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10 Articles in Volume 14, Issue #3
Practical Guide To Safe Use of Nonprescription Pain Medications
Common Causes of Acute Abdominal Pain
Early Treatment of TMD May Prevent Chronic Pain and Disability
Insomnia: Focus on New Dosing Concerns In Women
Is Marijuana Use Associated With Non-adherence To Opioid Therapy—Insights Gained From Urine Drug Monitoring
New Evidence-Based Diagnosis Criteria for TMD
New Rating Scale Helps Evaluate Refractory Chronic Migraine Patients
The Effect of Prolonged Knee Extension Immobilization on Knee Active Range of Motion: A Case Study on Arthrofibrosis
Opioid Bias Hurts Pain Patients
Can misoprostol be used for refractory chronic constipation?

Practical Guide To Safe Use of Nonprescription Pain Medications

Gaining a complete medication history often requires sleuthing skills akin to those of Sherlock Holmes. A complete over-the-counter (OTC) medication history should include the name and strength of the medication, how the patient takes it, the duration and frequency of use, the side effects experienced by the patient, and the degree of relief provided by the medication.

Nonprescription, or over-the-counter (OTC), analgesics accounted for 11% of all nonprescription drug sales in 2011.1 Benefits of OTC analgesic medication use include direct, rapid access to medications for pain relief, decreased health care utilization resulting in lower costs, and increased engagement of the patient with their own health care. However, OTC medications pose a safety risk when patients incorrectly self-diagnose and treat, unknowingly choose medications that interact with another medication they take, or do not take OTC medications according to the labeled directions (unintentionally or intentionally).2 In a 2011 survey, 52% of patients with muscle and joint pain or arthritis and 70% of patients with headache and migraines relied solely on self-treatment using OTC medications exclusively.3

What You Don’t Know About Your Patient’s Drug Regimen

The first step toward ensuring that your patients’ OTC analgesic use is safe is to obtain a complete profile of all the medications, including OTC and herbal products, the patient is taking. In a recent cross-sectional survey of 500 patients, 85.4% reported that they believed their physician was aware of all OTC medications they were taking, whereas only 46.0% of patients reported actually telling the physician about OTC medication use.4 Only 34.1% of the surveyed patients discussed their herbal supplement and vitamin use with their physician. Since OTC analgesic use can change over time, it is imperative to ask the patient what they are using at every visit.

Gaining an honest and complete medication history often requires sleuthing skills akin to those of Sherlock Holmes. A complete OTC medication history should include the name and strength of the medication, how the patient takes it, the duration and frequency of use, any side effects experienced by the patient, and the degree of relief provided by the medication. Don’t assume your patient takes the medication according to the label instructions! A 2003 survey by the National Council on Patient Information and Education found that one-third of Americans surveyed had taken more than the recommended dose of an OTC medication.5 Asking how much and often a patient needs to take a medicine to achieve pain relief will likely yield a truer picture than simply asking if the patient takes the medicine according to the instructions.

What’s In a Name? Dig a Little Deeper

Ms. Smith, your first appointment of the day, tells you she takes Midol for menstrual cramps every month. A savvy practitioner will respond, “Which one?” Midol Liquid Gels contains ibuprofen; Midol Extended Relief contains naproxen, and Midol Complete, Midol PM, and Midol Teen are all combination products containing acetaminophen.

During your next appointment, Mr. Fitzgerald reports that he has been taking Sudafed over the past week for congestion, “thanks to allergy season.” He also routinely takes Tylenol PM, to help him sleep. During the appointment, he asks for a glass of water because it is time for another Sudafed. You notice the box he takes out of his briefcase says “Sudafed PE Pressure & Pain.” Do you ask for a closer look at that box? If you do, you will see that Mr. Fitzgerald is taking 2 products that contain acetaminophen. The best way to know exactly what your patient is taking is to have them bring all their medications, vitamins, and supplements to their appointment. In the real world, that often doesn’t happen; so remember, a good medication history often requires you to put on your detective hat.

Knowledge is Power

If Mr. Fitzgerald knew how to read a label and was aware of the maximum safe dose of acetaminophen, the preceding scenario could have been avoided. Educating patients about safe use of OTC pain medications will give them the power to recognize safety issues themselves. In a 2012 study that simulated OTC product selection, 45.6% of the 500 participants demonstrated they would have overdosed on acetaminophen by “double-dipping” with 2 acetaminophen-containing products.6 During this study, limited literacy was independently associated with overdosing with acetaminophen-containing products.

