Virginia Board of Pharmacy Minutes1

June 7, 2005

VIRGINIA BOARD OF PHARMACY

MINUTES OF BOARD MEETING

June 7, 2005
Fifth Floor
Conference Room 2 / Department of Health Professions
6603 West Broad Street
Richmond, Virginia 23230
CALL TO ORDER: / A meeting of the Board of Pharmacy was called to order at 9:03 a.m.
PRESIDING: / Mark A. Oley, Chairman
MEMBERS PRESENT: / Gill B. Abernathy
Toni Aust
Michael J. Ayotte
John O. Beckner
Willie Brown
Michelle R. Easton
Bobby Ison
Diane M. Langhorst
Leo H. Ross
STAFF PRESENT: / Elizabeth Scott Russell, Executive Director
Cathy M. Reiniers-Day, Deputy Executive Director
Ralph A. Orr, Deputy Executive Director
Elaine J. Yeatts, Senior Regulatory Analyst
Howard M. Casway, Senior Assistant Attorney General
Donna M. Lee, Administrative Assistant
QUORUM: / With ten members of the Board present, a quorum was established.
THANK YOU: / Mr. Oley informed the Board that June 30, 2005 will end Mr. Ayotte’s tenure as a Board member. He commended Mr. Ayotte for his eight years of public service and stated that he was an excellent Board member.
WELCOMe: / Mr. Oley welcomed Diane Langhorst as a new citizen Board member replacing Kim Anderson who resigned.
Mr. Oley introduced Catherine Campbell as an intern with the Attorney General’s Office. He also introduced Noel Feminella and Woody Woodsworth as pharmacy interns with Lafayette Westwood Pharmacy.
APPROVAL OF AGENDA: / Mr. Oley called for changes or corrections to the agenda. Hearing no changes, the agenda was approved as presented.
PUBLIC COMMENTS: / No public comments were received at this time.
Ms. Reiniers-Day read the emergency evacuation procedure for Conference Room 2. She also reminded everyone to turn off cell phones during the meeting.
APPROVAL OF MINUTES: / Mr. Oley called for changes or corrections to the minutes of March 1, 2005. Hearing no changes, the minutes were approved as presented.
ELECTION OF OFFICERS: / Mr. Beckner nominated Leo Ross for the office of Chairman. There were no other nominations. The Board voted unanimously, to elect Leo Ross as Chairman for the term beginning July 1, 2005. Mr. Ross nominated John Beckner for the office of Vice-Chairman. There were no other nominations. The Board voted unanimously, to electJohn Beckner as Vice-Chairman for the term beginning July 1, 2005.
PUBLIC HEARING ON PROPOSED REGULATIONS TO CHANGE REFILL LIMITATION ON SCHEDULE VI PRESCRIPTIONS FROM 2 YEARS TO A 1 YEAR DEFAULT: / A public hearing on proposed regulations to change refill limitation on Schedule VI prescriptions from two years to a one year default was held beginning at 9:20 a.m. There were no public comments made on the proposed regulations. Mr. Oley stated that written comments can be received through July 29, 2005, and that adoption of final regulations will be at the next Board meeting to be held on September 13, 2005.
OVERVIEW OF ONGOING REGULATION PROCESSES: / Ms. Yeatts reviewed with the Board the status of ongoing regulatory processes for the Board of Pharmacy.
ADOPTION OF NOIRA ON A PEDIGREE SYSTEM FOR WHOLESALE DISTRIBUTORS: / The Board reviewed a draft Notice of Intended Regulatory Action (NOIRA) to establish a pedigree system for prescription drugs as required by Chapter 777 of the 2005 Acts of Assembly(Agenda pgs. 13-18, Attachment 10). Mr. Ayotte moved, and the Board voted unanimously, to adopt and publish the NOIRA to promulgate regulations for a pedigree system for wholesale distributors. The Chair appointed Mr. Ayotte, Mr. Beckner and Mr. Ison to serve on a committee to work on drafting proposed regulations.
ADOPTION OF final rules on outsourcing, discussion and response to public comment: / The Board reviewed public comment and draft responses on the proposed regulations for outsourcing prescription processing functions received from EPIC Pharmacies and NACDS (Agenda pgs 19-26, Attachment 10).
