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Post by cm5 on Apr 30, 2016 21:24:01 GMT -5
I don't think anyone is implying that "it's not a problem for a delay for a diabetic".
In fact, everyone---patients/families/physicians/other providers/hospitals/pharmacies/those who work in healthcare management and insurance-----is constantly aggravated by the cumbersome, convoluted massive maze of process/regulation in healthcare. This is an issue every single second of every single day for everyone involved. Nothing is simple, and every box much be checked before the next step is taken. One change leads to delay until the system is updated.
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Post by cm5 on Apr 30, 2016 21:14:07 GMT -5
Thanks.
So, perhaps this could be moved to another thread, because this is not really a true problem, but a temporary and not uncommon inconvenient delay.
Amazonian marketing has pushed the populace to being convinced that everything can happen instantly, and tolerance for acceptance of the time needed for a process to be completed is vanishing-------.... . . . . . . .
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Post by cm5 on Apr 30, 2016 20:32:14 GMT -5
NYlefty is correct.
And, sometimes a change in insurance has not been updated. Or, the electronically transmitted prescription simply was not received, and lost in cyberspace. Or wrong fax number was used when submitting a preauthorization request. On, and on, and on.
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Post by cm5 on Apr 30, 2016 20:21:50 GMT -5
Statement was "this kind of post".
Again, stocking issues, temporary backlogs from wholesalers (four majors in US, + secondaries), incomplete/inaccurate patient info, and incomplete/inaccurate physician data at particular pharmacies is what should be clarified before assuming that there is a major problem. This happens often, often, often --- many calls/pharmacy/patient requests to providers constantly on daily basis for all pharmaceuticals about "lack of availability".
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Post by cm5 on Apr 30, 2016 20:02:44 GMT -5
Fundamental problem with the referenced statement re: Safeway Pharmacy---availability---- - "Just in time" supply chain management of almost all pharmacies for inventory control means many, many times a return trip to a pharmacy.
- Was it a preauthorization isssue?
- Was it an issue of unclear patient information----ie, date of birth, address, telephone number, provider's NPI number, DEA number not on record at that particular pharmacy?
- Not at all uncommon for many pharmaceuticals to be in temporary, or even months long, back log!
In other words, this kind of post on Trudiabetes means nothing, and could well have been posted by a fudster.
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Post by cm5 on Apr 30, 2016 14:33:24 GMT -5
Plus, the knowledgeable/caring/enlightened physicians will discuss Afrezza with their patients.
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Post by cm5 on Apr 30, 2016 14:16:51 GMT -5
Here's the summary and the link to a lengthy article about Off Label Drug Use ( OLDU), Mayo Clin Proc. 2012 Oct; 87(10): 982–990 www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/. Please note this was published prior to the cases cited in the above post. "Off-label drug use involves prescribing medications for an indication, or using a dosage or dosage form, that has not been approved by the FDA. Since the FDA does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine, but it may be more common in areas of medicine in which the patient population is less likely to be included in clinical trials (eg, pediatric, pregnant, or psychiatric patients). Pharmaceutical companies are not allowed to promote their medications for an off-label use, which has lead to several large settlements for illegal marketing. To limit liability, physicians should prescribe medications only for indications that they believe are in the best interest of the patient on the basis of the most credible available evidence. In an era of global exchange of medical information, this approach to physician prescribing practices may have greater utility than restricting practices solely to indications approved by a US-based pharmaceutical labeling system. Health care professionals should continually educate themselves about OLDU to weigh the risks and benefits and provide the best possible care for their patients." |
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Post by cm5 on Apr 30, 2016 14:08:31 GMT -5
Regarding "Off-Label Use" and "Freedom of Speech Issues", see the following quotes and links: In other words, off label use prohibitions/restrictions are in a state of flux for manufacturers/pharmaceutical corporations, but physicians continue to have freedom of speech to be truthful about the uses/doses of pharmaceutical agents, with a nod toward current, accepted medical standards. University of Pennsylvania Law Review Online [Vol. 162: 239
scholarship.law.upenn.edu/cgi/viewcontent.cgi?article=1120&context=penn_law_review_online"The FDA can look to statements by pharmaceutical representatives as evidence of a drug’s intended use, thereby placing manufacturers that promote off-label in a Catch-22: the drug will be subject to the FDCA’s misbranding provisions if manufacturers add labeling instructions for that intended use, but also if they fail to add those instructions. To legally promote a new intended use, pharmaceutical companies must satisfy the FDA’s rigorous approval process. In United States v. Caronia, the Second Circuit Court of Appeals ruled
that the FDCA could not be interpreted to prohibit truthful, off-label promotion." See NYT, Court Forbids F.D.A. From Blocking Truthful Promotion of Drug AUG. 7, 2015
www.nytimes.com/2015/08/11/business/dealbook/fdas-off-label-drug-policy-leads-to-free-speech-fight.html
" It certainly seems odd that speaking the truth can violate the law. Yet the Food and Drug Administration takes the position that when it approves a drug for a particular treatment, the manufacturer of that drug cannot promote it for other uses even if those statements are true.
