The Pharmacist’s Role in the Appropriate Selection of a
Nonprescription Product for Pain Relief

Supported by an educational grant from Hisamitsu America, Inc.

FACULTY:

W. Steven Pray, PhD, DPh
Bernhardt Professor of Nonprescription Drugs and Devices
College of Pharmacy
Southwestern Oklahoma State University
Weatherford, OK

FACULTY DISCLOSURE STATEMENTS:

W. Steven Pray, PhD, DPh reports no arrangements or affiliation with commercial corporations whose products may be mentioned in this program. U.S. Pharmacist does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced, objective, and scientifically rigorous. Occasionally, authors may express opinions that represent their own viewpoint. Conclusions drawn by participants should be derived from objective analysis of scientific data.

ACCREDITATION STATEMENT:

Pharmacy Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Program No.: 430-000-08-017-H01-P; 430-000-08-017-H01-T
Credits: 2.0 hours (0.20 ceu)

TARGET AUDIENCE:

This accredited program is targeted to pharmacists and pharmacy technicians. Estimated time to complete this monograph and posttest is 90 to 120 minutes.

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DISCLAIMER:

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

GOAL:

To provide pharmacists with a detailed overview of currently available nonprescription products and devices for pain relief, with emphasis on topical therapies, and provide guidelines for appropriate selection of these products.

OBJECTIVES:

Upon completion of this article, the pharmacist should be able to:

• Describe the prevalence and etiology of persistent pain;*
• Differentiate the different types of pain, identifying those for which nonprescription therapy is appropriate;*
• Compare and contrast currently available nonprescription products and devices used for pain, including those for patients with persistent pain;*and
• Given a specific patient, correctly apply current FDA guidelines for selection of an appropriate nonprescription product or device for patients with pain, including those with persistent pain.

*Also applies to pharmacy technicians.

Pain is an unpleasant experience that affects untold millions of people each day. It can signal actual or pending tissue damage.¹ Pain is also the primary symptom driving patients to seek a physician appointment.² The patient who wishes to explore self-care options for pain is confronted with a wide variety of medications and modalities. They include internal analgesics, external analgesics, cryotherapy, and thermotherapy. An informed pharmacist can help patients to recognize which products are appropriate for the specific problem at hand, and can help in recognizing which products are contraindicated.

PREVALENCE AND ETIOLOGY OF PAIN

Pain is part of everyday life for a large percentage of the US population. Some experts estimate that 75 million US residents suffer from chronic, persistent, recurrent pain.³ Others estimate the incidence of persistent pain as 30% of the US population, which is a figure in excess of 91.3 million people.⁴ The basic mechanisms that are activated to generate pain are poorly understood. However, it is hypothesized that both acute and chronic pain arise when peripheral receptors carry energy from noxious stimuli to the central nervous system (CNS), where the brain interprets the transmitted impulses as pain.² The dorsal root ganglion is the location for the pain transduction receptors.

CLASSIFICATION OF PAIN SYNDROMES

Pain can be classified using several taxonomies, but none is universally accepted.

Somatic Versus Visceral Pain

Pain is often categorized as either visceral or somatic.¹ Somatic pain results from stimulation of sensory receptors known as nociceptors. These receptors react to noxious stimuli in either cutaneous or deep tissues. Patients with somatic pain describe constant, aching, and gnawing pain that can usually be localized.⁵ It can be sharp, stabbing, or a pinprick. It arises from such injuries as superficial lacerations or burns, extensive abrasions, or stomatitis. Typically useful nonprescription treatments include acetaminophen, cold packs, heat packs, and nonsteroidal anti-inflammatory drugs (NSAIDs).

Visceral pain is also mediated by nociceptors, but is deep, aching, and colicky. Patients find it difficult to localize the area of pain, as it is often experienced as a diffuse, referred pain in the skin. It is perceived as an ache or feeling of pressure, but can also be sharp. It may be caused by appendicitis, kidney stones, colic and muscle spasms, or by problems involving the periosteum, joints, or muscles. Nonprescription interventions include oral NSAIDs and topical products.

