Follow Dr. Tim Vanderveen, Vice President of the Center for Safety and Clinical Excellence at CareFusion, as he discusses trends in medication management.

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    Dr. Tim Vanderveen

    "Life is full of unanticipated events; changes that are not always welcome, circumstances beyond our control. I stay grounded in knowing that with change comes opportunity.”

Dr. Tim Vanderveen

Vice President, Center for Safety and Clinical Excellence, CareFusion

Tim Vanderveen credits much of his career to circumstance and serendipity. But, it was clearly no accident when his plans to become a veterinarian led him instead to a career in pharmacy.

In his clinical practice, Dr. Vanderveen specialized in intravenous nutrition and co-founded one of the first multidisciplinary nutrition support teams. His continued work in IV medication therapy drew him to the infusion device industry, where he went on to author patents in infusion technology and was one of the creators of Smart IV pumps. Today, his work continues to focus on the challenges and complexity of the medication use process. As vice president of the CareFusion Center for Safety and Clinical Excellence, he’s responsible for directing clinical, educational and research activities related to medication safety.

Tim holds a master’s degree from Purdue University School of Pharmacy and a PharmD degree from the Medical University of South Carolina.

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Dr. Tim Vanderveen - Vice President, Center for Safety and Clinical Excellence, CareFusion

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.

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.

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Dr. Tim Vanderveen - Vice President, Center for Safety and Clinical Excellence, CareFusion

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.

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.

 

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Dr. Tim Vanderveen - Vice President, Center for Safety and Clinical Excellence, CareFusion

For more than a decade, the CareFusion Center for Safety and Clinical Excellence has sponsored periodic Invited Conferences – a favorite event among the team. These meetings bring together multidisciplinary thought leaders from around the world to present on and participate in discussions on a single theme or topic. We recently hosted a scaled-down version of an Invited Conference focused on the medication use process.

For more than a decade, the CareFusion Center for Safety and Clinical Excellence has sponsored periodic Invited Conferences – a favorite event among the team.  These meetings bring together multidisciplinary thought leaders from around the world to present on and participate in discussions on a single theme or topic.

We recently hosted a scaled-down version of an Invited Conference focused on the medication use process, where seven hospital and clinical pharmacists came together to share their experiences and expertise on the subject.

We began with a presentation of results from the latest ASHP survey on the state of pharmacy practice, including the current state of the drug distribution process and adoption of medication safety technology.

Other discussions focused on the use of pharmacy robotics to compound injections and infusions, in-sourcing  and outsourcing of pharmacists for medication order review, improving IV compounding accuracy, integrating infusion pumps with the EHR for auto-programming and auto-documentation, continuous monitoring of opioid administration with end tidal CO2 and respiratory monitoring, and managing pharmaceutical waste. One of our invitees – a member of the Institute of Medicine’s (IOM) expert panel on Health Information Technology – shared an overview of the recent publication from the IOM. 

The presentations and discussions were insightful and educational for both our clinical team and the network of peers who attended the meeting. Here are a few of my key takeaways:

1) Significant changes are taking place within multiple aspects of the medication use process.  For example, technology is freeing up pharmacists to be more involved clinically, helping to improve medication safety and efficiency.  Technicians checking technicians; use of robotics to prepare IV medications; remote pharmacy review of orders; and, a growing reliance on automated cabinets for dispensing are among the advances allowing pharmacists to change their roles within hospitals. 

2) Still in the early stages, but very exciting, is the beginning of true interoperability between infusion pumps, bar code systems, and electronic health records. Among many benefits of this technology, nurses can now confirm automatic programming rather than the traditional programming involving multiple key presses. 

3) Finally, some important regulatory issues are surfacing and changing the medication use process, including mandatory medication order review prior to administration in areas like the emergency department, and EPA and state regulations guiding disposal of pharmaceutical waste. And, in the future, we may begin to see the FDA weigh in on certain aspects of healthcare IT. 

In this dynamic time of change, the CareFusion Center for Safety and Clinical Excellence continues to monitor these important topics. Look for upcoming webinars and events on the Center website.

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Dr. Tim Vanderveen - Vice President, Center for Safety and Clinical Excellence, CareFusion

I’ve been lucky during my lifetime to have always had plenty—plenty of food, plenty of water, shelter and resources, and, until recently in my clinical career, a seemingly unlimited supply of medications for the hospital pharmacy. A lot has changed in the last 10 years. We can no longer take for granted that we have medications on-hand to treat our patients.

One of the benefits of my role with the CareFusion Center for Safety and Clinical Excellence is the opportunity I have to work with many talented clinicians who are dedicated to and passionate about patient safety.  In a recent conversation with one such clinician, Rhonda McManus, PharmD, we discussed the national drug supply crisis and how it is impacting patient care.  I mentioned to Rhonda that I would be thrilled to have her as a guest author to contribute her perspective on this topic, and  she responded with the following comments. 

Thanks, Rhonda, for taking the time to share your thoughts.

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The land of…plenty?
Rhonda McManus, Pharm D, Director, Clinical Education and Development at CareFusion

I’ve been lucky during my lifetime to have always had plenty—plenty of food, plenty of water, shelter and resources, and, until recently in my clinical career, a seemingly unlimited supply of medications for the hospital pharmacy.  If a medication was not available from the primary supplier, the back-up distributor would likely have it.  And if the back-up distributor didn’t have it, then surely the hospital across town would be willing to loan a few doses.  In the worst case scenario, with the occurrence of a spider bite or some other rare event, another hospital in the state would have it, and the highway patrol would be willing to transport the needed medication. 

