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

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

2 Objectives - Pharmacists Explain the roles of board members and staff in 2017 Understand the purpose and activities of the 5 board members Identify the role of a new board member Review the state legislation that applies to pharmacy in 2017

3 Objectives - Technicians Identify the roles of the ALBOP members and staff in 2017 Recognize the purpose and activities of the 5 board members Review the activities of a new board member

4 Poll the audience. How many people work for the Alabama Board of Pharmacy? Answer: 20+ How many members sit on the Alabama Board of Pharmacy? Answer: Five

5 How is the ALBOP office organized? Administration Licensing Enforcement Board members

6 Administration Susan Alverson, Executive Secretary Responsibilities include: Office administration Board policies Compounding policies

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

8 Administration Vance Alexander, RPh, JD Adminstrative Hearing Officer

9 Adminstration James Ward, Esq. ALBOP attorney for over 20 years

10 Licensing Rhonda Coker, Licensing Supervisor Responsible for: All licensing activities Verification request Reporting disciplinary actions

11 Licensing - Pharmacists Lynn Martin

12 Licensing - Technicians Terry Lawrence

13 The Crew behind the scenes

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

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

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

17 Enforcement Glenn Wells Investigator for Blount, Calhoun, Cherokee, Cleburne, Colbert, Cullman, Dekalb, Etowah, Fayette, Franklin, Jackson, Lamar, Lauderdale, Lawrence, Limestone, Madison, Marion, Marshall, Morgan, St. Clair, Walker, and Winston counties

18 Enforcement Henry Burks Investigator for Marion, Winston, Lamar, Fayette, Walker, Blount, Etowah, St. Clair, Calhoun, Cherokee, and Cleburne counties

19 Enforcement Mark Delk Investigator for Bibb, Chambers, Chilton, Clay, Coosa, Elmore, Green, Hale, Jefferson, Lee, Perry, Pickens, Randolph, Russell, Shelby, Sumter, Talladega, Tallapoosa, and Tuscaloosa counties

20 Enforcement Peyton Zarzour Investigator for Bibb, Chambers, Chilton, Clay, Coosa, Elmore, Green, Hale, Lee, Perry, Pickens, Randolph, Russell, Sumter, Talladega, Tallapoosa, Tuscaloosa counties.

21 Enforcement Richard Lambruschi Investigator for Blount, Calhoun, Cherokee, Cleburne, Colbert, Cullman, Dekalb, Etowah, Fayette, Franklin, Jackson, Lamar, Lauderdale, Lawrence, Limestone, Madison, Marion, Marshall, Morgan, St. Clair, Walker, and Winston counties.

22 Enforcement Todd Brooks Investigator Currently completing a 797 program through Critical Point Territory: Autauga, Baldwin, Barbour, Bullock, Butler, Choctaw, Clarke, Coffee, Conecuh, Covington, Crenshaw, Dale, Dallas, Escambia, Geneva, Henry, Houston, Lowndes, Macon, Marengo, Mobile, Monroe, Montgomery, Pike, Washington, and Wilcox Counties

23 Enforcement Scott Daniel Investigator for Autauga, Baldwin, Barbour, Bullock, Butler, Choctaw, Clarke, Coffee, Conecuh, Covington, Crenshaw, Dale, Escambia, Geneva, Henry, Houston, Lowndes, Macon, Marengo, Mobile, Monroe, Montgomery, Pike, Washington, and Wilcox counties

24 Enforcement Mark Herbert Investigator for Autauga, Baldwin, Barbour, Bullock, Butler, Choctaw, Clarke, Coffee, Conecuh, Covington, Crenshaw, Dale, Dallas, Escambia, Geneva, Henry, Houston, Lowndes, Macon, Marengo, Mobile, Monroe, Montgomery, Pike, Washington, and Wilcox counties

25 ALBOP members Three appointed positions One independent pharmacy (Buddy Bunch) 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

26 2017 ALBOP members

27 Pharmacy Laws to Note Success in 2017

28 HB170.passed!!! Now ACT# (signed by Gov Ivey 5/26/17) Pharmacists Health Care Providers Investigators instead of the term inspector The legislation is LAW but will not go into code until next year when the Legislative Reference Service puts the new wording in code and is approved in the next legislative session.

29 Xanax.NOT a Schedule 2 CS Thank goodness! Pharmacy groups worked together to convince legislators that making Xanax a schedule 2 controlled substance in Alabama is not the answer to the addition issue.

30 Board Policy Changes Changing a 30 day supply to a 90 day supply on non-controlled maintenance medications.

31 Board Rule Changes Parenteral Sterile Therapy A rule addition (will be published 6/30 and public has until August 4 th for comment) 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,

32 Board Rule Changes 680-X-2.19 Changed because the accurate definition of parenteral is any drug dosage form that is not oral. The title changed to include Sterile and is now titled Parenteral Sterile Therapy. The rule was changed to accurately reflect items that are compounding that should be STERILE and not just the inferred injectables

33 True or False???? Xanax is now a schedule II controlled substance in the state of Alabama.

34 True or False???? Xanax is now a schedule II controlled substance in the state of Alabama.

35 HB170 designates that pharmacists are. A. Prescribers B. Health Care Providers C. Scientists

36 HB170 designates that pharmacists are. A. Prescribers B. Health Care Providers C. Scientists

37 ASHP House of Delegates Policies discussed at ASHP summer meeting

38 Policies and Recommendations 28 policies from five councils were reviewed. All passed except for one that was referred back for review by the Pharmacy Management Council Joint Council Task force policy on medical aid in dying passed with a stance of neutrality.

