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Health Systems Are Capable of Handling a REMS
To the Editor:
I would like to comment on the article in the February 2014 issue of P&T entitled “Specialty Pharmacy Networks for Hospitals in the Offing” by Stephen Barlas (pages 123–125, 143). I would like to commend the author on an excellent article that summarizes all the issues related to specialty pharmacy and health systems.
The heart of the issue with specialty pharmacy is limited distribution. There is a myth that REMS requires limited distribution. Mr. Barlas stated that “The FDA forces some manufacturers to limited distribution to specialty pharmacies as the price of their approval.” I believe that may be the opinion of many in the pharmaceutical industry; however it is not supported by fact. Indeed, the FDA’s most stringent REMS programs do not require limited distribution, specifically those for transmucosal immediate release fentanyl, thalidomide, clozapine, and isotretinoin. Mr. Barlas went on to describe the difficulty health systems have in implementing REMS programs; he stated “those and other tough conditions can be hard for a hospital pharmacy to meet.” I would like to point out that health systems across the country are trusted with clinical trials prior to drug approval, and certainly are more than capable of handling a REMS program post-approval. It is unbelievable and embarrassing when a drug that was available to the health system during clinical trials would not be available post-approval due to “limited distribution systems.” We providers in major academic health systems are capable of implementing REMS.
I would also like to point out that some new specialty drugs without REMS have limited distribution requirements. It is unclear why the distribution of non-REMS drugs is limited to specialty pharmacies, since there are no safety, handling, or administration requirements necessary for these drugs. Specifically, dimethyl fumarate and dalfampridine are oral agents for multiple sclerosis that do not have REMS requirements; however, the distribution is restricted to specialty pharmacies. There is no apparent reason why health systems, with their direct contact with the patients and access to the electronic medical records, would not be able to dispense the drugs directly to outpatients. These access restrictions may pose problems in start of therapy and transitions in care that affect patient outcomes.
I look forward to a continuing dialogue on specialty pharmacy and restricted distribution in P&T.