Webcast: What You Need to Know
About Over-the-Counter Analgesics
As more prescription products become available over the counter, it becomes even more important to educate patients about safe and effective use of OTC products. Because 60% of patients consult a health care professional when selecting an OTC product, family physicians have an opportunity to help patients avoid common problems with OTC analgesics.
At the end of this webcast, the participant will be able to:
- Educate patients about the potential for harm when taking multiple medications
- Educate patients with predisposing conditions about risks
- Equip patients to use OTC analgesics safely by teaching them about reading labels, safe storage, and other important factors
Ada D. Stewart, MD, FAAFP
Eau Claire Cooperative Health Centers
Moderator: Hello everyone, and welcome to today's webinar, "What You Need to Know About Over-the-counter Analgesics." Before we get started, I would like to go over a few items so you know how to participate in today's event. You have joined the presentation listening using your computer speaker system by default. If you prefer to join over the telephone, just select “telephone” in the audio pane and the download information will be displayed. You will have the opportunity to submit text questions to today's presenter by typing your questions into the questions pane in the control panel. You may send in your questions at any time during the presentation. We will collect these and address them during a Q&A session at the end. Today's webinar is being recorded and will be posted on aafp.org by March 1, 2017. Also, in March, you will receive a printed educational piece for your use. I would now like to introduce Dr. Ada Stewart to begin today's presentation.
Dr. Stewart: Thank you so much everyone for participating this evening. I am Dr. Ada Stewart, and I have nothing to disclose that would be in conflict with the content of this educational information.
The learning objectives for this evening: At the end of the presentation, the learner will be able to educate patients about the potential harm when taking multiple medications; educate patients with pre-existing conditions about risks of certain medications; and educate patients to use OTC analgesics safely by teaching them about reading labels, safe storage, and other important information.
The availability of OTC medications makes it possible for consumers to treat numerous ailments without the supervision of a health care professional. OTC medications are generally safe and effective when used as directed, but they can be associated with adverse effects and can be associated with certain risks when used in particular situations. Many patients mistakenly feel that these medications are without harm because they do not require a prescription. Some over-the-counter medications have been switched from prescription to OTC, and they can be available in various forms, such as creams, ointments, tablets, capsules, etc.
Pain is most commonly treated with over-the-counter medications. This presentation will be focused on those particular drugs. OTC analgesics are frequently used to relieve minor aches and pains due to headaches, toothaches, musculoskeletal pain, menstrual pain, fever, colds, and the flu. Commonly available products include acetaminophen; nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen; and salicylates, such as aspirin and magnesium salicylate.
Sixty percent of patients consult a health care professional when selecting an OTC product. Because of this, family physicians have an opportunity to help prevent common problems associated with their use. Patients should be provided verbal information on appropriate product selection, correct dosing, common side effects, and drug-drug interactions.
Just to review a couple of definitions, what is a prescription drug? This is something that is prescribed by a doctor, purchased at a pharmacy, and prescribed for and intended to be used by one person. They are also regulated by the U.S. Food and Drug Administration (FDA) through the new drug application (NDA) process. This is a formal step a drug sponsor takes to ask the FDA to consider approving a new drug for marketing in the United States. A new drug application includes all animal and human data, and analyses of these data, as well as information about how the drug will behave in the body and how it's manufactured. For more information regarding this process, you can go to www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm.
Let's define an over-the-counter drug. This does not require a doctor's prescription. It's purchased off the shelf in stores. It's commonly regulated by the FDA through OTC drug monographs. The OTC drug monographs are a “recipe book” covering acceptable ingredients, doses, formulations, and labeling. Monographs are continually updated, adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance. Those that do not must undergo separate review and approval through the new drug approval system. For more information regarding that process, you can go to www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100101.htm.
Many drugs have been switched from prescription (Rx) to OTC. This is done through a process that the FDA has made where there are procedures in which certain drugs have to follow certain criteria. With more products being switched from prescription to OTC, the need for education and counseling is particularly important to promote the safe and effective use of OTC products which, by definition, should be suitable for self-selection and generally should be safe.
