Holiday Gift for the Heart – The Apple Watch Series 4

Holiday Gift for the Heart – The Apple Watch Series 4

Capital Cardiology Associates

Holiday Heart Gift:
The Apple Watch Series 4

Why the Apple Series 4 Watch is the hot, holiday gift idea for heart patients this year

When was the last time you bought your parent or grandparent a watch? Spoiler alert: the hottest gift this Holiday Shopping Season will most likely be the latest wearable gadget, the Apple Watch Series 4.

As with most Apple product releases, the Apple Watch Series 4 announcement came with much excitement and wonder just before the Holiday Shopping season. Surprisingly, the flatter design, faster processing speeds, and new look were not what drove the anticipation. The new Apple Watch is the first smart-watch that can monitor your heart, and if it detects an irregular heart rhythm, notify you and record the episode. There’s more. That feature, when combined with the fall detection tech in the watch, enables the watch to call emergency services if you fall and are unresponsive for 60-seconds. The Apple Watch will also send your location with a message to your emergency contacts.

If you have a family member or loved one who is at risk of heart events, you can see why this watch is on the top of most shopping wish lists

Typically, as a Wristly report from 2016 shows, men who work outside of the tech industry (45%), are over the age of 55 (29%), followed by 45-54 year olds (25%) — own an Apple Watch. Most (27%) of those surveyed say they purchased the watch, “as a new type of computer on my wrist” to receive “notifications.” However, just two years ago, the most an Apple Watch could do at that time was serve as a glorified pedometer for tracking runs, workouts, and activity. In the Apple Watch Series 2 in 2016, Apple began to reveal it’s intentions to take their technology beyond tracking activity and workouts. Their core customer is a middle-aged, professional man with an interest in health and fitness. As Apple stated in their 2016 press release, “Apple Watch Series 2 is packed with features to help our customers live a healthy life.”

Technology that tracks your heartbeat

Fast forward two years. Apple is now working to get the ECG app and irregular rhythm notification out by the end of 2018. When the ECG app is live, the Apple Watch Series 4 will be capable of “generating an ECG similar to a single-lead electrocardiogram,” states the Apple website. This new feature is intended to, “indicate whether your heart rhythm shows signs of atrial fibrillation (AFib).” Dr. Lance Sullenberger, board-certified cardiologist at Capital Cardiology Associates, stated that “Atrial fibrillation is the most common abnormality that we experience in cardiology.”

The most common symptom of AFib is an irregular heartbeat or palpitations. Dr. Sullenberger describes a thumping or racing heart, some patients experience fluttering or feeling like their heart is skipping a beat. Other common symptoms are shortness of breath, dizziness or light-headedness, and fatigue. If you experience these symptoms, contact your doctor immediately. “Everyday I see patients who have heart palpitations,” notes Sullenberger. “What we are really trying to determine when we see a patient with palpitation is: do they have atrial fibrillation?”

The new Series 4 watch will be able to read your heart’s electrical signals, if it detects an irregularities, record the ECG waveform, and store the results in Health app on your iPhone. The Apple Heart Study, conducted by Apple and Stanford University, provided to the Food and Drug Administration, showed the app was able to “identify over 98% of the patients who had AFib, and over 99% of patients that had healthy heart rates. Cardiologists were able to read 90% of the total readings, although about 10% of them were unreadable.” This would put critical data on your arm, or in your phone, for doctors to review. For the starting price of $399, you can purchase a wearable heart-tracker that also tells time, keeps you connected with texts/email, and has a slew of other health and fitness apps.

Concerns from the medical community

Rich Mogull, a Boulder, Colorado EMT and blogger stated, “thanks to its health monitoring features, the new Apple Watch Series 4 will save lives, probably within weeks of launch.” In his article, he addressed the very technical education needed to understand an ECG. This is where lies the concern. How many of us can identify the P-Wave, the QRS complex, and T-Wave on an electrocardiogram graph?

