Changing Internet Pharmacy Legal Standards

The face and practice of e-commerce change often, with the changes ranging from the number of people using the Internet for critical and frivolous desires to online retailers' implementation of new technology and techniques to attract, satisfy and retain customers.

Telemedicine, on the scene medically and legally for several decades, is an area ' in the form, strictly speaking, of providing some kind of health care or health-care products or services ' under the Big Top of the e-commerce fair that is subjected regularly to regulatory scrutiny, debate, enforcement actions, improvements and all the other aspects of e-commerce, although sometimes at a slower pace than within the sector's other channels.

For example, the legal standards for prescribing medication based solely on an online questionnaire are changing. In the past, the sole use of an online questionnaire was generally deemed to be contrary to the standard level of care.

Indeed, many online pharmacies and other health concerns found themselves under federal, state and local regulatory agencies' microscopes, for instance, after the 9/11 attacks and the subsequent mailings to the media and government offices of anthrax bacterium in power so that the potentially lethal infectious agent could get into the air and people's lungs. Consumers, in a scramble to obtain the antibiotic Cipro (Ciprofloxacin) to fight anthrax, signed on in droves to online drug dispensaries, many of them based in Canada or overseas, and that often used only perfunctory online questionnaires with essentially meaningless questions that Web-site users had to answer before a physician working for the Web site would write a prescription for medicine that was then sent to the user, or to his or her drugstore. It turned out, in many cases, that physicians employed by Web sites ' physicians who didn't have the existing relationship with a patient that many states' board of medical practice require ' were writing prescriptions for Cipro, and other drugs, without “examining” the patients, thus running afoul of the law.

Looking at the New Legal Standard

The new legal standard allows the use of online questionnaires for prescription medications. The prior standard rendered the use of online questionnaires for prescription medications per se unlawful. Now the use of online questionnaires is considered valid if the questionnaires can help the physicians and pharmacists establish that the prescription was based on a documented patient evaluation, including an examination, adequate to establish a diagnosis, and to identify underlying conditions and contraindications to treatment.

For the purposes of the new standard, the requirement for an examination is usually met if an “in-person” examination has been completed in any of the following circumstances:

• The prescribing practitioner examines the patient at the time the prescription is issued;
• The prescribing practitioner has performed a prior examination of the patient;
• Another prescribing practitioner practicing within the same group or clinic as the prescribing practitioner has examined the patient;
• A consulting practitioner to whom the prescribing practitioner has referred the patient has examined the patient; or
• The referring practitioner has performed an examination in the role of a consultant practitioner issuing a prescription or drug order when providing services by means of telemedicine.

As in the past, entities fulfilling prescriptions may not dispense medication that they know, or would reasonably be expected to know, is by a prescription that isn't valid under the new legal standard. Also as in the past, Internet pharmacy marketers may rely on the licensed physicians and pharmacists to act lawfully unless they know, or would reasonably be expected to know, that such action was not valid under the new standard.

Why the Change?

One reason for the change in the standards for online questionnaires for prescription medications is that practitioners and their attorneys have successfully argued that a physical examination is not required to give rise to a physician-patient relationship.

The court in Stanley v. McCarver, 92 P.3d 849 (2004), for instance, found that a radiologist owed a duty of care to the applicant arising out of the radiologist's evaluation for pre-employment tuberculosis screening. Also, the court in Dougherty v. Gifford, 826 S.W.2d 668 (Tex. App. 1992), found an implied relationship between a patient and a pathologist because diagnostic services were furnished on the patient's behalf. In Walters v. Rinker, 520 N.E.2d 468 (Ind. Ct. App. 1988), the court found an implied relationship between a patient and a pathologist because the patient's treating physician had requested pathology services on the patient's behalf.

It has been argued that the new standards for the use of online questionnaires for prescription medications were not necessary. And it can be argued that the cases noted above may be distinguished from Internet pharmacy transactions because these cases stand for the proposition that the rendering of advice by a physician can create a duty between the physician and a person in the absence of a traditional physician-patient relationship but are suboptimal.

The new standard for Internet prescribing, dispensing or furnishing a prescription medication to a person requires either a physical examination of that person by a licensed physician or a review of records from a doctor with an established relationship with the patient or patients seeking to fill a prescription. It is not a common practice for a physician to rely on a person's description of a physical examination performed on the individual by another physician and the results of any such examination before prescribing prescription medicine. Consequently, Internet pharmacies associated with issuing prescriptions for medicines based on a physician's review of individuals' answers to Internet questionnaires alone will not normally meet this standard.

Thus, Internet pharmacy marketers may rely on the licensed physicians and pharmacists to act lawfully, unless the marketers know, or would reasonably be expected to know, that the prescriptions associated with their transactions were based solely on a physician's review of individuals' answers to Internet questionnaires. However, if a licensed pharmacist or other professional associated with a Web-based pharmacy knows of the physician's procedure and practices, and continues to fill the prescriptions created by the physician, then it is reasonable to use the existing procedure to rely solely on a physician's review of individuals' answers to Internet questionnaires.

