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Minutes of the Regularly Scheduled Meeting held on October 6, 2016, approved on November 1, 2016

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COMMONWEALTH OF MASSACHUSETTSBoard of Registration in Pharmacy

NOTICE OF THE REGULARLY SCHEDULED MEETING OF THEBOARD OF REGISTRATION IN PHARMACY

November 1, 2016239 Causeway Street ~ Room 417 A&B

Boston, Massachusetts 02114

Agenda

Time # Item Exhibits Contact

8:30 I CALL TO ORDER E. Taglieri

8:35 II APPROVAL OF AGENDA Introductions : Nazmin Khalifa - Pharmacy Intern

8:40 III APPROVAL OF BOARD MINUTES Draft of October 6, 2016 Regular Session Minutes

8:45 IV

APPLICATIONS Eaton Apothecary/Lynn Health Center – Relocation Community Health Center of Cape Cod- New Store Brigham and Women’s Hospital- Renovation

9:30 V

REPORTS Applications approved pursuant to Licensure Policy

13-01 Monthly report from probation Board Delegated Complaint Review pursuant to

licensure policy 14-02

ReportsR. HarrisK. Fishman

9:40 VI

POLICIES Proposed policies and standard consent agreement

for PSUD Above action level result staff action policy

V. Berg

M. ChanW. Frisch

10:10 VIIREGULATIONS

247 CMR 18.00: Non-Sterile Compounding 247 CMR 22.00: Fines

W. FrischM. Chan

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10:30 VIII

REGULATORY REVIEW

247 CMR 5.00:Orally and electronically transmitted prescriptions; Prescription Monitoring Program (PMP) reporting requirements

247 CMR 7.00:Wholesale Druggists 247 CMR 9.00:Code of professional conduct;

professional standards for registered pharmacists, pharmacies and pharmacy departments

247 CMR 12.00:Restricted Pharmacy 247 CMR 15.00: Continuous Quality Improvement 247 CMR 20.00:Reporting

V. Berg

11:15 IX

ADVISORY

Advisory on pain management training for pharmacists applying for, or renewing, an individual MCSR pursuant to a CDTM.

M. Chan

11:30 X

FLEX SESSION Nomination for officers Advisory committee update Public Hearing, November 30th at 3p.m.

1. 247 CMR 2.00: Definitions2. 247 CMR 13.00: Registration requirements

and minimal professional standards for nuclear pharmacies.

3. 247 CMR 14.00: Petition for waiver

D. Sencabaugh

V. Thaker

M. Botto

12:00 LUNCH BREAK

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1:00 XI

FILE REVIEW

FILE INVESTIGATOR

1 PHA-2015-0151, New England Life Care, DS3513 Tran

2 PHA-2016-0070, Apothecare Pharmacy, DS89983 Mogni

3 PHA-2016-0122, CVS #17957, DS90007 Santoro

4 SA-INV-10000, Omnicare of Northern MA, DS89931 Santoro

5 PHA-2015-0165, John Fanikos, PH19320 Tran

6 SA-INV-7313, Rite Aid Pharmacy #10085, DS3180 Morton

7 SA-INV-8899, St. Georges Pharmacy Corp., DS90034 Santoro

8 SA-INV-3258,Village Fertility Pharmacy, DS89658 Penta

1:30 XII

EXECUTIVE SESSIONThe 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.

Specifically, the Board will discuss and evaluate the Good

Moral Character as required for registration for pending applicant.

CLOSED SESSION

2:00 XIII ADJUDICATORY SESSION (M.G.L. c. 30A, § 18) CLOSED SESSION

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2:10 XIV M.G.L. c. 112, § 65C SESSION CLOSED SESSION

5:00 XV ADJOURNMENT

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COMMONWEALTH OF MASSACHUSETTSBOARD OF REGISTRATION IN PHARMACY

MINUTES OF THE REGULARLY SCHEDULED MEETING239 Causeway Street, Fourth Floor Room 417A

Boston Massachusetts, 02114

October 6, 2016

Board Members Present Board Members Not PresentEdmund Taglieri Jr., R.Ph, MSM, NHA William Cox CPhTPresident Richard Tinsley, MBA, M.Ed. Timothy Fensky, R.Ph, FACA Karen Conley, RN, DNPPresident –elect Patrick Gannon, RPh, MSSusan Cornacchio, JD Ali Raja, MD, M.B.A., M.P.H.Phillippe Bouvier, R.Ph.Catherine Basile, Pharm D, R.Ph.Andrew Stein, Pharm D, R.Ph. Michael Godek, R.Ph, SecretaryGarrett Cavanaugh, R.Ph

