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Journal of Legal Medicine Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/ulgm20
Regulation of mail‐order pharmacy a
Thomas H. Stanton J.D. & Delbert D. Konnor Pharm.M.S
b c
a
American Managed Care Pharmacy Association , 2300 Ninth Street South, Suite 210, Arlington, VA, 22204 b
Executive Vice President, American Managed Care Pharmacy Association , 2300 Ninth Street South, Suite 210, Arlington, VA, 22204 c
Adjunct Professor, Duquesne University School of Pharmacy , Published online: 23 Jul 2009.
To cite this article: Thomas H. Stanton J.D. & Delbert D. Konnor Pharm.M.S (1991) Regulation of mail‐order pharmacy, Journal of Legal Medicine, 12:2, 257-265, DOI: 10.1080/01947649109510855 To link to this article: http://dx.doi.org/10.1080/01947649109510855
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/ page/terms-and-conditions
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The Journal of Legal Medicine, 12:257-265 Copyright © 1991 by Hemisphere Publishing Corporation
REGULATION OF MAIL-ORDER PHARMACY
Downloaded by [York University Libraries] at 06:05 03 March 2015
A CRITIQUE Thomas H. Stanton, J.D.* Delbert D. Konnor, Pharm.M.S/
INTRODUCTION Gregory Munro, Assistant Professor of Law at the University of Montana, authored an article in the March 1991 issue of the Journal of Legal Medicine.1 In that article, he alleged that today's federal and state approaches to regulation of mail service pharmacies are "ill-fitted to the task of protecting those to whom the industry dispenses," and that policymakers must decide whether mail-order pharmacy should "continue to be deemed professional pharmacy practice, or is it better considered a drug product packaging and distribution operation."3 The analysis in that article lacks a proper foundation based on available facts. First, the author ignores the substantial and growing body of literature attesting to the generally high quality of dispensing by mail service pharmacies. Second, the author fails to substantiate his designation of mail service pharmacy as anything other than the practice of pharmacy properly regulated by the states in which the particular pharmacy is located. In fact, the United States Food and Drug Administration (FDA) conducted a field survey of mail service pharmacies in 1990 and concluded that mail service pharmacy practices "were not found to go be-
* Olwine, Connelly, Chase, O'Donnell, & Weyher, Washington, D.C. Mr. Stanton of the American Managed Care Pharmacy Association. Address correspondence Mr. Konnor at the American Managed Care Pharmacy Association, 2300 Ninth 210, Arlington, VA 22204. * Executive Vice President, American Managed Care Pharmacy Association, and Duquesne University School of Pharmacy. 1 Munro, Regulation of Mail-Order Pharmacy, 12 J. LEGAL MED. 1 (1991). 2 Id. at 58. 3 Id. at 3.
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yond the traditional practice of pharmacy."4 The FDA expressly determined that the retail pharmacy practices of these mail service pharmacies did not constitute repackaging or other activities that would warrant FDA regulatory action. Finally, a myriad of comments scattered throughout the article reveal that Mr. Munro essentially rejects the evolving nature of pharmacy practice today. Thus, he states that state regulation "assumes the direct involvement of the pharmacist with a patient during the process of dispensing,"5 and fears that "a major portion of prescription drugs in this country are going to be dispensed to patients absent a direct pharmacist/ patient relationship."6 The author also objects to the practice of pharmacy when "prescriptions are written by physicians not known to the pharmacist."7 Ultimately, as can be seen by his invocation of the words of Thomas Jefferson at the beginning of the article,8 he objects to the fact that many pharmacists are also businesspeople. The problem is that these issues permeate all forms of pharmacy practice—retail community and chain drugstores as well as mail service pharmacies. It is not inappropriate for Mr. Munro to decry the loss of old-time values and practices; however, he focuses solely on the demonstrably reputable group of mail service pharmacists and attempts to allege that the evils of modern times reside entirely with them.9 The article fails to point out that mail service pharmacies tend to stress professionalism to a significant degree. In contrast to the average retail drugstore that derives only a quarter of its revenues from prescription drugs and merely uses Pharmaceuticals "to lure customers into their stores," the mail service pharmacy tends to be dedicated exclusively to purchasing, storing, and dispensing prescription medicines.10 Mail service pharmacies use state-of-the-art technologies and ultra-modern facilities to assure a high level of quality at each step of the dispensing process.
4
Letter from Ronald G. Chesemore, Associate Commissioner for Regulatory Affairs, Food and Drug Administration, to James D. Dickinson, Re: 88P-0367/CP, Nov. 29, 1990. 5 Munro, supra note 1, at 16. 6 Id. at 7. 7 Id. at 45. 8 "Merchants have no country. The mere spot they stand on does not constitute so strong an attachment as that from which they draw their gains." Id. at 1. 9 Thus, for example, Mr. Munro never explains his passing reference to other forms of pharmacy practice that may omit a direct pharmacist/patient relationship. On page 35, for example, he begins the second paragraph "Chain operations aside" without explaining why this exemption is merited from the analysis of his entire article. 10 See Pharmacies Fight Off New Competition, N.Y. Times, Nov. 5, 1989, at F-17.
