Ad Hoc Cmte on Protocol Rel to the Est of Patient-Practitioner Relshp

Mrs. Knaperek David Landrith

Mr. Quelland Hal Wand

Mr. Weiers, Chairman

Members Absent

Mr. Brown Timothy C. Miller

Mr. Konopnicki Dr. Theodore G. Tong

Speakers Present

John Mills, Majority Research Analyst, Health Committee

Jonathan D. Linkous, Executive Director, American Telemedicine Association (ATA), Washington, D.C.

Joel Korsunsky, Secure Medical Incorporated

Stuart Goodman, Lobbyist, Arizona Medical Board

Adam Palmer, Attorney

Matt Salmon, Lobbyist, Secure Medical Incorporated

John Mills, Majority Research Analyst, Health Committee, stated that the underlying factor of the Committee is to see what needs to be done to establish a patient-practitioner protocol dealing with new tools becoming available in the medical community, such as telemedicine and the Internet.

Jonathan D. Linkous, Executive Director, American Telemedicine Association (ATA), Washington, D.C., advised that ATA is a nonprofit, membership-based organization that has been in existence since 1993. Members include individuals and institutions involved in telemedicine, such as physicians, nurses, hospitals, health care administrators, vendors of equipment, etc. The association supports and guides growth of the field of telemedicine, which is the exchange of medical information from one site to another via electronic communications to improve patients’ health status. Telemedicine is not a separate specialty for medicine nor is it always considered an adequate substitute for direct in-patient consultation with a physician; however, it can and should play a very important role in health care, particularly as it provides advances in efficiency, quality and access.

Mr. Linkous advised of telemedicine programs in Arizona: The Arizona Telemedicine Program headquartered in Tucson at the University of Arizona (Attachments 1, 2 and 3); the Northern Arizona Regional Behavioral Health Authority (RBHA), which provides remote mental health services to Medicaid patients primarily in Arizona; and MedAir, a private company that promotes remote medical services primarily to airlines, is headquartered in Arizona. The Legislature also has a history of supporting telemedicine.

He related that telemedicine is used in almost every state in the United States (U.S.) by large medical centers and small health centers. About 200 telemedicine networks currently in operation link about 3,500 sites and provide remote specialty service to thousands of people every day. About 50 specialty and major subspecialty groups provide information from dermatology to pathology to mental health. Home care monitoring is also provided, i.e., about
1 million patients in the U.S. have cardiac devices monitored remotely.

Mr. Linkous said telecommunications is transforming the way in which health care is delivered. One of the uses in telecommunications is the Internet by which over 20 million Americans seek health information every day. Some of the information is good and some is not, so it has become a challenge to regulators and health care providers to make sure consumers obtain accurate information. Traditionally, health care providers are considered the ultimate authority in medical care, but physicians are now challenged by patients who bring in reams of information from the Internet.

Mr. Linkous stated that the use of remote telecommunications has also become a way of obtaining prescriptions. For example, many telemedicine programs in the U.S. provide prescriptions using remote telepharmacy applications. Robotic telepharmacy applications exist in several states enabling access to pharmaceuticals. On-line web sites have become another source of prescription drugs, and in some cases, provide illegal drugs, sometimes issue prescriptions without the approval of an authorized practitioner, and use counterfeit or
low-quality materials; however, in many cases, on-line filling of prescriptions has become an important vehicle in the delivery of health care. In fact, every pharmaceutical chain in America now offers filling of prescriptions on-line.

Mr. Linkous conveyed that the Arizona Attorney General recently conducted a statewide prescription study over a five-month period and found that the price of prescribed drugs varies among pharmacies by as much as 60 percent, and consistently lower prices were available on-line or through mail order sources with typical savings of about 17 percent compared to the average Arizona price. Several issues affect the use of on-line pharmacies and on-line prescribing:

Who can prescribe. Every state licenses health care professionals and designates specific authority that individuals have in making a prescription, but in recent years many states have allowed non-physicians to make a limited number of prescriptions. According to a U.S. Department of Justice study, as many as 12 different mid-level health care professionals are authorized by various states to issue some form of prescription, such as physician assistants, nurse practitioners, psychologists and registered pharmacists. Usually these individuals are only allowed to prescribe certain low-risk drugs and the prescribing professional is sometimes, but not always, required to be under the direct supervision of a licensed physician.
Where a prescription can be issued. Each state requires that health care professionals licensed in that state be eligible to write a prescription that can be filled in that state; however, it is interesting that if a patient resides or is visiting in another state, that prescription can still be filled in the state if it originates from the patient’s regular physician.
What can be prescribed. Schedule I controlled substances identified by the Drug Enforcement Agency (DEA) are not and should not be available by prescription. Low-risk drugs receive the least amount of restrictions and many fall under regulations established by the Food and Drug Administration (FDA) or individual states.
On what basis a prescription can be made. Generally, there is agreement by government regulating bodies that a prescription should be made based on an understanding of the patient’s complaint, current health status and medical history. Although the U.S. Department of Justice addressed the issue of minimal standards for issuing prescriptions in about 10 states, which indicates a determination of the current health status based on an examination, there are no legal specifications as to what makes up such a physical examination. These judgments are up to the health professional who issues the prescription; however, certain types of conditions and resulting medications require different types of examinations.

