Introduction
Adequate evaluation and treatment of pain has become an area of intense interest on a national level. It is important that optometrists carefully assess patients for pain and treat appropriately. By the end of this course, the participant will be able to answer questions regarding the increased emphasis on pain management, pain assessment techniques, the risks, benefits, alternatives to NSAID use, and the use of narcotic analgesics in clinical care.
The scope of the problem of pain
Figure 1 - Acute pain.
Experiencing pain is a common phenomenon. It is estimated that acute and chronic pain are serious problems for 20-30% of population. At any point one-half of Americans have experienced pain within the past two weeks. Some 50 million people have disabling chronic pain. Pain has a huge economic cost as well. Greater then 550 million work days are lost each year in the U.S. at a cost of over $50 Billion.
Pain has been formally defined as, "An unpleasant sensory and emotional experience associated with actual and potential tissue damage or described in terms of such damage."[1] It is a problem that has not been well addressed in the medical community. Pain is the most common reason people seek medical attention. Research has linked unrelieved acute pain to the development of chronic pain. [2]
Why don't we manage pain better?
Figure 2 - Leaping Obstacles.
Many obstacles, whether real or perceived, have prevented health care professionals from adequately evaluating and treating the pain of patients. Fears surrounding the development of addiction in patients have been commonly cited.
Concerns are always present about the potential for addiction or tolerance that could develop when analgesics are prescribed. Even though the use of potent narcotic analgesics in the management of chronic pain has increased, the proportion of abuse of opioids relative to total drug abuse has decreased. [3]
Some definitions regarding the use and abuse of controlled substances can be helpful. [4]
Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.
Pseudoaddiction is pattern of drug-seeking behavior exhibited by people who are receiving inadequate treatment for their pain. It can be difficult to differentiate this from addiction. When patients do receive proper relief of their pain, any drug hoarding or other aberrant behaviors stop.
Physical dependence is a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. More of a drug is needed over time in order to produce the same effect. It is unclear whether tolerance to the analgesic effects of narcotics occurs. When patients on opioids complain of pain, it is likely that there is a new or worsened condition that needs to be addressed. [5]
Concerns regarding the side effects of both narcotic and non-narcotic analgesics and worries about potential drug interactions are valid concerns. Those issues will be addressed in this course.
Licensed professionals are also concerned regarding the possibilities of sanctions from state boards and risking their ability to continue to practice. Proper patient assessment, documentation, and appropriate prescribing within the limits of your own state's therapeutic legislation are imperative.
Appropriately assessing patients for pain
Figure 3 - JCAHO Badge.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has issued standards for assessment of pain. [6] It is mandated that in all JCAHO approved facilities that pain is addressed and managed. Standard RI.1.2.8 states that, "Patients have the right to appropriate assessment and management of pain." Since pain can be a common part of the patient experience and since unrelieved pain has adverse physical and psychological effects, a patient's right to pain management must be respected and supported. A health care organization must demonstrate that it plans, supports, and coordinates activities and resources to assure the pain of all patients is recognized and addressed appropriately.
All patients should be asked initial screening questions about the presence of pain. If the response is affirmative, other information regarding the pain, such as pain intensity, location, quality, patterns of radiation, character, onset, duration, variations and patterns, and alleviating and aggravating factors should be documented. Eliciting and recording the patient's own words whenever possible is helpful.
Recommendations have been made to address pain routinely in the intake and evaluation of all patients. Pain can be considered to be the "Fifth Vital Sign." When assessing blood pressure, pulse rate, respiratory rate, and temperature, health care professionals are also encouraged to ask simple questions to assess pain. While being a symptom, rather than a vital sign, pain must be assessed frequently, and JCAHO standards require this assessment to occur at the same time as vital signs are assessed. One should recognize a report of unrelieved pain as a "red flag."
Pain intensity scales can be used to facilitate both initial assessment of a patient's pain as well as to document pain relief and improvement from treatment.
Figure 4 - Various Pain Scales.
The A, B, C's of Pain Management have been suggested as a way for clinicians to systematically address this issue. [7]
A - Ask about pain regularly. Assess pain systematically.