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I. INADEQUATE CITATION TO LITERATURE DEMONSTRATING HIGH QUALITY OF MAIL SERVICE PHARMACIES Mr. Munro alleges that the public is poorly served by today's regulation of mail service pharmacies. He invokes "the specter of tail-end dispensing failures that could defeat the entire system," and cites anecdotes such as a purported mail service pharmacy dispensing failure from the year 1987.11 Mr. Munro further concedes that he has no statistical evidence that dispensing errors of mail service pharmacies are high or, indeed, any different from those of other retail pharmacies. He "calls for empirical study to determine the risk involved in mail order."12 Again, he states that "regulators need to abandon anecdotal evidence and seek answers based on empirical data determining whether there are abnormal risks in mail-order pharmacies and whether mail-order patients are subjected to risks patients of community-based pharmacies do not suffer."13 Yet, Mr. Munro couples these concessions about his lack of information with a series of troublesome innuendos. For example, he states, "however, considering the volume of drugs dispensed by mail in the industry, one might legitimately question whether the postal regulations are being honored more in the breach than in practice."14 Again, "will any legislation that does not impose unreasonable burdens on interstate commerce . . . be effective in dealing with the perceived safety hazards involved in high-volume delivery of legend drugs?"15 And, "tort liability will impose costs on the mail-order industry that will offset savings made by sacrificing customer safety."16 These innuendos are especially unfair given the considerable and growing volume of literature that concerns the high quality of dispensing practice of mail service pharmacies. For example, the results of a study performed by researchers at Brandeis University yielded the following conclusions:17 "[T]he quality of drug products dispensed by mail service firms is very good." Moreover, dispensing procedures at mail service pharmacies "certainly compare favorably with community pharmacy operations whose size generally precludes checking by two or more pharmacists." And, "[c]oncerns expressed by community pharmacies have generally re11
Munro, supra note 1, at 2-3. Id. at 3. 13 Id. at 57. 14 Id. at 14. 15 Id. at 52. 16 Id. at 54. 12
17
BIGEL INSTITUTE FOR HEALTH POLICY, STUDY TO EVALUATE THE USE OF MAIL SERVICE PHARMACIES VI-
1, VI-6, & III-6 (Sept. 21, 1989).
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fleeted their apprehension of a new competitor. . . . Evidence offered in support of these allegations and any subsequent deterioration of patient care is anecdotal." Similarly, in 1987, the House of Delegates of the American Medical Association found that "MSPs [mail service pharmacies] are less vulnerable to drug diversion than retail pharmacies. . . . Presently, the practice of obtaining drugs from mail service pharmacies appears to be relatively safe."18 A Joint Committee of the Michigan State Legislature issued a similar report in 1988 observing that "mail-order pharmacy appears to be a safe and convenient method of obtaining Pharmaceuticals for millions of Americans and hundreds of thousands of Michiganians. . . . There is anecdotal information reciting problems with MOPs [mail order pharmacies] but little or no documentation to support alleged problems."19 In 1989, a Joint Committee of the Maine State Legislature also reported that "the Committee found no evidence that there was any difference in safety between having a prescription filled by mail and through an in-state pharmacy."20 A similar finding was made by the Tennessee College of Pharmacy. In 1986, the College of Pharmacy at the University of Tennessee conducted a study to determine the satisfaction of consumers using mail service pharmacies compared to consumers using retail pharmacy services. The report concluded that "most mail-order users report few problems and the overall rating of the service was excellent or good. In fact, the rating for mailorder services was slightly better than the rating for community pharmacy services."21 Mr. Munro also alleges, again without documentation, that mail service pharmacies do not provide appropriate counseling to patients. He states that "the requirement of a 24-hour toll-free telephone line is highly favored by community-based pharmacists who have salt rubbed in their economic wounds when they are forced to spend office time fielding telephone requests for counseling from patients of mail-order pharmacies."22 Moreover, he says "some states protect their citizens by requiring patient counseling by pharmacists . . . such statutes would be troublesome for
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21
Resolution 9 1 , 1-86 adopted by the House of Delegates, American Medical Association (1987). Mail Order Prescriptions (Senate Concurrent Resolution 179), Joint Study Committee Report, Michigan State Legislature, Nov. 1988, at 7-8. Joint Standing Committee on Business Legislation, Report, Cost Containment for Prescription Drugs, State of Maine, 114th Legislature, Dec. 1989. T H E CENTER FOR PHARMACY MANAGEMENT AND RESEARCH, COLLEGE O F PHARMACY, UNIVERSITY OF TENNESSEE, EVALUATION OF CONSUMER OPINIONS OF PRESCRIPTION D R U G SERVICES FROM COMMUNITY AND M A I L O R D E R PHARMACIES 7 (1986).
22
Munro, supra note 1, at 3 1 .
