Why do we prescribe Vicodin?
2016; Elsevier BV; Volume: 147; Issue: 7 Linguagem: Inglês
10.1016/j.adaj.2016.05.005
ISSN1943-4723
AutoresPaul A. Moore, Raymond A. Dionne, Stephen A. Cooper, Elliot V. Hersh,
Tópico(s)Opioid Use Disorder Treatment
ResumoVicodin, a fixed-dose combination analgesic containing acetaminophen, or N-acetyl-p-aminophenol, (APAP) and hydrocodone, is the most frequently recommended opioid pain reliever prescribed by US oral surgeons after the extraction of third molars.1Moore P.A. Nahouraii H.S. Zovko J. Wisniewski S.R. Dental therapeutic practice patterns in the U.S. II. Analgesics, corticosteroids, and antibiotics.Gen Dent. 2006; 54: 201-207PubMed Google Scholar It was first introduced to the US market in 1978, and today, APAP-hydrocodone combinations (for example, Vicodin, Norco, Lortab, and Zydone) have the dubious reputation of being our nation’s most frequently prescribed analgesics, as well as our nation’s most frequently abused prescription drugs.2Symphony Health Solutions. Top 200 drugs of 2014: ranked by total prescription count (TRx count). Available at: http://symphonyhealth.com/wp-content/uploads/2015/05/Top-200-Drugs-of-2014.pdf. Accessed March 18, 2016.Google Scholar, 3Hydrocodone. Available at: http://www.deadiversion.usdoj.gov/drug_chem_info/hydrocodone.pdf. Accessed March 10, 2016.Google Scholar Surprisingly, we could find no references in the literature in which investigators found APAP-hydrocodone combinations, as currently prescribed and formulated, to be more effective than nonsteroidal anti-inflammatory drugs (NSAIDs). The analgesic efficacy of even the most common over-the-counter NSAIDs such as ibuprofen and naproxen sodium first became recognized in the 1980s.4Hersh E.V. Moore P.A. Over-the-counter analgesics and antipyretics: a critical assessment.Clin Ther. 2000; 22: 500-548Abstract Full Text PDF PubMed Scopus (154) Google Scholar Unlike APAP, NSAIDs are potent inhibitors of prostaglandin synthesis and target the inflammatory pain encountered with acute infection, tissue injury, and surgical trauma. Consequently, when treating inflammatory pain, NSAIDs consistently have been shown to be more effective than APAP.5Moore R.A. Wiffen P.J. Derry S. Maguire T. Roy Y.M. Tyrrell L. Non-prescription (OTC) oral analgesics for acute pain: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 11: CD010794PubMed Google Scholar, 6Cooper S.A. Schachtel B.P. Goldman E. Gelb S. Cohn P. Ibuprofen and acetaminophen in relief of acute pain: a randomized, double blind, placebo controlled study.J Clin Pharmacol. 1989; 29: 1026-1030Crossref PubMed Scopus (73) Google Scholar In 2015, investigators of 2 evidence-based Cochrane systematic reviews of oral analgesics assessed the efficacy and adverse effects of nearly all oral analgesic formulations.5Moore R.A. Wiffen P.J. Derry S. Maguire T. Roy Y.M. Tyrrell L. Non-prescription (OTC) oral analgesics for acute pain: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 11: CD010794PubMed Google Scholar, 7Moore R.A. Derry S. Aldington D. Wiffen P.J. Adverse events associated with single dose oral analgesics for acute postoperative pain in adults: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 10: CD011407PubMed Google Scholar These comprehensive meta-analyses included results from 350 individual randomized clinical trials in which investigators assessed data in more than 45,000 participants undergoing both dental and medical surgical procedures. The findings of these and other comprehensive reviews unequivocally confirm 2 major conclusions: NSAIDs are remarkably effective analgesics for relieving postoperative pain, and the opioid analgesic combinations are associated with high incidences of adverse effects (nausea, vomiting, constipation, and so on).5Moore R.A. Wiffen P.J. Derry S. Maguire T. Roy Y.M. Tyrrell L. Non-prescription (OTC) oral analgesics for acute pain: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 11: CD010794PubMed Google Scholar, 7Moore R.A. Derry S. Aldington D. Wiffen P.J. Adverse events associated with single dose oral analgesics for acute postoperative pain in adults: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 10: CD011407PubMed Google Scholar, 8Aminoshariae A. Kulild C. Donaldson M. Short-term use of nonsteroidal anti-inflammatory drugs and adverse effects: an updated systematic review.JADA. 2015; 147: 98-110PubMed Google Scholar, 9Au A.H. Choi S.W. Cheung C.W. Leung Y.Y. The efficacy and clinical safety of various analgesic combinations for post-operative pain after third molar surgery: a systematic review and meta-analysis.PLoS ONE. 2015; 10: e0127611Crossref Scopus (48) Google Scholar And of no less importance, relying