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‘SECRETARY OF STATE Fon EvERGENY RUNG Ona REGULATIONS ONLY For Fang Adina Reguations ‘Beco doa_sz3.2000 Slaton dae_ecagoo0 soe: Noa Sto ti Board of Pharmacy feet Ciasicaton: PROPOSED ADOPTED BY AGENCY x EMERGENCY Bit cesegton et acon: “The proposed amendment Authonyetaton other than 299% NAS 698.070 Nee Date: tren 29,2020 Dato of Adoption by Agonay: March 23,2020 He ring Date: March 23,2020 Nevada State Board of Pharmacy Smee ae AO mi do gl Wa Page pay go Mareb 23,2020 ‘VIA EMAIL AND HAND DELIVERY ‘The Honorable Steve Sislak, Governor 101 North Carson Street ~ Suite 1 Carson City, NV 89701 RE: Fmergeney regulation on prescribing and dispensing chloroquine and hhydroxyeHloroquine during COVID-19 pandemic Dear Governor Sisolak: ‘The Nevada State Board of Pharmacy (Board) has determined that an emergency exists ‘due tothe hoandng and stockpiling of chioroquine and hydroxychloroquine during the COVID- 19 pandemic and the resuling shortage of supplies ofthese drugs for legitimate medica purposes. ‘Currently, hydroxychloroqune is under investiguion for use in the treatment of COVID-19, At (his time, safety and effin-y have not been established! ‘The FDA has been working closely with other government agencies and academic ‘centers that are investigating the use of the drug ehloroguine, which is already approved for weaing malaria, pus and cheumatcld arthritis, o determine whether it ean be used to teat patents with mild-to-moderate COVID-19 to potential feduce the duration of symptoms, aswell s viral shedding, which can help prevent the spread of disesse. Studies are underway to determine the efficacy in using chloroquine to rea! COVID-19.? ‘Therefore, pursuantto NRS 253B,0613, the Board respectfully requests an emergency regulation in Chapter 639 cf the Nevada Administrative Code that reticts the preseibing and dispensing ofehloroquine ad hydzoxychloroquine daring the COVID-19 outbreak. These restrictions include prohibing the prescribing and dispensing of chloroquine and hhydroxychloroquine fora COVED 19 dingnosis o any new diagnosis made ae the effextive date of the regulation, and equiting an ICD-10 code and limit toa 30-day supply for any new prescription for these drugs. The provisions of this emergency regulation do net apply tow chart der for an inpatient in an institutional seing or oan existing couse of teatment fora ‘The Honorable Steve Sislak, Governor Mareh 23,2020 Page 2 iagnosis made before the effective date of the regulation. This emergency regulation is based ‘pon recommendations fom the Governor's COVID-19 Medical Advisory Team, As this emergency regulation will ensute acces for Nevada patients to chloroquine and ‘nydroxyehloroquine fr legitimate medical purpose, your endorsement is requested. Thank you fo your assistance ae consideration, Sincerely, Endorsed: 7 David Woes, RPh Se Bxocutive Secretary Go Nevada State Board of Pharmacy *Hydoxyeherquine. ost TW, ed, UpToDate. Waltham, MA: UpToDate Ine, hipsfwwwaptadte.com, ‘Ascsied March 20, 2020. 2 Coronas (COVID-18) Update: FDA Contines to Facilitate Developm of Testes 2020, March 19. ps: gpvnews-evenis/press-anouncemensleoronan-covi-19-ypdate-fs- tines facie developmen-ueuens Accessed March 20,2020 EMERGENCY REGULATION OF THE. STATE BOARD OF PHARMACY Maret 23,2020 EXPLANATION Mater in italics is now; mater in brackets oie rerio) Is teil Go be nie. Fling ofan Emergency Administrative Regulation AUTHORITY: NRS 639070. ‘A REGULATION relating to pharmacy; restricting the presribing and dispensing of chloroquine and hydroxychloroquine during the COVID-19 outbreak Explanation: Existing law authorizes the State Board of Pharmacy to adopt regulations appertaining to the practice of pharmacy. INRS 639.070) This emergency regulation probibits the prescribing and dispensing of chloroquine and hydroxychloroguine for a COVID-19 diagnosis or any new diagnosis made after the elective date of the regulation, and requires an ICD-10 code anda limit 10 430-day supply fr any prescription for these drugs. The provisions of this emergency ‘egulation do not apply to chart onder for an inpatient in an institutional setting orto an existing course of treatment fora dagnosis made before the effective date of the regulation, ‘Chapter 639 of NACiis tereby amended by adding thereto the following provisions: 1. A prescription for chloroquine or hydraxychloroguine may not be issued filled or dispensed tan outpatient 4) Fora COVID-I9 diagnosis; or 2) For any nev diagnosis made after the effective date of this regulation. 