Low-risk drugs require the least amount of assessment by a health care provider. Prescriptions by mid-level professionals do not necessarily include a physical examination of the patient in many states. In practice, many prescribing professionals issue prescriptions based on a survey filled out by the patient, a set of vital signs often taken by an assistant sometimes followed up by the professional and a brief conversation with the patient. Increasingly, health care providers are also using email to provide follow-up communications with a patient, including issuance of additional prescriptions for certain low-risk medications. Such communications are starting to be reimbursed by major private insurers and employer health plans throughout the country. In established telemedicine programs such consultations can and do involve an electronic visit with a patient where the prescribing professional is not physically in the same room, but can still access vital signs and communicate directly with the patient either using live communications or store and forward.

Mr. Linkous informed Mrs. Knaperek that a low-risk drug is a low-level pain reliever or drug prescribed by a physician for an ailment that might be used in other instances and does not have the same level of restrictions as high-risk drugs by the DEA or state.

Mrs. Knaperek stated that although it is not happening because of the advent of telecommunications in health care, individuals go to primary care physicians, specialists, etc., and different drugs are prescribed, but there is no medical “home” to consolidate all of the information; therefore, an individual could end up taking drugs that contradict each other. She questioned how that can be prevented or if there is some way to be proactive in dealing with the issue. Mr. Linkous responded that the problem has existed for a long time, but could be more serious now with more specialized drugs and the number of drugs available. There is a problem with patients shopping around. He advocated for a health information system that would provide a unified way of keeping track of patient medications using standardized programs that are available to automatically check the interaction of drugs.

Mr. Linkous submitted that an established telemedicine program sets consultations and prescriptions involve electronic visits, which do not necessarily involve direct hands-on physician-patient interactions. Remote services have become commonplace throughout the U.S. and many other parts of the world, and in rural out-of-the-way locations, support access to health care that otherwise could not be achieved, but also allows for more efficient use of health care.

He stated that although ATA has not taken a position on the basis for a prescription, it is clear that certain types of medications can and should only be made available based upon direct consultation with the patient, or in some cases, physically seeing the patient or making a referral to a specialist who may physically need to see the patient. In those cases, it is up to the licensed health professional to determine what vital signs are taken, if additional tests are necessary, and when a patient should be seen in person by another health professional; however, many states are starting to rethink what constitutes the traditional physician-patient relationship.

Mr. Linkous said some states allow certain medications to be filled by mid-level professionals, such as a pharmacist, without a direct physical examination, and generally all prescriptions should be filled by patients in their own location even if it is different from the location of the doctor. Telemedicine programs provide high quality health care, sometimes without the provider ever physically seeing the patient. Advances in technology and changing public opinion about consumer empowerment to make their own health care decisions have resulted in changing the public policy landscape. Any state or federal law that is considered regarding the issuance of prescription-based or electronic communication should be carefully crafted and hold foremost the rights and needs of the individual. Any action taken by the State Legislature or state medical board should be crafted in such a way that it does not interfere with the regular ongoing practices of established telemedicine programs.

Mr. Quelland noted that the Veterans’ Administration (VA) has one of the finer health information systems in the country in relation to dispensing of pharmaceuticals and asked if the VA allows prescriptions to be written and dispensed without a one-on-one consultation between the doctor and patient. Mr. Linkous answered that he is not familiar with VA regulations; however, the question is whether consultation with a physician one-on-one means an in-person, in-the-office physical examination. He is aware that the VA has about 300,000 remote visits per year with patients, but he does not know if prescriptions are issued based upon a non-physical examination.

Mr. Linkous clarified for Mr. Weiers that remote consultation in telemedicine varies. For example, the RBHA sees patients live, through interactive video, or store and forward where information is attached to emails and sent back and forth, so there is a discussion between the health care provider and the patient, and upon that basis, prescriptions are made.

Mr. Weiers asked if the store and forward occurs after the initial video consultation.
Mr. Linkous said not always. On some occasions a physician may not have a video consultation with a patient, but may have information provided through store and forward, such as vital signs or whatever is needed. For a dermatologic case, for example, it could be an image of the skin lesion in question, and a prescription is made on that basis.

Mr. Quelland noted that clinical pharmacists have one-on-one relationships with patients who have been prescribed drugs, and he is aware of several cases in which clinical pharmacists caught mistakes by doctors who prescribed medications that would be harmful in combination. He believes there should be some discussion about their role in doctor-patient Internet prescriptions. Mr. Linkous replied that as he stated earlier, states around the country are looking at a wide variety of mid-level professionals. The Department of Justice’s website contains a chart of the types of practices and professions allowed in different states.

Mr. Quelland asked how it is possible, in putting together a patient and a doctor with no prior relationship, to secure and access the medical history of the patient, especially if a new drug is prescribed. Mr. Linkous replied that it happens all the time. If a patient goes to a new physician, the patient fills out several pieces of paper, which are given to the physician who uses the information along with vital signs and issues a new prescription. In an ongoing situation where someone has a pre-existing condition, the physician will sometimes request or require the patient’s medical records from the previous health care provider, but often a new physician will insist on doing his/her own workup.

Mr. Quelland asked who has the right to access a patient’s medical history. Mr. Linkous surmised that it is fairly clear in federal law that a patient’s privacy should be protected, so a physician generally cannot release the information to a third party without approval of the patient.

