The Benefits of REMS Standardization and Multidimensional Communication Health Care Systems

You are a specialty pharmacist verifying a prescription for one of your patients. Sometimes you receive faxed prescriptions or the rare verbal order, but this current prescription was received electronically. 
This is no surprise to you, since the majority of the prescriptions that you dispense are received electronically. After all, e-prescribing (eRx) is the primary mode for prescription submission these days, accounting for 1.7 billion prescriptions in 2017. 
As part of the verification process, you check the standard prescription components for accuracy, such as patient demographics, secondary identifiers, strength, dosage form, directions, quantity, and refills. The prescribed medication and dose seem to be correct based on the patient’s indication. 
As a specialty pharmacist, you are aware that the medication you are about to verify has additional safety requirements. You check the directions and comment fields on the eRx to see if the prescriber free-texted the information, but unfortunately there is nothing to be found. 
You pick up the phone and make an outbound call to the prescriber’s office and wait on hold until you are finally transferred to the right department. The receptionist asks if you would be willing to leave a message for the prescriber, so you leave your request and put the prescription aside for future follow-up. 
Hopefully the prescriber returns your call soon so that you can finish dispensing the medication to the patient. Otherwise, you send a follow-up message within a day or so requesting the information again. In the meantime, you contact the patient and explain that there is a delay in their order. They are frustrated and don’t fully understand what the holdup is since we have a valid prescription from the prescriber.
This scenario might sound a bit exhausting to you, but it is a common occurrence in pharmacy practice these days—especially when it comes to Elements to Assure Safe Use (ETASU) and risk evaluation and mitigation strategies (REMS). ETASU and REMS requirements were derived from the FDA Amendments Act of 2007.  
These requirements were a means to ensure that the benefits of a medication outweighed its risks for the patient. The goal of REMS is to inform patients and prescribers of these serious risks and to provide mitigation strategies for these risks. 
It is the pharmacist’s responsibility to ensure that ETASU and REMS data are present and documented accordingly prior to dispensing of a patient’s prescription. If this information is missing or incomplete, a pharmacist is not authorized to dispense the prescription to the patient. The FDA describes ETASU as including 1 or more of the following:
  • Health care providers who prescribe the drug have particular training or experience or are specially certified.
  • Pharmacies, practitioners, or health care settings that dispense the drug are specially certified.
  • The drug may be dispensed only to patients in certain health care settings, such as in hospitals or infusion centers.
  • The drug is dispensed to patients with evidence or other documentation of safe-use conditions (for example, liver enzyme tests or pregnancy tests).
  • Each patient using the drug may be subject to certain monitoring or each patient using the drug must be enrolled in a registry.
As you can imagine, it may be difficult for a specialty pharmacist to keep track of the different requirements for each drug product. However, compliance to these requirements is critical both for patient safety and for the pharmacy’s ability to continue to dispense the medication. 

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