on NSAID analgesics rather than opioid pain relievers does not add to our nation's ongoing prescription opioid abuse epidemic.If nonsteroidal anti-inflammatory analgesics are at least as effective as acetaminophen-opioid pain relievers and have lower incidences of adverse effects, why do we prescribe acetaminophen-opioid pain relievers for patients? If nonsteroidal anti-inflammatory analgesics are at least as effective as acetaminophen-opioid pain relievers and have lower incidences of adverse effects, why do we prescribe acetaminophen-opioid pain relievers for patients? So what compels us to prescribe Vicodin and the other APAP-opioid analgesic combinations? As health care providers, we have a primary responsibility to treat disease and manage pain effectively when they occur. Pain control is fundamental for compassionate patient care and successful practice. If NSAID analgesics are at least as effective as APAP-opioid pain relievers and have lower incidences of adverse effects, why do we prescribe APAP-opioid pain relievers for our patients? Continuing to provide practice-tested therapies that we were taught in professional school and specialty training is not uncommon for either dental or medical practitioners. We were instructed to prescribe APAP-opioid combinations such as Vicodin (or, for older dentists, Tylenol with codeine) routinely because these combination formulations were thought to be the most effective oral analgesics for managing acute postoperative pain. It is difficult to change traditional thinking and initiate alternative drug therapies that may involve acquiring new knowledge in pharmacology and therapeutics.10Glick M. Dental-lore-based dentistry, or where is the evidence?.JADA. 2006; 137: 576-578Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar As health care providers, our attitude is often to stay with what we know and trust. Although this attitude is not surprising, it is not always in the patient’s best interest. Knowledge of the efficacy of APAP-opioids was established in the 1970s, nearly 10 years before the profound analgesic efficacy of NSAIDs was elucidated fully.11Beaver W.T. McMillan D. Methodological considerations in the evaluation of analgesic combinations: acetaminophen (paracetamol) and hydrocodone in postpartum pain.Br J Clin Pharmacol. 1980; 10: 215S-223SPubMed Google Scholar After the introduction of Vicodin and other APAP-opioids, we entered an era of more sophisticated clinical research of analgesic medications. Over the past several decades, investigators have used appropriately controlled comparators and established acute pain models by conducting large multicenter randomized clinical trials.12Cooper S.A. Desjardins P.J. Turk D.C. et al.Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.Pain. 2016; 157: 288-301Crossref PubMed Scopus (67) Google Scholar, 13Cooper S.A. Models for clinical assessment of oral analgesics.Am J Med. 1983; 75: 24-29Abstract Full Text PDF PubMed Scopus (49) Google Scholar Comparisons between clinical trials, particularly with use of the well-accepted impacted third-molar extraction model, became possible.5Moore R.A. Wiffen P.J. Derry S. Maguire T. Roy Y.M. Tyrrell L. Non-prescription (OTC) oral analgesics for acute pain: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 11: CD010794PubMed Google Scholar, 7Moore R.A. Derry S. Aldington D. Wiffen P.J. Adverse events associated with single dose oral analgesics for acute postoperative pain in adults: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 10: CD011407PubMed Google Scholar, 9Au A.H. Choi S.W. Cheung C.W. Leung Y.Y. The efficacy and clinical safety of various analgesic combinations for post-operative pain after third molar surgery: a systematic review and meta-analysis.PLoS ONE. 2015; 10: e0127611Crossref Scopus (48) Google Scholar, 10Glick M. Dental-lore-based dentistry, or where is the evidence?.JADA. 2006; 137: 576-578Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Advancements in our understanding of these effective nonopioid analgesics has been established and now can be used to improve patient care dramatically. Up-to-date knowledge of the efficacy and safety of the NSAID analgesics and their primary role for acute postoperative pain should be emphasized throughout a student's dental school experience, as well as our professional continuing education programs. When we prescribe opioid formulations, we understand that these agents are “strong” or “potent” and that they have significant abuse potential. This perception of strength was enhanced when the US Drug Enforcement Administration changed the classification of APAP-hydrocodone analgesics from schedule III to schedule II. Schedule