Repost:Criminalization of Medication Errors; Mistakes by Pharmacists

The following article appears at http://www.uspharmacist.com/content/c/16572/

Jesse C. Vivian, BS Pharm, JD

Professor, Department of Pharmacy Practice
College of Pharmacy and Health Sciences
Wayne State University
Detroit, Michigan

11/19/2009

US Pharm. 2009;34(11):66-68. Here is a sobering thought. A pharmacist makes a mistake. The error results in the death of a patient, and the pharmacist is charged with negligent homicide. He is found guilty of involuntary manslaughter and faces up to 5 years in prison and a maximum fine of $10,000. Of course, his pharmacist license is revoked and chances are he will never work in the profession again. His crime? He did not check the accuracy of calculations used by a pharmacy technician under his charge to compound the concentration of sodium chloride in a prescription for a cancer chemotherapy solution.
Negligent? Yes. Accountability and responsibility? Yes and Yes. Malpractice? Yes. Loss of license? Yes. Guilty? Yes. But a crime? Prison term? For a mistake, albeit a mistake with a worst-case outcome? That is tough medicine to swallow. More important, how is justice served by putting this pharmacist in jail? The message to pharmacists and perhaps all other health care practitioners—watch out. There may be prosecutors out there just itching to put you away.

Facts of the Case

On February 24, 2006, while working at the Rainbow Babies and Children’s Hospital in Cleveland, Ohio, licensed pharmacist Eric Cropp received a prescription for a chemotherapy solution of Eposin (etoposide phosphate) that was supposed to be mixed in an IV bag of normal saline containing 0.9% 
sodium chloride.¹ The patient, Emily Jerry, was diagnosed with a yolk sac tumor when she was about a year and a half old. The tumor was the size of a grapefruit and stemmed from the base of her spine into her abdomen. Her team of doctors and nurses assured the parents that Emily’s cancer was not only treatable but curable. Emily endured months of surgeries, testing, and rigorous chemotherapy sessions, each of which lasted for 5 or 6 days. Emily’s treatment had been so successful that her last MRI clearly showed that the tumor had shrunk dramatically, with minimal residual scar tissue. However, her physicians still felt one final treatment was necessary to prevent the tumor from reappearing. She was scheduled to begin her last chemotherapy session on her second birthday. This last treatment was just to be sure that there were no traces of cancer left.
The medication was to be the fourth and final round of treatment. Two days later, after the IV therapy was started, the child collapsed in her mother’s arms, crying in pain and vomiting. She grabbed her head and said, “Mommy, it hurts, it hurts.” The IV was started at 4:30 pm. By 5:30 pm, she was on life support. She went into a coma and died on March 1, 2006.² The infusion caused intense cerebral edema.
For reasons that have never been explained, the technician who made the mixture, Katie Dudash, used a saline base solution of 23.4% sodium chloride instead of the commercially available standard bag of normal saline. She told investigators that she did not recall why she decided to make a new solution of saline from scratch instead of grabbing a premade bag of normal saline that was available right there in the pharmacy. She said she was distracted because she was talking on her cell phone just before the incident happened, busy making plans for her upcoming wedding.
An investigation into the incident disclosed that many circumstances contributed to the error’s occurrence. The pharmacy computer system was not working and a backlog of physician orders was piling up. The pharmacy was short-staffed and everyone in the pharmacy was busy. The employee shortage meant that normal work and meal breaks were altered or not available. The technician was distracted from her normal routine. A floor nurse called the pharmacy and asked the pharmacist to send the solution early. As a result, he felt rushed. Ironically, it was later determined that the IV bag was not needed for several hours.
As can well be imagined, this incident took a terrible toll on the parents. They sued the hospital for malpractice and obtained a $7 million settlement.³ Soon afterward, the parents separated, and they divorced a year later. The mother, Kelly Jerry, had to obtain restraining orders against Emily’s father, Chris Jerry. He violated at least one of the orders and lost custody of both of his other children. In 2008, he was arrested for possession of marijuana and charged with resisting arrest. His case was diverted to a mental health court for sentencing. He sought psychological counseling as he looked for a way to work through his problems.
Then, in 2009, Chris Jerry found a way to make something out of this tragedy. Mr. Jerry began counseling families in local hospitals whose children were on life-support systems. He made himself present simply as one who understands what they were going through. “I can speak to these people because I have gone through something similar, I know what they need to hear,” he said. “I can relate to them in every way.”⁴ He also started Emily’s Foundation, a charity he hopes to use to push for a national law to govern the work of pharmacy technicians and help prevent medical errors like the one that killed his daughter.⁵
Kelly Jerry attended all of the civil and criminal proceedings and made a compelling statement at the board of pharmacy hearing on the administrative complaint against the pharmacist. Chris Jerry did not attend any of the legal actions, although now he no longer feels any anger against the pharmacist. In fact he has been quoted as saying, “I feel very sorry for the pharmacist. This guy is facing a prison sentence, and I know it was an accident.”⁶

