Pharmacist-Doctor Teams Help Keep Heart-Failure Patients Out of the Hospital

ARTICLE FROM MEDSCAPE, AUGUST 18TH

August 18, 2009 (Adelaide, Australia) — Collaboration between doctors and pharmacists can reduce medication-related problems and hospitalizations and improve health outcomes in patients with heart failure, Australian researchers report in a study published online before print August 18, 2009 in Circulation: Heart Failure [1].

A service wherein pharmacists visited heart-failure patients in their homes to review their medications and then reported the findings to the patients' doctors cut the rate of hospitalization for heart failure by 45% in its first year of operation, Dr Elizabeth E Roughead (University of South Australia, Adelaide) and colleagues write.

"Medication-related problems contribute to the problem of hospitalization for heart-failure patients, so educating these patients about drug use is important," Roughead told heartwire . "The home visit part of this program enables time for more thorough education. Clinicians should work with pharmacists to help their heart-failure patients."

A Synergistic Relationship

Dr Mauro Moscucci (University of Miami Miller School of Medicine, FL) agreed that the partnership between pharmacists and clinicians has important and positive implications for improving outcomes for heart-failure patients.

"It's the synergy that is impressive. Improved outcome is due not to pharmacists' visits alone but to the partnership between the two healthcare providers," Moscucci told heartwire .

Roughead and her colleagues sought to determine whether collaborative medication reviews, which have been shown to be successful in improving outcomes for patients with heart failure in randomized controlled trials, would also be successful in a "real-world" setting. Such reviews are nationally funded in Australia.

They retrospectively reviewed administrative claims data on veterans and war widows aged 65 years and older who were prescribed bisoprolol, carvedilol, or metoprolol succinate for heart failure and compared 273 patients who received general practitioner-pharmacist collaborative home medication review with 5444 controls who did not.

The average age of the patients in both groups was 81.6 years. The median number of comorbidities was eight in the group who received the collaborative reviews compared with seven in the group who did not (p<0.0001).>

"We chose to study a veteran population because they are elderly and an appropriate target population for home medicines review services," Roughead explained.

Review Delayed Hospitalization for Heart Failure

The time to hospitalization for heart failure was significantly delayed in the group that received a home medicines review, the investigators found. After adjustment for a variety of confounding variables, only 5.5% of the patients in the review group were hospitalized within a year, compared with 12% of the control group (hazard ratio [HR] 0.55, 95% CI 0.39–0.77; p<0.0001).

Pharmacist Dr Amy Seybert (University of Pittsburgh Medical Center, PA) told heartwire that pharmacists are particularly well-suited for counseling patients. "Definitely. It's what we are trained to do. We explain to patients why they should take their medications and stress the importance of compliance. We tell them how the drugs work. I really think that if patients understand why they are taking something and for what purpose, they are much more apt to be compliant."

Her colleague, Dr Joon Sun Lee (University of Pittsburgh Medical Center), agrees.

"The Australian study confirms much that is known. As treatment regimens, especially medication regimens for heart-failure patients, become more and more complex, the potential for patients to get confused becomes greater. So measures that confirm medication regimens and also check up on patients are effective at decreasing readmissions," he said.

It Works Well Down Under, But Will It Work in the US?

More and more institutions in the US are using pharmacists to help educate patients, usually as part of hospital discharge programs. But Sun Lee questions whether a partnership between pharmacist and clinician as the Australians have would be feasible in the US.

"One of the vulnerabilities and inefficiencies of the US healthcare system is that the collaborative medication review part of healthcare is not rewarded financially. It is an extra cost without reimbursement, whether you are talking about the hospital incurring the cost or the doctor's office. Right now, this is one of the cracks that exist in the delivery care system," he said

Diabetes May Soon Be Diagnosed by MRI

by, DIABETES PHARMACIST.COM
August 6, 2009 by Joel Shpigel R.Ph.

Using noninvasive imaging (Magnetic Resonance Imaging (MRI) ) for the first time in diabetes research, physicians at Massachusetts General Hospital and Harvard Medical School have discovered how it may aid in the early diagnosis, staging, and treatment of diabetes.

"With noninvasive MRI we have the ability to evaluate beta cell mass, a major factor of insulin secretion that is significantly reduced in type two diabetes and almost gone in type one,” said Anna Moore, MD, lead author of the study. “Knowing the number of functional beta cells left would allow physicians to develop the most appropriate treatment plans for their patients. It would also allow them to respond, change or manipulate those treatment plans at any time,” she said.