B - Believe the patient and family in their reports of pain and what relieves it.
C - Choose pain control options appropriate for the patient, family, and setting.
D - Deliver interventions in a timely, logical, coordinated fashion.
E - Empower patients and their families. Enable patients to control their course to the greatest extent possible.
General concepts in treating pain
The World Health Organization has provided some essential concepts for using analgesics in the management of pain. They recommend that medicines be given by mouth, which is the preferred route. Treatment should be provided "by the clock" rather then on an "as needed" basis. Increasing or unrelieved symptoms should be treated "by the ladder," which includes titration based on the WHO analgesic ladder. Lastly, treatment is for the individual, which involves developing an individualized treatment plan. Treatment should be given with attention to detail, selecting the correct medication, route, dose and schedule for that individual.
The WHO proposed a system to provide appropriate treatment to patients who demonstrate increasingly severe pain. [8] This concept of an analgesic ladder provides guidance to health care professionals. One starts treatment with a non-opioid medication with or without other adjuvant treatments as the basic foundation of the patient's care. As pain increases, so does the use of more powerful opioid analgesics.
Figure 5 - World Health Organization 3-Step Analgesic Ladder.
While the WHO description of the pain ladder approach fits well with chronic pain treatment, some have called for the opposite approach to acute pain. [9] In acute pain, it is essential to provide adequate analgesia quickly and on a schedule. Inadequate treatment of acute pain places that patient at increased risk for development of chronic pain. As the acute condition improves, less potent medications and/or smaller doses can be provided to the patient.
Figure 6 - A New Paradigm for Acute Pain Management
Prescribing within the Therapeutic Legislation of your State
Figure 7 - Practice within the limits of your License
One must be familiar with the laws governing the use of therapeutic pharmaceuticals in state in which you practice. In California, for example, Senate Bill No. 929 mandates the medications available for use by optometrists.[10] In regards to the oral medications allowed for pain and inflammation treatment, one can utilize any non-prescription medication that is used for rational treatment of ocular disease. Optometrists can also write for prescription oral non-steroidal anti-inflammatory agents with a limit of 3 days of use. If the condition is not resolved, referral is required. Oral analgesics that are not controlled substances are also an option. Finally, codeine with compounds and hydrocodone with compounds may be utilized but are limited to three days of use. If the problem persists then the patient must be referred.
In Oregon, optometrists may prescribe non-topical medications as found in Chapter 852, Division 80 of the Oregon Administrative Rules of the Board of Optometry.[11] The non-topical formulary includes nine categories of medications, including analgesics and antiinflammatory medications. The prescribing rules state that, "Doctors of optometry certified for non-topical TPA shall consult with a doctor of medicine or doctor of osteopathy prior to extending treatment with non-topical corticosteroids or Schedule III analgesics beyond 7 days."
Figure 8 - Pain is a Common Symptom in Optometry
Figure 9 - Pain Relief is Sometimes Required
Using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for the Treatment of Pain
It was noted that cells synthesized prostaglandins in response to tissue injury. Inhibition of the formation of these prostaglandins inhibited inflammation. NSAIDs as a class work by blocking the production of prostaglandins by cyclooxygenase (COX) enzymes in peripheral tissues. Traditional NSAIDS are nonselective, blocking both COX-1 and COX-2. COX-1 is a constitutive enzyme that helps protect gastrointestinal and other tissues, maintaining homeostasis. Theoretically, blocking its production could be harmful. COX-2 is an enzyme that is inducible by inflammation. It is not present at baseline, but increases in response to injury. The inhibition of COX-2 is a desirable effect.
Figure 10 - Biosynthesis
Figure 11 - The Current COX Concept
NSAIDs are medications that are used frequently, both in over the counter strengths and by prescription. [12] Rates of use of prescribed anti-inflammatory medicines increase as the population ages. Risks for complications of NSAID use, especially gastrointestinal ulcer formation with bleeding, increase with the age of the patient. Death from upper GI hemorrhage can occur in severe cases.