Alexander M. Macaulay addressed the Board on behalf of EPIC Pharmacies regarding 18VAC110-20-276(B)(2), and reiterated that any central or remote pharmacy should comply with Virginia laws and regulations with respect to duties that are performed by pharmacists and pharmacy technicians so that there is a level of protection for patients in Virginia. He also stated that the Board should ensure in regulation that the ratio issue is addressed and that persons performing as technicians in a contract arrangement have the minimum competencies that Virginia requires.
Mr. Ayotte and Mr. Beckner expressed concerns about the technician ratio requirement in other states and whether it should meet the standards set by Virginia. The Board was advised by Mr. Casway that it has no statutory authority to impose requirements on out-of-state pharmacies, but the Board can require that the Virginia licensed pharmacy that contracts with an out-of-state pharmacy ensure that the out-of-state pharmacy meets certain requirements in order to be allowed to outsource its prescription processing.
Rebecca Snead, Virginia Pharmacist Association, informed the Board that she individually supported the changes proposed by EPIC Pharmacies and that Virginia patients expect reasonable compliance with the standards set forth in Virginia regulations.
After further discussion, Mr. Ison moved, and the Board voted unanimously, to adopt 18VAC110-20-276(B)(2) as amended. (Attachment 1) to incorporate the clarifications requested by EPIC.
18VAC110-20-276(B)(3) - The Board discussed the proposed changes by NACDS to remove the requirement for a Virginia licensed pharmacist to check the remote processing and allow any pharmacist to perform the final check. During discussion, the Board members expressed concern that without the requirement for a final check by a Virginia licensed pharmacist, the accountability to the public would be lost, and that the public has an expectation when going to a Virginia pharmacy that a pharmacist licensed in Virginia will be checking the dispensing for accuracy. Mr. Ison moved, and the Board voted unanimously, to keep the original proposed language and to not make the changes proposed by NACDS. (Attachment 1)
18VAC110-20-515(B)(2) – The Board discussed the proposed changes by EPIC Pharmacies, which are the same concerns as with 18VAC110-20-276(B)(2). Mr. Ison moved, and the Board voted unanimously, to adopt 18VAC110-20-515(B)(2) as amended. (Attachment 1)
18VAC110-20-515(B)(3) – The Board reviewed the proposed changes by NACDS which are the same concerns as with 18VAC110-20-276(B)(2). Mr. Ison moved, and the Board voted unanimously, to reject the recommendation of NACDS for the reasons cited during the previous discussion and to adopt 18VAC110-20-515(B)(3) as amended. (Attachment 1)
ADOPTION OF EXEMPT CHANGES TO STERILE COMPOUNDING RULES: / The Board was advised that with passage of Chapter 200 of the 2005 Acts of Assembly, there are now regulations related to sterile compounding that will conflict with the statute. The Board reviewed draft exempt changes to the regulations repealing the section of regulations related to sterile compounding and several definitions only used in that section of regulations. Mr. Ison moved, and the Board voted unanimously, to adopt the exempt changes to the sterile compounding rulesas drafted by staff (Attachment 2), and for staff to create a guidance document that provides direction for pharmacists as to where in USP to look for the standards.
APPOINTMENT OF A COMMITTEE TO REVIEW COLLABORATIVE PRACTICE REGULATIONS: / Ms. Russell advised the Board that it had adopted a notice of periodic review at the previous meeting and requested that a committee be established to review the regulations in conjunction with the Board of Medicine. Mr. Oley appointed himself, Jill Abernathy, and Rebecca Snead to serve on the Committee. He also recommended that Ralph Small be contacted and invited to serve on the Committee.
SANCTION REFERENCE POINTS PROGRAM DISCUSSION: / This matter was continued from the March 1, 2005 Board meeting so that the Board could further discuss the concerns that were expressed about the distribution of the worksheet to respondents (Agenda pgs. 27-28, Attachment 10). Neal Kauder, President, VisualResearch, Inc., and Karen Perrine, Deputy Executive Director with the Board of Medicine, explained to the Board how and when the worksheet is utilized for disciplinary cases by the Board of Medicine. Ms. Perrine informed the Board that it is a great training tool for new board members when making decisions at the informal conference level.