- Diabetes Pharmacist has been named one of the 100 Best Blogs for Pharmacy Students by Jill Gordon on Nursing Schools.Net., a nursing school network and directory.

Medication Reconciliation Performed by Pharmacy Technicians at the Time of Preoperative Screening

Abstract

Background: Medication errors occur regularly in surgical patients, especially due to transfer problems at the time of hospital admission. A method for decreasing the error rate is medication reconciliation by hospital pharmacists as part of a preoperative clinic. The role of pharmacy technicians in this process has not been studied.
Objective: To study the use of pharmacy technicians in medication reconciliation by measuring the effect of early reconciliation in the preoperative clinic on medication and allergy discrepancies and on inadvertent continuation of antithrombotics. A secondary objective was to study the effect of community pharmacist follow-up on recommendations to discontinue antithrombotic therapy.
Methods: During the preintervention measurement period, patients received usual care by anesthesiologists, who recorded the medication and documented allergies of the patient. The intervention consisted of the addition of a pharmacy technician to the preoperative screening clinic to perform the same tasks as anesthesiologists as related to medication reconciliation. If necessary, the patient was advised on stopping the antithrombotic. On the day that the patient was supposed to stop the antithrombotic, that person's community pharmacist contacted the patient to determine whether this had been done. The main outcome measures were the proportions of patients with one or more medication discrepancy, one or more allergy discrepancy, and one or more antithrombotic error.
Results: In the preintervention period, 204 patients were evaluated; 93 were included in the postintervention analysis. The proportion of patients with one or more medication discrepancy (RR 0.29; 95% CI 0.12 to 0.71) was statistically significantly reduced in the postintervention group. The proportions of patients with one or more allergy discrepancy (RR 0.76; 95% CI 0.35 to 1.64) and one or more antithrombotic errors (RR 0.18; 95% CI 0.02 to 1.33) were reduced, but not significantly. Follow-up by the community pharmacist did not identify any patients who had not followed the preoperative clinic's advice on temporarily withholding their antithrombotics.
Conclusions: The results of this study show that pharmacy technicians can be successfully assigned to a preoperative clinic, resulting in a statistically significant decrease in medication discrepancies.

INNOVATION AWARDS FOR PHARMACIST & PHARMACY TECHNICIAN

See how a good team work between Pharmacist and Pharmacy Technicians on a innovation project in USA which gives more room to Pharmacist to practice in clinical works.

We should follow this steps too in Malaysia. Read more belows from MEDSCAPE.

New York (MedscapeWire) Dec 13 — Five teams of pharmacists and certified pharmacy technicians were declared the winners of this year's Innovations in Pharmaceutical Care Award on December 4th at the American Society of Health-System Pharmacists (ASHP) Midyear Conference in Las Vegas, Nevada.

Winners included a team at Duke University Medical Center that reengineered pharmacy work functions to allow pharmacists more time to focus on patient care. Another winning team, from North Mississippi Medical Center - Department of Pharmacy Services, uses a certified pharmacy technician in the medication error tracking and reporting process, giving pharmacists and other health professionals more time to implement new patient care programs.

The award, founded in 1998 by the Pharmacy Technician Certification Board (PTCB), recognizes innovations in pharmaceutical care by teams of pharmacists and certified pharmacy technicians in any practice setting. Each of the five winning teams received a cash award of $1,000 to be shared equally by the pharmacist and certified pharmacy technician and a framed certificate to be displayed in their respective practice settings.

"We take great pride in the Innovations Award Program," said Melissa M. Murer, RPh, PTCB Executive Director. "Efforts to enhance patient care, reduce medication errors and manage patient's chronic diseases serve as best practices for the over 70,800 certified pharmacy technicians nationwide."

ARTICLE FROM MEDSCAPE

New CDC Recommendation: All Children Should Receive Annual Seasonal Flu Vaccines

July 27, 2009 — The US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, is changing its recommendation for annual seasonal influenza vaccination for children aged 6 months to 18 years to a "full recommendation," Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, announced.

In addition, the CDC is advising a seasonal flu vaccine for anyone who feels they need one.

