Legislative Update. Brenda Denson, Pharm.D., FASHP ALBOP member, institutional position

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1 Legislative Update Brenda Denson, Pharm.D., FASHP ALBOP member, institutional position

2 Objectives - Pharmacists Understand the purpose and activities of the Alabama Board of Pharmacy Review the state legislation that applies to pharmacy in 2018 Discuss ASHP polices that were reviewed at the ASHP summer meeting 2018

3 Objectives - Technicians Identify some activities of the ALBOP members and staff Recognize key state legislation that applies to pharmacy in 2018 List some ASHP policies that were reviewed at the ASHP summer meeting

4 Poll the audience. How many staff member work for the Alabama Board of Pharmacy? How many members sit on the Alabama Board of Pharmacy?

5 How is the ALBOP office organized? Administration (4) Licensing (7) Enforcement (10) Board members (5)

6 ALBOP Fun Facts Established by legislative action in 1887 Duty is to carry out the purpose and enforce Title 34, Chapter 23 of the Practice of Pharmacy Act 205 and Title 20, Chapter 2 of the Uniformed Controlled Substance Act of 1407 Primary purpose is to protect the public health, safety and welfare of the people of Alabama

7 ALBOP NON -Facts ALBOP does NOT determine the Controlled Substance List in the State of AL (This is done by Dept of Health). ALBOP does NOT intend to conflict with Federal laws, rules, or guidelines ALBOP does NOT promote financial interests for companies or individuals

8 Administration Susan Alverson, Executive Secretary Responsibilities include: Office administration Board policies Compounding policies Just generally keeping everyone straight

9 Administration Cristal Anderson, Director of Compliance Responsibilities include: Case review process of complaints Pharmacy Applications Review Compounding inspections

10 Administration Vance Alexander, RPh, JD Adminstrative Hearing Officer Former UAB employee, adjunct professor at Samford (taught pharmacy law), former ALBOP board member

11 Adminstration James Ward, Esq. ALBOP attorney for over 30 years In addition, has been attorney for Dental board and Chiropractor board. Graduated from University of AL law school

12 Licensing Rhonda Coker, Licensing Supervisor Responsible for: All licensing activities Verification request Reporting disciplinary actions Other duties as assigned

13 Licensing - Pharmacists Lynn Martin

14 Licensing - Technicians Terry Lawrence

15 The Crew behind the scenes

16 Who at ALBOP oversees pharmacist licensure? A. Eddie Braden B. Terry Lawrence C. Lynn Martin D. Jim Ward

17 Who at ALBOP oversees pharmacist licensure? A. Eddie Braden B. Terry Lawrence C. Lynn Martin D. Jim Ward

18 Enforcement Eddie Braden Chief Investigator Coordinates case activities, investigates complaints and violations of the Pharmacy Practice Act

19 Enforcement Team (minus Casey not in the picture)

20 ALBOP members Three appointed positions One independent pharmacy (Chris Phung) One chain pharmacy (Donna Yeatman) One hospital (Brenda Denson) Two at large positions Voted upon by pharmacists within the state David Darby and Ralph Sorrell

21 2018 ALBOP members

22 What is the purpose of the board of pharmacy? A. To promote professional organizations B. To enhance pharmacy practice so pharmacists and businesses may profit C. To protect the citizens of Alabama D. All of the Above

23 What is the purpose of the board of pharmacy? A. To promote professional organizations B. To enhance pharmacy practice so pharmacists and businesses may profit C. To protect the citizens of Alabama D. All of the Above

24 ALBOP Website Tools Verification of individual and business licensure or permits Board meeting dates Board staff contacts Quick Links Frequently asked questions

25 Business Verification

26 Business Lookup Search

27 Board Meeting Calendar

28 Frequently Asked Questions

29 Who to contact for what?

30 Pharmacy Laws to Note Success in 2018

31 Outsourcing facilities Added to pharmacy statute as an entity licensed by the board of pharmacy.

32 Double Line Removal Act currently states that every written prescription issued in this state shall contain two signature lines one for Dispense as Written and one for Product Selection Permitted. The act also states that an oral prescription from the practitioner shall instruct the pharmacist whether or not a less expensive pharmaceutically and therapeutically equivalent drug product may be dispensed. The pharmacist is to note the instructions on the file copy of the prescription. Electronic prescriptions are not addressed (Act has not been updated since 2002)

33 Board Rule Changes Requirements for Compounding A rule addition This was presented last year but we found out that it could not be presented at the same time as an Act. Rule Number: 680-X-2.43 Title of Rule: Requirements for Compounding All pharmacies that engage in the compounding of drugs or drug products shall comply with all applicable and current regulations of United States Pharmacopeia National Formulary. Statutory Authority: Code of AL 1975, Already published in the administrative monthly for comment

34 Board Rule Changes Parenteral Sterile Therapy 680-X Changes for the rule includes that details of the clean room have been removed. Basically pharmacists and pharmacies must comply with USP797 for sterile parenteral therapy.

