Get to Know Your Jargon
If you’re new to patient advocacy, chances are you’ve come across acronyms that you don’t understand. Acronyms are common in healthcare. We abbreviate agencies, procedures, and treatments.
While that’s great for speeding up the decision-making process in surgery, shorthand excludes people who aren’t familiar with the terms. You would need formal medical training, a law degree and a lifetime as an insurance adjuster to fully understand the modern health care system.
Here at Patients Rising, we value the expertise of medical professionals. They have the skills, knowledge and training to provide life-saving treatments. We also believe that their knowledge and jargon cannot be used as a tool to exclude patients from the conversation.
First, patients can’t let jargon intimidate us. It’s ok that we don’t know every term.
Second, to the greatest extent possible, we need to learn the jargon. The discussion about important health care decisions — at both a personal and public policy level — will always involve jargon. We can’t rely on the experts to educate us. We must take action to inform ourselves.
Finally, we need to be ready to fight back and re-define words, phrases and euphemisms that wrongly frame the issue. Step therapy is a great example of insurance jargon that is used to control the debate. Would anyone defend a policy that requires patients to “fail first”? Of course not. Yet, the jargon itself can have life and death consequences for patients.
That’s why we’re introducing a new occasional series that breaks down the jargon.
Risk Evaluation & Mitigation Strategies: REMS
Today, we’re reviewing the Food and Drug Administration’s Brief Overview of Risk Evaluation & Mitigation Strategies.
Term Defined: “Risk Evaluation and Mitigation Strategies are required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks. The FDA can require a REMS before or after a drug is approved.”
What It Actually Means: Does a treatment need additional warning labels or special measures beyond the usual disclaimers? Do a drug’s benefits outweigh its risks?
Why It’s Important for Patients:
- FDA can require a REMS if the agency determines that safety measures are needed beyond the professional labeling to ensure that a drug’s benefits outweigh its risks
- FDA can require a REMS before or after a drug is approved
- REMS can be required for a single drug or a class of drugs
- Drug sponsors develop REMS programs, FDA reviews and approves them
Elements to Assure Safe Use: ETASU
Term Defined: “ETASU are required medical interventions or other actions healthcare professionals need to execute prior to prescribing or dispensing the drug to the patient. Some actions may also be required in order for the patient to continue on treatment.”
What It Actually Means: ETASU requirements are the most extensive elements of a REMS program
Why It’s Important for Patients: ETASU are required medical interventions or other actions healthcare professionals need to execute prior to prescribing or dispensing the drug to the patient. Some actions may also be required in order for the patient to continue on treatment.
In the News: ETASU vs. REMS
It’s no accident that we’ve started with ETASU and REMS. Earlier this month, the Associated Press alleged the misuse of treatment distribution systems for certain drugs.
AP Health Writer Matthew Perrone linked the rise in drug prices to the adoption of the above-mentioned risk management plans. “The trend began in 2007, when the FDA began requiring risk-management plans for certain drugs,” he writes. “The plans often feature various restrictions to make sure drugs are used safely, including limits on who can distribute them.”
Following the AP story, the Patients Alliance for Drug Safety Protections, a coalition of 19 public health, patient advocacy, health professional and disease organizations — including Patients Rising — raised the concern that the report glossed over the value that risk-management plans bring to patients.
For patients with diseases like cancer, kidney disease, and multiple sclerosis, FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) programs make it possible for patients with diseases like cancer, kidney disease, and multiple sclerosis to have access to valuable medicines that would not otherwise be on the market due to very serious safety risks.
However, the need for these programs is limited to high-risk medicines known to cause life-threatening complications, liver damage, birth defects, severe allergic reactions and infections, if not carefully controlled. In these situations, FDA can require stringent safety precautions called “Elements to Assure Safe Use,” including a restricted distribution system, to ensure the benefits of a needed medicine outweigh the drug’s risks.
Currently, of the 1,100 brand drugs approved by the FDA, only 41 medications are subject to REMS with “Elements to Assure Safe Use” and an even smaller number require restricted distribution systems. In these rare situations, ensuring safety and public health must remain the primary goal.
We share the concerns of Patients Alliance for Drug Safety Protections. We’d go a step further. Enough about price. Yes, the cost of healthcare is incredibly important. But, we can’t continue to allow price to drown out other important issues– like SAFETY– affecting patients.