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4 posts from February 2010

02/25/2010

Dispensing Error – And a Pharmacist in Prison

By Daniel A. Hussar, the Remington Professor of Pharmacy at the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

Almost all pharmacists, as well as those in most other lines of work, have experienced days in which the scope and pace of our responsibilities have been extraordinarily intensive. However, at the end of the day, other than being stressed and exhausted, the experience has usually been relatively uneventful. Unfortunately, this is not always the case and, for some patients, there have been tragic outcomes. As "routine" as dispensing prescriptions may become, pharmacists must recognize that every prescription has "life or death" implications, and that errors can occur on "slow" days, as well as the hectic, stressful days. We must never let our guard down!

Two-year old Emily Jerry of Ohio died on March 1, 2006 as a consequence of an error made by a pharmacy technician and pharmacist. In preparing a solution for intravenous infusion, the technician used an excessive amount of a 23.4% solution of sodium chloride, and the pharmacist failed to recognize the error. This tragedy is discussed in detail in communications of the Institute for Safe Medication Practices (ISMP [www.ismp.org]) and in an article by Jesse Vivian in the November 2009 issue of U.S. Pharmacist.

It is painful for me to even think of one of my children or grandchildren dying from any cause, let alone a cause that was preventable. Therefore, the emotions and anguish experienced by Emily's parents are beyond my experience and understanding, and extending heartfelt sympathy seems too inadequate.

There was an investigation following Emily's death and factors that contributed to the occurrence of the error were identified. The pharmacy computer was down for part of the day resulting in a backlog of orders, the pharmacy was short-staffed on the day of the error, the technician was distracted by other activities, and a call from a nurse suggested that the need for the medication was urgent. The importance of these and other system problems as contributing factors to the causes and occurrence of errors must be recognized and, to the extent possible, eliminated. However, as pharmacists we must be personally responsible and accountable for our actions, or lack thereof.

The other consequences

The pharmacist and technician were dismissed by the hospital at which they were employed. The pharmacist obtained employment in a community pharmacy and was reported to have been responsible for some dispensing errors in that setting. The Ohio Board of Pharmacy determined that the errors of the pharmacist represented unprofessional conduct in violation of state law, and took action to permanently revoke his license. The vote of the Board has been reported to be six in favor of this action and two opposed.

The consequences for the pharmacist continued. He was charged with criminal actions and he pleaded guilty to a charge of involuntary manslaughter. In August, 2009, he was sentenced to six months in prison, six months of home confinement with electronic monitoring, 400 hours of community service, a $5,000 fine, and payment of court costs. His prison term concludes this month.

The penalty of permanent revocation of the pharmacist's license can be debated at length. Indeed, the Ohio Board of Pharmacy was not unanimous in this decision. However, it is the consideration of this event as a criminal matter and the resultant prison term that prompt my strongest objection and concern.

The dispensing error was a horrible mistake with the worst possible consequence, but it should not be considered a criminal action. Tens of thousands of deaths occur each year in the United States as a consequence of tragic, but accidental, medical errors. Should all of these errors be considered as criminal actions that will result in jail terms? Other than being able to quickly and specifically identify the cause of death and the individuals who made the error, what makes the tragic event in Ohio different from most of the thousands of other deaths that result from medical errors? Recently, a prominent Pennsylvania Congressman died. News reports indicate that he was admitted to the hospital to have "minimally invasive" gallbladder surgery. Unfortunately, during this surgery his intestine was "nicked." Complications set in and he died as a consequence. Should this surgeon be charged with a criminal action? My response is an emphatic "No!"

What purpose was served by sending the Ohio pharmacist to prison? I can't identify any. Rather, for the following reasons, I would contend that society has been done a great disservice by this action. Many deaths are caused by medical errors but are not recognized as such. An environment that encourages the identification, causes, and candid discussion of errors will result in a greater awareness and understanding of these risks, and an opportunity to disseminate such information in an educational manner that will help other health professionals, and their patients, avoid such experiences. However, if the environment is one that threatens criminal action, prison terms, and permanent revocation of one's license for making an accidental but fatal error, can we realistically expect that health professionals will acknowledge errors they make if the cause of the death is not readily apparent and/or can be "covered up?" The experience of the Ohio pharmacist sends a chilling message that the penalties for dispensing mistakes may be very harsh. This is the wrong action and the wrong message.

