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S.B. 161 Enrolled

             1     

PHARMACY PRACTICE ACT REVISIONS

             2     
2012 GENERAL SESSION

             3     
STATE OF UTAH

             4     
Chief Sponsor: Curtis S. Bramble

             5     
House Sponsor: Evan J. Vickers

             6     
             7      LONG TITLE
             8      General Description:
             9          This bill amends the Pharmacy Practice Act to permit certain prescribing practitioners
             10      to dispense certain drugs without a license under the Pharmacy Practice Act, and makes
             11      conforming amendments in the Utah Optometry Practice Act, the Nurse Practice Act,
             12      the Utah Medical Practice Act, the Utah Osteopathic Medical Practice Act, and the
             13      Physician Assistant Act.
             14      Highlighted Provisions:
             15          This bill:
             16          .    requires a prescribing practitioner who will dispense a drug without being licensed
             17      under the Pharmacy Practice Act to notify the Division of Occupational and
             18      Professional Licensing of the practitioner's intent to dispense;
             19          .    requires the dispensing practitioner to follow purchasing and distribution
             20      requirements established by the division by administrative rule;
             21          .    defines cancer drug regimen;
             22          .    exempts an oncologist or medical personnel acting under the direction of an
             23      oncologist from being licensed under the Pharmacy Practice Act to dispense a
             24      cancer drug regimen to a patient who is undergoing chemotherapy in an outpatient
             25      clinic setting;
             26          .    excludes Schedule I, II, and III drugs from the drugs an oncologist may dispense;
             27          .    makes it unprofessional conduct for a prescribing practitioner who dispenses a drug,
             28      to dispense the drug in violation of the exemption in the Pharmacy Practice Act;
             29          .    directs the Division of Occupational and Professional Licensing to evaluate the


             30      prescribing practitioner exemptions from licensing for dispensing drugs and to report the
             31      findings of the evaluation to the Legislature; and
             32          .    sunsets the exemption from licensure for oncologists in July 2015.
             33      Money Appropriated in this Bill:
             34          None
             35      Other Special Clauses:
             36          None
             37      Utah Code Sections Affected:
             38      AMENDS:
             39          58-16a-502, as last amended by Laws of Utah 2000, Chapter 160
             40          58-17b-309, as last amended by Laws of Utah 2011, Chapter 76
             41          58-31b-502, as last amended by Laws of Utah 2006, Chapter 291
             42          58-67-502, as last amended by Laws of Utah 2011, Chapter 206
             43          58-68-502, as enacted by Laws of Utah 1996, Chapter 248
             44          58-70a-502, as enacted by Laws of Utah 1997, Chapter 229
             45          63I-1-258, as last amended by Laws of Utah 2010, Chapter 188
             46      ENACTS:
             47          58-17b-309.5, Utah Code Annotated 1953
             48     
             49      Be it enacted by the Legislature of the state of Utah:
             50          Section 1. Section 58-16a-502 is amended to read:
             51           58-16a-502. Unprofessional conduct.
             52          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 :
             53          (1) using or employing the services of an optometric assistant to assist a licensee in any
             54      manner not in accordance with:
             55          (a) the generally recognized practices and standards of ethics of the profession; or
             56          (b) applicable state law or division rule;
             57          (2) failure to refer a patient to an appropriate licensed practitioner when:


             58          (a) the patient's condition does not respond to treatment; or
             59          (b) the treatment is not within the scope of competence or licensure of the licensee;
             60          (3) providing confidential information regarding a patient to any third party who does
             61      not have a legal and professional ground for obtaining the information;
             62          (4) knowingly prescribing, selling, giving away, or administering any prescription drug
             63      [except] unless:
             64          (a) for a legitimate medical purpose [and];
             65          (b) upon a proper diagnosis indicating the use of the drug in the amount prescribed or
             66      provided; and
             67          (c) in compliance with Section 58-17b-309 ;
             68          (5) giving or receiving directly or indirectly any fee, commission, rebate, or other
             69      compensation for professional services not actually and personally rendered, except as part of a
             70      legal relationship within a lawful professional partnership, corporation, or association;
             71          (6) failure to transfer pertinent and necessary information from a patient's medical
             72      records to another optometrist or physician when so requested by the patient or his
             73      representative, as designated in writing; or
             74          (7) failure to provide a contact lens prescription to a person who sells contact lenses in
             75      accordance with Section 58-16a-306 .
             76          Section 2. Section 58-17b-309 is amended to read:
             77           58-17b-309. Exemptions from licensure.
             78          (1) For purposes of this section:
             79          (a) "Cosmetic drug":
             80          (i) means a prescription drug that is:
             81          (A) for the purpose of promoting attractiveness or altering the appearance of an
             82      individual; and
             83          (B) listed as a cosmetic drug subject to the exemption under this section by the division
             84      by administrative rule; and
             85          (ii) does not include a prescription drug that is:


