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2013年9月28日星期六

Asthma, -little information...



Asthma is a common disease which affects the respiratory system. It constricts the airways and they become inflamed and lined with mucus. It can be managed well.

Many children develop asthma, which eventually they grow out of. The triggers associated with asthma include:


• Allergies
• Stress
• Exercise
• Cold air


Genes may also play a role who is getting asthma and who not.


The symptoms of asthma include:


• Wheezing
• Coughing
• Chest tightness
• Short of breath


Early detection, diagnosis and treatment is important, otherwise asthma could become a life-threatening disease.


25% of the children will develop asthma and the percentage is not increasing, but only staggering.


The children must get enough breast milk as long as possible. The antibodies and the combination itself is the best for the infant to develop its immune system. Try to avoid cow milk for the infants till 12 months and here we observe these children get less allergies and asthma. If you are not having enough breast milk, select other food, but not milk or milk powder based formulas. Now-a-days without any problems this could be done.


Good medicines are available. Theophylline is the medicine used and it belongs to the group of thioxanthenes. Caffeine also belongs to this group and is good for persons who have asthma. But there is no cumulative effect from both. If we find theophylline values in toxic levels we ask the patient to drink four cups of strong coffee and the caffeine present there helps for the quick excretion of theyphylline.


Asthma is one of the fastest growing health problems in all developed countries.


This a short article to give you quick information.



2013年9月23日星期一

Drug Information Update - New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)



Drug Information Update – New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)


The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma. These changes are based on FDA’s analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.


LABAs are approved as single-ingredient products (Serevent and Foradil) and as an ingredient in combination products containing inhaled corticosteroids (Advair and Symbicort) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). They work by relaxing muscles in the airway and lungs. This helps patients breath easier, and lessens symptoms such as wheezing and shortness of breath. The new recommendations only apply to the use of LABAs in the treatment of asthma.


For more information, please visit: LABAs
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm


FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)


Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
FDA Approved Medications Containing a Long-Acting Beta Agonist (LABA)
Data Summary


Safety Announcement
[02-18-2010] Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma. These changes are based on FDA’s analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma (see Data Summary below).
LABAs are approved as single-ingredient products (Serevent and Foradil) and as an ingredient in combination products containing inhaled corticosteroids (Advair and Symbicort) for the treatment of asthma and chronic obstructive pulmonary disease (COPD). They work by relaxing muscles in the airway and lungs. This helps patients breath easier, and lessens symptoms such as wheezing and shortness of breath. The new recommendations only apply to the use of LABAs in the treatment of asthma.
To ensure the safe use of these products:
The use of LABAs is contraindicated without the use of an asthma controller medication such as an inhaled corticosteroid. Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.
FDA is also requiring a risk management program called a Risk Evaluation and Mitigation Strategy (REMS) for these products. The REMS for LABAs will include a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. In addition, FDA is requiring the manufacturers to conduct additional clinical trials to further evaluate the safety of LABAs when used in combination with inhaled corticosteroids. FDA will seek input on these studies at a public advisory committee meeting on March 10-11, 2010.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended above will improve the safe use of these drugs.
Additional Information for Patients
Long-Acting Beta Agonists (LABAs) do not relieve sudden-onset asthma symptoms. Patients should always have a rescue inhaler, such as an albuterol inhaler, to treat sudden onset asthma symptoms.
LABAs must never be taken alone for the treatment of asthma.
Patients who need a LABA plus an asthma controller medication that is not available as a combination product should work with their healthcare professionals to ensure that each individual medication is taken correctly.
Patients should read the Medication Guide for LABAs.
Patients should talk with their healthcare professional to learn the warning signs of worsening asthma.
Patients should discuss any questions they have about the use of LABAs with their healthcare professional.
Additional Information for Healthcare Professionals
Long-Acting Beta Agonists (LABAs) should not be started in patients with acutely deteriorating asthma.
Discuss with patients and families the warning signs of worsening asthma and advise them to seek immediate medical attention should their condition deteriorate.
LABAs do not relieve sudden-onset asthma symptoms. A rescue inhaler, such as an albuterol inhaler, should be prescribed to treat sudden asthma symptoms.
Encourage patients, families, and caregivers to read the Medication Guide that accompanies LABA prescriptions.
When possible, prescribe a combination inhaled corticosteroid – LABA product to pediatric and adolescent patients who need the addition of a LABA for better control of their asthma. Using a combination product will help ensure compliance with both of these medications.