Acute Versus Chronic Pain

Pain can also be categorized by duration, being either acute or chronic.¹ Acute pain is a short-term response to a temporary problem, signaling to patients that there may be an underlying problem that requires a physician appointment.⁶ It seldom lasts more than a few days or weeks.² Patients often exhibit anxiety if the pain is severe or the cause has not yet been determined. Patients may display such behaviors as moaning, rubbing the area, or “splinting.” If the acute pain is severe, patients may also experience sympathetic signs such as tachycardia, hypertension, sweating, or mydriasis.

If the acute pain persists for a sufficient period, it enters the medical realm of chronic, persistent pain.⁴ Chronic pain is often defined as pain lasting for more than three to six months, causing considerable distress and disability in many cases.^2,4 It recurs, is continuously present, and is usually a result of chronic diseases.⁷ It is most often a remote pain with an onset that is gradual. Patients may be irritable or depressed as a response to the pain and may experience lassitude, anorexia, weight loss, insomnia, and loss of libido. They may seek out the most comfortable position to reduce pain.²

Chronic pain can be usefully subcategorized. Chronic nociceptive pain may be visceral or somatic in nature. It can be due to such provoking factors as ongoing injury, actual tissue destruction, mechanical deformation of specific areas, or inflammation of the tissues. Standard analgesics and other devices are useful for this type of pain.

Chronic neuropathic pain arises from the peripheral or central nervous system, involving mast cells, neutrophils, macrophages, Schwann cells, and T cells.⁸ It is described as radiating or specific in nature.⁵ It can arise from trigeminal neuralgia, post-traumatic neuralgia, peripheral neuropathy (perhaps due to diabetes or HIV), limb amputation, or herpetic neuralgia.^9,10 Patients may describe a burning, prickling, tingling discomfort, or a sensation of electric shocks. It often does not respond well to standard analgesic interventions, although internal and external NSAIDs may provide relief and capsaicin is used for postherpetic neuralgia.^1,3 Analgesic adjuvant medications may also afford some relief.

Chronic pain may be of mixed or indeterminate pathophysiology. If no underlying pathology can be identified, it is known as an “idiopathic pain state.”² In these cases, various approaches may be attempted, as the degree of relief expected cannot be predicted.

Chronic pain may be caused by or primarily influenced by psychological issues, being known as a “psychogenic pain state.” In those cases, traditional analgesics have no role.

SPECIFIC TYPES OF PAIN

The foregoing discussion makes it clear that the causes of pain are multitudinous, and only a few can be discussed within the context of this program. This program will focus on treatment of pain with nonprescription products and devices, with an emphasis on topical therapy. Thus, it will be optimal to discuss the types of pain that are amenable to treatment with these agents. They include minor soft tissue injuries (eg, strains and sprains), certain arthritides, and backache. Should self-care modalities fail to help when used as directed for the labeled duration of use, patients should be urged to consult a physician for further evaluation.

Sprains and Strains

The ankle sprain is one of the most common soft tissue injuries that pharmacists see in daily community practice, with an incidence of 27,000 daily in the US.⁴ Ankle injuries are 21% of all injuries incurred in sports.¹¹ They include injuries to ligaments and tendons, as well as fractures. Early treatment of self-treatable ankle injuries involves rest, ice, compression and elevation, as well as use of oral analgesics. Long-term treatment and rehabilitation may include external analgesics, internal analgesics, and thermotherapy.

Arthritic Pain

Osteoarthritis is a chronic degeneration of bone, cartilage, and associated tissues that causes pain for 20 million Americans.^12,13 Among the multiple therapeutic options are oral prescription and nonprescription analgesics and topical analgesics such as menthol, capsaicin, and methyl salicylate.¹⁴ Acetaminophen is often considered a first-line option for moderate osteoarthritis, but it should not be used by certain patients, such as those who consume alcoholic beverages and those who are pregnant or breastfeeding.

Internal NSAIDs are often recommended for osteoarthritis that also has an inflammation associated with it, but these agents carry numerous FDA-mandated warnings against use in certain situations, such as in patients who regularly consume alcohol or who are taking interacting medications, and in those who are pregnant or breastfeeding.¹⁵ The American College of Rheumatology considers topical capsaicin or methyl salicylate to be appropriate monotherapies for osteoarthitis of the hip and knee.¹⁶

Sore Shoulder

Shoulder pain may be due to an acute sports injury, or to repetitive strain due to work or sports or recreational activities.¹⁷ Pharmacists should ascertain whether the duration of pain lies beyond that of the FDA-labeled durations for use of nonprescription products. If it does not, pharmacists may recommend cryotherapy, internal analgesics, and a physician appointment for an acute injury, or external analgesics, internal analgesics, or thermotherapy for a nonacute injury.^18-21