Electrocardiography (ECG, EKG) is a test of your heart. It lets your doctor see how well your heart is working. A doctor can use this test to find out if you have a heart problem, or to monitor a heart problem your doctor already knows you have. During a standard test, you lie still as the electrodes monitor your heart. The electrodes detect the electrical waves your heart makes. This is recorded on a chart. They can see if it has a steady rhythm. And, they can detect the strength of the electrical signals that trigger your heartbeat. It usually takes about five to ten minutes to complete the test.

The science of detecting and measuring electrical currents in your body dates back to 1790, when Luigi Galvani, an Italian physician, physicist, biologist and philosopher, discovered electricity in the body. He found that the muscles of dead frogs’ legs twitched when struck by an electrical spark, using a copper base, zinc connector, and a metal rod applied to the frog legs. It wasn’t until the mid 1880’s when the first practical ECG machine which was invented by Augustus Desiré Waller. This was the first time that physicians could record the heart’s electrical activity from skin surfaces. In 1901, a Dutch doctor and physiologist, Willem Einthoven, used wires, a large magnet, a light bulb, and a silvered wire to build the first EKG machine. He was able to read the heart’s waves on a scroll of photographic paper.

Over 100 years later, we live in a time when the heart’s abnormal electrical activity can be detected and recorded from a device strapped to our wrist.

The concern from medical professionals is not over the quality of the EGC from an Apple Watch. The question is whether patients will be able to understand what the readings mean and know when it’s time to seek medical attention. “How to read an ECG” is something you can search online. What you find is math, being able to identify irregular rhythms, measuring the cardiac axis by using leads (I, II, III), looking at the P-Waves to identify atrial activity, evaluating the P-R interval, assessing the QRS complex, and evaluating the ST, T, and U waves. The complexity of reading an ECG is overwhelming; processing and diagnosing the cardiac physiology is much more in depth.

“This complexity means that patients should not rely on the internet or step-by-step guides to diagnose their own symptoms,” stated Maryellen King, an Advance Practice Nurse. In addition to working with heart failure patients in the hospital as well as in outpatient settings, Maryellen is also Manager of Remote Monitoring at Capital Cardiology Associates. She specializes in cardiac device management and electrophysiology. “Most of these devices will allow patients to send PDF’s to a physician for evaluation. Mechanisms for doing this will vary by physician practice. At Capital Cardiology we have the ability to receive and evaluate patient reports.”

“The watch is good at recognizing irregular heart beats and giving you an alert,” said King. She explained how the Apple Watch is not the first type of wearable tech that has the ability to scan or monitor heart activity from home. The Holter monitor has been available for heart patients since the early 1960’s. There’s also a major difference in the report that comes from a wearable device versus a full ECG/EKG that would be performed at your doctor’s office or hospital. The Watch produces a PDF that is considered a strip, not the full EKG. “A rhythm strip is a one-lead transmission (Lead I) that can detect rate, irregularity, and presence or absence of P-waves, which is a good first step, something we use in cardiology.”

“Let’s say you’re looking at an object in your house and there are 12 different windows that you can look through. Apple’s watch looks at one. So you see one view of the flower vase or whatever you are looking at. It tells us and we can identify heart irregularities with that one view. A 12-lead looks through 12 different windows or views. That’s how we diagnose myocardial infarction (the irreversible death of heart muscle secondary to prolonged lack of oxygen supply), left ventricular hypertrophy (enlargement and thickening of the walls of the heart’s main pumping chamber), or different electrical conduction problems. You can diagnose AFib from one view but you need more data to see the additional causes of the cardiac disturbance,” King explained.

The Apple Watch Series 4 is the next step in emerging medical technology, a history that began over 200 years ago. This Watch offers features that were imaginable only in movies or in science fiction, and yes, we’re getting closer to “The Jetsons” lifestyle we grew up watching Sunday nights and Saturday mornings. At best, the Watch is a diagnostic tool for heart rhythm disturbances. That’s what it’s presently limited too. As far as a gift idea for heart patients, “it’s not an age thing for seniors when it comes to technology today,” said King. “Using cell phones is not always age specific. I think that demographical change will be when people see that they are able to use the Watch for more than recording exercise or activity. People have to wear it, they have to be comfortable with it.”