"While we are focusing a lot of attention on the 2009 H1N1 influenza virus, we do expect seasonal strains to emerge, and we are issuing updates of which strains to expect," Dr. Schuchat said. These include the A-H1N1, A-H3N2, and B strains, "which are available in this year's vaccine," she noted. "This past year's recommendations encouraged annual vaccination [of children].... This year, [the CDC] is no longer just advising vaccination whenever feasible but is [issuing] a full-out recommendation" of the seasonal flu vaccine.

Only about 40% of the US population received a flu vaccine last year. The CDC is recommending and emphasizing "an intensification of use" of the vaccine.

The CDC has specifically recommended that healthcare workers be immunized, as well as that campers at sleepover summer camps and attendees of military academies where there have been notable outbreaks of influenza receive the flu vaccine and antiviral agents, but only if appropriate.

"I don't think antiviral prophylaxis is a good idea," Dr. Schuchat said, noting that oseltamivir-resistant influenza strains have been reported.

Dr. Schuchat said that the latest laboratory-confirmed case count for the H1N1 influenza virus is 43,771 cases and 302 deaths, "but this is the last time we will be reporting cases in this way." Instead, the CDC will have a FluView Weekly Surveillance Report, updated every Friday, on its Web site.

The National Institutes of Health announced yesterday that clinical trials will begin as early as next week of 2 H1N1 influenza vaccine candidates in adults, either alone or in conjunction with the seasonal flu vaccine and, if safe, in children.

Sanofi Aventis and CSL Biotherapies, manufacturers of the 2 candidate vaccines, told a US Food and Drug Administration (FDA) advisory committee yesterday that they expect to have a vaccine available by October. Dr. Schuchat said that she is concerned that the flu season could be well underway by that time, because the school year begins within weeks in many areas.

The virus is unpredictable, she said, "skipping entire communities, while hitting others really hard." In addition, the virus can cause a wide spectrum of illness, from mild symptoms to respiratory arrest and neurological problems, including seizures. "That is why we are taking the virus so seriously." H1N1 often affects young, apparently healthy individuals, as well as those at high risk, and it could affect more than 40% of the population.

"We are preparing for the worst-case scenario of 60% of the population being affected," Dr. Schuchat said. "The value of worst-case scenario planning is that it allows for continuity planning."

The FDA's Advisory Committee on Immunization Practices is set to meet July 29 to propose H1N1 vaccine recommendations. Children aged 0 to 4 years will likely be the top priority, followed by school-age children, healthcare workers, pregnant women, and adults with chronic diseases.

Today, the FDA announced it had issued an emergency use authorization for a third diagnostic test for the 2009 H1N1 influenza virus because a public health emergency involving H1N1 was declared on April 26, 2009. It is the Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction diagnostic test.

The emergency use authorization allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments to perform high-complexity tests. This test is intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.

The test does not indicate the stage of infection, nor does a negative result preclude influenza virus infection, FDA officials emphasize.

MMWR Morb Mortal Wkly Rep. Posted online July 24, 2009

From MedscapeCME Cardiology

Raising Awareness of Resistant Hypertension: Burden, Diagnosis, and Emerging Therapies

Michael A. Weber, MD

Published: 07/31/2009

Introduction

Resistant hypertension is defined as blood pressure that remains above target goals despite concurrent use of 3 antihypertensive medications of different classes, including a diuretic, all at optimal doses.[1-3] The exact prevalence of resistant hypertension is not well defined, and there is no current standard of care for its management. Overall, resistant hypertension remains understudied and additional knowledge is needed to better identify and treat patients with the condition. Clinical data on novel therapeutic options for the management of treatment-resistant hypertension were highlighted at this year's meeting of the European of Society of Hypertension (ESH), held June 12-16, 2009 in Milan, Italy. To provide a context for these results, Linda Brookes, MSc, on behalf of MedscapeCME Cardiology, spoke with Michael A. Weber, MD, Professor of Medicine, SUNY Downstate College of Medicine, Brooklyn, New York. In the following interview, Dr. Weber discusses the global burden of the condition, diagnosis, and current and emerging treatment options.
Burden of Resistant Hypertension

MedscapeCME: Hypertension management guidelines are consistent about the definition of resistant hypertension as failure to achieve blood pressure goal (<>

Michael A. Weber, MD: Resistant hypertension may occur in only about 10% to 15% of all cases of hypertension, but bearing in mind that there are over 70 million people with hypertension in the United States, this means that there are several million people with resistant hypertension.[4] So if this were a disease all by itself, it would be regarded as a relatively common condition.