Let's go through the criteria that the FDA has. Before the FDA considers a prescription drug product for a switch to OTC, the drug must meet certain criteria. The indication or indications for which the product is to be used on an OTC basis should be similar to the prescription indication or indications and must permit easy diagnosis and monitoring by the patient. The drug should have favorable adverse-event and drug-interaction profiles; relatively low toxicity; and a low potential for abuse. This information is derived from clinical trial results and post-marketing safety surveillance data. It is submitted to the FDA by the manufacturer of the product. The drug should not have properties that make it impractical for OTC use (for example, the need for special monitoring or a narrow therapeutic index).
The impact of switching has had a profound effect on consumers because consumers view these switched products as strong, economically viable therapies. Changing drugs from prescription to OTC status permits patients to conveniently and effectively self-treat a number of minor ailments. OTC medications are cost-effective first-line therapies for many ailments. In 1993 alone, nine of the top 10 selling OTC products were switched from prescription to OTC status. The prescription-to-OTC switch process has a positive impact on the U.S. health care system by driving down overall health care costs. For example, according to a study conducted by the researchers at Northwestern University, using OTCs to treat certain upper respiratory infections could save $4.75 billion annually.
On this slide, we can see that in a study done many years ago, but still indicative of what we are finding now, 40% of Americans believe that OTC drugs are too weak to cause any real harm. And it is significant that 60% of people could not identify the active ingredient in their brand of pain reliever.
This PubMed study showed information regarding the patient's view of OTC medications. I'm just going to go through a few of these, and you can read them on your own. Forty-six percent of exclusive OTC users believed OTC medications were safer than prescription medications; 29% of exclusive OTC users believed that they were at risk for side effects from NSAIDs; 22% believed warning symptoms would always precede an NSAID-induced complication; and 15% reported daily use of OTCs.
There is a common misconception among patients that these OTC drugs are harmless because they're readily available without a prescription.
These misconceptions can lead to harm. The misconception about potential harm or lack thereof can lead to misuse and/or overdose of OTC medications. Even in the absence of physical or psychological addiction, the misuse of OTC medications can result in significant short-term and long-term problems. OTC and prescription drugs both have the potential for misuse. The difference is OTCs are easier to obtain.
Some of these misconceptions result in extended misuse and/or overdose of the OTC medications, and some health risks can occur after an individual's first experience misusing a certain drug. One of the most commonly misused OTC drug categories is pain medication; for example, acetaminophen can affect the liver and NSAIDS can affect the kidneys, and vice versa.
Pain and discomfort in everyday life are often treated with OTC analgesic medications, and up to 70% of the population in Western countries uses analgesics regularly, particularly for headaches, other specific types of pain, and febrile illnesses. These drugs are generally safe when used as directed, but serious side effects can occur. It is not known whether the patterns of use are consistent with good pain management practices.
The focus of this talk today is on OTC analgesics because it is found that one of the first-line pharmacological options for symptomatic treatment of mild-to-moderate pain is OTC analgesics, such as acetaminophen and nonsteroidal anti-inflammatory drugs. The choice between these two medications depends on the type of pain and patient risk factors for medication-related adverse effects, such as GI, renal, hepatic, or cardiovascular. Different NSAIDs have similar analgesic effects when taken in their labeled doses.
As we look at the World Health Organization's cancer pain relief ladder, we see that in step one, non-opioid medications such as acetaminophen and NSAIDs are used for the initial management of pain.
We must dialogue with our patients on OTC analgesics. As family physicians, we have an excellent opportunity to educate our patients. Family physicians are positioned to assist patients in understanding proper dosing, adverse effects, and drug-drug interactions with the use of OTC analgesics; to inform patients with health problems who regularly use OTC pain relievers that they need to talk with their family physician; and to let them know that OTC pain relievers are generally safe when used as directed. And that is as directed. They must know that side effects can occur.
As some of the most commonly used OTC analgesics, we have acetaminophen (otherwise known as Tylenol®); nonsteroidal anti-inflammatory drugs, such as ibuprofen (better known as Motrin® or Advil®) and naproxen (also known as Aleve®); and other salicylates, such as aspirin and magnesium salicylate.
We must educate our patients on these commonly used OTC medications. We'll first talk about acetaminophen. Some products do contain acetaminophen and aspirin, and we must make sure that our patients are aware of these drugs. Some of the brand names are Excedrin Extra Strength®, Excedrin Migraine®, and Vanquish®. Irreversible hepatotoxicity is the biggest risk of chronically using large doses of acetaminophen or overdosing, either intentionally or unintentionally. Signs and symptoms of liver damage can include abdominal pain, yellowing of the skin or eyes, and nausea or vomiting.
