home
RSS
Don't judge that generic pill by its color
December 31st, 2012
04:05 PM ET

Don't judge that generic pill by its color

It's not the color, but what's inside that counts when it comes to medication. However, doctors suspect that's not exactly how patients see it.

According to a study published Monday in the medical journal Archives of Internal Medicine, changes in pill color significantly increase the odds that a patient will fail to take their medication as prescribed by their doctor.

First, the basics

Generic drugs are approved by the U.S. Food & Drug Administration’s Office of Generic Drugs.  These off-brand alternatives must be “bioequivalent” to the brand-name version, meaning they must be identical in terms of dosage form, strength, route of administration, quality, intended use, and clinical efficacy. But the FDA does not require that the two versions look alike.

Generics are big business worldwide.  In America, they account for more than 70% of prescriptions dispensed, but only 16% of spending. Generic prescriptions are expected to increase even more, as top-selling brand-name medications reach the end of their market  - and profit - exclusivity and go “off patent.”  In the United States, drug patents offer 20 years of protection for the pharmaceutical company, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be somewhere around 7-12 years.

The study

Dr. Aaron Kesselheim, assistant professor of medicine at Brigham and Women’s Hospital in Boston, wanted to investigate whether switching between brand-name and different generic versions of a drug could lead patients to neglect refilling their prescriptions.

“An estimated 50-75% of patients do not take their medications as prescribed,” says Kesselheim.  When patients don't adhere to prescribed drug regimens, it can can have serious medical, financial, and social consequences.  Kesselheim chose to study antiepileptic drugs, due to the fact that epilepsy is a common disease affecting up to 2% of the general population. Additionally, these types of drugs are prescribed off-label for psychiatric disease, chronic pain and other conditions.

Kesselheim and his team analyzed national data gathered between 2001 and 2006, and subsequently split patients into two groups: those who became “nonpersistent” (defined, in this study, as a failure to fill a prescription within five days of the elapsed days supplied) and those who exhibited no delay in refilling.  The groups were further matched by age, sex, number of refills and the presence of a seizure disorder diagnosis.

Results

Researchers found when patients with epilepsy refilled their prescriptions and received a different color pill than they were used to, they were  53% more likely to take a break from taking their drugs as prescribed.  Twenty-seven percent of patients taking antiepileptic drugs for other reasons also took a break from their prescribed drug regimen.  "Someone who knows it’s so important they take their medication to avoid a seizure is much more in tune with color... and (becomes) more stressed out with any potential switch,” says Kesselheim.

Conclusion

Patients and caregivers frequently remove pills from their original bottles to organize them in daily pill planners.  “Visual cues thus become paramount to identification of pills,” says Kesselheim.  Therefore, changes in appearance may be jarring or confusing, leading patients to delay pill-taking while seeking validation from a physician, pharmacist, or other health care provider.

Perhaps even more interesting, a pill’s physical attributes have been linked to expectations of efficacy of both placebos and prescription drugs.  Kesselheim says, “changes in appearance may not only deprive patients of these expectations of efficacy, but potentially even have the opposite effect."  It's something that's called the "nocebo" effect, a belief that the newly-substituted pill will be less effective than the previous dose.

Lastly, it’s important to note that a filled prescription does not necessarily indicate that the patient actually took his or her medication, and vice-versa. Additionally, says Kesselheim, “what we observed as nonpersistence may have been physician-directed changes in medication dosing frequency.”

What's next

As more widely used brand-name drugs face generic competition, the study’s authors suggest physicians warn their patients about the possibility of a change in pill color, and that pharmacists take greater care to alert patients when changes in suppliers might lead to new pill characteristics.

In the United States, the FDA has recently started rejecting generic drugs that are larger in size than their brand-name counterparts, citing safety and efficacy concerns, such as increased risk of choking and patient dissatisfaction.

“Based on our results,” says Kesselheim, “the FDA would be justified in taking a similar posture about new generic drugs that differ in color.”

“At a minimum,” Kesselheim says, “our results should clarify that manufacturers cannot protect their drugs’ physical characteristics through the principle of ‘trade dress,'" - physical attributes such as color, shape, size, texture, aroma, and flavor.  By definition, trade dress attributes legally cannot affect the impact of a drug on a consumer. But this study concludes that's exactly what's happening.


soundoff (30 Responses)
  1. saveyourfeet

    hmnif you are a diabetic you need to read this blog. saveyourfeet.wordpress.com

    December 31, 2012 at 23:46 | Report abuse | Reply
  2. awayfromhere

    I've had quite a few therapy clients tell me they've stopped taking or are hesitant to take generics because of the physical characteristic changes. Pharmacies and doctors need to do a better job of pointing out changes and people need to become better health care consumers.

    January 1, 2013 at 03:38 | Report abuse | Reply
  3. RealGlaird

    We Sanjay, you have demonstrated to me, that you lack all intellectual honesty and credibility. I will be saving time in the future, by skipping any article with your byline on it.

    January 2, 2013 at 12:20 | Report abuse | Reply
  4. maha kumbh mela

    I was searching over google and I found your web site. Properly basically saying I really like your internet site plus your web site design. I appearance many sites and they also fails to look so user-friendly and color you are utilizing it packages your web site. Keep doing it.

    http://gurubhakti.org/kumbh/simhasth-ujjain-maha-kumbh-2016/

    December 2, 2015 at 13:28 | Report abuse | Reply
  5. Vera

    I contacted him for marriage help, He only said to me that i have come to the right place were i will be getting my heart desire without any side effect.He told me what i need to do,After it was been done,24 hours later,My Ex Husband called me on the phone and was saying sorry for living me and the kids before now and one week after my Husband called me to be pleading for forgiveness, I am so happy and overwhelmed that i have to tell this to the entire world to contact Robinson Buckler on his personal email address and get all your problem solve..No problem is too big for him to solve..He also cure herpes, Contact him for herpes cure too direct on: Robinsonbucler @{{gmail.}} com.https://robinbuckler. com....💕”💕”

    December 10, 2020 at 11:41 | Report abuse | Reply
  6. zortilo nrel

    Hey, you used to write wonderful, but the last several posts have been kinda boringK I miss your great writings. Past several posts are just a little bit out of track! come on!

    http://www.zortilonrel.com/

    December 19, 2020 at 16:23 | Report abuse | Reply
  7. Jeff Kennell

    Wowsuper article. I’ve examine a few other articles inside your weblog and discovered very educational and I understand many point as well from the meaningful posts.

    http://6dollarmillion.xyz

    December 20, 2020 at 19:09 | Report abuse | Reply
  8. frolep rotrem

    Keep working ,impressive job!

    http://www.froleprotrem.com/

    January 2, 2021 at 16:41 | Report abuse | Reply
  9. Anthony Pennycuff

    Of course, things are balanced out by some great characterisation work and developing relationships and the movie does well to mix the drama and development in amongst the spectacle but it still feels as if perhaps it could have added a little bit more to reinforce the scale of things and to impress on a simplistically entertaining level.

    http://yourmatrixcashmachine.com

    January 12, 2021 at 02:00 | Report abuse | Reply
  10. frolep rotrem

    I always was concerned in this subject and stock still am, regards for posting.

    http://www.froleprotrem.com/

    January 24, 2021 at 19:56 | Report abuse | Reply
  11. frolep rotrem

    This web site is really a walk-through for all of the info you wanted about this and didn’t know who to ask. Glimpse here, and you’ll definitely discover it.

    http://www.froleprotrem.com/

    February 2, 2021 at 18:56 | Report abuse | Reply
  12. malatya escort

    esenyurt escort bayanar bu sitede üstelik hepsi ücretsiz...

    http://www.cuba.tc/escort-kategori/malatya-escort-bayan

    February 4, 2021 at 12:52 | Report abuse | Reply
  13. zortilonrel

    Thanks a bunch for sharing this with all of us you actually know what you are talking about! Bookmarked. Kindly also visit my website =). We could have a link exchange agreement between us!

    http://www.zortilonrel.com/

    February 5, 2021 at 04:55 | Report abuse | Reply
  14. mersin escort

    esenyurt escort bayanar bu sitede üstelik hepsi ücretsiz...

    http://www.elitescorthatun.com/ad-category/mersin-escort/

    February 5, 2021 at 10:57 | Report abuse | Reply
  15. http://www.fokuszpalyazat.hu/

    Some genuinely great info , Glad I found this. "Genius is one of the many forms of insanity." by Cesare Lombroso.

    http://www.fokuszpalyazat.hu/

    February 9, 2021 at 03:41 | Report abuse | Reply
  16. fat burning pills

    You are my intake, I own few web logs and infrequently run out from post
    :).

    Feel free to surf to my webpage – fat burning pills

    February 14, 2021 at 06:53 | Report abuse | Reply
  17. brain boosting ingredients

    I am sure this article has touched all the internet people, its really really nice piece of writing on building up new website.

    My web page; brain boosting ingredients

    February 20, 2021 at 04:43 | Report abuse | Reply
  18. brain rule

    Superb post.Ne'er knew this, appreciate it for letting me know.

    My web site :: brain rule

    February 20, 2021 at 06:23 | Report abuse | Reply
  19. magic pill

    I conceive this web site has very fantastic pent content
    blog posts.

    Also visit my web blog magic pill

    February 21, 2021 at 18:06 | Report abuse | Reply
  20. hondia gordonii

    Hi! Do you know if they make any plugins to safeguard against
    hackers? I'm kinda paranoid about losing everything
    I've worked hard on. Any tips?

    My web blog; hondia gordonii

    February 22, 2021 at 06:49 | Report abuse | Reply
  21. peak brain function

    Its superb as your other content :D, thanks for putting up.

    my page – peak brain function

    February 22, 2021 at 07:59 | Report abuse | Reply
  22. anxiety pill take

    I still can not quite feel that I could become one of those studying the important ideas found on your web site.
    My family and I are sincerely thankful for your generosity and for offering me the
    chance to pursue my own chosen profession path. Thank you for the important information I got from your
    site.

    Feel free to surf to my page anxiety pill take

    February 23, 2021 at 05:23 | Report abuse | Reply
  23. lose weight fast

    As I website possessor I believe the content matter here is rattling fantastic
    , appreciate it for your hard work. You should keep it up forever!
    Best of luck.

    my site lose weight fast

    February 23, 2021 at 05:48 | Report abuse | Reply
  24. free diet pill

    Hi there! I'm at work surfing around your blog
    from my new iphone! Just wanted to say I love reading through your blog and look forward to all
    your posts! Keep up the superb work!

    my website :: free diet pill

    February 24, 2021 at 00:37 | Report abuse | Reply
  25. Danae Piette

    https://www.electricpercolatorcoffeepot.com/10-top-coffee-bloggers/

    March 4, 2021 at 11:12 | Report abuse | Reply
  26. hoodia diet supplement

    Thanks in support of sharing such a pleasant idea, article is fastidious, thats why i have read it entirely

    Feel free to surf to my homepage ... hoodia diet supplement

    March 5, 2021 at 01:53 | Report abuse | Reply
  27. herbal pills to stop smoking

    I think this is one of the most vital information for me.
    And i'm glad reading your article. But should remark on few general things, The web site style is wonderful,
    the articles is really excellent : D. Good job, cheers

    Here is my web site: herbal pills to stop smoking

    March 5, 2021 at 23:09 | Report abuse | Reply
  28. Nolan Yuki

    I have been reading out many of your stories and i must say pretty good stuff. I will definitely bookmark your website.

    https://www.electricpercolatorcoffeepot.com/10-top-coffee-bloggers/

    March 6, 2021 at 14:03 | Report abuse | Reply
  29. Alafaya roofing company

    203706 659027There is noticeably plenty of money to comprehend this. I assume you created certain good points in features also. 949533

    March 13, 2021 at 09:33 | Report abuse | Reply
  30. lucky day app review 2020

    950809 286408Very good post. I just stumbled upon your blog and wanted to say that Ive truly enjoyed surfing around your weblog posts. After all I will be subscribing to your feed and I hope you write again very soon! 725429

    March 23, 2021 at 20:30 | Report abuse | Reply

Post a comment


 

CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

Advertisement
About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.