Thankfully, Apple has perfected creating technology that is easy for all ages to understand. As well as creating many ways to personalize devices to make it feel like, “your own.”

Written by: Michael Arce, Media Specialist
Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.

Can Doctors Predict Heart Attacks?

Can Doctors Predict Heart Attacks?

Capital Cardiology Associates

Can Doctors Predict Heart Attacks?

A new procedure can pinpoint within years your risk of heart attack

Every year there are more than 3 million heart attacks in the United States. The American Heart Association breaks that down to about one heart attack every 40 seconds. Most Americans are aware that lifestyle habits, a healthy diet, and regular visits with their doctor to monitor their risk of heart disease help prevent us from becoming a statistic. Even with testing today that can gauge the risk of a heart attack or cardiac event within the next ten years, doctors are still searching for the “Holy Grail” of detection.

During a recent episode of HeartTalk presented by Capital Cardiology Associates, Dr. Robert Benton addressed the topic of predicting the risk heart attack thanks to new clinical testing being performed with CT scanning equipment. Dr. Benton is the Clinical Research Director of Capital Cardiology Associates and spoke about research on a new detection system, known as the Fat Attenuation Index (FAI), to measure plaque and detect risk.

The CT Scanner

The study involved a team of researchers from the University of Oxford in England and the Cleveland Clinic in Ohio who found a new application for CT Scans. Their detection system, known as the Fat Attenuation Index (FAI), uses standard non-invasive computed tomography (CT) scanning technology to measure plaque and detect risk. This helps “predict” and identify markers, noninvasively, to look at coronaries.

A traditional CT scan is an x-ray procedure that combines many x-ray images with the aid of a computer to generate cross-sectional views of the body. Cardiac CT uses the advanced CT technology with intravenous (IV) contrast (dye) to visualize your cardiac anatomy, coronary circulation and great vessels. Capital Cardiology Associates uses a state-of-the-art multi-row detector CT scanner. With multi-slice scanning, it is possible to acquire high-resolution three-dimensional images of the moving heart and great vessels. Learn more about cardiac CT scanning, here

“‘What’s the risk of something bad happening to me?'”, opened Dr. Benton. “Now that’s a complicated question because there are known risk factors go into the answer: family history, medications you are on, lifestyle, and many other factors. We have formulas that can give an estimate over 10 years what your risk might be. Now that’s over the next ten years, I didn’t say tomorrow morning or 9 years and 11 months from now. One of the toughest things a doctor has to do is predict how long a person has to live. We are notoriously terrible at predicting that.”

Doctors have long been searching for the identifying markers that can better pinpoint the immediate risk of heart attacks developing. Dr. Benton broke down the current diagnosis system. “When you go to your cardiologist, they can order biomarkers, a blood test for inflammation, for example. You can put these results into formulas that give a general idea on where you fit in with your peer group over the next ten years. How do we give people information that is more useful to them on if an event is going to occur this year, this month, or this week? We aren’t there yet.”

“But one thing we do know is that in heart attack patients, 50% of people have normal cholesterol levels. That tells us there are other things going on. You’ve heard doctors talk about plaque in your arteries. This plaque forms a blockage in the artery causing a lack of blood flow in the artery. Many of those people had a prior to a heart attack, insignificant blockage of 10%, not 80%. What is it about that 10% blockage that makes it crack when, let’s say, bowling or running; what makes that heart attack occur?”

3D rendering of plaque in arteries

Plaque is made up of fat, cholesterol, calcium, and other substances found in the blood. Over time, plaque hardens and narrows your arteries. This limits the flow of oxygen-rich blood to your organs and other parts of your body. “We think what causes the plaque to break is inflammation, meaning that the white blood cells have infiltrated the plaque, making it soft,” stated Dr. Benton. Your white blood cells begin to attack the plaque as part of your bodies natural defense. As the blood runs by the weakened plaque, your blood pressure rises, or the heart rate goes up, it causes the plaque to rupture. This triggers a heart attack or stroke as the plaque now clogs another artery in your heart, or in the case of stroke, the blood supply to part of your brain is interrupted or reduced, depriving brain tissue of oxygen and nutrients.