Stiff Neck

Stiff neck can be due to acute injury, but is often due to nonacute causes. Patients may relate a gradually increasing discomfort, to the point where they seek self-care assistance. Internal analgesics, external analgesics, and thermotherapy may provide relief.^17,22-25

Backache

Backache is experienced by 6 million people yearly.²⁶ At least 40% to 50% of patients will improve in one week.²⁷ In most cases, there is no acute injury, and the condition is known as nonspecific low back pain. When the lumbar area is the point of discomfort, patients refer to it as “lumbago.” External analgesics, internal analgesics, or thermotherapy may provide relief. However, patients with back pain should be referred to a physician if they also have any of the following: gait abnormalities; bowel and/or bladder incontinence; weakness, numbness, or tingling; pain in the lower leg that radiates down the back of the thigh to the leg; persistent, progressive pain unrelieved by medication, rest, or immobilization; onset at less than 20 years or more than 55 years; systemic weight loss (eg, 10 pounds in 90 days) or systemic illness; fever or chills; history of cancer, a traumatic event (eg, fall, motor vehicle accident, sports injury), use of intravenous drugs, or chronic disease (eg, diabetes, HIV, and hepatitis); pain that worsens at night or when lying down; and urethral discharge or a burning sensation on urination.²⁷

Joint Pain

Joint pain can be due to numerous problems, such as acute injury, repetitive strain injury, or osteoarthritis. Patients may be urged to use external analgesics, internal analgesics, or thermotherapy to ascertain whether any of the modalities provides relief.

BARRIERS TO SUCCESSFUL MANAGEMENT OF PERSISTENT PAIN

Successful management of persistent pain may be out of reach for many patients for a variety of reasons. Socioeconomic reasons are common. Many patients simply lack the financial resources and/or insurance coverage to seek a physician who can examine them and diagnose their pain. They may have the misperception that the only treatments for persistent pain require sophisticated lab work and diagnostic examinations.

Some patients wish to avoid further pain. They often anticipate that treatment of pain may involve injections, minor or major surgery, and invasive procedures. After experiencing a given level of pain, they may settle for that level rather than risk the medically necessary and potentially painful procedures that are administered without a guarantee that the original pain will actually be eliminated or even lessened to any material degree.

Other patients do not appreciate the capability of nonprescription products and devices to offer relief from pain. They may not understand that pharmacists can choose from an armamentarium of several nonprescription products and devices that can help to arrest pain and, therefore, they may not think to ask their pharmacist to recommend a product.

Even for patients who wish to approach their pharmacist for help with pain, some pharmacies are not conducive to conducting these discussions. In some, the pharmacy department is not located in a central position that allows pharmacists to visualize the nonprescription shelves. In others, the workload required to fill a large number of prescriptions does not allow pharmacists to exit the pharmacy department to conduct discussions about minor health conditions.

Some patients are able to approach pharmacists (or vice versa) but pharmacists may not be fully cognizant of the various nonprescription products and devices that can be helpful for pain. This can be remedied by appropriate educational endeavors that focus on this common patient complaint.

NONPRESCRIPTION PRODUCTS AND DEVICES FOR PAIN RELIEF

The market for nonprescription pain relief products is estimated in the billions of dollars.³ Numerous nonprescription products and devices promise pain relief. Some are targeted for specific problems, such as migraine headache or toothache. This discussion will be limited to products and devices marketed for the conditions described in this article, such as minor soft tissue injuries (eg, strains and sprains), certain arthritides, and backache.

Internal Analgesics

Internal analgesics are a disparate group of chemicals and many are found in combinations containing rational ingredients such as caffeine and also ingredients not proven safe and/or effective, such as antihistamines and salicylamide.²⁷

NSAIDS exert anti-inflammatory and analgesic effects through inhibition of prostaglandins and other actions (eg, reducing superoxide radicals or inducing apoptosis).³ Aspirin (eg, Bayer^® Coated Aspirin Tablets and Ecotrin^® Maximum Strength Arthritis Relief) is not used widely as an analgesic, but retains popularity as a once-daily tablet to reduce the risk of stroke or myocardial infarction. Its use can cause tinnitus. Magnesium salicylate is a common ingredient in backache products (eg, Doan’s^® Regular or Extra Strength Caplets and Momentum^®).²⁷ As with all other NSAIDs (eg, ibuprofen and naproxen sodium), aspirin and magnesium salicylate use may cause gastrointestinal (GI) problems, including perforation, ulceration, and bleeding.^28,29

Ibuprofen (eg, Advil^™ and Motrin^® IB) and naproxen sodium (Aleve^®) are the only other oral NSAIDs available as nonprescription products at this time. Ketoprofen (Orudis^®) was discontinued several years ago.