When Mr. Quelland asked if a patient in the U.S. can obtain his/her medical information from a health care provider free of charge, Mr. Landrith explained that Arizona’s medical records statute enacted in the mid-1990s states that the patient is entitled to a free copy of his/her medical record or a summary if the record is huge. If it is to be used for further medical purposes, other people have to pay for the record.

Mr. Linkous submitted that if there are radiological or video images, such as an ultrasound or EKG, a substantial cost could be involved in reproduction. Mr. Landrith said doctors do not like the law for that reason, but medical record is defined in the statute as including all of those items. Sometimes it is possible to negotiate with the patient on what may or may not be needed, but if a patient insists, the patient can have a copy of the entire record.

Mr. Quelland opined that it is important to the state to establish a health information system. Doctors and hospitals would probably lose rather than gain income, but the real winners would be health care plans and individuals who should bear the brunt of the cost.

Mr. Landrith remarked that consultations, almost by definition, are based upon a referral from another physician who has already seen the patient, developed a record and is looking for advice on an area in which the physician is not familiar. In the telemedicine sense, sometimes the physician is present with the patient and sometimes not, but information goes back to the original record from the consulting physician who has information that makes it more appropriate to issue a prescription. Mr. Linkous agreed that happens in many cases.

Mr. Weiers asked the definition of a doctor-patient relationship. Mr. Linkous responded that he does not have an answer since the ATA Board has not taken up the specific definition.

Public Testimony

Joel Korsunsky, Secure Medical Incorporated, commented that it is unfortunate there is no representation from the Arizona Medical Board whom he hoped would have the opportunity to address Mr. Linkous. He stated that he believes the philosophy shared today is that a health care system driven by consumers and shaped by market forces, powered by technology can actually improve efficiency, lower costs, increase choice for consumers, and improve quality without sacrificing patient safety. Technology changed the landscape for obtaining medical advice and prescription medications, and the use of an on-line or telephone consultation to provide medical information, along with a prior medical history, allows a licensed U.S. physician to approve or deny a prescription for a previously diagnosed condition, and thereby, should constitute a doctor-patient relationship.

Mr. Weiers asked if he is aware of a prescription ever being denied because of a telephone conversation between a doctor and patient, to which Mr. Korsunsky answered in the affirmative.

Mr. Korsunsky stated that the crux of the issue is the definition of the doctor-patient relationship. He noted that lifestyle drugs are optional medications that are not needed to survive and are generally low risk, such as Propecia for hair loss, Viagra for erectile dysfunction and Tamiflu for the Avian bird flu. For example, if someone is on a business trip to Romania where there is a threat of the Avian flu, and there is a shortage of Tamiflu, there is no quantitative test a physician could perform. Since it is a prescription medication, the only thing that could be done is provide a questionnaire about the patient’s health as justification for providing the prescription.

Mr. Weiers asked if a telemedicine situation becomes part of the patient’s medical history.
Mr. Korsunsky agreed that it does. He read excerpts from American board certified physicians who have been prescribing selected low-risk medications by utilizing an on-line questionnaire in conjunction with a prior patient history derived from the patient verbally or electronically to determine eligibility for prescription medication. The physicians could not attend the meeting or chose not to for anonymity:

Physician #1: Unquestionably more qualified than the traditional clinic-based family practitioner, I have been involved with the field of telemedicine for over five years both as a treating physician and as a Web consultant. My experience includes reviewing medical records, telemedicine consultations with evaluation of medical records and patient discussions of condition (live), evaluation of patient histories with specific attention to chief complaint, and Web Cam exams, done in real time with medical records reviews. Each and every one has been based upon an established physician-patient relationship sufficiently detailed so as to enable adequate assessment of the patient’s chief complaint, past medical/surgical history, review of current medications, allergies and adverse reactions, recommendations for therapy, further testing, and/or expectations of the treatment plan. I have not found one method to be more effective than another provided the information submitted is sufficiently explicit so as to allow a clear and thorough understanding of the stable, chronic condition under review (entire comments, Attachment 4).

Physician #2: One may argue the definition of the doctor-patient relationship; however, such discourse is obviated as we require all patients who request prescriptions for such lifestyle medicines as Propecia, Viagra, etc., to affirm that they have an established local licensed physician (either M.D. or D.O.) that approves of their use of the requested pharmaceuticals. Additionally, patients must promise to follow-up with their physician at least annually or more often as instructed for full physical exams and laboratory studies. Finally, their physician’s name and office number are provided should the need for validation arise. Such prescriptions have proved relatively safe and lend themselves to on-line prescribing as opposed to controlled substances, which I do not prescribe even in my own practice except in very rare extreme circumstances.

An absolute hallmark of on-line prescribing is E-Prescriptions whereby the data of the script is transmitted securely and instantly to the fulfilling pharmacy and in a most legible fashion, thus eliminating human error due to attempts at deciphering handwriting. On-line prescribing was first to utilize this important advance years ahead of traditional medicine’s acceptance and implementation.

