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CME / ABIM MOC / CE

OTC Analgesics/Antipyretics in a Post-Pandemic World: Rational Guidance for Improved Outcomes

  • Authors: Charles Vega, MD, FAAFP; Steven P. Cohen, MD; Susan Cornell, BS, PharmD, CDCES, FAPhA, FADCES
  • CME / ABIM MOC / CE Released: 1/28/2022
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 1/28/2023
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Target Audience and Goal Statement

This activity is intended for pain specialists, anesthesiologists, neurologists, primary care physicians, ID/HIV specialists, nurses, nurse practitioners, physician assistants, pharmacists, and dentists.

The goal of this activity is to reinforce the role of over-the-counter (OTC) analgesics as "essential medicines."

Upon completion of this activity, participants will:

  • Have increased knowledge regarding how to
    • Apply rational guidance regarding the safety of OTC analgesic drugs
    • Manage patient expectations about the appropriate treatment of pain/fever
  • Demonstrate improved performance associated with
    • Applying safe use of OTC analgesics within the interprofessional team


Disclosures

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All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated according to Medscape policies. Others involved in the planning of this activity have no relevant financial relationships.

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The faculty reported the following relevant financial relationships with ineligible entities related to the educational content of this CE activity:


Faculty

  • Charles Vega, MD, FAAFP

    Clinical Professor of Family Medicine
    Assistant Dean, University of California-Irvine
    Director, UC Irvine Program in Medical Education for the Latino Community (PRIME-LC)
    Irvine, California

    Disclosures

    Disclosure: Charles Vega, MD, FAAFP, has disclosed the following relevant financial relationships:
    Speaker or member of speakers bureau for: Johnson & Johnson

  • Steven P. Cohen, MD

    Professor of Anesthesiology & Critical Care Medicine, Neurology, Physical Medicine & Rehabilitation and Psychiatry and Behavioral Sciences
    Johns Hopkins School of Medicine
    Baltimore, Maryland
    Chief, Pain Medicine 
    Director, Pain Operations
    Johns Hopkins Hospital 
    Director of Pain Research 
    Walter Reed National Military Medical Center 
    Uniformed Services University of the Health Sciences
    Bethesda, Maryland

    Participation by Dr. Cohen does not constitute or imply endorsement by the Johns Hopkins University or the Johns Hopkins Hospital and Health System.

    Disclosures

    Disclosure: Steven P. Cohen, MD, has disclosed the following relevant financial relationships:
    Grants for clinical research from: Scilex
    Advisor or consultant for: Persica; Releviate; Scilex; SWORD Health

  • Susan Cornell, BS, PharmD, CDCES, FAPhA, FADCES

    Professor of Pharmacy Practice
    Associate Director of Experiential Education
    Midwestern University College of Pharmacy Downers Grove
    Downers Grove, Illinois
    Medication Therapy Management/Diabetes Care Provider
    Bolingbrook Christian Health Clinic
    Bolingbrook, Illinois

    Disclosures

    Disclosure: Susan Cornell, BS, PharmD, CDCES, FAPhA, FADCES, has disclosed the following relevant financial relationships:
    Advisor or consultant for: Bayer; Novo Nordisk; Sanofi
    Speaker or member of speakers bureau for: Novo Nordisk

Editors

  • Kathy Merlo

    Medical Education Director, Medscape, LLC

    Disclosures

    Disclosure: Kathy Merlo has disclosed no relevant financial relationships.

  • Frances McFarland, PhD, MA

    Associate Medical Education Director, Medscape, LLC

    Disclosures

    Disclosure: Frances McFarland, PhD, MA, has disclosed no relevant financial relationships.

Compliance Reviewer/Nurse Planner

  • Stephanie Corder, ND, RN, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Disclosure: Stephanie Corder, ND, RN, CHCP, has no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has no relevant financial relationships.

PIM

The PIM planners and others have disclosed no relevant financial relationships.


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Developed through a partnership between the Postgraduate Institute for Medicine and Medscape.



In support of improving patient care, Medscape, LLC is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 0.50 Interprofessional Continuing Education (IPCE) credit for learning and change.

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  • Medscape, LLC designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.50 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Aggregate participant data will be shared with commercial supporters of this activity.