NSAIDS may cause serious and possibly fatal adverse reactions when used for self-care of persistent pain. Research has confirmed that 81% of adult patients who purchase these products do not specifically seek out usage directions, which include FDA-mandated label warnings to halt unsupervised use at the end of ten days.³⁰ In patients taking oral NSAIDs for one year, 2% to 40% experienced symptomatic ulcers as well as major GI complications such as obstruction, perforation, and bleeding.

Acetaminophen (eg, Tylenol^®) has a more favorable safety profile compared with oral NSAIDs when used for persistent pain, but FDA-mandated labels caution against use without physician supervision for more than 10 days. Its presence in a household with young children is troublesome, as acetaminophen use is the single most common reason for calls to poison control centers in the US.²⁷ Patients who wish to purchase acetaminophen for self-care should be warned to store it where children cannot obtain it, and that the recommended dose must never be exceeded. Further, in any overdose situation, they must understand that prompt medical attention is critical for adults and children, even if no visible signs or symptoms of poisoning are evident.²⁷

There are a number of ancillary ingredients that can be found in internal analgesics. Caffeine is a proven adjunct to internal analgesics through its ability to synergize the effects of aspirin.²⁷ Examples of products that contain caffeine include Anacin^®, Cope^®, Excedrin^® Extra Strength, and Vanquish^®. Buffering agents (eg, aluminum hydroxide, calcium carbonate, and magnesium hydroxide) may help to reduce stomach irritation, although the FDA has not approved this claim. Examples of products that contain buffering agents include Bayer^® Plus Extra Strength and Bufferin^®.

Salicylamide has not been proven safe or effective as an analgesic or synergizing agent and may cause tinnitus, ecchymoses, hemorrhagic lesions, leukopenia, or thrombocytopenia.²⁷ Any product containing it should not be recommended.

Phenyltoloxamine is an antihistamine added to boost the potency of acetaminophen in some products, but this claim has not been proven valid and the drowsiness induced by the antihistamine could be dangerous for those who must remain alert while taking it.²⁷

External Analgesics

Topically applied analgesic products are chosen by 60 million adult patients yearly in the US, with an estimated annual market of $150 million or more.³¹

External analgesics used for minor soft tissue injuries, osteoarthritis, and backache are confined to the group of medications known as counterirritants. Counterirritant chemicals produce reversible, transient irritation or mild inflammation of the surface tissues following application. This mild surface tissue disruption stimulates cutaneous sensory receptors. Experts theorize that the sensation produced at the skin surface (eg, itching, burning, warmth, or cooling) masks pain that is present more deeply in the body.²⁷ Thus, application of counterirritants relieves pain and discomfort in muscles, joints, or viscera beneath the site of application. They are labeled as follows: “For the temporary relief of minor aches and pains or muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises and sprains.”

There are four discrete groups of counterirritants.²⁷ Some may produce redness, with methyl salicylate being the most common example. Some may produce a cooling sensation, such as camphor and menthol. Some do not produce redness, exemplified by capsicum and capsaicin. A final group directly vasodilates vessels below the point of application.

Camphor is a common ingredient in external analgesics in concentrations as high as 11%.²⁷ Its mechanism may be inhibition of catecholamine secretion.¹⁵ The cooling effect initially experienced by the patient often gradually becomes a soothing warmth. Examples of products that contain camphor include several Ben Gay^® products, Heet^® Pain Relieving Liniment, and several Salonpas^® products. Of note, Salonpas^® Pain Relief Patch and Salonpas^® Arthritis Pain, approved by the FDA in February 2008, are indicated for mild-to-moderate pain. Products that are not covered by an approved NDA are limited to an indication for minor pain. (See sidebar on FDA Regulation of Nonprescription Products)

