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Examining Product Risk in Contextmarket Withdrawal Of Examining Product Risk in Context. Market Withdrawal of Zomepirac as a Case Study The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Ross-Degnan, Dennis. 1993. “Examining Product Risk in Context.” JAMA 270 (16) (October 27): 1937. doi:10.1001/ jama.1993.03510160055029. Published Version doi:10.1001/jama.1993.03510160055029 Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:32692587 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Examining Product Risk in Context Market Withdrawal of Zomepirac as a Case Study Dennis Ross-Degnan, ScD; Stephen B. Soumerai, ScD; Eric E. Fortess, ScD, MPH; Jerry H. Gurwitz, MD Objective.\p=m-\Toexamine changes in the prescribing of analgesics after the mar- as nonsteroidal anti-inflammatory drugs ket entry and subsequent withdrawal of zomepirac sodium, a nonsteroidal anti\x=req-\ (NSAIDs). The drug was first marketed inflammatory drug (NSAID), following repeated reports of zomepirac-related deaths. in the United States by McNeil Phar¬ evaluate this natural we conducted time-series maceutical, Spring House, Pa, in No¬ Design.\p=m-\To quasi experiment, vember under the analyses to compare prescribing in two cohorts of primary care physicians from July 1980, proprietary name Zomax.5 Indications for which it 1980 1983. through September was marketed included relief of moder¬ care to Setting.\p=m-\Studyphysicians provided outpatient pharmaceutical patients ate to severe as well enrolled in the New postoperative pain, Jersey Medicaid program. as acute and chronic orthopedic condi¬ Participants.\p=m-\Weidentified 260 primary care physicians who provided 10 or tions, osteoarthritis, muscle-contraction more prescriptions for zomepirac (zomepirac prescribers) and 308 who provided headache, dysmenorrhea, and the 10 or more prescriptions for NSAIDs other than zomepirac (other-NSAID prescrib- chronic pain of cancer.6 Zomepirac ers) in Medicaid during the study period. achieved rapid acceptance, accounting Main Outcome Measures.\p=m-\Monthlyrates of prescribing for zomepirac and for 11% of new analgesic prescriptions within months of its several categories of substitute analgesics among Medicaid patients seen by study 4 introduction.7,8 physicians. Main Results.\p=m-\Zomepiracaccounted for a stable 11.0% of analgesic prescrib- For editorial comment see 1976. ing among the zomepirac-prescriber cohort; label changes and manufacturer 11 months the withdrawal from market product-risk warnings before product's the The first report of an apparent ana- had no impact on use. After market entry, zomepirac prescribers reduced use of phylactic reaction to zomepirac was pub¬ other NSAIDs and propoxyphene (hydrochloride or napsylate) in comparison with lished in April 1981, about 5 months after other-NSAID prescribers (-8.1% and -2.8% of total analgesic prescribing, the product was released.9 In July 1981, respectively; P<.001). After the product's withdrawal from the market, zomepirac McNeil included a mild warning in all prescribers showed significant increases in relative prescribing of other NSAIDs product labeling stating that "reactions (+6.8%; P<.001), propoxyphene (+2.1%; P<.05), and analgesics containing bar- have been reported."1" After further case biturates reports of zomepirac-associated anaphy- (+2.7%; P<.001). laxis in the medical litera¬ Conclusions.\p=m-\Thesudden withdrawal of from the market resulted appeared zomepirac the manufacturer sent in substitutions of but also of alternative ture,11·12 warning not only other NSAIDs, analgesics that carry letters in 1982 to 200000 risks of and adverse effects. in April physi¬ habituation Apparent gains patient safety resulting cians, alerting them to the drug's poten¬ from market withdrawal of medications must be evaluated in comparison with risks tial for serious allergic reactions. How¬ of medications likely to be substituted. ever, 1 week later, the company launched (JAMA. 1993;270:1937-1942) a major 10-week sales campaign ("Op¬ eration 111") intended to increase sales ofzomepirac and tolmetin, two ofits most DURING the past two decades, an in¬ the market, as in the recent case of tria- successful analgesics. On March 3, 1983, creasing number of government, medi¬ zolam in the United Kingdom.3 One ra¬ a Syracuse, NY, television report cited cal, and lay press reports have focused tionale for product removal is an un¬ five zomepirac-associated deaths, includ¬ on the problem ofunanticipated adverse stated assumption by regulators and ing a dramatic account by a physician reactions to prescription drugs.1 Gov¬ policymakers that all clinical risks at¬ who suffered a life-threatening anaphy- ernment and industry responses have tributable to a drug are eliminated when lactic reaction.13 The following day, Mc¬ ranged from modest label warnings2 to it is withdrawn; rarely do they examine Neilvoluntarily recalled the product from withdrawal