Physician connectivity: electronic prescribing

ISSUE BRIEF
Physician Connectivity:Electronic Prescribing Wednesday, February 23, 2000Washington, DC Jean Paul Gagnon, Ph.D.
Helene Levens-Lipton, Ph.D.
Schools of Pharmacy and MedicineUniversity of California, San Francisco David J. Gibson, M.D.
President
Harold M. Koenig, M.D.
Surgeon General (retired)U.S. Navy With comments from a representative of the pharmacy industry Online .com drug stores are healthcare destinationsfor commerce and content. . . . The market is stillsorting out how to value these companies. For exam-ple, companies like Drugstore.com trade at 398 times Physician connectivity—the electronic linking of trailing revenue, while a real estate–based Walgreen physicians with online resources such as clinical trades at 1.4 times revenue. It is clear that, in the long databases and sophisticated formulary systems—is term, these virtual companies will be valued upon allowing growing numbers of physicians to prescribe their contractual relationships. It is also clear thatwithout front-end electronic connectivity to the online via a handheld computer complete with formu- prescribing physician (emphasis added), the .com lary information as well as patient data and drug infor- pharmacies cannot deliver their promised increased mation. Advocates of this technology point out that it will yield fewer medication errors as well as increasedformulary compliance. Others, however, are not as This Forum session will focus on physician connec- enthusiastic, citing general concerns about online tivity within the broader milieu of online prescribing.
Specifically, discussions will highlight the use ofinformation technology in managing pharmacy risk. To On-line pharmacies are not only reshaping the way show how the actual process works, one of the speakers pharmaceuticals are prescribed, dispensed, and distrib- will demonstrate the use of electronic handheld wireless uted, but are also having a profound effect on the technology. The audience will also learn how physician parties involved: patients, doctors, pharmacists, bricks- connectivity is being used in the military. In addition, and-mortar drugstores, pharmacy benefit managers, and speakers will address issues of e-commerce as well as entrepreneurs. As is the case in all sectors of the digital its intended and unintended consequences and its effect economy, prescribing in cyberspace poses challenging on various stakeholders as traditional relationships are policy questions. As regulators tread gingerly, balanc- ing First Amendment rights with consumer protectionand weighing ethical and safety issues against patientempowerment and convenience, questions of jurisdic- PRESCRIBING ONLINE
tion and responsibility have become entangled, result- “Physicians should never again write a prescription.
Given the explosion of scientific information and Many different types of prescriptions are written, representing several distinctions which need to beindividually assessed in determining appropriate regula-tory policy. The American Medical Association (AMA)articulated these in its June 23, 1999, resolution oppos- ISSUE BRIEF/No. 752
ing Internet prescribing. As reported in the July 19, Analyst/Writer:
1999, issue of Millin’s Health Fraud Monitor, back- ground materials prepared for the AMA’s House ofDelegates carefully distinguished between National Health Policy Forum
legitimate telemedicine as opposed to mail order pharmacy with a little electronic form perused by a physician to give it legitimacy. There also were distinctions for physicians ordering refills for patients and physicians taking action over the Internet when the physicians know the patients and have their medical records available when prescribing. Simplytransmitting prescriptions to pharmacies via the Judith Miller Jones, Director
Karen Matherlee, Co-Director
Not surprisingly, Wall Street has also taken an Judith D. Moore, Co-Director
interest in these online companies, and their relationship Michele Black, Publications Director
to pharmaceutical prices, company margins, pharma- NHPF is a nonpartisan education and information
ceutical benefit trends, and managed care profitability.
exchange for federal health policymakers.
A new player has emerged to challenge the dominantposition enjoyed by the community-based pharmacy.
advances in computer technology, prescribing medica- eliminating errors stemming from illegible handwriting tions on a blank piece of paper will soon seem as on paper prescriptions, physician connectivity products antiquated as ordering tinctures of botanicals in Latin.”3 can supply the prescribing physician with several keypieces of patient-specific data, including the patient’s Gordon Schiff and Donald Rucker used the above history and drug interaction warnings, enabling doctors quote to open an April 1998 article in the Journal of the to closely monitor compliance and dosing regimens.