Capsicum is the fruit of the African chile, tabasco pepper, or several other peppers. Its active ingredient is capsaicin.^27.32 Capsaicin excites nociceptive afferent nerves to produce warmth when initially applied, but with repeated application it desensitizes unmyelinated nerve fibers to produce hypalgesia without also causing patients to experience a reddening or blistering.^32,33 Investigators have cloned a vanilloid-1 receptor, which is highly localized on nociceptive afferent nerve fibers and is activated by temperatures over 109.4º F or by capsaicin.^15,34 Capsaicin is a useful counterirritant, but it has also been widely recommended for postherpetic neuralgia (PHN), a painful condition that persists beyond an attack of shingles, and which has been identified as the leading cause of suicide in chronic pain sufferers over the age of 50 years.^27,35-37

The mechanism of capsaicin in alleviating PHN is hypothesized to be reversibly depleting small sensory C-fiber peripheral afferent neurons of substance P neuropeptide, a chemical that facilitates transmission of pain impulses.³⁸ Depletion of this neuropeptide thus desensitizes the nerve fiber.^15,39 Examples of products that contain capsaicin include Capzasin^®-P, Salonpas^® Hot Patch, and Zostrix^®-HP Cream.

Menthol causes coolness that eventually warms the area, in a manner similar to camphor.²⁷ Recent research has elucidated its mechanism of action.³⁴ Investigators cloned a menthol receptor that is activated by cool to cold temperatures and is also activated by application of menthol. Examples of products that contain menthol include several Ben Gay^® products, Mineral Ice^® Gel, Mentholatum^® Pain Patch, and several Salonpas^® products. When used in combination with methyl salicylate, menthol enhances the penetration of the methyl salicylate.¹⁵ It may accomplish this by its vasodilating effect, and/or by lessening the barrier function of the upper epidermal stratum corneum through its lipophilic properties.

Methyl salicylate is also known as wintergreen oil. It produces a heating sensation when applied. Methyl salicylate may exert analgesic and anti-inflammatory effects through inhibition of local prostaglandin and leukotriene synthesis. These chemicals act to sensitize nociceptors, and inhibiting them lessens pain.¹⁵ When used according to label directions, methyl salicylate is usually safe. Patients should never exceed the label directions due to the risk of salicylate toxicity. Examples of products that contain methyl salicylate include Mentholatum^® Arthritis Patch, several Salonpas^® products, and Thera-Gesic^® Cream.

Trolamine (triethanolamine salicylate) is marketed with claimed counterirritant ability, but the FDA has not yet published a ruling in which it has judged the ingredient to be safe and effective for this use, and research indicated that it is thought to be no better than placebo.⁴⁰ Examples of products that contain triethanolamine salicylate include Aspercreme^®, Mobisyl^®, and Sportscreme^®.

There are several other little-used counterirritants, such as allyl isothiocyanate, histamine, methyl nicotinate, stronger ammonia water, and turpentine oil. They will not be discussed further.

Cryotherapy

Cryotherapy, or application of cold, is a vital part of the emergency treatment of an acute injury, such as an ankle sprain. It is usually recommended for use during the first 24 to 48 hours post-injury, although several authorities now recommend its use for as long as 72 hours after the injury.²⁷ Application of cold has little use in persistent pain.

Application of cryotherapy to the acute injury results in local cooling of the treated area, decreasing the temperature of the skin and the underlying subcutaneous tissues.²⁷ It also decreases inflammation within injured ligaments through inhibiting release or activity of histamine, neutrophils, collagenase, and synovial leukocytes. By limiting the extent of inflammation in injured tissue, cryotherapy lessens the time for the patient to return to normal function. Cryotherapy also reduces tissue metabolism, thereby reducing the extent of secondary damage that might result from hypoxia. This allows marginally damaged cells to remain viable.

Application of cold may penetrate to muscle, depending on the modality used and the length of application. If muscles are cooled, the temperature decrease lasts longer than it would in upper layers. Application of cold can also decrease joint temperatures. Cryotherapy can be accomplished with the use of one-time cryogenic packs or reusable gel packets.

