Although FDA inspections of clinical sites are not an indictment of something being wrong with a clinical site, it can nevertheless still be a scary experience, especially if you are not properly prepared.

An FDA inspection is basically a quality assurance process that is used to confirm clinical data management/integrity and regulatory compliance.  Here we show you how to make it a piece of cake for your site and your nerves.

Kinds of inspections

-The most common FDA inspection is the ‘routine inspection’, prompted by a New Drug Application (NDA) submission.  The typical candidates for a routine inspection are clinical sites that enroll the majority of patients in the NDA’s critical clinical  trials.

-‘For Cause inspections’ are not common, and are prompted when the FDA receives a report of, or becomes aware of, suspicious behavior.  Here are some reasons that may bring about such an audit:

_ The carrying out of many clinical trials

_ The carrying out of clinical studies outside of your specialization field

_ The reporting of much better effectiveness, less unfavorable effects, or different laboratory results from other sites studying the same drug

_ Having noticeable access to a large number of patients with a specific disease state for the setting

_ Complaints from a patient or sponsor in regards to regulations, protocol, or human rights violations

-Customer complaints that may trigger a product recall

How it all starts

It all starts with a phone call.  The FDA will call to program an inspection at a time that is agreed between both parties and that does not interrupt the site’s activity.  Nevertheless, they will only give you between 5 to 14 days notice, and will spend around 2 to 3 days on site.

You are entitled to ask what study they are going to inspect and who should be available during the visit, and contact the study sponsor immediately, because this sponsor can give you good suggestions and they are not directly notified by the FDA about clinical site inspections.

Before the inspection, gather these documents for the study in question:

-Protocol

-Investigator’s brochure and IND Safety Reports

-Form FDA 1572 with accompanying CVs

-IRB correspondence, including approval documentation and final report to IRB and Sponsor

-IRB-approved Informed Consent form

-IRB-approved advertising

-Correspondence related to the study, excluding investigator agreement and financial information

-Monitor sign-in log

-Laboratory certification documents

-Drug accountability records

-Each subject’s signed informed consent

-Assess support areas, like pharmacy or lab, to make sure they are properly prepared.  The FDA may tour the facility

Be ready to answer these questions:

-    Where was the study done?

-    What special equipment was used?

-    Who assisted in doing the study?

-    What were each person’s specific responsibilities?

-    Describe the sponsor’s monitoring procedures and your interaction with the monitor.

-    How did you account for the drug received, distributed to, or returned from subjects?  Were all drugs returned to the sponsor?

Train your personnel to relate to the FDA.  You must show you are a professional and should answer questions in a direct way, without giving information they haven’t requested.

When the inspector arrives

First, check his ID, because you don’t want an unauthorized person checking your files.  The inspector will fill a Notice of Inspection (FDA Form 482) and will hand it to you.

1.The inspector will begin by determining the nature of the investigator’s conduct of the study.  He may want to tour the facilities and talk to everyone who took part in the study.

His intention is to establish the level of delegation of the investigator’s authority, where specific procedures were performed, where and how the data was gathered, and where the drug was accounted for and stored.

These things are normally checked:

-Communication capability with the IRB, including the initial submission document, adverse event reporting, and progress reports

-Totality of accountability documentation for the receipt, storage, administration, and return of test article (drug, device, etc.)

-Compliance with the study protocol and documentation that each deviation/amendment received the approval of the IRB and the sponsor

-Aptness of the informed consent process

-Timely and full reporting of adverse events to the IRB and sponsor

-Compliance with the record retention requirements and that the investigator had instant access to the study records during the trial

-Ample monitoring of the site and communication with the sponsor

2.The inspector will move on to audit the data.  He will compare the data submitted to the FDA with the medical charts and source documents that support it.

He will review data from before and after the subject’s participation to make sure the subject had the medical condition under treatment and that excluded medications were not given to him or her during the study period.

3.After finishing the audit, the inspector will meet with the investigator to talk about the results.  Any inconsistencies will be registered on FDA Form 483, of which you will receive a copy.

4.The inspector will write an Establishment Inspection Report (EIR) that will be sent to the FDA for evaluation.  You will receive a letter after this evaluation is finished.

This letter may show one of three scenarios:

-It may simply recognize that the inspection was done and that nothing significant was found.

-It may list deficiencies found during the inspection, but may point out that no response is necessary.  Nevertheless, it is important that the site acts on these deficiencies in view of future inspections.

-It may point out serious negative discoveries.  The site and the data are at risk here, and you must answer immediately to clarify what steps you will take to solve the situation.

