Rite Aid Corporation Legal Department - DOC

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					                                               BOARD OF PHARMACY
                                 Secretary of State, Office of Professional Regulation
                          National Life Building, North, Floor 2, Montpelier, VT 05620-3402
                                               UNAPPROVED MINUTES
                                               Meeting of June 25, 2008

1.   The meeting was called to order at 9:01 AM.

     Members present: Earl W. Pease, Pharm.D., Chair; Steven M. Vincent, R.Ph., Vice-Chair; Emma J. Pudvah,
     Secretary; Julie A. Eaton, R.Ph.; Larry Labor, R.Ph. and Ann Overton. Absent: Jeffrey P. Firlik, R.Ph.

     OPR Personnel: Larry S. Novins, Board Counsel, Carla Preston, Unit Administrator, Amy Carlson, Chief Investigator;
     Daniel Vincent, Inspector; Edward G. Adrian, State Prosecuting Attorney and Kristi Kemp, Staff Secretary.

     Others present: Kylie Gould, District Manager for Rite Aid Corporation; Rachel Thomas, R.Ph.; Anthony Otis, Esq. and
     Kerri Ryan, R.Ph., CVS Pharmacies.

2.   The Chair called for approval of the Minutes of the May 28th meeting. The first sentence of paragraph two on page
     two was amended to reflect that a disadvantage to the system is that there is no way to indicate a patient’s diagnosis.
     Mr. Vincent made a motion, seconded by Ms. Pudvah, to approve the Minutes of the May 28, 2008 meeting as
     amended. Motion passed unanimously.

3.   Guests:

     At 9:15 AM, Amy Carlson, Chief Investigator and Daniel Vincent, Inspector, attended the meeting to present a revised
     inspection form and for clarification on a few points. Ms. Carlson explained that Inspector Vincent will have this
     (fillable) form on a laptop so that future inspections would be typewritten. She said overall there were only few
     changes to the form. Statute or rule references have been added for the benefit of the inspector , staff, and the
     pharmacist manager. They asked for feedback on the revised form as soon as possible.

     Inspector Vincent said he has added a place for additional contact information (web sites, fax numbers, and email
     addresses). He said he has updated the addendums for specialty pharmacies such as those requiring a hood for
     preparation of sterile products. Inspector Vincent asked about some drug interaction references that are not
     specifically listed in the rules but that pharmacists have advised have been approved. He said he would be creating an
     abbreviated inspection form to be used for an initial inspection (temporary) of new retail pharmacies and will present
     that for Board consideration at the July meeting. He said he is also working on an inspection form for hospital
     pharmacies which he will be presenting at a later date.

     The Board clarified procedures with regard to blister packs, restocking, and unit dose for the Inspector. The Board
     verified that a few references other than those listed in the rules have been approved (e.g., Clinical Pharmacology and
     Gold Standard). The Board asked Ms. Preston to research previously approved references that can be added to the
     list. That information will also be provided to Inspector Vincent.

     Attorney Novins advised Ms. Carlson and Inspector Vincent that the Board is in the process of updating its rules
     which includes renumbering parts and sections. The inspection form would need to be updated to incorporate the
     appropriate rule reference. He will provide them with a copy of the latest draft of the rules.

4.   Hearings/Stipulations et al.

     a.   At 10:00 AM a hearing was held to consider a Motion to Remove/Modify Conditions in the matter of Rachel (Sala)
          Thomas, R.Ph., Docket Number RX29-0305. The Respondent, Ms. Thomas and Kylie Gould, District Manager
          for Rite Aid Corporation, were present. Larry Novins presided for the Board. Edward G. Adrian, Prosecuting
          Attorney, was present for the State.
Board of Pharmacy
Minutes – June 25, 2008                                                                                      Page 2

           Ms. Thomas stated that she was asking to have the direct supervision condition eliminated or reduced so that she
           would be allowed to work solo. The Board voted to go into deliberative session at 10:35 AM and out at 11:01
           AM. A written Order stating the Board’s decision will be issued soon.

5.     Follow-Up Cases:

       The Board reviewed the documents submitted concerning the follow -up cases below and took action as indicated.

       RX11-0806 – William Aimi/Corner Drug Co., Inc. – The Board found Mr. Aimi and his pharmacy to be in compliance
       with the conditions imposed on those licenses.

       APP-RX23-0106 – PetMed Express Inc. d/b/a 1-800-PetMeds Express – The Board found PetMed Express Inc. to be
       in compliance with the conditions imposed on its license.

       RX15-0303- Hugh Douglas Bryan – The Board reviewed Mr. Bryan’s request for reinstatement. A hearing will be
       scheduled.

       RX16-0601- Richard Barker. Based on the documents provided, the Board voted to remove the conditions imposed
       on Mr. Barker’s pharmacist license.