How Is FAI Different Than A Calcium Score?

Currently, to get a better assessment of your doctor would order a coronary CT calcium scan of your heart. A CT scan is a low risk procedure that has been around since the 1990’s. This 30-minute procedure looks for calcium deposits in the coronary arteries that can narrow arteries and increase the risk of heart attack. A calcium score of zero gives you a risk of somewhere in the range of .5% risk of heart attack over the next five years on an annual basis and there’s nothing else, no math model, no stress test, or anything else. The highest score we have seen a symptomatic person was in the 12,000 range, that’s very usual.

“Calcium score can identify plaque but doesn’t tell us how strong or weak it is,” added Dr. Benton. “This new study is looking at the small amount of fat that surrounds the coronary arteries, naturally, to cushion and protect arteries. What this study did is look at the quality of that fat. Specifically if the fat became liquid or soluble as a marker of inflammation. They came up with a technical scale and found that if you had this attenuation, that is a predictor of future of events within three to four year range.” Those with an abnormal FAI number were up to nine times more likely to have a fatal heart attack in the next five years.

Dr. Benton expanded on the findings of this new research. “What we understand about this process is that when the fat becomes unhealthy, that’s a marker of inflammation in the plaque itself. We are still researching the causes of the inflammation, but the two are related, and being able to measure this with a low-radiation CT scan, we can judge the stability of the plaque. These tests would give us the information we need to tell a smoker, for example, to stop smoking that cigarette because they are more immediate risk of heart attack due to the inflammation of plaque caused by tobacco. This testing is not ready for primetime right now but I would say within a year or two, it will be ready for a wider population of patients.”

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Soon a CAT scan would be able to tell us the amount of calcium, the bulk of the plaque in your heart’s arteries and the nature of that plaque, in terms of inflammation. “There is so much information that is right over the horizon,” said Dr. Benton. “There will be more clinical trials on which patients should have this type of procedure. Your going to look for people that are in the moderate risk group. People who have risk factors like family history, chest pain at times, or other biomarkers in their blood. What’s interesting in this test is that, you are going to try and identify those people who have, the 10% blockage, who won’t have chest pain. They are the ones who would have an acute heart attack. Those are the type that occur suddenly. The 10% are also the ones at a higher risk of heart attack because we already can identify those at 70% or greater blockage.”

Written by: Michael Arce, Host of HeartTalk presented by Capital Cardiology Associates
Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.

World Stroke Day

World Stroke Day

Capital Cardiology Associates

World Stroke Day

Joining together for one day to fight the #2 cause of death in the world

Stroke is a leading cause of death around the world. But that’s just part of the story. 80 million people in the world have had a stroke, 50 million stroke survivors live with some form of permanent disability. The fact is, stroke is largely treatable and with healthy lifestyle changes, starting today, you can reduce your risk of becoming a statistic this year.

The World Stroke Organization is dedicated to improve care for stroke survivors worldwide.

What Happens

Director of Clinical Research, Dr. Robert Benton explains how a stroke event is similar to a heart attack. “Essentially for both of them you have an instance where you’re losing blood flow to a part of the brain or the heart. That is the common finding in both of them. In the heart, usually, this is caused by a cholesterol plaque that has become inflamed, ruptures because you are smoking, or because you have high blood pressure, and there’s a blood clot that forms and blocks blood flow to the heart. When the heart muscle doesn’t get blood, it dies. The brain is similar in that you can have plaque in your brain but the brain is also susceptible to other findings, that would be emboli that fly either from your neck, clotting breaking off from the arteries or the aorta, or one of the common causes of stroke called, atrial fibrillation (AFib).

