New anticoagulant blood thinner regulations hit hospitals
Medical malpractice happens when sensitive anticoagulation medications aren't carefully prescribed and monitored within narrow ranges
Lots of people are prescribed anticoagulant drugs, also called blood thinners. These medications reduce blood clotting and are commonly prescribed to people who’ve experienced a stroke or heart attack and to reduce the risk of deep vein thrombosis (DVT), pulmonary embolism and other conditions.
Common anticoagulation medications include heparin, warfarin (Coumadin), rivaroxaban (Xarelto), dabigatran (Pradaxa), apixaban (Eliquis), edoxaban (Savaysa), enoxaparin (Lovenox), and fondaprinux (Arixtra).
According to The Joint Commission, the major hospital-accrediting organization in the United States, there has been a rise in adverse drug events associated with oral anticoagulation medications.
In my experience as a Houston, Texas, medical malpractice lawyer, the major risk of blood thinners is that they must be administered, used, and monitored with great precision. Even a slight error can create life-threatening consequences.
Medical negligence lawsuits involving anticoagulants typically focus on one of two mistakes by physicians and health care providers. First, there can be human error in prescribing or administering the wrong dosage of blood thinners. Second, doctors can fail to monitor patients to make sure that anticoagulants are at appropriate levels in the blood, called the therapeutic range.
When there is a quality of care concern of enough significance, The Joint Commission addresses it through a National Patient Safety Goal. As a former hospital administrator, I know that its standards get the attention of hospital leaders and practitioners.
The Joint Commission recently announced a new National Patient Safety Goal for hospitals regarding anticoagulation therapy. Here are the highlights:
New practice guidelines for prescribing anticoagulants
Anticoagulation medications are high-risk drugs that can involve complex dosing, insufficient monitoring, and inconsistency in patients taking them as scheduled.
Hospitals are now required to use approved protocols and guidelines for starting and maintaining anticoagulant therapy. They must include information for selecting the correct medication and dosages; adjustments for age and renal and liver function; avoiding interactions of the medication with other drugs and food types; and other applicable risk factors.
New practice guidelines for reversing anticoagulants
Given that anticoagulants work by preventing blood from clotting, it’s no surprise that the most common complication of all anticoagulant medications is bleeding. Like heparin and warfarin, the way to reverse each of the direct oral anticoagulation drugs is different.
To make sure that healthcare providers can timely and appropriately respond to bleeding issues, hospitals now must implement approved protocols and practice guidelines on how to reverse anticoagulation medications.
New surgical practice guidelines
The surgical team needs to be aware of patients who take oral anticoagulation medications. They need to be prepared to minimize the risk of bleeding during surgery. In some situations, this can require stopping an oral anticoagulant drug, starting a temporary bridging anticoagulant medication during the operative period, and then later restarting the oral drug.
The Joint Commission is now requiring hospitals to use approved protocols and practice guidelines for the surgical management of patients on oral anticoagulants.
New required lab work
Patients receiving heparin and warfarin are required to have routine laboratory testing, including partial thromboplastin time (PTT) and international normalized ratio (INR) testing. In contrast, direct oral anticoagulation drugs were invented to be given at fixed doses and don’t require routine coagulation monitoring. Sometimes though, this is necessary.
Hospitals are now required to have a written policy defining whether baseline and ongoing lab work is necessary to monitor and adjust anticoagulation therapy. This can include regular assessment of renal function and liver function for patients taking these medications.
New standards for adverse drug events
Anticoagulation drugs, including low-molecular weight heparin, heparin, warfarin, and direct oral anticoagulants, are one of four medication classes that commonly cause adverse drug events. It’s important for hospitals and physicians to be aware of these common events and how to prevent them.
Under the new standards, hospitals must consider anticoagulation safety practices by establishing appropriate processes to identify, respond to, and report adverse drug events. Hospitals also must implement anticoagulation safety practices.
Helping patients succeed with anticoagulation therapy
Healthcare providers describe patient conduct that’s inconsistent with prescriptions and recommendations as being “noncompliant.” Some patients are deliberately noncompliant, but many others, in my experience, do their best to follow instructions.
When it comes to anticoagulation therapy, it’s important for healthcare providers to communicate to patients that not following the prescribing instructions places them at risk for bleeding and clotting that could lead to severe adverse drug events. Good counseling from physicians in the nursing staff should focus on taking medications as instructed, including the correct dosages and schedule, avoiding certain other drugs and foods, and keeping up with follow-up appointments and lab testing.
The Joint Commission now requires hospitals to provide this type of education to patients being prescribed anticoagulation medications.
Avoiding medication errors
Hospitals are now required to use only oral pre-dosed products and pre-filled syringes of anticoagulation medications, when they are available. This will reduce human error in preparing the correct dosages in these highly-sensitive and specific drugs.
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Robert Painter is a medical malpractice attorney at Painter Law Firm PLLC, in Houston, Texas. He is a former hospital administrator who represents patients and family members in medical negligence and wrongful death lawsuits against hospitals, physicians, surgeons, anesthesiologists, and other healthcare providers. A member of the board of directors of the Houston Bar Association, he was honored, in 2018, by H Texas as one of Houston’s top lawyers. Also, in 2018, the Better Business Bureau recognized Painter Law Firm PLLC with its Award of Distinction.
Robert Painter is a medical malpractice lawyer at Painter Law Firm PLLC.
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