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Immunosuppressant Drug Therapy & Generics
EasyLink Access #: 459
By Jacqueline Harris, RN, BSN, CCTC
Today, generic midications ar being offered or substituted for barnd name medications. There are many generics on the market currently for blood pressure and lipids as well as organ transplant rejection medications. Several transplant medicines are losing their patent protection so your pharmacy may send you a generic without any prior warning. The aim of this article is to make you more aware of your transplant immunosuppressive medication and what you need to do to understand what steps you need to take if your tranplant medication is switched to a generic. Your immunosuppressant medication falls under the narrow therapeutic index (NTI) category of medications. Narrow therapeutic index meds are those that your physician monitors by blood levels (meds such as Prograf, Cyclosporine, etc). They are dosed based on body weight. These drugs work best when the blood level falls within a certain range. If that level is too high, it can be toxic; too low and not enough medication is in your body to prevent rejection. Many people, including myself when I was a transplant coordinator, think that if the FDA approves a medication that it’s been tested in patients that have the disease or condition that it’s treating. This is a major misconception! Generics only need to be proven safe in the general population and tested on 24-36 healthy volunteers. They also have a “range” that they can fall within for effectiveness that can be from 80-125%.
You could get different generics each time you fill your prescription, so if those vary, say 85% one month and 120% the next, you can see where issues can occur. To be approved by the FDA as “equivalent” to the original brand name drug, a generic manufacturer only has to prove that it falls within this range. Needless to say, when your transplant organ is on the line, you want to make sure you’re getting the right amount of medication that you need – every dose, every week, month after month. When receiving generics, your medication can be substituted even among the generics, if there are multiple companies making that particular drug, depending on the best price that the pharmacy gets that month. You may receive generic “A” one month and generic “B” the next. And remember the difference between “A” and “B” can be within that 80-125% range. One may be high, the other on the lower end. For many, especially transplant patients, they believe that using generics will save them money. This is not always the case, and frequently, there is incentive for the pharmacy to make significant money on their end with only a slight savings benefit offered to the patient. There are significant financial benefits to a pharmacy to dispense generics over name brand drugs as they make a higher profit on their end. For Medicare Part B patients, your medication costs are the same whether it’s for generic or name brand. The many insurance companies have varied prices and co-pays, but there are discount cards available to cover any differences in your out of pocket costs. This is a significant issue that you need to discuss in-depth with your healthcare provider and transplant team. Be aware of what medications you are taking and notify your physician or transplant coordinator should you receive a different color or shaped pill, as you may have received a generic substitution. Your healthcare team will need to be aware of that, as it could affect your blood levels. You may need to have additional blood tests done to monitor this very closely. The best course of action for a patient with a stable transplant is to continue using the prescribed medication from the same manufacturer. Your physician can help prevent substitutions by making sure that your prescription states “DNS” on it or the wording do not substitute. This can vary by state and needs to have that marked clearly on the prescription or verbally told if the prescription is “called in” to the pharmacy. If it’s a written prescription, double check this before leaving the office with a new prescription! Also, if you are getting refills, those outstanding refills can be substituted with a generic at any time if it’s not marked do not substitute. There are many pharmacy assistance programs and value cards available that can assist you should there be any co-pay difference, which in some cases would make the name brand cheaper than the generic. Your transplant social worker is a wealth of resources in this area and should be called upon for any needs that you may have. You can be your own best advocate as well and speak to your pharmacist and inform them that your transplant drugs should not be changed without consulting your physician. Talk with your physician and stay current on the transplant educational materials available. Attend support group meetings and keep informed! Remember, a healthy patient is an educated, well-informed patient!
About the Author
Jacki Harris is a Senior Executive Healthcare Specialist with the Immunology division of Astellas Pharma US. She is an RN, Clinical Nurse Specialist & former transplant coordinator at Cedars-Sinai Medical Center & UCLA Medical Centers. She has over 20 years of ICU, critical care & Nephrology experience. She is a board member & volunteer with RSN. She is also a private pilot & enjoys flying whenever able. She lives in La Canada, CA.
Last Updated October 2009
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