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  • Medscape, LLC designates this continuing education activity for 0.50 contact hour(s) (0.050 CEUs) (Universal Activity Number JA0007105-0000-22-023-H01-P).

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    In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Medscape. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

    Postgraduate Institute for Medicine is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of the credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to the Commission for Continuing Education Provider Recognition at ADA.org/CERP.

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CME / ABIM MOC / CE

OTC Analgesics/Antipyretics in a Post-Pandemic World: Rational Guidance for Improved Outcomes

Authors: Charles Vega, MD, FAAFP; Steven P. Cohen, MD; Susan Cornell, BS, PharmD, CDCES, FAPhA, FADCESFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME / ABIM MOC / CE Released: 1/28/2022

Valid for credit through: 1/28/2023

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Activity Transcript

Charles P. Vega, MD, FAAFP: Hello, I'm Dr Charles Vega and I'm a clinical professor of family medicine at the University of California at Irvine. Welcome this program titled, "OTC Analgesics/Antipyretics in a Post-Pandemic World: Rational Guidance for Improved Outcomes." I'm delighted to be joined today by Dr Steven Cohen, who is professor of anesthesiology in critical care medicine, neurology, physical medicine and rehabilitation, and psychiatry and behavioral sciences at John's Hopkins School of Medicine in Baltimore, Maryland. Also joining us today is Dr Susan Cornell. She is professor of pharmacy practice and associate director of experiential education at Midwestern University College of Pharmacy in Downers Grove, Illinois. Welcome to both of you.

Today, we are going to be talking about over-the-counter (OTC) drugs and their application. I find that OTC drugs are incredibly common in clinical practice. They're very important, but they're also understudied and underappreciated by patients, to some degree, who many times don't necessarily think of OTC drugs as medications, and by healthcare providers as well. Yet we know that they're used every day in the United States by a wide variety of different individuals seeking relief from conditions such as fever, headache, low back pain, and other pain conditions. In one study, it was estimated that, in 1 year, Americans spent over $2.5 billion on OTC nonsteroidal anti-inflammatory drugs (NSAIDs) alone. And 83% of American adults reported OTC analgesic use in the past year; 15% of those use these medications every day. That equates to approximately 36 million US residents who use OTC analgesics daily. And so we put that in the context of our typical cold and flu season, and now we have the context of the COVID-19 pandemic on top of that.

Let's start with seasonality. When it comes to antipyretics, their use goes up in the wintertime in the United States because that's when we have cold and flu season. Usually the season starts around October, peaks in February, and can last until May. Now, 2020/2021 was remarkable because there was no flu season. We saw historically low rates of influenza. Why? The precautions that we were taking every day to prevent COVID-19 infection, washing our hands, distancing from one another, wearing a mask, which is very important, and other factors probably made a difference, particularly for influenza. School closures, while I have young kids and I am no fan of school closures, probably did make a difference in terms of transmission of flu. And then the lack of travel, particularly international travel, stopped mutation rates with influenza, and so we saw almost no flu season last year.

Right now, at the moment of this recording, we are on the edge of flu season in the United States, and we are seeing some uptick, more than last year. So the flu levels are still fairly low right now, in mid-December, but they are rising and they're not inconsequential. We have to watch out for influenza, as we watch out for COVID-19, certainly. And there is some concern that, perhaps, this flu season could be worse than previous flu seasons because we had no flu season last year and a lot of the immunity conferred from actual infections is not present. So it's a very important time to vaccinate everybody we can and then remind patients that there is more out there than COVID-19 to think about. I'm co-testing individuals with upper respiratory infection for influenza, respiratory syncytial virus (RSV), and COVID-19. Steven, I'm going to turn to you first. Maybe you could walk us through some of the differences between the common cold and flu, both of which we might still be seeing these days during the pandemic.

Steven P. Cohen, MD: They can occur anytime, but usually around the same timeframe. There are more similarities than differences. Cough is more common in flu. It can be severe, often nonproductive. It's usually milder with a cold, it could be productive, usually with clear or yellow-tinged sputum. Sneezing, nasal congestion, and sore throat are all more common with the common cold. Body aches consisting of arthralgias, myalgias, and headache are more common with the flu. Fatigue can happen with both, often more severe with the common cold, and fevers are very common with the flu, and they can be quite high, usually not a big problem with cold, none or mild.

