HB4480 H DA AM #1
The Select Committee on Prevention and Treatment of Substance Abuse moved to amend the bill on page 1, by striking everything after the enacting clause and inserting in lieu thereof the following:
“That the Code of West Virginia, 1931, as amended, be amended by adding thereto a new article, designated §16-51-1, §16-51-2 and §16-51-3, all to read as follows:
ARTICLE 51. Addiction Treatment.
As used in this article:
(1) “Addictions specialist” means a licensed allopathic or osteopathic physician who is certified as an addictions specialist by the American Board of Addiction Medicine.
(2) ”Buccal” means a drug that is absorbed across buccal mucosa directly into the venous circulation.
(3) “Controlled substance” means a drug, substance or immediate precursor in Schedules I through V of article two, chapter sixty-a of this code.
(4) “Physician” means a person licensed to practice allopathic medicine pursuant to article three of chapter thirty of this code or osteopathic medicine pursuant to article fourteen, chapter thirty of this code.
(5) “Sublingual” means a pharmacological route of administration by which drugs diffuse into the blood through tissues under the tongue.
(6) “Tablet” means sublingual flat tablet intended to be inserted beneath the tongue, where the active ingredient is absorbed directly through the oral mucosa.
(7) “Therapeutic equivalent” means a drug that has essentially the same effect in the maintenance treatment of opioid dependence as one or more other drugs that may or may not be chemically equivalent, bioequivalent, or generically equivalent but has the same active ingredient or ingredients, but due to ingredient composition or delivery process may have differing amounts of active ingredient or ingredients.
§16-51-2. Limitations on prescribing.
(a) A physician may only prescribe drugs or combinations of drugs that have been approved for use in maintenance or detoxification treatment under the federal food, drug, and cosmetic Act, 21 U.S.C. 301 et seq., or section 351 of the federal Public Health Service Act to a person:
(1) Who has a documented diagnosis of opiate addiction as shown in their medical record;
(2) Who receives treatment from a physician practicing under 21 U.S.C. § 823(g)(2); and
(3) Who is counted against the total number of patients allowed to the provider as set forth in 21 U.S.C. § 823(g)(2).
(b) If an abuse deterrent form of buprenorphine or buprenorphine/naloxone is approved by the Food and Drug Administration and enters the market or is already on the market and receives a new indication of abuse deterrent, other than naloxone being in combination with buprenorphine, as provided in FDA Guidance to Industry, the Board of Pharmacy shall notify all physicians prescribing buprenorphine or buprenorphine/naloxone within sixty days of the availability of the abuse deterrent product or products. Upon receipt of the notice the physicians shall migrate their patients using buprenorphine or buprenorphine/naloxone to the abuse deterrent form of the pharmaceutical.
(c) (1) A prescription for buprenorphine mono or for buprenorphine without use of naloxone for the maintenance treatment of opioid dependence is only permitted to a patient who is:
(B) A nursing mother; or
(C) Has a documented history of an adverse reaction or hypersensitivity to naloxone.
(2) If the prescriber of buprenorphine mono or buprenorphine without use of naloxone for a patient under paragraphs (A) or (B), is not the patient’s obstetrical or gynecological provider, the physician shall consult with the patient’s obstetrical or gynecological provider to the extent possible to determine whether the prescription is appropriate for the patient.
(d) (1) A prescriber who treats a patient with more than sixteen milligrams per day of buprenorphine in the sublingual, buccal or oral solid dosage form for more than thirty days for treatment of opioid dependence shall clearly document in the patient’s medical record the reason that requires the patient to receive a higher dosage amount of buprenorphine. For buprenorphine medications that use a different delivery methodology those dosages, such as a buccal administration or future delivery systems must be at a level that is therapeutically equivalent to the buprenorphine sublingual film or the oral solid dosage form. All patients within six months of the start of treatment must be titrated down to a dosage of twelve milligrams of buprenorphine in the sublingual, buccal, or oral solid dosage form. For buprenorphine medications that use a different delivery methodology those dosages must be at a level that is therapeutically equivalent to the buprenorphine sublingual film, buccal, or the oral solid dosage form.
(2) Treatment with the use of products containing buprenorphine at twelve milligrams or the therapeutic equivalents’ approved by the Food and Drug Administration may be no longer than five consecutive years. At the end of five years of treatment the patient may receive up to four milligrams per day or equivalent dosing of buprenorphine/naloxone, or bupenorphine during pregnancy, nursing or documented allergic reaction.
(3) A physician who exceeds the dosage requirements of this subsection and treats a patient with more than sixteen milligrams per day of buprenorphine in the sublingual, buccal, or oral solid dosage form for more than thirty consecutive days for treatment of opioid dependence shall consult with an addiction specialist or refer the patient to an addiction specialist for management of the patient’s treatment plan, except that for buprenorphine medications that use a different delivery methodology those dosages must be at a level that is therapeutically equivalent to the buprenorphine sublingual film, buccal, or the oral solid dosage form.
(4) If there is a higher dosage used then clear medical notes shall be placed in the patient’s medical file indicating the clinical reason or reasons for the higher level of dosage, not to exceed the higher dose for more than two years.