Causes of Stroke

There are three main areas of stroke risk factors: lifestyle, medical, and uncontrollable. Dr. Benton advises that we work with our doctor to identify our personal risk factors for stroke as we would with heart disease. “Heart attack and stroke can have very similar risk factors that lead to them. Smoking, hypertension, high cholesterol, diabetes, a sedentary lifestyle… all of those things can contribute to your risk.” Tobacco use and smoking double the risk of stroke when compared to a nonsmoker. Smoking increases clot formation, thickens blood, and increases the amount of plaque buildup in the arteries. “People can have a genetic pre-disposition to stroke: high blood pressure, arrhythmia, cholesterol levels, these things can be genetically programmed. Then you do yourself no big favor by smoking cigarettes, eating a poor diet, not exercising where you can compound your genetic disposition for stroke with poor or bad lifestyle choices. Those two factors really work together,” pointed out Benton.

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Prevention Is The Best Cure For Stroke

The good news is, 80% of strokes can be prevented. “Strokes are as preventable as a heart attack and they are actually quite similar,” states Mary Ellen King, Nurse Practitioner at Capital Cardiology Associates. “With heart attacks people know eat a healthy diet, manage cholesterol, exercise and a stroke is the same thing.” Ultimately, regular visits with your healthcare provider will assess and monitor your risk for stroke.

Most importantly if you are over the age of 60 and haven’t been checked for AFib, see your doctor. “Most people with AFib don’t feel it. We find it on an EKG. Or a pacemaker, heart monitor, or they are wearing their FitBit or Apple Watch, whatever it is, they notice their heart rate is jumping all over the place and it’s faster than what it used to be.” Early detection of stroke is the biggest element in prevention. “The time piece of identifying stroke is so important because the longer that part of the brain goes without blood and oxygen supply, the worse the outcome is. Unfortunately, people live through strokes but they can be very debilitating and life altering,” explained King.

Monday, October 29th is World Stroke Day. Join Capital Cardiology and The World Stroke Association in the effort to raise awareness of stroke prevention, treatment and support. Meet with your doctor this fall to discuss your risk of stroke. If you are a stroke survivor, consider connecting with other members, partners, and survivors in the Capital Region by joining organizations involved with local support events.

Written by: Michael Arce, Media Specialist
Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.

Canadian Healthcare System

Canadian Healthcare System

Capital Cardiology Associates

The Canadian Healthcare System

The Pro’s and Con’s of Canada’s healthcare system

Canada’s health-care system is a point of pride for most Canadians. In 1947, the government of Saskatchewan introduced a province-wide, universal hospital care plan. By 1950, both British Columbia and Alberta had similar plans. When the Medical Care Act passed in 1966, the Canadian government began to fund public healthcare. Within six years, universal coverage for medically necessary health care services provided on the basis of need, rather than the ability to pay became a right for all Canadians.

During the Obamacare town hall debates in 2008 and with every election cycle since, Americans have heard quite bit about the Canadian health care system. I sat down with Dr. Connor Healey, a board-certified cardiologist during a recent episode (Sunday, September 9th) of HeartTalk presented by Capital Cardiology Associates to discuss the pro’s and con’s of the Canadian healthcare system. Dr. Healey is from Eastern Ontario Canada and admits to being an Ottawa Senators fan. “I was fortunate because my father was a family physician but I did have a family doctor for regular visits and immunizations,” Healey noted. One of the benefits touted about the Canadian system is that it’s “free.” Canada’s healthcare is “single-payer”, meaning that coverage is publicly-funded by federal or provincial (state) taxes. An estimate from 2017 figured the average Canadian paid about $5,789 for health care.

Example of Ontario health card

In Canada, health coverage is paid by the government meaning that individual visits to the doctor or hospital come without a bill. As Dr. Healey outlined, “I broke my hand playing hockey. My parents took me to the hospital, it was my first visit to the Emergency Room. I was treated and when I was ready for discharge; we left. There was no bill, nothing to pay to an administrator. All of you tests, procedures, x-rays, blood work, cat scan, prescriptions, everything involved with treatment was covered as long as you had your provincial card which demonstrates you a resident of that province, for me that was Ontario, that’s all it took.”