Board Staff PresentDavid Sencabaugh, R.Ph., Executive DirectorMonica Vasquez, CPhT, Associate Executive DirectorWilliam Frisch, Director of Pharmacy ComplianceMichelle Chan, R.Ph., Quality Assurance PharmacistHeather Engman, JD, MPH Board CounselJoanne Trifone, R.Ph., Director of Pharmacy InvestigationsRichard Harris, Program AnalystJulienne Tran, PharmD, RPh. Pharmacy InvestigatorGreg Melton, JD, R.Ph., Pharmacy InvestigatorVita Palazzolo Berg, JD, Chief Board CounselJoe Santoro, R.Ph. Contract InvestigatorKimberly Morton, CPhT, Compliance OfficerSam Penta, R.Ph. Chief Pharmacy InvestigatorVishal Thaker, Pharm D, R.Ph., Contract Pharmacist

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TOPIC I.CALL TO ORDER 8:35 AMDISCUSSION: A quorum of the Board was present, established by roll call. President E. TAGLIERI chaired the meeting and asked if anyone was recording. Hearing “no”, he explained that the Board of Pharmacy was recording the meeting.

TOPIC II.APPROVAL OF AGENDADISCUSSION: NoneACTION:Motion by C. BASILE, seconded by M. GODEK, and voted unanimously to approve the agenda. P. BOUVIER had not arrived for the vote.Executive Director D. SENCABAUGH introduced APPE student Jordan LACOSTE, from MCPHS University. President Taglieri asked other interns in the room to introduce themselves.

TOPIC III. APPROVAL OF BOARD MINUTES1. Draft August 30, 2016, Regular Session MinutesDISCUSSION: H. ENGMAN recommended removal of the word “warehouse from the minutes on the “US Pharmatrade” application review, and changes to the language on the disposition of the “CureAid” application review.ACTION: Motion by C. BASILE, seconded by G. CAVANAUGH, and voted unanimously to approve the minutes of the Regular Session from August 30, 2016, with noted changes. M. GODEK, A. RAJA, and S. CORNACCHIO abstained, since they were not present on August 30th).

TOPIC IV:APPLICATIONS TIME: 8:42 am

1. Sturdy Memorial Hospital – New Outpatient Retail Pharmacy

RECUSAL: noneDISCUSSION: Sturdy was represented by Mr. Ben Sturm from Integrated Pharmacy Solutions, and by the proposed MOR Mr. Kieran Brennan. Sturm reported that the HCQl had approved the construction at the hospital, while DPH (Nancy O’Leary) had been informed of the planned use of space, and had no objections. The representatives answered the Board members’questions to their satisfaction. They are planning for a February 2017 opening.ACTION: Motion by C BASILE, seconded by, A. STEIN, and voted unanimously in the affirmative to approve the application for the new outpatient retail pharmacy, pending a successful inspection.

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2. KEYES Pharmacy – Renovation / Expansion

RECUSAL: None

DISCUSSION: Keyes Pharmacy was represented by Mr. Ray Dinno, Co-owner and MOR, Mr. SAAD Dinno, Co-owner / RPh, and Mr. Rob Adams from Controlled Environment Structures, who is designing the new clean room. W. FRISCH reported that Board of Pharmacy QA Pharmacists have had discussions with Keyes, reviewed the plans, and are comfortable with them moving forward. Keyes representatives answered the Board Members’ questions to their satisfaction.

ACTION: Motion by A. STEIN second by T. FENSKY, and voted unanimously to approve Keyes Pharmacy to conduct the planned renovation, pending a successful inspection.

3. MEDMINDER SYSTEMS - Relocation

RECUSAL: Phil Bouvier (arrived at 9:04 and immediately recused)

DISCUSSION: Medminder Systems was represented by Brian Bouvier, Operations Manager. Medminder is moving from Marlborough to Needham for growth and consolidation reasons. Mr. Bouvier presented two options to the Board, and the Board voted to approve the second option, showing the sink located more proximal to the prescription filling area. Two separate actions were taken:

ACTION: Motion by M. GODEK, seconded by G. CAVANAUGH, and voted unanimously to deny the first set of plans showing the sink in a separate area, somewhat distant from the actual prescription filling section of the pharmacy.