Closed Session: / Mr. Ross moved, and the Board voted unanimously, to enter into closed session pursuant to Section 2.2-3711(A(7) of the Code of Virginia for consultation with and the provision of legal advice by Howard Casway in the matter of the Sanction Reference Points Program. Additionally, he moved that Scotti Russell, Cathy Reiniers-Day, Howard Casway, Ralph Orr, Donna Lee, Karen Perrine, Neal Kauder and Katherine Campbell attend the closed session because their presence was deemed necessary and would aid the Board in its consideration of this matter.
Reconvene: / Mr. Ross moved, and the Board voted unanimously, that only public business matters lawfully exempted from open meeting requirements and only such public business matters as were identified in the motion for closed session were heard, discussed or considered during the closed session.
Mr. Beckner departed at 11:20 a.m. during the closed session.
Ms. Perrine answered questions posed by the Board pertaining to the effectiveness of the Sanction Reference worksheet since implementation by the Board of Medicine.
Mr. Kauder advised the Board that an evaluation of the Sanction Reference worksheet process will be presented at the Board of Medicine’s November board meeting.
Mr. Ison moved, and the Board voted unanimously, that a decision in this matter be deferred for one year so that more data can be obtained from the Board of Medicine with respect to appeals from informal conference decisions,as well as other pertinent information the Board of Medicine may provide for review.
2006 LEGISLATIVE PROPOSALS: / Rescheduling Bill and DEA 222 – The Board was advised that DEA changed official orders for Schedule II drugs to allow for electronic orders; therefore, § 54.1-3414 and § 54.1-3415 are changed to reflect the new provision. Ms. Russell informed the Board that Zopiclone was also added under the list of Schedule IV drugs in § 54.1-3452.
Wholesale distributors criminal record requirement –Ms. Russell stated that in § 54.1-3435 the language was added to state that a national criminal record check will be required of all applicants for a wholesale distributor license.
Non-resident pharmacy inspection requirement– Ms. Russell informed the Board that §54.1-3434.1 was changed to add the requirement that the inspection report shall be deemed current if conducted within the past five years; and that if an applicant was not able to meet the 5-year requirement, the Board may accept an inspection report by another entity that the Board has determined to be credible. Ms. Russell asked that the Board approve the proposal in concept, with the understanding that she and Mr. Casway would develop the actual language for the proposal.
Mr. Ayotte moved, and the Board voted unanimously, to approve the 2006 legislative proposals as presented by Ms. Russell with the understanding that the non-resident pharmacy proposal will be revised by Ms. Russell and Mr. Casway, but will not recognize any one specific entity as acceptable for conducting inspections. (Attachment 3)
GUIDANCE DOCUMENT ON NON-RESIDENT PHARMACIES, REQUIREMENT FOR RECENT INSPECTION: / Ms. Russell reminded the Board that this matter was continued from the March 1, 2005, Board meeting where it was requested that a guidance document be drafted to define the term “recent” to reflect a time period of five years for an inspection report that is submitted with an application for a non-resident pharmacy permit. Ms. Russell also informed the Board that the guidance document is to assist the Board until such time as the statute can be changed.
Mr. Brown moved, and the Board voted unanimously, to adopt Guidance Document 110-38. (Attachment 4)
revision to guidance document 110-09, confidential consent agreements: / The Board was informed that currently, if a pharmacist-in-charge allows an unlicensed person to practice as a technician or if a pharmacy technician practices without being registered or enrolled in an approved training program, a CCA is offered for the first occurrence in each instance. Ms. Russell requested that the Board grant permission for a CCA to be offered in these types of cases without having to present the case to a Special Conference Committee for approval.