             86          (A) a controlled substance;
             87          (B) compounded by the physician; or
             88          (C) prescribed or used for the patient for the purpose of diagnosing, curing, mitigating,
             89      treating, or preventing a disease.
             90          (b) "Injectable weight loss drug":
             91          (i) means an injectable prescription drug:
             92          (A) prescribed to promote weight loss; and
             93          (B) listed as an injectable prescription drug subject to exemption under this section by
             94      the division by administrative rule; and
             95          (ii) does not include a prescription drug that is a controlled substance.
             96          (c) "Prescribing practitioner" means an individual licensed under:
             97          (i) Chapter 31b, Nurse Practice Act, as an advanced practice registered nurse with
             98      prescriptive practice;
             99          (ii) Chapter 67, Utah Medical Practice Act;
             100          (iii) Chapter 68, Utah Osteopathic Medical Practice Act; or
             101          (iv) Chapter 70a, Physician Assistant Act.
             102          (2) In addition to the exemptions from licensure in [Section] Sections 58-1-307 and
             103      58-17b-309.5 , the following individuals may engage in the acts or practices described in this
             104      section without being licensed under this chapter:
             105          (a) if the individual is described in Subsections (2)(b), (d), and (e), the individual
             106      notifies the division in writing of the individual's intent to dispense a drug under this
             107      subsection;
             108          [(a)] (b) a person selling or providing contact lenses in accordance with Section
             109      58-16a-801 ;
             110          [(b)] (c) an individual engaging in the practice of pharmacy technician under the direct
             111      personal supervision of a pharmacist while making satisfactory progress in an approved
             112      program as defined in division rule;
             113          [(c)] (d) a prescribing practitioner who prescribes and dispenses a cosmetic drug or an


             114      injectable weight loss drug to the prescribing practitioner's patient in accordance with
             115      Subsection (4); [and] or
             116          [(d)] (e) an optometrist, as defined in Section 58-16a-102 , acting within the
             117      optometrist's scope of practice as defined in Section 58-16a-601 , who prescribes and dispenses
             118      a cosmetic drug to the optometrist's patient in accordance with Subsection (4).
             119          (3) In accordance with Subsection 58-1-303 (1)(a), an individual exempt under
             120      Subsection (2)[(b)](c) must take all examinations as required by division rule following
             121      completion of an approved curriculum of education, within the required time frame. This
             122      exemption expires immediately upon notification of a failing score of an examination, and the
             123      individual may not continue working as a pharmacy technician even under direct supervision.
             124          (4) A prescribing practitioner or optometrist is exempt from licensing under the
             125      provisions of this part if the prescribing practitioner or optometrist:
             126          (a) (i) writes a prescription for a drug the prescribing practitioner or optometrist has the
             127      authority to dispense under Subsection (4)(b); and
             128          (ii) informs the patient:
             129          (A) that the prescription may be filled at a pharmacy or dispensed in the prescribing
             130      practitioner's or optometrist's office;
             131          (B) of the directions for appropriate use of the drug;
             132          (C) of potential side-effects to the use of the drug; and
             133          (D) how to contact the prescribing practitioner or optometrist if the patient has
             134      questions or concerns regarding the drug;
             135          (b) dispenses a cosmetic drug or injectable weight loss drug only to the prescribing
             136      practitioner's patients or for an optometrist, dispenses a cosmetic drug only to the optometrist's
             137      patients; [and]
             138          (c) follows labeling, record keeping, patient counseling, [and] storage, purchasing and
             139      distribution, operating, treatment, and quality of care requirements established by
             140      administrative rule adopted by the division in consultation with the boards listed in Subsection
             141      (5)(a)[.]; and


