Wednesday, September 2, 2009
Tuesday, September 1, 2009
Latest pharmacy news
Antiplatelet drugs, PPIs can be simultaneously prescribed to heart patients, investigators say.
According to Bloomberg News (9/1, Cortez), approximately "two million people worldwide undergo procedures to clear heart arteries each year, then take aspirin plus Plavix [clopidogrel] or Effient [prasugrel] from Eli Lilly & Co. and Daiichi Sankyo Co. to prevent re-clogging." What's more, these patients are "routinely prescribed pills" like Nexium [esomerprazole magnesium] or Prilosec [omeprazole], which are proton-pumps inhibitors (PPIs), "to reduce...stomach acid at the same time, since the other medications can cause gastrointestinal trouble." There have been "concerns that mixing the medications may reduce the effectiveness of" the "blood thinner."
Dow Jones Newswires (9/1, Favole) notes that "earlier this year, the FDA asked Plavix marketers Bristol-Myers and Sanofi to update the drug's label to warn of risks with the drug when used in combinations with PPIs." But new research by Brigham and Women's Hospital appears to contradict earlier studies.
For the study appearing online in The Lancet, WebMD (8/31, Boyles) reported, investigators analyzed the results of two trials -- TRITON-TIMI 38 and PRINCIPLE-TIMI 44 -- with the "larger of the two" including "about 13,600 patients who had a previous heart attack or unstable angina treated with one of the two drugs." One-third of the participants "were also taking a PPI, but PPI use was not found to be associated with an increased risk of a second heart attack, stroke, or cardiovascular death with either of the two anti-clotting drugs."
But "evidence of the pharmacodynamic effect of the PPI-thienopyridine interaction was clear in data from the PRINCIPLE trial,"MedPage Today (8/31, Peck) pointed out. Ralph G. Brindis, MD, MPH, President-elect of the American College of Cardiology, said that "even though there is evidence in the test tube that inhibition of platelet aggregation is diminished with PPI therapy, there is no clinical effect." The new findings should not "be construed as a signal to return to routine prophylaxis with PPI," he added. "But for high risk patients who need these drugs, I think we can be a little more confident using PPIs." Reuters (9/1, Hirschler) also covers the story.
Drug Approvals
FDA approves Valcyte to prevent cytomegalovirus in young kidney, heart transplant patients.
The AP (9/1) reports, "Roche said Monday the Food and Drug Administration approved Valcyte [valganciclovir hydrochloride] to prevent the common cytomegalovirus in children who have received kidney or heart transplants." Valcyte "is already approved to treat Cytomegalovirus Retina, an infection of the eye, in patients with AIDS," and "to prevent cytomegalovirus in kidney, heart and kidney-pancreas transplant patients at high risk."
HealthDay (8/31, Roberts) added that the FDA approved the drug for "children 4 months to 16 years who are undergoing kidney or heart transplant, Swiss drug maker Roche said Monday." Roche also said that as "part of the approval, the FDA sanctioned a new oral liquid form of the drug to allow for easier use in children."
FDA grants doxorubicin orphan drug status.
The AP (8/31) reported, "Delcath Systems Inc. said Monday the Food and Drug Administration gave its developing liver cancer treatment doxorubicin orphan drug status." The status "is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market," and allows "seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits." The AP added, "Delcath focuses on using drug delivery technology that gives ultra-high doses of anticancer drugs to the liver."
Medication Use
FDA approves six new marketable volumes, concentrations of heparin.
The AP (9/1) reports, "Drug delivery system and device maker Hospira Inc. said Monday it received Food and Drug Administration approval to market the blood thinner heparin in six new volumes and concentrations." The doses "range from one milliliter to 30 milliliters in size," according to Hospira, and the "concentrations range from 1,000 units per milliliter to 10,000 units per milliliter." The AP adds, "The approval covers three single-dose vials and three multiple-dose vials."
Quality and Safety
Flu shot focus may be overshadowing necessity of meningococcal meningitis vaccination, experts say.
The AP (9/1) reports that although it can often initially seem "like a stomach bug or the flu," bacterial meningitis "can go on to kill terrifyingly fast." And, the "prime targets are tweens, teens and college freshmen." But there are concerns that the onslaught of flu shot headlines may be overshadowing the need to seek "vaccination against meningococcal meningitis." In the "two years since the government recommended that every adolescent be vaccinated, close to 40 percent of tweens and teens are." But while there "are multiple types of meningitis," nearly "15 percent of the people who catch this fast-moving germ die -- and one in five of the survivors --suffer permanent disabilities including brain damage, deafness or amputated limbs." So, many universities "now require freshmen to be vaccinated, whether they're dorm-dwellers or not." What's more, "a growing number of states are passing legislation making a meningococcal shot a requirement to enter certain grades."
Sunday, August 9, 2009
Pharmacy medication errors may be ruled criminal
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.
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.