MedscapeCME: Is this why resistant hypertension seems to have been the subject of so much attention recently?

Dr. Weber: In many places around the world, physicians are pressured to do a better job in treating common chronic conditions and to demonstrate that they are doing everything they possibly can to treat them. In hypertension, they must show either that they have the patient's blood pressure well controlled or at least that they have gone through all the steps to try and get it well controlled. Yet there will be a proportion of patients who will be difficult to treat, and I believe experts are focused on that problem now.
Challenges in Diagnosing and Managing Resistant Hypertension

MedscapeCME: What about the diagnosis of resistant hypertension? This seems to involve 3 questions: What makes hypertension truly "resistant?" How early can it be recognized? And is there a genotype or a typical phenotype associated with resistant hypertension?

Dr. Weber: For a start, there isn't a recognized genotype. And there really isn't an obvious predictive finding that tells you in advance that a particular patient is going to have treatment-resistant hypertension. Many people with treatment-resistant hypertension emerge with that classification only after several weeks or months of disappointments for the physician trying to manage the hypertension.

MedscapeCME: So how does a physician confirm that a patient has resistant hypertension?

Dr. Weber: First, it is important to ensure, as best you can, that the patients are actually taking their medications. This may involve a lot of detailed discussion with patients to satisfy doctors that the patients really are following their treatment. If they are, the next question is whether the treatment regimen is a logical one. For instance, does it include drugs that ought to be part of any hypertension treatment plan, such as a diuretic and a blocker of the renin-angiotensin system, and are the drugs being given at appropriate doses?

In terms of diuretics, I believe that our efforts in the past few years have sometimes been inadequate in that we have tended to often rely on low-dose hydrochlorothiazide (HCTZ). This works well in most hypertensive patients when it is paired with a drug such as an angiotensin-receptor blocker (ARB), an angiotensin-converting enzyme (ACE) inhibitor, or a calcium-channel blocker. However, in people with resistant hypertension, who often have diminished renal function, HCTZ at a dose of 12.5 or 25 mg may not be effective and chlorthalidone should be considered instead. Also, much of the clinical trial experience demonstrating prevention of major outcomes, such as stroke, has been with chlorthalidone rather than HCTZ.[5-9]

So if the right drugs are being prescribed in the right doses and the patient is taking their medications, is something happening to prevent these drugs from working effectively? One explanation may be that the patient has an underlying so-called "secondary cause'" for hypertension that does not respond to drugs -- for example, an adrenal cortex tumor, a pheochromocytoma, renal artery stenosis, or advanced kidney disease.[2] The other main cause of not responding adequately despite a good treatment regimen is that the patient is taking a medication that is raising blood pressure and interfering with the actions of the antihypertensive drugs.[2] Culprits include nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives, and some common cold remedies.

MedscapeCME: Wouldn't patients usually be warned about taking other medications at the start of their treatment?

Dr. Weber: Not necessarily. Some physicians overlook the fact that drugs such as NSAIDs might be a problem, and second, they may not always know that a patient is taking drugs like ibuprofen or naproxen because they are usually acquired over the counter and not reported to the doctor. So it is necessary to think proactively about drugs that could be interfering with blood pressure-lowering medications.

MedscapeCME: Presumably it is fairly straightforward to deal with those sorts of problems, but identifying or ruling out secondary causes is more complicated and time-consuming?

Dr. Weber: That is correct. The modern approach to looking for secondary causes typically involves some sort of imaging -- for example, an angiogram, computerized tomography scan, or magnetic resonance imaging. So it can be a fairly major commitment to consider a secondary cause of hypertension. It has to be on the list of possible causes to check, however. You have to decide that these conditions are unlikely before you can conclude that a patient truly has treatment-resistant hypertension.

MedscapeCME: At that point should a patient have been referred to a clinical hypertension specialist?

Dr. Weber: Yes. If you are really pursuing secondary hypertension, the patient is probably served best in the hands of a specialist who has experience in working up these kinds of conditions. In reality, these conditions are relatively uncommon and most physicians have probably not had much experience in the latest diagnostic methods for identifying underlying causes of hypertension. So the patient should be referred to a hypertension specialist, or if there isn't one readily available, then a nephrologist or other specialist who has experience with secondary hypertension.