Figure 12 - Frequency of NSAID use
Figure 13 - NSAID-related Deaths Compared to Deaths from Other Causes in the USA, 1994
Many factors can increase the relative risks of complicated peptic ulcer in patients taking NSAIDs compared with non-users. The greatest risks occur in the elderly and in those with a prior history of UGI ulcer with bleeding. [13]
Figure 14 - Relative Risks of Complicated Peptic Ulcer in Patients taking NSAIDs Compared to Non-Users
Figure 15 - Risk for UGIB for NSAID Users Compared with Non-Users
Protecting patients from NSAID induced ulcers can be accomplished by providing for a short duration of therapy, taking the medicine only with food, using proton-pump inhibitors (i.e., Nexium, Aciphex, Prilosec, Prevacid, etc.) to protect the stomach mucosa, avoid aggravating activities (like the use of coumadin, other NSAIDS, ASA, steroids, tobacco, or alcohol) and treating H. pylori bacteria (an infectious cause of peptic ulcers), if it's present.
Before prescribing NSAIDs, it is of the utmost importance to carefully consider whether the patient is an appropriate candidate. Obtaining a complete and careful past medical history and documenting medication use and allergies is essential. Caution should be taken in patients with a history of GI bleeding (as discussed above), those with congestive heart failure (or ischemic heart disease, as will be discussed later) and, potentially, in those patients with asthma.
Does your patient have uncompensated CHF?
NSAIDs may increase sodium and fluid retention. Signs of CHF to look for include dyspnea on exertion and ankle edema. One should examine the medication list, especially for ACE Inhibitors (Lisinopril, Enalapril, etc.), diuretics (Furosemide, Spironolactone, etc.), and certain beta blockers (Carvedilol, Metoprolol). Page and Henry reported in their research that patients who used NSAIDs in the previous week were twice as likely to be admitted to the hospital with CHF as those who had not. [14] Also, patients with a history of heart disease who used NSAIDs were 6 times as likely to be admitted with heart failure. These findings were unexpected and surprising. These authors have stated that, "The burden of illness resulting from NSAID-related CHF may exceed that from GI damage." Care needs to be utilized in the consideration of NSAID prescriptions in those who have a history of congestive heart failure or those who are at risk.
Figure 16 - Does your Patient have Asthma?
One must also take a careful history regarding a patient's asthma. Some asthma patients have a triad of findings that include asthma, allergy and aspirin sensitivity. These same patients may also have nasal polyp history. Use of NSAIDs in this subset of asthma patients could exacerbate their breathing symptoms and is to be avoided.
Are NSAIDS effective analgesics? Shouldn't I just use a narcotic for my patient's pain?
Figure 17 - Pain Rating
Effective relief can be achieved with oral non-opioids, non-steroidal anti-inflammatory drugs, and opioid analgesics. Matching the medication to the appropriate candidate is the key. Analgesic efficacy for any of these classes of medicines can be expressed as the NNT (number needed to treat). This is the number of patients who need to receive the active drug for one patient to achieve at least 50% relief of pain compared with placebo over a 4-6 hour treatment period. The most effective drugs have a low NNT of about 2. This means that for every two patients who receive the drug, one patient will get at least 50% relief because of the treatment. In discussing individual agents, the NNT will be provided (where available) in order to allow you to compare the relative potencies of each medicine.
Figure 18 - Number Needed to Treat for Various Analgesics. Ibuprofen 800 mg with a NNT of About 2 is the Most Potent
Figure 19 - League Table of Number Needed to Treat
There are many OTC and prescription NSAIDs from which to choose. It may be helpful to be familiar with one or two agents in a couple different classes of NSAIDs. Some people do have better luck with one family of NSAID as opposed to another (e.g., a propionic acid derivative versus a salicylate.) Deciding on which specific NSAID to use depends on several factors. There is no evidence demonstrating that one NSAID is more efficacious than another in the treatment of pain. The NNT do allow for some degree of comparison, however. Factors that might influence selection include ease of the dosing schedule, the prior experiences of the patient and provider, the safety profile of the medication being considered, the specific medical history of the patient, and, finally, cost.