Thermotherapy

Thermotherapy, or application of heat, is not of use in the initial phases of an acute injury. However, it is valuable in the subacute and rehabilitative phases, and is also useful in therapy for various conditions that do not arise as a result of acute injury (eg, repetitive strain injury and osteoarthritis).^27,41 Thermotherapy can be achieved with the use of hot water bottles, heating pads, clay/gel packs, exothermic chemicals (eg, The Heat Solution^® or Zap Pac^® ), or therapeutic heat wraps (eg, ThermaCare^®).

GUIDELINES FOR SELECTING NONPRESCRIPTION PAIN PRODUCTS

The FDA has in some cases issued clear guidelines for the use of nonprescription products and devices in conditions causing pain through the FDA OTC Review Process. In other cases, the FDA and specific manufacturers have developed the guidelines through the NDA process.

Internal analgesics labeled for pain include age limits below which the products are not proven to be safe and effective without a physician or prescriber recommendation.²⁷ For acetaminophen, the lowest approved age is two years. Aspirin must not be recommended by pharmacists for patients aged less than three years. Ibuprofen has FDA-approved dosing down to the age of three months, if the infant concentrated drop is chosen. Oral suspensions, junior-strength tablets, and adult tablets all carry age recommendations appropriate to the strength. Naproxen sodium should not be recommended for self-care below the age of 12 years. Further, labels warn patients who are 60 years of age or older to ask physicians before use.

For topical analgesic products containing counterirritants, the age cut-off is generally two years, although some manufacturers have labeled products against use in patients under 12 years to ensure an added safety margin.²⁷

Therapeutic heat wraps warn against use in patients unable to remove the product, such as children, infants, and some elderly patients. The labeling also cautions against placing the product in contact with skin in patients 55 and older due to an increased risk of burning.²⁷ Patients are instructed to wear it over a layer of clothing instead.

Devices used for pain did not pass through the FDA OTC Review Process, and lack FDA-mandated labeling for minimal ages of use as developed for other products that did pass the review. They include heating pads, hot water bottles, warm gel packs, exothermic crystal heat generators, instant cold packs, and cold gel packs. In these cases, manufacturers may provide an age limit, but the source is not referenced on the packaging, making it difficult at best to determine the accuracy of the safety information.

The FDA has also promulgated guidelines for duration of use of various products used for pain before patients are advised to discontinue use and make an appointment with a physician.²⁷ The time limits for unsupervised self-use of internal analgesics are noted in TABLE 1.

Counterirritant products carry a FDA-mandated warning against use for more than seven days, or in conditions that clear up but recur again within a few days.²⁷ Therapeutic heat wraps warn patients that pain that worsens or remains unchanged after seven days of use may indicate a more serious condition.²⁷

As was the case with the age guidelines, the pain devices that did not pass through the FDA OTC Review Process lack FDA-mandated labeling for maximum durations of use prior to discontinuing use and seeking physician care. Thus, manufacturers of heating pads, hot water bottles, warm gel packs, exothermic chemical heat generators, instant cold packs, and cold gel packs may provide a maximal duration for use, but the source is not referenced on the packaging, making it extremely difficult to determine its veracity.

Internal analgesics carry a specific warning in regard to use with alcohol.²⁷ If the product contains acetaminophen, the FDA mandates a warning similar to this: Alcohol Warning: If you consume three or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause or increase the risk of liver damage.

If the product contains aspirin, ibuprofen, magnesium salicylate, other salicylates, or naproxen sodium it may carry a warning label similar to this: Alcohol Warning: If you consume three or more alcoholic drinks every day, ask your doctor whether you should take this product or other pain relievers/fever reducers. This product may cause or increase the risk of stomach bleeding.²⁷

Products containing salicylates also carry a warning advising patients not to use them if they are currently taking a prescription medication for anticoagulation, diabetes, gout, or arthritis, except under a physician’s supervision.²⁷

Products containing ibuprofen advise patients to speak to a doctor or pharmacist before use if they are taking any other product containing ibuprofen, any other pain reliever/fever reducer, prescription medications for anticoagulation, any diuretic, or any other medication.²⁷

Products containing naproxen sodium advise patients not to use them before speaking to a doctor or pharmacist if they are taking any other medication, taking any product containing naproxen sodium, or taking any other pain reliever/fever reducer.²⁷

Counterirritants do not carry any FDA-mandated drug interaction warning. However, they should not be used with other sources of heat, such as heating pads, hot water bottles, or therapeutic heat wraps.