Where are the pharmacy associations?

Over a period of many years, Michael Cohen and his colleagues at ISMP have provided exceptional educational programs and commentaries with a goal of preventing medication errors. Their analyses and warnings regarding errors and the tragedies that sometimes result have been of great value in identifying the medications and circumstances that are associated with the greatest likelihood of error. Tragedies are not reversible but, once they have occurred, what can be learned and communicated for the benefit of others so that the experience is not repeated? This is the commendable focus of ISMP's analyses and warnings. Without ignoring the importance of health professionals being accountable for their actions, this organization emphasizes the prevention of similar future errors, rather than focusing on blame and penalties. ISMP has been highly active in addressing the tragic error that took Emily's life, as well as the professional and personal circumstances of the Ohio pharmacist. But, to my knowledge our pharmacy associations, such as the American Pharmacists Association (APhA) and the American Society of Health-System Pharmacists (ASHP), have been silent!

The implications of the Ohio experience are huge for pharmacists and our profession. I realize that I do not know all the details of the situation but, based on the information that is available, I have great concern about the criminal action pursued against the pharmacist and the resultant prison sentence because of his error. I would like to think that our professional associations would vigorously defend pharmacists against such punitive actions. They should do that even if the pharmacist charged is not one of their members, because the same risks and implications also exist for their members. Indeed, implications exist not only for pharmacists, but also for physicians, nurses, and other health professionals whose responsibilities involve life-or-death decisions and actions, that will sometimes result in errors. Our pharmacy associations should not only be actively addressing these situations on behalf of pharmacists, but should also be actively working with their counterparts in medicine and nursing to establish practice environments and policies that will keep errors to an absolute minimum, and to protect health professionals against criminal and punitive penalties for mistakes. It may be that APhA and ASHP have addressed the experience of the Ohio pharmacist and I am just not aware of their efforts. However, if they have done or said something, it has not been adequately publicized.

Personal responsibility and accountability

Our goal as pharmacists is to never make even one error! However, we will and do make errors, and can only hope that our errors will not have serious consequences. We sometimes have a false sense of assurance that our employer provides the needed insurance and support to protect us in the event of an error. In the Ohio experience, the hospital fired the pharmacist and technician. We must protect our patients, and ourselves, against stressful working conditions that increase the risk of errors. If you find yourself in such an employment situation, I urge you to communicate your concern to your manager and/or employer, and document your discussion. If no action is taken to reduce the stress and risk in your practice responsibilities, I urge you to seek employment elsewhere. The risks and potential consequences are too important, first of all for the patients we serve, and then for ourselves, to continue to be part of an unacceptable practice situation that we might forever regret.

Emily

In my passion to be an advocate for and to protect pharmacists, I must not forget Emily. She is the inspiration for this commentary regarding the need to design better systems that will increase the effectiveness and safety of health care and drug therapy, and the importance of pharmacists being more accountable. Emily's death has also been the inspiration for the enactment of Emily's Law in Ohio that establishes standards for pharmacy technicians.

02/22/2010

Proper Preparation for Inflight Emergencies

How prepared are we for inflight medical emergencies?

On Saturday it was reported that about 20 people were injured by turbulence aboard a flight to Japan, one of the injuries was a possible fracture. This reminded me of my own inflight medical emergencies on a flight also bound for Japan. The two medical emergencies I encountered on my trans-Pacific flight involved an elderly women with chest pain and a second one with a likely kidney stone. This was my second medical event – my first one being a full blown cardiac arrest on a domestic flight a year ago.

These events got me thinking about how prepared we are to handle inflight emergencies since they seem to occur with an increasing degree of frequency. This trend will continue as flights become longer and an increasing number of seniors take to the skies.

The Federal Aviation Administration (FAA) reported 13 serious events per day on domestic flights, one death per 1.5-4.7 billion passenger miles flown and approximately 1,000 cardiac arrests per year. These events were attended by a healthcare professional some 69 percent of the time – with 40 percent being physicians, 25 percent nurses, 4 percent paramedics.