Figure 20 - Drug Categories
Ibuprofen (Motrin ®), a nonsteroidal anti-inflammatory agent belonging to the group of propionic acid derivatives, non-selectively inhibits cyclooxygenase. It is assumed that the inhibition of the prostaglandin synthesis is the cause for the analgesic, antipyretic, and anti-inflammatory action of the drug. Ibuprofen is an effective analgesic. A single dose administration of 400 mg had an NNT of 2.4 (2.3 to 2.6) for at least 50% pain relief over 4 to 6 hours compared with placebo in pain of moderate to severe intensity. Surprisingly, this means that it is as effective as a 10 mg intramuscular dose of morphine. Ibuprofen 800 mg has an even more impressive NNT of approximately 1.8. Ibuprofen is available in doses of 200 (OTC), 400, 600, and 800 mg. Total dose is limited to 3200 mg per day. Doses of all NSAIDs, including ibuprofen, are best take with food.
Adverse reactions with ibuprofen predominantly are gastrointestinal problems (dyspepsia, nausea, vomiting, and epigastric pain). According to different studies, ibuprofen seems to cause fewer such side effects than many other anti-inflammatory agents. Dangerous complications (bleeding ulcers, perforations) are not common. Contraindications to use include hypersensitivity to aspirin or another nonsteroidal anti-inflammatory agent and active peptic ulcer. Again, there is a potential for increased risks in elderly patients (gastric problems, renal complications, CHF, etc.)
Figure 21 - Peptic Ulcer Caused by NSAID
Figure 22 - Risk of UGIB for Particular NSAIDs; Users Compared to Non-Users
Figure 23 - Dose Response for Ibuprofen Compared with Placebo
Naproxen (Naprosyn ®) is a propionic acid derivative whose structure and effect are similar to ibuprofen. This anti-inflammatory agent also has analgesic and antipyretic actions. Like other non-steroidal anti-inflammatory agents, naproxen inhibits prostaglandin synthesis. In many studies, naproxen proved to be equally as effective as other non-steroidal anti-inflammatory agents. Dosage strengths include 250, 375, and 500 mg tablets. One potential advantage is the longer half-life of naproxen which allows BID (twice a day) dosing. Enteric coated capsules are also available by prescription.
Ketorolac (Toradol ®) is another effective analgesic to consider. A single dose of oral ketorolac 10 mg had an NNT of 2.6 (2.3 to 3.1) for at least 50% pain relief over 4-6 hours in patients with moderate or severe pain compared with placebo. Based on very small amounts of data, 20 mg of oral ketorolac provides effective pain relief with an NNT of 1.8 (1.4 to 2.5). The manufacturer recommends that ketorolac use be limited to 5 days of treatment. An injectable form of ketorolac is available as well for intramuscular injection for the treatment of acute pain.
COX-2 Selective NSAIDS
These are the drugs approved in the U.S. that are designed to block COX-2 but not COX-1 and, therefore, have anti-inflammatory properties. Theoretically these agents would avoid inhibiting synthesis of gastrointestinal prostaglandins which would help to limit the possibility of ulcer formation. They also would not inhibit platelet thromboxane and thereby decrease the chance of bleeding complications.
Three of these agents are currently available for use: Vioxx® (Rofecoxib) available 12.5, 25, and 50 mg once a day, Celebrex® (Celecoxib) 100-200 mg once or twice a day, and Bextra® (Valdecoxib) 10 to 20 mg once a day. The 50 mg dose of Vioxx is limited to 5 days of use for acute pain only.
The VIGOR trial (Vioxx Gastrointestinal Outcomes Research) compared 50 mg per day of Vioxx to 1000 mg daily of Naproxen. [15] This study demonstrated a significantly lower incidence of serious upper GI adverse events (i.e., major bleeding, perforation, obstruction) with Vioxx when compared to the naproxen group.
There was a difference found in rates on non-fatal myocardial infarction between groups and therefore the FDA advises doctors to use caution in prescribing Vioxx for patients with ischemic heart disease. The product labeling also states that the use of Vioxx 50 mg for more then 5 days for management of acute pain has not been studied. Decreased risks of complications with COX-2 medications may be lost if aspirin is used concomitantly. In addition, patients should not use Bextra if there is a history of a sulfa allergy.
