COMMONWEALTH OF MASSACHUSETTS
NOTICE OF THE REGULARLY SCHEDULED MEETING OF THE
BOARD OF REGISTRATION IN PHARMACY
November 5, 2013
239 Causeway Street ~ Room 417 A&B
Boston, Massachusetts 02114
AGENDA
Time / # /Item
/ Exhibits / Staff Contact8:30 / I. /
CALL TO ORDER
8:30 / II. / APPROVAL OF AGENDA8:45 / III. / EXECUTIVE SESSION
Remarks from the Chair on Conducting the Meeting
The Board will meet in Executive Session as authorized pursuant to M.G.L. c.30A, § 21(a)(1) for the purpose of discussing the reputation, character, physical condition or mental health, rather than professional competence, of an individual, or to discuss the discipline or dismissal of, or complaints or charges brought against, a public officer, employee, staff member or individual.
1. Specifically, the Board will discuss and evaluate the Good Moral Character as required for registration for pending applicants.
2. Specifically, the Board will discuss and evaluate the reputation, character, physical condition or mental health, rather than professional competence, of licensees relevant to their petitions for license status change.
3. Approval of prior executive session minutes in accordance with M.G.L. ch.30A, § 22(f) for sessions held during the September 10, 2013 and October 1, 2013 meetings. / CLOSED SESSION
9:15 / IV. / ADJUDICATORY SESSION (M.G.L. ch. 30A, § 18) / CLOSED SESSION
9:20 / V. / M.G.L. c. 112, § 65C SESSION / CLOSED SESSION
11:30 / VI. / APPROVAL OF BOARD MINUTES
1. Draft Minutes for the October 1, 2010 Meeting of the Board of Registration in Pharmacy, Regular Session / Minutes / V. Berg
11:35 / VII. / REPORTS
1. Applications approved pursuant to Licensure Policy 13-01
2. Plans of Correction reviewed pursuant to Enforcement
Policy 13-02 / Reports / M. Cittadino
H.Engman
11:35 / VIII. / POLICY
Proposed Licensing Policy 13-05: Staff Action to Identify License Applications requiring Good Moral Character evaluation. / Proposed
Policy / V. Berg
12:30 – 1:00 / LUNCH
11:45 – 12:30,
1:00 – 2:30 / IX. / FILE REVIEW
1) SA-INV-4132, Anthony Rozzi, PH17821
2) SA-INV-4065, Hopkinton Drug, DS8191
3) SA-INV-3270, Hopkinton Drug, DS8191
4) SA-INV-4126, Dennis Katz, PH17067
5) PHA-2013-0077, Edward Lynsky, PH15346
6) SA-INV-4138, Fresenius Medical Care North America, DS2969
7) PHA-2013-0140, Robert Play, PH19655
8) SA-INV-3089, Rite Aid #10067, DS2552
9) SA-INV-3050, North Shore Pharmacy, DS3458
10) PHA-2012-0192, John Finnegan, PH16847
11) PHA-2012-0147, Martha Michael, PH20417
12) PHA-2012-0146, Mufid Najjar, PH23467
13) SA-INV-3273, IntegriScript, DS89726
14) SA-INV-3980, Jeanne Szwajkowski, PH27446 / Investigation Reports / S. Penta
W. Frisch
L. McKenna
C. Lathum
V. Berg
2:30 / X. / LICENSE STATUS CHANGE
1. North Shore Pharmacy Services, DS3458 petition for termination of probation
2:45 / XI. / APPLICATIONS
1. Progressive Pharmacy Solutions
39 Haverhill St, Methuen, MA 03079
Reconsideration of New Community Pharmacy Application
2. SJ MedSave Solutions
121 Brick Kiln Road, Suite 235
Chelmsford, 02184
Reconsideration of Wholesale Distributor Application
3. The Medicine Shoppe 0500 (DS2876)
409 Cabot Street, Beverly
Transfer of Ownership Application
4. North Falmouth Pharmacy (DS89831)
111 County Road, Falmouth
Transfer of Ownership Application
5. Genoa Healthcare