But that policy has been called into question in a decision by Judge Paul A. Engelmayer of the Federal District Court in Manhattan, who found that the First Amendment protects drug companies that want to make truthful statements about their drugs, even if it is for an unapproved use. His decision sets up a likely appeal to determine just how far the government can go to punish speech that is truthful. ---- Amarin Pharma, a small drug manufacturer, challenged the F.D.A. when it sought to promote the off-label use of its cardiovascular health drug, Vascepa, for patients with a different condition. An F.D.A.-approved study showed that the use of the drug was effective, but the agency had denied approval for use by those patients. The company and four doctors sued the F.D.A. after it threatened to bring civil charges against them if they used the study to help sell off-label use of Vascepa. They claim that the agency’s rule on off-label promotion violates their First Amendment right to free speech, asking the district court to block any enforcement action. Judge Engelmayer sided with the company, pointing out the many incongruities in the F.D.A.’s approach to off-label marketing. The agency does not prohibit doctors from prescribing medications for nonapproved uses because it does not have direct authority over them. The judge pointed out that “the therapeutic — indeed, sometimes lifesaving — value of off-label uses of F.D.A.-approved drugs has been widely recognized.” For some conditions “off-label prescription is the norm rather than the exception,” a fact the F.D.A. is aware of and even encourages on occasion.
""That appeal would go to the United States Court of Appeals for the Second Circuit, however, and the conclusion in the Caronia case that the First Amendment protects truthful statements about off-label drug use will be difficult to overcome, especially when there is no evidence of fraud or other deception by Amarin. Pursuing the issue to the Supreme Court may also present substantial hurdles for the F.D.A.’s regulation of off-label marketing. The justices have been receptive in the last few years to First Amendment claims by corporations, as the decision in Citizens United v. Federal Election Commission shows, so they may well side with companies that want to make truthful statements about their products."
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Post by cm5 on Apr 30, 2016 13:32:31 GMT -5
Off-Label Use of Approved Drugs, quoted below from FDA site:
"Off-Label Use of Approved Drugs
The drug label of FDA-approved drugs gives information about the drug, including the approved doses and how it's to be given to treat the medical condition for which it was approved. When a drug is used in a way that is different from that described in the FDA-approved drug label, it is said to be an "off-label" use. This can mean that the drug is:
Used for a different disease or medical condition.
Given in a different way (such as by a different route).
Given in a different dose.
For example, when a chemotherapy drug is approved for treating one type of cancer, but is used to treat a different cancer, it is off-label use.
Off-label is also called "non-approved" or "unapproved" use of a drug. New uses for these drugs may have been found, and often medical evidence supports the new use. But the makers of the drugs have not put them through the formal, lengthy, and often costly studies required by FDA to officially approve the drug for new uses."
In other words, the provider is not restricted to the "approved" use(s) of a pharmaceutical agent. Many, many pharmaceutical agents are widely prescribed "off label", according to current, accepted medical practice.
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Post by cm5 on Apr 30, 2016 12:27:45 GMT -5
Alzheimer's disease and Diabetes - the common pathogenesis----
More evidence that Afrezza, inhaled monomeric human insulin, will cause a cataclysm in health care. See quotation below and link to PubMed.
"Epidemiological studies presented evidence that Alzheimer's disease and type 2 diabetes share common features in their pathophysiology and clinical patterns. Insulin resistance is a characteristic feature of both diseases. According to the pathomechanism, inflammatory, metabolic, and an atypical form based on the deficiency of zinc ions can be distinguished. Glucose metabolic disorders, related to Alzheimer's disease, are type 2 diabetes, and prediabetes/metabolic syndrome. Based on the common pathophysiological patterns of these two diseases, Alzheimer's disease is customary (sic) called type 3 diabetes. In the research on dementias, insulin resistance stands in the highlight for its documented harmful effects on cognitive function and causes dementia." Neuropsychopharmacol Hung. 2016 Mar;18(1):5-19 www.ncbi.nlm.nih.gov/pubmed/27038867
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Post by cm5 on Apr 30, 2016 11:47:48 GMT -5
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Post by cm5 on Apr 30, 2016 11:23:34 GMT -5
Re: "conflict of interest", see complete acknowledgements and conflict of interest.