COX-2 agents are convenient; all agents can be dosed once a day. Cost, however, is another issue. These agents are four to five times more expensive than nonselective NSAIDs. Again, there is no evidence that these medications are any more effective in the treatment of pain and inflammation, only safer.
The International COX-2 Study Group was formed in order to establish recommendations for use of these agents. [16] Their Consensus Statement purports that COX-2 agents are associated with lower incidence of clinically important upper GI events. They recommend that if any patients are taking ASA prophylaxis and are at risk for PUD, they should consider GI mucosal protective therapy irrespective of whether using COX-2 specific inhibitors (i.e., the protectiveness of COX-2 medications is lost when aspirin is added). COX-2 NSAIDs have similar effects on renal function and the reported rates of hypertension and edema in are similar to nonselective NSAIDs as well. If ASA is needed, one should not hold ASA for use of COX-2 NSAIDS, since they do not affect thromboxane and do not therefore have an effect on platelet adhesion.
Other agents to consider
Aspirin inhibits cyclooxygenase and thus prostaglandin synthesis. The drug has analgesic, anti-inflammatory and antipyretic effects. Through its effect on the thrombocyte-cyclooxygenase it inhibits the formation of a highly effective platelet aggregator and a vasoconstrictor (thromboxane A2). Since the platelets do not synthesize proteins, the effect remains demonstrable as long as the affected thrombocytes live (7-10 days).
When used as an analgesic aspirin often causes stomach pain, nausea, vomiting, and occult gastrointestinal blood loss. Dangerous gastrointestinal complications (bleeding, perforated ulcers) are relatively rare. An uncommon phenomenon called aspirin intolerance can result in potentially life-threatening bronchospasm. It occurs more frequently in persons with asthma, nasal polyps, or urticaria. High doses of aspirin can cause ringing in the ear and even hearing loss. Concerns over the development of Reye's syndrome in children with viral infections and fever limit the utility of aspirin in this age group.
Acetaminophen (Tylenol® and others) inhibits prostaglandin biosynthesis in the central nervous system but not in the peripheral tissues. This agent only has minimal anti-inflammatory action compared to non-steroidal anti-inflammatory agents. Acetaminophen does, however, have good analgesic and antipyretic properties. It is suitable for the treatment of pains of all kinds and is especially useful in children, who often should avoid aspirin use. It is used for mild pain or it can be administered in combination with opioids (e.g. codeine and hydrocodone). Acetaminophen has been compared to many other analgesics and is considered approximately equipotent to aspirin. However, it does not always reach the efficacy of usual doses of modern non-steroidal analgesics (especially compared to ibuprofen). A 1000 mg dose of acetaminophen has an NNT of 3.8. Various strengths and preparations are available OTC including tablet doses of 325, 500, and 650 mg. Acetaminophen has a 4000 mg per day maximum dosage. One should also be aware of a 2000 mg per day limit in patients with concomitant Warfarin (Coumadin®) use or in patients with end stage liver disease.
Using Opioid Analgesics
Figure 24 - Opioid Dosing "By the Clock"
The Drug Enforcement Agency registers health care providers and regulates the use of controlled substances for their patients. The Controlled Substance Act (CSA) defined five classed of narcotics based on whether there were legitimate medical uses for the drug and whether there was a potential for physical and psychological dependence.[17]
A Schedule I drug has a high potential for abuse and has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug under medical supervision. These are substances that are usually considers drugs of abuse only. Examples of Schedule I drugs include heroin, lysergic acid diethylamide (LSD), mescaline and peyote. The DEA also classifies marijuana as a Schedule 1 drug.
A Schedule II drug is a substance which has a high potential for abuse but unlike a Schedule I drug, does indeed have a currently accepted medical use in treatment. Abuse of it may lead to severe psychological or physical dependence.