6.     Reports:

7.     Legislation/Rulemaking:

       The Board discussed the new law effective July 1, 2008 concerning the change from 10 days to 30 days for the filling
       of prescriptions for schedule II medications. The Board will send a Memorandum to all pharmacies, the Board of
       Medical Practice and other prescribers advising them of this statutory change.

       The Board discussed a few changes to the rules as they arose during the meeting. The Board agreed to include
       language that addresses investigative/research facilities. A special work session was scheduled for July 14, 2008 to
       continue working on the rules.

8.     Complaints:

       The Board reviewed the following Reports of Concluded Investigation and took action as indicated.

       RX33-0306 – The Report of Concluded Investigation was discussed but not accepted. The case was remanded back
       to the Investigative Team.

       RX70-0507 and RX71-0507 – Mr. Vincent made a motion, seconded by Ms. Pudvah, to accept the Investigative
       Team’s recommendation and conclude these cases without charges. Motion passed. Ms. Eaton, Investigating
       Member, did not participate in the vote.

       RX47-0208 – Ms. Eaton made a motion, seconded by Mr. Vincent, to accept the Investigative Team’s
       recommendation and conclude this case without charges. Motion passed. Mr. Pease, Investigating Member, did not
       participate in the vote.
Board of Pharmacy
Minutes – June 25, 2008                                                                                       Page 3
8.     Complaints       -       continued

       RX52-0107, RX53-0107, and RX54-0107 - Ms. Eaton made a motion, seconded by Mr. Vincent, to accept the
       Investigative Team’s recommendation and conclude these cases without charges. Motion passed. Mr. Pease,
       Investigating Member, did not participate in the vote.

       RX16-0807 – Ms. Overton made a motion, seconded by Mr. Labor, to accept the Investigative Team’s
       recommendation and conclude this case without charges. Motion passed. Ms. Eaton, Investigating Member, did not
       participate in the vote.

       RX07-0807, RX08-0807 and RX09-0807 – Mr. Vincent made a motion, seconded by Ms. Pudvah, to accept the
       Investigative Team’s recommendation and conclude these cases without charges. Motion passed. John W. Vincent,
       Ad Hoc Investigating Member was not present.

 9.    Pharmacist Applications

       The Board reviewed and approved the following applicant for licensure as a Pharmacist:

               Debra A. Spero, R.Ph.

       The Board reviewed the following applications from recent graduates who have applied to sit for the NAPLEX/MPJE.
        The Board confirmed that candidates/applicants must register as pharmacist interns while working in Vermont
       regardless of whether the hours earned are a portion of their school rotations or applied toward the 500 non-school
       related internship hours required. The pharmacist manager, preceptor, and intern all share in the responsibility of
       submitting the proper paperwork and becoming registered. The Board requires pharmacist interns to register in order
       to receive credit for internship hours earned. The Board suggested amending the Verification of Education form to
       include the total number of internship/extern hours the student earned in that school’s pharmacy program. The
       number of program hours is not included on the transcript.

       Craigg L. Barr – Mr. Barr’s application to become registered as an intern was approved. In addition his preceptor,
       James Sawyer, R.Ph. was also approved. The Board was unable to accept Mr. Barr’s reported internship hours
       because it appeared that they were earned in Vermont prior to his becoming registered as an Intern. The Board also
       requested additional clarification pertaining to internship hours he earned in New York.

       Brent Dela Bruere - Mr. Dela Bruere’s application to become registered as an intern was reviewed. The hours
       reported were in 2006 and 2007 during which time he was not registered as an intern. His current preceptor must be
       registered. The Board also requested additional clarification pertaining to internship hours he earned in other states.

       Kelli Rothenberger – Ms. Rothenberger had previously registered as an intern and submitted internship hours for
       approval. The school Ms. Rothenberger attended provided transcripts but did not provide a separate letter indicating
       the number of hours she completed in its pharmacy program. To be accredited a pharmacy school must have a
       program consisting of at least 1500 hours. The Verification of Education form will be modified to include the number
       of hours a student has completed. The Board verified she had sufficient internship and/or externship hours and
       approved for her to sit for the examinations.