             142          (d) follows USP-NF 797 standards for sterile compounding if the drug dispensed to
             143      patients is reconstituted or compounded.
             144          (5) (a) The division, in consultation with the board under this chapter, the Physician
             145      Licensing Board, the Osteopathic Physician Licensing Board, the Physician Assistant Licensing
             146      Board, the Board of Nursing, and the Optometrist Licensing Board shall adopt administrative
             147      rules pursuant to Title 63G, Chapter 3, Utah Administrative Rulemaking Act to designate:
             148          (i) the prescription drugs that may be dispensed as a cosmetic drug or weight loss drug
             149      under this section; and
             150          (ii) the requirements under Subsection (4)(c).
             151          (b) When making a determination under Subsection (1)(a), the division and boards
             152      listed in Subsection (5)(a), may consider any federal Food and Drug Administration indications
             153      or approval associated with a drug when adopting a rule to designate a prescription drug that
             154      may be dispensed under this section.
             155          (c) The division may inspect the office of a prescribing practitioner or optometrist who
             156      is dispensing under the provisions of this section, in order to determine whether the prescribing
             157      practitioner or optometrist is in compliance with the provisions of this section. If a prescribing
             158      practitioner or optometrist chooses to dispense under the provisions of this section, the
             159      prescribing practitioner or optometrist consents to the jurisdiction of the division to inspect the
             160      prescribing practitioner's or optometrist's office and determine if the provisions of this section
             161      are being met by the prescribing practitioner and optometrist.
             162          (d) If a prescribing practitioner or optometrist violates a provision of this section, the
             163      prescribing practitioner or optometrist may be subject to discipline under:
             164          (i) this chapter; and
             165          (ii) (A) Chapter 16a, Utah Optometry Practice Act;
             166          (B) Chapter 31b, Nurse Practice Act;
             167          (C) Chapter 67, Utah Medical Practice Act;
             168          (D) Chapter 68, Utah Osteopathic Medical Practice Act; or
             169          (E) Chapter 70a, Physician Assistant Act.


             170          (6) Except as provided in Subsection (2)[(d)](e), this section does not restrict or limit
             171      the scope of practice of an optometrist or optometric physician licensed under Chapter 16a,
             172      Utah Optometry Practice Act.
             173          Section 3. Section 58-17b-309.5 is enacted to read:
             174          58-17b-309.5. Exemption for prescribing practitioner of cancer drug regimen --
             175      Division study of dispensing practitioners.
             176          (1) For purposes of this section, "cancer drug treatment regimen":
             177          (a) means a prescription drug used to treat cancer, manage its symptoms, or provide
             178      continuity of care for a cancer patient;
             179          (b) includes:
             180          (i) a chemotherapy drug administered intravenously, orally, rectally, or by dermal
             181      methods; and
             182          (ii) a drug used to support cancer treatment, including to treat, alleviate, or minimize
             183      physical and psychological symptoms or pain, or to improve patient tolerance of cancer
             184      treatments or prepare a patient for a subsequent course of therapy; and
             185          (c) does not mean a drug listed under federal law as a Schedule I, II, or III drug.
             186          (2) In addition to the exemption from licensure under Section 58-1-307 , the following
             187      individuals are exempt from licensure under this chapter:
             188          (a) an individual who:
             189          (i) meets the requirements of Subsection (2)(b) or (c); and
             190          (ii) notifies the division that the individual intends to dispense a cancer drug regimen
             191      under this section;
             192          (b) a prescribing practitioner who:
             193          (i) treats a patient who is currently undergoing chemotherapy in an outpatient clinic
             194      setting;
             195          (ii) prescribes a cancer drug treatment regimen to the patient;
             196          (iii) determines that providing the cancer drug treatment regimen to the patient in the
             197      outpatient clinic setting is in the best interest of the patient, or provides better access to care for


