What is Anticoagulation Safety?
Oral anticoagulants, particularly warfarin, are a type of drug that has been connected with serious side effects for many years. Numerous cases have shown that using these drugs can result in hospital admissions and extended hospital stays due to negative reactions, such as bleeding.
According to the Institute of Safe Medication Practices (ISMP), oral anticoagulants are considered high alert medications. This means they can potentially cause harm when used in medical treatments. Numerous reports have highlighted the risk of bleeding when these drugs are combined with similar medicines, if the same treatment is repeated, due to dosage mistakes, unintentional discontinuation of the treatment, or issues with tracking its use.
Unlike warfarin, the newer oral anticoagulants do not have an extensive history of use in clinical medicine. Therefore, it’s too early to say if they are safer. Nonetheless, proactive steps and specific education should be pursued to avoid any negative effects from the newer anticoagulants. The Joint Commission has specifically included cautious use of oral anticoagulants in their National Patient Safety Goals (NQF) in aims of minimizing potential harm.
What Causes Anticoagulation Safety?
How dangerous are oral anticoagulants?
According to research, major bleeding incidents for patients taking a drug called warfarin happen between 0.4% and 7.2% yearly. Even small-scale bleeding can reach up to 15% a year. The broad range is mainly due to individual health factors unique to each patient. Medical professionals generally classify major bleeding as an event requiring hospital admission, a severe or even deadly hemorrhage, bleeding in vital areas like the brain, or requiring a transfusion of at least two units of red blood cells. Major bleeding incidents can increase the chance of death several times for up to a year following the incident.
Multiple studies indicate an increased risk of bleeding for patients on warfarin. Bleeding risks for patients treated for irregular heartbeats (atrial fibrillation) is roughly 0.3-0.5% every year. This often involves bleeding inside the skull (intracranial bleeding), a major cause of disability and death.
Patients suffering from deep vein thrombosis (a type of blood clot) receiving warfarin treatment may have an even higher bleed risk than those treated for atrial fibrillation. This is believed to be due to their simultaneous additional health conditions. The bleeding risk in venous thrombosis sufferers is estimated to be about 13.4 cases per 100 people every year.
Even though bleeding within the skull is highly dangerous, it’s not the most common type of bleeding after taking oral anticoagulants. The most typical site is the gastrointestinal tract. However, a bleeding incident within the skull has a much higher mortality rate at 50% compared with 5.1% for gastrointestinal tract bleeding.
A strong connection exists between venous thrombosis and cancer. Many studies note a high prevalence of both small and large-scale bleeding in cancer patients treated with oral anticoagulants. This might be due to other coexisting diseases or ongoing medication.
In a significant five-year retrospective study, approximately 48.8% of harmful drug events involving anticoagulation were the result of medication mistakes. These events increased 30-day mortality rates by 11% in the same study. Other studies show that emergency hospitalizations due to warfarin-related bleeding are frequent. Long-term safety data on new oral anticoagulants are limited or not available, meaning most data on newer drugs tends to excude less negative outcomes or appear more pleasing.
Before 2010, warfarin was the only approved oral anticoagulant available. Since then, new ones like dabigatran, apixaban, edoxaban, and rivaroxaban have been introduced. These newus drugs work by blocking blood clot formation through platelet activation and slowing down the clumping together of blood cells (thrombin), reducing the creation of clots.
Risk Factors and Frequency for Anticoagulation Safety
There are several significant differences between warfarin and the newer oral anticoagulants. Newer anticoagulants can’t be monitored with the usual blood clotting tests, unlike warfarin. Also, they don’t need any changes in the diet and start working quicker, usually within a day, while warfarin may take up to a week. However, these new anticoagulants are often expensive and are not as readily available. It’s also noteworthy that there isn’t as much known about their long-term effects. Furthermore, healthcare professionals often do not know how to deal with emergencies related to these anticoagulants, such as uncontrolled bleeding or preparing a patient for surgery.
- Anticoagulants can’t be easily removed from one’s system through dialysis as they bind to proteins in the body.