10.    Drug Outlets:
Board of Pharmacy
Minutes – June 25, 2008                                                                                          Page 4

       The Board reviewed the applications and most recent inspections for the following drug outlets and took action as
       indicated.

       a.   Extended Care Pharmacy, LLC, (closed pharmacy – long term care), located at 207 North Street, Bennington,
            VT. Based on the favorable inspection conducted on June 3, 2008, the Board approved this facility for full
            licensure.

       b. Kinney Drugs Inc. #29, (038-0002470) located at 308 Shelburne Road, Burlington, VT (formerly located at 789
          Pine Street, Burlington, VT – July 7, 2008 anticipated opening date), submitted a new application to reflect change
          in location. Inspection of new facility to be conducted on or about July 1, 2008.

       c. New England Home Therapies, Inc., c/o Critical Homecare Solutions, Inc. d/b/a Wilcox Home Infusion, located
          at 400 Cornerstone Drive, Suite 130, Williston, VT, submitted a new application to reflect a change in ownership.
           Based on the favorable inspection conducted on June 18, 2008, the Board approved this facility for full licensure.

       d. New England Home Therapies, Inc., c/o Critical Homecare Solutions, Inc. d/b/a Wilcox Home Infusion, located
          at 250 Stratton Road, Rutland, VT, submitted a new application to reflect a change in ownership. Based on the
          favorable inspection conducted on June 13, 2008, the Board approved this facility for full licensure.

       e.   The Board discussed Omega Optical, a research facility to be located in the State of Vermont. The Board concluded
            that based on the statutory requirement research and investigative programs/facilities must be licensed. The applicants
            will be advised. The Board agreed to include details of requirements in its updated rules.

11.    Changes in Pharmacist Managers:

       Ms. Eaton made a motion, seconded by Ms. Pudvah, to approve the following changes in pharmacist managers. The
       question was called and the motion passed unanimously.

       a. Rite Aid Pharmacy #10336, (038-3370), located at 82 Route 15 West, Hardwick, Vermont, submitted an
          application for change in pharmacist manager from Waldemar Wierzbicki to Christopher Hazuda.
       b. Rite Aid Pharmacy #10317, (038-3365), located at 158 Cherry Street, Burlington, Vermont, submitted an
          application for change in pharmacist manager from Yogeshkumar Patel to Timothy J. Luneau.
       c. Price Chopper Pharmacy #165, (038-2951), located at 595 Shelburne Road, Burlington, Vermont, submitted an
          application for change in pharmacist manager from Jaime Romano to Jacie L. Scott.

12.    Non-Resident Drug Outlets:

       Mr. Vincent made a motion, seconded by Ms. Overton, to approve the following non-resident drug outlets. The
       question was called and the motion passed unanimously.

       a.   Biomed PA, Inc. d/b/a Biomed Pharmaceuticals, Sharon Hill, PA.
       b.   FarmVet.com, Inc., Franklin, TN.
       c.   United Health Group d/b/a Innoviant Pharmacy Inc., Huntingdon Valley, PA.
       d.   Abbott Endocrinology, Inc. d/b/a Pharmacy Solutions, Deerfield, IL.
       e.   Prescription Giant, LLC, Rochester Hills, MI.

13.    Wholesale Drug Outlets:
Board of Pharmacy
Minutes – June 25, 2008                                                                                      Page 5
       Mr. Vincent made a motion, seconded by Ms. Pudvah, to approve the following non-resident wholesaler drug outlets.
       The question was called and the motion passed unanimously.

       a.   Air Liquide Healthcare America Corporation, Plumsteadville, PA.
       b.   Amneal Pharmaceuticals, LLC, Fountain Run, KY.
       c.   Caraco Pharmaceutical Laboratories, Ltd., Wixom, MI.
       d.   Cephazone Pharma, LLC, Pomona, CA.
       e.   Genco I, Inc., Tobyhanna, PA.
       f.   Kenco Colonial Heights, Colonial Heights, VA.
       g.   Kimberly-Clark Global Sales, Tucson, AZ.
       h.   Priority Air Express, LLC d/b/a Priority Solutions International, Swedesboro, NJ.
       i.   Priority Air Express, LLC d/b/a Priority Solutions International, Memphis, TN.

       j.   The Board reviewed and noted the June 24, 2008 letter from Dr. Randy S. Stoloff, MD stating that he would not
            request a hearing concerning the preliminary denial of his application for an in-state wholesaler.

14.    Drug Outlet remodeling, changes in Officers/Directors, hours of operation, etc.:

15.    Continuing Education Requests:

       The following requests for approval of continuing education programs were approved by the Board. To assist with
       CE audits, a code will be added to the number issued to indicate whether the course is didactic or live (L).

       a.  “Vermont DUR Board Meeting,” submitted by Andrew Miller, was approved for two hours for his attendance at
           the Vermont DUR Board meeting held on May 13, 2008. The approval number issued is CE309(L)-0608.
16.    Intern/Preceptor application(s)

       Ms. Eaton made a motion, seconded by Ms. Pudvah, to approve the following applications as indicated. Motion
       passed unanimously.

       a.   Marianne Khalil – Ms. Khalil’s Application for Registration of Intern was approved pending receipt of verification
            from her school of pharmacy. Her preceptor at the pharmacy where she will work and earn hours must also be
            registered. The Board also reviewed Ms. Khalil’s Intern’s and Preceptor’s Evaluation of Internship hours that she
            earned in Canada but is unable to accept hours earned in another country.

