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What Cost Samples?
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Despite new regulations from the Food & Drug Administration,
doctors continue to dispense millions of samples every day to patients
around the United States. Are those samples truly free, or are there
costs to pay?
The proliferation of sample medications appears to be giving pharmaceutical companies a free hand to distribute their products without the mandated written instructions, creating a new great cost to healthcare and the patient.
Under Federal law and FDA rules, sample medications are mandated to include written material which describes in detail the manner in which the medication should be taken, any warnings or contraindications and a description of any potential side effects. This critical information allows patients to determine whether the sample just given to them will react badly with other medications they're already taking or, what to look for if some adverse reaction occurs.
There are two distinct types of adverse reactions to medications. One, an allergic reaction - hives, coughing, wheezing, rash, itching, swelling, redness, sweating, chills, nausea, etc. These reactions are usually temporary, and can be quickly treated, if caught in time, but can be life threatening if not.
The other type of reaction can be more long-lasting and may include damage to internal systems or organs, tendonitis, neuropathies, heart-attacks, stroke, blindness or other temporary or permanent conditions, some fatal.
Despite the proliferation of these information-lacking samples, the FDA refuses to take appropriate actions to police the pharmaceutical companies - even after they have failed miserably to police the food supply resulting in deaths and injury from tainted foods.
When our citizens take these medications and experience adverse reactions, there is a clear cost involved. In fact, many costs, not the least of which may be the loss of a family member. But from a financial and economic perspective, those costs include increased Medicare expense as patients have to return to their doctors now to treat more than the original condition for which the sample was provided, but the adverse reaction as well; emergent medical care to deal with the drug reaction; long-term care, often by specialists, to deal with potentially permanent injury; lawsuits - as a cost to the states and the court systems from related torts; long-term hospice care, when a patient has been so severely injured that they must have permanent full-time care; and so on.
The Commonwealth of Massachussets in 2008 took steps to regulate samples within that jurisdiction, but few other states have addressed the high costs incurred from this issue.
The Center for Disease Control doesn't keep statistics, nor does the FDA, on adverse drug reactions from sample medications. However, several physicians - specialists in adverse reactions - have informed The Institute that the number could well be into thetens of millions of patients. While they admit the majority of reactions will be simple allergic reactions, they point out that it is likely more than 1 million people annually experience severe or permanent injury due to sample medications.
When a patient receives a written prescription, goes to the pharmacy to fill it, the pharmacist will advise about any contraindications with other medications that patient is taking, and will provide a simple print-out telling the patient how to take it, and what to look for, or how to cope with any reactions. If samples lack that basic written material, the patient will be potentially unaware of the potential to create toxic reactions between medications; or what to do when something odd begins to happen.
While the pharmaceutical industry will correctly point out that the samples provided help patients, particularly the poor; they should insure that manufacturers not only guarantee that written materials are included with every sample, but that sales reps educate doctors to tell patients to read the written material before taking the samples.
We would hope that the FDA would immediately conduct an investigation into the lack of written materials with samples, and demand that manufacturers comply with existing Federal laws and FDA regulations, under penalty of license suspensions. We also believe Congress should conduct hearings as soon as possible into the mismanagement of this issue by the FDA, and demand that they and CDC keep more accurate records about drug reactions, whether from prescriptions or samples.
The cost to taxpayers, business and families is far too high a price to pay for a "free" sample.
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August 7, 2009 by Epicurus
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