Another myth about the Canadian system is that everything is covered. Sadly, that is not the case. “There is supplemental insurance you can get,” pointed out Dr. Healey. Approximately 65% of surveyed Canadians have private supplemental health insurance, mostly through their employers. An additional 11% of people have access to supplemental services through government-sponsored insurance plans. “For instance, medications for the most part are not covered across the board.” Nearly one in four Canadian households reports that someone in that household is not taking their medications because of inability to pay. “Now, in general, they are much cheaper and that is why a lot of people venture up to Canada or order from a Canadian pharmacy. But there are insurance plans available that would cover that and a lot of those plans will also take care of vision and dental. That is very similar to what we have in America,” remarked Dr. Healey.

In the United States, our health system is comprised of government programs (Medicare and Medicaid) available to those who qualify and private medical insurance companies. About 65% of Americans, according to a 2017 US Census report, receive health care that is provided by employers (private companies). “I’ve been a patient in America as well. I had another hockey injury… maybe I should stop playing,” shared Dr. Healey. “My experience was different, $50 co-pay, signing my life away on different forms, big bill at the end – fortunately my insurance covered most of it. But I also had regular checkup appointment recently and that experience reminded me of a visit back home.”

Healthcare affordability is a major issue in the US. Despite legislation in 2010 that moved the country closer to achieving quality, affordable healthcare, costs have continued to rise and nearly 26 million Americans are still uninsured according to the Congressional Budget Office.

The question of the level of quality of care in “public” health systems during private systems frequently comes up. “I would say in terms of in the quality of care from physicians and nurses, it’s equal,” said Dr. Healey. “Physicians trained in Canada who then come down to America or vice versa, you really don’t notice a difference.” Dr. Healey attended medical school at St. George’s University in Grenada where he graduated cum laude. He completed his internal medicine residency and cardiovascular fellowship at NYU Winthrop Hospital on Long Island.

Canadians have recently begun to address the challenge of long wait-times. Dr. Healey gave the following example, “you cannot make an appointment with a specialist like your cardiologist in Canada, you would have to be referred by your primary doctor. Now you can still request who you want to see but it make take one, two, or three months to see that specialist. To control the costs, Canada limits the amount of physicians that are available and the amount of testing that can be ordered. MRI is probably is the most famous example. If you need a test for an emergency or life-saving procedure, you will get it when it’s ordered. If you injury yourself playing ultimate frisbee, you could wait 6-8 weeks to have that test and by then, perhaps it’s too late. That’s an instance where Canadians will cross the border, pay out of pocket, and get that elective MRI.”

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Since health care is essentially a right in Canada, long-wait times and health-care delivery are issues that have been taken to the Supreme Court of Canada. It’s an area that government is addressing considering the growing aging population that lives in primarily in dense city areas; it is an hot-button issue. “This weekend I was speaking with a colleague of mine who was trained in Buffalo but is now in practice up north,” said Dr. Healey. “He doesn’t seem inhibited at all. Very specialized testing like cardiac MRI (again, back to the MRI example) is probably limited but if he wants to order a stress test, cardiac cath, CAT scan, all of those are readily available. The caveat in Canada is that they don’t have to get authorization to have the test. Because it is a single-payer system, the test is, essentially, automatically approved.”

As we navigated through the list of pro’s and con’s, it was apparent that when comparing the US and Canadian system there was no clear winner. I asked Dr. Healey with everyone objectively looking for the best model, did a perfect system exist? “I don’t know if a perfect system exists, but having been to Europe there is a program that incorporates a model that works,” he shared. “It’s a hybrid system that offers universal healthcare coverage for everybody, so know matter what your means may be, your appointment with your doctor or hospital visit is covered. Often there is a small co-pay involved to provide some mild deterrent to prevent people from abusing unnecessary medical care. But, they also have a second private system that is run very similar to what we have the States. If that’s covered by your employer, tremendous. It also works if you have to pay out-of-pocket, that also works. And that off loads the burden on public system while providing and influx of cash that is necessary to fuel the public system. I believe a two-tiered system is the way to go but I also believe that there should be blanket coverage to start.”

