Emergency medicine team working on patient (848 x 565 px)

In his article, “A SEC for Health Care?“, Dr. Peter Pronovost, Ph.D., FCCM (Professor, Departments of Anesthesiology/Critical Care Medicine and Surgery, The Johns Hopkins University School of Medicine and Medical Director, Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality) discusses the tremendous variability in the quality and measures of healthcare provided across this country:

Depending where you look, you often get a different story about the quality of care at a given institution. For example, none of the 17 hospitals listed in U.S. News and World Report’s “Best Hospitals Honor Roll” were identified by the Joint Commission as top performers in its 2010 list of institutions that received a composite score of at least 95 percent on key process measures.

As an illustration of the variability of quality, the Emily Jerry Foundation released its “2013 National Pharmacy Technician Regulation Scorecard“. The development of this scorecard was prompted by the heartbreaking story of what happened to two-year-old Emily Jerry.

Emily Jerry

Emily had waged a successful battle against cancer. Her treatment had been so successful that her last MRI clearly showed that the tumor miraculously disappeared. In fact, three radiologists had to review her MRI films due to the fact that there wasn’t even any residual scar tissue left. Emily’s doctors said it was as if she never had cancer! Regardless, she was scheduled to begin her last chemotherapy session on her second birthday, February 24, 2006. This last treatment was just to be sure that there were no traces of cancer left inside of her little body. Tragically, it was not cancer or the reoccurrence of cancer that ended Emily’s life. She was killed by an overdose of sodium chloride in the last chemotherapy IV bag she received.

Shortly, after Emily’s tragic death, it was determined that a pharmacy technician, who did not have the proper training or core competency to be compounding IV chemotherapy, had made the deadly compounding error. The primary reason the pharmacy technician involved in Emily’s death lacked the core competency to be compounding IV medications safely was due to the simple fact that in 2006, in the state of Ohio, there were absolutely no requirements to become a pharmacy technician, aside from having your high school diploma. No training requirements, no continuing education requirements, no oversight by the Ohio State Pharmacy Board, no licensing or registration requirements, etc.

What is even more disturbing, is the fact that The Emily Jerry Foundation has been receiving an outpouring of concern from most people in the general public, as well as, the caregivers themselves, who were previously completely unaware that in all of our nation’s world-renowned medical facilities, including the leading pediatric facility where Emily was treated, pharmacy technicians are the individuals responsible for compounding virtually all IV medications in the clinical pharmacy. It was this type of variability in quality, in terms of pharmacy technician requirements, coupled with the fact that the pharmacy technician’s overall scope of responsibilities have expanded greatly in recent decades, that led to the passage of Emily’s Law in the state of Ohio in January of 2009. Even though Emily’s Law significantly helped to reduce much of this variability in quality in the state of Ohio, this inherent problem is still very evident in many other states across the nation.

 

Healthcare performance measures

The Emily Jerry Foundation’s 2013 National Pharmacy Technician Regulation Scorecard highlights the states that are doing a great job of protecting their patients through strict controls and educational requirements for pharmacy techs, as well as encourage those that are lagging behind to make improvements in their own standards in order to improve care and potentially save lives. States like North Dakota received a perfect score based on the Foundation’s grading criteria. However, it’s now 2013 and six states still have no oversight by their respective state boards of pharmacy and, subsequently, no regulation regarding their pharmacy technicians. Numerous studies have shown that overall pharmacy error rates are volume dependent. With that fact in mind, pharmacy technician oversight and regulation issues like these become even more of a serious matter of public safety in states like New York, which currently has the second highest prescription volume in the United States (253,796,344 Rx filled in 2012).

How should this variability in quality be fixed and subsequently managed?

Dr. Pronovost, together with his colleagues, in their paper, “Achieving the Potential of Health Care Performance Measures” propose seven recommendations:

  1. Decisively move from measuring processes to outcomes;
  2. Use quality measures strategically, adopting other quality improvement approaches where measures fall short;
  3. Measure quality at the level of the organization, rather than the clinician;
  4. Measure patient experience with care and patient-reported outcomes as ends in themselves;
  5. Use measurement to promote the concept of the rapid-learning health care system;
  6. Invest in the “basic science” of measurement development and applications, including an emphasis on anticipating and preventing unintended adverse consequences; and
  7. Task a single entity with defining standards for measuring and reporting quality and cost data, similar to the role the Securities and Exchange Commission (SEC) serves for the reporting of corporate financial data, to improve the validity, comparability, and transparency of publicly-reported health care quality data.

Dr. Pronovost says the last proposal would bring about the most change:

Of the proposals, perhaps the biggest game-changer would be the creation of an entity to serve as the health care equivalent of the U.S. Securities and Exchange Commission. Rather than wading through a bevy of competing and often contradictory measures, patients and others would have one source of quality data that has national consensus behind it.

 

Building a consensus, such as a checklist

While the merits and demerits of a SEC for healthcare can be debated, one thing is clear from the comments posted in reply to Dr. Pronovost’s article—experts in specific areas should build consensus and determine what the ideal system should look like.

An example of the development of consensus is in checklists. The checklist developed by the Physician-Patient Alliance for Health & Safety reminds caregivers of the essential steps needed to be taken to initiate patient-controlled analgesia (PCA) with a patient and to continue to assess that patient’s use of PCA.