Physician #3: This is to inform you that during the course of the past five years, I have been privileged to have been able to prescribe lifestyle medications for patients over the Internet. In innumerable of these patients’ cases, the given patient has communicated to me just how pleased he felt to be able to avail himself of “this more impersonal, but nevertheless, professional” way of receiving medication without, for instance, having to go to his private physician who might have been a golfing partner or having to be observed by that physician’s medical assistant who might have been his wife’s cousin and/or without his having had to face his brother-in-law pharmacist were he, otherwise, to have had to go to his small town’s only pharmacy. I do sincerely hope that the above information helps you to understand that, when practiced properly, Internet prescribing for lifestyle medications can be performed in a highly professional manner for the patient’s benefit (entire comments, Attachment 5).

Mr. Landrith referred to the scenario Mr. Korsunsky envisioned regarding Tamiflu and stated that it does not sound any different than that of malaria medication when someone visits Peru or another place where big misquotes bite; however, malaria medication would not be viewed as a lifestyle drug because of the side effects and medical need for the medication. Based upon that analogy, Tamiflu falls into the category of need and not lifestyle. Mr. Korsunsky apologized and remarked that Mr. Landrith is 100 percent correct.

Mr. Korsunsky stated that his goal is to satisfy the Committee that board certified physicians are placing their licenses on the line every time they write a prescription for lifestyle medications. Physicians are highly trained individuals who should be allowed the courtesy of utilizing their knowledge and expertise in the fields in which they practice, and to that end, these people are reputable and know what they are doing.

Mr. Weiers noted that flu shots are given at clinics and he is not even sure a questionnaire must be filled out prior to receiving the shot. It appears that caution has been “thrown to the wind” to see how many people can be vaccinated, but that is a prescription.

Mr. Wand indicated that there is a difference between administering and dispensing a drug. A doctor can administer a drug like a flu vaccine, which is what happens in situations in Fry’s and Walgreen’s. Dr. Mollen, a D.O. in Phoenix, runs many clinics in town and across the country where flu shots are administered to patients based on his authority. Pharmacists cannot dispense a flu vaccine without a written or verbal prescription. He acknowledged that there is not a doctor on site, but the shots are given by nurses under the authority of a physician at a remote location.

Mr. Landrith indicated to Mrs. Knaperek that to his knowledge, there is no definition for lifestyle medications in statute. There is a classification system for drugs based upon the potential for harm infliction, etc., but he believes lifestyle medication is a relatively new issue.

Mrs. Knaperek surmised that Accutane for acne should not be available for purchase over the Internet, to which Mr. Wand agreed. When Mrs. Knaperek indicated that some guidelines are needed, Mr. Wand remarked that the FDA is involved in most of these decisions. He served on a task force where drugs were reviewed to determine if the medications should be over-the-counter (OTC) or prescription. The state could not pass a law saying a medication is OTC against federal law, which is an issue for some of the drugs. There are probably many drugs that could be OTC, but that is a political issue he would rather not address.

Mr. Wand clarified that the committees formed by the FDA take into account the cost benefit relationship and if there is a side effect that could impact a significant number of people. The scientific committee must be convinced it is safe to go OTC. He is not aware of a standard that is used; the medications are either OTC or prescription. Over the years, many pharmacists have tried to make a third class of drugs that pharmacists could dispense. Florida has a pilot program in which pharmacists can prescribe about six or ten drugs even though the medications are federal prescription items. There is limited prescription authority to pharmacists in several states, including Arizona. He clarified for Mr. Weiers that a waiver was obtained for the Florida program, or it is under a protocol approved by the medical and pharmacy boards.

Mr. Weiers remarked that the ultimate goal is to do what is best for the consumer, which is protecting the patient, getting the best cost, convenience, and there is the issue of politics. Some medications are still prescription in order to reimburse the cost for research and development of the medication. If that is not done, no one would go into that field and new drugs would no longer be developed. Several years ago, there was a huge fight about whether people should be able to obtain contact lenses through the mail with claims made that people would go blind and the world would come to an end. Some politics were involved, but ultimately the legislation passed and contacts can now be ordered through the mail. Another bill was introduced by former Representative Susan Gerard, which he co-sponsored, to allow OTC items, such as aspirin to be sold through vending machines, but pharmacists fought it tooth and nail. In this situation, something is needed that makes sense for the consumer.

Mr. Mills pointed out that often when a drug goes from prescription to OTC, many of the companies manufacturing the drug fight it because a great revenue stream would be lost since the insurance companies provide reimbursement for prescription drugs, but not OTC drugs. Most of the time when a drug goes OTC, it is a company at the end of the life of the patent trying to cut anybody else out of the profit. For Claritin, an allergy medication, the request for OTC was made by a third party, possibly an insurance company, which the manufacturer fought against, but it is now OTC anyway.

Mr. Wand remarked that to clarify his statement about politics, the FDA is “darned if they do and darned if they don’t.” Some people believe the agency approves a switch too fast and some people believe it is not fast enough, so it is ultimately a political decision that the FDA is told to speed up the process or not speed up the process, which is sometimes based on funding issues.

In relation to the flu vaccination, Mr. Korsunsky opined that dispensing or non-dispensing is not the point. The point is that members of the public are allowed to receive a prescription medication without a prior face-to-face visit with a physician. Unfortunately, he had the pleasure of visiting with a gentleman in a wheelchair at a Starbucks last summer who developed
Guillain-Barré Syndrome from a flu injection at a local Arizona school. This is a neurological disorder in which the body’s immune system attacks part of the peripheral nervous system. The ailment has been attributed as one of the side effects from a flu vaccination that individuals of the public are able to receive. It is interesting how one prescription medication as opposed to another can be administered without a prior doctor-patient relationship.

