NEBRASKA BOARD OF PHARMACY MEETING MINUTES September 16, 2013

Transcription

1 NEBRASKA BOARD OF PHARMACY MEETING MINUTES September 16, 2013 ROLL CALL Ken Saunders, R.P., Chairperson, called the meeting of the Board of Pharmacy to order at 8:33 a.m. in the Lighthouse Room of the Country Inn & Suites, located at 5353 North 27 th Street, Lincoln, Nebraska. The agenda was provided to Board members, posted on a public bulletin board in the Nebraska State Office Building, posted on the Department s website, and ed to the interested parties list prior to the meeting. The following Board members answered roll call: Kenneth Saunders, R.P., Chair Michael Losee, Vice-Chair Robert Marshall, R.P., Secretary Kevin Borcher, R.P. Patricia Gollner, R.P. A quorum was present, and the meeting convened. Also present were: Lisa Anderson, Assistant Attorney General; Mike Rueb, R.P., Pharmacy Inspector; Gary Cheloha, R.P., Pharmacy Inspector; Dean Willson, Jr., R.P., Pharmacy Inspector; Jeff Newman, Investigator; Michael Grutsch, Program Manager, Investigations Unit; Becky Wisell, Program Manager, and Vonda Apking, Health Licensing Coordinator. REVIEW OF AGENDA Adoption of Agenda Marshall moved, seconded by Borcher, to approve the agenda as presented with the Chair having the authority to rearrange as needed. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Absent: none. Motion carried. Additions, Modification, Reordering The Board requested that the following applications be removed from the consent agenda: Jacob Heim Pharmacy Technician application Joshua James - Pharmacy Technician application Megan Landkamer - Pharmacy Technician application Lana Pridgen - Pharmacy Technician application Joseph Stidd - Pharmacy Technician reinstatement application Mark Talbot - Pharmacy Technician reinstatement application Ryan Brambell - Pharmacy Technician application Trisha Murray - Pharmacy Technician application Brooke McKee Pharmacist Intern application Charles Rygh-Wallin Pharmacist Intern application Joseph Statz Pharmacist Intern application Scott Cerami Pharmacist application DermaTran Health Solutions, LLC Mail Service Pharmacy application Adoption of Consent Agenda Gollner moved, seconded by Marshall, to approve the consent agenda as amended. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Absent: none. Motion carried. 1

2 WALGREENS WELL EXPERIENCE PRESENTATION BILL COVER, RP Bill Cover, RP, of Walgreens, presented information about the Walgreens Well Experience. Walgreens is changing the look of the traditional pharmacy so pharmacists are more accessible to patients and can focus on providing pharmacy services to patients. Walgreens has researched Nebraska s rules and regulations and did not find any to be prohibitive of these changes. The Board thanked Mr. Cover for the presentation. INVESTIGATIONAL REPORTS, DISCIPLINARY REPORTS, CONTROLLED SUBSTANCES AUDIT REPORTS & APPLICATION REVIEW CLOSED SESSION Marshall moved, seconded by Losee, to close the session at 9:15 a.m. to review investigational reports, disciplinary reports, controlled substances audit reports and applications. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Roger Brink, Department Legal, joined the meeting at 9:36 a.m. Roger Brink, Department Legal, left the meeting at 11:00 a.m. Borcher moved, seconded by Marshall, to open the session at 11:14 a.m. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Roger Brink, Department Legal, rejoined the meeting at 11:14 a.m. APPROVAL OF MINUTES May 13, 2013 Page 1: No changes. Page 2: No changes. Page 3: No changes. Page 4: Under 2013 LEGISLATION, last paragraph, last sentence, change vending machines to automated medication distribution machines. Page 5: No changes. Marshall moved, seconded by Borcher, to approve the May 13, 2013, minutes as amended. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: None. Motion carried. July 15, 2013 Page 1: No changes. Page 2: No changes. Page 3: No changes. Page 4: No changes. Page 5: No changes. Marshall moved, seconded by Losee, to approve the July 15, 2013, minutes as presented. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: None. Motion carried. Wisell will follow-up on writing a request for an Attorney General s Opinion regarding utilizing controlled substances in Pharmaceutical Care Agreements. DESIGNATION OF THE METHOD BY WHICH THIS BODY WILL GIVE PUBLIC NOTICE OF ITS MEETINGS Wisell explained that the Open Meetings Act requires boards to designate how they notify the public about their meetings. Wisell commented that the Department normally posts Board of Pharmacy meeting agendas at the Department and on the Department s website. Department staff also generates s to persons that have requested to be on an interested parties list. Borcher moved, seconded by Marshall, that public meeting notices for the Board of Pharmacy will be posted at the Department, posted on the Department s website, and ed to the interested parties list. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: None. Motion carried. 2