For all of the debate that we have heard in the past 10 years over healthcare in the United States, it was a rewarding experience to have a productive discussion with a physician engaged on the topic. Dr. Healey reminded me that at their core, medical professionals in both countries are on the side of patient care. “Doctors, for a collective group of individuals with experience on this issue, we are awfully quiet and we generally sit on the sidelines. I don’t know if it’s because we are busy treating patients or are more focused on patient care which is what we enjoy. We are also far outnumbered when it comes to lobbyists in Washington or in Albany. And because of that, I don’t think our voice is heard. I enjoy talking about healthcare and enjoy learning about how we can improve not only the quality of care but also the availability of care for everyone. That’s what our passion is as doctors, caring for people.”

Written by: Michael Arce, Host of HeartTalk presented by Capital Cardiology Associates
Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.

Making Sense of Medication Package Inserts

Making Sense of Medication Package Inserts

Capital Cardiology Associates

Making Sense of Medication Package Inserts

The “fine print” on how a drug works

It is not unusual to pick up a prescription and receive a very long and detailed medication package insert. After realizing how wordy and small the font is, you want to decide what the most important sections to read are.

Medication package inserts contain comprehensive information approved by the U.S. Food and Drug Administration (FDA) based on research/clinical trials in which the medication is taken by patients. Package inserts contain in-depth clinical evidence which is often difficult for patients to interpret and laborious for healthcare professionals to read through. Patients often ask questions regarding information they heard about a medication in a TV commercial; this information comes straight from a package insert.

In the chart below, common sections found in package inserts are listed. There are many other sections found in package inserts, but some of the most important are explained below. If you have any questions after reading a package insert, feel free to contact the Capital Cardiology Associates pharmacist.

Section Title

Explanation

Indications and Usage:

This section lists the FDA approved indications for the medication. It is important to know that a doctor may prescribe medications for an indication not approved by the FDA or an “off-label” usage; this does not mean the medication is being used inappropriately. Before providing a patient with drug information, it is very important to know why they are taking the medication.

Dosage and Administration:

This section explains the FDA recommended dosages of the medication and how to take the medication. This section can be very important to find if a patient should take the medication with or without food, what time of the day to take their dose, etc. It is very important to know that sometimes different dosages are recommended based on a patient’s health problems or other medications they are also taking. Some medications may need reduced dosing based on a patient’s liver or kidney function because of the way medications are metabolized (broken-down/processed in the body) or eliminated from the body.

Adverse Reactions:

This section lists ALL side effects that were reported while the medication was being studied in clinical trials, including uncommon side effects. Many patients may read this section and be hesitant to use a medication because of the side effects listed. Often the percent of patients that the side effect occurred in is listed. Usually, the benefit of using the medication outweighs the risk of having a side effect.

Contraindications:

This section lists situations in which the medication should not be used. For example, there are certain medical conditions that may put a patient at higher risk for dangerous side effects if they use the medication.

Drug Interactions:

This section is often hard to interpret. Depending on the drug interaction, there may be different recommendations for monitoring, dose reductions, discontinuation of concomitant medications, etc. If you have any questions regarding a drug interaction, please contact Dr. Kate Cabral, Capital Cardiology’s Clinical Pharmacist for a consultation.

Other information you may find in a package insert: proper medication storage, clinical trial data, use in special populations (pregnancy or lactation, elderly people, children, etc.), black box warnings (important safety information that explains a serious hazard/risk associated with the drug), and dosage strength/forms (tablet, capsule, liquid, etc.) the medication comes in. Lastly, at the end of the package insert, there is often a patient education guide that is written in patient friendly terms that may be provided to help answer common questions.

Written by: Katie Parsels, Albany College of Pharmacy and Health Sciences Intern at Capital Cardiology Associates
Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional.