Next, read the 26-page prescribing information.
Next, read the patient's 3-page medication guide.
Next, fill out a database form for the drug company to add yourself to their new-and-improved database (even though you've already registered with them once before) once again before January 1, 2012.
Next, (and this is important), agree to the following:
- That patients initiated or reinitiated on the medication should be admitted for three days and a bunch of other stuff with that,
- That you understand that following the treatment initiation and dosing guidelines in the drug's label will decrease the chance of a drug-induced arrhythmia
- That you will inform the patients of the risk of arrhythmias
- That you will need to see them for an EKG and blood tests every three months
- That you will provide a Medication Guide to each patient at the initiation and re-initiation of the drug's therapy and that you will review the contents of the medication guide personally with each patient.
I have no idea where the every "three month" suggested lab testing and EKG requirement came from and have to wonder: if I sign their form, what is the economic burden to patients who must pay for this mandated testing? Who will enforce these requirements? Will following these recommendations absolve a doctor from potential liability with this medication? Do any of these requirements tell us anything about problems with the medication after they are prescribed?
But these requirements make our regulators feel good while ignoring the very real financial and time costs that they impose directly on patients and doctors.
For instance, I called the company and asked if they would provide me their required Medication Guide to give my patients. They politely suggested I take the time to print out the guide from their TikosynREMS.com website for each patient. Or better yet, maybe I could have my staff make copies of the three-page form for my patients!
No doubt we'll soon have PradaxaREMS.com, EliquisREMS.com, SeroquelREMS.com, ViagraREMS.com and hundreds to thousands of other REMS websites, each with their own prescribing guides, patient medication quides and database registrations.
Safety first, remember?
I just wonder when I'll have the time to see all of my other patients.