Take a few minutes to teach your patients how to read a medication label to determine what active ingredients they are taking. Clinicians need to reinforce the maximum doses. Educate your patients to ask for their pharmacist’s help in choosing an OTC medication; this is especially important for patients with poor health literacy or those without the cognitive ability to synthesize information from multiple product labels. For acetaminophen specifically, the Acetaminophen Awareness Coalition has created the Know Your Dose campaign (www.knowyourdose.org) to increase awareness of acetaminophen safety. Find general OTC medication educational resources at www.bemedwise.org and www.fda.gov/medsinmyhome, including a helpful handout on teaching patients how to read the Drug Facts portion of a nonprescription medication label. These websites also have a section of resources on OTC analgesics. Remind patients to store OTC medications away from children and to properly use the child safety caps if they have children or children visit their home.

Table 1, lists common combinations of OTC analgesic products and Table 2, summarizes common OTC analgesics and their safety information, including contraindications and drug interactions.

Evaluate the Patient’s Choices

Patients often independently initiate self-care with an OTC product, but health care providers should evaluate the appropriateness of the chosen self-care regimen and recommend changes to the OTC and prescription medication regimen as needed. Here are 5 suggestions for clinicians when they are evaluating OTC medications:

1. Ensure the Medication is Not Contraindicated for the Patient. Acetaminophen should not be used by patients with severe hepatic impairment or by those who drink more than 3 alcoholic drinks daily because it increases risk for liver failure in these populations. Patients with the triad of asthma, nasal polyps, and chronic rhinitis or urticaria should not receive aspirin or NSAIDs because it increases the risk for angioedema or bronchospasm in these patients. Furthermore, it should be noted that more than 90% of patients who are intolerant to aspirin will exhibit cross-sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).7,8

2. Determine if the Patient has Risk Factors that Increase the Risk for Adverse Events. Alcoholism and malnutrition can increase the risk for acetaminophen-induced liver failure, but liver failure is not the only severe adverse effect associated with acetaminophen. There have been case reports of patients with glucose 6-phosphate dehydrogenase deficiency developing hemolytic anemia due to acetaminophen use. Therefore, acetaminophen should be used cautiously in these patients.9 Acetaminophen has also been associated with rare cases of serious skin rashes, known as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. These reactions may be fatal, and patients should immediately stop using acetaminophen and contact their health care provider if they experience a skin reaction such as rash, blisters, or skin peeling.10

NSAIDs and salicylates cause dose-related increases in risk of gastrointestinal (GI) ulceration and bleeding. Several patient-related factors can increase the risk for GI bleeding at any dose of NSAIDs or salicylates. These include age greater than 60 years old, Helicobacter pylori infection, rheumatoid arthritis, and a history of peptic ulcers. In addition, ingesting more than 3 alcoholic drinks daily can increase the risk of NSAID-induced bleeding.11 Taking enteric-coated aspirin can decrease the risk of GI ulceration, but it doesn’t lower the risk for a major GI bleed.

To mitigate the risk of NSAID-induced GI bleeding, patients can concurrently take proton pump inhibitors (PPIs). This strategy is not without risk because PPI use can increase the risk of Clostridium difficile-associated diarrhea and osteoporosis-related bone fractures. Combination products have been developed to provide GI protection with NSAID therapy. These include a PPI-NSAID combination (esomeprazole-naproxen) and a histamine-2 receptor antagonist (H2-RA) combination (famotidine-ibuprofen); these are available by prescription only. In patients at higher risk, a prescription-only cyclooxygenase (COX)-2 selective inhibitor (celecoxib [Celebrex]) can be used in combination with a PPI.

Because all NSAIDs carry a black-box warning regarding the risk for increased cardiovascular thrombotic events, including stroke and myocardial infarction (MI), they should be avoided in patients who have a higher risk for vascular thrombosis. The Coxib and Traditional NSAIDs Trialists Collaboration found that for prescription-strength doses of NSAIDs, naproxen showed less vascular risk than ibuprofen, diclofenac, or celecoxib. Thus, in a patient who needs a systemic NSAID but has cardiovascular risk, naproxen may be a better choice.12 However, at a February 2014 Food and Drug Administration (FDA) advisory committee meeting held to evaluate changing the naproxen level to indicate a lower cardiovascular risk in comparison to other NSAIDs, advisory committee members voted against making this change.13,14 While advisory committee votes are not binding, FDA typically follows their recommendations, and it is not expected that the naproxen label will be changed with regard to cardiac safety.