Dr Vega: I always think that those more systemic symptoms, the myalgias, fever, and severe fatigue are more aligned with the flu than the common cold, which has symptoms from here up. But then we have COVID-19, a very different infection. Can you separate that clinically speaking, when patients first present with the flu or COVID-19?

Dr Cohen: Sure. Well, it [COVID-19] is more virulent, right? The mortality rate is much higher. Even now that the mortality rate is lower it's still more than 10-fold. And there are a lot of geographical differences between countries. I think one of the major things that separates [COVID-19 and the flu] is that a high percentage, between 30% and, in some studies, over 80%, of people who suffer from COVID-19 experience a loss of taste or smell. But because there's such overlap, tests are really needed to distinguish between them. There are 2 kinds of tests - polymerase chain reaction (PCR) tests that detect the virus's genetic material, and then there are antigen tests that detect specific proteins on the surface of the virus, and those tests are faster, easier, less accurate, and there's some judgment call on the part of the lab as to where to put the cutoff for sensitivity and specificity.

Dr Vega: Really good point. The Center for Disease Control and Prevention (CDC) recommends co-testing during flu season. The hard part is knowing when the flu is circulating. I think we get a lot of news, inundated actually, regarding how much COVID-19 we're seeing. Oftentimes, we're able to get reports from our local community because there's broad awareness and interest. Influenza, I would dig deep to find out exactly, as specifically as you can, in your town or in your county, what's going on with influenza, because that's going to dictate times for co-testing and treatment. Treatment is different between the 2. For COVID-19, you could offer a monoclonal antibody for an outpatient, and there are effective anti-influenza drugs for influenza, but those don't work on the other infection. They only work on the specific thing they were designed to do. Thank you very much, Steven.

Susan, I'm going to turn to you because most patients are actually going to treat any of these infections with OTC products, whether they have a fever, aches and pains, or headache. And so maybe you could talk about what are considered as essential medications and introduce that concept to those of us who aren't as familiar with it.

Susan Cornell, BS, PharmD, CDCES, FAPhA, FADCES: Sure and thanks, Chuck. And Steven did a great job of differentiating between the cold, flu, and COVID-19. I appreciate that because, when we think about it, many times people, when they come down with signs and symptoms of these conditions, come to the pharmacy or they'll try self-care or to self-treat. And so what is safe and effective OTC? And when we say safe and effective OTC, we have to think about across the world because there are different medications and different approaches. How many people prefer more of a holistic approach or an herbal approach compared with more of a Western-medicine type OTC treatment? And so the World Health Organization (WHO) publishes the Essential Medicines List, and it's updated every 2 years.

The 22nd edition, which was updated recently, lists the core medications for a basic healthcare system, and we have to look at changes within the system, etc. Probably one of the things we want to look at in this list is what is accessible for people; safe, effective, and affordable; and can be used by people with various conditions. And then the priority conditions are selected based on current and estimated future public health relevance. So we have to look, again, at what is a safe and effective, but also affordable, treatment, because if people can't afford it, they're not going to be able to take it. When we talk, specifically, about OTC, and there are various sections within this Essential Medicines List, I want to point out, quickly, that there are 2 lists. There's the Essential Medicines List, which is for adults, and there's also the Essential Medicines List for Children. So there are 2 separate lists, and most of what we're talking here is the adult list. I want to clarify that for folks.

When we look at section 2, which is about medications for pain and palliative care, there are 3 [OTC] products listed. So, specifically, aspirin, ibuprofen, an NSAID, and, of course, acetaminophen. And when we look at these we have to look at the different effects of these medications, because some are better at reducing inflammation, where others are more of an antipyretic. And so acetaminophen, for example, is better as an antipyretic compared with ibuprofen, which is much better as an anti-inflammatory. Although naproxen is not on the WHO Essential Medicines List, I want to put it out there because, in my experience, I've seen more people use naproxen than ibuprofen. So I think it's just something for folks to be aware of that the nonsteroidal category extends beyond ibuprofen at this point.