A lot has changed in the last 10 years.  We can no longer take for granted that we have medications on-hand to treat our patients.  With more than 170 medications on the drug shortage list1, hospital pharmacies have been forced to obtain medications from compounding pharmacies, when they can get the raw materials, or from the “gray market.”  These alternative sources come at a price. In fact, average markup on the gray market is 650 percent over the usual price charged for most medications.2 When medications are not available through alternative sources, therapeutic substitutions may be offered.  In those cases, or when alternative strengths are obtained, communication is critical to prevent medication errors and avoid patient harm.  For example, I recently heard about a case involving epinephrine, where a different strength than what is normally supplied was in the crash cart, and the patient received the wrong dose.

The problem of drug shortages is a national issue and cause for serious concern among hospitals and patients. The topic has generated public attention, and questions are being raised including: What are the ethical implications of the drug shortage?  What if the shortage becomes so critical that we have waiting lists for drug therapy, similar to organ transplants? Who would select which patients receive medication once it becomes available?

The good news is that the U.S. Senate and the U.S. House of Representatives recently passed legislation that requires manufacturers to notify the FDA at least six months in advance of a production interruption or prior to discontinuing a medication. This advance notification is essential to avoiding drug shortages.  The bill also allows for repackaging of medications in short supply to be used within the same health system.  President Obama signed the bill on July 9.  

The American Society of Health-System Pharmacists, the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology and the Institute for Safe Medication Practices worked closely with members of Congress to develop the new bill. Please join me in thanking these organizations and continuing to support their efforts to improve patient care.

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References

  1. http://www.ashp.org/DrugShortages/Current/.  Accessed 5/21/2012
  2. https://www.premierinc.com/about/news/11-aug/Gray-Market/Gray-Market-Analysis-08152011.pdf.  Accessed 5/21/2012
  3. http://www.ashp.org/menu/AboutUs/ForPress/PressReleases/PressRelease.aspx?id=692. Accessed 6/5/2012. 
  4. http://www.ashp.org/menu/News/NewsCapsules/Article.aspx?id=442. Access 7/4/2012
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Dr. Tim Vanderveen - Vice President, Center for Safety and Clinical Excellence, CareFusion

Under the leadership of Dr. David Bates from the Brigham and Women's Hospital in Boston, a three-year multi-hospital study on IV infusions is underway. Dr. Bates and his staff have recruited a dozen hospitals of various sizes, structures and patient populations to conduct an infusion assessment, examining every aspect of in-process IV infusions according to a standardized protocol.

The past several years have been very interesting in the world of intravenous (IV) medication therapy.  In previous blog entries, I discussed the 10 year anniversary of smart IV pumps, shared new data on infusion pump alarms and reviewed progress toward wireless connectivity. We’ve made substantial advances over the past decade, however there is still much work to be done to help caregivers address the complexity of IV therapy.  

Every lecture or presentation I have made over the past seven years has started with a discussion of a research study published in 2005 by Marla Husch and her colleagues at Northwestern University Hospital in Chicago. Their research involved an assessment of 435 in-process IV infusions over an eight-hour period, starting with the IV drug container, the IV tubing, and the infusion pump settings, etc. They followed this bedside review with a review of each physicians’ order and the related nursing documentation. What they discovered was shocking: 67 percent of the IV infusions had one or more errors. Many of these errors were previously considered to be minor breaks in policy or procedure, but Marla and her colleagues identified infusions without physician orders, IVs still infusing after orders to stop, a large number of infusion rate errors, and one critical heparin infusion that was one-sixth of the ordered dose.  

When I share this research today, I often ask the audience to think about what the results might be if their institutions were to repeat Marla’s study. I no longer find it surprising that just about everyone estimates a significant error range, often between 25-50 percent. I attribute this to long-standing experience and an understanding of just how complex IV therapy has become. But while the study methodology seems straightforward, and the potential findings could be quite valuable, I have not heard of another institution that has repeated Marla’s study—until now.

Under the leadership of Dr. David Bates from the Brigham and Women’s Hospital in Boston, a three-year multi-hospital study on IV infusions is underway. Dr. Bates and his staff have recruited a dozen hospitals of various sizes, structures and patient populations to repeat the infusion assessment, examining every aspect of in-process IV infusions according to a standardized protocol. The hospitals will share results with Dr. Bates and his team, who will later formally present the finding presented in a peer reviewed publication.  

The idea for this study came about through the efforts of the National Steering Committee for Infusion Safety established by the Association for Advancement of Medical Instrumentation (AAMI) and the FDA. AAMI and the FDA co-sponsored a summit on infusion pumps in October 2010, and have continued to focus on this area of high-risk medication therapy.  The study is funded by a grant from The CareFusion Foundation.

Smart pumps will be used in each of the study hospitals and compliance with the use of the dose error reduction system (DERS) will be assessed, however, like Marla’s study, the research will seek to uncover best practices in infusion therapy and the multiple variables at play which include but span well beyond the optimal use of smart pumps. Time will tell how these results will impact the next decade, but if history is any judge – and with experts working together for improvement – the next ten years will bring even more progress in medication safety, both in theory and technology.
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Reference

Husch M, Sullivan C, Rooney D, et al. Insights from the sharp end of medication errors: Implications for infusion pump technology. Quality and Safety in Health Care 2005;14:80-6.

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