55 Federal Street, Suite 105, Greenfield
New Community Pharmacy Application with Waivers
6. Baystate Pharmacy
50 Watson Avenue, Springfield
New Community Pharmacy Application
7. Baystate Specialty Pharmacy
298 Carew Street, Worcester
New Community Pharmacy Application with Waivers / Applications and supporting documents / M. Cittadino
4:30 / XI. / FLEX SESSION
1. Board Approved Continuing Education
2. FAQs – Chapter 244 – Section 4
3. Complete the Cycle – Recycle Program for GSK Respiratory Inhalers
4. Elections in December
5. Topics for upcoming meetings
5:00 / XII. / ADJOURNMENT
COMMONWEALTH OF MASSACHUSETTS
BOARD OF REGISTRATION IN PHARMACY
MINUTES OF THE REGULARLY SCHEDULED MEETING
239 Causeway Street, Fourth Floor ~ Room 417A
Boston, Massachusetts 02114
Tuesday, November 5, 2013
Board Members Present
James T. DeVita, RPh , President
Anita Young, RPh, EdD, Secretary
Karen Ryle, RPh, President Elect
Jane F. Franke, RN, MHA
Patrick M. Gannon, RPh, MS, FABC
Anthony Perrone, RPh, MD, MBA
Edmund Taglieri, RPh, MSM, NHA
Richard Tinsley, MBA, MEd
Joanne Trifone, RPh
Board Members Not Present
Board Staff Present
Margaret Cittadino, MEd, Associate Director
Heather Engman JD, MPH, Board Counsel
Vita P. Berg, JD, Board Counsel
Leo McKenna, RPh, PharmD, Quality Assurance Coordinator
Samuel Penta, RPh, Investigator Supervisor
William E. Frisch, Jr., RPh, Investigator
Cheryl Lathum, RPh, PharmD, Investigator
Joseph Sceppa, RPh, Consultant
Board Staff Not Present
______
I. CALL TO ORDER
DISCUSSION: A quorum of the Board was present. J. DEVITA announced that the meeting was being recorded and that a new amplification system is in use.
ACTION: At 8:32 a.m. J. DEVITA, President, called the November 5, 2013, meeting of the Board of Registration in Pharmacy to order.
______TOPIC:
II. APPROVAL OF AGENDA
DISCUSSION: Board members reviewed the tentative agenda. V. BERG announced that certain items will be deferred to the December Meeting, including Section V1 approval of minutes, and File Review #6 (Fresenius). Also, changes: Section XI, #4 (North Falmouth) includes waivers, XI #7 (Bay State) strike “with waivers” and the correct city is Springfield, MA., Reports: Nothing to Report. Add to the Flex Session: “Nominations” for 2014 officers, for a vote during December meeting. K. Ryle suggested nominating Jim Devita for NABP award, and J. Devita added an Open Meeting Law discussion.
ACTION: Motion by, P. GANNON to approve the agenda with changes, seconded by A. YOUNG, and voted unanimously to approve the agenda with the above changes.
______
Remarks from the Chair
Board of Pharmacy President Jim Devita welcomed new members. He explained that the Board needs to be more organized and efficient than ever, since regulation writing would be part of 2014 and takes a long time, and there is still a heavy caseload waiting to be heard.
He wanted to remind the members to follow “Roberts Rules” during the meeting, be prepared, and respect other Board members
TOPIC:
III. EXECUTIVE SESSION
ACTION: Motion by J. TRIFONE seconded by E. TAGLIERI and passed by unanimous roll call vote to enter into Executive Session at 8:44 a.m. J. DEVITA: yes; J. TRIFONE: yes; A. YOUNG: yes; E. TAGLIERI: yes; J. FRANKE: yes; P. GANNON: yes; A. PERRONE: yes; R. TINSLEY: yes.
______
EXECUTIVE SESSION (8:44 – 9:47 a.m.)
