Source: http://www.wvlegislature.gov/wvcode/code.cfm?chap=30&art=5
Timestamp: 2020-08-03 17:55:01
Document Index: 598009837

Matched Legal Cases: ['§30', '§30', '§30', '§29', '§29', '§30', '§60', '§60']

§30-5-35. Conversion of prescriptions authorizing refills.
§30-5-36. Emergency prescriptions for life-sustaining medication
(4) Stock medications;
(5) Complete a list of a patient’s current prescription and nonprescription medications to provide for medication reconciliation;
(6) Supervise registered pharmacy technicians and pharmacy technician trainees;
(7) Medical records screening; and
(8) Perform pharmacy technician product verification, where no clinical judgment is necessary and the pharmacist makes the final verification; if the registered pharmacy technician furnishes to the Board an affidavit signed and dated by the supervising pharmacist-in-charge of the facility which will employee the applicant attesting to the applicant’s competency in the advanced areas of practice that he or she will practice; and has either:
(A) Worked as a full-time registered pharmacy technician holding a pharmacy technician endorsement in West Virginia for at least the previous two years; or
(B) Worked as a full-time registered pharmacy technician holding a pharmacy technician license in good standing in another jurisdiction for at least the previous two years.
(b) A registered pharmacy technician may perform the following under indirect supervision of a licensed pharmacist:
(6) Prescription transfer;
(7) Receive new oral prescription drug orders;
(8) An act within the practice of pharmacist care that involves discretion or independent professional judgment; or
(9) A function which the registrant has not been trained and the function has not been specified in a written protocol with competency established.
(d) Indirect supervision of a registered pharmacy technician is permitted to allow a pharmacist to take one break of no more than 30 minutes during any contiguous eight-hour period. The pharmacist may leave the pharmacy area but may not leave the building during the break. When a pharmacist is on break, a pharmacy technician may continue to prepare prescriptions for the pharmacist(s verification. A prescription may not be delivered until the pharmacist has verified the accuracy of the prescription, and counseling, if required, has been provided to or refused by the patient.
(e) A pharmacy that permits indirect supervision of a pharmacy technician during a pharmacist(s break shall have either an interactive voice response system or a voice mail system installed on the pharmacy phone line in order to receive new prescription orders and refill authorizations during the break.
(f) The pharmacy shall establish protocols that require a registered pharmacy technician to interrupt the pharmacist(s break if an emergency arises.
(g) A registered pharmacy technician who has obtained a nuclear pharmacy technician endorsement, may under the direct supervision of the licensed nuclear pharmacist, perform the following:
(3) Mix compound ingredients for liquid products, suspensions, ointments, mixes, or blend for tablet granulations and capsule powders;
(4) Prepare radiopharmaceuticals;
(5) Record keeping;
(6) File and organize prescriptions;
(7) Create reports;
(8) Inventory tasks;
(9) Handle raw materials and intermediate or finished products;
(10) Perform general maintenance as required on pumps, homogenizers, filter presses, tablet compression machines, and other like machines;
(11) Perform standard operating procedures to meet current good manufacturing practices (GMP);
(12) Maintain records;
(13) Monitor and verify quality in accordance with statistical process or other control procedures; and
(14) Stock medications.
(h) A registered pharmacy technician who has obtained a nuclear pharmacy technician endorsement may not perform the following:
(4) Receive new oral prescription drug orders.
(1) "Brand name" means the proprietary or trade name selected by the manufacturer and placed upon a drug or drug product, its container, label, or wrapping at the time of packaging.
(2) "Covered entity" means:
(A) Any hospital or medical service organization, insurer, health coverage plan, or health maintenance organization licensed in the state that contracts with another entity to provide prescription drug benefits for its customers or clients;
(B) Any health program administered by the state in its capacity as provider of health coverage; or
(C) Any employer, labor union, or other group of persons organized in the state that contracts with another entity to provide prescription drug benefits for its employees or members.
(3) "Covered individual" means a member, participant, enrollee, contract holder, policy holder, or beneficiary of a covered entity who is provided a prescription drug benefit by a covered entity. The term "covered individual" includes a dependent or other person provided a prescription drug benefit through a policy, contract, or plan for a covered individual.
(4) "Generic name" means the official title of a drug or drug combination for which a new drug application, or an abbreviated new drug application, has been approved by the United States Food and Drug Administration and is in effect.
(5) "Substitute" means to dispense a therapeutically equivalent generic drug product in the place of the drug ordered or prescribed.
(6) "Equivalent" means drugs or drug products which are the same amounts of identical active ingredients and same dosage form and which will provide the same therapeutic efficacy and toxicity when administered to an individual and is approved by the United States Food and Drug Administration.
(b) A pharmacist who receives a prescription for a brand name drug or drug product shall substitute a less expensive equivalent generic name drug or drug product unless, in the exercise of his or her professional judgment, the pharmacist believes that the less expensive drug is not suitable for the particular patient: Provided, That a substitution may not be made by the pharmacist where the prescribing practitioner indicates that, in his or her professional judgment, a specific brand name drug is medically necessary for a particular patient.