Therapeutic heat wraps warn the patient against concomitant use with pain rubs (eg, counterirritants), medicated lotions, creams or ointments, or with any other form of heat.²⁷

GUIDELINES AGAINST USE WITH CERTAIN MEDICAL CONDITIONS

Internal analgesics carry a host of FDA-mandated contraindications to their unsupervised use. They should not be used if the area is red or swollen. They should not be given to children for the pain of arthritis.²⁷

Products containing salicylates should not be taken in an unsupervised manner if patients have stomach problems such as heartburn, upset stomach, or stomach pain that persists or recurs, or if patients have ulcers or bleeding problems.²⁷ They should not be taken if patients are allergic to salicylates (including aspirin), or if they have asthma. Patients should not take aspirin products in a chewable dosage form for seven days following tonsillectomy or oral surgery. Products containing magnesium salicylate in a sufficient quantity that patients might take more than 50 mEq of magnesium in the recommended daily dose will warn against use if patients have kidney disease. All salicylates will warn against use in children or teenagers who have or are recovering from chicken pox of flu-like symptoms in order to prevent Reye’s syndrome.

Products containing aspirin, ibuprofen, magnesium salicylate, and naproxen sodium will all warn patients against use if the patients have ever had an allergic reaction to any other pain reliever/fever reducer, in order to prevent a severe allergic reaction which may result in hives, facial swelling, asthma, or shock.²⁷

All warn against use in pregnancy or when breastfeeding, and specifically in the last three months of pregnancy to prevent problems in the unborn child or complications during delivery.

Labels on ibuprofen and naproxen sodium products will warn aspirin-sensitive patients to avoid them if they have previously experienced a severe allergic reaction to aspirin (eg, asthma, swelling, shock, or hives).²⁷ They also caution potential purchasers to speak to their physicians before use if they have any condition requiring the use of prescription medications.

Ibuprofen labels warn against use in patients with asthma, in those who have had problems or serious side effects from taking pain relievers or fever reducers, in those who have stomach problems that last or come back (eg, heartburn, upset stomach, or stomach pain), in those with ulcers, bleeding problems, high blood pressure, heart or kidney disease, and in those who are taking a diuretic.²⁷

Acetaminophen labels caution pregnant and breastfeeding patients against use unless they consult a physician.

Counterirritants warn against use when patients have wounded or damaged skin in the area of application.²⁷ However, they lack many of the contraindications common to internal analgesics previously mentioned.

Therapeutic heat wraps advise against use (without first asking a physician) if patients have diabetes, poor circulation, or rheumatoid arthritis, or they are pregnant.²⁷ They should not be used on unhealthy, damaged, or broken skin; on areas of bruising or swelling that have occurred within 48 hours; or on areas of the body where one cannot perceive heat.

STRATEGIES TO EDUCATE, COUNSEL, AND MONITOR PATIENTS WITH PERSISTENT PAIN

Educating patients with persistent pain should begin at the point when they approach the nonprescription product aisles. Pharmacists should strive to approach patients in the area in which they are seeking a product and ask if they can be of assistance. When the patient asks about a condition causing pain, the pharmacist should ask the age of the patient, the duration of pain, whether the patient uses medications or alcohol, and whether the patient has any medical conditions. Armed with this information, the pharmacist is ready to help the patient choose an appropriate product for persistent pain. When the most appropriate product has been chosen, it must be presented to the patient with a justification for its use. The patient must then be educated on the use of that specific product through targeted counseling. The pharmacist should point out such matters as the maximum duration of use, contraindications for use, when to stop use and seek physician care, etc.

Monitoring the patient’s progress is difficult unless the pharmacist is acquainted with the patient. The best strategy is to ask for the patient’s phone number or e-mail address. If the patient is willing to allow post-visit contact, a follow-up call can help the pharmacist ascertain whether the recommended medications and/or devices were effective in relieving the patient’s discomfort.

CONCLUSION

The patient with acute pain or persistent pain has a number of potential options for self-care. They range from internal analgesics to external analgesics, cryotherapy, and thermotherapy. Each of these medications or modalities has specific guidelines regarding who may use it and who should not, as well as warnings that must be followed to help ensure patient safety. Research has verified that most patients fail to read the labels of these products prior to purchase. An informed pharmacist is vital in helping patients weigh the pros and cons of each product and in facilitating their choice of the product that best fits their particular situation.

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