Acknowledgements
The authors acknowledge medical writing support from Paul Tisdale, PhD and editorial/submission support from Daria Renshaw, both of Watermeadow Medical Limited, UK (an Ashfield company). This support was funded by Novo Nordisk. K. K. and M. J. D. would like to acknowledge support for this work from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care East Midlands, and the NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, University of Leicester. S. K. P. acknowledges infrastructure research support from the Australian Government's National Collaborative Research Infrastructure Strategy initiative through Therapeutic Innovation Australia.
Conflict of Interest
K. K. has acted as a consultant and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Janssen, Astra Zeneca and Boehringer Ingelheim. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim, Merck Sharp & Dohme, Janssen and Roche. K. K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk, Boehringer Ingelheim, Janssen and Astra Zeneca. M. J. D. has acted as consultant, advisory board member and speaker for Novo Nordisk, Sanofi-Aventis, Eli Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, Astra Zeneca and Janssen, and as a speaker for Mitsubishi Tanabe Pharma Corporation. She has received grants in support of investigator and investigator-initiated trials from Novo Nordisk, Sanofi-Aventis and Eli Lilly. M. A. has acted as a consultant for Novo Nordisk. A. N. and B. L. T. are employees and shareholders of Novo Nordisk A/S. S. K. P. has acted as a consultant and/or speaker for Novartis, GI Dynamics, Roche, AstraZeneca, Guangzhou Zhongyi Pharmaceutical and Amylin Pharmaceuticals LLC. He has received grants in support of investigator and investigator-initiated clinical studies from Merck, Novo Nordisk, Astra Zeneca, Hospira, Amylin Pharmaceuticals, Sanofi-Aventis and Pfizer.
K. K. and S. K. P. contributed equally to the study design, statistical analysis plan, data interpretation and writing of this manuscript. A. N. and B. L. T. contributed to the study design, analysis and interpretation of data, and review of the manuscript. M. J. D. contributed to the research idea, and the interpretation of the data and results, and commented on the manuscript. M. A. contributed to the study design, statistical analysis and review of the manuscript.
K. K. is the guarantor of this work and, as such, had full access to the study data and takes responsibility for the integrity of the data and the accuracy of the data analysis.
All authors were involved in the decision to submit the article for publication. Novo Nordisk sponsored data analysis, medical writing and editorial/submission support, contributed to study design, analysis and interpretation of data, and was also responsible for obtaining data from the CPRD.
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Post by cm5 on Apr 30, 2016 11:01:28 GMT -5
Please, that's rude.
Without a Wiley subscription, one cannot read article.
Second, your comment about physicians' financial incentive to treat is a personal editorial comment, and not clarified as such.
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Post by cm5 on Apr 30, 2016 7:46:03 GMT -5
Clinical inertia is a global phenomenon, which is putting people with Type 2 diabetes at further risk of preventable complications associated with the condition.
More proof of the obvious, and the obvious need for global availability/prescribing of Afrezza-----
See summary below of:
K. Khunti, A. Nikolajsen, B. L. Thorsted, M. Andersen, M. J. Davies, S. K. Paul. Clinical inertia with regard to intensifying therapy in people with type 2 diabetes treated with basal insulin. Diabetes, Obesity and Metabolism, 2016; 18 (4): 401 DOI: 10.1111/dom.12626
"People with Type 2 diabetes are being 'let down' because they are being forced to wait for further treatment when needed.
Research has shown the average waiting time for increased treatment from the start of insulin is 3.7 years.
Maintaining tight control of blood sugars in people with Type 2 diabetes can lead to significant reductions in related complications, previous evidence has shown."
However 'clinical inertia', which is the term given for the delay of increasing medication needed for patients, is preventing this from happening, according to a study published in the Diabetes, Obesity and Metabolism journal.
The research was carried out by NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) East Midlands, an organisation which turns research into cost-saving and high-quality care through cutting-edge innovation.
Professor Kamlesh Khunti, Director of CLAHRC East Midlands and Professor of Primary Care Diabetes & Vascular Medicine at the University of Leicester based at the Leicester Diabetes Centre, said: "Of the 11,000 patients we studied, only a third of those needing further medication were actually given it.