             198      the patient;
             199          (iv) discloses to the patient that the cancer drug treatment regimen may be obtained
             200      from a pharmacy unaffiliated with the prescribing practitioner and offers to the patient the
             201      opportunity to consult with a pharmacist if the patient desires patient counseling;
             202          (v) does not directly or indirectly mark up, charge a commission, or make a profit on
             203      providing the cancer drug regimen, but may obtain payment for expenses and services related
             204      to providing the cancer drug regimen;
             205          (vi) provides the cancer drug treatment regimen to the patient, or directs another person
             206      under Subsection (2)(c) to provide the cancer drug treatment regimen to the patient;
             207          (vii) is certified or eligible to be certified by the American Board of Internal Medicine
             208      in medical oncology;
             209          (viii) reports to the Utah Controlled Substance Database in the same manner as
             210      required by Section 58-37f-203 , and follows labeling, recordkeeping, patient counseling,
             211      purchasing and distribution, operating, treatment, quality of care, and storage requirements
             212      established by administrative rule adopted by the division in consultation with the board; and
             213          (ix) follows the USP-NF 797 standards for sterile compounding if the drug dispensed
             214      to the patient is reconstituted or compounded; and
             215          (c) a person who is not a prescribing practitioner who:
             216          (i) is employed as a health care provider by a prescribing practitioner or the outpatient
             217      clinic setting in which the prescribing practitioner works and is acting within the individual's
             218      scope of practice;
             219          (ii) is acting under the direction of a prescribing practitioner who is immediately
             220      available on site for any necessary consultation, and who has complied with Subsection
             221      (2)(b)(i);
             222          (iii) prepares or provides the cancer drug treatment regimen to the patient at the
             223      outpatient clinic setting; and
             224          (iv) follows Subsections (2)(b)(iv), (v), and (viii).
             225          (3) (a) The division shall work with stakeholders to evaluate the exemptions to


             226      licensure under this title in Subsections 58-17b-309 (2)(b), (d), and (e) and this section.
             227          (b) The evaluation under this Subsection (3) shall include:
             228          (i) practitioner compliance with the requirements of this section and Section
             229      58-17b-309 ;
             230          (ii) current research on dispensing and patient safety;
             231          (iii) survey of other state dispensing laws; and
             232          (iv) recommendations for future action concerning practitioner dispensing.
             233          (c) The division shall report to the Legislature's Health and Human Services Interim
             234      Committee by November 30, 2012, and by November 30, 2013, with the results and
             235      recommendations from the evaluation required by this Subsection (3).
             236          (4) This section sunsets in accordance with Section 63I-1-258 .
             237          Section 4. Section 58-31b-502 is amended to read:
             238           58-31b-502. Unprofessional conduct.
             239          "Unprofessional conduct" includes:
             240          (1) failure to safeguard a patient's right to privacy as to the patient's person, condition,
             241      diagnosis, personal effects, or any other matter about which the licensee is privileged to know
             242      because of the licensee's or person with a certification's position or practice as a nurse or
             243      practice as a medication aide certified;
             244          (2) failure to provide nursing service or service as a medication aide certified in a
             245      manner that demonstrates respect for the patient's human dignity and unique personal character
             246      and needs without regard to the patient's race, religion, ethnic background, socioeconomic
             247      status, age, sex, or the nature of the patient's health problem;
             248          (3) engaging in sexual relations with a patient during any:
             249          (a) period when a generally recognized professional relationship exists between the
             250      person licensed or certified under this chapter and patient; or
             251          (b) extended period when a patient has reasonable cause to believe a professional
             252      relationship exists between the person licensed or certified under the provisions of this chapter
             253      and the patient;