In addition to ischemic cardiovascular concerns, NSAID use can precipitate acute decompensated heart failure and should be avoided in patients with heart failure. Effervescent formulations of aspirin contain a large amount of sodium and are even more worrisome for patients with hypertension, heart failure, or renal failure.11 NSAIDs also are associated with the same rare toxic skin reactions as acetaminophen, and this risk is described in the warning section of their label.10

3. Look for Duplicate Therapy. Check for acetaminophen in all OTC and prescription medications the patient is receiving. For example, your patient could be taking Tylenol #3 as well as an OTC product containing acetaminophen. Studies have shown that most acetaminophen-induced liver failure is associated with doses of more than 4,000 mg daily. In 2011, the FDA asked manufacturers to limit prescription-strength acetaminophen-containing medications to 325 mg per dosage unit. Most prescription combination acetaminophen products also contain opioids. The FDA found no evidence that a higher dose of acetaminophen in these combination products provided benefit that would outweigh the risk of acetaminophen overdose and possible liver injury.15 In addition, in January 2014, the FDA asked health care providers to stop prescribing and dispensing prescription-only combination products with more than 325 mg acetaminophen per single-ingredient dosage unit.16 Nonprescription acetaminophen-containing products have thus far been exempt from this dose limitation and are available in 325 mg immediate-release, 500 mg immediate-release, and 650 mg extended-release tablets.

Currently, the maximum dose of acetaminophen is 4,000 mg per day from all prescription and OTC products, according to the FDA.9,15,16 However, McNeil, the manufacturer of Tylenol, voluntarily lowered the maximum recommended acetaminophen dose for single-ingredient Extra-Strength (500 mg) Tylenol to 3,000 mg per day for OTC use. McNeil changed the label of Regular-Strength (325 mg) Tylenol to recommend a maximum acetaminophen dose of 3,250 mg per day. If that isn’t confusing enough, if a patient buys Tylenol Arthritis Pain, McNeil suggests a maximum acetaminophen dose of 3,900 mg/day.17 All of these varying recommendations can result in confusion for both patients and health care providers! The best course of action is to ensure patients receive no more than 4,000 mg per day of acetaminophen from all sources (all OTC products and all prescription medication). Patients should be taught to correctly read and use the drug facts label on OTC products, and to adhere to the maximum doses for acetaminophen listed in Table 3.18-20

Duplicate therapy also is a concern with NSAIDs. Every NSAID independently increases the risk of GI bleeding 2- to 4-fold. Ask about cough and cold medications to get a complete picture of NSAID and acetaminophen use. Make sure your patient is not taking both ibuprofen and naproxen.

4. Consider Drug-drug Interactions Between OTC, Prescription, and Herbal Therapies.8,11,21,22 In addition to patient-related factors, drug interactions can increase the risk of NSAID-induced hemorrhagic events. Concurrent use of antiplatelet agents, anticoagulants, corticosteroids, or selective serotonin reuptake inhibitors with NSAIDs increases the risk for GI ulceration and bleeding. Bisphosphonate use also adds to the risk for GI ulceration in patients taking NSAIDs. Many herbal products have antiplatelet effects, including some herbals used for pain, such as white willow bark, SAM-e, ginger, and turmeric/curcumin. Other commonly used herbals, including dong quai, green tea, and ginkgo biloba, also have antiplatelet effects.11,22

OTC analgesics also can interact with each other. Is your patient taking 81 mg of aspirin daily for cardiovascular protection? NSAIDs such as ibuprofen can interfere with the antiplatelet effect of aspirin. Advise your patient to take aspirin 30 minutes before or 8 hours after ibuprofen to avoid this interaction.8,11

5. Assess Whether OTC Offers the Best Option. Is the benefit the patient is receiving greater than the risk of harm? Make sure the patient is receiving appropriate non-pharmacologic therapy to minimize their need for medications. Don’t forget to incorporate topical medications to minimize systemic side effects (Table 4). Topical analgesics typically include a warming (camphor) and/or cooling (menthol) agent, possibly in combination with a salicylate pain reliever.11 Topical analgesics may be effective for patients with musculoskeletal discomfort, such as that due to an injury or osteoarthritis. Because systemic absorption of topical analgesics is limited, these agents may help patients avoid the adverse effects associated with oral agents (such as hepatic toxicity with acetaminophen and renal and cardiovascular toxicity with NSAIDs). However, patients should be cautioned to stop using topical analgesics if a red rash develops. In addition, because camphor can be fatal when used in children under 2 years of age, patients should be cautioned against using topical camphor products in children under age 2 and should store their medications out of reach of children.11 Finally, consider whether prescription medication would be safer and/or provide more relief.


Last updated on: March 5, 2019
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