Herb Denenberg
Obama Botching National Flu Emergency
The Advocate
By Herb Denenberg, The Bulletin
The Obama Administration and the federal bureaucracy have demonstrated they can’t handle a single healthcare problem, even one declared to be a national emergency. So, how can we trust them to restructure our health delivery system, do so in an unseemly rush, and accomplish what they promise? We can’t. If America is foolish enough to go along with the Obama Administration’s insane health-care proposals, built on a foundation of incompetence, half-baked proposals, radicalism, socialism, and lies, perhaps it deserves its destruction, which President Barack Obama will guarantee if not stopped cold now and in an hurry.
The single problem I have in mind, for openers, is dealing with the seasonal flu and H1N1 swine flu, which President Barack “The Anointed One” Obama has declared to be a national emergency. In case you haven’t noticed, the Obama Administration is botching this “national emergency” from A to Z, so you can be assured that Obamacare will deliver results that are a million times more catastrophic.
To support this view, I rely on the conclusions of Dr. Daniel Hussar, the Remington Professor of Pharmacy at the Philadelphia College of Pharmacy, and who is one of the leading national authorities on pharmacy practice. I’ve relied on Dr. Hussar for countless reports and investigations of prescription drugs and related problems and have found him to always be right on target. In one of his latest editorials, published in his Internet newsletter, The Pharmacist Activist, he reports on what he calls “The Influenza Follies.”
President Obama declared H1N1 (swine) influenza a national emergency on Oct.24, 2009. But Dr. Hussar finds, “[H]owever, prior to this action, some of the efforts to address an anticipated influenza epidemic could almost be considered comical if the situation was not so serious. Numerous initiatives have been poorly planned and implemented and important questions exist.” The threat posed by H1N1 was recognized last year and predicted to be a much bigger problem this year. Despite that, Dr. Hussar finds “problems have been experienced that could have been avoided.”
Where Is The Vaccine?
Despite the experience of pharmaceutical companies over many years in producing influenza vaccine, we face a significant shortage of both vaccines at this time. Pharmacists and physicians have anticipated their needs and submitted their vaccine orders many months ago, but have still received only a fraction of their requirements. Dr. Hussar writes, “They are informed that there is a shortage, but provided with little or no information as to whether or when the shortage will be resolved, and when they can expect to receive additional supplies.” For an account of the shortage of both flu vaccines and the confusion about eventual delivery, see the account in The Times of Trenton (Oct. 29, 2009), headlined “Flu-shot shortages continue: Mercer residents seek answers.” There are also reports of a shortage of the liquid form of Tamiflu, a drug used to treat the flu in children. In Philadelphia, Mayor Michael Nutter declared the rapid spread of H1N1 flu to be a public health emergency. That gives hospitals the authority to move emergency rooms off site and to use volunteers to help with the increased patient load (Philadelphia Daily News, Oct. 30, 2009).
Federal officials have reassured the public that there will be adequate supplies of vaccine…eventually. However, “eventually” is not defined and eventually may be after the H1N1 and seasonal flu casualties are counted. Dr. Hussar poses some of the questions that should be answered: “Why is it that one large chain pharmacy reports that its supply of seasonal influence vaccine is fine, but another large chain pharmacy, as well as many other pharmacies and physician practices, have received only a small fraction of the supplies of vaccine they ordered? Why is it that, as recently as a month ago, the public was informed that supplies of the H1N1 influenza vaccine would be available even sooner than anticipated, but now we are informed that supplies of the vaccine are much smaller than anticipated and there will be significant delays in obtaining the anticipated supplies?” The federal officials have offered explanations for the shortage, but Dr. Hussar thinks they “are thinly disguised excuses for poor planning.”
Issues Of Pharmacist Participation In Influenza Program
Other problems with the vaccine program are documented by Dr. Hussar. He notes that important questions have not been answered by the federal government and, until those answers are forthcoming, the vaccine effort will lag. For example, there is still a question in many states as to whether pharmacists will be able to participate in the H1N1 immunization program. Although many pharmacists, including those in Pennsylvania, participate in the seasonal flu vaccine immunization program, it is not clear whether pharmacists will be able to participate in the H1N1 program and whether they will have supplies to do so. These questions should be resolved immediately, and Dr. Hussar asks whether the federal government, in view of the national emergency, might be able to do something so states would not have to take action individually. Dr. Hussar notes there has already been a significant delay in getting people immunized and steps should be taken on the pharmacist participation issue so as not to further extend that delay.
The ability of pharmacists to participate is important, as it would provide quick access for those who need the vaccines. As most people know, access to a pharmacist is at lightning speed compared to access to a doctor.
