e-Profile Login and ID Quick Search
Minnesota News: The Internet and the Abuse of Prescription Drugs (Part 1)
Reprinted from the October 2008 Minnesota Board of Pharmacy Newsletter.
As noted in this issue’s Disciplinary Actions, the Board recently disciplined five pharmacists and one pharmacy for involvement with Internet Web sites that offered to arrange for the sale of legend drugs. The Web sites paid physicians and a physician assistant, licensed in other states, to write prescriptions based on their review of questionnaires filled out by customers. In one case, the prescribers supposedly also reviewed copies of medical records submitted by the customers. Those purported prescriptions were then made available electronically to the pharmacists who worked at two licensed Minnesota pharmacies, Byron Marketplace Pharmacy in Byron and Market Pharmacy in Bemidji. The pharmacists shipped legend drugs to customers located across the country. Controlled substances were shipped by the Bemidji, but not the Byron, pharmacy. The actions of the pharmacists violated a number of state and federal laws and rules.
The legislature passed a law earlier this year that establishes that prescriptions for controlled substances and certain other drugs (carisoprodol, tramadol, muscle relaxants, and erectile dysfunction drugs) are not valid unless the prescriptions or orders are based on a documented patient evaluation, including an in-person examination, adequate to establish a diagnosis and identify underlying conditions and contraindications to treatment. Pharmacists are prohibited from knowingly dispensing such prescriptions. This provision is intended to prevent pharmacies and pharmacists from contracting or knowingly working with illegitimate Internet Web sites.
The in-person examination does not have to take place at the time that a prescription is written and does not have to necessarily be performed by the prescriber. The requirement for an in-person examination can be met in any of the following ways:
the prescribing practitioner examines the patient at the time the prescription or drug order 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.
Federal rules administered by the US Drug Enforcement Administration (DEA) require that a prescription for a controlled substance be “issued for a legitimate medical purpose” by a practitioner acting in the usual course of sound professional practice. Per the DEA’s Pharmacist Manual, “the practitioner is responsible for the proper prescribing and dispensing of controlled substances. However, a corresponding responsibility rests with the pharmacist who dispenses the prescription. An order for a controlled substance which purports to be a valid prescription, but is not issued in the course of professional treatment, or for legitimate and authorized research, is not a valid prescription.”
DEA takes the position that for a physician to be “acting in the usual course of professional practice, there must be a bona fide doctor/patient relationship.” DEA considers the following four elements as an indication that a legitimate doctor-patient relationship has been established:
(i) a patient has a medical complaint;
(ii) a medical history has been taken;
(iii) a physical examination has been performed; and
(iv) some logical connection exists between the medical complaint, the medical history, the physical examination and the drug prescribed.
Further, DEA advises that “[a] patient completing a questionnaire that is then reviewed by a physician hired by or working on behalf of an Internet pharmacy does not establish a doctor/patient relationship. A consumer can more easily provide false information in a questionnaire than in a face-to-face meeting with the physician. It is illegal to receive a prescription for a controlled substance without the establishment of a legitimate doctor/patient relationship, and it is unlikely for such a relationship to be formed through Internet correspondence alone.”
As illustrated by the disciplinary cases described above, the Board has the authority to pursue action against pharmacists and pharmacies involved in the processing of prescriptions that they know originate from illegitimate Web sites. However, pharmacists must also keep in mind that it is unprofessional conduct to refuse to dispense a prescription that a pharmacist would reasonably be expected to dispense. The Board is aware that many patients with chronic pain are undertreated, sometimes because practitioners and pharmacists fear disciplinary action. The Board acknowledges that it can sometimes be difficult for pharmacists to assess the validity of a prescription. While each case must rest on its own merits, it is unlikely that the Board would discipline a pharmacist who, while using sound professional judgment and practicing in a reasonable and prudent manner, unknowingly dispenses a prescription that later turns out to be invalid.