Get the help of your sponsor, because the pharmaceutical company has lots to lose too, and contact your pharmaceutical consultant for guidance and support.

If you do not respond correctly, you may be banned from performing other studies; your study data, or even the whole marketing application, can be rejected; and you may even face criminal charges.

The EIR is available, upon request, to the site, sponsor, and general public, after 4 to 6 months through the Freedom of Information Act.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain!

The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues.

For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms.

These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right place and in the right size, shape, and orientation.

Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans.

If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason.

This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, where rogue stem cells can cause Leukemia.

Smed-prep is vital to correctly differentiate and to locate the cells that compose the head of the planarian worm and to define where this organ is located in the worm.

The scientists have discovered that even though Smed-prep is crucial for the head and brain to be in the right place, the worm stem cells can nevertheless be persuaded to form brain cells due to the action of other unrelated genes.  However, without Smed-prep, these cells are unable to organize themselves to form a normal brain.

The team knows that it is crucial to understand the molecular basis for tissue regeneration and remodeling in order to advance in regenerative medicine.

The planarians are famous for their incredible regenerative capabilities, and these scientists have been able to characterize the first gene, the Smed-prep, that is necessary for correct anterior fate and patterning during regeneration.

Contact your pharmaceutical consultant for guidance and more information in regards to tissue regeneration milestones.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Maintaining a top-functioning Quality System in regulated pharma environments can add serious problems to the company’s bottom line.  Nevertheless, the ROI can be significant with solutions that automate routine and administrative tasks related to Quality System maintenance.

Within the pharmaceutical industry, it is not easy to find a Quality System model that offers a meeting point for agreement, be it direct or indirect, with the FDA’s cGMP initiative, 21 CFR Parts 210 and 211 regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and/or the requisites of foreign regulatory bodies.

However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’ support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep on, growing a top-functioning Quality System capable of meeting the institution’s regulations and requisites.

The quality systems model proposed by the FDA is divided into four major categories:

1.Management responsibilities
2.Resources
3.Manufacturing operations
4.Evaluation activities

Here, we’ll discuss the first category, Management Responsibilities, and how many administrative chores related to pharmaceutical Quality Systems management could be automated.

According to the Quality System model proposed by the FDA, management staff in pharmaceutical environments has two main responsibilities:

-First responsibility: “Senior management must show commitment to developing and maintaining their Quality System.”
Developing a Quality System is a task that takes time and requires dedication.

Even if a quality manager knows a lot about the difficulties and particulars of different Quality System models, he or she will most definitely have to show commitment to developing the Quality System itself.

The management staff also holds the responsibility of maintaining the Quality System.  There are five stages linked to Quality System maintenance:

1.Observation of the Quality System
2.Identification of deviations and nonconformance events
3.Reporting
4.Analysis
5.Appropriate action

Management has to be accountable for every stage of Quality System maintenance and normally will hold the biggest responsibility in regards to data analysis and later decision making.

In spite of this, it is common to see managers spending most of their energy on the first three levels, which are the ones that pose the heaviest burden and are also the ones that are perfect for automation.

The benefits of automation are very clear:

_More time for analysis and associated research
_Less administrative responsibility

There are software options that act as an “observer” of the company’s quality system, and with these, quality management staff in regulated pharmaceutical environments can benefit from the advantages of automation.

These solutions should offer data and trending technology that simplify the identification of Quality System deviations and nonconformance events, as well as sophisticated auditing capabilities, and should allow for the effortless creation of reports that show data trends.

With good automation technology in place, management will still hold the major responsibilities in regards to Quality System maintenance, but timely and uninteresting administrative chores disappear from the picture.

-Second responsibility: “Quality System plans should be aligned with a manufacturer’s strategic plans to ensure that the system is part of the manufacturer’s mission and quality strategies.”
A Quality System is not an entity unto itself, it meddles in everyone’s business, and this is why it is crucial that the Quality System be linked to other pharmaceutical systems and processes’ goals and realities.

Nevertheless, it may not be easy to line up Quality System management with the other processes and departments because these have a tendency to be disorganized and subjective.

Good automation will let pharma companies connect quality, compliance, and everyday routine processes with solutions that take-off from one platform.  This sole platform offers two benefits:

-Faster and more effective communication between departments
-Less quality system errors due to manufacturing and quality disconnects

Within pharmaceuticals, the aspects of management responsibility seem countless, but there are modern quality management solutions that have been designed to consolidate and greatly simplify the job of pharma management staff.