Unprofessional Conduct

The pharmacist and the technician were dismissed by the hospital about 1 month after the incident. The tech went to back to work at CVS/pharmacy where she had been employed before working at the hospital. The pharmacist found a job at a local retail pharmacy just a few weeks later. There, according to records, he made an additional 13 more dispensing errors over a 10-month period. One of those errors caused harm to another child.⁷
The Ohio State Board of Pharmacy held a hearing on a formal complaint against the pharmacist on April 11, 2007, a little over a year after the incident that caused the death of Emily Jerry.⁸ For this error, the board found him responsible for misbranding and mislabeling a drug in violation of Ohio law.⁹ But this incident was actually only the beginning of Mr. Cropp’s problems.
On April 26, 2006, while working at a community pharmacy, Eric Cropp misbranded a prescription for Compazine (prochlorperazine) 10-mg tablets prescribed for “nausea and vomiting.”¹⁰ He typed the label indicating the medication was to be taken “as needed for pain.” While at the same store, on July 18, he dispensed tramadol with acetaminophen instead of the prescribed Vicoprofen (hydrocodone and ibuprofen). On July 25, he dispensed metformin ER 500-mg tablets to a patient instead of the Biaxin XL (clarithromycin) 500-mg tablets that were prescribed. On that same day, he gave the Biaxin to the patient who should have been given the metformin. On August 18, he received a prescription for Phenergan (promethazine) 25-mg suppositories with directions to be used “rectally every 8 hours.” Instead, he typed a label indicating the medication was to be “taken by mouth.” On September 19, he dispensed Adderall XR (amphetamine and dextroamphetamine) 5-mg capsules to an 8-year-old child who had been prescribed Focalin XR (dexmethylphenidate) 5-mg capsules. The child suffered undisclosed injuries. On November 13, he received a prescription for Disalcid (salsalate) 500 mg. He dispensed Azulfidine (sulfasalazine) 500 mg instead. On November 18, he received a prescription for VoSol HC (hydrocortisone and acetic acid) from an ear, nose, and throat physician with indications that the medication was to be used “in the ear.” He labeled the drug as for use “in the eye.” On December 12, he received a prescription for Zoloft (sertraline) 100-mg tablets with directions that the patient should take “two tablets every evening.” He labeled the medication to be taken “twice daily.” On December 15, he received a prescription for Avelox (moxifloxacin) 400 mg. He labeled and dispensed the drug to the wrong patient. On December 26, he received a prescription for Zoloft (sertraline) 100-mg tablets. Instead, he dispensed 50-mg tablets. On February 3, 2007, he received a prescription for E.E.S. (erythromycin ethylsuccinate) 200 mg/5 mL suspension. Instead, he dispensed erythromycin with sulfisoxazole suspension. Finally, on the following day, he received a prescription for two boxes of Imitrex (sumatriptan) 6 mg/0.5 mL and dispensed a quantity less than what was called for by the prescription.
The Ohio Board of Pharmacy found that all of the above conduct constitutes “unprofessional conduct” in violation of state law and then permanently revoked the pharmacist’s license.¹¹ The vote was six in favor of this resolution with two board members in opposition.
In May 2009, the pharmacist pleaded no contest to a charge of involuntary manslaughter for improperly supervising the technician. On August 14, 2009, Mr. Cropp was sentenced to 6 months in prison, 6 months of home confinement with electronic monitoring, 400 hours of community service, a $5,000 fine, and payment of court costs.¹² Part of the community service sentence requires him to seek out medical and legal organizations where he can tell his story and, hopefully, help prevent others from making a similar mistake. Remember that his pharmacist license was permanently revoked, so he will have a significant loss of future income. And then, of course, there are the undisclosed attorney fees that the pharmacist incurred in his hearing in front of the Board of Pharmacy and his criminal prosecution.
Oh, and by the way, what happened to the pharmacy tech that made the fatal error? Katie Dudash was charged by the prosecutor with negligent homicide, but the grand jury gave her a “get out of jail free card.” She gets off with no real penalty and is now working in a retail pharmacy. She was not licensed, registered, or certified by the state to work as a technician, so there were no administrative sanctions available. She has no accountability or responsibility. She was just an employee doing a job. She did not do her job right, but there were no consequences—other than losing her job and maybe having to live with the idea that her actions directly caused the death of another human being.