Dr Vega: Thanks, Susan, for that great summary. Yeah, I personally think of those as pretty essential. When I'm at work in clinic and get a headache, I'm happy to have an analgesic around because, otherwise, it turns into a pretty long day. It doesn't happen a lot, but I am happy to carry it. And the same thing goes with my kids, when we're traveling and they have a fever, definitely best to have something available. The value with these medications is that they are convenient, you can take them anywhere, and they are effective. I think that there's something empowering anytime my patients take hold and want to treat their illness. And that could be using OTC analgesics and antipyretics, it could be taking a supplement, or it could be starting an exercise regimen or changing their diet. I encourage these things because at least they're [patients] acknowledging there's an issue and they're trying to do something about it. And so I try to be very positive, even sometimes when those interventions go sideways a little bit. I still want to be positive and say "well that's great that you tried this. I want you to be aware of X, Y, and Z. Let's rethink this a little bit," but let's keep coming back and keep trying." Because that's really important, especially when you're managing a lot of acute illness on top of a chronic illness, in the state of pandemic, where accessibility to care and accessibility to medications can be limited. It's really important.

That said, there are some potential downsides associated with OTC medications. What if a patient self-diagnoses incorrectly, and what they have is not the common cold, but actually COVID-19. They infect others in their household and then leads to more morbidity and even mortality in that household. What about knowing about drug-drug interactions? Because these OTC medications are certainly drugs, and they can interact with either other OTC drugs or prescribed medications. Or there may be interactions between a patient's long-term conditions, say they have a history of chronic kidney disease and gastric ulcers and they're taking a lot of NSAIDs. This would be a bad idea because of the potential toxicities associated with NSAIDs. And so I think there's a strong upside and I believe in the use of OTC drugs, but there are some potential downsides that we need to address.

And I think it becomes very confusing, particularly during a pandemic, where the science is in evolution every single day. We're getting news alerts regarding some new findings, and as science goes, it's never linear, it zigs and zags. People can get very confused between the messages. This is exactly what happened in the early days of the COVID-19 pandemic, when it came to the use of NSAIDs, ibuprofen, in particular, for symptom relief. Confusion can be increased as the story changes, and that's essentially what happened during the COVID-19 pandemic when we think about the application of NSAIDs for symptom relief among individuals with COVID-19. Susan, can you pick up the story and explain what happened?

Dr Cornell: Sure. Thanks, Chuck. The confusion about OTC use in self-care has been going on for years, ever since medicines like ibuprofen, which used to be prescription only, became available OTC. When we look at many of these medications, which were formally, again, as I mentioned, prescription only and are now available OTC, people are self-treating and they look to anyone and everyone for advice. And I want to share just to kind of have folks understand the relevance of this. In a perfect world, we want our patients to be coming to us, to pharmacists, to physicians, to physician assistants and nurse practitioners, to get advice about medications, drug interactions, etc, which you've already brought up.

In reality, people read the newspaper, they read social media, they listen to their friends or their family, and my personal all-time favorite, the lady at the Dunkin Donuts. And I've actually had this happen, where one of my patients came in, because she had a question about an OTC medication and a prescription drug. She was insisting that the lady at the Dunkin Donuts told her to take it and everything would be good. So it goes back to this misinformation or references. Where are people getting their information? And all of us tend to practice evidence-based medicine, so when we talk to people about this, the question is: "What is the clinical background to what they're hearing?" "What are the clinical trials saying?"

When COVID-19 first came out, hit, and really manifested itself here in March 2020, all of a sudden they're saying, "Don't use ibuprofen for symptoms [of or] to treat the COVID-19 infection because it's going to make COVID worse." This information came out and, within a couple of days, it was redacted because it was found to not be backed by clinical science. This misinformation was being replicated by social media, news media, etc, and creating more of a panic. So I think our job as healthcare professionals is that we need to make sure we're calming our patients and providing them with the science that goes behind all of the clinical trials and the data. So Steven, what about you? What have you seen?

Dr Cohen: We did a study that was published this year in Mayo Clinic Proceedings and we were looking at 3 major hospitals: a major teaching hospital in New York City, a major teaching hospital in Seoul, Korea, and John's Hopkins. And we wanted to see the prevalence of pain with COVID-19, and we wanted to see whether or not pain could predict outcome, ie, death or admission to an intensive care unit (ICU). We thought that people who had pain, that it might indicate a more virulent strain or a greater viral load, and they would be more likely to die. Well, it turns out that the opposite was true. If you had pain, you were less likely to die, and it's a little bit complicated. But the very interesting thing is that the most common symptoms were diffused body aches, myalgias, arthralgias, and headaches, things that NSAIDs would work very well for. But even among doctors at really famous teaching hospitals, I was surprised because these patients did not get NSAIDs, almost no one got NSAIDs, and the reason is because, like you say, patients didn't want NSAIDs or perhaps the healthcare providers continued to have some doubts or misconceptions.