Your pharmaceutical consulting firm has powerful inside information to guide your choice of quality management solutions for your company.  They are there to help you make the right choices!

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

In April 2010, an important number of the world’s top experts in pediatric pharmacogenomics and personalized medicine came together at a unique conference to change the way childhood diseases are treated.

The conference was hosted by the Children’s Mercy Hospitals and Clinics, and its goal was to apply genomic tools to medical problems so as to tailor treatments to the unique requirements of children patients in order to improve results.

The conference’s organizer, Stephen Spielberg, MD, PhD, Director of the Children’s Mercy Center for Personalized Medicine and Therapeutic Innovation; Marion Merrell Dow Chair in Pediatric Pharmacogenomics; and Professor of Pediatrics, University of Missouri- Kansas City School of Medicine, stated that personalized medicine utilizes the latest developments in genomics and molecular data so that they can give the correct medication to the correct patient, in the correct dosage, and at the correct time.

He added that right now, a lot of medications work just for about 50% of the patients who take them, thus, personalized medicine shows high potential to transform the way in which they treat diseases.

During the conference, different experts from academia, government, and the private sector in the US, Canada, and Japan shared their knowledge of clinical applications, bioethics, and the development of pediatric personalized medicine programs.

Some of the clinical applications that were discussed were from the research programs being run at the Children’s Mercy, which tackle significant patient challenges like:

-Applying genomic strategies to improve the safety and efficiency of medications employed to treat cancer in children.

-Improving the effectiveness and benefit/risk percentage of a common therapeutic agent in treating Juvenile Idiopathic Arthritis, where inter-patient inconsistency causes 40% of the patients to fail to see results.

-Revealing genetic and developmental factors that contribute to the risk of serious adverse drug reactions in children.

-Identifying a non-invasive marker for inflammation concerning asthma, allowing doctors to predict correctly if the patients will respond to steroid treatment, and if not, guide them in the direction of better therapies.

-Utilizing genetic biomarkers to forecast which newborns are in danger of developing hyperbilirubinemia, which is the most common reason why newborns are hospitalized; up to 85% of readmissions during the first two weeks of life are due to this condition.

The occasion also prompted exchanges that help address crucial concerns created by personalized medicine, for example:

-Genetic discrimination
-Cost-benefit analysis
-Universal standards for managing genomic information in electronic medical records
-Biobanking
-Strategies to educate practitioners and patients

Children’s Mercy Hospitals and Clinics is a national leader in pediatric personalized medicine, and they are about to launch two new programs to increase medication safety:

-The outpatient Personalized Medicine and Therapeutic Innovation Clinic

-An inpatient adverse drug reaction program

Both programs will deliver first-class drug therapies, encouraging the use of discoveries to impact treatment decisions.  The clinics will be open to referrals of patients that show diagnostic and therapeutic challenges and are not responding to a therapy in progress or have had a sudden, unfavorable reaction to a certain medication.

The personalized medicine clinic will offer better therapies for children by using various approaches, which include genomic technologies and the cooperation between clinical pharmacologists and pediatric subspecialists.

Contact your life sciences consulting firm for more information about the future of personalized medicine.

A study of almost 100 clinical trials that were stopped prematurely because they showed positive treatment effects has shown that a large number of those effects were exaggerated.

The study was published in the Journal of the American Medical Association and recommends that researchers do not fall for the temptation to end clinical trials prematurely but rather continue with them for longer periods of time before thinking about ending them.

Victor Montori, M.D., Mayo Clinic endocrinologist and one of the authors of the study, explained that they discovered that in the majority of cases where the clinical trial was stopped prematurely, the effects of the treatment were deceptive, and that these ambiguous estimations will most probably produce unwise decisions in regards to the estimation of the therapy’s risks and benefits.

He added that, “On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials.  Treatments with a true relative risk reduction of 20 percent would show a reduction of over 40 percent.”

The clinical trials that were analyzed in the study were stopped prematurely due to a credible and normally large apparent difference between an experimental treatment and an established standard therapy.

The trials were stopped so that the people taking a placebo, or a medication that was less effective, could take the drug in trial.  In addition, this allowed doctors to prescribe the therapy earlier, since it would reach the market faster.

Dr. Montori explained that almost everyone doctors, researchers, investors, pharmaceutical firms, scientific journals, and even reporters benefits from the premature stop of a clinical trial; the only one that is affected is the patient, because he or she may wind up being treated with a therapy that is based on deceptive data in regards to its benefits.