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mail-order pharmacy services, but for the likelihood they are roundly ignored."23 And, "does an industry giant mailing 10,000 prescriptions per day meet the statute by having a single toll-free line?"24 Again, Mr. Munro ignores some important facts. The pharmacy practice standards of the American Managed Care Pharmacy Association call for the availability of consulting pharmacists to counsel patients "on problems with or questions regarding their drug therapy at any time prior to, during, or subsequent to drug therapy."25 Indeed, there is some evidence that mail service pharmacies may provide more counseling and information than do other kinds of pharmacies. As the Office of the Inspector General of the United States Department of Health and Human Services has found: [T]he differences in clinical services provided by MSPs [mail service pharmacies] versus other retail settings may be more theoretical than actual. In theory, pharmacists who have face-to-face contact with patients on a regular basis are significantly better equipped to elicit information, counsel patients, and monitor drug regimens. But, given the relatively low level of services that are actually provided in community settings, there may be little difference in the interventions received by patients, and in some cases, the information provided by MSP package inserts may be more than patients receive from their neighborhood pharmacists.26
Finally, it is worth noting that Mr. Munro concedes that any pharmacy with high error rates would be put out of business by the tort system. He properly observes that the legal standards for mail service pharmacies and other pharmacies are indistinguishable.27 As he points out, "the tort system is effective in assessing costs of consumer injury and death on the enterprise that caused the damage."28 As Mr. Munro concedes, mail service pharmacies have been doing business for more than 30 years. This is enough time to develop a track record and for the tort system to make its influences felt if necessary. In fact, independent observers have repeatedly reported on the high quality of mail service pharmacy practices. The author fails to discuss or even cite any of the relevant literature.
23 24 25
Id. at 32-33. Id. at 5 0 . AMCPA PHARMACY PRACTICE STANDARDS, PATIENT COUNSELING AND INSTRUCTIONAL INFORMATION
Standard VIII, at ¶ 2 . 26
See O F F I C E OF ANALYSIS AND INSPECTIONS, O F F I C E O F INSPECTOR G E N E R A L , DEPARTMENT O F HEALTH AND H U M A N SERVICES, T H E CLINICAL R O L E O F THE COMMUNITY PHARMACIST 9-10 (Nov. 1990).
28
Munro, supra note 1, at 5 4 . Id. at 5 5 .
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H. MAIL SERVICE PHARMACISTS ENGAGE IN THE PRACTICE OF PHARMACY Mr. Munro compounds the factual shortcomings of his article with conceptual confusion. He frames the conceptual issue as follows: "If, on the other hand, society deems the mail-order pharmacies too far removed from professional practice to be regulated like community-based pharmacists, then one need look no further than the pharmaceutical manufacturing industry for a model upon which to base regulation."29 Mr. Munro believes that mail service pharmacies are repackagers rather than retail pharmacies.30 But this is simply wrong, because it ignores the fact that mail service pharmacies provide their services directly to the ultimate consumer.31 It also ignores the recent investigation by FDA on this point. As the FDA concluded, "based on FDA's field survey results, the agency cannot agree . . . that [mail-order pharmacies] warrant application of CGMP [current good manufacturing practice] regulations. Nor did the survey find any repackaging practices that would warrant FDA enforcement."32 The author's analysis fails because mail service pharmacies, in fact, are responsibly engaging in the practice of pharmacy, as the FDA has determined. III. THE STATES TODAY ARE ACTING RESPONSIBLY BY RELYING PRIMARILY ON THE STATE IN WHICH THE PHARMACY IS LOCATED TO REGULATE MAIL SERVICE PHARMACIES Mr. Munro states: "[T]he primary and key issue that should occupy regulators is whether the public is adequately protected by the present federal and state regulatory web whose spinners did not contemplate the management of mail-order pharmacy."33 Failing to answer this question, except by innuendo, he rejects the usefulness of California-type disclosure legislation as a means of addressing the particular issues raised by the interstate activities of many mail service pharmacies.34 He argues that 29 30 31
32 33 34
Id. at 56. Id. at 4 2 . Thus, Mr. Munro makes the mistake of relying on United States v. Sene X Eleemosynary Corp., 479 F. Supp. 970 (S.D. Fla. 1979), to justify his proposal. He notes " t h e lack of a one-on-one relations h i p " or any relationship at all between the mail-order pharmacy and the patient that was the basis for that case. In fact, unlike the pharmacy in the Sene X case, mail service pharmacies receive their prescriptions directly from the patient or practitioner and dispense their pharmaceutical medications directly to the patient. F D A Letter, supra note 4 , at 3 . Munro, supra note 1, at 56-57. Id. at 5 1 .