Dr Vega: That's interesting. And you mentioned using NSAIDs for discomfort associated with an acute infection or other pain. Steven, can you cover some points for our audience regarding how effective these drugs are?

Dr Cohen: Sure. So NSAIDs are a good treatment and have been shown in many clinical trials to work for a certain type of pain. Pain can be classified, and it's probably really continuing into 3 categories: nerve pain, which is pain from injury or disease affecting the nervous system, so diabetic neuropathy would be a classic symptom; nociceptive pain, which stems from tissue damage or potential tissue damage, so axial back pain or arthritis those are classical nociceptive conditions; and then there's a newer category that's about 5 years old called nociplastic pain, and those are conditions such as fibromyalgia or irritable bowel syndrome and they arise from really overly sensitized nervous systems. So NSAIDs are very effective for nociceptive pain, so pain that results from tissue injury, things like arthritis, axial back pain.

People have looked at the effectiveness of NSAIDs for cold symptoms as well. And so the rationale for that is that NSAIDs inhibit the enzyme cyclooxygenase, which is involved in the production of prostaglandins, and prostaglandins are involved in the symptoms of fever, pain, and inflammation. And there's a Cochrane Review of 9 trials, over 1000 patients, and they found no benefit for NSAIDs compared with placebo for [reducing] the severity of cold symptoms in general - the severity of symptoms and the duration of symptoms. However, NSAIDS were effective for pain, pain across the board, so muscle pain, throat pain, and headaches. Acetaminophen, the mechanism of action is still really unknown. When I was in medical school, we used to say that it was a central inhibitor of cyclooxygenase. Now it's not really clear. It may be that acetaminophen reduces the active oxidized form of cyclooxygenase to an inactive form. In a meta-analysis of 4 trials with over 750 patients looking at acetaminophen for cold, there was significant improvement in nasal congestion, 2 studies, and it was superior to placebo in [reducing] the severity of rhinorrhea or having a runny nose.

Acetaminophen has been shown to be effective for certain types of pain - dental pain and acute pain from tissue injury. There've been a whole bunch of meta-analyses in high-impact journals looking at it for other conditions. So these tend to define that it has a very small effect for arthritis, usually studied for knee and for hip, and it may not be clinically meaningful in many people. NSAIDs, because of their anti-inflammatory effects, tend to be more effective analgesic drugs. NSAIDs can also be applied topically, because they work on enzymes in the periphery, and if you have a regional pain condition like tendonitis, they're very effective. So NSAIDs such as ibuprofen and naproxen have been shown to be effective for headache, back and neck pain, including in topical form for neck pain, general musculoskeletal pain, arthritis, and third molar extractions. There are also several studies and systematic reviews that have compared NSAIDs with opioids for acute pain, including kidney stones; ear, nose, and throat (ENT) surgery; or endoscopy, and they're generally found to be noninferior to opioids.

Dr Vega: Getting opioids off is a priority and NSAIDS can be a good way to do that. I'll just mention briefly that both acetaminophen and NSAIDs are used commonly against fever associated with these infections, and they're both effective in terms of being antipyretics. There are some question as to whether we could be doing potential harm to patients who have fever as part of the natural immune response to infection. There are some theoretical models that maybe we're blunting the immune response to infection, but that really hasn't been born out in clinical trials looking at the application of these drugs. So I feel okay about using antipyretics, whatever the patient chooses OTC for fever, and I don't really think that their infection, even COVID-19, is necessarily lengthened by that intervention. But that said, more data may be forthcoming there.

Another issue that's happened, particularly over the past year with a broad application of the COVID-19 vaccines, is that we've become familiar with the number of systemic side effects with the COVID-19 vaccine, which can exceed 50% when we think about the messenger RNA (mRNA)-based vaccines in particular. Susan, what do you tell patients about managing the side effects of the COVID-19 vaccine, should they develop them?