We must inform our patients about who should not take acetaminophen. This includes patients with acetaminophen allergies or who are taking other products that contain acetaminophen. We should instruct our patients that they should ask their doctor before taking acetaminophen if they're taking a blood thinner, such as warfarin or any of the other new anticoagulants; if they have liver disease, such as cirrhosis; or if they're pregnant or breastfeeding. Although side effects of acetaminophen are rare, they can exist; this includes liver damage, especially if someone takes too much acetaminophen or if they have three or more alcoholic drinks while taking acetaminophen. Unless directed by a doctor, adults are instructed not to take more than the indicated amount per the formulation. The first one is 3,250 milligrams in 24 hours for regular strength, 3,000 milligrams in 24 hours for extra strength, and 3,900 milligrams in 24 hours for the extended release. That is per formulation.
There are significant drug-drug interactions, as mentioned before, especially with warfarin, as well as liver warnings. One must not take more than 4,000 milligrams of acetaminophen in 24 hours. More than 4,000 milligrams can be toxic, especially if a patient is drinking more than three alcoholic drinks per day while using this particular product.
Next, we'll talk about ibuprofen. Ibuprofen can cause a severe allergic reaction, especially in people allergic to aspirin. Allergic reaction symptoms include hives, facial swelling, asthma, shock, skin reddening, rash, and blisters. If an allergic reaction occurs, one must stop and seek medical help immediately.
We also must be aware of the drug-drug interactions and note that NSAIDs can interact with certain blood pressure medications. Instruct patients who are taking blood pressure medication that while they are taking an NSAID, their blood pressure medication may not work as well as it should.
The side effects of NSAIDs include severe stomach bleeding, and the chance is higher if a patient is 60 years or older; if they have history of stomach ulcers or bleeding problems; if they're taking an anticoagulant, methotrexate, or a steroid drug; if they're taking other prescription or non-prescription NSAIDs in addition to the OTC ones; if they consume three or more alcoholic drinks every day; or if they take more or for a longer period of time than actually directed. NSAIDs should not be used if a patient experienced an allergic reaction to any other pain relievers or fever reducers. In addition, they should not be taken right before or after heart surgery.
Some of the recommendations of the American Heart Association suggest that patients with high risk or at higher risk for cardiovascular diseases should avoid NSAIDs and patients should use the lowest possible dose for the shortest duration of time. In addition, the FDA states that one should take NSAIDs for no more than 10 days unless otherwise directed by a physician. Just recently, the FDA recommended against any NSAID if one has cardiovascular disease. This came out, I think, in April 2016, which was after the formation of this presentation.
Now we'll talk about salicylates. Some of the over-the-counter salicylates are aspirin and magnesium salicylate. We find aspirin under the trade name Bayer® or St. Joseph®. We also must note that there are products that, as mentioned previously, do contain acetaminophen and aspirin. Side effects with salicylates on the whole are really rare. This drug is actually well tolerated by the vast majority of patients, but several side effects have been reported, including cardiovascular effects (dysrhythmias, hypotension, and tachycardia); fluid and electrolyte imbalances; and hearing loss or tinnitus. These are dose-related side effects. And, of course, GI irritation and bleeding.
Individuals 15 years and younger who are recovering from chicken pox or influenza should not use aspirin or other salicylates. Individuals with certain disorders should speak with their family physician prior to taking aspirin or other salicylates. Those conditions include gout, diabetes, and renal impairment. Individuals who have risk factors for upper GI bleeding should avoid the use of aspirin, especially those on anticoagulants. In addition, individuals who are taking methotrexate should avoid the use of aspirin.
The recommendation for salicylates is a maximum OTC analgesic dose for self-medication with aspirin of four grams per day. Prescription dosages of four to six grams per day may be needed to produce the actual anti-inflammatory effects.
We must educate our patients on the safe use of all OTC analgesics. The following can be signs of serious conditions for which you should stop use and ask your doctor: if the pain gets worse or lasts more than 10 days; if fever gets worse or lasts more than three days; if new symptoms occur; or if there's redness or swelling, feeling faint, vomiting, or having black or bloody stools.