             254          (4) (a) as a result of any circumstance under Subsection (3), exploiting or using
             255      information about a patient or exploiting the licensee's or the person with a certification's
             256      professional relationship between the licensee or holder of a certification under this chapter and
             257      the patient; or
             258          (b) exploiting the patient by use of the licensee's or person with a certification's
             259      knowledge of the patient obtained while acting as a nurse or a medication aide certified;
             260          (5) unlawfully obtaining, possessing, or using any prescription drug or illicit drug;
             261          (6) unauthorized taking or personal use of nursing supplies from an employer;
             262          (7) unauthorized taking or personal use of a patient's personal property;
             263          (8) knowingly entering into any medical record any false or misleading information or
             264      altering a medical record in any way for the purpose of concealing an act, omission, or record
             265      of events, medical condition, or any other circumstance related to the patient and the medical or
             266      nursing care provided;
             267          (9) unlawful or inappropriate delegation of nursing care;
             268          (10) failure to exercise appropriate supervision of persons providing patient care
             269      services under supervision of the licensed nurse;
             270          (11) employing or aiding and abetting the employment of an unqualified or unlicensed
             271      person to practice as a nurse;
             272          (12) failure to file or record any medical report as required by law, impeding or
             273      obstructing the filing or recording of such a report, or inducing another to fail to file or record
             274      such a report;
             275          (13) breach of a statutory, common law, regulatory, or ethical requirement of
             276      confidentiality with respect to a person who is a patient, unless ordered by a court;
             277          (14) failure to pay a penalty imposed by the division;
             278          (15) prescribing a schedule II-III controlled substance without a consulting physician or
             279      outside of a consultation and referral plan; [and]
             280          (16) violating Section 58-31b-801 [.]; and
             281          (17) violating the dispensing requirements of Section 58-17b-309 or 58-17b-309.5 , if


             282      applicable.
             283          Section 5. Section 58-67-502 is amended to read:
             284           58-67-502. Unprofessional conduct.
             285          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 [,]:
             286          (1) using or employing the services of any individual to assist a licensee in any manner
             287      not in accordance with the generally recognized practices, standards, or ethics of the
             288      profession, state law, or division rule[, or];
             289          (2) making a material misrepresentation regarding the qualifications for licensure under
             290      Section 58-67-302.7 [.]; or
             291          (3) violating the dispensing requirements of Section 58-17b-309 or 58-17b-309.5 if
             292      applicable.
             293          Section 6. Section 58-68-502 is amended to read:
             294           58-68-502. Unprofessional conduct.
             295          "Unprofessional conduct" includes, in addition to the definition in Section 58-1-501 [,]:
             296          (1) using or employing the services of any individual to assist a licensee in any manner
             297      not in accordance with the generally recognized practices, standards, or ethics of the
             298      profession, state law, or division rule[.]; or
             299          (2) violating the dispensing requirements of Section 58-17b-309 or 58-17b-309.5 if
             300      applicable.
             301          Section 7. Section 58-70a-502 is amended to read:
             302           58-70a-502. Unlawful conduct.
             303          "Unlawful conduct" includes:
             304          (1) engaging in practice as a licensed physician assistant while not under the
             305      supervision of a supervising physician or substitute supervising physician[.]; or
             306          (2) violating the drug dispensing requirements of Section 58-17b-309 or 58-17b-309.5 ,
             307      if applicable.
             308          Section 8. Section 63I-1-258 is amended to read:
             309           63I-1-258. Repeal dates, Title 58.


             310          (1) Title 58, Chapter 9, Funeral Services Licensing Act, is repealed July 1, 2018.
             311          (2) Title 58, Chapter 13, Health Care Providers Immunity from Liability Act, is
             312      repealed July 1, 2016.
             313          (3) Title 58, Chapter 15, Health Facility Administrator Act, is repealed July 1, 2015.
             314          (4) Section 58-17b-309.5 is repealed July 1, 2015.
             315          [(4)] (5) Title 58, Chapter 20a, Environmental Health Scientist Act, is repealed July 1,
             316      2013.
             317          [(5)] (6) Title 58, Chapter 40, Recreational Therapy Practice Act, is repealed July 1,
             318      2013.
             319          [(6)] (7) Title 58, Chapter 41, Speech-language Pathology and Audiology Licensing
             320      Act, is repealed July 1, 2019.
             321          [(7)] (8) Title 58, Chapter 42a, Occupational Therapy Practice Act, is repealed July 1,
             322      2015.
             323          [(8)] (9) Title 58, Chapter 46a, Hearing Instrument Specialist Licensing Act, is
             324      repealed July 1, 2013.
             325          [(9)] (10) Title 58, Chapter 47b, Massage Therapy Practice Act, is repealed July 1,
             326      2014.
             327          [(10)] (11) Title 58, Chapter 72, Acupuncture Licensing Act, is repealed July 1, 2017.
             328          [(11)] (12) Section 58-13-2.5 is repealed July 1, 2013.


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