Monitoring patients receiving opioids by PCA is a critical patient safety issue. In its Sentinel Event Alert, “Safe Use of Opioids in Hospitals“, The Joint Commission recently stated:

While opioid use is generally safe for most patients, opioid analgesics may be associated with adverse effects, the most serious effect being respiratory depression, which is generally preceded by sedation.

More than 56,000 adverse events and 700 patient deaths were linked to PCA pumps in reports to the Food and Drug Administration (FDA) between 2005 and 2009. One out of 378 post-surgical patients is harmed or die from errors related to the patient-controlled pumps that help relieve pain after surgical procedures, such as knee or abdominal surgery.

More recently, Pennsylvania Patient Safety Authority released its analysis of medication errors and adverse drug reactions involving intravenous fentanyl that were reported to them. Researchers found 2,319 events between June 2004 to March 2012—that’s almost 25 events per month or about one every day. Although one error a day may seem high, their analysis is confined to reports made to the Pennsylvania Patient Safety Authority and only include fentaNYL, a potent, synthetic narcotic analgesic with a rapid onset and short duration of action.

Consequently, to provide greater patient safety, one of the recommended steps of the PCA Safety Checklist therefore provides:

Patient is electronically monitored with both:

  • pulse oximetry and
  • capnography

 

The bottom line

The relentless push for quality and better patient safety must continue. To do otherwise will mean more Emily Jerrys and Amanda Abbiehls (who died after unmonitored use of a PCA).

Amanda Abbiehls

For those of us who might think that death in a healthcare facility cannot happen to us or someone we know, Dr. Pronovost reminds us that preventable deaths are a leading cause of death. As he recently stated on The Katie Couric Show:

Frame the size of your problem. I suspect that all of your viewers either have been touched by or a family member has been harmed by mistakes. It is the third leading cause of death in this country. More people die from medical mistakes each year than died per year in the civil war.

So, make sure adequate training is provided for all those involved in healthcare delivery, like pharmacy technicians, and use checklists as a reminder of essential steps, such as the PCA Safety Checklist. It just may save a life.

Michael Wong, JD
Michael Wong, JD is the founder and Executive Director of the Physician-Patient Alliance for Health and Safety (PPAHS). He has been at the forefront in driving practical solutions that reduce healthcare costs, decrease medical errors, and improve patient health outcomes. He has been particularly active in these areas that most affect patient safety: • Improving patient adherence (i.e. helping patients to take their medications as prescribed by their physicians) • Enhancing patient access to healthcare • Reducing medical errors (PPAHS), is an advocacy group of physicians, patient advocates, and healthcare organizations. Supporters of and commenters for PPAHS include highly respected physicians and healthcare organizations, including the The Joint Commission, Anesthesia Patient Safety Foundation, Anesthesia Quality Institute, Johns Hopkins School of Medicine, Harvard Medical School, Stanford University School of Medicine, and the Cleveland Clinic.

2 COMMENTS

  1. The health plan pharmacy board saw my chart that I was taking Armour, and they still approved the pseudoephedrine. They didn’t give a F if they killed me or not. I wanted to add this point.

  2. I use Armour thyroid. Before my thyroid was diagnosed, I had problems with OTC meds-cough syrups with the D stuff, sudafed, acetaphinmen. and pseudoephedrine.

    I was poisoned by statins, and one of the permanent side-effects is a runny nose-like a child. My doctor prescribed antihistamines-to make sure that I didn’t get sick from a side-effect. I saw his script order on the EHR. I went in to pick it up. Somebody decided to change it-I think that the pharmacy decided it would make more money with OTC. I know the pharmacy board was involved, as they had to authorize the change. I took a package in and my doctor said-They lied to him and he punched the wall.

    My temp went down to 94, My clothes and hair were constantly wet from sweat. I drooled, my nose ran like a faucet. My eyes hurt. I got a sinus infection. I was so weak. My whole body was trembling. My heart felt like a jack hammer trying to break my ribs to get out. I took the pills for 3 days, and I quit. My family wanted to take me in to the hospital. I cried, and said they’ll kill me.They’re killing me now.

    I was so mad, that I called the number on the box. To my surprise, I was put on a conference call with the lab and the woman that I was talking to. I had been transferred up to an executive. I listed my meds- how long I took thyroid, why I wasn’t on synthroid, where I bought this. They asked if I had patient counseling. I asked if a screaming match with 3 pharmacists and techs counted? I told them that I didn’t want it, but they told me it was what I had been taking. That happened to me before. It had 250 mgs of pseudoephedrine in each pill. They asked me if I’d gone to the doctor-ER-I told them that I was scared they’d kill me. Look how sick I was from the F**** pharmacy board.

    They called up about every 5 days. If my son answered the phone, they actually asked him if I was still alive. They asked me to take the box in, and point to the contradictions and ask the pharmacy why it listed a warning for thyroid-and call them up and tell them what the pharmacy said. The pharmacist said that thyroid didn’t mean anything.

    That chain pharmacy now has new pharmacists and staff. My doctor was upset that I didn’t go in. I told him that I knew the pharmacy board changed the script, and I was scared to go in, because I was scared the hospital would kill me-my body couldn’t handle anything more. This state has pretty high standards. The techs have to be licensed. But training and licensing doesn’t make any difference if the people don’t give a tinker’s darn.

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