We must use these tips to educate our patients. Take only the amount recommended on the medication label. Don't assume that more medication will work better or quicker. Taking more than the recommended amount can be dangerous. If a patient is taking a prescription medication, discuss how the OTC analgesic will work with their current regimen. We must make sure that we have our patients bring in all their medications that they are taking as we reconcile their medication list and look to see if there are any possible drug interactions.
In addition, don't use more than one OTC analgesic at a time, unless approved by a health care professional, because some may have similar active ingredients that can add up to be too much medication. Examine current OTC medications being taken to see if they contain acetaminophen. As I said before, many combination medications have both acetaminophen and other products as part of their active ingredients. Taking too much acetaminophen or NSAIDs can cause health problems. One must read the directions on the drug facts label to learn how a medication is to be taken, how much to take, and how often to take it. In the next couple of slides, I will go over one of the drug facts labels. In addition, one must keep a record of which OTCs they are currently taking and when these medications are being taken.
Some other tips: If pregnant or breastfeeding, ask a health care professional before taking an OTC analgesic. It is especially important not to use ibuprofen during the last three months of pregnancy unless definitely directed to do so by a doctor. This can cause problems in the unborn child or complications during delivery. Children and teenagers who have or who are recovering from chicken pox or flu-like symptoms should not use aspirin. If aspirin is used and there are changes in behavior or nausea and vomiting occur, then consult a doctor because these symptoms may be early signs of Reye's syndrome. In addition, one must make sure that they have the information for the Poison Control Center readily available.
Let's educate our patients on the safety of OTC analgesics by teaching them how to read the label, safe storage, safe dosing, and when to avoid.
We're going to talk briefly about the OTC drug facts label. The labeling of OTC medications has always contained usage and safety information. In the Federal Register of March 1999, the FDA published the OTC Drug Facts Label regulation. With this introduction of the drug facts label, the information became more uniform and easier to read.
The content of the OTC drug facts label has seven sections: 1) active ingredients; 2) the uses (indications); 3) warnings (safety information); 4) directions (how to use and how often, for liquids: the correct dose measuring device); 5) other information (e.g., how to store the product); 6) inactive ingredients (preservatives, binding agents, and food coloring); and 7) questions or comments. It usually has a toll-free number for the manufacturer if one has questions or wants to share comments about the medication.
Here's an example of a drug facts label. You can see there are active ingredients, uses, warnings, directions, other information, and inactive ingredients.
I just want to mention the Up & Away Campaign and the PROTECT Initiative. This is a partnership with the Centers for Disease Control and Prevention. Up & Away means put your medications up and away and out of sight. The safe storage of medications is very important to prevent the unintentional use and overdose of medication, especially for kids. We have to make sure that we keep this in mind. It is actually Poison Control Week at the end of March, and this is one initiative that is going to be highlighted during that time.
In addition, the PROTECT Initiative came about based on the frequency of use of OTC medications, which increases the potential for unintentional (accidental) overdoses. Prescription medications, along with vitamins, minerals, and supplements, were also noted to be significant sources of unintentional overdose. Children are particularly vulnerable to these unintentional overdoses, and most of these can be prevented. One of the biggest goals of the PROTECT initiative is to prevent the unintentional overdose and over-usage of medications in children.
It has involved many organizations, and it started in 2008. A group of individuals—such as public health agencies, leading manufacturers of OTC medications, packaging manufacturers, the poison control centers, health professionals, societies such as AAFP and AAP, consumer patient advocates—got together, and they looked at different means and mechanisms to avoid overdoses in kids. This is where some of the new dosing forms have been developed and are used, so this has been an important initiative. How they're looking at how successful they are is looking at the number of ER visits that they are preventing over this time. This is something that is very important, especially in overdose and safe uses in children. Hopefully, with overdoses of OTCs, this will advance to using and looking at prescription medications.
This is some more information regarding the PROTECT Initiative. As I said, they're working with partners to develop safe OTC dosage delivery devices and encouraging dosage standardization on package labels to reduce caregiver confusion.
This just talks about some of the objectives of the PROTECT Initiative.
Regarding typical misuse, the FDA reports that some patients take more than the recommended doses, and this increases the potential for adverse effects. Factors related to these problems, especially with acetaminophen, include repeated dosing in excess of the recommended dose, using multiple products that contain acetaminophen, and the chronic use of alcohol.