2._A prescription for chloroquine or hydroxychloroquine issued after the effective date of ‘this regulation: 4) Must contain a confirmed, writen ICD-10 diagnose code fom the prescribers and 1b) Must be tiited to no more that a 30-day supply at anytime, 4. The provisions ofthis regulation do not apply: 1) To. chart rder for an inpatient in an instittlonal setting; ar 2) Toam existing cours of treatment fora diagnosis made before the effective date ofthis regulation, )MATIONAL ‘OF ADOPTED REGULATIONS -QUIRED BY NRS 2338, ‘The informational statement required by NRS 238.066 numerically conforms tothe subsections of the statute as follows: 1. EXPLANATIONOF THE NEED FOR THE ADOPTED REGULATION Pursuant to the Governor's Declaration of Emergency Issued March 12, 2020, the State {sin an emergency statis due to the COVID-19 pandemic. This has resulted in the hoarding and stockpiing of chloroquine and hydroxychloroquina during COVID-19 pandemic and the resuling shortage of supplies of these drugs fr legitimate medical purposes. An emergency regulation is neoded to an emergency regulation In Chapter 6639 of the Nevada Administrative Code that restricts the prasorbing and dispensing of chloroquine an hydraxychloroquine during the COVID-19 autbreek. These restrictions Include prohibiting the greseibing and dispensing of chloroquine and hyelroxychloroquine for COVID-19 diagnosis or any new diagnosis made after the cffectvo date of the regulation, and requiring an ICD-10 code and a init to a 30-day ‘supply for any new prescription for these drugs. 6, THE ESTIMATED ECONOMIC EFFECT OF THE REGULATION ON THE BUSINESS WHICH IT IS TO REGULATE AND ON THE PUBLIC. THESE MUST BE STATED SEPARATELY, AND IN EACH CASE MUST INCLUDE: A) BOTH ADVERSE AND BENEFICIAL EFFECTS, ‘The Board anticipates that there wil be no adverse or beneticlal economic impact from this regulation on either the providers of pharmaceutical care that will be subject to the ragulalion nor onthe publ. 1B) BOTH IMMEDIATE AND LONG-TERM EFFECTS. ‘The Board anticipates that there willbe no immediate or long-term economic effect on either the providers of pharmaceutical cara that wll be subject tothe ragulation nor on the publi, or that any such effects wil be negligible. 7, THE ESTIMATED COST TO THE AGENCY FOR ENFORCEMENT OF THE PROPOSEN REGULATION, There wil be no adtional or special costs incurred by the Board for enforcement of this regulation, 8, ADESCRIPTIONOF ANY REGULATIONS OF OTHER STATE OR GOVERNMENT AGENCIES WHIGH THE PROPOSED REGULATION OVERLAPS OR LUPLICATES AND A STATEMENT EXPLAINING WHY THE DUPLICATION OR OVERLAPPING IS NECESSARY, IF THE REGULATION 1 OVERLAPS OR DUPLICATES A FEDERAL REGULATION, THE NAME OF ‘THE REGULATING FEDERAL AGENCY. ‘The Board of Pharmacy isnot aware of any similar regulations of other state or ‘government agencies thatthe proposed regulation overlaps or duplicates, 8. _ IE THE REGULATION INCLUDES PROVISIONS WHICH ARE MORE STTINGCNT THAN A FEDERAL REGULATION WHICH REGULATES THE ‘SANE ACTIVITY, A SUMMARY OF SUCH PROVISIONS. ‘The Board of Pharmacy isnot aware of any similar regulations ofthe same activity in which the federal regulation is more stringent. 10. _IF-THE REGULATION PROVIDES A NEW FEE OR INCREASES AN EXISTING FEE, THE TOTA_ ANNUAL AMOUNT THE AGENCY EXPECTS TO COLLECT ‘AND THE MANNER IN WHICH THE MONEY WILL BE USED. ‘This regulation does not provide a new or ierease of fees,