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"such statutes will not be effective to ensure safety in the production line type setting in which this enterprise's drug products are dispensed."35 This conclusion fails along with its premise. Given the repeatedly demonstrated high quality of mail service pharmacy practice, the present form of pharmacy regulation by the states appears to be working quite well in protecting the health and safety of patients across the country. Mr. Munro also recognizes that regulation of mail service pharmacies must not create an unreasonable burden under the Commerce Clause of the United States Constitution. He observes that "the 'catch-22' that hampers the National Association of Boards of Pharmacy (NABP) in its proposal is fashioning a legislative tool that will effectively collar the industry without being an unreasonable burden on interstate commerce when potentially enforced by 50 states."36 What Mr. Munro fails to do is recognize that there is no need to "collar" mail service pharmacies. They are already well-regulated and inspected by the Boards of Pharmacy in the states in which they are located. Thus, the FDA stated: "FDA also disagrees with the petitioner that the states have not been effective in regulating mail-order pharmacies."37 Indeed, Mr. Munro concedes that he has no evidence that mail service pharmacies seek to locate in states that seem to have "the most lenient regulation."38 IV. THE NEED FOR WORKABLE IMPROVEMENTS Mr. Munro fails to propose workable improvements in today's responsible (and evolving) system of state regulation of the practice of pharmacy. First, he correctly cites the requirements of the Commerce Clause and then disregards it. He properly cites Pike v. Bruce Church, Inc.,39 and its three-part test: (1) Is the statute enacted to protect local economic interests against interstate competition? (2) Will the burden imposed on interstate commerce by the statute be outweighed by the benefit to the local interest protected? (3) Is there an alternative to the regulation that will impose a lesser burden on interstate commerce? Yet, after discussing the Commerce Clause, Mr. Munro proposes a burdensome regulatory system, including the following: licensure (not
35
Id. at 52. If Mr. Munro's reference to "production line" refers to the possibility of stress on the pharmacist, this again is an issue that affects all forms of pharmacy practice. See, e.g., Reducing Pharmacists' Stress, American Druggist, Jan. 1991, at 38-44. In fact, responsible pharmacies and pharmacists—whether mail service pharmacies or retail drugstores—take preventive steps to reduce pharmacist stress and assure quality dispensing practices. Munro, supra note 1, at 5 1 .
37
FDA Letter, supra note 4 , at 4. Munro, supra note 1, at 34. Id. at 17-18.
38 39
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registration); designation of a pharmacist that "some argue" should be "licensed in each state into which the pharmacy intends to mail"; conducting of inspections "if the home state's examinations are inadequate"; and finally, "it is doubtful that fewer requirements . . . will do any more than give a false appearance of regulatory control and safety."40 These regulatory burdens could cripple out-of-state pharmacies. A mail service pharmacy can comply completely with the pharmacy laws and regulations of any single state. As with Mr. Munro's suggestion that pharmacists be licensed in all of the states, compliance with multiple and overlapping state requirements is burdensome to the point of being economically prohibitive. On the other hand, this regulatory system offers few benefits. Mail service pharmacies are generally of high professional quality, and the FDA has found that today's system of state regulation properly protects the health and safety of consumers. Second, lacking evidence to show that mail service pharmacies provide anything but the highest quality pharmacy services, Mr. Munro has difficulty even defining the class of pharmacies to be subjected to his makeshift scheme. Thus, he proposes to exempt intrastate mail service pharmacies and mailings by community-based pharmacies "to patients visiting other states even for extended periods of time."41 He proposes these exemptions even if such pharmacies lack the face-to-face patient/ pharmacist relationship or personal knowledge of the prescribing physician whose absence he decries with respect to nonresident mail service pharmacies. Finally, Mr. Munro seems willing to jettison entirely his burdensome state-by-state regulatory system if the FDA were willing to regulate mail service pharmacies as manufacturers or repackagers. There is no logic to this approach. The scheme of federal regulation of manufacturers and repackagers is profoundly different and meets quite different health and safety concerns than does regulation of the practice of pharmacy that involves dispensing to the patient. While FDA Current Good Manufacturing Practice (CGMP) regulations address issues of purity and consistency of pharmaceuticals, it is state regulation of pharmacy that addresses the pharmacist/patient relationship and regulates dispensing practices. The ease with which Mr. Munro would give up his requirements such as multiple licensure of pharmacies and pharmacists by the 50 states betrays his own lack of confidence that they are needed or useful.
40 41
Id. at 47-48. Id. at 38.
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CONCLUSION In summary, Mr. Munro's article proposes an irrelevant remedy at the federal level (because FDA CGMP regulations do not apply to the practice of pharmacy), and unworkable remedies at the state level, to address a problem that does not exist. At the core of the article is a concern that emerging technological improvements can undermine traditional professional standards. Missing is recognition that technological progress—computerized patient records for checking drug interactions, and toll-free (800) telephone lines that provide an opportunity for patient counseling in greater privacy than is available in many drugstores, for example—can enhance rather than detract from professionalism. We are fortunate that technological advances are available for all types of pharmacies, including community and chain drugstores as well as mail service pharmacies. The responsibility of the pharmacy profession is to ensure that new technologies are adopted in such a way as to maximize the quality of dispensing practices and professional pharmacy services for patients.