Support, and Roads to Reasonable Reliance

This reasonable reliance is supported by Brighton Pharmacy, 160 P.3d 412, which confirmed the general rule that pharmacists shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner. This proposition is understood to mean that a pharmacist shall not dispense a prescription drug if he or she knows, or should have known, that the order for such drug was issued on the basis of an insufficient Internet-based questionnaire, Internet-based consultation, or a combination of these situations, without a valid, preexisting patient-practitioner relationship in place prior to the issuance of the prescription.

Although reasonable reliance may increase the likelihood of prevailing in litigation, it is neither a total bar to losing a lawsuit nor avoiding litigation. To more nearly approximate the new standard for prescribing, dispensing or furnishing a prescription medication to a person, several operational options are available to Internet pharmacy sites.

One option is to supplement the Internet responses with additional questions asked of those seeking medication for access to their medical records relating to in-person examinations, and to have information relevant for an adequate establishment of a diagnosis so that underlying conditions can be identified and contraindications to treatment can be confirmed.

A second option is to require Internet users to secure a copy of the results and conclusions of their most recent physical examination and have it reviewed by a medical practitioner to confirm that it contains information sought through option one.

A third option is for the pharmacist to establish a sufficient relationship via e-mail with the doctor who performed the in-person examination to qualify as a related practitioner for the purposes of the new standard.

Each of these recommendations is designed to reduce the likelihood that the Internet pharmacy marketer will be associated with transactions related to prescribing improper or dangerous medications. The rule of thumb for avoiding litigation and unlawful acts associated with Internet pharmacy transactions is to minimize or ameliorate conduct or practice that is, or might be, harmful or otherwise dangerous to the health of the patient or the public.

Ideally, the Internet pharmacy marketer should:

• Assist the prescribing physician to obtain a reliable medical history and perform a physical examination of the patient that would be adequate to establish the diagnosis for which the drug is being prescribed, and to identify underlying conditions and/or contraindications to the treatment recommended or provided;
• Have sufficient dialogue with the patient regarding treatment options and the risks and benefits of treatment(s);
• Maintain communication with the Internet patient as appropriate, to follow up with the patient to assess the therapeutic outcome;
• Maintain a contemporaneous medical record that is readily available to the patient and, subject to the patient's consent, to his or her other health-care professionals; and
• Include the electronic prescription information as part of the patient medical record.

The implementation of the ideal program is not likely to be cost-effective. But the implementation of any procedures that make the existing process closer to the ideal process reduces the risks of litigation and unlawful acts ' and the risks to patients who are acting as e-commerce consumers to protect or restore their health.

The face and practice of e-commerce change often, with the changes ranging from the number of people using the Internet for critical and frivolous desires to online retailers' implementation of new technology and techniques to attract, satisfy and retain customers.

Telemedicine, on the scene medically and legally for several decades, is an area ' in the form, strictly speaking, of providing some kind of health care or health-care products or services ' under the Big Top of the e-commerce fair that is subjected regularly to regulatory scrutiny, debate, enforcement actions, improvements and all the other aspects of e-commerce, although sometimes at a slower pace than within the sector's other channels.

For example, the legal standards for prescribing medication based solely on an online questionnaire are changing. In the past, the sole use of an online questionnaire was generally deemed to be contrary to the standard level of care.

Indeed, many online pharmacies and other health concerns found themselves under federal, state and local regulatory agencies' microscopes, for instance, after the 9/11 attacks and the subsequent mailings to the media and government offices of anthrax bacterium in power so that the potentially lethal infectious agent could get into the air and people's lungs. Consumers, in a scramble to obtain the antibiotic Cipro (Ciprofloxacin) to fight anthrax, signed on in droves to online drug dispensaries, many of them based in Canada or overseas, and that often used only perfunctory online questionnaires with essentially meaningless questions that Web-site users had to answer before a physician working for the Web site would write a prescription for medicine that was then sent to the user, or to his or her drugstore. It turned out, in many cases, that physicians employed by Web sites ' physicians who didn't have the existing relationship with a patient that many states' board of medical practice require ' were writing prescriptions for Cipro, and other drugs, without “examining” the patients, thus running afoul of the law.

Looking at the New Legal Standard

The new legal standard allows the use of online questionnaires for prescription medications. The prior standard rendered the use of online questionnaires for prescription medications per se unlawful. Now the use of online questionnaires is considered valid if the questionnaires can help the physicians and pharmacists establish that the prescription was based on a documented patient evaluation, including an examination, adequate to establish a diagnosis, and to identify underlying conditions and contraindications to treatment.

For the purposes of the new standard, the requirement for an examination is usually met if an “in-person” examination has been completed in any of the following circumstances:

• The prescribing practitioner examines the patient at the time the prescription is issued;
• The prescribing practitioner has performed a prior examination of the patient;
• Another prescribing practitioner practicing within the same group or clinic as the prescribing practitioner has examined the patient;
• A consulting practitioner to whom the prescribing practitioner has referred the patient has examined the patient; or
• The referring practitioner has performed an examination in the role of a consultant practitioner issuing a prescription or drug order when providing services by means of telemedicine.