       b.   Stephen J. Lyons – Mr. Lyons’ Application for Registration of Intern was approved pending receipt of
            verification from his school of pharmacy.

       c. Christina Sheehan – Ms. Sheehan’s Intern’s Evaluation of Internship Period and Preceptor’s Affidavit of
          Internship Hours was approved for the 678 hours she earned during the period of January 2, 2008 through April
          26, 2008 while working at Rite Aid Pharmacy in Barre, Vermont.

       d. Madhulatha Malireddy – Ms. Malireddy’s Intern’s Evaluation of Internship Period and Preceptor’s Affidavit of
          Internship Hours was approved for the 571 hours she earned during the period of March 29, 2008 through June
          14, 2008 while working at Rite Aid Pharmacy in Springfield, Vermont.



16.    Intern/Preceptor application(s)      -     continued
Board of Pharmacy
Minutes – June 25, 2008                                                                                         Page 6
       e.   Bryan J. Trombley – Mr. Trombley’s Application for Registration of Intern was approved pending receipt of
            verification from his school of pharmacy.

       f.   Thomas U. Kaufmann – Mr. Kaufmann’s Application for Registration of Intern was approved pending receipt of
            verification from his school of pharmacy.

       g. Craig Robbins, RPH – Mr. Robbins’ Application as a Preceptor was approved pending signature of owner or
          department head and legal forms.

       h. James A. Sawyer, R.Ph. – Mr. Sawyer’s Application as a Preceptor was approved.

17.    Pharmacy Technicians: Total number of Active Registered Technicians is 1,288.

18.    Newsletter Topics!

       Ms. Eaton agreed to draft topics for the newsletter which included clarification of blister packs, unit dose, their
       expiration dates, and so on.

19.    Miscellaneous Correspondence

       a.   The Board reviewed and discussed the June 2, 2008 Email from Landmark Medical Management LLC concerning
            physician dispensing of compounded medications. It was unclear who would be preparing the compound. If a
            pharmacist prepares the compound it can only be for direct application in the physician’s office, not for resale.
            If the physician is preparing the compound, they must contact the Vermont Board of Medical Practice.
       b.   The Board reviewed and discussed the May 12, 2008 E-Mail from Brian Czochara concerning physician
            dispensing. He will be referred to the Vermont Board of Medical Practice.
       c.   The Board reviewed and discussed the June 13, 2008 letter from Medi-Scripts concerning approval of their
            prescription pad design. They will be referred to Title 18 V.S.A § 4606 regarding generic substitution. They
            must also comply with tamper resistant requirements.
       d.   The Board reviewed and noted the June 2, 2008 letter from NACDS concerning consumer returns to pharmacies
            of controlled substances.
       e.   The Board reviewed and discussed the April 21, 2008 Email from Jagrutiben Patel to determine whether
            Michigan’s requirements for pharmacist licensure are substantially equal to Vermont’s requirements. She must
            submit an application.
       f.   The Board reviewed the June 24, 2008 Email from Jill Geiger, RPh concerning E-prescribing of Schedule III’s
            through V’s. Ms. Eaton will respond noting the federal regulations and the difference between E-scripts and
            faxing.
       g.   The Board reviewed the June 24, 2008 Email from Alisha Daddario with Price Chopper Supermarkets concerning
            pharmacists immunizing and required training. The Board noted that the scope of practice provides for
            collaborative practice but does not expand upon specifics with regard to training or the process. The APHA has
            guidelines for immunizations. The topic will be clarified in the Board’s updated rules.
       h.   The Board reviewed the June 24, 2008 Email from Steven Matsukas with Omnicare, Inc. concerning preparation
            of replacement E-Kits. His inquiry concerning emergency kits is addressed in Part F, Rule 7.1.7 which states,
            “Drugs shall be removed from emergency kits pursuant to a valid prescription drug order only;” Even though
            they are an out-of-state pharmacy they must comply with Vermont’s regulations since they are shipping products
            to the State of Vermont.


20.    National Association of Boards of Pharmacy (NABP) Correspondence:
Board of Pharmacy
Minutes – June 25, 2008                                                                                Page 7
        The Board reviewed and noted NABP Correspondence, none of which required Board action.

21.     Public Comment

22.     Other Business Introduced

23.     The next meeting is scheduled for Wednesday, July 23, 2008 at 9:00 AM. Future meetings for 2008 are scheduled
        as follows: August 27th ; September 24th ; October 22nd ; and December 3rd .

24.     There being no further business, the meeting was adjourned at 2:55 PM.

Respectfully submitted,



Carla Preston, Unit Administrator
Office of Professional Regulation

				
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