"Clinical inertia is a global phenomenon, which is putting people with Type 2 diabetes at further risk of preventable complications associated with the condition.
"Failure by healthcare professionals to intensify medication in the pursuit of tighter glycaemic control is due to a number of complex reasons related to patient and health care professional factors. However, we need to make great efforts to reverse these trends and improve patients reaching tight glucose targets from diagnosis of diabetes"
The study concluded that more should be done to avoid clinical inertia and patients should have their treatment intensified where appropriate.
Long-term complications and mortality associated with Type 2 diabetes can be significantly reduced if therapies are initiated earlier."
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Post by cm5 on Apr 22, 2016 5:20:55 GMT -5
Increasing cases of anaphylaxis among children:
"Posted: 21 Apr 2016 10:38 AM PDT
Anaphylaxis, known to be a sudden and potentially life-threatening allergic reaction, seems to be increasing among children, according to a new study. The findings reveal that the percentage of emergency department visits due to anaphylaxis doubled over a four-year period."
"Anaphylaxis, known to be a sudden and potentially life-threatening allergic reaction, seems to be increasing among children, according to a new study led by a team at the Research Institute of the McGill University Health Centre (RI-MUHC). The findings, published this week in the Journal of Allergy and Clinical Immunology (JACI), reveal that the percentage of emergency department (ED) visits due to anaphylaxis doubled over a four-year period based on data collected from the Montreal Children's Hospital of the MUHC (MCH-MUHC)."
"With the rising rates of allergies among Canadian children, we were interested in determining if anaphylaxis rates are also increasing," says the study's senior author Dr. Moshe Ben-Shoshan who is a pediatric allergist and immunologist at the MCH-MUHC and an assistant professor of Pediatrics at McGill University. "Our findings suggest a worrisome increase in anaphylaxis rate that is consistent with the world-wide reported increase."
It is estimated that almost 600,000 Canadians will experience anaphylaxis in their lifetime and that more than half of the individuals who had anaphylaxis were not equipped with life-saving epinephrine. Anaphylaxis can occur within seconds or minutes of exposure to an allergen which can include certain foods, medications, insect venom or latex, for example. The allergic response is marked by swelling, hives, lowered blood pressure, and dilated blood vessels. In severe cases, the reaction can be life-threatening."
The researchers collected data from 965 anaphylaxis cases seen at the MCH-MUHC between April 2011 and April 2015, as part of the nationwide Cross-Canada Anaphylaxis REgistry (C-CARE)--a project of the Allergy, Genes and Environment Network (AllerGen). C-CARE is led by RI-MUHC researcher Dr. Ben-Shoshan and is the first prospective study on anaphylaxis to assess the rate, triggers and management of anaphylaxis in different provinces and settings across Canada. Anaphylaxis was defined in the study as the involvement of two organ systems and/or hypotension in response to a potential allergen.
The study shows that between 2011 and 2015, the annual percentage of ED visits to the MCH-MUHC due to anaphylaxis rose from 0.20% to 0.41%, with the largest annual increase between 2013-14 and 2014-15. The team also observed that the majority (80.2%) of anaphylaxis cases were triggered by food, principally peanut and tree nut, and that children who did not receive epinephrine prior to arrival at the ED were more likely to receive multiple (two or more) doses of epinephrine at the hospital.
The under use of epinephrine auto-injectors was also highlighted in the research.
"Only slightly more than half of those who had an auto-injector used it prior to arrival in the emergency department," adds the study's lead author Dr. Elana Hochstadter, who is currently doing a fellowship in Pediatric Emergency Medicine at SickKids, and who was a pediatric resident at the Children's Hospital at London Health Sciences Centre at the time of the study. "This increased the risk of administration of multiple epinephrine doses in hospital, therefore, it is of critical importance for parents and healthcare providers to work together to ensure the appropriate and timely use of epinephrine auto-injectors in the case of anaphylactic reactions."
Elana Hochstadter MD, Ann Clarke MD MSc, Sarah De Schryver, MD, Sebastien LaVieille MD MSc, Reza Alizadehfar MD, Lawrence Joseph, PhD, Harley Eisman MD, Moshe Ben-Shoshan MD MSc. Increasing visits for anaphylaxis and the benefits of early epinephrine administration: A 4 year study at a pediatric emergency department in Montreal, Canada. Journal of Allergy and Clinical Immunology, Volume 137, Issue 6. (2016) DOI: 10.1016/j.jaci.2016.02.016
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