(c) A written prescription order shall permit the pharmacist to substitute an equivalent generic name drug or drug product except where the prescribing practitioner has indicated in his or her own handwriting the words "Brand Medically Necessary". The following sentence shall be printed on the prescription form: "This prescription may be filled with a generically equivalent drug product unless the words "Brand Medically Necessary" are written, in the practitioner’s own handwriting, on this prescription form": Provided, That "Brand Medically Necessary" may be indicated on the prescription order other than in the prescribing practitioner’s own handwriting unless otherwise required by federal mandate.
(d) A verbal prescription order shall permit the pharmacist to substitute an equivalent generic name drug or drug product except where the prescribing practitioner indicates to the pharmacist that the prescription is "Brand Necessary" or "Brand Medically Necessary". The pharmacist shall note the instructions on the file copy of the prescription or chart order form.
(e) A person may not by trade rule, work rule, contract or in any other way prohibit, restrict, limit, or attempt to prohibit, restrict, or limit the making of a generic name substitution under the provisions of this section. An employer or his or her agent may not use coercion or other means to interfere with the professional judgment of the pharmacist in deciding which generic name drugs or drug products shall be stocked or substituted: Provided, That this section may not be construed to permit the pharmacist to generally refuse to substitute less expensive therapeutically equivalent generic drugs for brand name drugs and that any pharmacist so refusing is subject to the penalties prescribed §30-5-34 of this code.
(f) A pharmacist may substitute a drug pursuant to the provisions of this section only where there will be a savings to the purchaser. Where substitution is proper, pursuant to this section, or where the practitioner prescribes the drug by generic name, the pharmacist shall, consistent with his or her professional judgment, dispense the lowest retail cost-effective brand which is in stock.
(g) If a pharmacist substitutes a drug pursuant to the provisions of this section, the patient shall receive the savings which shall be equal to the difference in the patient’s acquisition cost of the product prescribed and the acquisition cost of the substituted product: Provided, That this subsection may not apply if the patient is a covered individual.
(h) Each pharmacy shall maintain a record of any substitution of an equivalent generic name drug product for a prescribed brand name drug product on the file copy of a written, electronic or verbal prescription or chart order. The record shall include the manufacturer and generic name of the drug product selected.
(j) Unless the practitioner directs otherwise, the prescription label on all drugs dispensed by the pharmacist shall indicate the generic name using abbreviations, if necessary, and either the name of the manufacturer or packager, whichever is applicable in the pharmacist’s discretion. The same notation will be made on the original prescription retained by the pharmacist.
(3) Marking products with an identification code or monogram; and
(l) The West Virginia Board of Pharmacy shall promulgate rules in accordance with the provisions of §29A-3-1 et seq. of this code which establish a formulary of generic type and brand name drug products which are determined by the board to demonstrate significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication. The formulary shall be promulgated by the board within 90 days of the date of passage of this section and may be amended in accordance with the provisions of that chapter.
(m) A pharmacist may not substitute a generic-named therapeutically equivalent drug product for a prescribed brand name drug product if the brand name drug product or the generic drug type is listed on the formulary established by the West Virginia Board of Pharmacy pursuant to this article or is found to be in violation of the requirements of the United States Food and Drug Administration.
(n) Any pharmacist who substitutes any drug shall, either personally or through his or her agent, assistant, or employee, notify the person presenting the prescription of the substitution. The person presenting the prescription may refuse the substitution. Upon request the pharmacist shall relate the retail price difference between the brand name and the drug substituted for it.
(o) Every pharmacy shall post in a prominent place that is in clear and unobstructed public view, at or near the place where prescriptions are dispensed, a sign which shall read: "West Virginia law requires pharmacists to substitute a less expensive generic-named therapeutically equivalent drug for a brand name drug, if available, unless you or your physician direct otherwise". The sign shall be printed with lettering of at least one and one-half inches in height with appropriate margins and spacing as prescribed by the West Virginia Board of Pharmacy.
(p) The West Virginia Board of Pharmacy shall promulgate rules in accordance with §29A-3-1 et seq. of this code setting standards for substituted drug products and obtaining compliance with the provisions of this section. The board has the primary responsibility for enforcing the provisions of this section.
(q) Any person may file a complaint with the West Virginia Board of Pharmacy regarding any violation of the provisions of this article. The complaints shall be investigated by the Board of Pharmacy.
(r) Fifteen days after the board has notified, by registered mail, a person, firm, corporation, or copartnership that the person, firm, corporation, or copartnership is suspected of being in violation of a provision of this section, the board shall hold a hearing on the matter. If, as a result of the hearing, the board determines that a person, firm, corporation, or copartnership is violating any of the provisions of this section, it may, in addition to any penalties prescribed by §30-5-22 of this code, suspend or revoke the permit of any person, firm, corporation, or copartnership to operate a pharmacy.
(s) A pharmacist or pharmacy complying with the provisions of this section may not be liable in any way for the dispensing of a generic-named therapeutically equivalent drug, substituted under the provisions of this section, unless the generic-named therapeutically equivalent drug was incorrectly substituted.
(t) In no event where the pharmacist substitutes a drug under the provisions of this section may the prescribing physician be liable in any action for loss, damage, injury, or death of any person occasioned by or arising from the use of the substitute drug unless the original drug was incorrectly prescribed.