We're going to talk about, in the next couple of slides, particular populations. Regarding misuse in elderly, education in the elderly population is really vital. An estimated 20% to 30% of patients over the age of 65 take analgesics daily, and they are more likely to take OTC medications with prescription medications, which could result in possible drug-drug interactions and potential side effects.
In regards to children, we must educate the patients about the use of analgesics to treat cold, flu, and fever in kids. We must make them aware of possible dosing errors. Now, of course, there is standardized dosing for single concentrations of acetaminophen. Let's note that both acetaminophen and ibuprofen are the most frequently used OTC medications in children. Beware of signs of Reye's syndrome and use the avoidance of aspirin in children and teenagers who have flu-like symptoms or are recovering from chicken pox.
Continuing on with kids, cold and cough medications are among the top 20 substances leading to death in children younger than five years of age. In 2008, the U.S. Food and Drug Administration recommended OTC cough and cold medications be avoided in children younger than two years old. Following the removal of OTC infant cough and cold medications from pharmacy shelves, there was a decrease in ED visits for adverse effects involving these medications in children younger than two. Manufacturers of these medications have voluntarily modified the product labels to state that they should not be used in children younger than four years old, and this was a compromise. Acetaminophen manufacturers voluntarily changed the packaging for safe dosing and to avoid any kind of accidental ingestion.
How do we reduce the risk? We can reduce the risk of OTC drug therapy in older adults by patient/health care provider education and improved labeling of OTC analgesics whereby we increase the identification of the ingredients in various products. We can reduce risk of drug-drug interactions by making sure that we know what our patients are taking.
In summary, family physicians have an excellent opportunity to educate patients. More than 60% of patients see a health care provider in the office setting prior to the use of OTC analgesics. Family physicians are positioned to assist patients in understanding proper dosing, adverse effects, and drug-drug interactions with the use of OTC analgesics. Family physicians must have conversations with their patients and make use of printed education materials to help guide in educating our patients on the use of these products.
Family physicians should be aware that health information is readily available to patients on television, the Internet, and also on social media. Family physicians must be aware of the increasing trend toward self-care. Family physicians should be aware of the use of these products and that there is a potential of adverse effects if not used as recommended. We must identify instances in which they should not be used, which can end up having a significant impact on public health.
The next couple of slides are references, and you can review those.
All right, we'll open the floor to questions. Thank you so much for your participation.
Moderator: Thank you, Dr. Stewart. And before we move on to our first question, I would like to remind our listeners, you can still submit your questions using the questions pane on the GoToWebinar control panel. Dr. Stewart, our first question is what considerations does a physician need to be aware of when using OTCs with Coumadin or other anticoagulants?
Dr. Stewart: The biggest thing is that with Coumadin, many of the OTC analgesics can cause increased GI bleeding. So we need to make sure that our patients are aware of that. This does not mean that you cannot use aspirin or one of the other NSAIDs with this, but beware that there is an increased risk of GI bleed. So then, that's a perfect opportunity for us to be able to inform our patients that this could be a potential problem.
Moderator: Thank you. Our next question is where do you typically find most frequent misuse of OTCs in your practice?
Dr. Stewart: Most of the time, it's with patients using medications and they do not know that the medications may contain an ingredient that they're already taking. I had a patient that came in and they were taking aspirin in addition to ibuprofen. With those two medications, I was able to inform the patient that they should not be taking them together. Also, I've had patients who are taking an OTC NSAID in addition to a prescription NSAID. We have a perfect opportunity to educate our patients when they come in. And we must encourage them to bring in all their medications, whether they're taking things over-the-counter or via a prescription by ourselves or by others, because this is a great time for us to educate them on what medications are what, which are similar, and which are different. Those are things that I've seen in my particular practice.
Moderator: Great. Thank you. The last question for today—and we've gotten several requests—is will a copy of the presentation be available? And I can answer that question. The presentation will be available on aafp.org on March 1, 2017. So, thank you, that was our final question for today. I want to thank Dr. Stewart and thank you, everyone, for attending today's webinar, "What You Need to Know About Over-the-counter Analgesics." We'd also like to thank Johnson & Johnson Consumer Inc., whose funding and support made this webinar possible. You will receive a follow-up email within a week with a link to view the recording of this webinar. On behalf of our presenter Dr. Stewart and the AAFP, thank you for joining us and have a great rest of the day.