As a physician, health policy expert, and frequent flier, I am working to develop a higher level of preparedness for inflight emergencies. Because of the expected increase in inflight emergencies, healthcare professions need to be trained in how to handle these emergencies with the equipment and staff available in flight. In addition, healthcare professionals need to understand fully how to best advise the pilot in making a recommendation for an emergency landing of the plane because of the danger and cost involved with each emergency landing.

Lastly, in today’s environment these prepared healthcare professionals should have a background check provided through the TSA so that pilots and flight attendants can be confident that not only are these individuals trained, but they are cleared to provide advice and use the inflight emergency equipment.

Just yelling “is there a doctor on board” can not assure one that the physician answering the call is trained to handle an inflight emergency nor has the best interest of everyone on board in mind. The time has definitely come for developing a formal training program so that we are prepared to appropriately handle inflight medical emergencies.

Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD
Institute for Geriatric Studies
University of the Sciences

02/18/2010

Recent Expert Broadcast Coverage

Karin Richards Talks Heart Health on CBS3
On Feb. 16, Karin Richards, director of the exercise science and wellness management program, spoke with CBS3’s Ukee Washington about tips to cut your risk of heart disease.
WATCH: To watch the video, click here.

Dr. Kay Scanlon Shares Snow Shoveling Tips on NBC10
NBC 10 – Feb. 9
Assistant Professor of Physical Therapy Dr. Kay Scanlon was live on NBC 10 in advance of a winter storm on Feb. 9, 2010, to talk about avoiding injuries while shoveling snow.
WATCH: To watch the clip, click here.

02/04/2010

Health Care Reform - Let's Start Over and Do It Right!

The following editorial is being re-posted from the Pharmacist Activist Newsletter with permsision from its author. Dr. Daniel A. Hussar.

The voters of Massachusetts have done our country a great service. And just in time! They exercised their anger, frustration, and right to vote in sending a strong message rejecting a broken political system that was on the verge of pushing our health care system into further chaos. Does our health system need to be reformed? Absolutely! However, both the direction and the process of the recent, and continuing, "reform" debacle have threatened to make the system worse. Let's terminate the current process, identify what can be learned from the experience, and start again.

What have we learned?

Reform must benefit individuals and society - Let's agree that the initial intention of health care reform was valid and honorable. There are individuals in this country who cannot afford or, for other reasons, do not have access to health care but need such services. However, the term "health care reform" quickly became a misnomer as the "care" for the people to be served disappeared in an avalanche of political, corporate, and personal interests. Indeed, a more accurate designation for the distorted emphasis would be "health insurance reform."

The quality of health care was ignored or compromised - Access to health care is of limited value unless the quality of that care is assured. Yet this critical dimension of a health system has been rarely mentioned.

Very limited involvement of health professionals - If any health system is going to be effective, it is essential that the health professionals who provide the patient care and services are involved in designing and implementing the system. The American Medical Association (AMA) had a role in the "negotiations," but many of its own members were angered by some of the positions taken by their leadership, and the AMA support (some say "deal") was quickly politicized by the administration.

Although leaders of national pharmacy associations publicized meetings with high-level officials and legislators, pharmacy did not have "a seat at the table." In fact, other than support for the inclusion of recognition of medication therapy management (MTM), the national pharmacy associations have not appeared to take a position supporting or opposing the proposed legislation that has been evolving. Although I disagree with the position that the AMA took, at least I know where it stands and can respond accordingly.

The inclusion of recognition of MTM could actually be an illusion for the pharmacists who are directly involved in providing care and services for patients if there is not funding to support this service and/or if pharmacy benefit managers (PBMs) and insurance companies attempt to provide MTM from a distance via mail or phone.