Dosing Errors With Tamiflu
Tamiflu, a drug to treat the flu, has dosing instructions that are likely to lead to errors in its administration. The drug comes in 30 mg, 45 mg, and 75 mg capsules and as a powder for oral suspension, which is often prescribed as a teaspoonful or some fraction thereof or as a designated number of milliliters (mL). But an oral dispenser comes with Tamiflu that is calibrated for doses of 30 mg, 45 mg, and 60 mg dispensing. This leads to confusion when prescribers write for a teaspoon or milliliter dose. The oral dosing dispenser that comes from the drug doesn’t take that prescribing option into account. This has led to dosage errors. The FDA in September 2009 did issue this alert: “If prescription instructions specify administration using mL, the dosing device accompanying the product should be replaced with a measuring device (e.g., a syringe) calibrated in mL.” That’s well and good, but what if a pharmacist doesn’t get or read that alert? It doesn’t take a genius to realize that the manufacturer of Tamiflu, Roche, should make the necessary changes in the dosing instructions and dispenser to prevent the dosage errors occurring now. If the federal government can’t insist on this kind of correction, if it can’t correct this obvious and egregious deficiency, what happens when it writes Obamacare?
Emergency Compounding Of Tamiflu
There is a shortage of the commercially marketed Tamiflu for Oral Suspension formulation. So in the labeling of Tamiflu, there is a section addressing “Emergency Compounding of an Oral Suspension from Tamiflu Capsules.” Specific instructions are provided for pharmacists to take the capsules and “compound” the oral suspension. The FDA, according to Dr. Hussar, has paranoia regarding pharmacist compounding. So, the pharmacist can compound Tamiflu in the event of an emergency. However, if the instructions for compounding Tamiflu that come with the drug are followed, you get a concentration of 15mg/mL that is different from the 12mg/mL concentration of the product supplied by the company when it is available. So, if the pharmacist follows the instructions provided by the manufacturer, Roche, he gets a different concentration. Dr. Hussar writes: “This situation is ludicrous and the FDA and Roche are responsible for creating another situation that results in confusion and error!”
Conclusion
Dr. Hussar writes, “If the federal government is not successful in containing, preventing, and treating influenza, is there any reason to think that it will be successful in addressing the much more comprehensive and complex challenges of health care reform? At this time I cannot give the government a passing grade in dealing with the issues regarding influenza!”
Herb Denenberg has served as the Pennsylvania insurance commissioner, a member of the Pennsylvania Public Utility Commission, and the Loman Professor of Insurance at the Wharton School of the University of Pennsylvania. He is a member of the Institute of Medicine of the National Academy of the Sciences and has frequently testified before Congress on health and insurance issues. Herb Denenberg can be reached at advocate@thebulletin.us.
The single problem I have in mind, for openers, is dealing with the seasonal flu and H1N1 swine flu, which President Barack “The Anointed One” Obama has declared to be a national emergency. In case you haven’t noticed, the Obama Administration is botching this “national emergency” from A to Z, so you can be assured that Obamacare will deliver results that are a million times more catastrophic.
To support this view, I rely on the conclusions of Dr. Daniel Hussar, the Remington Professor of Pharmacy at the Philadelphia College of Pharmacy, and who is one of the leading national authorities on pharmacy practice. I’ve relied on Dr. Hussar for countless reports and investigations of prescription drugs and related problems and have found him to always be right on target. In one of his latest editorials, published in his Internet newsletter, The Pharmacist Activist, he reports on what he calls “The Influenza Follies.”
President Obama declared H1N1 (swine) influenza a national emergency on Oct.24, 2009. But Dr. Hussar finds, “[H]owever, prior to this action, some of the efforts to address an anticipated influenza epidemic could almost be considered comical if the situation was not so serious. Numerous initiatives have been poorly planned and implemented and important questions exist.” The threat posed by H1N1 was recognized last year and predicted to be a much bigger problem this year. Despite that, Dr. Hussar finds “problems have been experienced that could have been avoided.”
Where Is The Vaccine?
Despite the experience of pharmaceutical companies over many years in producing influenza vaccine, we face a significant shortage of both vaccines at this time. Pharmacists and physicians have anticipated their needs and submitted their vaccine orders many months ago, but have still received only a fraction of their requirements. Dr. Hussar writes, “They are informed that there is a shortage, but provided with little or no information as to whether or when the shortage will be resolved, and when they can expect to receive additional supplies.” For an account of the shortage of both flu vaccines and the confusion about eventual delivery, see the account in The Times of Trenton (Oct. 29, 2009), headlined “Flu-shot shortages continue: Mercer residents seek answers.” There are also reports of a shortage of the liquid form of Tamiflu, a drug used to treat the flu in children. In Philadelphia, Mayor Michael Nutter declared the rapid spread of H1N1 flu to be a public health emergency. That gives hospitals the authority to move emergency rooms off site and to use volunteers to help with the increased patient load (Philadelphia Daily News, Oct. 30, 2009).