As in the past, entities fulfilling prescriptions may not dispense medication that they know, or would reasonably be expected to know, is by a prescription that isn't valid under the new legal standard. Also as in the past, Internet pharmacy marketers may rely on the licensed physicians and pharmacists to act lawfully unless they know, or would reasonably be expected to know, that such action was not valid under the new standard.

Why the Change?

One reason for the change in the standards for online questionnaires for prescription medications is that practitioners and their attorneys have successfully argued that a physical examination is not required to give rise to a physician-patient relationship.

The court in Stanley v. McCarver , 92 P.3d 849 (2004), for instance, found that a radiologist owed a duty of care to the applicant arising out of the radiologist's evaluation for pre-employment tuberculosis screening. Also, the court in Dougherty v. Gifford , 826 S.W.2d 668 (Tex. App. 1992), found an implied relationship between a patient and a pathologist because diagnostic services were furnished on the patient's behalf. In Walters v. Rinker , 520 N.E.2d 468 (Ind. Ct. App. 1988), the court found an implied relationship between a patient and a pathologist because the patient's treating physician had requested pathology services on the patient's behalf.

It has been argued that the new standards for the use of online questionnaires for prescription medications were not necessary. And it can be argued that the cases noted above may be distinguished from Internet pharmacy transactions because these cases stand for the proposition that the rendering of advice by a physician can create a duty between the physician and a person in the absence of a traditional physician-patient relationship but are suboptimal.

The new standard for Internet prescribing, dispensing or furnishing a prescription medication to a person requires either a physical examination of that person by a licensed physician or a review of records from a doctor with an established relationship with the patient or patients seeking to fill a prescription. It is not a common practice for a physician to rely on a person's description of a physical examination performed on the individual by another physician and the results of any such examination before prescribing prescription medicine. Consequently, Internet pharmacies associated with issuing prescriptions for medicines based on a physician's review of individuals' answers to Internet questionnaires alone will not normally meet this standard.

Thus, Internet pharmacy marketers may rely on the licensed physicians and pharmacists to act lawfully, unless the marketers know, or would reasonably be expected to know, that the prescriptions associated with their transactions were based solely on a physician's review of individuals' answers to Internet questionnaires. However, if a licensed pharmacist or other professional associated with a Web-based pharmacy knows of the physician's procedure and practices, and continues to fill the prescriptions created by the physician, then it is reasonable to use the existing procedure to rely solely on a physician's review of individuals' answers to Internet questionnaires.

Support, and Roads to Reasonable Reliance

This reasonable reliance is supported by Brighton Pharmacy, 160 P.3d 412, which confirmed the general rule that pharmacists shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner. This proposition is understood to mean that a pharmacist shall not dispense a prescription drug if he or she knows, or should have known, that the order for such drug was issued on the basis of an insufficient Internet-based questionnaire, Internet-based consultation, or a combination of these situations, without a valid, preexisting patient-practitioner relationship in place prior to the issuance of the prescription.

Although reasonable reliance may increase the likelihood of prevailing in litigation, it is neither a total bar to losing a lawsuit nor avoiding litigation. To more nearly approximate the new standard for prescribing, dispensing or furnishing a prescription medication to a person, several operational options are available to Internet pharmacy sites.

One option is to supplement the Internet responses with additional questions asked of those seeking medication for access to their medical records relating to in-person examinations, and to have information relevant for an adequate establishment of a diagnosis so that underlying conditions can be identified and contraindications to treatment can be confirmed.

A second option is to require Internet users to secure a copy of the results and conclusions of their most recent physical examination and have it reviewed by a medical practitioner to confirm that it contains information sought through option one.

A third option is for the pharmacist to establish a sufficient relationship via e-mail with the doctor who performed the in-person examination to qualify as a related practitioner for the purposes of the new standard.

Each of these recommendations is designed to reduce the likelihood that the Internet pharmacy marketer will be associated with transactions related to prescribing improper or dangerous medications. The rule of thumb for avoiding litigation and unlawful acts associated with Internet pharmacy transactions is to minimize or ameliorate conduct or practice that is, or might be, harmful or otherwise dangerous to the health of the patient or the public.

Ideally, the Internet pharmacy marketer should:

• Assist the prescribing physician to obtain a reliable medical history and perform a physical examination of the patient that would be adequate to establish the diagnosis for which the drug is being prescribed, and to identify underlying conditions and/or contraindications to the treatment recommended or provided;
• Have sufficient dialogue with the patient regarding treatment options and the risks and benefits of treatment(s);
• Maintain communication with the Internet patient as appropriate, to follow up with the patient to assess the therapeutic outcome;
• Maintain a contemporaneous medical record that is readily available to the patient and, subject to the patient's consent, to his or her other health-care professionals; and
• Include the electronic prescription information as part of the patient medical record.

The implementation of the ideal program is not likely to be cost-effective. But the implementation of any procedures that make the existing process closer to the ideal process reduces the risks of litigation and unlawful acts ' and the risks to patients who are acting as e-commerce consumers to protect or restore their health.