- Despite these challenges, they have a lower risk of causing severe bleeding and fewer events of intracranial bleeding than warfarin. However, in elderly patients and those with kidney problems, certain oral anticoagulants might increase the risk of intracranial bleeding.
The selection of an oral anticoagulant usually depends on factors such as the risk of bleeding, presence of a mechanical heart valve, kidney and liver function, body weight, a history of peptic ulcers or indigestion, patient preference, patient compliance, and past success with oral anticoagulation.
- Adverse events associated with anticoagulants usually occur in medical and surgical units, telemetry, rehabilitation, the emergency room, and outpatient clinics.
- Among the oral anticoagulants used today are warfarin, rivaroxaban, dabigatran, and apixaban.
- The potential for medication mistakes with oral anticoagulants leading to adverse events is significant and can include dose omission, extra dose, wrong dose/overdose, lab issues in monitoring, medication given at the wrong time, underdose, prescription refill delayed, wrong patient, drug-drug interaction.
Bleeding can occur after the use of oral anticoagulants for a variety of reasons. Most often, it’s due to the variability in patients’ responses to the drug in the first 90 days of use and the intensity of anticoagulation. Additionally, patient characteristics such as advanced age, diabetes, anemia, hypertension, congestive heart failure, female sex, transient ischemic attack, history of stroke, renal failure, liver disease, lack of patient education about atrial fibrillation and the risk of stroke, non-compliance (most common in middle-aged patients), varying INR monitoring protocols, and diet can all increase bleeding risk.
The risk of bleeding can also be increased by other medications, including antidepressants, antibiotics, acetaminophen, NSAIDs, fenofibrate, proton pump inhibitors, alcohol, and the influenza vaccine. Lastly, some genetic variations can affect how warfarin is metabolized, which can also increase the risk of bleeding.
Signs and Symptoms of Anticoagulation Safety
If a person takes too much of a certain type of blood-thinning medication, they might have internal bleeding a few days later. However, clear signs of bleeding might not show up within the first day after taking the drug. Aside from bleeding in the brain, people may also experience:
- Nosebleeds
- Bleeding under the lining of the eye
- Vaginal bleeding
- Bleeding gums
- Blood in the urine
Testing for Anticoagulation Safety
If you’ve experienced any adverse events related to blood-thinning medications, your doctor may need to carry out several tests to understand your situation better. This list of routine tests includes:
- A complete blood count, which measures different components of your blood
- A coagulation profile, which includes prothrombin time, activated partial thromboplastin time, and d-dimer tests to understand how your blood clots
- A count of your platelets, which are blood cells that help with clotting
- A CT scan of your head to detect any bleeding inside your brain
- An echocardiogram, or heart ultrasound, if your doctor suspects that a blood clot has formed in your heart valve
- Another echocardiogram to specifically check for a blood clot in the left section of your heart
- A nuclear scan to locate any bleeding within your digestive tract
Remember, any additional tests you might need will depend on the symptoms you’re experiencing and how you’re feeling overall.
Treatment Options for Anticoagulation Safety
If someone is bleeding and they are on blood thinners, they may need to stop taking those medications right away. Recombinant factor VIIa, a substance available in plasma transfusions, can help lower a measure of blood coagulation called INR. Vitamin K can counteract the bleeding caused by a specific type of blood thinner called warfarin.
Fresh frozen plasma is often given to patients who are bleeding due to newer blood thinners, but this treatment isn’t always very effective. In some medical centers, a substance called prothrombin complex concentrate is administered to patients with severe gastrointestinal bleeding. This can be beneficial in treating life-threatening bleeding due to vitamin K antagonists. However, there is no proof that bleeding related to newer oral blood thinners is improved with prothrombin complex concentrate.
When bleeding is very severe, fluids might need to be given through a vein. It’s important to watch for signs of a brain bleed, such as changes in behavior, mood, or consciousness. If the patient has a nosebleed, a medical professional might pack the nose to stop the bleeding.