Journal of Legal Medicine Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/ulgm20
Regulation of mail‐order pharmacy a
Thomas H. Stanton J.D. & Delbert D. Konnor Pharm.M.S
b c
a
American Managed Care Pharmacy Association , 2300 Ninth Street South, Suite 210, Arlington, VA, 22204 b
Executive Vice President, American Managed Care Pharmacy Association , 2300 Ninth Street South, Suite 210, Arlington, VA, 22204 c
Adjunct Professor, Duquesne University School of Pharmacy , Published online: 23 Jul 2009.
To cite this article: Thomas H. Stanton J.D. & Delbert D. Konnor Pharm.M.S (1991) Regulation of mail‐order pharmacy, Journal of Legal Medicine, 12:2, 257-265, DOI: 10.1080/01947649109510855 To link to this article: http://dx.doi.org/10.1080/01947649109510855
PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/ page/terms-and-conditions
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Reactions
The Journal of Legal Medicine, 12:257-265 Copyright © 1991 by Hemisphere Publishing Corporation
REGULATION OF MAIL-ORDER PHARMACY
Downloaded by [York University Libraries] at 06:05 03 March 2015
A CRITIQUE Thomas H. Stanton, J.D.* Delbert D. Konnor, Pharm.M.S/
INTRODUCTION Gregory Munro, Assistant Professor of Law at the University of Montana, authored an article in the March 1991 issue of the Journal of Legal Medicine.1 In that article, he alleged that today's federal and state approaches to regulation of mail service pharmacies are "ill-fitted to the task of protecting those to whom the industry dispenses," and that policymakers must decide whether mail-order pharmacy should "continue to be deemed professional pharmacy practice, or is it better considered a drug product packaging and distribution operation."3 The analysis in that article lacks a proper foundation based on available facts. First, the author ignores the substantial and growing body of literature attesting to the generally high quality of dispensing by mail service pharmacies. Second, the author fails to substantiate his designation of mail service pharmacy as anything other than the practice of pharmacy properly regulated by the states in which the particular pharmacy is located. In fact, the United States Food and Drug Administration (FDA) conducted a field survey of mail service pharmacies in 1990 and concluded that mail service pharmacy practices "were not found to go be-
* Olwine, Connelly, Chase, O'Donnell, & Weyher, Washington, D.C. Mr. Stanton of the American Managed Care Pharmacy Association. Address correspondence Mr. Konnor at the American Managed Care Pharmacy Association, 2300 Ninth 210, Arlington, VA 22204. * Executive Vice President, American Managed Care Pharmacy Association, and Duquesne University School of Pharmacy. 1 Munro, Regulation of Mail-Order Pharmacy, 12 J. LEGAL MED. 1 (1991). 2 Id. at 58. 3 Id. at 3.
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yond the traditional practice of pharmacy."4 The FDA expressly determined that the retail pharmacy practices of these mail service pharmacies did not constitute repackaging or other activities that would warrant FDA regulatory action. Finally, a myriad of comments scattered throughout the article reveal that Mr. Munro essentially rejects the evolving nature of pharmacy practice today. Thus, he states that state regulation "assumes the direct involvement of the pharmacist with a patient during the process of dispensing,"5 and fears that "a major portion of prescription drugs in this country are going to be dispensed to patients absent a direct pharmacist/ patient relationship."6 The author also objects to the practice of pharmacy when "prescriptions are written by physicians not known to the pharmacist."7 Ultimately, as can be seen by his invocation of the words of Thomas Jefferson at the beginning of the article,8 he objects to the fact that many pharmacists are also businesspeople. The problem is that these issues permeate all forms of pharmacy practice—retail community and chain drugstores as well as mail service pharmacies. It is not inappropriate for Mr. Munro to decry the loss of old-time values and practices; however, he focuses solely on the demonstrably reputable group of mail service pharmacists and attempts to allege that the evils of modern times reside entirely with them.9 The article fails to point out that mail service pharmacies tend to stress professionalism to a significant degree. In contrast to the average retail drugstore that derives only a quarter of its revenues from prescription drugs and merely uses Pharmaceuticals "to lure customers into their stores," the mail service pharmacy tends to be dedicated exclusively to purchasing, storing, and dispensing prescription medicines.10 Mail service pharmacies use state-of-the-art technologies and ultra-modern facilities to assure a high level of quality at each step of the dispensing process.
4
Letter from Ronald G. Chesemore, Associate Commissioner for Regulatory Affairs, Food and Drug Administration, to James D. Dickinson, Re: 88P-0367/CP, Nov. 29, 1990. 5 Munro, supra note 1, at 16. 6 Id. at 7. 7 Id. at 45. 8 "Merchants have no country. The mere spot they stand on does not constitute so strong an attachment as that from which they draw their gains." Id. at 1. 9 Thus, for example, Mr. Munro never explains his passing reference to other forms of pharmacy practice that may omit a direct pharmacist/patient relationship. On page 35, for example, he begins the second paragraph "Chain operations aside" without explaining why this exemption is merited from the analysis of his entire article. 10 See Pharmacies Fight Off New Competition, N.Y. Times, Nov. 5, 1989, at F-17.