(u) Failure of a practitioner to specify that a specific brand name is necessary for a particular patient may not constitute evidence of negligence unless the practitioner had reasonable cause to believe that the health of the patient required the use of a certain product and no other.
“Substitute” means to dispense without the prescriber’s express authorization an interchangeable biological product in the place of the drug ordered or prescribed.
(g) Unless the practitioner directs otherwise, the prescription label on all biological products dispensed by the pharmacist shall indicate the proper name using abbreviations, if necessary, and either the name of the manufacturer or packager, whichever is applicable, in the pharmacist’s discretion. The same notation will be made on the original prescription retained by the pharmacist.
(l) In no event where the pharmacist substitutes an interchangeable biological product under the provisions of this section shall the prescribing physician be liable in any action for loss, damage, injury, or death of any person occasioned by or arising from, the use of the substitute biological product unless the original biological product was incorrectly prescribed.
(i) The provisions of this section do not apply to the sale of nonprescription drugs which are not required to be dispensed pursuant to a practitioner’s prescription.
(a) If a prescription authorizes a drug to be dispensed by refilling the prescription one or more times and the total quantity of the drug does not exceed a 90-day supply of the drug, a pharmacist who is filling or refilling the prescription may dispense a quantity of the drug that varies from the quantity or amount of the drug originally written on the prescription, if all of these conditions are met:
(1) The action taken by the pharmacist does not result in a quantity or amount of the drug being dispensed that exceeds the total quantity that may be dispensed by filling and refilling the prescription.
(2) The prescription is for one of the following:
(A) A maintenance drug to be taken on a regular, recurring basis to treat a chronic condition;
(B) A drug to be taken on a regular, recurring basis to prevent disease; or
(C) A contraceptive.
(3) If the prescription is for a maintenance drug, the patient has used an initial 30-day supply of the drug, or a 90-day supply of the drug has previously been prescribed to the patient, and the pharmacist determines, after consulting with the patient, that the drug has stabilized the patient’s condition.
(4) The prescription is not for a controlled substance, as set forth in §60A-1-1 et seq.; and
(5) The pharmacist consults with the patient, and the pharmacist determines the action authorized by this section is appropriate for the patient.
(b) When a licensed practitioner authorizes a drug to be dispensed in a certain dosage, and the pharmacist is unable to dispense the drug in the same dosage as specified, the pharmacist may substitute the same drug in a different dosage, if the aggregate dosage of the prescription remains the same and the following conditions are met:
(1) The pharmacist counsels the patient on the differences; and
(2) The pharmacist notifies the patient’s prescriber of the drug product substitution within five business days of the substitution.
(c) This section does not require a health care insurer, government health care program, pharmacy benefit manager, or other entity that offers health benefit plans to provide coverage for a drug in a manner that is inconsistent with the patient’s benefit plan.
(a) A pharmacist may distribute or sell a dangerous drug, other than a schedule II-controlled substance as defined in §60A-2-206, without a written or oral prescription from a licensed health professional authorized to prescribe drugs if all the following conditions are met:
(1) The pharmacy at which the pharmacist works has a record of a prescription for the drug in the name of the patient who is requesting it, but the prescription does not provide for a refill or the time permitted by the rules adopted by the state board of pharmacy for providing refills has elapsed;
(2) The pharmacist is unable to obtain authorization to refill the prescription from a health care professional who issued the prescription or another health professional responsible for the patient’s care;
(3) In the exercise of the pharmacist’s professional judgment:
(4) Except as provided in this section, the amount of the drug that is dispensed or sold under this section does not exceed a seventy-two-hour supply as provided in the prescription; and
(5) If the drug sold or dispensed under this section is not a controlled substance and the patient has been on a consistent drug therapy as demonstrated by records maintained by a pharmacy, the amount of the drug dispensed or sold does not exceed a thirty-day supply as provided in the prescription or, if the standard unit of dispensing for the drug exceeds a thirty-day supply, the amount of the drug dispensed or sold does not exceed the standard unit of dispensing. A pharmacist shall not dispense or sell a particular drug to the same patient in an amount described in this section more than once in any twelve-month period.
(b) A Pharmacist who dispenses or sells a drug under this section shall:
(2) Notify the health professional who issued the initial prescription or another health professional responsible for the patient’s care not later than seventy-two hours after the drug is sold or dispensed; and within seven days after authorizing an emergency oral prescription, the practitioner has a written prescription for the emergency quantity prescribed delivered to the dispensing pharmacist. The prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the orally or electronically transmitted prescription. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven-day period. Upon receipt, the dispensing pharmacist shall attach this written prescription to the emergency oral prescription which had earlier been reduced to writing or to the hard copy of the electronically transmitted prescription. The pharmacist shall notify the nearest office of the U.S. Drug Enforcement Administration if the prescribing practitioner fails to deliver a written prescription.
(3) If applicable, obtain authorization for additional dispensing from one of the health professionals in division (A) (1) of this section.
(4) A pharmacist who dispenses or sells a drug under this section may do so once for each prescription described here.