3 BOARD RECOMMENDATIONS ON APPLICATIONS FOR LICENSURE AND REGISTRATION Pharmacy Technician Applications Borcher moved, seconded by Marshall, to recommend denying a pharmacy technician registration to Jacob Heim. The basis for the denial is the applicant s misrepresentation of material facts on his pharmacy technician application. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Borcher moved, seconded by Marshall, to recommend issuing a pharmacy technician registration to Joshua James. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Borcher moved, seconded by Marshall, to recommend issuing a pharmacy technician registration to Megan Landkamer. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Borcher moved, seconded by Marshall, to recommend issuing a pharmacy technician registration to Lana Pridgen. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Borcher moved, seconded by Marshall, to recommend issuing a pharmacy technician registration to Joseph Stidd. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Borcher moved, seconded by Marshall, to recommend issuing a pharmacy technician registration to Mark Talbot. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Marshall moved, seconded by Borcher, to recommend issuing a pharmacy technician registration on probation for 5 years to Ryan Bramball. The basis for the probationary offer is the diagnosis of alcohol dependence. The probationary terms and conditions are those commonly used when there is a diagnosis of alcohol dependence. The probationary terms and conditions shall include random body fluid screens, at least 2 Alcoholics Anonymous (AA) meetings per week, quarterly employer reports, abstain from alcohol, and any standard conditions for alcohol dependence. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Borcher moved, seconded by Marshall, to recommend issuing a pharmacy technician registration to Trisha Murray. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Pharmacy Technician Reinstatement Application The Board chose not to take any additional action against Kelsey Smith for practicing as a pharmacy technician on an expired registration. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Pharmacist Intern Applications Borcher moved, seconded by Gollner, to postpone action on the application for pharmacist intern registration of Brooke McKee in order to obtain additional information. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Marshall moved, seconded by Gollner, to recommend issuing a pharmacist intern registration to Charles Rygh-Wallin. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Marshall moved, seconded by Gollner, to recommend issuing a pharmacist intern registration to Joseph Statz. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Pharmacist License Applications Borcher moved, seconded by Marshall, to postpone action on the application for pharmacist licensure of Scott Cerami in order to get additional information. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. 3

4 Mail Service Pharmacy Applications Borcher moved, seconded by Marshall, to recommend issuing a mail service pharmacy license to DermaTran Health Solutions, LLC. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Mail Service Pharmacy Renewal Applications CONSENT Mail Service Pharmacy Reinstatement Application Marshall moved, seconded by Saunders, to recommend denying the Mail Service Pharmacy license reinstatement of KRS Global Biotechnology, Inc. The basis for recommending denial was misrepresentation of material facts in procuring or attempting to procure a license and previous disciplinary action in another state. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. APPROVAL OF PHARMACY TECHNICIAN MANUALS CONSENT REVIEW OF PHARMACEUTICAL CARE AGREEMENTS CONSENT 2013 LEGISLATION IMPLEMENTATION OF LB 326 LONG-TERM CARE AUTOMATED PHARMACY Wisell explained the Department s implementation plans for LB 326. The application for a Long-Term Care Automated Pharmacy is available on the Department s website, and the inspection form has been developed. No applications have been received for a long-term care automated pharmacy license. Several questions were received regarding LB 326. Some of the changes that result from the passage of LB 326 also pertain to hospitals that use automated medication systems, specifically who can fill an automated medication system. The new statutory language requires hospitals, long-term care facilities, and pharmacies to describe the process used by a pharmacist or a pharmacy technician for filling an automated medication system. There has been discussion with several hospitals about registering their staff as pharmacy technicians so they are able to help fill the automated medication systems. Borcher had questions regarding the definitions of supervision and verification. Supervision of a pharmacy technician can be performed by means of a real-time audiovisual communication system in any setting. However, verification of the accuracy and completeness of the acts, tasks, or functions undertaken by a pharmacy technician to assist a pharmacist in the practice of pharmacy must occur by a pharmacist who is on duty in the facility where the pharmacy technician is working. Using the Walgreens Well Experience presentation from earlier in the meeting as an example, a pharmacist who is located in the same facility where the pharmacy technician is performing acts, tasks, or functions to assist the pharmacist in the practice of pharmacy can verify the pharmacy technician s activities or functions via a real-time audiovisual communication system. There is an exception in the statute that allows the pharmacist verification of the acts, tasks, or functions performed by a pharmacy technician to occur by means of a real-time audiovisual communication system if the prescribed drugs or devices will be administered to persons who are patients or residents of a facility by a credentialed individual authorized to administer medications. In a long-term care facility where credentialed individuals administer medications to residents of the facility, the verification of pharmacy technician acts, tasks, or functions can occur by means of a real-time audiovisual communication system. Marshall requested that a copy of the application and the inspection form be sent to the Board members. UPDATES TO PRESCRIBERS AND PRESCRIBING AUTHORITY CHART Wisell explained that Ron Hospodka, RP, submitted proposed changes to the Prescribing Authority Chart after discussion with Karen Bowen, Program Manager, Nursing and Nursing Support. The Board suggested that changes should be made to the footnotes for Dentists and Podiatrists so the footnotes match the statutory language. Marshall suggested the chart be corrected and brought back to Board at their next meeting. PRACTICE QUESTIONS Consider Establishing a Procedure for Responding to Practice Questions Wisell explained that the pharmacy profession values the opinion of the Board of Pharmacy on practice matters and wondered if the Board would like to establish a procedure for responding to practice questions. Marshall mentioned that the Board s opinion is not set in stone and the Board s opinion could change at a 4