Mr. Weiers submitted that flu is a public health issue and does not fall under the same criteria. Mr. Korsunsky replied that if protecting the consumer and safety is the case, perhaps a bit more should be done with respect to administering a flu injection that could possibly create a paralyzing illness without at least advising the patient of the possible side effects rather than watching the 10 o’clock news and seeing that there is now a drive-in clinic for flu shots. He presented the following facts:

Last year over 50,000 Arizona residents legitimately ordered medications on-line.
The national figure for lifestyle medications purchased last year was 2,836,817.
For an idea as to the services available to members of the public, a search for the illegal term (because there is no generic for the product Viagra) results in 3,700,000 website links. Efforts by U.S. Customs and the FDA have not been able to slow down this illegal activity, so he does not know how the medical and pharmaceutical community can be expected to solve the problem.
A search for Web Doctors, an on-line consulting service for patients who would like to find out what is going on without seeing the doctor, produced 54,600,000 site links on Google.
The National Association of Boards of Pharmacy identified approximately 200 domestic websites that dispense prescription drugs, but do not offer an on-line prescribing service, violating the law that a prescription medication cannot be provided without an on-line consultation or prescription.
A recent Chicago Tribune article cited by the American Medical Association indicated that at least 400 websites dispense and offer prescribing services, half of which are located in foreign countries. Some have estimated that the number of websites selling prescription drugs may be closer to 1,000.
The products ordered are overwhelmingly lifestyle or comfort medications that are primarily used to deal with embarrassing health issues, except Tamiflu and a few others.
The requested list of approved lifestyle products that could be safe for on-line prescribing through certified physicians and certified pharmacies, utilizing FDA approved products, is up to the Committee to ascertain; however, it will not include narcotics, stimulants, depressants, hallucinogenics, anabolic steroids, and others. Although many of these drugs have useful and effective medical purposes, the need to regulate access to these controlled substances and prevent their diversion for illegal purposes is beyond the scope and not the purpose of this meeting.
Studies are available proving that patients are more willing to discuss private ailments with a licensed physician over the telephone or by computer than in a face-to-face environment.
The consumer’s primary objective is to order an FDA-approved product from a licensed pharmacy employing a licensed U.S. physician, while preserving the patient’s anonymity and providing privacy through a safe vehicle.
In most cases, the prices consumers pay are higher than at the local pharmacy, so saving money is not the issue when it comes to lifestyle medications. Client anonymity is the issue.
The danger the industry faces is from fake generics and illicit websites that offer on-line products without a doctor’s prescription, which should indicate to the consumer that the product is not being obtained from a licensed dispensing pharmacy; however, the demand for these products is so great that people take a chance and order and ingest the product, which can create a more severe illness.
There is no effective exam for the prescription medication Tamiflu. Coincidentally, there is an exception for the face-to-face doctor-patient relationship for the flu shot.
Arizona would not be the first state allowing questionnaires to be utilized for licensed physicians to prescribe lifestyle medications.
The common interest everyone shares is patient safety. An agency called Teledoc.com contains the following quotation on its website: The determination for a physical or face- to-face examination by a physician, according to our research, is not required for approximately 66 to 75 percent of available prescriptions written.

Mr. Korsunsky quoted from the FDA Web site: The FDA and the medical boards are focusing on Internet medication sales utilizing health questionnaires as well as those that do not have physician consultations. The Federated State of Medical Boards (FSMB) bill, which was introduced in early March of 2004, targets domestic Internet pharmacies that sell drugs over the Internet without a valid prescription. These medications are generalized, including narcotics and amphetamines. Even considering the potency of these drugs, their comments are that they do not support a health questionnaire as the only source for prescribing; however, note that they have not said it is illegal.” He related FDA guidelines for a safe website:

· Licensed by the state board of pharmacy where the website is operating (check www.nadp.info for a list of state boards of pharmacy).

· Have a licensed pharmacist to answer questions.

· Require a prescription from a doctor or other health care professional who is licensed in the U. S. to write prescriptions for medicine.

· Have a way for people to talk to a person about problems.

Mr. Korsunsky said an interesting question on the website is if there are benefits to purchasing approved drugs and the answer is: Yes. Legitimate pharmacy sites on the Internet provide consumers with a convenient, private way to obtain needed medications, sometimes at more affordable prices. The elderly and persons in remote areas can avoid the inconvenience of traveling to a store to purchase medications. Many reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their home. Moreover, Internet pharmacies can provide customers with written product information and references to other sources of information like traditional storefront pharmacy. Finally, the increasing use of the computer technology to transmit prescriptions from doctors to pharmacies is likely to reduce prescription errors.

He stated that an item the physicians outlined in the excerpts is the fact that the prescriptions are all on-line, thereby reducing some of the harmful effects related to not being able to decipher the handwriting of physicians. In 2006, a Pennsylvania company that sells prescription drugs over the Internet, a New York doctor and a Utah pharmacist sued the U.S. Attorney General, as well as the DEA administrator, claiming they have no right “categorically to declare as a matter of federal law that a legitimate doctor-patient relationship cannot be established without a face-to-face meeting between a physician and a patient” and that “software design and delivery safeguards can provide at least as stringent protection for consumers and patients, and at least as much protection against abuse as the requirement of a face-to-face meeting between physician and patient.”