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I. INADEQUATE CITATION TO LITERATURE DEMONSTRATING HIGH QUALITY OF MAIL SERVICE PHARMACIES Mr. Munro alleges that the public is poorly served by today's regulation of mail service pharmacies. He invokes "the specter of tail-end dispensing failures that could defeat the entire system," and cites anecdotes such as a purported mail service pharmacy dispensing failure from the year 1987.11 Mr. Munro further concedes that he has no statistical evidence that dispensing errors of mail service pharmacies are high or, indeed, any different from those of other retail pharmacies. He "calls for empirical study to determine the risk involved in mail order."12 Again, he states that "regulators need to abandon anecdotal evidence and seek answers based on empirical data determining whether there are abnormal risks in mail-order pharmacies and whether mail-order patients are subjected to risks patients of community-based pharmacies do not suffer."13 Yet, Mr. Munro couples these concessions about his lack of information with a series of troublesome innuendos. For example, he states, "however, considering the volume of drugs dispensed by mail in the industry, one might legitimately question whether the postal regulations are being honored more in the breach than in practice."14 Again, "will any legislation that does not impose unreasonable burdens on interstate commerce . . . be effective in dealing with the perceived safety hazards involved in high-volume delivery of legend drugs?"15 And, "tort liability will impose costs on the mail-order industry that will offset savings made by sacrificing customer safety."16 These innuendos are especially unfair given the considerable and growing volume of literature that concerns the high quality of dispensing practice of mail service pharmacies. For example, the results of a study performed by researchers at Brandeis University yielded the following conclusions:17 "[T]he quality of drug products dispensed by mail service firms is very good." Moreover, dispensing procedures at mail service pharmacies "certainly compare favorably with community pharmacy operations whose size generally precludes checking by two or more pharmacists." And, "[c]oncerns expressed by community pharmacies have generally re11
Munro, supra note 1, at 2-3. Id. at 3. 13 Id. at 57. 14 Id. at 14. 15 Id. at 52. 16 Id. at 54. 12
17
BIGEL INSTITUTE FOR HEALTH POLICY, STUDY TO EVALUATE THE USE OF MAIL SERVICE PHARMACIES VI-
1, VI-6, & III-6 (Sept. 21, 1989).
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fleeted their apprehension of a new competitor. . . . Evidence offered in support of these allegations and any subsequent deterioration of patient care is anecdotal." Similarly, in 1987, the House of Delegates of the American Medical Association found that "MSPs [mail service pharmacies] are less vulnerable to drug diversion than retail pharmacies. . . . Presently, the practice of obtaining drugs from mail service pharmacies appears to be relatively safe."18 A Joint Committee of the Michigan State Legislature issued a similar report in 1988 observing that "mail-order pharmacy appears to be a safe and convenient method of obtaining Pharmaceuticals for millions of Americans and hundreds of thousands of Michiganians. . . . There is anecdotal information reciting problems with MOPs [mail order pharmacies] but little or no documentation to support alleged problems."19 In 1989, a Joint Committee of the Maine State Legislature also reported that "the Committee found no evidence that there was any difference in safety between having a prescription filled by mail and through an in-state pharmacy."20 A similar finding was made by the Tennessee College of Pharmacy. In 1986, the College of Pharmacy at the University of Tennessee conducted a study to determine the satisfaction of consumers using mail service pharmacies compared to consumers using retail pharmacy services. The report concluded that "most mail-order users report few problems and the overall rating of the service was excellent or good. In fact, the rating for mailorder services was slightly better than the rating for community pharmacy services."21 Mr. Munro also alleges, again without documentation, that mail service pharmacies do not provide appropriate counseling to patients. He states that "the requirement of a 24-hour toll-free telephone line is highly favored by community-based pharmacists who have salt rubbed in their economic wounds when they are forced to spend office time fielding telephone requests for counseling from patients of mail-order pharmacies."22 Moreover, he says "some states protect their citizens by requiring patient counseling by pharmacists . . . such statutes would be troublesome for
18 19
20
21
Resolution 9 1 , 1-86 adopted by the House of Delegates, American Medical Association (1987). Mail Order Prescriptions (Senate Concurrent Resolution 179), Joint Study Committee Report, Michigan State Legislature, Nov. 1988, at 7-8. Joint Standing Committee on Business Legislation, Report, Cost Containment for Prescription Drugs, State of Maine, 114th Legislature, Dec. 1989. T H E CENTER FOR PHARMACY MANAGEMENT AND RESEARCH, COLLEGE O F PHARMACY, UNIVERSITY OF TENNESSEE, EVALUATION OF CONSUMER OPINIONS OF PRESCRIPTION D R U G SERVICES FROM COMMUNITY AND M A I L O R D E R PHARMACIES 7 (1986).
22
Munro, supra note 1, at 3 1 .