No more deals! - From the beginning of this initiative to reform health care, deals were made with pharmaceutical companies, insurance companies, hospitals, unions, the AMA, and others who might be in a position to mount formidable opposition to the Administration's plans. To consider just one of these deals, the pharmaceutical companies outsmarted the Administration and the Congress and they still do not realize they have been outsmarted. The pharmaceutical companies made a commitment of $80 billion over 10 years to develop and promote the proposed health care plan. However, there will be many millions more patients covered by this plan who will be prescribed medications made by these companies in a program that favors use of brand-name drugs rather than generics, there will be no importation of drugs from countries such as Canada in which these same brand-name medications are available at much lower prices, and there are no restrictions/limitations on the prices these companies can charge for their medications and how often and by how much they can increase these prices. The pharmaceutical companies will experience increased revenues that far exceed the $80 billion it has committed to support health care "reform." And this is just one example of the flaws in the "reform" that has been proposed.

In recent months, the deals went from bad to worse to unconscionable as exemplified by the efforts/bribes to obtain support from legislators in Louisiana and Nebraska, as well as union leadership.

Insurance companies have excessive influence - Insurance companies contribute little or nothing to the quality of health care but their policies often place inappropriate restrictions/limitations on the scope and quality of health care. Some of these companies have been discontinuing programs that they deem to be no longer in their best financial interest, leaving thousands of subscribers in a situation in which they must purchase more expensive policies on short notice. And yet we have still come very close to approving "reform" that would serve the interest of the insurance companies but not the interests of patients.

No more unrealistic deadlines - To accomplish needed reform of the health care system in an effective and progressive manner is a huge challenge that cannot be accomplished within the politically motivated deadlines that were established. The request for a bill on the President's desk before Christmas was a clear signal that adequate time was not being provided for the importance and scope of the task to be accomplished.

No more secrecy - Once the Senate passed its bill, continuing discussions involved the leadership of only one political party and were held under a cloak of secrecy. This occurred even though the President of the same political party made a commitment during his campaign to not just have open discussions but to have them televised. Secrecy results in suspicion and distrust.

Bipartisan support is necessary - The domination of one political party has resulted in a position that support from the other party is not needed, and placed the country on the precipice of a gross abuse of power. Perhaps the most important lesson from this experience is that our country is not well served if either major political party has such a majority that it can conclude that it does not need to work with the other party.

We need to start over

The problems inherent in the proposals developed by the Senate and the House are too important and numerous to fix. We need to start over and the following actions should be given priority:
  1. There must be trust and cooperation. In view of the acrimony and polarization in recent months, it may be impossible to establish trust among our elected officials. If this is the case it will probably be necessary to reform our political system before it will be possible to accomplish meaningful reform of the health system.
  2. The health care needs and interests of the people must be the central focus of reform and given the highest priority.
  3. Many individuals have urgent health care needs now. These situations should be addressed immediately through the establishment of an interim program that can be provided during the time that the components of comprehensive health care reform are being determined.
  4. A coalition of patients and health professionals should have the initial responsibility for identifying a system that will provide the care, and the scope and quality of services, that will best meet the health needs of patients, and provide professional fulfillment and equitable compensation for health professionals. Pharmacists have the drug therapy expertise and a strategic position to have an important role in designing and implementing this system.
  5. The health care system must place a strong emphasis on health education, wellness, and disease prevention.
  6. The health care system must emphasize the attainment of quality indicators and positive health outcomes, and provide incentives for meeting these goals. An investment in these parameters will result in substantial financial savings by reducing inadequate care, errors, and drug-related problems that currently cost billions of dollars a year to address.
  7. Efficiencies and areas for cost containment must be identified. This is an extremely difficult challenge that will necessitate the determination of the roles and the extent of the influence and profits that are appropriate for the entities that are not the direct and personal providers of health care (e.g., government, insurance companies, pharmaceutical companies).
  8. Fraud must not be tolerated. One of the travesties of the recent discussions of "reform" is the observation that billions of dollars are wasted each year as a result of fraud and abuse in the system, and that seemingly we need comprehensive health care reform before we can address this situation. If enough is known about the fraud to determine that billions are being lost, there should be enough information to take action now to stop those who are perpetrating the fraud.
  9. Discussions, decisions, and actions must be transparent and receptive to consideration of diverse recommendations and opinions.
  10. Bipartisan legislative support must be attained.

Dr. Daniel A. Hussar is the Remington Professor of Pharmacy at the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia. He serves as the author and editor of the Pharmacist Activist Newsletter (http://www.pharmacistactivist.com).  

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