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  • E-Articles - The Last Line of Defense Against Medication Errors: What You Need to Know to Keep your Family Safe

    This is a true story.

    Yesterday, I picked up a new antibiotic prescription for my daughter from my local pharmacy.

    (We recently adopted my daughter from India where she had recurrent ear infections resulting in severe hearing loss. And, she is about t
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    o undergo the second of several planned surgeries in order to try to repair the damage.)

    Before putting her to sleep, I got the new medication out of the bag, glanced at the instructions, and prepared to give her the drug according to the instructions
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    n the label.

    Just before doing so, I had a quick double-take.

    Something seemed to be wrong. I looked at the instructions again, and thought to myself slowly, *What*s going on...this doesn*t seem right.* Then, it hit me that the dose seemed awfully hig
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    h for her.

    It took me a minute or two to put the pieces together (it had been an unusually tough fight getting her ready for bed, I was tired, I was confident in my daughter*s physician, and I was thinking perhaps less critically that I should have). A
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    d then I noticed it. The label had a stranger*s name on it.

    After another moment or two, I saw what had really happened.

    The medication came in a box. Each side of the box had a different label...one label was for my daughter and one label was for a s
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ranger. And, the stranger*s dose was more than double what my daughter*s surgeon had recommended.

    (This error didn*t happen in a mom-and-pop pharmacy. It happened in a modern new chain pharmacy whose name you would recognize from advertisements on TV.)
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc


    I*m not a surgeon...and I*m not a pediatrician...but I am a physician trained in internal medicine and I have spent most of the last twelve years writing about, speaking about, and developing systems to reduce the frequency of medication error and imp
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    ove the safety of pharmacy practice.

    This pharmacy error brought the topic of drug safety home to me...literally.

    What I can tell you is that this sort of error occurs all too often in the United States (and around the world). And, that it can have de
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    astating consequences for the people involved.

    A recent study in the New England Journal of Medicine indicated that 25% of patients who take one or more prescription medications will experience an adverse drug event within three months-and 39% of these
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    are preventable or avoidable.

    The Harvard Medical Practice Study found reported in JAMA in 2001 that 30% of patients with drug-related injuries died or were disabled for more than 6 months.

    And, what almost everyone who studies this problem agrees is
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    that current systems for selecting drugs, dosing them, communicating a prescription to a pharmacy, dispensing drugs, and instructing patients on their safe use are woefully inadequate.

    In this series, we are going to take a close look at the processes
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    hat cause medication errors (some things that your physician and pharmacist may not even want you to know) and what steps you can specifically take to make sure that you and your love ones are protected from this hazard.

    Ten years ago, your ability to
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    get current, objective, reliable information on your medications in a quick and easy way was practically non-existent. It probably would have involved a trip to the library and required considerable knowledge about pharmacology to get the answers.

    Toda
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    , that*s not the case. There is a host of on-line tools, databases, and resources that allow you to learn information about medications that even your physician and pharmacist may not know.

    We*re going to talk about them, show you were to go, tell you
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    he key things you need to know about medications, expose some myths, and let you know the questions you should be asking. It*s not as hard as it may seem.

    In fact, you need to become the final line of defense in the battle against medication errors.

    T
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    hroughout, we are going to give you some key rules that should guide your defense.

    So, Rule Number 1. Trust, but verify. Never assume that the medication you have received is the right medication for you or that it is dosed correctly for you. Specifica
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ly, you should check:



    • the name of the patient on the bottle;

    • the name of the doctor on the bottle;

    • the name of the medication (and cross check it to be sure that it treats a disease or problem you actually have... there are lots of
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ook-alike/sound-alike drug names out there);

  • the dose (from an independent source...to make sure that it is a plausible dose for you);

  • the *route* (to make sure, for example, that eye drops are being prescribed for the eye, and not the mouth,
  • .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    or the ear...amazingly injuries from drug misplacement occur all the time);

  • the expiration date.



    We*ll talk about some specific resources that will help with each of these throughout this series.

    The result, we hope, will be the piece of m
  • elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    nd to know that you and your family are getting your 7 rights:



    • right drug;

    • right patient;

    • right dose;

    • right time;

    • right route;

    • right reason;

    • right documentation.



    Right on!

    © 2004 Timothy McNamara, MD, MP


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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