A Schedule III drug is defined by the CSA as one with a potential for abuse less than the drugs in the prior schedules. It must have a currently accepted medical use and moderate or low physical dependence or high psychological dependence that could occur with its abuse. This is the level of narcotic analgesic approved for use by optometrists by many state's therapeutic pharmaceutical legislation. Codeine in combination with other compounds is one option specifically described in the CSA. To be considered in Schedule III there should not be more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
Jointly, the Drug Enforcement Agency and 21 health care organizations have written a consensus statement that supports the use of opioid analgesics for the treatment of pain while recognizing the potential for patients to abuse them. There is agreement on many facts, including that under treatment of pain is a serious concern in the U.S. and that for many patients use of narcotic analgesics is the most effective way to treat their pain and often the only treatment option that provides significant relief. [18] Prescribers of these medications have to balance the need to actively and appropriately treat pain with avoiding the potential for abuse. The Oregon prescribing rules specifically state that, "(Optometrists) should be diligent in preventing the diversion of drugs for illegitimate purposes." [11]
Narcotics are the mainstay for treatment of moderately severe to severe pain. Initial administration should be on a scheduled rather then as need basis. This "by the clock" dosing avoids problems of windup and recruitment of nociceptor nerves.
Figure 25 - Titrate Opioids to Effect; The Key Principle is to Titrate the Dose Against the Desired Effect - Pain Relief - and Minimize Unwanted Effects
Narcotic analgesics should be titrated to effect. Adequate doses are withheld because of traditions, misconceptions, ignorance and fear. Addiction and respiratory depression are usually not problems with acute pain treatment. Over eleven thousand patients were followed up a year after opioids were given for acute pain, and just four were considered addicts [19]
Figure 26 - Safe and Effective Opiate Use
Codeine is an opioid with a relatively limited analgesic effect. It does not cause significant respiratory depression and is relatively safe to use. It is probably a better cough medicine then a pain medicine because of its good antitussive properties. In most humans 10% of a codeine dose is transformed to morphine through demethylation in the liver. Nausea is often a side effect that limits its utility. As with other narcotics, chronic use can be associated with constipation too. Codeine is suitable for the treatment of mild and moderate pain. Codeine can be combined with non-opioid analgesics for improved efficacy.
Codeine 60 mg orally is not an effective analgesic with a NNT of 16.7 (11-48) in order to achieve 50% pain relief over 4 to 6 hours compared with placebo in pain of moderate to severe intensity. A single dose of 1000 mg acetaminophen had an NNT of 3.8. Acetaminophen 1000 mg and codeine 60 mg has a NNT of 2.2
Codeine is available by prescription in combination with acetaminophen as Tylenol #2 ® (15 mg/300 mg) 1-2 tab dosed every 4-6 hours. It is also available as Tylenol #3 ® (30/300) 1-2 tab every 4-6 hours and Tylenol# 4® (60/300) 1-2 tab q 4-6 hours.
Another option of narcotic analgesic for use by the optometrist is hydrocodone. It causes much less nausea and is much more potent then codeine. It is available by prescription in combination with acetaminophen as Vicodin® 5/500, Vicodin ES® 7.5/750, or Vicodin HP® 10/660. Other brands include Lortab® 2.5, 5, 7.5, 10 with 500 mg; and Norco® 10/325. This last formulation is particularly useful in patients who need to have a limited dose of acetaminophen (such as those on oral anticoagulants.) It is also available in combination with Ibuprofen® as Vicoprofen® 7.5/200 mg.
The California prescribing bill allows use of "oral analgesics that are not controlled substances."[10] This means that nonscheduled analgesics are options for treatment as well. Tramadol (Ultram®) is a prescription drug approved for moderate to moderately severe pain. It is a synthetic, centrally acting analgesic that is chemically non-narcotic and therefore, not a controlled substance. However it does act at brain and spinal cord Mu receptors as narcotics do. It also provides analgesic effects by acting peripherally by decreasing serotonin and norepinephrine. Side effects include nausea, constipation and drowsiness. Less euphoric or respiratory depressant side effects are seen than with opioids. Effective daily doses 200-300 mg (50-100 mg per dose up to QID). A single 100 mg oral dose of tramadol is roughly equivalent to 1000 mg acetaminophen. A dose of 100 mg had an NNT of 4.6.