Dr Cornell: Great question, Chuck, and we see this a lot. Obviously, every person is different, and the reaction to the vaccine is very different person to person, so we do our best to individualize it. And one of the things is that many people come in [for] and, of course, one of their first questions is: "What side effects does this vaccine have?" And, historically, we always give the routine standard answer: injection site soreness or redness and maybe a little inflammation, but probably more from this vaccine than the flu shot. We tend to also see some signs and symptoms that mimic COVID-19. So you may develop the signs and symptoms of COVID-19 from the vaccine, and, of course, it doesn't mean that you necessarily have COVID-19, it's just that's how the vaccine is working.

And we all know that it takes at least 2 weeks to activate from the injection time. And so, in this case, we talk about how you may become tired, and headache, nausea, fever, chills, and muscle pain are very common. Of course, people want to know, well, what can I do? Can I take an OTC product? And we want to encourage them to be comfortable. There was some talk and concerns over the fact that using NSAIDs, specifically ibuprofen or meloxicam, prior to the COVID-19 vaccine may actually interfere with and reduce the production of antibodies. So the CDC then came out and said: "Don't take this before" [getting the vaccine]. So don't do a preventive approach, let's do a reactive approach on this. When you come in for the vaccine, don't take ibuprofen, aspirin, or acetaminophen ahead of time. And what you want to do is wait and see. If you develop these symptoms after you get the vaccine, within 24 hours or 48 hours, then go ahead and give it a try.

And, at that point too, this isn't something that we want people to be doing regularly for a long time. So if they take 1 dose or 2 doses, that's usually safe and effective. If they don't need it and it's not that bad, then don't take it. So one of the things is, again, historically, like with flu shots, we would say to people: "How do you react to flu shots?" And they'd say, "Oh, well, I end up having a sore arm." We would say: "Well, before you get the shot, take ibuprofen or acetaminophen." But, in this case, we're doing the opposite. We're saying, "Don't do that. Wait and see what happens and then go from there."

Dr Vega: Right. I've just been reassuring patients. Certainly, it's not 100% of folks who have some kind of reaction that's more systemic, after that second dose particularly. If it's 60%, that means 4 out of 10 times you're not going to need anything. So don't pre-dose, and it'll certainly be effective if you wait until after you develop symptoms, for those unfortunate folks who do. This does kind of lend itself to the safety of OTC analgesics and antipyretics. Steven, can you pick up on the themes of safety, as we start to close out our discussion today?

Dr Cohen: Sure. So there are major warnings for acetaminophen regarding hepatotoxicity, or toxicity to the liver. It can cause acute liver failure, but that tends to be dose dependent. It results from when the amount of acetaminophen that someone takes overwhelms one of the major metabolic pathways and this leads to the buildup of a toxic metabolite. So, it's important to remember that there's a lot of products that have acetaminophen in them, because it's OTC. People often don't know when something has acetaminophen in it. They could be taking something to go to sleep and it has acetaminophen. There's opioid analgesics that come with acetaminophen. And it can quickly lead to taking amounts that exceed the daily recommended dose, which is 4 g per day.

I think people underestimate acetaminophen toxicity, especially with alcohol consumption. The presence of liver disease, such as cirrhosis, hepatitis, or Wilson's Disease, can increase the risk. One of the major sources of side effects or toxicity from NSAIDs involves the gastrointestinal tract and this can lead to ulcers, gastritis, or perforation of the esophagus, stomach, small intestine, and the large intestine. When it comes to this, all NSAIDs aren't the same. There are specific kinds of NSAIDs. There are different sub-enzymes, and there are NSAIDs that block only one of these called cyclooxygenase (COX)-2-specific NSAIDs, and they carry a much lower risk. The risk can also be lowered by using NSAIDs with protein pump inhibitors, and that'll reduce the risk in the upper gastrointestinal tract, but not the risk for perforation or bleeding further down, like in the colon. And there's also an increased risk for cardiovascular events, like stroke or myocardial infarction.

Dr Vega: There are a lot of complicated issues there in terms of what we know about the pharmacodynamics and the safety of these OTC agents. That practical aspect of counseling patients and trying to help them manage their pain or fever effectively, but also keeping them safe. Susan, can you delve into a bit about collaborating with patients, as well as other healthcare providers, in promoting the safe and effective use of OTC products?