______
ACTION: Motion by P.GANNON seconded by R. TINSLEY and passed by unanimous roll call vote to enter Adjudicatory at 9:47 a.m. J. DEVITA: yes; J. TRIFONE: yes; A. YOUNG: yes; E. TAGLIERI: yes; J. FRANKE: yes; P. GANNON: yes; A. PERRONE: yes; R. TINSLEY: yes.
______ADJUDICATORY SESSION (9:47 a.m - 10:15 am.)
______
TOPIC
VIII. POLICY
DISCUSSION: V. Berg presented a draft of a proposed policy 13-5 related to authorizing staff action on Good Moral Character Evaluations. Members made suggestions related to conditions which could be approved by staff action and would not require an appearance before the board. Further, the Board members were firm in their intent to see all applicants with drug class A,B,C and D possessions appear before the Board for a vote.
ACTION: V. Berg will submit a revised policy at the December meeting.
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TOPIC:
IX. FILE REVIEW
1. Anthony Rozzi SA-INV-4132
RECUSED: E. Taglieri
DISCUSSION: S. Penta presented the case and board concluded that discipline is not warranted
ACTION: Motion by A. YOUNG and seconded by J. FRANKE and voted unanimously to close the staff assignment, discipline not warranted.
______
2. Hopkinton Drug SA-INV-4065 (DS8191)
DISCUSSION: C. Lathum reported that Hopkinton Drug had made impressive changes which resolved the deficiencies.
ACTION: Motion by A. YOUNG and seconded by P. GANNON and voted unanimously to close the staff assignment, discipline not warranted.
3. Hopkinton Drug SA-INV-3270 (DS8191)
DISCUSSION: This staff assignment related to an inspection in which the deficiencies have already been corrected.
ACTION: Motion by J. TRIFONE and seconded by P. GANNON and voted unanimously to close the staff assignment, discipline not warranted.
4. Dennis Katz SA-INV-4126 (PH17067)
DISCUSSION: This staff assignment related to an inspection in which the deficiencies have already been corrected.
ACTION: Motion by J. TRIFONE and seconded by P. GANNON and voted unanimously to close the staff assignment, discipline not warranted. Approved
______
5. Edward Lynsky PHA-2013-0077(PH15346)
Deferred to a future meeting
______
6. Fresenius Health Care SA-INV-4138 (DS2969)
Deferred to a future meeting
______
7. Robert Play PHA-2013-0140 (PH19655)
DISCUSSSION: S. Penta presented this discipline in another jurisdiction case. Licensee entered into a consent agreement with Maine. The consent agreement had terms including continuing education requirements.
ACTION: Motion by J. TRIFONE and seconded by J. FRANKIE and voted unanimously to refer to the Office of Prosecution for the issuance of an Order to Show Cause and in the alternative to authorize a consent agreement for a reprimand with a pre-condition to show proof compliance with terms of Maine consent agreement. ______
8. Rite-Aid 10067 SA-INV-3089 (DS2552)
DISCUSSION: S. Penta presented this diversion case. No individual was named in the diversion after the corporate investigation. A pharmacy associate went on personal leave after the event from which they never returned. There have been no additional losses since and there has been no further investigation by the corporation.
ACTION: Board requested that a pharmacist investigator follow up with corporation for further information. No vote taken.
______
9. North Shore Pharmacy Services - SA-INV-3050 (DS3458)
DISCUSSION: C. Lathum presented for OPP Investigator M. Sheckman who prepared the investigation report. This involved a complaint by a staff member who worked six months at NSPS and reported observing unlicensed pharmacy technicians working over 1000 hours without becoming licensed and conducting duties inappropriate for pharmacy techs-in-training. The complainant was experiencing job performance issues with the employer.
ACTION: Motion by A. YOUNG and seconded by P. GANNON and voted unanimously to close the staff assignment, with no violation noted.
