CHANGING INTERNET PHARMACY LEGAL STANDARDS
New Jersey Law Journal Volume 193, No. 12 September 22, 2008
CHANGING INTERNET PHARMACY LEGAL STANDARDS -- USING ONLINE QUESTIONNAIRES TO PRESCRIBE MEDICATIONS
By Jonathan Bick Bick is of counsel to WolfBlock of Roseland and is an adjunct professor of Internet law at Pace Law School and Rutgers Law School. He is also the author of '101 Things You Need To Know About Internet Law' [Random House 2000] .
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. Now the use of online questionnaires are considered valid if it can be established that the prescription was based on a documented patient evaluation, including an examination, adequate to establish a diagnosis and 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 case of a consultant practitioner issuing a prescription or drug order when providing services by means of telemedicine.
As in the past, entities fulfilling prescription may not dispense medication which they know or would reasonably be expected to know, were not valid under the new standard. Also as in the past, Internet pharmacy marketers may rely upon the licensed physicians and pharmacists to act lawfully unless they know or would reasonably be expected to know, that such action were not valid under the new standard.
The new 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.
One reason for the change in the standards for online questionnaires for prescription medications is the fact that it has been 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), 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 implying a 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. It can be argued that the cases noted above may be distinguished from Internet pharmacy transactions because these cases arguably 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 doctor patient relationship. It is not a common practice for a physician to rely upon 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 upon a physician's review of individuals' answers to Internet questionnaires alone will not normally meet this standard.
Thus, Internet pharmacy marketers may rely upon the licensed physicians and pharmacists to act lawfully unless they know or would reasonably be expected to know, that the prescriptions associated with their transactions were based solely upon a physician's review of individuals' answers to Internet questionnaires. However, if a licensed pharmacy is aware of the physician's procedure and practices and continues to fill the prescriptions created by the physician, then it is reasonable to rely upon the existing procedure to rely solely upon a physician's review of individuals' answers to Internet questionnaires.
This reasonable reliance is supported by Brighton Pharmacy, 160 P.3d 412, which confirmed the general rule that pharmacist 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 the pharmacist knows or should have known that the order for such drug was issued on the basis of an insufficient Internet-based questionnaire and/or Internet-based consultation, without a valid, pre-existing patient-practitioner relationship.
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 have information relevant for an adequate establishment of a diagnosis and to identify underlying conditions and to contraindications to treatment confirmed. A second option is to require Internet users to secure a copy of their most recent physical examination and have it reviewed by a medical practitioner to confirm it contains information sought through option one above. A third option is to establish a sufficient relationship via e-mail with the doctor which performed the in-person examination to qualify as a related practitioner for the purposes of the new standard.
Each of the aforementioned 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 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, adequate to establish the diagnosis for which the drug is being prescribed and to identify underlying conditions and/or contraindications to the treatment recommended/provided; have sufficient dialogue with the patient regarding treatment options and the risks and benefits of treatment(s); maintain communications 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. However, the implementation of any procedures which make the existing process closer to the ideal process reduces the risks of litigation and unlawful acts.