verbal order as “every 4 to 8 hours” instead of “every forty-eight hours.”^[9]

In order to minimize risks associated with verbal orders, both the prescriber and person receiving the verbal order should spell the name of the drug (e.g., saying “A as in alpha”). If abbreviations are used, the script recipient should read the script back to the prescriber (e.g., if the prescriber says “QID,” it should be read back as “four times a day”). QID, or four times a day, has often been mistaken for QD, which means every day or QOD, meaning every other day. 

Additional safeguards should ask for the clinical indications on a verbal order, so nursing staff and LTC physicians can check that the prescribed drug comports with a resident’s diagnosis and clinical condition.

“ROOT CAUSE ANALYSIS" AND REPORTING

Performing a root cause analysis (RCA) is a useful strategy for preventing medication errors. In today’s age of data analytics, facilities should consider performing a RCA not just on actual medication errors, but also on the “near misses” as well. Reporting is another consideration. Apart from those instances that trigger mandatory reporting to the State Survey Agency, facilities may want to confidentially report medication errors and “near misses” to a Patient Safety Organization, such as ISMP, which can provide confidentiality to provider sites.

Michael Cohen, the president and founder of ISMP, agrees. “I think more emphasis is needed on the value of confidential adverse event reporting programs operated by federally recognized Patient Safety Organizations,” he said in an email interview. “Our focus at the Institute for Safe Medication Practices, one of the PSOs, is medication error prevention. I believe we’ve made some good progress in this area by giving practitioners a safe forum to communicate about actual medication errors through the National Medication Error Reporting Program that we operate. Practitioners also send us information about near misses and potentially hazardous conditions like poor labeling of certain drug products. In turn, we apply our expertise in analyzing and publishing information that provides evidence-based or peer-reviewed prevention strategies. We also advocate for changes in products and practices through our relationships with regulatory agencies, standards organizations and product manufacturers. This has led to many changes for safety reasons, including numerous products that have been removed from the market, changes in drug names and/or labeling, and practice changes as well. More needs to be done to study, support and promote these programs.”

Preventing ADEs requires input from all stakeholders. It is not just about the nurses, the prescribers or the pharmacists; everyone involved with medication ordering, dispensing, administering and monitoring plays a key role. As noted by Dr. Patricia Nay, the Executive Director of Maryland’s Office of Health Care Quality, “Medication management is a team sport—all members of the interdisciplinary team, as well as the patient, share in this crucial process. The systems governing medication management must be made fault-tolerant to include redundancies to compensate for inevitable human error.”[10]

Educating all stake-holders involved with medication safety is essential. There is no dearth of useful resources, many of which are available at no cost.^[11] Providers should consider the starter list of successful strategies above, nd should also consider other proven methods of reducing ADEs. When it comes to resident safety, the maxim of primum non nocere (first, do no harm) should be the overarching principal.

REFERENCES

^[1]  James JT, A new, evidence-based estimate of patient harms associated with hospital care. J Patient Safety.  2013;9(3):122-128.

²  Nursing Home Data Compendium 2012 Ed. available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/downloads/nursinghomedatacompendium_508.pdf.

³  Handler SM, Hanlon JT.  Detecting adverse drug events using a nursing home specific trigger tool.  Ann Longterm Care. 2010 May;18(5):17-22.

⁴  Gurwitz JH, Avorn J, McCormick, D, et al.  Incidence and preventability of adverse drug events in nursing homes.  Am J Med. 2000 Aug 1;109:(2)87-94.

⁵  Tija J, Bonner A, Briesacher BA, et al.  Medication discrepancies upon hospital to skilled nursing facility transitions.  J Gen Intern Med 2009;24(5):630-5

⁶  Forster AJ, Clark HD, Menard A, et al.  Adverse events among patients after discharge from hospital.  CMAJ 2004;170:345-349.

⁷  Handler, SM, Boyce RD, et. al.  Use and perceived benefits of mobile devices by physicians in preventing adverse drug events in the nursing home.  JAMDA October 4, 2013 (online at www.jamda.org).

⁸  For a more detailed list of look-alike and sound-alike drugs, see, ISMP’s List of Confused Drug Names, available at: https://www.ismp.org/tools/confuseddrugnames.pdf.

⁹  Long-Term Care Advise-ERR, available at: www.ismp.org.

10  Email from Patricia Tomsko Nay, MD, CMD, CHCQM, FAAFP, FAIGQ, FAAHPM (Executive Director, Office of Health Care Quality, Maryland Department of Health and Mental Hygiene) to Alan C. Horowitz (September 26, 2013) (copy on file with author).

¹¹ For example, Long-Term Care Advise-ERR, and many useful medication safety toolkits and resources are available from ISMP at no cost. See, www.ismp.org.

Alan C. Horowitz

Alan C. Horowitz, Esq., is a partner at Arnall Golden Gregory LLP, where he focuses his legal practice on regulatory compliance for skilled nursing homes, hospices and home health agencies and manages cases where the Centers for Medicare and Medicaid Services (CMS) has imposed an enforcement action. He is a former assistant regional counsel Office of the General Counsel, U.S. Department of Health and Human Services. As counsel to CMS, he was involved with hundreds of enforcement actions and successfully handled appeals before administrative law judges, the HHS Departmental Appeal Board and in federal court. He also has clinical healthcare experience as a registered respiratory therapist and registered nurse. He can be reached at alan.horowitz@agg.com.