______
10. John Finnegan - PHA-2012-0192 (PH16847)
DISCUSSION: V. Berg reported that the licensee has been non-responsive to the Consent Agreement sent from the Board. (At the time of this presentation there was no related document available)
ACTION: Motion by A. YOUNG and seconded by A. PERRONE and voted unanimously to refer the complaint to the Office of Prosecution for the issuance of an order to show cause and in the alternative to authorize a consent agreement for suspension until all conditions of the PHA-2010-0013 Consent Agreement have been met.
______
11. Martha Michael - PHA-2012-0147 (PH20417)
DISCUSSION: V. Berg reported that the licensee has been non-responsive to the Consent Agreement sent from the Board.
ACTION: Motion by P. GANNON and seconded by J. FRANKE and voted unanimously to refer the Complaint to the Office of Prosecution for the issuance of an order to show cause and in the alternative to authorize a consent agreement for a reprimand.
______
12. Mufid Najjar - PHA-2012-0146 (PH23467)
Discussion: V. Berg reported that the licensee has been non-responsive to the Consent Agreement sent from the Board.
Action: Motion by P. GANNON and seconded by J. TRIFONE and voted unanimously to refer the matter to the Office of Prosecution for the issuance of an order to show cause and in the alternative to authorize a consent agreement for 1 year probation with terms to include 4 contact hours of continuing education in law.
______
13. Integriscript - SA-INV-3273 (DS89726)
Deferred to a future meeting
______
14. Jeanne Szwajkowski - SA-INV-3980 (PH27446)
Deferred to a future meeting
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TOPIC
XI. APPLICATIONS
1. Progressive Pharmacy Solutions
39 Haverhill St, Methuen, MA 03079
Reconsideration of New Community Pharmacy Application (appearance)
DISCUSSION: Edwin K Ngaruiya, (PH233353) proposed Manager of Record (MOR), and Peter Edgerly, proposed co-owner, appeared before the Board for Reconsideration of a New Community Pharmacy Application and answered questions of the Board. The proposed Registrant pharmacy location would be engaged in approximately 50% direct patient dispensing and 50% of the prescriptions would be delivered to VNA Services (Peabody) to the patient’s agent / caregiver; authorization would be provided by the patient for the agent / caregiver. Board members expressed security concerns regarding the storage of the prescription medications at the drop-off site. Board noted that this model, as presented by the applicants, appears to comply with Board regulations.
ACTION: Motion by A. Young, seconded by ______, and the Board voted to conditionally approve the application subject to successful inspection of the proposed pharmacy, review of policies & procedures related prescription drop-off as well as a review by Board inspectors of security provisions for prescription medications at the drop-off location. E. TAGLIERI opposed.
______
2. SJ MedSAV Solutions
121 Brick Kiln Road, Suite 235, Chelmsford, 02184
Reconsideration of Wholesale Distributor Application (no appearance)
DISCUSSION: The Board discussed a Reconsideration of a Wholesale Distributor Application. Board Counsel indicated that the proposed owner’s initial application and appearance to the Board for a Wholesale Distributor license was specific to the distribution of medical / surgical supplies. The proposed owner’s second appearance extended the scope of products to Schedule VI medications. Current Board of Pharmacy regulations do not directly address virtual drug wholesaler models and are non-excluding. According to Board Counsel, the Board is aware of one other similar model in Massachusetts. There is no legal basis for denial of the application. Board members expressed concern regarding the chain of custody, fulfillment, security, storage, and transport of medications since the proposed Registrant never takes physical possession of the drug products. Board Counsel relayed that the proposed Registrant was responsible for the compliance with all requirements for a Wholesaler Drug Distributor licensed by the Board under the regulations.
ACTION: Motion by K. RYLE, seconded by R. TINSLEY, and the Board voted by a majority to conditionally approve the application pending successful inspection. A. YOUNG and A.PERRONE opposed the motion. J.TRIFONE Abstained.
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3. The Medicine Shoppe 0500 (DS2876)
409 Cabot Street, Beverly, MA 01915
Application for DS (Drug Store)-Transfer of Ownership (appearance)