Mr. Ison moved, and the Board voted unanimously, to adopt Guidance Document 110-09 as amended. (Attachment 5)
PROPOSED BYLAWS AMENDMENTS: / Ms. Russell reviewed with the Board the proposed amendments to Article V of the Bylaws, primarily related to the delegation to staff the authority to convene telephone conference calls for the purpose of summary suspensions or settlements and the authority to make a determination of probable cause in certain circumstances. Mr. Ross moved, and the Board voted unanimously, to adopt the proposed bylaws as amended. (Attachment 6)
REQUEST BY DEPARTMENT OF HISTORIC RESOURCES, REFERENCE BRUCE’S DRUGSTORE: / Ms. Russell stated that this matter was previously before the Board in January of 2004 when the Town of Scottsville requested that the Board allow the pharmacy sign at Bruce’s Drug Store to remain, even though the pharmacy closed. The pharmacy name was etched into the stained glass window and the building is considered a historic landmark. The Board notified the Town of Scottsville that it had no authority to waive § 54.1-3433, and that the sign would have to be removed. The Town of Scottsville agreed to cover the sign while they pursued legislative action to give the Board the authority to grant exemptions.
Ms. Russell further explained that the 2005 General Assembly amended § 54.1-3433 to provide the Board with the authority to grant exemptions provided the site is approved for such an exemption by the Department of Historic Resources. Kathleen S. Kilpatrick, Director, Department of Historic Resources, submitted a letter stating that this building has been properly designated as a historic landmark, and the mayor of the Town of Scottsville requested an exemption under the new law (Agenda pgs. 43-48, Attachment 10).
Mr. Brown moved, and the Board voted unanimously, that effective July 1, 2005, the exemption shall be granted.
REQUEST BY FREE CLINIC OF CENTRAL VIRGINIA TO ALLOW VOLUNTEER WORK TO COUNT AS APPROVED CE: / The Board reviewed and discussed the request by Free Clinic of Central Virginia to allow volunteer work at a free clinic to count as approved continuing education for pharmacists (Agenda pg. 49, Attachment 10). There was a brief discussion of the fact that North Carolina allows this. Ms. Russell stated that the Board has previously declined to allow practical experience of any type to count as approved continuing education, because most pharmacists engage in practice daily, and still have to obtain additional continuing education. Ms. Abernathy moved, and the Board voted unanimously, to deny the request by Free Clinic of Central Virginia.
PHYSICIANS DISPENSING DURING CLINICAL TRIALS, CSRC VS. LICENSE TO SELL: / Ms. Russell informed the Board that physicians working in clinical trialsdo sometimes dispense medications, but they cannot meet the requirements to apply for a License for Practitioner of the Healing Arts to Sell Controlled Substances. She also stated that researchers apply for a Controlled Substance Registration Certificate. Ms. Russell requested that the Board grant approval for physicians dispensing during clinical trials onlyto be allowed to apply for a Controlled Substance RegistrationCertificate as a researcher instead of a license to sell.
Ms. Abernathy moved, and the Board voted unanimously, to accept the recommendation of Ms. Russell and to grant approval that physicians dispensing during clinical trials can be registered with a Controlled Substance RegistrationCertificate provided the dispensing is limited to the duration and scope of the clinical trial.
GUIDANCE ON DISPENSING ERROR CASES INVOLVING WRONG DRUG IN BAG OR WRONG BAG GIVEN TO PATIENT: / The Board was informed that there are disciplinary cases involving a prescription placed in a wrong bag or wrong bag given to a patient, however, the prescription was filled correctly by the pharmacist. Ms. Russell asked the Board for guidance as to who the case should be docketed against initially; the pharmacist-in-charge or the facility permit holder. It is currently being docketed against the pharmacist on duty at the time the bag is given out, but often that pharmacist had nothing to do with the dispensing of that prescription. In many cases this relates to a system problem rather than an individual error.
Mr. Brown moved that the case should initially be docketed against the pharmacy permit if the wrong drug is placed in the bag or the wrong bag given to the patient.
Ms. Abernathy offered an amendment to the main motion that the case should initially be docketed against the pharmacist-in-charge in such instances.
The Chair ruled that the discussion would be on the main motion. After further discussion, the Board voted 6-3 that a case should initially be docketed against the pharmacy permit if the wrong drug is placed in the bag or the wrong bag given to the patient, with the understanding that it would be docketed against a specific pharmacy and not the corporation, as the system problem may be related to that specific pharmacy.
REPORT FROM THE BOARD OF HEALTH PROFESSIONS – MICHELLE EASTON: / Ms. Easton stated that the April 13, 2005 minutes from the Board of Health Professions were an accurate reflection of what occurred at the meeting.