Clinical Thoughts

We often hear media reports about the dangers of medication errors, on both the patient and the “second victim” –- the clinician who accidentally and unintentionally made the harmful mistake. A recent report on 60 Minutes called attention to something we – thankfully – rarely hear about: A nurse intentionally administering lethal doses of medications to kill patients. How someone could do this is beyond comprehension.

The shocking story, which happened over the course of many years before the nurse was caught and convicted about 10 years ago, called attention to the important role medication dispensing cabinets – like the Pyxis MedStation® – play in helping to manage, secure and track medications at the point of care. In fact, the 60 Minutes segment cited the transaction logs from the Pyxis MedStation as a primary piece of evidence.

In parts of the 60 Minutes piece, an uneducated viewer may have been led to believe that it was easy for this nurse to access lethal drugs, but those of us who work in the health care industry know that modern medication dispensing is much safer and more sophisticated than in the past, when these incidents occurred.

As medication dispensing at the point of care became more ubiquitous in hospitals, more controls were added to the technology including individual username and passwords (or fingerprint recognition) to access the system, individual “CUBIES®” and compartments that only give access to the individual drug(s) prescribed to the patient. Other than in emergency situations, drugs are not available for removal until a pharmacist has reviewed the physician’s order for that patient. The scenario painted by 60 Minutes of the nurse accessing lethal medication and disguising it by telling the system he was removing Tylenol would be unlikely with proper implementation of today’s technology.

As CareFusion and hospitals gained more experience with automated dispensing cabinets, the technology continued to evolve and additional safeguards were created to help prevent unintended medication errors. This includes best practices such as storing medications that had a look-alike names or packaging in segregated, single medication containers.

Today’s technology also can restrict nurses’ access to only the medications that have legitimate physicians’ orders, and are reviewed by a  pharmacist for correct dose, therapeutic application and potentially harmful interactions with other medication. When nurses’ access is limited to medications that have a physician’s order and are verified by a pharmacist, the nurse has access to only the medication ordered. No other medications can be accessed. This reduces the risk of a nurse removing an incorrect medication, either deliberately or by accident.

Finally, most hospitals have incorporated bar code scanning at the bedside of the patient’s ID and medication as a final check to ensure proper administration. All of these technologies have improved the safety of the medication process.

The Institute for Safe Medication Practices (ISMP) has also developed guidelines and a safety self-assessment for automated dispensing cabinets. These tools can help hospitals ensure they are following best practices and offer a self-assessment to determine the hospital’s individual level of safety in the use of automated dispensing cabinets.

Importantly, since this case took place, many states have adopted laws that strengthen requirements for criminal background checks and employer disclosures.

While it’s not always possible to stop an evil person who intends to harm people, modern medication dispensing technology would make it much more difficult, to harm patients intentionally through improper medication administration. As horrific as the story was on 60 Minutes, I am comforted knowing that good people have worked for their entire careers to develop the technology and best practices to create a safer and more secure system of dispensing medication in hospitals.

A Pennsylvania surgical center recently agreed to a $6 million settlement in the case of 17-year-old Mariah Edwards who died of respiratory depression following a routine tonsillectomy. The story is a heartrending example of why “alarm fatigue” is a patient safety issue that we cannot afford to ignore.

Mariah’s death occurred at an outpatient surgical center where she was recovering after a successful procedure. A nurse admitted in a deposition that the teenager’s clinical monitors had been muted.

Mariah’s tragic death represents the worst possible outcome related to alarm fatigue, which occurs when caregivers feel overwhelmed by the plethora of patient monitor alarms sounding-off around them.  It can lead to what Dr. Robert Stoelting, president of the Anesthesia Patient Safety Foundation (APSF) describes as the “unfortunate consequence when a caregiver fails to recognize early signs of (danger) by either being too sensitive or insufficiently sensitive.”

In other words, when alarm fatigue occurs, caregivers may miss, ignore or disable the technology in place to help them protect their patients’ safety.

The issue has become so pervasive that the Joint Commission now considers alarm fatigue a national patient safety concern.  In fact, alarm fatigue is at the heart of the Commission’s Proposed 2014 National Patient Safety Goal (NPSG) on Alarm Management.  In addition, the ERCI Institute—an independent organization that identifies best practices for improving the safety, quality and cost-effectiveness of patient care —continues to rank alarm management at the top of its “Top 10 Health Technology Hazards” list.

