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Search Terms: internet w/10 prescription, House or Senate or Joint

Document 40 of 60.

JULY 30, 1999, FRIDAY

SECTION: IN THE NEWS

LENGTH: 2609 words

HEADLINE: PREPARED STATEMENT OF
DR. HERMAN ABROMOWITZ
MEMBER, BOARD OF TRUSTEES
AMERICAN MEDICAL ASSOCIATION
BEFORE THE HOUSE COMMERCE COMMITTEE
OVERSIGHT AND INVESTIGATIONS SUBCOMMITTEE

BODY:

The American Medical Association (AMA) appreciates the opportunity to present to the Subcommittee its views on prescribing pharmaceuticals over the Internet, and applauds the efforts of the Chairman and members of the Subcommittee for focusing on this important issue.
The use of the Internet for prescribing and dispensing medications is a practice that has become increasingly prevalent during recent years as the Internet has become more popular and accessible to consumers. The Internet can be an extremely valuable medical resource under certain circumstances, and there currently are many legitimate uses of the Internet for prescribing and dispensing medications. The AMA, however, is gravely concerned about current misuse of the Internet for prescribing purposes. The Food, Drug and Cosmetic Act requires physician involvement in making prescription drugs available. This requirement is part of the safety analysis conducted by the Food and Drug Administration (FDA) prior to the approval of any new drug. Everyday patients are endangered when they are permitted to receive prescription medications via the Internet without adherence to proper safeguards that ensure good medical practice. Use of the Internet does not obviate the physician's obligation to meet appropriate standards of care when treating any patient.
Recently the AMA considered Internet prescribing issues and set forth its concerns with this matter. Today our testimony addresses the concerns that must be considered in connection with misuse of the Internet for prescribing and dispensing prescription drugs.
In summary, we believe that before prescribing a medication, a physician must -
* Ensure that a medical history is obtained or readily available;
* Provide information to the patient about the benefits and risks of the prescribed medication;
* Generally perform an examination of the patient to determine a specific diagnosis and whether there actually is a medical problem; and
* Initiate additional interventions and follow-up care, if necessary, especially when the drug in question (e.g., Viagra) may have serious side effects.
These are the requirements that a physician must meet in a setting traditionally used to visit with and treat patients. Treating patients via the Internet is no different, and thus these same requirements must also be met in this context. Web sites that offer a prescription solely on the basis of a simple questionnaire are not sufficient.
The Problem with Internet Prescribing
Internet prescribing has become more prevalent with the advent of certain drugs, such as sidenafil (Viagra), a prescription drug used to treat erectile dysfunction. Often, the information requested on a web site that is necessary to issue and fill a prescription via the Internet is insufficient, as is accompanying information that should be provided to the patient concerning the prescription.
For example, a typical web site will advertise the advantages of obtaining Viagra via the Internet. In addition, the web site will require the purchaser to acknowledge a liability waiver, select a quantity of Viagra to be purchased, and fill out a short questionnaire. An example of such questionnaire is attached as Appendix I.
The questionnaire used does not meet standards that would be considered good medical practice. It usually requests minimal information about the medical history of the purchaser, and some terms used in the questionnaire (e.g., nitrates, arrhythmia, unstable angina, retinitis pigmentosa) are likely to be beyond the level of understanding of a lay person. Further, there is no mechanism to determine whether the purchaser has answered the questions accurately or truthfully. Incorrect answers could be deliberate in order to obtain the medication or could result from a failure to understand the questions. Moreover, some web sites make no attempt to explain the potential risks of a drug, such as Viagra therapy, for example.
More important, the AMA is very concerned that prescription drugs are being ordered without the benefit of a physical examination, which allows full evaluation of any potential underlying cause of a patient's dysfunction or disease, as well as an assessment of the most appropriate intervention. Clearly, current Internet prescribing practices for the most part do not involve any medical assessment or follow-up to determine whether the medication has been effective or if there are side effects.
This type of prescribing practice can be extremely dangerous for patients. For example, while Viagra has been beneficial to many men with properly diagnosed erectile dysfunction, it also carries substantial risks for some patients and over 100 deaths have been associated with its use. Without appropriate information and discourse between physician and patient, there is a substantial risk that a drug may inappropriately be prescribed via the Internet that may cause significant harmful side effects and even death.
Without medical standards to serve as a safeguard against these dangerous practices, Internet prescribing could become extremely problematic. Indeed, prescriptions for an increasing variety of prescription drugs may become available to the public through the Internet. Appendix II presents just a few examples of the many Internet prescription and dispensing services, and many more such services exist on the Internet. According to an article published June 16, 1999 in the Chicago Tribune: "No one has a clear grasp of the scope of the phenomenon, but some experts estimate that about 400 such instant-prescription Web sites exist, about half based overseas."
Internet prescribing problems are compounded by the fact that some foreign companies are illegally promoting and distributing (selling) prescription drug products in the United States through their Internet web sites. A recent example of this was described in an article published May 11, 1999 in the New York Times: "a company based in the Channel Islands of Britain called Direct Response Marketing is selling Xenical over the Internet to just about anybody who electronically fills out a medical questionnaire that is reviewed by a company doctor who then 'prescribes' the drug." "This wonder pill promises to be one of the defining drugs of the 90's along with Prozac and Viagra" the company states on its World Wide Web site. "Most overweight people harbor a sneaking suspicion that somewhere there is a product that will solve all of their weight-loss problems. Well, now that product has arrived."
If this trend continues, a triple problem exists. First, patients in the United States would easily be able to obtain drugs that have not been approved by the U.S. FDA. Second, these drugs would not have been tested in rigorous clinical trials; and third, patients would be receiving these drugs without the advice of a physician. There virtually is no accountability and there are no safeguards that address drugs obtained from foreign web sites. You should not allow this trend to continue.