Federal officials have reassured the public that there will be adequate supplies of vaccine…eventually. However, “eventually” is not defined and eventually may be after the H1N1 and seasonal flu casualties are counted. Dr. Hussar poses some of the questions that should be answered: “Why is it that one large chain pharmacy reports that its supply of seasonal influence vaccine is fine, but another large chain pharmacy, as well as many other pharmacies and physician practices, have received only a small fraction of the supplies of vaccine they ordered? Why is it that, as recently as a month ago, the public was informed that supplies of the H1N1 influenza vaccine would be available even sooner than anticipated, but now we are informed that supplies of the vaccine are much smaller than anticipated and there will be significant delays in obtaining the anticipated supplies?” The federal officials have offered explanations for the shortage, but Dr. Hussar thinks they “are thinly disguised excuses for poor planning.”
Issues Of Pharmacist Participation In Influenza Program
Other problems with the vaccine program are documented by Dr. Hussar. He notes that important questions have not been answered by the federal government and, until those answers are forthcoming, the vaccine effort will lag. For example, there is still a question in many states as to whether pharmacists will be able to participate in the H1N1 immunization program. Although many pharmacists, including those in Pennsylvania, participate in the seasonal flu vaccine immunization program, it is not clear whether pharmacists will be able to participate in the H1N1 program and whether they will have supplies to do so. These questions should be resolved immediately, and Dr. Hussar asks whether the federal government, in view of the national emergency, might be able to do something so states would not have to take action individually. Dr. Hussar notes there has already been a significant delay in getting people immunized and steps should be taken on the pharmacist participation issue so as not to further extend that delay.
The ability of pharmacists to participate is important, as it would provide quick access for those who need the vaccines. As most people know, access to a pharmacist is at lightning speed compared to access to a doctor.
Dosing Errors With Tamiflu
Tamiflu, a drug to treat the flu, has dosing instructions that are likely to lead to errors in its administration. The drug comes in 30 mg, 45 mg, and 75 mg capsules and as a powder for oral suspension, which is often prescribed as a teaspoonful or some fraction thereof or as a designated number of milliliters (mL). But an oral dispenser comes with Tamiflu that is calibrated for doses of 30 mg, 45 mg, and 60 mg dispensing. This leads to confusion when prescribers write for a teaspoon or milliliter dose. The oral dosing dispenser that comes from the drug doesn’t take that prescribing option into account. This has led to dosage errors. The FDA in September 2009 did issue this alert: “If prescription instructions specify administration using mL, the dosing device accompanying the product should be replaced with a measuring device (e.g., a syringe) calibrated in mL.” That’s well and good, but what if a pharmacist doesn’t get or read that alert? It doesn’t take a genius to realize that the manufacturer of Tamiflu, Roche, should make the necessary changes in the dosing instructions and dispenser to prevent the dosage errors occurring now. If the federal government can’t insist on this kind of correction, if it can’t correct this obvious and egregious deficiency, what happens when it writes Obamacare?
Emergency Compounding Of Tamiflu
There is a shortage of the commercially marketed Tamiflu for Oral Suspension formulation. So in the labeling of Tamiflu, there is a section addressing “Emergency Compounding of an Oral Suspension from Tamiflu Capsules.” Specific instructions are provided for pharmacists to take the capsules and “compound” the oral suspension. The FDA, according to Dr. Hussar, has paranoia regarding pharmacist compounding. So, the pharmacist can compound Tamiflu in the event of an emergency. However, if the instructions for compounding Tamiflu that come with the drug are followed, you get a concentration of 15mg/mL that is different from the 12mg/mL concentration of the product supplied by the company when it is available. So, if the pharmacist follows the instructions provided by the manufacturer, Roche, he gets a different concentration. Dr. Hussar writes: “This situation is ludicrous and the FDA and Roche are responsible for creating another situation that results in confusion and error!”
Conclusion
Dr. Hussar writes, “If the federal government is not successful in containing, preventing, and treating influenza, is there any reason to think that it will be successful in addressing the much more comprehensive and complex challenges of health care reform? At this time I cannot give the government a passing grade in dealing with the issues regarding influenza!”
Herb Denenberg has served as the Pennsylvania insurance commissioner, a member of the Pennsylvania Public Utility Commission, and the Loman Professor of Insurance at the Wharton School of the University of Pennsylvania. He is a member of the Institute of Medicine of the National Academy of the Sciences and has frequently testified before Congress on health and insurance issues. Herb Denenberg can be reached at advocate@thebulletin.us.
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