American Medical Association extolling the virtues ofcomputerized prescribing. The authors wrote about the Advocates of physician connectivity also point to the positive impact computerized prescribing could have on greater efficiencies such online information can provide Reliance on the telephone to conduct health care Patient role in pharmacotherapy risk-benefit deci- transactions is part of the inefficiency estimated to cost the industry as much as $280 billion a year. In  Screening for interactions (drug-drug, drug-labora- round numbers, of the 30 billion health care transac-tions per year, more than 90 percent are conducted by phone, fax, or mail. At the moment, prescription  Linkages between laboratory and pharmacy.
writing takes up an incredible amount of time. Atypical primary care doctor writes as many as 30  Dosing calculations and scheduling.
prescriptions daily and handles an equal number of renewals. Renewals, usually triggered by a call from Coordination between team members, particularly the pharmacist, are particularly time-consuming. After the patient’s chart is pulled, at a cost of $5 to $7, the doctor must review the prescription, consider new Monitoring and documenting adverse effects.
medical conditions that may have arisen, check the  Postmarketing surveillance of therapy outcomes.
patient’s formulary and drug history, and screen forpotential adverse reactions. A nurse then calls the The authors conceded, however, that “development of pharmacy back. Studies of doctors’ offices by Merck- this tool has been impeded by a number of conceptual, Medco found that nurses on average spend 80 percent implementation, and policy barriers.” The almost two of their time handling prescriptions. For doctors, the years since their article was published have seen great average is 30 minutes. More than half of the clinicalcalls to doctors concern pharmacy issues.4 advances in technology and the use of the Internet.
Computerized prescribing, where the physician enters Physician connectivity would cut the time spent on orders into pharmacy computers is evolving into today’s these issues dramatically. And, by enabling physicians more ergonomically acceptable handheld wireless to send prescriptions directly to the retail pharmacy or the mail order facility, physician connectivity promisesto further improve quality and enhance efficiency.
While some experts are concerned about the poten- tial marketing and commercial exploitation of online Decreasing Costs and Managing Risk
prescribing, advocates cheer its potential to improve thequality of health care, decrease costs, manage risk The improved efficiencies to doctors and pharma- cists and throughout the entire drug distribution systemis likely to lead to a restructuring in the marketplace. It Improving Quality and Enhancing
will be some time before all these interrelated factors Efficiency
“shake out” but advocates of physician connectivitypredict these system efficiencies will translate into The Institute of Medicine’s (IOM’s) Committee on overall cost savings, along with reductions in the Quality of Health Care in America released its report on number of liability suits as quality improves and medi- medical errors and patient safety on November 29, 1999. The report, which emphasized the widespreadnature of medical errors, including medication errors American consumers spend over $100 billion a year and adverse drug reactions, stated that “having physi- on prescription medications. As more practice groups go cians enter and transmit medication orders online at risk, managing drug costs will be critical for their (computerized physician order entry) is a powerful survival. At the December 1999 National Congress on method of preventing medication errors due to misrep- the Future of Pharmaceuticals in Medical Care, David J.
resentation of hand-written orders.” In addition to Gibson, M.D., president of RxPhysician.com, indicated that practice groups making mistakes on their per- General Jeremiah “Jay” Nixon alleged that “the defen- member-per-month contracted budgets are financially dants violated state medical and merchandising laws by doomed and will fail. Also important is getting the trend selling prescription drugs to consumers without a line right. According to Gibson, “a group cannot man- license and on the basis of information provided solely age risk without a point-of-decision-making information in on-line consultations.”5 Illinois and Kansas have filed system,” that is, physician connectivity. At its core, physician connectivity is a variation on the onlineprescribing theme.
Federal Authority
States are not alone in their efforts to combat un- REGULATORY RESPONSIBILITY
sound practices. The Federal Trade Commission is HERE AND ABROAD
concerned with consumer protection, rooting out fraudand misinformation as well as shouldering responsibil- As traditional pharmacy “morphs” into online ity for the advertising of nonprescription drug products.
pharmacy, the existing regulatory apparatus is ill- The FDA oversees drug quality and the advertising of equipped to deal with the complex emerging issues that prescription drugs, while the Drug Enforcement Admin- cross state, national, and international boundaries. It is istration regulates controlled substances. The Depart- this issue that concerns many experts.
ment of Justice enforces civil consumer protectionstatutes as well as criminal provisions. Lastly, the U.S.
Domestic Sites
Customs Service and the U.S. Postal Service enforce In the United States, non-over-the-counter medica- regulations and laws governing the importation and tions require a prescription written by a physician. The domestic mailing of pharmaceutical products.