MedscapeCME: What about primary aldosteronism -- is that a common secondary cause?

Dr. Weber: A fair number of people with resistant hypertension have high aldosterone levels, so the simplest, most effective approach might be to try an aldosterone-receptor blocker, such as spironolactone or eplerenone, for a few weeks and see whether it works. Experience suggests that this should produce a good result quite often,[10-14] especially in African American patients, although there have not been comprehensive studies to confirm this.

MedscapeCME: Even after trying an aldosterone-receptor blocker, there are a number of other classes of drugs that might be tried, such as beta-blockers and centrally acting alpha-agonists. How does a physician decide which one to add?

Dr. Weber: A beta-blocker, preferably one that does not carry the metabolic and symptomatic side effects of the more traditional beta-blockers, may be effective (ie, nebivolol or carvedilol). Then you can consider the centrally acting drugs, such as clonidine, which can be quite efficacious even though they may cause drowsiness in some patients.[1] It is possible to consider even older drugs like reserpine, although it has been shown that some patients experience negative emotional disturbances with the drug.[1] Hydralazine can be effective; it is a vasodilator, but it causes fluid retention, so you should ensure that the patient is getting a good diuretic. It can also accelerate the heart rate, so you usually need to give a beta-blocker as well. If you want to be more aggressive than hydralazine, you can give a stronger vasodilator, minoxidil, which can be effective in patients with complicated cases of refractory hypertension and concomitant kidney disease.[1] In short, some of these older drugs work, but they can be difficult to use.
Emerging Therapeutic Options

MedscapeCME: So it appears that even after exercising all of these options, there are some patients whose blood pressure remains uncontrolled. What is the future, as far as new drugs are concerned, with different mechanisms of action?

Dr. Weber: There are a number of investigational drugs and interventions in development for the management of resistant hypertension. The effects of endothelin antagonism, for example, were discussed at this year's ESH meeting.

We presented the results of the phase 3 clinical trial, DAR-311 (also known as DORADO), which evaluated the use of darusentan (Gilead Sciences; Foster City, California), an investigational oral, once-daily endothelin- receptor antagonist for the treatment of resistant hypertension.[15] As reported at the American Society of Hypertension (ASH) meeting in San Francisco[16] and at the ESH meeting,[17] the findings showed that compared with placebo, darusentan was associated with significant reductions in blood pressure in patients with resistant hypertension.

All patients enrolled in the DAR-311 trial were already taking at least 3 well-selected and well-dosed drugs -- in fact, 60% were taking 4 or more drugs -- so they were getting good treatment. With the addition of darusentan they achieved close to an additional 10-mm Hg decrease in systolic blood pressure compared with placebo. Previously in a phase 2 study, darusentan was seen to decrease mean systolic and diastolic blood pressure and was well tolerated compared with placebo in over 100 patients with resistant hypertension.[18]

MedscapeCME: Darusentan is a selective endothelin type A-receptor antagonist. Do these phase 3 data tell us more about the role of endogenous endothelin in hypertension?

Dr. Weber: We know theoretically that endothelin could have adverse vascular effects that might be associated with the major cardiovascular outcomes of hypertension. However, there are many endogenous factors that potentially could have adverse vascular effects, so we must be careful that we don't overinterpret our results. Although the findings with endothelin blockade are interesting, we should be cautious about using these data to speculate about underlying causes of resistant hypertension.

MedscapeCME: Can you comment on the cardiac side effects associated with darusentan that occurred in the phase 3 trial?

Dr. Weber: We reported a number of cardiac side effects, but it is important to understand that the treatment-resistant patients we studied were a high-risk group: 40% of them had diabetes, about one third had kidney disease, and about one third had a history of coronary disease. This group was at high cardiovascular risk and it shouldn't be a surprise that 2 patients taking darusentan had nonfatal myocardial infarctions and 1 patient on placebo had sudden cardiac death. There were also some patients who had the clinical findings of heart failure. One case was a patient known to have heart failure before the study began and should not have been enrolled in the trial. The other heart failure cases in patients receiving darusentan appeared to be related to fluid retention and manifested as pulmonary congestion. In fact, the patients with heart failure all had preserved left ventricular systolic function with normal ejection fractions. My personal belief is that these patients, who responded rapidly to appropriate diuretic therapy, most likely represented an unmasking of underlying left ventricular diastolic dysfunction in patients with long-standing severe hypertension. Bearing in mind that these events, with concomitant fluid retention, became apparent in the first few weeks of therapy, it seems unlikely that the drug affected heart function independently of its volume effects. This phenomenon has also been observed with other vasodilatory drugs used in hypertension.

