Texas Pharmacists Police Physician-Patient Relationship

Ronald L. Scott
Rscott@central.uh.edu

Texas Senate Bill 768 from the 77th Legislative Session amends § 483.021 (a) and §481.074(a), Texas Health and Safety Code, to provide that "[a] pharmacist may not dispense a [prescription] drug if the pharmacist knows or should have known that the prescription was issued without a valid patient-practitioner relationship." A rule recently promulgated by the Texas Board of Pharmacy goes even further.

Prior to dispensing a prescription, pharmacists shall determine, in the exercise of sound professional judgment, that the prescription is a valid prescription. A pharmacist may not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued on the basis of an Internet-based or telephonic consultation without a valid patient-practitioner relationship. See 26 Texas Register 6911 (Sept. 7, 2001).

All states have a board of pharmacy that requires pharmacists to be licensed or registered to practice pharmacy. The requirements vary among the states, but generally, pharmacists must: have a degree from an accredited college of pharmacy; complete a residency or internship program; pass a licensing examination; and meet continuing education requirements for practicing pharmacists in most states. See Melanie Margolis, You Can Get Anything You Want: Internet Pharmacies Overstep Boundaries.

Although both pharmacies and pharmacists are licensed by the states for the practice of pharmacy within a state’s borders, federal law also regulates aspects of the practice of pharmacy. The federal Food, Drug, and Cosmetic Act (FDCA) prohibits the manufacture and distribution of misbranded and adulterated drugs, mandates labeling standards, and requires that drugs be handled in a manner that will prevent contamination or misuse. See 21 U.S.C. § 301 et seq. The regulatory scheme is designed to protect the public from abuses arising from the sale of prescription drugs. Section 353 provides that "[a] drug intended for use by man which is… not safe for use except under the supervision of a practitioner licensed by law to administer such drug…shall be dispensed only…upon a written prescription of a practitioner licensed by law to administer such drug." The regulatory scheme relies on both a physician and a pharmacist to protect patients from intentional or accidental misuse of prescription drugs. See The Electronic Frontier: The Challenge Of Unlawful Conduct Involving The Use Of The Internet.

Further, the FDCA provides that dispensing a prescription drug contrary to the provisions of Section 353 (b)(1) "shall be deemed to b e an act which results in the drug being misbranded…" Section 331 of the FDCA prohibits the introduction or delivery of misbranded drugs into interstate commerce. Clearly, an online pharmacy providing drugs without any prescription would be introducing or delivering "misbranded" drugs in violation of FDCA Section 331. For pharmacies that offer a prescription based on a questionnaire or knowingly accept a prescription from a physician that does not have an established physician-patient relationship, the issue is whether a valid prescription exists under FDCA Section 353. The federal law does not specifically address the validity of such prescriptions, so resolution of the issue may be dependent on state law. Therefore, the newly enacted Texas law could increase pharmacies' and pharmacists' exposure under federal law, as well as subject them to sanctions under Texas law.

10/23/01