Still, there’s no universal solution to address alarm fatigue, and it’s up to hospitals and health care facilities to begin aggressively investigating the expanding pool of research and best practices on the subject.  The APSF recently sponsored a conference to identify monitoring strategies that could reduce clinically significant, drug-induced respiratory depression.  The conference yielded many insightful recommendations that could help health care organizations prepare their own policies and programs.

In addition, hospitals and health care facilities should take note of the growing body of evidence that demonstrates how “Smart Alarm” technology can play an instrumental role in reducing alarm fatigue.  Smart alarm technology bases alarms on physiologic trends detected over a period of time. More specifically, the technology can significantly reduce the number of “false alarms” that create alarm fatigue via signal filtering, algorithms and/or artificial intelligence systems.

Numerous case histories and clinical studies are available today that help illustrate the efficacy of smart alarm technology in combating alarm fatigue. Hospitals and health care facilities should study these best practices when developing their own action plans to address the issue. The Medical University of South Carolina (MUSC)  and  Mercy Hospital in Canton, Ohio, offer two examples worth noting.

It’s clear that national patient safety guidelines for alarm fatigue would be widely welcomed in the health care industry, though it’s not clear when such standards will come to be. What’s most evident is that health care administrators must take proactive steps now to build their own policies and programs for reducing alarm fatigue. Mariah’s tragic case proves that doing nothing can be far too costly.

For the past seven years, I have had the privilege of collaborating with a group of highly motivated nurses, pharmacists, respiratory therapists and physicians, meeting periodically throughout the year to discuss trends and challenges and set-forth new best practices to address common and pressing patient safety issues.  Representing 17 local hospitals in the Southern California region, these clinicians set aside competition and business politics in order to focus on what matters most to all of us – our patients. The group is known as the San Diego Patient Safety Council and is hosted and sponsored by the CareFusion Center for Safety and Clinical Excellence.

The Council convenes every 6-8 weeks to establish and work toward projects modeled after the highly successful Institute for Healthcare Improvement tool kits. To date, the Council has completed four tool kits and is several months into a fifth initiative. Completed tool kits cover topics including standardization of high risk IV medications, Patient Controlled Analgesia (PCA), intensive care sedation, and recommended dose alert limits for IV medications. The latest project focuses on best practices for patient monitoring outside the ICU.

The Council was initially funded by a grant from the Cardinal Health Foundation. Support from CareFusion and our Center for Safety and Clinical Excellence allows the Council to continue offering educational seminars and collaborate with national experts. The Council has served as a model for other healthcare collaborations and has been  recognized by The Institute for Safe Medication Practices who awarded the Council one of their prestigious Cheers awards for the PCA project.

Over the years, with so many changes and transitions in the healthcare industry, it’s been both exciting and reassuring that these clinicians continue to volunteer their time to help make patent care safer for our community and beyond.

Controlled substance abuse is a serious problem in the United States. Eighty percent of opioid analgesics in the world are consumed in the U.S., and as sales of opioid narcotics have increased, there has been a parallel increase in the number of deaths attributed to overdose. Unintended prescription opioid overdoses cause more deaths in the U.S. than cocaine and heroin combined, and prescription drug overdose cause more deaths than automobile accidents.

How are these drugs getting in to the community? Widely publicized are prescription fraud, “pill mills” and “doctor shopping” to obtain medications outside the standards of medical practice. Another source may be medications that are “leftover” after treatments. Fifty-five percent of people who abuse prescription painkillers report getting them from friends or relatives.

Unfortunately, controlled substances are sometimes willingly or carelessly diverted from the healthcare system into the hands of addicts or enablers. In far too many cases, those individuals are members of the healthcare profession. A 2007 study found that 10-15 percent of health professionals develop serious substance abuse/addiction problems at some point in their professional career.

CareFusion recently presented a webinar on diversion trends and prevention strategies. I encourage you to take the time to view the full presentation, but if you can’t, I offer three key takeaways:

1)     Technology is helping hospitals better control medication inventories and reduce opportunities for diversion. One study, involving 68 hospitals, bears that out convincingly. Before installing automated cabinets for controlled substances, the hospitals identified .36 instances of diversion per 100 beds per year. After installing automated cabinets, that number jumped to 1.12—a 321 percent increase in detection. If you apply that to a 350-bed hospital, that means the technology would help identify about four diversions per year—each a potential life saved.

2)     Education and communication are critical. This includes involving the pharmacy in orientation and training programs for nurses, a strong internal communication network within hospitals, and ongoing professional development and training in best practices in medication management. Of course, diligence and accountability are just as important. Proactive organizations will build guardrails into organizational processes for medication purchasing, handling and waste management.