Emily’s Law

At the time, Ohio was one of many states that had no minimum training, licensing, registration, or certification requirements for pharmacy technicians. State regulations vary tremendously with respect to pharmacy technicians. Currently, only eight states license technicians, 31 states have registration, and five states certify techs. Twenty states have no educational requirements (training, continuing education, or certification exam) for technicians.¹³ On January 7, 2009, the governor of Ohio signed SB 203, known as “Emily’s Law,” which establishes standards for qualified pharmacy technicians and requires them to undergo a criminal background check.¹⁴ They must also pass a competency test. It also establishes penalties for certain activities, including compounding, packaging, and preparing a drug by an individual who is not a pharmacist, pharmacy intern, or qualified pharmacy technician.¹⁵
The downside of making this mistake, awful as it was, into a criminal case with incarceration for the offender is that it discourages others from ever wanting to report errors with serious consequences. “We need to change the system. I’m hopeful that we can find something meaningful in terms of safety from this child’s death,” said Bona Benjamin, director of medication use quality improvement at the American Society of Health-System Pharmacists (ASHP).¹⁶ Some pharmacy groups are beginning to push for greater standardization of technician training. ASHP has developed a model curriculum for pharmacy technician training program accreditation as the first effort to develop a national standard. In addition, the National Pharmacy Technician Association, the Institute for the Certification of Pharmacy Technicians, and the Pharmacy Technician Certification Board have all worked to develop technician training standards.¹⁷
If nothing else, this case should send a loud and serious message to pharmacists. You can delegate activities associated with the practice of pharmacy to technicians and others. But you can never delegate responsibility or accountability. It is your name on the license, and there are no excuses for mistakes of this type.

REFERENCES

1. Emily’s Story. Emily Jerry Foundation. http://emilyjerryfoundation.org/emilys-story/. Accessed October 11, 2009.
2. Robins M. Fatal dose: Ohio girl is killed by medical mistake. January 31, 2007. www.firstcoastnews.com/news/usworld/news-article.aspx?storyid=75102. Accessed October 4, 2009.
3. Whitley M. Chris Jerry, whose daughter Emily died from a pharmacy technician’s mistake, starts foundation to push for national law. June 13, 2009. http://blog.cleveland.com/metro/2009/06/chris_jerry_whose_daughter_emi.html. Accessed October 11, 2009.
4. News. Emily Jerry Foundation. October 7, 2009. http://emilyjerryfoundation.org/chris-jerry-whose-daughter-emily-died-from-a-pharmacy-technicians-mistake-starts-foundation-to-push-for-national-law/. Accessed October 11, 2009.
5. See note 4, supra. The Web site states, in part: “The core of the Emily Jerry Foundation focuses on protecting our nation’s babies and children from the all too redundant medical errors that keep occurring over and over again in hospitals across the nation. These countless mistakes are killing our children and are most often avoidable. We are increasing public awareness of these issues and striving to get better legislation in place across the United States. The Emily Jerry Foundation is helping to save countless lives, as well as make our world-renowned medical facilities much safer.”
6. See note 4, supra.
7. Failure to track pharmacy mistakes may be “prescription for trouble.” NewsNet5. March 23, 2009. www.newsnet5.com/news/18917359/detail.html. Accessed October 11, 2009.
8. Minutes of the April 9-11, 2007 meeting of the Ohio State Board of Pharmacy. Docket Number D-061108-012. http://pharmacy.ohio.gov/minutes/mins07040911.pdf. Accessed October 11, 2009.
9. ORC § 3715.52(A)(2) and OHC Rule 4729-17-10.
10. See note 8, supra.
11. ORC § 4729.16.
12. Not a wonderful life: no George Bailey for pharmacist Eric Cropp or his patient. September 5, 2009. http://jparadisirn.com/2009/09/05/not-a-wonderful-life-no-george-bailey-for-pharmacist-eric-cropp-or-his-patient/. Accessed October 4, 2009.
13. Reid P. Former pharmacist indicted for manslaughter after med error. Drug Topics. September 17, 2007. http://drugtopics.modernmedicine.com/drugtopics/Community+Pharmacy/Former-pharmacist-indicted-for-manslaughter-after-/ArticleStandard/Article/detail/456584. Accessed October 11, 2009.
14. Sangiacomo M. Ohio governor signs “Emily’s Law” forcing standards for pharmacy technicians. Cleveland Plain Dealer. January 7, 2009. www.cleveland.com/medical/index.ssf/2009/01/emilys_law_enacted_by_gov_stri.html. Accessed October 11, 2009.
15. Governor signs “Emily’s Law” legislation. www.governor.ohio.gov/News/PressReleases/2009/January2009/News1709/tabid/956/Default.aspx. Accessed October 11, 2009.
16. See note 13, supra.
17. See note 13, supra.
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