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mail-order pharmacy services, but for the likelihood they are roundly ignored."23 And, "does an industry giant mailing 10,000 prescriptions per day meet the statute by having a single toll-free line?"24 Again, Mr. Munro ignores some important facts. The pharmacy practice standards of the American Managed Care Pharmacy Association call for the availability of consulting pharmacists to counsel patients "on problems with or questions regarding their drug therapy at any time prior to, during, or subsequent to drug therapy."25 Indeed, there is some evidence that mail service pharmacies may provide more counseling and information than do other kinds of pharmacies. As the Office of the Inspector General of the United States Department of Health and Human Services has found: [T]he differences in clinical services provided by MSPs [mail service pharmacies] versus other retail settings may be more theoretical than actual. In theory, pharmacists who have face-to-face contact with patients on a regular basis are significantly better equipped to elicit information, counsel patients, and monitor drug regimens. But, given the relatively low level of services that are actually provided in community settings, there may be little difference in the interventions received by patients, and in some cases, the information provided by MSP package inserts may be more than patients receive from their neighborhood pharmacists.26
Finally, it is worth noting that Mr. Munro concedes that any pharmacy with high error rates would be put out of business by the tort system. He properly observes that the legal standards for mail service pharmacies and other pharmacies are indistinguishable.27 As he points out, "the tort system is effective in assessing costs of consumer injury and death on the enterprise that caused the damage."28 As Mr. Munro concedes, mail service pharmacies have been doing business for more than 30 years. This is enough time to develop a track record and for the tort system to make its influences felt if necessary. In fact, independent observers have repeatedly reported on the high quality of mail service pharmacy practices. The author fails to discuss or even cite any of the relevant literature.
23 24 25
Id. at 32-33. Id. at 5 0 . AMCPA PHARMACY PRACTICE STANDARDS, PATIENT COUNSELING AND INSTRUCTIONAL INFORMATION
Standard VIII, at ¶ 2 . 26
See O F F I C E OF ANALYSIS AND INSPECTIONS, O F F I C E O F INSPECTOR G E N E R A L , DEPARTMENT O F HEALTH AND H U M A N SERVICES, T H E CLINICAL R O L E O F THE COMMUNITY PHARMACIST 9-10 (Nov. 1990).
28
Munro, supra note 1, at 5 4 . Id. at 5 5 .
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H. MAIL SERVICE PHARMACISTS ENGAGE IN THE PRACTICE OF PHARMACY Mr. Munro compounds the factual shortcomings of his article with conceptual confusion. He frames the conceptual issue as follows: "If, on the other hand, society deems the mail-order pharmacies too far removed from professional practice to be regulated like community-based pharmacists, then one need look no further than the pharmaceutical manufacturing industry for a model upon which to base regulation."29 Mr. Munro believes that mail service pharmacies are repackagers rather than retail pharmacies.30 But this is simply wrong, because it ignores the fact that mail service pharmacies provide their services directly to the ultimate consumer.31 It also ignores the recent investigation by FDA on this point. As the FDA concluded, "based on FDA's field survey results, the agency cannot agree . . . that [mail-order pharmacies] warrant application of CGMP [current good manufacturing practice] regulations. Nor did the survey find any repackaging practices that would warrant FDA enforcement."32 The author's analysis fails because mail service pharmacies, in fact, are responsibly engaging in the practice of pharmacy, as the FDA has determined. III. THE STATES TODAY ARE ACTING RESPONSIBLY BY RELYING PRIMARILY ON THE STATE IN WHICH THE PHARMACY IS LOCATED TO REGULATE MAIL SERVICE PHARMACIES Mr. Munro states: "[T]he primary and key issue that should occupy regulators is whether the public is adequately protected by the present federal and state regulatory web whose spinners did not contemplate the management of mail-order pharmacy."33 Failing to answer this question, except by innuendo, he rejects the usefulness of California-type disclosure legislation as a means of addressing the particular issues raised by the interstate activities of many mail service pharmacies.34 He argues that 29 30 31
32 33 34
Id. at 56. Id. at 4 2 . Thus, Mr. Munro makes the mistake of relying on United States v. Sene X Eleemosynary Corp., 479 F. Supp. 970 (S.D. Fla. 1979), to justify his proposal. He notes " t h e lack of a one-on-one relations h i p " or any relationship at all between the mail-order pharmacy and the patient that was the basis for that case. In fact, unlike the pharmacy in the Sene X case, mail service pharmacies receive their prescriptions directly from the patient or practitioner and dispense their pharmaceutical medications directly to the patient. F D A Letter, supra note 4 , at 3 . Munro, supra note 1, at 56-57. Id. at 5 1 .