35 Drug Destruction Rule 680-X-2.42 Proposal to follow federal guidelines for return and drug destruction for pharmacies

36 Collaborative Practice There has been no legislative movement in this area this year. Susan Alverson to speak about this subject.

37 Other laws of note Substitution of drugs or brands of drugs New licensing fee schedule Schedule 2 partial fills

38 Question for Input from the Audience. For pharmacy renewals what do you think may be important questions to ask under the hospital section of the application? What is important for us to know? Hazardous drug compounding? Do you purchase from 503B s??????

39 FDA 483 s issued Public record ALBOP looks for pattern of gross non-compliance that may harm patients. Examples: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

40 The removal of the double signature in the prescription is applicable to which of the following? A. Written prescriptions B. E-prescribing C. Faxed prescriptions D. All of the above

41 The removal of the double signature in the prescription is applicable to which of the following? A. Written prescriptions B. E-prescribing C. Faxed prescriptions D. All of the above

42 Thomas H. Cobb, Pharm.D. SUMMARY OF ACTIONS OF THE ASHP HOUSE OF DELEGATES

43 ASHP House of Delegates Ultimate Authority on Professional Policy Expresses the Society s stance on issues related to the practice of pharmacy and medication use. Provides guidance to ASHP staff on issues in DC and at state level Meets three time a year March, June, and March

44 Summary of ASHP House of Delegates The HOD considered 31 policy recommendations 18 were amended Two had editorial changes 10 were passed as written One was defeated

45 Use of International System of Units for Patient- and Medication-related Measurements To advocate that the U.S. healthcare system adopt and only use the International System of Units (SI units) for all patient and medication-related measurements and calculations; further, To advocate that healthcare organizations use clinical decision support systems, equipment, and devices that allow input and display of patient and medication-related measurements and calculations in SI format only; further To advocate that health information technology manufacturers utilize only SI units in their product designs for patient- and medication-related measurements; further To promote education in the use of SI units and the importance of using SI units to prevent medical errors.

46 Use of Closed-System Transfer Devices to Reduce Drug Waste To recognize that a growing body of evidence supports the ability of specific closed-system transfer devices (CSTDs) to maintain sterility beyond the in-use time of currently recommended by United States Pharmacopeia Chapter 797, when those CSTDs are used with aseptic technique and following current sterile compounding standards; further, To foster additional research on and develop standards and best practices for use of CSTDs for drug vial optimization; further, To educate healthcare professionals, especially pharmacists and pharmacy technicians, about standards and best practices for the use of CSTDs in drug vial optimization.

47 Intravenous Fluid Manufacturing Facilities as Critical Public Health Infrastructure To advocate that federal and state governments recognize intravenous fluids and associated supply manufacturing facilities as critical public health infrastructure.

48 Clinician Well-Being and Resilience To affirm that burnout adversely affects an individual s well-being and healthcare outcomes; further, To acknowledge that the healthcare workforce encounters unique stressors throughout their education, training, and careers that contribute to burnout; further, To declare that healthcare workforce well-being and resilience requires shared responsibility among healthcare team members and between individuals and organizations; further,

49 Clinician Well-Being and Resilience To encourage individuals to embrace resilience and wellbeing as a personal responsibility that should be supported by organizational cultural; further, To encourage the development of programs aimed at prevention, recognition, and treatment of burnout, and to support participation in these programs; further, To encourage education and research on stress, burnout, and well-being; further, To collaborate with other professions and stakeholders to identify effective preventive and treatment strategies at an individual, organizational, and system level.

50 Student Pharmacist Drug Testing To advocate for the use of pre-enrollment, random, and forcause drug testing throughout pharmacy education and pharmacy practice experiences, based on defined criteria with appropriate testing validation procedures; further, To encourage colleges of pharmacy to develop policies and processes to identify impaired individuals; further, To encourage colleges of pharmacy to facilitate access to and promote programs for the treatment and to support recovery; further, To encourage colleges of pharmacy to use validates testing panels that have demonstrated effectiveness detecting commonly misused, abused, or illegally used substances.

51 A. ASHP Policies of Note in 2018 are as follows? A. Clinician Well-Being and Resilience B. Intravenous Fluid Manufacturing Facilities as Critical Public Health Infrastructure C. Student Pharmacist Drug Testing D. Use of International System of Units for Patient- and Medication-related Measurements E. All of the Above

52 Conclusion