Mr. Korsunsky reminded the Committee that telemedicine started more than half a century ago when telephones became commonplace in households and people started calling physicians for advice. The next phase was inaugurated with the emergence of the home personal computer with features like email allowing people to communicate with doctors. The government should take action to speed electronic prescribing, including fostering technology improvements so the myriad computer programs used by doctors, hospitals, and drug stores are compatible. In order to ensure that medications are not sold to someone who is providing false information when there is not a face-to-face doctor-patient relationship, technological programs are available from companies like IDology Incorporated that validate a person’s age, birth date, address and credit card (Attachment 6).

In summary, Mr. Korsunsky said technology is rapidly changing and becoming a very popular choice in health care solutions because of cost savings to the patient, convenience and no loss of time from work. Restricting pharmacies and physicians from practicing safe Internet prescribing will only increase demand for illegal offshore companies where the U.S. has little or no jurisdiction. The business practices of a well-regulated pharmacy in Arizona practicing a safe business model utilizing on-line prescribing for medications is just as safe as the existing model of administrating a flu shot prescription medication without a prior face-to-face doctor-patient relationship. He hopes the Committee has seen that enough evidence exists to establish that doctor-patient relationships can be securely attempted with on-line prescribing. The intent is not to find a shortcut for allowing the patient to obtain a prescription medication without a doctor’s prescription, but merely to keep up with the times similar to the banking and other industries that have accepted technology (written presentation, Attachment 7).

Mr. Korsunsky indicated to Mr. Quelland that as the Chief Operating Officer of Secure Medical, he availed himself to the procedures and protocols utilized in a local Arizona company to administer the sale of lifestyle medications with licensed physicians and licensed pharmacies using FDA products. He had the opportunity to review the comments and talk to consumers, which allowed him to establish some of the comments provided regarding patient anonymity being the number one factor. With respect to the fact that general practitioners (GPs) advised that these patients should be seeing GPs, the answer is that the patients are still seeing GPs, but for this particular ailment, choose not to, so the name of their GP is disclosed for reference material. It is the nature of the ailment that prohibits individuals from seeking their primary health care, insurance records, and the chain of events that goes along with something like a sexually transmitted disease, etc.

Mr. Quelland said he hopes to hear from doctors in the future.

Mr. Korsunsky related to Mr. Landrith that the State of Utah allows Internet prescribing utilizing a questionnaire. An article in Fortune magazine stated that the Dean of Pharmacology conducted an analysis on the results and standard of care given to patients seeking on-line consultation as opposed to face-to-face and found the practice was just as safe. Utah has been doing this for several years with cooperation from the Attorney General’s Office and the Board of Pharmacy, which have open access to the company’s technology and profiles of patients receiving the medications. He believes 30 or 40 states do not have a policy on the topic.

Mr. Wand remarked that he is somewhat familiar with Utah from about two years ago, and the last time he looked, the statute said the board by rule shall decide how Internet pharmacies work. He believes only one pharmacy was approved, called KwikMed. He noted that electronic prescriptions have been allowed since 1999 or 2000; however, some doctors are choosing the wrong medication when entering the prescription into the electronic system, and many systems produce electronic prescriptions where the name of the drug is in one area, but time release is over in the corner, so pharmacists are giving the non-time release product. Electronic prescriptions are great, but some safety issues still exist.

When Mrs. Knaperek surmised that Arizona does not have a policy on electronic prescriptions, Mr. Wand indicated that there is an existing Arizona Medical Board rule requiring a physical examination or referral by someone who conducted a physical examination before the prescription is issued. The statute states that the pharmacist cannot fill the prescription if the pharmacist knows there was no physical examination by the first physician or the physician the person was referred to. Also, there is a federal issue that those drugs are perhaps misbranded because a valid prescription was not issued.

Mr. Korsunsky advised Mrs. Knaperek that Secure Medical operates throughout North America. Internationally, prescriptions are sent to foreign pharmacies that are licensed in Canada or overseas. He pointed out that the medications for which a revision in the statutes is being requested were not around when the statutes were written. Because residents are able to purchase these products already on-line without a prescription, it behooves the state to look at regulations to give consumers safe choices rather than ordering illicit products from overseas, the flow of which cannot even be curbed by the FDA. He clarified for Mrs. Knaperek that the company contracts licensed physicians to approve or deny prescriptions based on the electronic questionnaire with medical information and prior history, so the company does pay the physicians. The consumer pays indirectly because it is built into the price.

Stuart Goodman, Lobbyist, Arizona Medical Board, conveyed that the board is in the process of developing a substantive policy statement addressing this issue and plans to work with interested parties.

Mr. Quelland said he was under the impression that discussions would be held on this topic throughout the summer, but no one approached him between the spring and now. Mr. Goodman responded that the Medical Board has been working on the rule relating to this on an internal basis since the end of the past session. Chairman Weiers noted that the Committee was originally planned as a joint effort by the House and Senate, but there were difficulties in coordinating, which is one of the reasons for getting off to a slow start.

Mr. Goodman advised that Mr. Miller could not attend the meeting because of a regularly scheduled board meeting.