2013年9月13日星期五

The Genetic Information Nondiscrimination Act (GINA), Health Risk Assessments (HRAs) and Lawyers Run Amok

The Disease Management Care Blog received a DMAA email containing this press release today. It calls for a moratorium in “GINA regulation implementation.”




What’s this about you ask? The DMCB at your service.



GINA is part of the logarithmically expanding blob of Washington D.C. acronyms. This particular one refers to the ‘Genetic Information Nondiscrimation Act’ that was signed into law by President Bush on May 21, 2008. Its intent was to prevent discrimination based on genetic information by health insurers and employers.


In reading about the act here, it appears that the way discrimination is prevented is by prohibiting employers and health insurers from collecting any genetic information in the first place. In addition to not collecting it, insurers are also prohibited from using it for decisions about coverage or rates (by insurers) or for hiring, firing, promotions or other decisions about the terms of employment (employers).


So far so good.


So the intrepid DMCB went to the text of the law itself and found a lot of language stating that collecting and use of ‘genetic information’ was prohibited in health insurance ‘underwriting.’ The statute has very clear definitions of underwriting (‘health insurance rules used to determine eligibility, computation of premiums, exclusions of pre-existing conditions and other activities related to contracting health benefits’) and genetic information (‘results of genetic tests of the individual or the family members and the manifestation of a disease or disorder in family members of an individual’).


The DMCB is struck by the inclusion of ‘family history.’ Read on and you’ll see why.


On Oct 7, 2009, the Departments of Labor, Treasury, HHS and the Equality Employment Opportunity Commission released proposed regulations a.k.a interim final rules that are intended to guide their interpretation and enforcement of GINA. The rules become effective on December 8, 2009.


The lawyers that crafted these regulations must have also been struck by the term ‘family history,’ because they’ve addressed it in the context of health risk assessments (HRAs).


HRAs are widely used in the population-based health care. It typically consists of questionnaire that asks a series of health related questions. The individual answers can then be summed up to determine an overall risk score in one or more health domains. This is an example of an HRA used to assess the risk from being overweight, while this HRA determines the risk of future heart attack. Note that both of these examples include family history as one factor in the overall assessment of risk.


What do the interim final rules say? They correctly point out that HRAs that include family history questions are typically distributed at the time of new or re-enrollment and are often accompanied by incentives to complete the survey. When present, these incentives consist of rewards such a premium reductions, lower deductibles and cash bonuses. Since this is money that is tied to the premium which is defined to be part of underwriting, the practice will become illegal on December 7.


What’s more, if the HRA is requested prior to enrollment, even if there is no payment to the enrollee, the act of collecting the ‘genetic information is also a violation of the law.


If your disease management organization, population-based care company, employees benefit plan or health insurer uses HRAs at the time of open enrollment, you have two choices:


Change how the HRA is done: No financial incentives, period. What’s more, the HRA can’t be distributed or collected until after enrollment,


or


Strip all the family history questions out of the HRA.


The DMCB agrees with the DMAA that the interim rules need to be put on hold until this twisted pretzel logic of lawyers run amok is straightened out.


First of all, while inquiries about family history can be intrusive to individuals completing HRAs, the cash value of the incentives are undoubtedly very welcome and are a fair value transaction.


The DMCB also did a word search of the original statute and did not find the term ‘health risk assessment.’ It doubts our legislators intended to sweep HRAs into the scope of this legislation.


It is also illogical to group the practice of increased payment to all enrollees with and without significant family histories with the other repugnant practices of charging more or denying benefits on the basis of genetic history. The resemblance is superficial to anyone with common sense.


In addition, in real practice, it is highly unlikely that the underwriters in any health plan would harvest the data from HRAs and mathematically price it into their premium decision-making. It is theoretically possible, but that’s simply not how the business is operates.


Last but not least, the risk of harm from showing some flexibility around this topic is far less than the risk of harm from hobbling how HRAs are distributed, completed and used. Thanks to HRAs, companies are not only extending hard cash but using the information to provide a higher level of service to individuals who would benefit from it.







If the DMCB is reading things right, comments on this silliness can apparently still be submitted (E-OHPSCA.EBSA@dol.gov) through January 5, 2010. The DMCB copied the above text and simply emailed it in over its signature.