PA

Generic Prescriptions Concerns Lead to New Symptoms

Be your own Advocate- Psychotropic Drugs and Generic Substitutes

I started on this topic by chance.  What I found my surprise you, it certainly did me. I appreciate the cost saving by a generic made drug as much as anyone.  I do see a need to manage the information for each individual if they have sudden symptoms or changes.

Forty percent of American drugs consumed are generic drugs made in India.  The only thing that needs to be the same is the active ingredient.  This means the other ingredients like binders can be anything the drug company chooses.  No test is done on the efficacy of the additives and binders or if it lessens the efficacy on the active ingredients.  The only test is done to are to see if the active ingredient is in the drug and in the correct amount. 

One of my clients told me she had been experiencing some strange mental behavior like repeating herself that was not normal at all for her.  Her husband and her friend who is a nurse both commented on it.  She started considering what may have caused this sudden change.  After considering her past few weeks she had not changed any medications or her diet.  The only thing that changed was the Wellbutrin she takes, she was given a generic brand instead of the brand name. 

Here is the strange part, I also take a generic form of a similar drug and about the time I started the research for her I noticed some of my chronic pain symptoms returning after a long absence.  Thinking I was crazy and having a sympathy symptoms I checked and I had a different manufacturer of Cymbalta. This was from TORRENT Pharmaceuticals.  As soon as I switched back to the old genetic formula from Lupin I was fine again.  Both factories are in India.  This may be ok for some drugs but we are talking about psychotropic drugs that cross the blood brain barrier or maybe not cross the blood brain barrier in which case this is a problem. 

The drugs tested and approved by the FDA are the original patent.  When the patent runs out other companies make a similar drug with the active ingredient.  Because most of my clients are geriatric and are very sensitive to drugs I see this as a big problem. Geriatric patients become more sensitive as they age.

The Food and Drug Administration approved a record 763 generic drugs in the year ending in September 2017.  I can see the need to keep our drug prices down as much as possible but at the expense of people they are claiming to help is not right.  FDA Commissioner Scott Gottlieb has vowed to tackle a lack of competition he has said is “a root cause of high drug prices.” How do we know we are receiving the same quality and quantity? Generic drugs are supposed to be deemed "bioequivalent" by the FDA, which means they should have the same amount of active ingredient as their brand counterparts as demonstrated on healthy volunteers.  Testing on healthy volunteers?  What about patients that have symptoms? 

Just before finishing this I had a friend tell me she got very dizzy from a drug she never had a problem with.  The pharmacy did tell her “this is the same drug but it is a different color and shape”.  This means she got a different formula.  We are still waiting on the outcome.

If your insurance (or the pharmacist) tells you "it's not covered" even after your doctor has checked the "dispense as written" box, find out if brand name can be approved with a "prior authorization", or "PA".  Many times, a pharmacy will insist something is not covered but unless they call the insurance (i.e. not just input into the computer) you don't know for sure.  If the pharmacist won't call, you can call yourself or look it up online.  You can also download prior authorization forms from your insurance company's website.  

 

https://www.psychologytoday.com/us/blog/mental-wealth/201203/brand-vs-generic-when-it-matters-and-what-do-when-it-does

 

https://www.bloomberg.com/news/articles/2018-01-05/plan-to-slash-u-s-drug-costs-leans-on-problem-plagued-factories

 

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm584749.htm

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