We did learn a lesson, though, which was that in using vasodilatory drugs like darusentan, we cannot assume that the low doses of HCTZ typically prescribed in hypertension will be adequate. In patients who have diabetes or kidney disease or a history of coronary events, this type of diuretic therapy is not sufficient. I believe that we either need to use higher doses of HCTZ or, even better, work with a drug like chlorthalidone or consider a long-acting loop diuretic like torsemide (rather than furosemide, which is difficult to work with long-term in hypertensive patients).

MedscapeCME: Is there another phase 3 trial ongoing with darusentan?

Dr. Weber: A long-term extension of the recently completed trial and an additional phase 3 study (DAR-312 [also known as DORADO-AC]) comparing darusentan with active treatment rather than with placebo are being done.[19] I believe that the latter trial will be finished before the end of the year.

We have shown that darusentan is an effective strategy in treatment-resistant hypertension. Our next task is to devise clear information for physicians on its use -- in other words, how to choose the correct dose and how to optimize the other drugs that are taken with it. These are areas that we have an obligation to study.

MedscapeCME: What about the other investigational drugs in clinical development for resistant hypertension?

Dr. Weber: LCI699 (Novartis AG; Basel, Switzerland) is an aldosterone-synthase inhibitor in clinical trials for resistant hypertension.[20] This is an interesting drug, as it provides an alternative to aldosterone-receptor blockers but may be better tolerated than spironolactone. Another promising strategy for the future may be LCZ696 (Novartis Pharmaceuticals; East Hanover, New Jersey), a novel vasopeptidase inhibitor that acts as a dual ARB inhibitor plus neutral endopeptidase (NEP) inhibitor. Unlike omapatrilat, a dual ACE inhibitor plus NEP inhibitor that was effective but associated with severe angioedema, LCZ696 has been shown to be effective but apparently without major adverse effects.[21,22] I have also heard about a nicotinic-channel blocker, TC-5214 (Targacept, Inc; Winston-Salem, North Carolina), that is being looked at as a possible augmentation therapy for resistant hypertension.[23,24]

MedscapeCME: There are 2 interventional approaches that are being developed for patients with resistant hypertension: the Rheos® Hypertension Therapy system (CVRx, Inc; Minneapolis, Minnesota), an implantable device that has been shown in clinical trials to lower blood pressure through activation of carotid baroreceptors[25]; and renal sympathetic denervation, a catheter-based interventional procedure, which has been shown to be effective in a proof-of-concept study.[26]

Dr. Weber: These approaches have shown encouraging results, although they both involve significant interventions. They should be studied further because there are so many patients who are very hard to treat.

Perspective

MedscapeCME: Are you hopeful for the future treatment of resistant hypertension in general?

Dr. Weber: One of the good things about these recent developments is that they have drawn a lot of physicians' attention to resistant hypertension. These cases can draw nihilism after 3 or 4 drugs have been tried without success. This new focus on resistant hypertension will, I believe, energize many physicians to try a little longer and a little harder with their patients to find an answer to their hypertension problems.

This activity is supported by an independent educational grant from Gilead Sciences, Inc.

Pharmacy medication errors may be ruled criminal???

Aug 8, 2009
By: Kenneth R. Baker, BS Pharm, JD
Health-System Edition

Every pharmacist makes mistakes, and all too often they are medication errors. Sometimes the system does not catch a medication error and it reaches a patient. Sometimes, thankfully not often, an error injures a patient.

In such an instance, we can be held liable in a civil suit for money damages as compensation for the injury. We carry malpractice insurance because we know that no matter how good we are, we will never eliminate the possibility of a negligent act that may result in human error and injury to a patient.

What if, however, our medication error resulted in a criminal charge? In May, an Ohio pharmacist pleaded "No contest" (essentially equivalent to a guilty plea without admission of guilt) to a charge of involuntary manslaughter. He faces up to five years in prison and a fine of up to $10,000.

We commonly think that a person charged with a crime is a "bad person." The pharmacist in the Ohio case was not a bad person, but a mistake occurred under his supervision that resulted in the death of a two-year-old girl.