medication must be approved by the Food and Drug As a result of congressional prodding, these agencies Administration (FDA), the physician must be licensed are in the process of sorting out which agency should take by a state medical board, and the pharmacy and its the lead responsibility for online prescribing activities. A pharmacists dispensing the medication must be licensed March 25, 1999, letter on the subject of Internet pharma- by state pharmaceutical boards. Online pharmacies have ceutical sales, cosigned by Reps. Henry A. Waxman (D- distorted this process. For example, in most states, a Calif.), John D. Dingell (D-Mich.), Ron Klink (D-Pa.), physician’s prescribing of medications for patients and Sherrod Brown (D-Ohio), posed several questions to outside the state where the physician is licensed (which the FDA as Commerce Committee Democrats pushed to often is the case with online pharmacies) constitutes the clarify which agency should take the lead. The following In some cases, physicians employed by Internet sites  What agency or department (at either the state or (cyberdoctors) write prescriptions for “patients” they have federal level) does FDA believe is the primary regula- never met or examined, a practice the American Medical tor of Internet pharmacies? For this question, please Association has proclaimed unethical—although, as the also identify and describe the roles of the other state/ AMA points out, the practice is not illegal. Not all online federal agencies that may make up this structure.
pharmacies employ cyberdocs or violate licensing laws,however. Sites such as CVS.com (which purchased  What specific activities or functions does FDA Soma.com) and others do not use cyberdocs; rather, believe it is responsible for with regard to regulating prescriptions are verified by patients’ doctors over the Internet pharmacies? Please describe both the telephone. Also, many sites are or are in the process of precise activities now conducted by FDA, and the becoming licensed in every state in which they ship.
number of full-time equivalents (FTEs) dedicated toall identified efforts. Does FDA believe it has Still, the number of online pharmacy sites is growing enough resources to conduct the activities it pres- and many are arguably on shaky ground when it comes ently feels are under its jurisdiction in this regard? If to sound safety, ethical, and legal practices. A recent not, what additional resources does FDA require? court case, Missouri v. Stallknecht, highlights some ofthese concerns. In this case, a Missouri judge issued an  Does FDA believe that existing laws and regula- injunction against the online Texas-based pharmacy, tions, or the present state/federal regulatory structure Pillbox.com, owned by Bill Stallknecht, blocking the adequately regulate online pharmacy operations? If site’s unlawful sale of prescription-only drugs to not, what are the discrepancies, and what changes, Missourians over the Internet. Missouri Attorney  Please describe FDA’s knowledge regarding the from a regulatory and enforcement perspective. Robert differences between existing online pharmacies. For Pear reported in a January 9, 2000, New York Times example, some reports suggest that most online article that “the number of packages with prescription pharmacies only fill prescriptions. Other reports, drugs seized by the U.S. Customs Service totaled 9,725 however, have suggested that some actually provide in 1999, 4.5 times as many as in 1998.” Experts ac- for a doctor consultation (for example, a quick knowledge that this is only the tip of the iceberg. In questionnaire is submitted over the Internet, it is addition to violating import laws, many of the products reviewed, and then the prescription is approved and seized have been found to have been misbranded, non- sent directly to the patient without a doctor ever FDA approved, and of substandard quality. Successfully seeing the patient). How prevalent is this latter remedying the safety, ethical and legal challenges will operation? Do any trends appear in comparing one require the cooperation of a wide range of authorities, organizations, and regulatory agencies, as well as the pharmaceutical and pharmacy industries themselves.
What is FDA’s understanding of how these firmsdeal with issues such as medical records, privacy/ But the road ahead will not be smooth. Pear makes protection, the selling of controlled substances, or drug interactions? How serious are these issues and regulation of offshore Internet sites is tricky for the what shortcomings, if any, do online pharmacies Clinton administration because Vice President Al have with regard to these issues? Does FDA have Gore and other Democrats continually berate drug any knowledge of how online pharmacies prevent companies for charging higher prices in the United unqualified persons from receiving prescriptions? States than in other countries, and one of the main Are online pharmacies more susceptible to fraud or reasons consumers buy online from foreign pharma- deception? If so, please explain how.
 Finally, what quality issues does FDA believe relate Others, however, take issue with the claim that prices of to the methods used to ship online pharmaceutical pharmaceutical products purchased online are lower products, and does FDA believe it has jurisdiction in and point to embarrassment and convenience as the Although many sites advertise lower prices to con- The FDA responded to the questions of Waxman sumers than otherwise available, Bloom and col- and his colleagues with a letter dated May 7, 1999, and leagues found that this was not the case. On average, signed by Melinda K. Plaisier, interim associate com- prices for Viagra and Propecia were about 10 percent missioner for legislative affairs, with copies sent to more expensive when they were obtained from a local Reps. Thomas J. Bliley Jr. (R-Va.), Michael Bilirakis Web site than from a local pharmacy. Of course, (R-Fla.), and Fred Upton (R-Mich.). (The FDA’s Web consumers may be willing to pay more for the conve- site, at http://www.fda.gov, addresses many of the Nevertheless, the Clinton administration has moved ahead with a plan to crack down on Internet pharmacy Foreign Sites
irregularities by having the FDA require Web sites tocertify that they are in compliance with existing state A June 18, 1999, FDA Week article, “House Panel laws and to display a seal. The White House proposal Asks Feds to Clarify Roles on Regulating Internet Rx,” calls for $10 million for FDA to hire more personnel to regulate both domestic and foreign sites that prescribe While the committee as a whole is looking into the matter, congressional sources say a rift is developingbetween Democrats and Republicans because the In addition to the Clinton proposal, similar measures Republicans are more protective of the states’ juris- are sprouting up in the private sector. In an effort to diction over pharmacies. But Democrats stress that the assist consumers with determining “reputable” sites problems posed by foreign sites are beyond the states’ (that is, sites that have licensed pharmacists), the ability to regulate on their own and need federal National Association of Boards of Pharmacy (NABP) has established a voluntary certification program called While all indications point to the eventual monitoring VIPPS—Verified Internet Pharmacy Practice Sites.
