Arkansas Pharmacy Law Update. John Clay Kirtley, Pharm.D. Assistant Director Arkansas State Board of Pharmacy

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1 Arkansas Pharmacy Law Update John Clay Kirtley, Pharm.D. Assistant Director Arkansas State Board of Pharmacy

2 Objectives Analyze recent changes in Pharmacy regulations in Arkansas Discuss the reasoning behind changes to pharmacy regulations Have participants demonstrate understanding of recent pharmacy regulatory changes and challenges

3 About the Board of Pharmacy The Board licenses: Individuals Businesses The Board tracks over 21 different license configurations / types We have a 3 member administrative team We are always busy Please remember to be patient and polite Employment change notifications are required

4 Permits RPh Techs Bus Technician Permits Expire at the end of even years Does not include Charity Clinics or NH permits Does not include: Preceptor, Immunization, Consultant or Intern permits

5 State Board of Pharmacy Board News & Events Pharmacist Information - Newsletters Forms & Instructions Pharmacy Lawbook Regulation Changes Complete Up-to-Date Lawbook

6 Board Issues Violations of Controlled Substance Laws Diversion for Personal Use Diversion for Distribution Chemical Addictions Arkansas Pharmacy Support Group The Arkansas Pharmacy Support Group helps pharmacy professionals who are fighting addiction. We know how to help, because we've been there. If you or someone you know has a problem, call: The Arkansas Pharmacy Support Group HELP LINE (870) or

7 Regulation Changes Oct 2010 Regulation 02 Pharmacists Regulation 04 Pharmacy Regulation 7 Drug Products/ Prescriptions

8 Regulation 02 Pharmacists Allow for consideration of a pharmacist s practice history outside a permitted pharmacy when applying for reciprocity. Update language regarding the North American Pharmacist Licensure Examination to reflect changes made by NAPLEX and to reflect the period of validity for a score transfer. Update requirements for Board of Pharmacy accreditation of pharmacist continuing education to explain requirements for anyone requesting CE so that the Board can verify participation by pharmacists.

9 Regulation 04 Pharmacy Clarify that both the pharmacist in charge and the pharmacy permit holder are responsible for the security and accountability of controlled substances. These changes will describe the different roles of the permit holder and pharmacist in charge and give examples of appropriate steps and procedures that pharmacies and pharmacists may take in order to maintain security over controlled substances.

10 Regulation 04 Pharmacy Add a section providing guidance on how a pharmacy may provide prescription medications to animals as part of a contractual agreement with the veterinarian. Update requirements for the handling of paper prescription orders by a pharmacy when processed which will decrease the burdens of maintaining paper files of these prescriptions. Add language requiring hospitals to develop and routinely evaluate Medication Error Reduction Plans to identify medication related errors to increase safety in hospitals.

11 Regulation 7 Drug Products/Prescriptions Delete the prohibition on pharmacy compounding for veterinarian office stock. This will allow pharmacies to prepare customized medications to be administered by veterinarians in their practice which will give veterinarians additional choices to best treat animals. Compounding for office stock for veterinarians is prohibited, except for compounds to be used in lifethreatening situations where lack of immediate availability of the product could result in patient harm and no FDA-approved product is commercially available.

12 Proposed Regulation Changes PUBLIC NOTICE On June 28, 2011 at 9:30 AM, the Arkansas State Board of Pharmacy will hold a public hearing at the Arkansas State Board of Pharmacy, 101 E. Capitol Suite 218, Little Rock, AR The following regulation changes will be considered

13 Proposed Regulation Changes Regulation 1 General Operations: Regulation 2 Pharmacists Regulation 5 Long-Term-Care Facilities Regulation 7 Drug Products/ Prescriptions Regulation 9 - Pharmaceutical Care/Patient Counseling

14 Regulation 1 General Operations Change the expiration dates for nursing home consultant pharmacist permits and pharmacist preceptor permits to December 31 of odd numbered years. These changes will cause endorsements on a pharmacist s license to expire at the same time as the pharmacist license in accordance with Act 597 of 2011.

15 Regulation 2 Pharmacists Simplify the requirements for pharmacist interns to work in pharmacies and will also allow consideration of graduation from a nationally accredited college of pharmacy as fully meeting the experiential requirements to apply for pharmacist licensure in Arkansas.

16 Regulation 5 Long-Term- Care Facilities Specify that any emergency kits provided in Arkansas by an out of state pharmacy must be approved by the Arkansas State Board of Pharmacy and may be subject to the same restrictions imposed by their home state when supplying emergency kits from Arkansas. This rule is being adopted in accordance with Act 1019 of 2011.

17 Regulation 7 Drug Products/ Prescriptions Update language regarding the sale of Schedule V Exempt Products and adding language specifically related to the selling of Pharmacist Authorized Drugs such as pseudoephedrine, ephedrine and phenylpropanolamine in accordance with Act 588 of

18 Regulation 9 - Pharmaceutical Care/Patient Counseling Update the age restrictions for pharmacists to provide pharmaceutical care to patients seven (7) years of age and older in accordance with Act 147 of 2011.

19 CPE Monitor The new National Association of Boards of Pharmacy (NABP ) CPE Monitor service, a collaborative effort between NABP, the Accreditation Council for Pharmacy Education (ACPE) and their providers, will allow pharmacists and technicians to easily track their ACPE-accredited continuing pharmacy education (CPE) credits beginning in the latter part of 2011.

20 CPE Monitor Cont. Pharmacists can obtain their ID by creating an NABP e-profile using the portal in the Pharmacists section of the NABP Web site at Visit for more information.

21 Monitor, Secure and Dispose Patients should know what they are taking and how much they have Secure their prescription medications Properly dispose of prescription drugs.

22 Questions? Arkansas State Board of Pharmacy (501)

23 Post Test Questions 1. When will nursing home consultant pharmacist permits and pharmacist preceptor permits expire according to proposed regulations? A. May 31 of any odd year B. May 31 of any even year C. December 31 of any odd year D. They never expire

24 Post Test Questions 2. Under proposed regulation changes for pharmacy interns, when will the Pharmacist in Charge need to file affidavits of experience for students in a college of pharmacy? A. Prior to May 31 each year B. Prior to December 31 each year C. Prior to the student s graduation D. Never

25 Post Test Questions 3. Which OTC medications are included in regulation changes for Pharmacist Authorized Medications? A. Pseudoephedrine products B. Exempt Schedule V Narcotics C. Ephedrine products D. All of the above

26 Post Test Questions 4. What will the lower age limit be for patients receiving influenza immunizations from pharmacists according to protocols this winter? A. 18 B. 15 C. 7 D. Any age