The study investigated 63 medical questions about 91 trials that were stopped and compared them to 424 equivalent trials that remained active.  The discovery was that the trials that were prematurely stopped, especially small trials of a few hundred participants, showed effects that were exaggerated or deceptive, and these deceptive conclusions were aggravate over time because researchers wouldn’t go back to check what was previously considered a positive treatment.

It is recommended by the research team that clinical trials are stopped only when these are near the end and only for a very good reason, otherwise, patients, as much as doctors, will be making choices based on the wrong information and will be considering treatments that may not work as well as others.

The Medical Research Council of the U.K backed this study, and collaborated on it, together with Dr. Montori: Dirk Bassler, M.D.; Matthias Briel, M.D.; Qi Zhou, Ph.D.; Stephen Walter, Ph.D.; Gordon Guyatt, M.D.; and Diane Heels-Ansdell, all from McMaster University, Ontario; Melanie Lane, Mayo Clinic; and Paul Glasziou, M.B.B.S., Ph.D., University of Oxford, England.

Contact pharmaceutical consultants for more information, guidance, and to get the competitive edge you need to be the market leader in healthcare products.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

According to Mexican researchers, agave, the plant from which tequila is made, may help fight osteoporosis and other bone diseases through one of its components.

Agave, as well as artichokes, garlic, onions, and chicory, is a powerful natural source of fructans, non-edible carbohydrates that consist of molecules of fructose joined together into chains.

Experimental studies indicate that fructans could be helpful for patients with diabetes or obesity, to stimulate the immune system, to decrease levels of bacteria that cause intestinal illness, to relieve constipation, and to reduce the risk of colon cancer.

Fructans have also been shown to stimulate the growth of good bacteria in the large intestine, boosting the body’s assimilation of minerals, including calcium and magnesium, essential for bone growth.  So, even though it is not a tequila shot per se, fructans may do a lot of good to a sick person’s bones.

Mercedes Lopez, from the National Polytechnic Institute in Guanajuato, tested the agave fructans on mice bone growth.  The sample fed with agave fructans absorbed more calcium from food, expelled less calcium in their feces, and increased in 50% their levels of a protein associated with the development of new bone tissue, all three, conditions that were not observed in other mice.

The natural conclusion is that by enriching the mice’s normal diet with agave fructans, bone loss was prevented and bone formation was enhanced.  This suggests that agave fructans may play an important part in maintaining bone health.

Agave fructans can be used in many products for children and infants to inhibit several illnesses, and also used as a sugar substitute in ice cream.

Lopez clarifies that the conventional tequila shot is actually not an option, since fructans become alcohol when agave is processed into the drink.

Ask your pharmaceutical consultant for more information or research on agave fructans; there’s no better source of valid information and advice in the pharmaceutical industry.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Starting now, and for the next 10 years, developing countries will start receiving pneumonia vaccines from GlaxoSmithKline and Pfizer Inc.

GAVI Alliance, the public-private partnership based in Geneva, recently announced this new commitment.  The program GAVI established to treat pneumococcal disease initially received $1.5 billion in funding, which came from the Italian, U.K., Canadian, Russian, and Norwegian governments, and from the Bill & Melinda Gates Foundation.

This new development promises to put new affordable vaccines in the hands of people that need them urgently.  GAVI states that the pneumococcal disease, which includes pneumonia, kills 1.6 million people per year, 800,000 of which are children under the age of five.  Over 90% of the deaths take place in developing countries, where pneumonia ends the life of one in every four children.

GAVI established the ‘Advance Market Commitment’ program to make drugs available to people in need, affirming that vaccines that are affordable could save 900,000 lives by 2015 and 7 million lives by 2030.

Glaxo will deliver 30 million doses and Pfizer an equal amount, for the next 10 years.

Pfizer is enhancing its manufacturing capacity to meet the global demand and to deliver Prevenar 13, which can be used in infants and small children throughout more than 40 countries.

Jeffrey Kindler, Pfizer Chairman and CEO, affirmed that, “Pfizer is dedicated to broadening access around the world to our medicines, and public-private partnerships such as the one involving the Advance Market Commitment are critical to achieving true inroads on this front.”

Glaxo announced it invested over $400 million to build a manufacturing plant in Singapore that will be devoted to producing hundreds of millions of doses of Synflorix, the drug it will be delivering, in the next years.

These vaccines will start being sold at $7 the dose, however, the price will drop to $3.50 and will remain so for the long run.  The vaccines will be paid by GAVI and the developing countries they will benefit.

According to GAVI, the total cost of the pneumococcal vaccines is only a fraction of their current cost in many industrialized countries.