39 Pharmaceutical Distribution Systems To support drug distribution business models that meet the requirements of hospitals and health systems with respect to availability and timely delivery of products, minimizing short-term outages and long-term product shortages, managing and responding to product recalls, fostering producthandling and transaction efficiency, preserving the integrity of products as they move through the supply chain, and maintaining affordable service costs; further,

40 Pharmaceutical Distribution Systems (Cont d) To oppose manufacturers, distributors, and wholesalers making availability of drug products contingent on how those products are used.

41 Controlled Substance Diversion Prevention New ASHP Policy To encourage healthcare organizations to develop controlled substance diversion prevention programs and policies that delineate the roles, responsibilities, and oversight of all personnel who have access to controlled substances to ensure compliance with applicable laws and scopes of practice; further, To encourage healthcare organizations to ensure that all healthcare workers are appropriately screened for substance abuse prior to initial employment and surveillance, auditing, and monitoring conducted on an ongoing basis to support a safe patient-care environment, protect co-workers, and discourage controlled substances diversion.

42 Ready to Administer Packaging for Hazardous Drug Products intended for home use. To advocate that pharmaceutical manufacturers provide hazardous drug products intended for home use in ready-toadminister packaging; further, To advocate that regulators (e.g., FDA) have the authority to impose requirements on pharmaceutical manufacturers to provide hazardous drug products intended for home use in ready-to-administer packaging; further, To advocate that, when hazardous drug products intended for home use are not available from manufacturers in ready-toadminister packaging, pharmacies repackage those drug products to minimize the risk of exposure; further, To advocate that hazardous drug products intended for home use be labeled to warn that special handling is required for safety; further, To advocate that pharmacists provide education to patients and caregivers regarding safe handling and disposal of hazardous drug products intended for home use.

43 Restricted Drug Distribution A Revision of an ASHP policy To oppose restricted drug distribution systems that (1) limit patient access to medications; (2) undermine continuity of care; (3) impede population health management; (4) adversely impact patient outcomes; (5) erode patients' relationships with their healthcare providers, including pharmacists; (6) are not supported by publicly available evidence that they are the least restrictive means to improve patient safety; (7) interfere with the professional practice of healthcare providers; or (8) are created for any reason other than patient safety.

44 Collaborative Drug Therapy Management Revision of Policy To pursue the development of federal and state laws and regulations that authorize pharmacists as providers within collaborative practice; further, To advocate expansion of federal and state laws and regulations that optimize pharmacists ability to provide the full range of professional services within their scope of expertise; further, To advocate for state and federal laws and regulations that would allow pharmacists to prescribe and transmit prescriptions electronically; further, To acknowledge that as part of these advanced collaborative practices, pharmacists, as active members in team-based care, must be responsible and accountable for medication related outcomes; further, To support affiliated state societies in the pursuit of state-level regulations allowing collaborative practice for pharmacists.

45 Drug Testing Revision of Policy To recognize the use of pre-employment and random or for-cause drug testing during employment based on defined criteria and with appropriate testing validation procedures; further, To support employer-sponsored drug programs that include a policy and process that promote the recovery of impaired individuals; further, To advocate that employers use validated testing panels that have demonstrated effectiveness detecting commonly abused or illegally used substances.

46 Therapeutic and Psychosocial Considerations of Transgender Patients NEW policy To support medication and disease management of transgender patients as part of care unique to this population; further, To advocate that transgender patients have access to pharmacist care to ensure safe and effective medication use; further, To promote research on, education about, and development and implementation of therapeutic and biopsychosocial best practices in the care of transgender patients; further, To encourage structured documentation of both a patient s birth sex and self-identified gender in electronic health records.

47 Safe and Effective Use of Invertebrates To recognize use of medical invertebrates as an alternative treatment in limited clinical circumstances; further, To educate pharmacists, patients, and the public about the risks and benefits of medical invertebrates use and about best practices for use; further, To advocate that pharmacy departments, in cooperation with other departments, provide oversight of medical invertebrates to assure appropriate formulary consideration and safe procurement, storage, control, prescribing, preparation, dispensing, administration, documentation, clinical and regulatory monitoring, and disposal; further, To encourage independent research and reporting on the therapeutic use of medical invertebrates

48 The first year on ALBOP In the words of a 29 year old with a few years experience

49 Thank you to all who support our joint endeavors Thank you to all who support and believe that I can help accomplish wonderful things in this position.

50 First of all, what do I do???? Hearings on one (or more) Tuesdays per month from 8am-until One Wednesday per month for public Board Meeting, Executive session, Candidates for licensure s, s, s Law, law, law, and other things that I need another degree for. Texts and calls because all of the sudden I know the answer (LOL)

51 Secondly, what have I learned? I need to learn more about all of the groups and laws that involve pharmacy. There are a lot of moving parts. We all need to get more engaged with our legislators (they know we contribute to better health care REMIND them!) Some things just take a lot of time. Sometimes you feel like you are watching paint dry on a humid day. Enlightenment at how much politics are involved in the profession at times.

52 Thirdly, how has it changed my outlook on pharmacy? I am very proud of our profession now and for what it can be. Very heartbroken over the people who make bad choices. Very proud of those who do make the right choices and put the patient first.

53 Lastly, what do I hope for the future in the next 4 ½ years on the board? Collaborative Practice in our State Clarifications or guidance for pharmacists on laws/rules To make ALBOP rules that will benefit our patients in Alabama (e.g. 30 day to 90 day rule on maintenance medications) More prescriber accountability To see some progress in the war against addiction

54 Conclusion Working together in pharmacy we can accomplish much. org