One particular concern is this medications ability to lower seizure thresholds. Therefore, any patient with a history of epilepsy should not be prescribed tramadol. While it may have less addiction potential then for opioid analgesics, there still is potential for abuse and dependence with the chronic use of this medicine.
Ultracet® is a combination of tramadol 37.5 mg and acetaminophen 325 mg. It is indicated for acute pain. It is more powerful than tramadol alone. It has fast onset and long duration of pain relief. There are no associated prostaglandin-mediated side effects since it has no anti-inflammatory effect. It is also a non-scheduled opioid-like drug.
Regular dosing of medication is essential in order to provide adequate pain relief. Using a combination of medicine for around-the-clock analgesia is a consideration. Ibuprofen® 600 may be dosed q 6 hours as could Tylenol # 3® two tablets each dose. One could alternate doses of medicines every 3 hours for improved analgesia.
Regulatory issues in pain management
Figure 27 - Regulatory Issues
The Controlled Substance Act of 1970 regulates the prescribing of narcotic analgesics.[17] In order for a prescription for a controlled substance to be effective it must be "for a legitimate medical purpose by an individual practitioner, who is acting in the usual course of his professional practice, and in the scope of a Doctor/Patient relationship." This means that one must therefore document the purpose of the prescription medication, use it for an optometric purpose within the scope of your care within the confines of a relationship with a patient. One should not, for example, write a narcotic analgesic prescription for a friend with a tooth ache, since that order would not meet the above mentioned criteria to be valid.
There also is a corresponding responsibility that rests with the pharmacist filling the prescription of which one must be aware. An order purporting to be a prescription that is not issued in the course of a professional treatment, is not a prescription with the meaning and intent of the Act and the Dr or RPh is subject to penalties for violating the law. This means that if the pharmacist is suspicious of your intentions, he or she has an obligation to report you.
To be completely legitimate, the prescription must meet specific criteria. All prescriptions for a controlled substance must be dated as of, and signed on the date when issued (i.e., no post-dating). It must bear the full name and address of patient and the doctor with his or her DEA number. Finally it must include the drug name, strength, form, dosage and quantity. Most states require that the quantity be listed both in number and script forms (e.g., #30-thirty).
While these requirements seem daunting, any adverse actions from liability associated with narcotic analgesic writing is actually fairly rare. [20] There are approximately 925,000 DEA registrants. There were 850 investigations in 2001. About _ resulted in some action, usually a letter. Only 79 had registration removed (<0.01%). The Federation of State Medical Boards reports that there are 700,000 licenses to practice medicine. There were 4617 actions in 2000. 319 of these were for controlled substances violations. The percentage of license actions related to controlled substances is actually declining (11.3% in 1993 and 6.9% in 2000).
Figure 28 - Avoiding "Self-Generated" Malpractice Litigation
Most adverse events from the prescribing of narcotic analgesics can be avoided. One increases the chance of "self-generated" malpractice litigation by obtaining a limited or poor history, performing a limited, poor, scanty, incomplete physical exam, by completing poor documentation, by prescribing inappropriately, and by not obtaining prior records when indicated.
Figure 29 - Good Optometric Practice
In summary, therapeutic pharmaceutical legislation allows optometrist to treat patients' pain and inflammation effectively. Doctors of Optometry should assess all patients for pain and document degree of pain and dysfunction. One can effectively utilize oral analgesics as necessary, including narcotics, as discussed. One should always discuss and document benefits, risk, complications, alternatives, and side effects with patients. As always, be ready to seek consultation when appropriate in order to facilitate optimal treatment for our patients.
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20. Roberts R. Personal coverage: Meeting of the FDA Anesthetic and Life Support Drug Advisory Committee (ALSDAC) to discuss opioid therapies in the treatment of pain. Gaithersberg, MD; 2002.
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Michael L. Grover, DO
Department of Family Medicine
25455 Barton Rd., Suite 209-B
Loma Linda CA 92354
mlgrover@som.llu.edu
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