3)     Ultimately, successful diversion detection and prevention programs will incorporate new technologies and best practices as part of a holistic effort—including pharmacies, nursing and security staffs, human resources, hospital administration and more—aimed at changing the healthcare culture as it relates to medication management.

If you missed the webinar, I encourage you to view the recorded replay.

Standing at the bedside of a terminally ill family member is difficult. Recently, two physicians told me about their experience of something that made this situation worse – the noise of multiple infusion pump alarms that were a continuous source of anxiety and aggravation. The nurses, who knew the alarms were not emergencies, often did not respond quickly. The patient, who did not know the alarms were not urgent, felt the nurses were indifferent, and family members felt that their loved one was not receiving the best possible care.

This unfortunate situation highlights an emerging area of focus for hospitals: The importance of patient and family satisfaction. The two physicians suggested a possible solution—instead of sounding infusion alarms and other medical device alarms at the bedside, send the alarms to the central nursing station and to the mobile device of the responsible nurse, which would make the hospital environment much quieter and less stressful. Fortunately, work is already underway working to make remote or “distributed” device alarms possible. These efforts, however, will need to clear multiple technical and regulatory hurdles and address several requirements:

1)  The first requirement for remote alarm notification is wireless connectivity that integrates bedside devices and the hospital’s information technology (IT) network. The infusion pump industry has been at the forefront of this effort. For CareFusion, more than half of our installed pumps are already on wireless networks. Wireless connectivity makes it easier to update “smart” pump drug libraries and collect continuous quality improvement (CQI) data on alerts. Additional wireless capabilities are already in clinical use, including integrating the pump with the electronic medical record (EMR) on the hospital IT network. This interoperability makes it possible to send the physician’s orders from the EMR to pre-program the pump with the intended infusion parameters, which can help decrease human error when using the keypad. It also sends back data to the EMR to automatically document the infusion.

2)  Any medical device manufacturer will need to consider regulations from the U.S. Food and Drug Administration and other international regulatory bodies for the types and sound volumes of medical device alarms when designing potential distributed alarm notifications. Under the current standards, even if an infusion pump sends the alarms to a remote communication system, the bedside alarm still must sound. Changing such standards often takes years.

3)  Alarm system developers will need to ensure that critical alarms sent to a third-party system initiate communication back to the device itself to indicate that the alarm was received. Repeat alarms would also need to be sent if the device alarm is not addressed within a specified time limit. This capability does not exist in the current generation of infusion pumps, which number more than 1 million in the U.S. alone.

4)  Finally, another challenge is that while medical devices are regulated by the FDA in the U.S., healthcare information technology (HIT) systems and other technologies are not.

The noise problem goes beyond just alarms and medical devices, as Pauline Chen, MD, a transplant surgeon at the University of California at Los Angeles described in her recent column in the New York Times,titled “Clatter in the Hospital Room.” Medical device interoperability is a major focus for device manufacturers, IT companies, researchers and clinicians. In October 2011, more than 300 engineers, clinicians, representatives from medical device and HIT companies, the FDA and other agencies met at the Clinical Alarms Summit convened by the Association for the Advancement of Medical Instrumentation (AAMI), the FDA, The Joint Commission, American College of Clinical Engineering (ACCE), and the ECRI Institute. For more than two days, this multidisciplinary group of experts focused on the issues and opportunities related to integrating medical devices with HIT networks. As detailed in the conference report, results included both short-term, follow-up items and a research agenda for the longer-term.

CareFusion is collecting and analyzing alarm and alert data from hundreds of thousands of its infusion pumps to better understand pump alarms. Unlike monitors, which are notorious for false alarms, we have found that pump alarms are true alarms. Our focus is to help hospitals reduce the alarms. For example, an analysis of more than 12 million alarms showed that half were associated with occlusions and more than 90 percent of these were in Intensive Care Units and medical/surgical units. Many of the occlusion alarms were related to catheter placement issues when catheters became kinked as patients moved their arms. In our analysis, a significant percentage of alarms and alerts were related to specific patient-care practices that we believe can be addressed by sharing and implementing best practices across individual hospitals.

In summary, efforts are underway in this area, led by companies that are focusing specifically on alarms. These efforts include using technology to send more meaningful messages through the nurse call systems, sending pre-alarm alerts to nurses when infusion bags are near empty, allowing nurses to remotely reset medical devices and informing nurses of where and why a specific pump is alarming.

It is clear that alarms are an important focus area for the medical device industry. While changes won’t happen overnight, the converging focus across government and industry shows promise for a solution to this important issue.