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On November 4, 2009, the FDA introduced its "Safe Use Initiative," an effort to collaborate with the health care field to reduce the preventable harm resulting from medication use and misuse.

The Initiative is in response to the millions of consumers who are harmed each year because of the misuse of medications. The inappropriate use of medications can be a result of several factors, including (1) incomplete access to information, (2) unintentional misuse of medications, medication abuse, and attempts by people to harm themselves with medications, or (3) taking prescription drugs prescribed for other people.

Taking prescription drugs prescribed for other people is a serious abuse, as even one single dose of certain medications, such as opioid drugs, can cause severe harm or death to the person not prescribed the medication.

Through the Initiative, the FDA will work alongside health care professionals to identify drugs that are linked to preventable harm. The FDA intends to collaborate with health care professionals to (1) evaluate consumer medication information, (2) communicate about the risk of inadvertent overexposure to acetaminophen, (3) apply safeguards against surgery fires caused by alcohol-based surgical preparations, and (4) avoid contamination of multiple-use medication vials.


  1. Gravatar for Jim O'Hare AIC AIS VP med mal claims
    Jim O'Hare AIC AIS VP med mal claims

    Several comments from a med mal claims guy since 1985

    - Aetna and BC/BS do not provide healthcare, they are just brokers with a 35% overhead.

    - There is too much med mal. I dont buy 98000, as I dont believe that only 5% of med mal turns into litigation. Can the plaintiffs bar really allow 90000 claims go un attended?

    - RE the 5 Myths:

    1 - There arent too many frivelous suits, as it costs money for you to bring them. Some are better than others.

    2 - Healthcare costs is the problem with HC costs. There is a license for them to steal. Med mal is a distant cousin to the cost of HC. Who would care about defensive medicine if it was cheap?

    3 - Doctors do flee. Ill and Tx and Pa had huge problems til tort reform brought them back. There are counties in Fl w/o neurosurgeons and OB's.

    4 - Of course the # of claims drives up premiums. This is true for all lines. i.e.- find me cheap hurricane insurance in Florida. Not there. Why? - the # of claims. See what happens to juniors auto premium when he reports his 3rd accident.

    5 - tort reform does lower rates. In 2004 there were 3 med mal writers in Fl, now there are 30+. A cap for P&S allows underwriters and raters to plug a real objective number into the premium equation, as protection against an open ended concept as what pain is worth. You cant rate infinity and make an equation work. WE can discuss the amount of the cap , but not the necessity. Rates in Florida have decreased 5 years in a row due to tort reform and competition. The same would work for healthcare.

    regards Jim

  2. Gravatar for Mike Bryant
    Mike Bryant

    Interesting that you would use a hurricane and a third at fault accident as the examples. If a doctor gets to that level of malpractice shouldn't their rates go up? Should they even be treating anyone? Also you use the myth that things are better in Texas. Have you seen the list of most expensive places to find care? Caps only shift the burden to society and let those at fault do cost benefit analysis on peoples lives.

  3. Gravatar for Jim O'Hare med mal claims guy
    Jim O'Hare med mal claims guy

    Dear Mike- My point was that the number of claims are a direct cause of premiums going up, this is always true for any type of claim. Hurricane insurance would be dirt cheap in Kentucky- no claims.

    Things are better in Texas, evidenced by doctors moving there, strictly due to a better litigation climate due to reforms. They didnt go there because the HC is expensive. The cost of the healthcare in Texas is completely unrelated to the med mal climate. Healthcare costs are not set by the physicians are they? The Healtcare brokerage megagiants are driving that bus. How do you connect med mal reforms to the cost of healthcare. Kinda like blaming Ford for the price of a gallon of gas.

    regards Jim

  4. Gravatar for Mike Bryant
    Mike Bryant

    Sure, people with more claims should pay higher premiums. So your doctor with hurrican type damge shouldn't be shocked. Actually shouldn't be practicing medicine.

    I'm not the one making the link. You are. I understand what you wrote as calling for caps to make a differance in this healthcare bill. It simply won't. Texas still has high costs with caps, they may have attracted bad docters and in the end the consumer suffers. The practice of medicine is not safer in anyway what's so ever.

    Minnesota has low rates, low number of cases and great heathcare. No caps. We have a system that works.

  5. Gravatar for Jim O'Hare AIC AIS VP med mal claims
    Jim O'Hare AIC AIS VP med mal claims

    Dear Mike - I think that you missed my point all together. The cost of healthcare has nothing to do with med mal costs. Med mal, litigation and PL premiums are in one bucket, and the cost of getting your broken leg fixed is another bucket for the price of an arm and a leg, is in the other bucket.

    You can say the cost of HC causes medical mistakes, as most cases are related to fatigue, poor staffing and bad communication due to fatigue. All staffing issues due to the cost of HC.

    regards Jim

  6. Gravatar for Mike Bryant
    Mike Bryant

    I agree with everything there. So why are you calling for caps? They don't work for the consumer. We do need real reform, and we very much need a health care bill that not only provides coverage, but protects people.

  7. Gravatar for Jim O'Hare AIC AIS VP med mal claims
    Jim O'Hare AIC AIS VP med mal claims

    Dear Mike:

    Math guys, actuaries, raters and underwriters get together and come up with complicated calculations to arrive at a premium for a specified amount of insurance. Policy limit is = to a cap of sorts.

    So you know what you are selling for the price. A cap or policy limit is just an upper end, worse case scenario, to make all the equations work to justify the premium. If you place a zero or infinity in any equation, it yields no result.That is why we need a cap and speed limits.

    As I said- we can argue the amount of the cap but not that they arent needed., if only to make the math work.

    For every other cause of compensible action there is a formula. Lets say, my insured kills your client , he is 60 earning $50k/yr. What are the economics here and how did you determine it? You objectively determined the value of an objective loss. What is it worth if he was to work forever?

    Pain and suffering is a subjective concept that cant be measured, seen, tasted nor weighed. Alot is always a good response for what pain is worth. One guys pain cant be measured against another to determine a value. A cap is just an upper limit. I have seen $1mil awarded for pain, suffered for 3 minutes, as well as a lifetime worth.

    You cant buy happiness nor pain and suffering.

    regards Jim

    Yes fix healthcare, the #1 problem

  8. Gravatar for Mike Bryant
    Mike Bryant

    Actually you talk of damages as if they are mystical. In reality they are affected by experienced lawyers that know how to work up a claim, ask the right questions, and prove the case. I've never had an issue with arguing pain and suffering. But I deal with real people and not just numbers.

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