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"such statutes will not be effective to ensure safety in the production line type setting in which this enterprise's drug products are dispensed."35 This conclusion fails along with its premise. Given the repeatedly demonstrated high quality of mail service pharmacy practice, the present form of pharmacy regulation by the states appears to be working quite well in protecting the health and safety of patients across the country. Mr. Munro also recognizes that regulation of mail service pharmacies must not create an unreasonable burden under the Commerce Clause of the United States Constitution. He observes that "the 'catch-22' that hampers the National Association of Boards of Pharmacy (NABP) in its proposal is fashioning a legislative tool that will effectively collar the industry without being an unreasonable burden on interstate commerce when potentially enforced by 50 states."36 What Mr. Munro fails to do is recognize that there is no need to "collar" mail service pharmacies. They are already well-regulated and inspected by the Boards of Pharmacy in the states in which they are located. Thus, the FDA stated: "FDA also disagrees with the petitioner that the states have not been effective in regulating mail-order pharmacies."37 Indeed, Mr. Munro concedes that he has no evidence that mail service pharmacies seek to locate in states that seem to have "the most lenient regulation."38 IV. THE NEED FOR WORKABLE IMPROVEMENTS Mr. Munro fails to propose workable improvements in today's responsible (and evolving) system of state regulation of the practice of pharmacy. First, he correctly cites the requirements of the Commerce Clause and then disregards it. He properly cites Pike v. Bruce Church, Inc.,39 and its three-part test: (1) Is the statute enacted to protect local economic interests against interstate competition? (2) Will the burden imposed on interstate commerce by the statute be outweighed by the benefit to the local interest protected? (3) Is there an alternative to the regulation that will impose a lesser burden on interstate commerce? Yet, after discussing the Commerce Clause, Mr. Munro proposes a burdensome regulatory system, including the following: licensure (not
35
Id. at 52. If Mr. Munro's reference to "production line" refers to the possibility of stress on the pharmacist, this again is an issue that affects all forms of pharmacy practice. See, e.g., Reducing Pharmacists' Stress, American Druggist, Jan. 1991, at 38-44. In fact, responsible pharmacies and pharmacists—whether mail service pharmacies or retail drugstores—take preventive steps to reduce pharmacist stress and assure quality dispensing practices. Munro, supra note 1, at 5 1 .
37
FDA Letter, supra note 4 , at 4. Munro, supra note 1, at 34. Id. at 17-18.
38 39
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registration); designation of a pharmacist that "some argue" should be "licensed in each state into which the pharmacy intends to mail"; conducting of inspections "if the home state's examinations are inadequate"; and finally, "it is doubtful that fewer requirements . . . will do any more than give a false appearance of regulatory control and safety."40 These regulatory burdens could cripple out-of-state pharmacies. A mail service pharmacy can comply completely with the pharmacy laws and regulations of any single state. As with Mr. Munro's suggestion that pharmacists be licensed in all of the states, compliance with multiple and overlapping state requirements is burdensome to the point of being economically prohibitive. On the other hand, this regulatory system offers few benefits. Mail service pharmacies are generally of high professional quality, and the FDA has found that today's system of state regulation properly protects the health and safety of consumers. Second, lacking evidence to show that mail service pharmacies provide anything but the highest quality pharmacy services, Mr. Munro has difficulty even defining the class of pharmacies to be subjected to his makeshift scheme. Thus, he proposes to exempt intrastate mail service pharmacies and mailings by community-based pharmacies "to patients visiting other states even for extended periods of time."41 He proposes these exemptions even if such pharmacies lack the face-to-face patient/ pharmacist relationship or personal knowledge of the prescribing physician whose absence he decries with respect to nonresident mail service pharmacies. Finally, Mr. Munro seems willing to jettison entirely his burdensome state-by-state regulatory system if the FDA were willing to regulate mail service pharmacies as manufacturers or repackagers. There is no logic to this approach. The scheme of federal regulation of manufacturers and repackagers is profoundly different and meets quite different health and safety concerns than does regulation of the practice of pharmacy that involves dispensing to the patient. While FDA Current Good Manufacturing Practice (CGMP) regulations address issues of purity and consistency of pharmaceuticals, it is state regulation of pharmacy that addresses the pharmacist/patient relationship and regulates dispensing practices. The ease with which Mr. Munro would give up his requirements such as multiple licensure of pharmacies and pharmacists by the 50 states betrays his own lack of confidence that they are needed or useful.
40 41
Id. at 47-48. Id. at 38.
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CONCLUSION In summary, Mr. Munro's article proposes an irrelevant remedy at the federal level (because FDA CGMP regulations do not apply to the practice of pharmacy), and unworkable remedies at the state level, to address a problem that does not exist. At the core of the article is a concern that emerging technological improvements can undermine traditional professional standards. Missing is recognition that technological progress—computerized patient records for checking drug interactions, and toll-free (800) telephone lines that provide an opportunity for patient counseling in greater privacy than is available in many drugstores, for example—can enhance rather than detract from professionalism. We are fortunate that technological advances are available for all types of pharmacies, including community and chain drugstores as well as mail service pharmacies. The responsibility of the pharmacy profession is to ensure that new technologies are adopted in such a way as to maximize the quality of dispensing practices and professional pharmacy services for patients.
