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Posts Tagged ‘prescription drugs’

The FDA has announced a new program to help doctors check the approved indications and other information in drug “labels.”  These “labels” are the FDA-approved educational information sheets that drug companies package with medication. See information below:

Online Service Enables Physicians To Check FDA-Approved Medication Labeling Via EHRs.

Healthcare IT News (1/27, Merrill) reported that to “boost drug safety, a new online service has been launched that allows doctors to check the FDA -approved labeling for the most commonly prescribed drugs.” The service is part “of a new campaign” called “Know the Label,” which is being “launched in concert with the FDA’s efforts to provide up-to-date and complete prescribing information to physicians.” It is being delivered to all US physicians and providers “electronically via the websites of PDR Network, The Doctors Company and other liability carriers, via EHR systems. … ‘We congratulate The Doctors Company and PDR Network for finding a practical and novel way for physicians to access the full updated labeling through electronic means and have it available at the point of prescribing,'” said Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research.

I doubt this new program to disseminate the label information is going to help patients much.  At least in my field, use of medication is based on  patients’ individual conditions and results of studies that go far beyond what’s in the FDA-approved “label.”  Medications are used for conditions other than FDA-approved uses.  Different doses are used.  Combinations that the FDA-approved label says are bad may often be exactly what a patient needs. I guess it won’t hurt to give doctors the information on FDA-approved medication labeling, unless it discourages doctors from giving patients needed treatments for unapproved conditions.

For best results, a doctor’s  good judgment is the best guide to treatment.

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In a big move toward transparency in medicine, ProPublica unveiled a publicly accessible database that shows how much money several large drug companies paid physicians for speaking, consulting or research.  My son looked me up and saw that I had received over $3,000 from one of the companies (other companies have paid me considerably more as I have been paid to give lectures to doctors and consult with companies about the treatment of psoriasis and other skin conditions).

I have the sense that some people think there’s a conflict of interest when doctors take money from drug companies, even if it is for lecturing or other activities.  I don’t doubt that there is potential for conflict and perception of conflict, but there’s also a lot of good that comes from doctors educating other doctors about new treatments for patients, giving companies advice on patients’ needs and helping drug companies develop new treatments.

Because these activities are good, there’s no need to hide them. I welcome transparency.  Just like online doctor ratings are good for the public to see, making these payments more transparent should help alleviate patients’ concerns.

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The Financial Times reported on September 30, 2010, that England will try to revise drug prices to get them in alignment with their value for patients. That sounds good, but can governments and regulators really make good decisions about this?

In a socialist world where government takes responsibility for providing medical care, government has to decide what it will and won’t pay, and what it will and won’t cover.  Another approach is for patients to decide how much to pay by deciding how much a drug treatment is worth to them.  That system seems to work well in the rest of the economy.

So many of us have come to rely on others — insurers or the government — to make our health care decisions for us.  I’m not saying whether that’s good or bad, just that it is.  If we want to control the cost of health care, we’re either going to have to let insurers or the government make those decisions for us, or we’re going to have to change to a system in which we make those decisions for ourselves.  But to do that, we have to be responsible for paying for our health care.  I discuss this in more detail in my Primer on Health Care Reform, available for free by clicking here.

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The Washington Post reports that the FDA may try to recall a device that was approved for repairing damaged knee joints.  The report says that the device was originally approved with little testing under rules that allow fast-track approval for products that are similar to other products already on the market.

Apparently FDA scientists thought more testing needed to be done, but the product was approved because of political pressure.

The FDA has a tough job.  It has to assure the efficacy and safety of new drugs and medical devices.  But there’s no way to show that anything is completely safe.  There has to be a balance between assuring safety and making products available to help patients in need.

I don’t know how much need there was for this knee joint replacement product.  It may be that getting it to market quickly helped far more people than it hurt.  Ideally, though, it would be good if objective decisions about benefits and risks could be made without political interference.  But it’s also important that the folks at the FDA not be allowed to spend too much time and resources assuring safety if in doing so they block patients’ access to helpful new treatments.

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More doctors are using electronic prescribing.  I am.  It’s cool that the prescription goes straight to the pharmacy, perhaps ready for the patient by the time the patient arrives at the pharmacy.  And no more worries about bad handwriting (instead, we’ll have worries about hitting the wrong button).

I imagine the prescription pad will soon find a place next to slide rules and dial telephones among what our kids regard as old relics and antiques.

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