There seems little question that negligence was involved. According to newspaper accounts and Board of Pharmacy minutes, a hospital pharmacy technician mistakenly mixed chemotherapy solution with 23.4 percent instead of 0.9 percent sodium chloride. The parents' civil suit charging negligence against the hospital was settled out of court.

Negligence charges are common in civil cases involving professional malpractice. In civil cases, negligence means deviation from professional standards of practice or failure to exercise due care. In criminal cases, negligence means something more. An earlier Ohio court explained:

A person is [criminally] negligent when, because of a substantial slip from the standard of care [the person] fails to take steps to evade a risk that his conduct may cause a certain result. ... It defines a higher degree of negligence than ordinary negligence. For one to be [criminally] negligent ... he must be guilty of a substantial departure from due care, whereas ordinary negligence merely requires a failure to exercise due care.

It does not happen often that a pharmacist is charged with a crime for a medication error. Whether the pharmacist in this case would have been found guilty had the case continued through a trial, we cannot know.

How can a pharmacist "take steps to evade a risk that his conduct may cause a certain result?" Every time we fill a prescription or drug order, there is a chance that we might make a mistake. When we dispense or compound dangerous drugs, i.e., ones that are designated Rx only, any selection of wrong drug or wrong strength could be a "substantial slip" if the only thing we judge by is the result. The only way to actually "evade a risk" of making a mistake that will result in a predictable (certain) outcome is to refuse to fill the prescription or drug order.

Mike Cohen, president of the Institute for Safe Medical Practices, said about this case, "Focusing on the individual is unlikely to have a positive effect in the long run. I have not read anywhere that he purposefully tried to hurt the patient." I agree; nothing I have read about this case indicates that the pharmacist's conduct rose to the level of a criminal violation. A criminal conviction here serves no purpose. It may also have a dangerous, unintended consequence and may result in injury to a future patient.

The Institute of Medicine (IOM) report "To Err Is Human" found that medical errors are among the leading causes of death in the United States; it estimated that each year 40,000 to 98,000 patients die in hospitals from preventable adverse events — medical errors. The IOM, as part of its report, cited studies estimating that there are 7,000 deaths each year just from medication errors. How many of the professionals involved in these cases should be put in jail?

Prosecutors and grand juries, the ones who make such decisions, are as much subject to pressure to "do something" as the rest of us. They need to think hard about this type of case in the future and resist easy, "feel good" decisions. I was taught in law school that a person should be able to conform his or her actions to avoid being charged with a crime. In this case, to conform your actions, you'd have to avoid being a fallible human being — or refuse to fill the drug order.

There is a reason we teach that when a medication error occurs, we fix the system and do not punish the person. This is the basis of risk management and avoidance of medication errors. Systems are in place because people make mistakes. If people never made mistakes, we wouldn't need systems. If systems never failed, none of our mistakes would ever reach a patient.

Routinely punishing the person who made the mistake may make it less likely that we will learn of every mistake. If we do not learn of an error, we will not have a chance to fix the system. The result will be that some day, some patient will be injured when we could have modified the system to prevent the error from reaching the patient. In the present case, it is the prosecutors who need to fix their system.

This article is not intended as legal advice; it is intended to promote thought about ways to reduce medication errors. For legal advice, consult your own attorney.

Ken Baker is a pharmacist, attorney, and consultant on risk management. Contact him at ken@kenbakerconsulting.com

CPE ONLINE

Prograf
from: http://www.thepharmacytechnician.com/

Generic Name: tacrolimus (oral) (ta CRAL ih mus)
Brand Names: Prograf

What is Prograf?

Prograf lowers your body’s immune system. The immune system helps your body fight infections. The immune system can also fight or “reject” a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Prograf is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

Prograf may also be used for other purposes not listed in this medication guide.
Important information about Prograf

Taking Prograf may increase your risk of developing certain types of cancer, especially skin cancer. The risk may be higher in people who are treated over long periods of time with drugs that weaken the immune system. Talk with your doctor about your individual risk.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

There are many other medicines that can interact with Prograf. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Do not consume grapefruit or grapefruit juice during treatment with Prograf unless your doctor has told you do. Prograf can have a dangerous interaction with grapefruit or grapefruit juice.

Prograf can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Some people receiving Prograf after a kidney transplant have developed diabetes, most often in people who are Hispanic or African-American. Talk with your doctor about your individual risk of diabetes.