Dr Cornell: I think it's just so important that people, as I like to say, educate before they medicate, and that goes not only with prescriptions, but also OTC products. And so we really encourage people, before they purchase anything OTC, to talk to their pharmacist, physician, or prescriber, because drug-drug interactions or drug/disease interactions are so common. And, as Steven pointed out, there is acetaminophen, as well as ibuprofen or other NSAIDs, in other products. I think that people need to ask these questions and then, to get the most out of the medicine, they need to take it at the right time, to get the best effect, with the least amount of side effects. As Steven already brought up, with NSAIDs, one of the biggest challenges is it upsets the GI track, and many people don't realize that they should be taking this [medication] with food to mitigate that. And so, just some simple educational points can go a long way for the safe and effective use of OTC products. And, as a pharmacist, one of the things we do is delve deep into a medication history. We ask a lot of different questions in different ways to find out truly what the patient is taking and what they're taking it for.

Dr Vega: We're all on the same team and that's team patient, whoever that patient may be. What would you encourage all healthcare professionals to be inquiring of their patients regarding OTC drug use?

Dr Cornell: This is where, again, we all have to go deep, because so many people think "Well, it's OTC, so, therefore it's safe and effective to use and it won't harm me at all." And so we want to get at what are they taking. What do you take daily vs what do you take as needed? In most cases, obviously, pain medications are as needed, but they may be taking vitamins every day, or they may be taking some other OTC medication on a daily basis, something for allergies. And so finding out exactly what they're taking and making sure that we're covering not only the OTC products, but natural medicines as well, like herbs or homeopathic remedies, because there are so many things that people take that they don't remember to tell us.

So really needling down and saying, "Well, what about herbal agents?" And other questions, too: "Is this a prescribed product?" "Did it come as a recommendation from your prescriber or from a pharmacist?" And then what are they taking it for? And how are they currently taking it? Again, is it every day or as needed. And what have they noticed that's different? What problems are they having? Basically, I'm trying to get at side effects when we say, "Well, what have you noticed is different since you started taking it?" And then the other big thing, too, that there's a lot of confusion over, is "do I just have to take this one time or is this something ongoing?" So how long did your prescriber tell you that you would need to take this medication or how long have you been taking it? And then, what happens when they miss a dose? If it is something they should be taking every day, how often do they miss a dose? And last but not least, and probably one of the top things, is affordability. What concerns do they have about the cost of medications? And how many times people are concerned about the cost of a prescription, so they're looking for an OTC product to replace the prescription. So, again, as the team we need to make sure we get a thorough investigation of the patient's medication, prescription and OTC use.

Dr Vega: Those are all really good salient points. I make it a practice to counsel my patients, but also I will prescribe agents, like acetaminophen, ibuprofen, or naproxen, even though they're OTC, because then it will be part of our medication reconciliation and to remind myself. And if they end up in emergency department or with another provider, that's there as well, and it's also going to be on their pharmacy list. So I think it's just better for communication all around, and it helps reframe these OTC medications as drugs, so patients will think about them differently and they will consider the safety and efficacy issues as well.

Because we know, just to provide some conclusion, that there's OTC analgesics and antipyretics being used daily in the United States. I don't have a lot of data, but I would suspect that, particularly early in the pandemic, the rate of OTC drug use went up as more people were getting sick with COVID-19, and particularly, as healthcare access just declined. Whether you're talking about in the clinical setting, hospital setting, or the pharmacy setting, it was really difficult. Now, we're trying to welcome people back into healthcare so they can take care of those chronic conditions and give them effective and safe treatment for those more acute issues. Because OTC products play a really important role: they can provide comfort when there's not a cure. We don't have a cure for the common cold or COVID-19, but they can help patients feel better, when they could be, instead, suffering unnecessarily, being disabled, having more morbidity, etc. That said, there are some real important safety issues to consider. It's how to use them effectively, but also safely, that both of you really were eloquent in describing. And I think that, in general, Susan, your points are really well taken. There should be advice and input from the healthcare provider, whoever that person may be, and so we all have to step into that role and keep patients treated effectively, but also treated safely over time.

Drs Cornell and Cohen, this was a great discussion. Thank you so much for your participation. And thank you all in on our audience for participating in this activity, hopefully you found it clinically relevant. Please continue on to answer the questions that follow and complete the evaluation.

This is a verbatim transcript and has not been copyedited.

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