A Pharmacist Explains Generics and More

A pharmacist has written an informative comment to my last post on generic-same-as-brand Concerta. (Thank you, RL in Florida!) 

I am re-posting it here to make sure more readers have a chance to read this helpful information. Your comments and questions welcome. – Gina

Hello Gina and Everyone:

I’m chiming in on behalf of the pharmacists, on the topic of generic versions of medications.

Just a little background on me. I live and work in Florida at a Walgreens pharmacy. I’ve been in the profession for 8 years now. We  have a large base of ADHD patients and we keep a large stock of every medication for a large population.

After reading all of the posts here, I am sorry that everyone has experienced the problems they have written about here. I’m providing a little bit more information that may help some people—even though some others may not accept it.

Pay Attention to Pill Markings

My first point is about the markings and the tablets found in the US.

When a generic medication is approved by the FDA for distribution, if it is not made with the same exact process and ingredients, the manufacturers are required to change the markings on it and often the shape or colors are also changed. This is to signify  the manufacturer of that medication, for identification purposes. If they change one iota of the manufacturing process or they change one ingredient such as a binder or filler or anything else, this holds true.

Therefore, the medication that is being dispensed as the authorized generic Concerta is in fact the brand, because it looks exactly the same (assuming there aren’t any counterfeit medications going around) and has the same exact markings.

Now, to the point that there is less medication in these [authorized] generic Concerta capsules or that it is being changed for the generic. Every company has to follow strict quality-control procedures. Moreover, medications are a lot stricter than other types of manufacturing facility. The batches are all numbered, and they must give consistent results. Otherwise, we would get a notification of a recall due to whatever the problem was  found.

So, I do not believe that there are any problems with the [authorized] generic Concerta medications before they get to the Watson plant for packaging. [Note from Gina: in the early days of the new “true” generics for Concerta, there was much confusion. We were still trying to figure out what might be happening.]

The Meaning of “Bioequivalence”

That brings us to bioequivalance.

For a generic to be approved, it has to expose the body to 80-125% of the same medication compared to the brand (not other generics), as Gina referred to previously.

This is calculated as the AUC (area under the curve). This means that as the body breaks it down, you can measure blood levels of it every hour until it reaches clinically insignificant levels. Add up all those levels  for the brand and then multiply it by 80% and 125% to give you the range of what you need to see.

The medication can give exactly the same curve, higher at times and shorter length of effect. Or it might give longer effect and lower curves or whatever combination that gets it within that range.

For most medications, this isn’t significant, such as with Ciprofloxacin, whose dosages are 250mg and 500mg. But with medications such as Synthroid, which have very small increments, this can create a very significant response.

Now, that’s not a reason to avoid generic medications. That just means that you usually have to go up to the next higher dosage or sometimes two times higher to get the same result.

The “Negative Formulary”

I do not claim to know all the laws in all other states, but Florida has something called a negative formulary. With this formulary, medications whose generics do not show similar pharmacokinetecs are deemed to be NOT SUBSTITUTABLE based on the AB rating found in the orange book.

Synthroid was on this list in the past but has been removed. Some items on our list are conjugated estrogens and extended-release theophyline. There are 6 drugs on Florida’s list now for us, and other states also have these negative formularies, which  might explain why one person who commented on this blog said their pharmacy required the prescription be written in certain way.

The Mail-Order Option

Yes, if it is available to you, mail order is an effective way to get any of these medications at a cheaper price.

All mail-order facilities must comply with the laws of their state and the states to which they are distributing. The Controlled Substance Act (CSA) does not state an expiration date on any Schedule II medication or C-II medication. Nor does it place limitations on the quantity for which the prescription can be written.

Some states, however, do put limitations on these; for example, in Florida, all C-II prescriptions expire one year after they are written. But all other prescriptions do that too, with the exception of C-III to V, which expire 6 months from the date that they’re written.

So, in theory, your doctor could write you one script for a year’s supply of the medication, but I doubt that anyone would fill it or an insurance company would pay for it. Good general practice guidelines would be that if it’s older than 3 months ago, contacting the doctor to see if it’s still appropriate and the current dosage should be done.

[Note from Gina: Check this blog post for more information (Tip: Home Delivery of Stimulant Medications)]

Before You Buy, Check!

Another thing that ADHD Roller Coaster readers have commented about is the possibility of returning an unwanted prescription.

I attended a conference hosted by the DEA, and this topic was discussed. It is actually Illegal, according to the Drug Enforcement Administration (DEA) for a pharmacy to accept any controlled substance back from patients for any reason.

Therefore, I always suggest before paying for your medications, ask to examine it, ask what it is, and what it is for, and if brand or generic was dispensed, etc. That way, you don’t buy something that you don’t want and get stuck for a month without the preferred medication.

Beware Improper Substitutions

Another commenter asked about getting Methlyn ER one month and then being given Metadate CD the next month. These are two very different formulations which should not have been interchanged unless the prescription states it.

Methlyn ER is a tablet and Metadate CD is a capsule. This is not an acceptable interchange as they are different dosage forms and have some different pharmacokinetics and would have definitely seen a difference in effect.

For that person, I’d suggest visiting that pharmacy and ask for a copy of the prescription. If it says a dosage form on it (like ER), I’d bring it up to the pharmacy manager and ask for a refund for a mistake that was made.

Our store policy is to make amends for such mistakes. We have an internal review process that protects us legally from errors. Everyone can make a mistake. But as long as you learn from it, it shouldn’t happen again. Normally, we just refund your co-payment so there would have been no cost to you. Even if there wasn’t a cost out-of-pocket, the pharmacy needs to know about the error so it doesn’t happen again.

 

14 thoughts on “A Pharmacist Explains Generics and More”

  1. Thanks Gina for your suggestion regarding Vyvanse. Unfortunately, it didn’t provide me with a full days coverage, but it’s an option worth exploring for those affected. Better than nothing, for sure.

    We have a thread over at ADD forums where we are kicking around ideas. If you have time stop by. Would love to get your input. Also, I am thinking of putting up a website to direct action, through use of Popvox etc., for those affected. The thread is at: http://www.addforums.com/forums/showthread.php?t=135403

    All the best and thanks for your advocacy on our behalf!

    1. Hey Paul,

      You’re most welcome! We’re all in this together, is how I see it.

      AS for the full day’s coverage, I’m sure you know about “booster” dosages. Except I’ve always found it wise to “boost” with the same medication, if possible, in the same delivery system. For example, a 54 mg Concerta at 7 am and a 36 mg at 3 pm.

      I’m wondering why Daytrana hasn’t become more popular. It had problems with adhesive/rash initially, but I’ve heard that’s resolved. If I were taking a stimulant, that would be the first one I’d try!

      I’ll check the thread. tx
      g

  2. Question…what happened with the FDA regulations which decide if Methylphen ER tabs for Concerta is considered brand or generic? In the month of September 2012 my co-pay was $8 for 30 day supply and in October it shot back up to $100. My prescription plan carrier tells me this was a decision by the FDA that generic Concerta is no longer a generic but Brand. As two members in our family take Concerta this is a great increase for the drug to suddenly return to Brand status. Can anyone explain how the FDA can legally change the status of a drug in less than 4 weeks? Thanks. Laurie

    1. Good question, Laurie. Thanks for asking. Have you tried calling the manufacturer?

      I might be skeptical about the explanation from the prescription plan carrier. Sometimes these judgments are discretionary, but they might not want to tell that to subscribers.

      g

    2. Sorry to hear of the increase in price for your medication. We are also seeing a massive increase in the price of generic dextroamphetamine. Over the past month the price of this, 80 year old, generic medication, has quadrupled. What last month, cost $100 for a monthly supply, has now shot up to over $400 in some areas.

      For those without insurance, this puts us in an impossible situation and most likely not to be able to afford our medication.

      We need to take a stand against these price increases and make the drug companies/insurance companies/distributors know we exist and will put up a fight when they manipulate prices.

      I encourage anyone that can no longer afford their medication, due to an egregious price increase, to file a complaint with the FTC at: https://www.ftccomplaintassistant.gov/

      The voices of those affected must be heard, in order to compel action, by regulatory agencies.

    3. Holy cow, for generic Dex?

      The insurance racket has also contributed to this state of events.

      Yes, file complaints and write to your representatives. Especially those opposing healthcare reform.

      I know that the supply of stimulants has been limited by the DEA, and it has caused severe shortages. (More people being diagnosed with ADHD and prescribed the Rx, but supplies not keeping pace.)

      Meanwhile, if Dextroamphetamine works for you, you might want to check out Vyvanse (which is really dex in a sophisticated delivery system), including the manufacturer’s program for financial assistance.

      http://www.shire.com/shireplc/en/contactus/patientassistance

      Gina

  3. Dear Gina – Thank you! I just spoke with CVS and he said that it is ok to have it filled.
    Yes, prioritizing is very important. Filling my meds always causes me anxiety because it is a process, and not a cheap one either!
    I live in Miami, Florida..don’t know if that will help other readers but I guess here my rx has NOT expired.
    Also, this will be the first time I try the Johnson & Johnson patience assistant card. If this allows me to obtain my meds for free it will be a blessing! I will try it out tomorrow 🙂 I suggest other readers (without insurance) check it out. You can find the link via the website of your medication.
    Good luck all, and thanks again Gina for all of your help! Sarah

    1. That’s great!

      I know….the whole refill process is a PITA. My husband and I are fortunate that our medical coverage includes a mail-order pharmacy, so we can get a 90-day supply. That cuts the process down to 4 times a year — much better!

      Also, our insurance allows us to order the refill 60 days into the current 90 day supply. That gives you 30 days leeway. Play your cards right, and you can build up a bit of a buffer.

      Maybe you can find such an outlet. Costco has one; I wonder if you could use it:

      http://www.costco.com/Service/FeaturePage.aspx?ProductNo=11622895

      Mail order can be tricky, too, though. You have to send it in far enough in advance to receive it in time. But I put it on the calendar and NEVER ignore it. The price paid will be too big! 🙂
      g

  4. Hello!
    I have recently been granted free or discounted prescription for Concerta through Johnson & Johnson.
    I just realized that my rx date is from June 2012. Can I still fill this? I really hope to be able because Concerta is very expensive, even the generic. I accidentally handed in the one from July instead of June (I had two rx’s from my doctor).
    Anyway, I hope it hasn’t expired and that I can fill it this week because I am about to run out and may not be able to see my Dr. for an appointment.
    Concerta is very effective for me (for A.D.D.) but the process for getting the prescription (having to see my psychiatrist monthly) plus the high price, and that it is so closely controlled is discouraging.
    So the question is: can I still fill a prescription that has the date June 21, 2012?

    1. Hi Sarah,

      I don’t know if that prescription has expired. It might vary by state.

      The only way to know for sure is to call or visit the pharmacy.

      You are lucky to get free/discounted medication. Now you just need to make it a priority to get it filled. 🙂

      Put up notes everywhere that will remind you; set alarms. And don’t procrastinate. I know…tough words. But this should be your TOP PRIORITY. There is no other way. This scrambling at the last minute only ratchets up anxiety and often leads to missed dosages, which only exacerbates challenges.

      If you can tie it to something else you do monthly, that might help. Perhaps paying rent or mortgage or another regular bill.

      Good luck!
      g

  5. Thanks for this article. I was recently diagnosed w adult ADD & there’s no doubt of the diagnosis. Unfortunately, my Insurance appointed psychiatrist, while kind, is very hands off and uninformative so I’ve had to spend literally days online combing for information and guidance 🙁

    My husband takes a generic methylphenidate short acting – 20 mg – manufactured by Mallinkrodt. I was prescribed their 10 mg (and told to play around with it then call him when I hit on a dosage that works ).

    I swear I have noticed that mine at 2 pills produced stronger side effects and over dosing effects than one of his pills. One pill of mine still had stronger side effects but still didn’t seem to help w ADD symptoms. When I cut his in half (10 mg) the benefits were detectable although not adequate and the side effects again minimal.

    My husband thought I was crazy and melodramatic till he tried mine and had the same problem. We both tested this several times to eliminate environmental factors ( absorption interference, lack of sleep, other vitamins or meds etc.)

    What is going on? I did extensive research and the manufacturer is definitely the same. I only found one other reference online to someone else noticing a difference and it was on a drug abuser’s forum so I couldn’t get any helpful
    insight.

    Could there be differences in the coating, fillers or binders? Could his be Methylin – their name before changing to Methylphenidat hcl – and could Mallinkrodt have changed their inactive ingredients when they changed names?

    Amy insight here would be appreciated because I need to have something to bring back to my doctor.

    Kashi

    1. Kashi,

      I think if you read through my blog posts on generic medications, you’ll find the answer to your questions.

      For one, as I mention in the original post on generics (search the blog and you’ll find it), generic manufacturers have a generous leeway up or down. In other words, your 10 mg generic pill might be more like 12 mg or 15 mg.

      If I were you, I’d start with the brand name, so you can establish a baseline. Once you know what mg works for you, you can then try moving to generics if you need to save money. Otherwise, you are dealing with too many variables at once, in my opinion.

      good luck!
      g

  6. This is an exceptional article that this pharmacist in Florida has written. I will be printing and keeping nearby for reference. There’s so much useful and factual information. Thanks to RL for taking the time to inform us.

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