Adam Palmer, Attorney, indicated that he has been representing pharmacists, pharmacies, and doctors in Arizona and throughout the country litigating telemedicine for about eight years, so this issue is not new to Arizona. It is a federal issue, but the federal government is letting the states deal with it, and the states are having a difficult time. He understands the purpose of the meeting is to examine the patient-practitioner relationship, which is found in Arizona Revised Statutes (A.R.S.) Section 32-1401. With all due respect to Mr. Wand, what he said about the statute is not the law, but interpretation of the law by the Arizona State Board of Pharmacy and the Arizona Medical Board. He currently has a case on appeal that will interpret this statute and he will have another case in 30 days, so something is going to bend with respect to the statutes that deal with telemedicine. He suggested that since the Legislature created these statutes, issues should be resolved by the Legislature.

Mr. Palmer advised Chairman Weiers that he defends pharmacists, pharmacies and doctors in state courts, district courts and through administrative processes against litigation by boards or states attorneys general who believe his clients are violating laws by dispensing medications. He is also disappointed that Mr. Miller is not present to provide input from the Arizona Medical Board because doctors are losing licenses or being censored because of the Arizona Medical Board and Arizona State Board of Pharmacy misinterpretations of the law.

Regarding the flu vaccine, Mr. Arnold opined that colds and flu are not epidemics. Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus are epidemics, but people cannot go to local grocery stores and receive shots for those. He submitted that Section 32-1401, Paragraph 27(ss), specifically provides that a doctor has to establish a prior doctor-patient relationship before issuing a prescription, which the Arizona Medical Board and Arizona State Board of Pharmacy have interpreted as meeting face-to-face, but it does not say that in the legislation.

Mr. Arnold submitted that the public wants access to the Internet to be able to purchase, for example, Viagra and Propecia, which are termed vanity drugs or lifestyle medications. There should be a carve-out for certain types of medications because he is not aware of any abuse. He noted that he and his wife went to his son’s high school last year where flu shots were given, but not administered by a doctor or pharmacist. Mr. Wand tried to make a distinction between dispensing and issuing, which is semantics. Pharmacists issue prescriptions written by medical doctors, but Section 32-1401 says a doctor cannot write a prescription without establishing a prior patient relationship. He and his wife never met Dr. Mollen and there was no doctor present at the high school, yet they could have received prescription medication by paying $25, which is clear selective enforcement of the laws of Arizona. The question is why, which is what the Committee needs to answer, if a doctor issues a prescription only medication without a prior doctor-patient relationship, the doctor acted unprofessionally.

Referring to the misbranding statute, Section 32-1968, Mr. Arnold submitted that it does not say if a doctor acts unprofessionally, the prescription the doctor writes is now invalid, illegal and misbranded, but that is how the Arizona State Board of Pharmacy is interpreting the statute, which is incorrect. He has challenged these statutes as being unconstitutional. Interestingly, the Arizona State Board of Pharmacy and Arizona Medical Board claim that telemedicine with the questionnaires is inherently dangerous; however, an Arizona doctor issued tens of thousands of prescriptions, and he is not aware of one complaint ever filed by a patient who received the wrong medication or the wrong amount of medication. If someone is on a trip and wants to obtain Viagra that has been confiscated because of a terror threat and the person cannot take the prescription medication along, that person should be able to obtain it on-line.

Mr. Arnold said there is an exception in Section 32-1401 that was carved out by the doctors. If a doctor is part of a group and on-call for the weekend, if someone calls whose gout flared up, for example, and says they saw the doctor’s partner and asks for a prescription for Allopurinol, the doctor can ask the patient a few questions and prescribe the medication. That exception does not say how long ago the person saw the partner, which is a problem. What telemedicine is doing with the questionnaire is the same medical process on-call doctors are using by talking to a patient over the phone. Without examining the patient and not having access to the patient’s chart at home, a prescription can be issued based on the patient’s representation that the doctor’s partner is the treating doctor, which establishes a prior doctor-patient relationship.

Mr. Palmer clarified for Mr. Quelland that doctors who prescribe medications based on questionnaires are going before the Arizona Medical Board whose members say that a doctor-patient relationship has not been established without physically seeing a patient, which violates the statute. What is interesting is that the FDA and FSMB issued guidelines for Internet prescribing of doctors specifically stating that a physical examination is not necessary to establish the doctor-patient relationship. If the patient is willing to provide private health information, the doctor reviews the information, makes a diagnosis and develops a course of treatment that the patient is willing to accept, a doctor-patient relationship has been established; however, four paragraphs later it says this does not apply to telemedicine, so even those agencies are confused.

Mr. Arnold related that one of his doctor clients lost his license to practice medicine in Arizona about seven years ago for not establishing doctor-patient relationships, and current doctors he represents have been assessed civil penalties of $10,000, had to take additional medical education, and are on probation. One doctor he currently represents whose case is on appeal to the Appellate Courts is board certified in two disciplines, one of which is internal medicine. An internal medicine doctor is competent to examine medical records and determine if someone is a candidate for hair loss or weight loss. His clients are business people who want to make money lawfully.