of domestic drug Web sites for safe, ethical, and legal Receiving a VIPPS seal of approval requires on-site practices, non-U.S. sites pose a monumental problem inspection and compliance with 17 criteria, including documentation of licensure compliance in all jurisdic- impure online prescription or suffers some other tions where the site conducts business. In a recent development, the FDA is considering working with the  What are the minimum requirements for clinical NABP to oversee pharmaceutical Web site inspections.
(Details, such as the retention of FDA oversight author-ity and federal access to information, are still under This Forum session will begin with an overview of discussion.) In a similar vein, the Federation of State e-commerce and an update on Internet pharmacies by Medical Boards is working with the AMA to develop a Jean Paul Gagnon, Ph.D., director of health policy for
model practice act that would delineate the minimum Aventis Pharmaceuticals (the new life sciences com- steps necessary to generate a valid prescription, such as pany resulting from the merger of Hoechst Marion taking a history, conducting a physical, and providing Roussel and Rhone-Poulenc Rorer). David J. Gibson,
M.D., president of RxPhysician.com, will discuss the
use of information technology to manage pharmacy
risk. Dr. Gibson will provide a demonstration of the
THE FORUM SESSION
cutting-edge technology being piloted in many physi- A number of policy questions arise as experts cian practices today. Helene Levens-Lipton, Ph.D., a
grapple with the complexities of online prescribing and professor at the Schools of Pharmacy and Medicine at physician connectivity. Among them are the following: the University of California at San Francisco, willaddress the issue of patient-provider relationships,  How will the traditional roles of pharmacist, physi- examining the intended and unintended consequences cian, and patient evolve as a result of online pre- of online prescribing. Physician connectivity is not a new phenomenon in the military. Harold M. Koenig,
 What impact will online prescribing and physician M.D., a retired surgeon general of the navy, will
connectivity have on future pharmacy benefit design? highlight the lessons learned regarding the use of onlineprescribing and physician connectivity in military  What role, if any, will online prescribing and physi- medicine. Wrapping up the session will be comments cian connectivity play in research (that is, clinical from a representative of the pharmacy industry.
 Who will have access to patient data? As physician connectivity takes hold, what effect ENDNOTES
 How will physician connectivity affect market share 1. “AMA Opposes Internet Prescribing, As Do AGs in Kansas and Missouri,” Millin’s Health Fraud Monitor, July19, 1999, 5.
 Who bears the costs associated with physician connectivity? Who realizes the savings (that is, from 2. David J. Gibson, “Innovation in Pharmaceutical Distribu-tion: Wholesale, Retail, Mail Order and Internet,” paper improved physician compliance with formularies)? presented at the National Congress on the Future of Pharma-  Are prescription drugs really less expensive when ceuticals in Medical Care, December 8-10, 1999.
purchased over the Internet, given shipping charges 3. Gordon D. Schiff and Donald Rucker, “Computerized and, in some cases, the lack of acceptance of pre- Prescribing: Building the Electronic Infrastructure for Better Medication Usage,” Journal of the American MedicalAssociation, 279, no. 13 (April 1, 1998), 1024.
 How will the pharmaceutical distribution process change as a digital infrastructure is incorporated into 4. Michael Menduno, “apothecary.now,” Hospitals and Health Networks, July 1999, 35-36.
 What, if any, is the future of group purchasing? 5. “Cyberpharmacies Zapped by State Regs—Legal Update,”Business and Health, December 1999, 12.
 What, if anything, can be done to protect consumers 6. Katrina Armstrong and Bernard S. Bloom, “Sale of against illegal offshore sites selling and distributing Prescription Drugs over the Internet,” LDI Issue Brief, 5, no.
 Who or what entity would be liable when someone is injured as a result of receiving an incorrect or

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