Andexanet alfa is a medication that reverses the effects of certain blood thinners like apixaban and rivaroxaban. It’s typically given as a quick, concentrated dose, followed by a slower infusion over two hours. This treatment is effective at stopping bleeding in approximately 82% of patients within a 12-hour period. The common side effects of andexanet are urinary tract infections and pneumonia. Idarucizumab is a manufactured antibody used to reverse the effects of a blood thinner known as dabigatran.
What else can Anticoagulation Safety be?
When a doctor is diagnosing your condition, they will need to eliminate other conditions that may be causing your symptoms. These could be:
- Subarachnoid hemorrhage (bleeding in the space between the brain and the surrounding membrane)
- Epistaxis (a nosebleed)
- Hemophilia (a medical condition where the ability of the blood to clot is severely reduced)
- Liver failure
- Deficiency of Factor V and X (these are proteins needed for blood to clot properly)
- Dysfibrinogenemia (an abnormality in the protein fibrinogen that helps in blood clotting)
- Vitamin K deficiency (Vitamin K helps make proteins needed for blood clotting)
- Peptic ulcer disease (sores that form in the lining of the stomach and the first part of the small intestine)
The doctor will look at all these possibilities carefully and conduct necessary tests to arrive at the correct diagnosis.
Possible Complications When Diagnosed with Anticoagulation Safety
Oral anticoagulants, which are medications used to prevent blood clots, can sometimes have complications. Here are some of them:
- Bleeding, which could occur in various parts of the body such as:
- The gastrointestinal tract
- The pericardium, the sac-like structure around the heart
- Retroperitoneal area, or the space in the abdominal cavity
- The brain
- The chest cavity
- Thrombosis, or blood clot formation which could happen in different places like:
- Your heart valves
- The brain, causing a type of stroke
- The legs, causing it to suddenly become very cold
- The mesentery, or the tissue that supplies the intestines with blood
Recovery from Anticoagulation Safety
Oral anticoagulants, which are types of blood-thinning medicine, are widely used in treating many patients, often with other health conditions. It’s important for all healthcare staff to learn about these medications. Those who prescribe, dispense or administer these medicines should be knowledgeable about their usage, dosage, and any potential interactions.
Additionally, staff should be informed whenever a new oral anticoagulant is added to the list of medications available in the hospital or clinic. This could be done via newsletter, email, electronic notification, or an in-service. Even though educational programs might have some limitations, detailed information about the new medication can be shared with all staff through the intranet.
Updated information about the new medication, such as its antidotes, how it should be monitored, and any potential side effects, should also be shared whenever a new oral anticoagulant is included.
Healthcare professionals need to be aware of the risks associated with these medicines. All patients taking oral anticoagulants and oral antiplatelet agents (medications that prevent blood clots) are at risk of bleeding. Therefore, healthcare professionals prescribing this combination of medications must be fully aware of the risk and monitor the patient closely.
Preventing Anticoagulation Safety
How to Decrease the Chance of Bleeding
If a person has irregular heart rhythms (atrial fibrillation) and is at high risk for bleeding or has had a stroke in the past, the doctor may consider a procedure called atrial arrhythmia ablation. Current studies show that, while those who get this procedure still need blood thinners (anticoagulation), they may have a slightly lower chance of bleeding than those who take certain medications like dabigatran or warfarin.
People who are set to go for a planned surgery and are taking oral blood thinners always have a risk of bleeding. Due to this, the present advice is to stop the blood thinner called warfarin 5-6 days before the procedure and switch the person to an alternative called heparin or low molecular weight heparin. Once the surgery is completed and there is no more bleeding, the person can start taking warfarin again 12-24 hours later.
In the case of surgeries where there is a high chance of bleeding such as spinal surgeries or brain surgery (craniotomy), blood thinning medications should be stopped until the chance of bleeding is low or gone completely. If the person is at risk of blood clots in the veins, the doctor can consider using heparin or low molecular weight heparin and compression stockings. An important thing to consider in people taking warfarin is what to do if they are also taking antiplatelet therapy at the same time. This combination is used to prevent coronary disease, keep a stent open, or prevent a stroke. It is often associated with increased risk of bleeding in the brain especially in elderly people who also take warfarin. Even a minor head injury can increase the chance of bleeding. In such cases, medical alert bracelets are advised.