Mr. Quelland remarked that rectifying this situation will require lots of time and many people working together to reach an agreement. He wondered if Mr. Palmer is willing to take the time necessary to protect the health of Arizonans and clarify the law. Mr. Palmer replied that the Judiciary is about 30 days away from an appellate decision on one of the cases involving a doctor specifically interpreting the constitutionality of Section 32-1401. Whoever loses will appeal the case to the Court of Appeals, which would probably take another year-and-a-half, so there is time to work on this. Either the Legislature will correct the statute or the Judiciary will decide if it is unconstitutional.

Mr. Wand said Section 32-1401 Paragraph 27(ss) is existing Arizona Medical Board statute. He is not an Arizona Medical Board person, but it does help the boards decide if Section 32-1968 is violated because if there was no physical examination, which the Arizona Medical Board believes is unprofessional conduct, then the judge who heard the case at the Office of Administrative Hearings concluded that was a misbranded prescription.

Mrs. Knaperek assumed that because the statute does not say low-risk drugs, if Mr. Palmer’s client wins in court, any kind of prescription could be purchased over the Internet. Mr. Palmer stated that is not correct. He is challenging the constitutionality of the statute as written being capable of being interpreted in many ways, and therefore, it is illegal. Also, Section 32-1968, the pharmacy statute, lists what constitutes a misbranded drug and does not say if a doctor acts unprofessionally that it is a misbranded drug, but the boards are holding and pulling licenses of pharmacies for dispensing prescriptions from doctors that acted unprofessionally when nowhere is the authority provided to do that.

Mr. Wand stated that the case is under appeal or will be soon so he would rather not comment other than all prescription drugs in the U.S. are approved by the FDA and have to be dispensed in the original manufacturer’s container with the manufacturer’s label, unless there is a valid prescription by a prescriber who is licensed to prescribe, then the pharmacist can put their own label on it. If there is no valid prescription, the pharmacist cannot put their own label on it, but has to sell it in the original container with the original label only to wholesalers, manufacturers and other people, not to end users like patients. That is the misbranding statute.

Mrs. Knaperek asked if any of Mr. Palmer’s clients approached the Legislature before going to court. Mr. Palmer responded that attempts were made to resolve the issue administratively with the respective board, which could not be done. The Legislature was asked to change the statute, but he is not sure of the timing.

Mrs. Knaperek conveyed that no one ever talked to her about this issue. Also, the flu epidemic is a public health concern. Many people actually die from the flu, which also causes many workforce development issues.

Mr. Palmer asked the location of a carve-out exemption in law for Dr. Mollen to give flu shots at a high school.

Mr. Wand indicated to Mr. Quelland that the Arizona State Board of Pharmacy has not revoked any licenses, but disciplined doctors. One case is under appeal that he would rather not comment on where the license was revoked and the revocation was stayed pending the laws are followed as interpreted by the board, i.e. have a valid prescription and dispense medication pursuant to that valid prescription. About 30 Internet pharmacies in Arizona dispense electronic prescriptions; in fact, Arizona is a state that most mail order companies move to because of receptive and flexible laws that allow many electronic prescriptions. He clarified that mail order prescriptions are filled legally, i.e., pursuant to a valid prescription based on an examination or previous reference from a physician who conducted an examination.

Matt Salmon, Lobbyist, Secure Medical Incorporated, stated that he and another gentleman got a flu shot two days ago. The shot was not given by a doctor and a form had to be filled out absolving the company of liability should adverse reactions occur and indicating any allergies to eggs and other items. A physician was not present. It is a prescription drug and there can be adverse reactions, but he believes it is good policy. He surmised that the issue was raised not because it is bad policy, but it is inconsistent as are many policies in Arizona, such as the fact that inmates do not need face-to-face visits with the doctor nor is it necessary on Indian lands. The intent is to try to do what is convenient.

He related that last week he went to a brand new doctor because his family doctor retired. He asked for a prescription for allergies. The doctor did not check his ears or anything, but suggested a few medications, which Mr. Salmon said he had tried that did not work, so the doctor suggested Singulair and wrote a prescription. He questioned how that is any different than writing out symptoms, medications that have been tried before, and requesting a prescription. He does not believe this discussion should be limited to lifestyle drugs. For example, if an outbreak of Avian flu were to occur, a mechanism needs to be developed so people can obtain Tamiflu or the drug of choice at that time without having a face-to-face visit with a physician because doctors’ offices will be very crowded.

Mr. Salmon stated that Secure Medical is a legitimate company that has safeguards in place with questionnaires. He would prefer that the Legislature rather than the Judiciary resolve this issue by crafting good policy that protects citizens. If Secure Medical went out of business, 1,000 other companies offshore would still market drugs over the Internet. Secure Medical wants to sell these medications legally, and this is an opportunity to craft policy that is sensible so citizens can obtain these drugs in a safe and cost-effective manner.

Mr. Landrith asked ATA’s position on a bill introduced in Congress dealing with telemedicine and prescribing. Mr. Linkous replied that he is pleased with the bill’s progress; however, it will not pass this year, but will probably be redrafted and introduced again next year.

Without objection, the meeting adjourned at 12:08 p.m.

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Linda Taylor, Committee Secretary

October 19, 2006

(Original minutes, attachments, and tape are on file in the Office of the Chief Clerk.)

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AD HOC COMMITTEE ON PROTOCOL RELATING

TO THE ESTABLISHMENT OF THE

PATIENT-PRACTITIONER RELATIONSHIP

October 12, 2006

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Members Present