So far, generic drugs have not gone viral in America
When it comes to generic drugs, American consumers have much to learn about their cost, ingredients, and effectiveness, according to a recently released study by Prescription Solutions and UnitedHealth Group.
Generic drugs have saved the health system an estimated $734 billion over the past decade. Still, many Americans are apprehensive about using them. The study found that nearly a third of Americans surveyed don't believe generics have the same active ingredients as brand-name drugs, or are as effective. Two-thirds of those surveyed did not understand that generics are usually less expensive than brand-name drugs.
"Using generics helps make healthcare more affordable without compromising results. Many Americans erroneously believe that the most expensive drug is always the most effective drug," said Jacqueline Kosecoff, CEO of Prescription Solutions, a pharmacy benefit management organization. "By helping change perceptions, we can help people save money and still get the best treatment available."
As other studies have done, this latest one revealed that tough economic times have forced many Americans to change the way they manage their prescriptions. Specifically, 27 percent of those surveyed said that to save money they have delayed filling, not filled, or not taken a prescription drug as directed. "At a time when rising costs are taking an increasing toll on many American families, especially during the economic crisis, [we are] working to ensure that consumers have access to lower-priced generic drugs," Kosecoff said.
The study also showed that 21 percent of respondents had spoken to their physicians or pharmacists about switching to less expensive drugs. Of those who regularly take generics, 64 percent said that their physicians had suggested generics and 43 percent said their pharmacists had done so.
Nearly half, 47 percent, of all survey respondents take generics, with 82 percent of that group saying they do so because of the lower cost. Of those who do not take generics, 58 percent said there is no generic equivalent available for the drug they need. Of those who don't take generics, 58 percent said they would, if their pharmacists offered identical, less expensive substitutes.
Generic drugs have saved the health system an estimated $734 billion over the past decade. Still, many Americans are apprehensive about using them. The study found that nearly a third of Americans surveyed don't believe generics have the same active ingredients as brand-name drugs, or are as effective. Two-thirds of those surveyed did not understand that generics are usually less expensive than brand-name drugs.
"Using generics helps make healthcare more affordable without compromising results. Many Americans erroneously believe that the most expensive drug is always the most effective drug," said Jacqueline Kosecoff, CEO of Prescription Solutions, a pharmacy benefit management organization. "By helping change perceptions, we can help people save money and still get the best treatment available."
As other studies have done, this latest one revealed that tough economic times have forced many Americans to change the way they manage their prescriptions. Specifically, 27 percent of those surveyed said that to save money they have delayed filling, not filled, or not taken a prescription drug as directed. "At a time when rising costs are taking an increasing toll on many American families, especially during the economic crisis, [we are] working to ensure that consumers have access to lower-priced generic drugs," Kosecoff said.
The study also showed that 21 percent of respondents had spoken to their physicians or pharmacists about switching to less expensive drugs. Of those who regularly take generics, 64 percent said that their physicians had suggested generics and 43 percent said their pharmacists had done so.
Nearly half, 47 percent, of all survey respondents take generics, with 82 percent of that group saying they do so because of the lower cost. Of those who do not take generics, 58 percent said there is no generic equivalent available for the drug they need. Of those who don't take generics, 58 percent said they would, if their pharmacists offered identical, less expensive substitutes.
Sunday, July 12, 2009
Questions to Pharmacists Rise After Michael Jackson's Death Consumers more alert to overdose risks from prescription drugs, survey suggests
News reports about a possible link between pop star Michael Jackson's death and his alleged abuse of prescription drugs may have increased the public's concern about prescription medication overdose risks, suggests a survey of U.S. pharmacists.
Of the more than 200 respondents who work in home, ambulatory and chronic care practices, 28 percent of the pharmacists saidpatients have been asking more questions about the risks of prescription painkillers since Jackson's death on June 25.
The American Society of Health-System Pharmacists (ASHP) survey was conducted on July 1.
"While circumstances surrounding Michael Jackson's cause of death are still speculative, the media attention has opened dialogue about the dangers of prescription drug abuse," ASHP president Lynnae M. Mahaney, said in a news release.
"Medications can make a tremendous difference for people suffering with chronic pain and these patients should seek treatment," she said. "However, these medications are extremely powerful and when used improperly they can cause serious harm, even death."
Pharmacists, especially those trained in pain management, can assist patients by guiding them towards pain therapy that can minimize their risks for abuse and addiction, according to the ASHP.
The group offers the following safety tips for patients:
- Compile a list of your medications so that you can keep track of which medicines you're taking, including the doses and frequency, and make the list available to your pharmacist and other health care providers.
- Fill all of your prescriptions at one pharmacy, or use those with interconnected computer systems so that they can access your records and check for adverse drug interactions between different medications you're taking.
- If you have questions about your medications, ask your pharmacist.
More information
The U.S. Food and Drug Administration offers a guide to the safe use of pain medications.
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