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H.B. 361 Enrolled

             1     

ANTI-SEIZURE DRUG NOTIFICATION

             2     
2008 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Eric K. Hutchings

             5     
Senate Sponsor: Curtis S. Bramble

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill amends the Pharmacy Practice Act by requiring notification of a prescribing
             10      practitioner when substituting a drug product equivalent for an epilepsy drug prescribed
             11      to treat or prevent seizures.
             12      Highlighted Provisions:
             13          This bill:
             14          .    requires a pharmacist or pharmacy intern who substitutes a drug product equivalent
             15      for an epilepsy drug prescribed to a patient to treat or prevent seizures to notify the
             16      prescribing practitioner prior to the substitution, regardless of whether the
             17      substitution is a substitution of a generic drug for another generic drug, a generic
             18      drug for a nongeneric drug, a nongeneric drug for another nongeneric drug, or a
             19      nongeneric drug for a generic drug;
             20          .    provides an exception to the notification requirement; and
             21          .    makes technical changes.
             22      Monies Appropriated in this Bill:
             23          None
             24      Other Special Clauses:
             25          None
             26      Utah Code Sections Affected:
             27      AMENDS:
             28          58-17b-605, as enacted by Laws of Utah 2004, Chapter 280
             29     


             30      Be it enacted by the Legislature of the state of Utah:
             31          Section 1. Section 58-17b-605 is amended to read:
             32           58-17b-605. Drug product equivalents.
             33          (1) A pharmacist or pharmacy intern dispensing a prescription order for a specific drug
             34      by brand or proprietary name may substitute [another] a drug product equivalent, as defined in
             35      Section 58-17b-102 , for the prescribed drug only if:
             36          (a) the purchaser specifically requests or consents to the substitution of a drug product
             37      equivalent;
             38          (b) the [substituted] drug product equivalent is of the same generic type and is
             39      designated the therapeutic equivalent in the approved drug products with therapeutic
             40      equivalence evaluations prepared by the Center for Drug Evaluation and Research of the
             41      Federal Food and Drug Administration;
             42          (c) the [substituted] drug product equivalent is permitted to move in interstate
             43      commerce;
             44          (d) the pharmacist or pharmacy intern counsels the patient on the use and the expected
             45      response to the prescribed drug, whether a substitute or not, and the substitution is not
             46      otherwise prohibited by this chapter;
             47          (e) the prescribing practitioner has not indicated that [an equivalent] a drug product [is
             48      not to] equivalent may not be substituted for the drug, as provided in Subsection (5); and
             49          (f) the substitution is not otherwise prohibited by law.
             50          (2) (a) Each out-of-state mail service pharmacy dispensing a [substituted] drug product
             51      equivalent as a substitute for another drug into this state shall notify the patient of the
             52      substitution either by telephone or in writing.
             53          (b) Each out-of-state mail service pharmacy shall comply with the requirements of this
             54      chapter with respect to [drugs which may be] a drug product equivalent substituted for another
             55      drug, including labeling and record keeping[, when dispensing substituted drug products].
             56          (3) Pharmacists or pharmacy interns may not substitute without the prescriber's
             57      authorization on trade name drug product prescriptions unless the product is currently


             58      categorized in the approved drug products with therapeutic equivalence evaluations prepared by
             59      the Center for Drug Evaluation and Research of the Federal Food and Drug Administration as a
             60      drug product considered to be therapeutically equivalent to another drug product.
             61          (4) A pharmacist or pharmacy intern who dispenses a prescription with a drug product
             62      equivalent under this section assumes no greater liability than would be incurred had the
             63      pharmacist or pharmacy intern dispensed the prescription with the drug product prescribed.
             64          (5) (a) If, in the opinion of the prescribing practitioner, it is in the best interest of the
             65      patient that [an equivalent] a drug product equivalent not be substituted for a prescribed drug,
             66      the practitioner may indicate a prohibition on substitution either by writing "dispense as written"
             67      or [may sign] signing in the appropriate space where two lines have been preprinted on a
             68      prescription order and captioned "dispense as written" or "substitution permitted".
             69          (b) If the prescription is communicated orally by the prescribing practitioner to the
             70      pharmacist or pharmacy intern, the practitioner shall indicate the prohibition on substitution and
             71      that indication shall be noted in writing by the pharmacist or pharmacy intern with the name of
             72      the practitioner and the words "orally by" and the initials of the pharmacist or pharmacy
             73      [practitioner] intern written after it.
             74          (6) [The] A pharmacist or pharmacy intern who substitutes a drug product equivalent
             75      for a prescribed drug shall communicate the substitution[, if any, shall be communicated] to the
             76      purchaser. The drug product equivalent container shall be labeled with the name of the drug
             77      dispensed, and the pharmacist, pharmacy intern, or pharmacy technician shall indicate on the file
             78      copy of the prescription both the name of the prescribed drug and the name of the drug product
             79      equivalent dispensed in its place.
             80          (7) (a) For purposes of Subsection (7), "substitutes" means to substitute:
             81          (i) a generic drug for another generic drug;
             82          (ii) a generic drug for a nongeneric drug;
             83          (iii) a nongeneric drug for another nongeneric drug; or
             84          (iv) a nongeneric drug for a generic drug.
             85          (b) A prescribing practitioner who makes a finding under Subsection (5)(a) for a patient


             86      with a seizure disorder shall indicate a prohibition on substitution of a drug product equivalent
             87      in the manner provided in Subsection (5)(a) or (b).
             88          (c) Except as provided in Subsection (7)(d), a pharmacist or pharmacy intern who
             89      cannot dispense the prescribed drug as written, and who needs to substitute a drug product
             90      equivalent for the drug prescribed to the patient to treat or prevent seizures shall notify the
             91      prescribing practitioner prior to the substitution.
             92          (d) Notification under Subsection (7)(c) is not required if the drug product equivalent is
             93      paid for in whole or in part by Medicaid.
             94          [(7)] (8) Failure of a licensed medical practitioner to specify that no substitution is
             95      authorized does not constitute evidence of negligence.


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