Ask your pharmaceutical consulting firm for information and guidance to gain the competitive edge you need to be the market leader in healthcare products.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

The time when body organs become replaceable is just around the corner.  Soon enough, scientists will be able to extend the life span of a human being dozens of years through his or her stem cells.

The first step has been taken already, with a 10-year-old boy receiving a revolutionary tracheal transplant in London, at the Great Ormond Street Hospital.

An organ that will grow inside the boy’s body through his stem cells has substituted the windpipe, bendable tube connecting the nose, mouth and lungs.

The boy was born with a condition known as long segment tracheal stenosis, which is a weakening condition that leaves the person with an airway of 1mm in width, putting him at risk of suffocation and death.

Previously, the boy was treated with stents, but these collapsed, interrupted the airflow and harmed the boy’s aorta.  After the child could barely breathe, his doctors called Paolo Macchiarini, at Careggi University Hospital in Florence, who decided to try a dangerous but bold procedure: re-growing the organ inside the boy’s body using stem cells.

Macchiarini’s team took a donor’s windpipe and removed all cells to prevent immune response.  The tissue was successfully implanted after having been seeded with the child’s stem cells and with a blend of chemicals that promote growth.  The patient responded well, he breathed normally and started talking right after the procedure.

This is truly a milestone in more than one way, because besides the implications it has for human life and health, this is the first time a child has received stem-cell organ treatment, it is the longest airway that has been substituted ever, and by letting the boy’s own cells re-grow the tissue, the costs were lowered considerably, by tens of thousands of pounds.

This success opens the door for stem-cell organ transplants to be performed in other medical facilities besides highly specialized hospitals, and although it won’t replace conventional transplants shortly, it most certainly can be applied to some aspects of these types of surgeries.

Regenerative medicine must become an important part of healthcare, and things are moving in that direction.  The next possible and intrepid step will be to perform larynx or esophagus stem cell transplants.

For now, doctors are waiting to see how the boy further responds to the transplant and if his recovery is as successful as expected.  If he recovers completely, as it is believed he will, we will have moved a step closer to immortality.

Talk to your life sciences consulting firm to learn about the latest developments in the pharmaceutical industry and to find the best ways to take advantage of the stem cell miracles that are unfolding around the world today.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).

Now that  the year long, and oftentimes ugly journey towards health care reform is coming to an end, many are curious as well as concerned about what this health care overhaul means for them.  What we have heard is that this new landmark legislation will extend health care coverage to 32 million Americans who are currently uninsured, and stop insurance companies from discriminating from patients with pre-existing conditions.

But what else will this milestone legislation cover? With so many half truths being spoken it is not surprising that the misinformation about health care circulating has confused most Americans. Now the question being asked  by many is what does this change actually mean for them personally and how will it change their lives?

While many of the provisions in this bill do not officially start until 2014, there are a few key provisions that will be effective immediately.  One of these provisions is that starting this year, children and young adults will able to stay on their parents’ health plan until they are 26 years old.  Another immediate provision, as we mentioned earlier, is that insurance companies can no longer discriminate towards people who may have pre-existing conditions, and these people, for the first time, will also be eligible for high risk insurance programs.

Other reforms starting this year include a small business tax credit of up to 35% of the cost of any premiums.  Also, insurance companies will be banned from lifetime caps on coverage and are  no longer able to cancel a policy

And yet another new provision that will take effect in the upcoming year is the provision of prohibiting insurance companies to enable pre-existing condition policies when it comes to the coverage of children.

While these reforms will be taking place immediately, the major bulk of the bill will take into effect as of 2014.  This is when new insurance marketplaces, or exchanges, will be set up in states all over the country to offer individuals competitive health policies for businesses or individuals that don’t have coverage.  Lifetime and annual limits on coverage will also be eliminated at this time.  Other stipulations include, starting 2014, that any persons who do not obtain coverage will have to pay a penalty of either $95 or 1% of their income, whichever one is the highest.

While many of these stipulations are real positive steps toward true health care reform, one of the main questions being asked is how these new laws will affect your current health care plan.  While there is still no consensus on this matter, many in the pharmaceutical industry like manufactures, pharmaceutical consultants, even doctors do not feel this will affect your plans in any way.  Many news reports about this health care bill, they feel, have been distorted in the way the spirit of the bill was intended.

Many believe that , not only will this new health care reform not change your existing insurance, it will be a positive step in the right direction towards true health care reform.

If you liked this article, tell all your friends about it. They’ll thank you for it. If you have a blog or website, you can link to it or even post it to your own site (don’t forget to mention www.smartconsultinggroup.com as the original source).