II drugs are designated as having a higher abuse potential and include parenteral analgesics such as fentanyl, hydromorphone, and morphine.3Hydrocodone. Available at: http://www.deadiversion.usdoj.gov/drug_chem_info/hydrocodone.pdf. Accessed March 10, 2016.Google Scholar With this change, a patient is required to provide the pharmacist with a written or electronic prescription. Except in an emergency, a prescription order for a schedule II drug may not be called in to many pharmacies. Refills for schedule II prescription drugs also are prohibited.14Drug Enforcement Administration, Office of Diversion Control. Valid prescription requirements. Available at: http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm. Accessed March 17, 2016.Google Scholar Despite the inconvenience of the schedule II regulations for both patients and practitioners, we continue to prescribe APAP-hydrocodone combinations partly because of familiarity and partly to avoid after-hours emergencies. These requirements only heighten our belief that these agents are truly effective. In the past 40 years, investigators in almost all clinical trials in which they have evaluated new analgesic medications have assessed analgesic efficacy compared with that of a placebo. Results from these studies consistently indicate that placebo pills are effective at least 10% to 20% of the time, particularly during the initial evaluation periods.12Cooper S.A. Desjardins P.J. Turk D.C. et al.Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.Pain. 2016; 157: 288-301Crossref PubMed Scopus (67) Google Scholar The less severe the pain episode, the greater the placebo response. In clinical trials involving simple extractions, osteoarthritis, or muscle soreness, the placebo response is often greater than 40%.12Cooper S.A. Desjardins P.J. Turk D.C. et al.Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.Pain. 2016; 157: 288-301Crossref PubMed Scopus (67) Google Scholar The pain relief that a patient experiences when taking an active analgesic is defined as the benefit of the active drug over and above the placebo response. In clinical practice, prescription opioid formulations produce significantly enhanced placebo responses. With these prescription drugs, patients incur additional costs, the inconvenience of traveling to a pharmacy, and receipt of written and verbal precautions. Prescriptions are written using Latin abbreviations and are dispensed by a pharmacist, reinforcing the narrative supporting a patient’s belief that these agents are more effective than over-the-counter analgesics. The tablets dispensed by the pharmacist often have unique shapes and a mysterious code embossed on the side. Beyond the inert “sugar pill” used in clinical research studies, placebo responses in clinical practice include deep-seated beliefs and expectations that are ingrained in both patients and practitioners.15Marchant J. Cure: A Journey Into the Science of Mind Over Body. Crown Publishers, New York, NY2016: 40Google Scholar, 16Glick M. Placebo and its evil twin, nocebo.JADA. 2016; 147: 227-228Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar, 17Gracely R.H. Dubner R. Deeter W.R. Wolskee P. Clinicians’ expectations influence placebo analgesia.Lancet. 1985; 325: 43Abstract Scopus (219) Google Scholar Most of our analgesic prescriptions are provided for management of postoperative pain. After various dental and oral surgical procedures, we make a decision to prescribe a specific analgesic agent, at a specific dose, and with a specific regimen. At the moment we make this decision, the patient is usually still numb and not in pain. We are making our best judgment of the patient’s needs on the basis of the length of the procedure and degree of surgical trauma. Given that we actually do not know how much pain a patient will experience, we most often provide a prescription for an opioid analgesic sufficient to manage the worst case scenario—that is, those few patients who will have the most painful recovery.18Mutlu I. Abubaker A.O. Laskin D.M. Narcotic prescribing habits and other methods of pain control by oral and maxillofacial surgeons after impacted third molar removal.J Oral Maxillofac Surg. 2013; 71: 1500-1503Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar By writing a prescription that may benefit 20% of patients who will experience severe discomfort, we unnecessarily provide 80% of patients with a prescription they may not need. The dilemma is determining who will need an opioid analgesic and who will not. The inability to predict who may need an opioid analgesic after outpatient surgery is a problem for both medicine and dentistry. Patient education and counseling when providing an opioid prescription is necessary and has the potential to avoid unnecessarily filling an opioid analgesic prescription and possibly curtailing its use when not absolutely required. When APAP is used in an opioid analgesic combination, we assume that it is formulated to optimize the analgesic benefit. However, because of concern for APAP-induced hepatic toxicity, the US Food and Drug Administration in 2013 requested pharmaceutical companies to limit the APAP dose in these combination formulations to 325 milligrams.19Larson A.M. Polson J. Fontana R.J. et al.Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study.Hepatology. 2005; 42: 1364-1372Crossref PubMed Scopus (1464) Google Scholar, 20Guggenheimer J. Moore P.A. Therapeutic applications and risks associated with acetaminophen: a review and update.JADA. 2011; 142: 38-44PubMed Google Scholar, 21US Food and Drug Administration. Acetaminophen prescription products limited to 325 mg per dosage unit: drug safety communication. Available at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239955.htm. Accessed May 13, 2013.Google Scholar This lowered APAP dose in opioid combinations reduces the potential for liver damage but also provides less analgesia than did the formulations that previously contained 500 or 750 mg of APAP. In clinical dental practice, prescriptions for Vicodin and Percocet most often are written for 16 to 24 tablets, with instructions to take 1 tablet every 4 to 6 hours, as needed, for pain.1Moore P.A. Nahouraii H.S. Zovko J. Wisniewski S.R. Dental therapeutic practice patterns in the U.S. II. Analgesics, corticosteroids, and antibiotics.Gen Dent. 2006; 54: 201-207PubMed Google Scholar, 18Mutlu I. Abubaker A.O. Laskin D.M. Narcotic prescribing habits and other methods of pain control by oral and maxillofacial surgeons after impacted third molar removal.J Oral Maxillofac Surg. 2013; 71: 1500-1503Abstract Full Text Full Text PDF PubMed Scopus (59) Google Scholar, 22Baker J.A. Avorn J. Levin R. Bateman B.T. Opioid prescribing after surgical extraction of teeth in Medicaid patients, 2000-2010.JAMA. 2016; 315: 1653-1654Crossref PubMed Scopus (51) Google Scholar, 23Wunsch H. Wijeysundera D.N. Passarella M.A. Neuman M.D. Opioids prescribed after low-risk surgical procedures in the United States, 2004-2012.JAMA. 2016; 315: 1654-1657Crossref PubMed Scopus (226) Google Scholar Consequently, the amount of the APAP in 1 tablet of a combination opioid analgesic is often suboptimal. After completing any surgical procedure, patients expect and deserve our best efforts to manage any pain experienced during their days of recovery at home. Because a patient expects to receive the most effective of pain relievers, dental and medical care practitioners often feel obligated to prescribe opioid combinations such as Vicodin or Percocet. If we prescribe or recommend a nonopioid, some patients may be dissatisfied and may consider the provider uncaring or unsympathetic. Effective pain management is, after all, the Holy Grail for achieving patient satisfaction.24Lembke A. Why doctors prescribe opioids to known opioid abusers.N Engl J Med. 2012; 367: 1580-1581Crossref PubMed Scopus (87) Google Scholar Not providing an opioid prescription also can have significant consequences for today’s medical and dental practice models. Formal provider reviews conducted by corporate and hospital administrators can include poor ratings from patients who are disgruntled when they have not received their preferred opioid analgesic, even when it is not indicated. Because many dental and medical practices provide care in private settings, practitioners risk receiving critical postings on social media sites as well. These unwarranted reports are in the public domain and can result in loss of referrals from other patients and practitioners. We prescribe opioid analgesics to manage patients’ potentially severe postoperative pain, and at times we feel influenced to provide opioid analgesics to ensure patient satisfaction. Because of the safety and efficacy of NSAID analgesics, unless contraindicated, they should continue to be our primary agents for managing postoperative pain. A prescription for an opioid combination analgesic after outpatient surgery may be needed for certain patients and after certain procedures; therefore, opioid pain relievers remain an essential part of a dentist’s therapeutic options. However, there are other effective strategies for postoperative pain management that do not require Vicodin and the other APAP-hydrocodone formulations. One effective alternative is the combination of APAP and ibuprofen.25Moore P.A. Hersh E.V. Combining ibuprofen and acetaminophen for acute