ofthe offending product from the comparative risks and benefits of the market.14 Following 2 years of law¬ alternative medications that may be sub¬ suits and hearings by both the Food and From the Drug Policy Research Group, Department stituted for the withdrawn product.4 We Drug Administration and Congress, Mc¬ of Social Medicine, and the Department of Ambulatory are not aware of any controlled studies Neil permanently withdrew zomepirac Care and Prevention, Harvard Medical School, Boston, in Mass (Drs Ross-Degnan and Soumerai); the Depart- that have examined this question. This May 1985.16 ment of Public Management/Health Administration investigation analyzes changes in the Zomepirac's rapid capture of a sizable Concentration, Suffolk University, Boston, Mass (Dr use of various alternative fol¬ share of the followed and the for of Clinical Strat- analgesics analgesic market, Fortess); Program Analysis stable use for an extended be¬ egies, Gerontology Division, Department of Medicine, lowing the market entry and withdrawal by period Brigham and Women's Hospital and Harvard Medical of zomepirac sodium. fore sudden withdrawal, provides an op¬ School, Boston, Mass (Dr Gurwitz). is a syn- to assess both and Reprint requests to Department of Ambulatory Care Zomepirac prostaglandin portunity expected and Prevention, Harvard Medical School, 126 Brookline thetase inhibitor, one of a class of anal¬ unanticipated substitution effects caused Ave, Suite 200, Boston, MA 02215 (Dr Soumerai). gesic products referred to collectively by market availability of a popular drug. Downloaded From: http://jamanetwork.com/pdfaccess.ashx?url=/data/journals/jama/9819/ by a Harvard University User on 02/22/2017 Table 1.—Prescriptions for Study Analgesics per 100 Medicaid Recipients in Practice by Provider Specialty, July 1980 Through November 1981 Study Analgesics Physicians, Zomepirac Other Analgesic Analgesic All Study Physician Group No. Sodium NSAIDs* With Opioidst With Barbiturates Analgesics General practice 5.1 39.2 34,4 8.8 87.5 Internal medicine 73.7 12.9 147.4 Family practice 238 3.7 45.3 33.0 8.2 90.2 All Primary Care Physicians 1183 4.9 49.0 100.7 Dentistry, oral surgery 140 3.3 4.9 81.8 94.2 Pediatrics 121 0.2 2.7 4.9 0.7 8.5 General surgery 36.1 33.3 80.9 Obstetrics, gynecology 106 1.3 9.8 21.7 5.7 38.5 Other specialty 287 3.1 29.8 42.8 7.0 82.7 All Non-Primary Care Physicians 776 1.5 13.1 4.0 *NSAID indicates nonsteroidal anti-inflammatory drug. tAnalgesIc products containing propoxyphene (hydrochloride or napsylate), pentazocine, meperidine hydrochloride, or codeine. Few studies have examined drug sub¬ dac, and tolmetin. We did not include recipients. We also obtained a complete stitution in a critical way,16 and even fewer over-the-counter products such as ac¬ Medicaid provider file, which included have studied the comparative risks as¬ etaminophen or salicylates since we the stated specialties of all physicians sociated with substituted agents.17 Herein lacked complete data on their use. participating in the New Jersey Med¬ we analyze shifts in analgesic prescrib¬ The study drugs selected by the ex¬ icaid program during the study period. ing patterns associated with zomepirac's pert panel vary greatly in safety and Using prescriber and recipient identi¬ market entry; changes in product use efficacy. For example, zomepirac has fying numbers, we calculated for every during its market life span, particularly been estimated to have 500 to 1000 times provider the total number of undupli- at the time of warnings about its safety; the risk of producing a severe anaphy- cated Medicaid recipients in our patient and the impact of its rapid withdrawal. lactic reaction as other NSAIDs.15 The sample for whom a medication of any We conclude with a discussion ofthe need opioid analgesics can be habituating, and type was prescribed, which was used as to evaluate drugs in relation to theirlikely have also been associated with the oc¬ a proxy for Medicaid practice size. substitutes and implications for health currence of other adverse effects, in¬ policy decision making. cluding hip fracture.20 Propoxyphene Selection of Physician Study Group be no more effective an may analgesic To describe changes in prescribing an¬ METHODS than and its use has been asso¬ aspirin, algesics in a stable population of pri¬ ciated with a substantial number of over¬ Study Analgesics care we first identified dose deaths.21 Other mary providers, We identified all drugs that were po¬ opioid analgesics 1964 physicians, dentists, and osteopaths such as can a risk of tential alternatives to meperidine pose with at least one filled for analgesic zomepi¬ toxic effects.22·23 Fi¬ prescription rac at the time of the as deter¬ neuropsychiatrie in 6-month study, that contain any study analgesic every mined an of nally, analgesics long-act¬ the This by expert panel physicians barbiturates period throughout study.
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