5 later date. Discussion cannot take place outside of a Board meeting. If someone wants clarification on a Board opinion, the question would need to come back to the Board. Responses to practice questions would be a collaborative effort between staff and the Board. The Board members did not want to establish a procedure. Marshall mentioned that Board members need to be cautious to not have discussions on Boardrelated matters outside of a public meeting of the Board. Pharmacy Software Compliance with Recordkeeping Requirements Kubat Pharmacy Kubat Pharmacy asked whether they could combine their two pharmacies computer systems and use one computer system. In doing so, Kubat Pharmacy would end up with six files for filing dispensed prescriptions. Marshall mentioned that the Board had determined at an earlier meeting that this would be allowable if the records were readily retrievable. This issue will be revisited at a future Board of Pharmacy meeting after a legal analysis of the statutes and regulations. Supervision of Pharmacist Interns Creighton University School of Pharmacy and Health Professions has an experiential training program for pharmacist interns that would involve dispensing medications to patients at a homeless shelter that is not licensed as a pharmacy. Wisell, Borcher, and Brink met with Dean Bradberry, Creighton University, regarding this issue. It was determined that a pharmacy license would be needed. A dispensing practitioner pharmacy license could be utilized because it is a type of pharmacy facility license. If a doctor at the homeless shelter obtained a dispensing practitioner pharmacy license, the dispensing practitioner would be required to hire a pharmacist to supervise the pharmacist interns because there is no statutory authority for a dispensing practitioner to supervise pharmacist interns. Marshall asked whether a pharmacist could dispense under the dispensing practitioner pharmacy license. Brink explained that since the dispensing practitioner license is a pharmacy license, a pharmacist could dispense under that license. Prescription Labeling Baxter Renal Pharmacy Sheryl Havermann, RP, Baxter Renal Pharmacy, explained that their prescription label does not include a serial number as required pursuant to 172 NAC Instead, the customer number and an invoice number are used. Her question is whether the procedure she is using is acceptable under 172 NAC in meeting the requirements for a prescription label. The order/invoice will be given a prescription number at a later date. An order/invoice could contain multiple prescription items. Wisell provided the definition of serial number which is a unique code assigned to a single unit. The single unit would be the prescription item. Brink asked whether the assigning of a serial number could be a delegated task. It was determined that a prescription number needs to be on the label prior to delivering the medication to the patient. Prescribing/Dispensing Methadone Gary Cheloha, RP The practice question is May a community pharmacy dispense methadone liquid for a newborn infant, born to an addicted mother who is being discharged from the hospital? Methadone cannot be dispensed for addiction unless that patient is enrolled in a treatment program; however, treatment programs do not enroll infants. It was determined that the prescription for the infant should be written for the treatment of pain. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (NABP) ISSUES Report on NABP District V Meeting Losee represented the Board in attending the NABP District V Meeting in Winnipeg, Manitoba, Canada. Losee reported that several topics were addressed, such as.pharmacy and educating the public, compounding and manufacturing, and Iowa s non-resident pharmacy inspection program. Losee explained that Iowa has approximately 600 non-resident pharmacies. Iowa was able to inspect 281 of those pharmacies, of which approximately half were compounding pharmacies, prior to the District Five meeting. Losee thought it was interesting that some of Iowa s non-resident pharmacies forfeited their license instead of submitting to the inspection. Losee has made documents from the meeting available to the Board members. The next District Five meeting will be held in Deadwood, South Dakota, in August Interactive Executive Officer Forum Wisell will be attending this forum on September 24-25,

6 Multi-State Pharmacy Jurisprudence Examination (MPJE) Item Review Dean Willson, RP, will be attending this review session. SCHEDULE TIME FOR BOARD OF PHARMACY STRATEGIC PLANNING The Board decided to schedule a strategic planning session on November 18, 2013, following the Board of Pharmacy meeting. The strategic planning session will begin at 2:00 p.m. GENERAL INFORMATION The next Board of Pharmacy meeting is scheduled for November 18, ADJOURNMENT Marshall moved, seconded by Gollner, to adjourn the meeting at 2:37 pm. Voting aye: Borcher, Gollner, Losee, Marshall, and Saunders. Voting nay: none. Motion carried. Respectfully submitted, Robert Marshall, R.P., Secretary Board of Pharmacy 6