postoperative pain management: translating clinical research to dental practice.JADA. 2013; 144: 898-908Abstract Full Text Full Text PDF PubMed Scopus (121) Google Scholar, 26Mehlisch D.R. Aspley S. Daniels S.E. Bandy D.P. Comparison of the analgesic efficacy of concurrent ibuprofen and paracetamol with ibuprofen or paracetamol alone in the management of moderate-to-severe postoperative dental pain in adolescents and adults: a randomized, double-blind, placebo-controlled, parallel-group, single-dose, two-center, modified factorial study.Clin Ther. 2010; 32: 882-895Abstract Full Text PDF PubMed Scopus (73) Google Scholar, 27Derry S. Wiffen P.J. Moore R.A. Relative efficacy of oral analgesics after third molar extractions: 2011 update.Brit Dent J. 2011; 211: 419-420Crossref PubMed Scopus (25) Google Scholar, 28Daniels S.E. Goulder M.A. Aspley S. Reader S. A randomized, five-parallel-group, placebo-controlled trial comparing the efficacy and tolerability of analgesic combinations including a novel single-tablet combination of ibuprofen/paracetamol for postoperative dental pain.Pain. 2011; 152: 632-642Abstract Full Text Full Text PDF PubMed Scopus (68) Google Scholar If pain is severe and an opioid is deemed necessary, an analgesic combination containing an NSAID such as ibuprofen rather than APAP is likely to be more effective when appropriate.7Moore R.A. Derry S. Aldington D. Wiffen P.J. Adverse events associated with single dose oral analgesics for acute postoperative pain in adults: an overview of Cochrane reviews.Cochrane Database Syst Rev. 2015; 10: CD011407PubMed Google Scholar, 9Au A.H. Choi S.W. Cheung C.W. Leung Y.Y. The efficacy and clinical safety of various analgesic combinations for post-operative pain after third molar surgery: a systematic review and meta-analysis.PLoS ONE. 2015; 10: e0127611Crossref Scopus (48) Google Scholar Multimodal perioperative pain management approaches that include preemptive NSAIDs to limit pain severity, long-acting local anesthetics to delay pain onset, and corticosteroids to limit postoperative inflammation and swelling may diminish or eliminate the need for opioid analgesics.25Moore P.A. Hersh E.V. Combining ibuprofen and acetaminophen for acute postoperative pain management: translating clinical research to dental practice.JADA. 2013; 144: 898-908Abstract Full Text Full Text PDF PubMed Scopus (121) Google Scholar, 29Denisco R.C. Kenna G.A. O’Neill M.G. et al.Prevention of prescription opioid abuse: the role of the dentist.JADA. 2011; 142: 800-810Abstract Full Text Full Text PDF PubMed Scopus (110) Google Scholar Counseling patients about their anticipated postoperative pain experience and possible need for opioids must be provided as well. Surgical extraction of third molars is an outpatient procedure provided to approximately 3.5 million young adults in the United States each year.1Moore P.A. Nahouraii H.S. Zovko J. Wisniewski S.R. Dental therapeutic practice patterns in the U.S. II. Analgesics, corticosteroids, and antibiotics.Gen Dent. 2006; 54: 201-207PubMed Google Scholar This common procedure has provided a wealth of clinical and research evidence of oral analgesic efficacy. The use of APAP-hydrocodone analgesics after minor outpatient surgery performed in dentistry and in medicine have similar prescribing issues and nonpharmacologic reasons for their use.22Baker J.A. Avorn J. Levin R. Bateman B.T. Opioid prescribing after surgical extraction of teeth in Medicaid patients, 2000-2010.JAMA. 2016; 315: 1653-1654Crossref PubMed Scopus (51) Google Scholar, 23Wunsch H. Wijeysundera D.N. Passarella M.A. Neuman M.D. Opioids prescribed after low-risk surgical procedures in the United States, 2004-2012.JAMA. 2016; 315: 1654-1657Crossref PubMed Scopus (226) Google Scholar Many effective alternatives for managing postoperative pain that are opioid sparing are available. Clearly, it is time for all of us, both providers and patients, to reexamine our continued reliance on Vicodin to manage postoperative pain. Dr. Moore is a professor, Pharmacology, Dental Anesthesiology and Dental Public Health, School of Dental Medicine, University of Pittsburgh, 386 Salk Hall, Pittsburgh, PA 15261. Dr. Dionne is a research professor, Department of Pharmacology and Toxicology, Brody School of Medicine, and a research professor, Department of Foundational Sciences, School of Dental Medicine, East Carolina University, Greenville, NC. Dr. Cooper is the president, Stephen A. Cooper, LLC, Palm Beach Gardens, FL. Dr. Hersh is a professor, Department of Oral & Maxillofacial Surgery/Pharmacology, School of Dental Medicine, University of Pennsylvania, Philadelphia, PA.
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