Accordingly, we again emphasize the importance of ensuring that minimum standards of proper medical care are met with respect to prescribing, including Internet prescribing.
Minimum Standards for Proper Medical Care
To avoid the serious problems discussed above, the AMA strongly advocates that diagnostic and treatment decisions made by physicians, including the issuing of a prescription for medication via the Internet or any setting, should be supported by appropriate information. The evaluation leading to diagnostic and treatment decisions generally includes an adequate medical history and an appropriate physical examination. The length and complexity of this evaluation often is dependent upon the problem being presented by the patient. At times, the history and/or the physical examination may not need to be repeated if it is already on record as part of an ongoing relationship between patient and physician.
The AMA strongly believes prescribing practices over the Internet must at least meet the following minimum standards of care-
* There generally must be an examination of the patient to determine a specific diagnosis and whether there actually is a medical problem;
* There must be a dialogue between the physician and patient to discuss treatment alternatives and determine the best course of treatment;
* The physician must establish or have ready access to a reliable medical history;
* The physician must provide information to the patient about the benefits and risks of the prescribed medication; and
* The physician must follow-up with the patient to assess the therapeutic outcome.
AMA Involvement in Ensuring Proper Internet Prescribing Practices
The AMA will continue its involvement in studying the issue of Internet prescribing practices. Recently, the AMA adopted a report on Internet prescribing at our June 1999 annual meeting, and it included a number of recommendations for AMA involvement in ensuring proper medical practice with respect to Internet prescribing practices.
In accordance with these recommendations, the AMA will, among other things, develop principles describing appropriate use of the Internet in prescribing medications. These principles likely will be based on the guidelines discussed in the June report and this testimony, and will support use of the Internet as a prescribing mechanism where appropriate safeguards are in place to ensure standards for high quality medical care.
In addition, the AMA will work with state medical societies in urging state medical licensing boards to ensure high quality medical care by investigating and, when appropriate, taking necessary action against physicians who fail to meet local standards of medical care when issuing prescriptions through Internet web sites that also dispense prescription medications. Finally, as discussed further below, we believe there is a strong role that both state and federal authorities can play in this matter. We wish to work with the Federation of State Medical Boards and others in endorsing or developing model state legislation to establish limitations on Internet prescribing, as well as with federal and state regulatory bodies to close down Internet web sites of companies that are illegally promoting and distributing (selling) prescription drug products in the United States.
Finally, we will continue our review of legitimate uses of the Internet and update our recommendations concerning proper standards of practice on the Internet as changes in technology may dictate changes in these standards or even permit additional legitimate Internet prescribing practices.
Legitimate Uses of the Internet for Prescribing and Dispensing Drugs
As discussed above, despite problems with misuse of the Internet for prescribing and dispensing, the Internet can be a valuable source for prescription medications, and a number of appropriately licensed Internet pharmacy practice sites are legitimately dispensing prescription medications pursuant to a valid prescription. Care must be taken to protect and even enhance legitimate electronic prescribing and dispensing practices.
Some examples of the Internet being used for legitimate electronic prescribing purposes are:
* Computer order entry and on-line transmission of prescriptions. After a physician sees a patient and performs an adequate medical history and physical, computer order entry and on-line transmission of a prescription to a pharmacy provides an alternative mechanism for prescription transmission. Many experts believe computer order entry of prescriptions can reduce errors that occur from failure to understand handwritten prescriptions. Because technology exists to allow validation of electronic signatures and the encryption of prescription information, even the Drug Enforcement Administration (DEA) is considering allowing this route of prescription ordering, including the ordering of Schedule II drugs.
* Ordering refills - either patient to pharmacy or physician to pharmacy. There is a legitimate clinical decision under circumstances where the physician does not see the patient at the time a refill is ordered, but the patient has been and remains under that physician's care and has been seen in person in the recent past. If the refills are authorized on the original prescription, the patient can electronically contact the pharmacy directly and request the refill. This could be a community, mail service, or legitimate Internet pharmacy. When no refills are remaining on the original prescription, the patient could call or electronically contact the physician requesting that a refill be authorized. If the physician believes the refill is needed, the physician can electronically send the renewed prescription to the pharmacy.
* Electronic consults between physician and patient where the outcome is an ordered prescription. There can be a legitimate clinical decision under circumstances where the physician does not see the patient at the time a new prescription is ordered. This occurs when the patient is under that physician's care, the physician has the patient's medical history and physical information in the medical record, and the patient has been seen in person in the recent past. For example, a patient may inform his or her physician via telephone or electronic mail of a flare up in a seasonal allergy or a documented problem, and the physician may then electronically transmit a prescription for an antihistamine to the pharmacy without an additional office visit. It is critical here that the physician and patient have an ongoing relationship, the patient routinely uses this physician, and the patient's history and physical information are already in the medical record.
In addition to legitimate electronic prescribing via the Internet, there also are appropriately licensed Internet pharmacy practice web sites that provide an alternative consumer option for the dispensing of prescriptions. Recently, the National Association of Boards of Pharmacy (NABP) announced its decision to develop the NABP Verified Internet Pharmacy Practice Sites (VIPPS) program. The VIPPS program will verify the licensure of Internet pharmacy practice sites and inform the public, through a database on the NABP web site, about whether those web sites are licensed in good standing with the appropriate state board(s) of pharmacy or other regulatory agencies. The AMA has participated on a NABP Task Force to develop criteria for the VIPPS program, and will continue to work with the NABP and support their VIPPS program so that physicians and patients can easily identify legitimate Internet pharmacice sites.
State and Federal Involvement in Internet Prescribing
The AMA believes that Internet prescribing practices not based on appropriate safeguards to ensure high quality medical care are dangerous and highly inappropriate. State authorities, including state medical and pharmacy boards, as well as the federal government have a significant role to play in restricting these practices, but must take care not to interfere with legitimate uses of the Internet.
For the most part, states have primary jurisdiction in these matters, and this is appropriate. Under existing law in the majority of states, prescribing drugs to a patient outside the state where the physician is licensed is considered the unlicensed practice of medicine. Additionally, under most state laws, state medical and pharmacy licensure boards have been delegated jurisdiction, respectively, over medical and pharmaceutical professional practices.

LOAD-DATE: August 4, 1999

Document 40 of 60.


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