Current through Register Vol. XLI, No. 36, September 6, 2024
Section 64-33-6 - Drug Procurement - Physician Eligibility6.1. A physician is eligible to prescribe delta-9- THC (marihuana) if he meets the following criteria. 6.1.1 The patient qualification review board shall review and certify physician practioners for participation in the controlled substances therapeutic research program. 6.1.2. Each physician desiring to participate in the controlled substances therapeutic research program shall apply to the patient qualification review board in a format prescribed by such board. 6.1.3. The physician shall document experience in cancer therapy. 6.1.4. The physician shall have a current drug enforcement administration controlled substances registration number. 6.1.5. The physician shall register with a registered pharmacy as hereinafter described and the National Cancer Institute. 6.1.6. The physician shall affirm that the patient has signed an informed consent form. A copy of such signed consent form shall be maintained by the patient qualification review board. 6.1.7. The physician shall limit drug usage to the purposes herein contained. 6.1.8. The physician shall report adverse drug reactions immediately to the Investigational Drug Bank, National Cancer Institute and to the patient qualification review board. 6.1.9. The patient qualification review hoard shall issue a certificate of registry to each physician meeting the requirements of these rules and regulations. The patient qualification review board may revoke such certificate of registry for good cause shown. Those affected persons desiring a public hearing shall do so in the manner prescribed in and by the Rules of Procedure for Contested Case Hearings and Declaratory Rulings, West Virginia Department of Health Procedural Rules, Series I, 1983. The aforementioned rules of procedure are incorporated herein by reference. 6.1.10. Physicians wishing to participate in the controlled substances therapeutic research program shall register by completing and signing Federal Drug Administration Form 1573. Upon certification by the patient qualification review board such Federal Drug Administration Form 1573 shall be presented to a registered pharmacy which will submit the form to the National Cancer Institute for approval. 6.1.11. The National Cancer Institute will notify the applicant pharmacy of the physician's eligibility status and the physician will be notified by the registered pharmacy. 6.1.12. Once certified, registered and approved the prescribing physician shall complete a "Research Order for Medication." The Research Order for Medication will be presented to a registered pharmacy by the patient. Such Research Order for Medication is identical to a prescription order. A standard prescription blank may be used, but it must contain a statement that informed patient consent has been obtained. 6.1.13. The quantity of delta 9-THC dispensed is limited to 25 capsules (5mg strength) for each single prescription. 6.1.14. The director shall apply to contract with the National Institute on Drug Abuse or any federally registered distributor or manufacturer for receipt of marihunana pursuant to and in accordance with regulations promulgated by the National Institute on Drug Abuse, the Food and Drug Administration and pursuant to the provisions of these rules and regulations. 6.1.15. The director may cause such analyzed marihuana to be transferred to a certified licensed pharmacy for distribution to a certified patient upon the written prescription of a certified practioner pursuant to the provisions of these rules and regulations. 6.1.16. The physician shall advise the patient as to the effects and possible side effects of the drug (delta 9-THC) prior to the initial administration thereof. 6.1.17. The director shall provide each registered physician and registered pharmacy with a copy of the Group C Guidelines for the use of Delta 9-Tetraydrocannabinol NSC 134454 for Nausea and Vomiting Induced by Antineplastic Chemotherapy, September 1980, Investigational Drug Branch Cancer Therapy Evaluation Program, Bethesda,. Maryland. 6.1.18. Delta 9-THC (marihuana) shall be provided to each qualified patient pursuant to these rules and regulations at no cost.