ACTION: Motion by T. FENSKY, seconded by, C. BASILE, and voted unanimously in the affirmative to approve the application for relocation showing the sink in the prescription filling area, pending the addition of a splashguard, and a successful inspection.

4. New England Home Therapies – Renovation / Expansion

RECUSAL: None

DISCUSSION: New England Home Therapies was represented by MOR Gina Matthews, Operations Manager Mike Carroll, Tom Choate from Air Systems Technologies, and Rick Coan from CES (Construction Engineering.)

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W. FRISCH informed the Board that QA Pharmacists from Board Staff have been in communication with NEHT, and that they are comfortable with them moving forward. NEHT answered the Board’s questions to their satisfaction, and they committed to a stepped-up EM schedule, during the process; 2x /month until containment is proven, then monthlyACTION: Motion by T. FENSKY second by M. GODEK, and voted unanimously by those present to approve New England Home Therapies’ plans for renovation and expansion, pending a successful inspection.

TOPIC V.

REPORTSApplications Approved Pursuant to Licensure Policy 13-01, 16-01 9:01 am

DISCUSSION: R. HARRIS noted that during the past month there have been twenty-five (25) change-of-managers, two (2) new Community Pharmacies, one (1) closing, three (3) renovations/ expansions, and eleven (8) registered non-resident Outsourcing Facilities.

Board Delegated Review Pursuant to BDCR PolicyThere was 1 Board Delegated Review case heard on September 29, 2016 involving self-reports of CE deficiency. It had been satisfactorily remediated and the file was closed with no discipline warranted. The Board Delegated Review session was attended by E.TAGLIERI as the Board Member, H. ENGMAN as Board Counsel, W. FRISCH, Director of Pharmacy Compliance, and Executive Director D. SENCABAUGH.

ACTION: So noted

Report of activities Probation MonitorDISCUSSION: D. SENCABAUGH (for K.FISHMAN) provided the August 19, 2016 – September 27, 2016, Board of Pharmacy Statistics Report for the Probation monitor, which noted that: there are forty-five (45) licensees on probation, thirty-one (31) satisfactorily completed probation, four (4) licensee did not cure within 30 days, eight (8) given the opportunity to cure, and two (2) notices of further discipline.

ACTION: So noted

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TOPIC VI POLICIES Time: 10:10am

Proposed policy and standard consent agreement for PSUD

Discussion: Board members received a copy of statue Chapter 112, section 24 H effective March 2016. V.Berg outlined the statue for board members and distributed a preliminary draft of a consent agreement. This topic will be revisited at the November Board meeting, where a vote is likely.

M: Ed, Tim, Cathy, Susan, Phil, Andy, Patrick, Garrett, Ali, MikeS: Ed, Tim, Cathy, Susan, Phil, Andy, Patrick, Garrett, Ali, MikeV:

TOPIC VII Regulations

Section 18:00 Non-Sterile Compounding

Discussion: Public comment collated and reviewed with Board members. Recommendations made by Board staff. Next steps will be to redraft and have 1 vote at the November meeting then it moves to administrative review.

Action: None at this time. Vote of redraft planned for November meeting.

M: Ed, Tim, Cathy, Susan, Phil, Andy, Patrick, Garrett, Ali, MikeS: Ed, Tim, Cathy, Susan, Phil, Andy, Patrick, Garrett, Ali, Mike

Section 19:00 Hazardous Medication

Discussion: Guidance document will be developed pertaining to OSHA items. No substantive change to proposed regulations therefore went to vote.

ACTION: Motion by M. GODEK, seconded by C. BASILE, and voted unanimously by those present, to approve section 19 to be sent for Administrative Review and public comments.

TOPIC VIII: FLEX SESSION TIME: 9:26am

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Announcement of Board Officer Elections for 2017Presented by: Dave Sencabaugh

Discussion: Nominations for officers will take place at the November meeting. Open positions will be for President-Elect and Secretary. Current President –Elect, Tim Fensky will become President. Executive Director Sencabaugh reminded Board members that they can’t discuss this with each other.

TOPIC VIII FLEX SESSION Time: 9:26am

NABP District I + II meeting Update:Presented by: Tim Fensky

The meeting was held September 15 — 17, 2016 at The Greenbrier Resort in White Sulphur Springs, West Virginia (District II). In attendance were Dave Sencabaugh, Tim Fensky, and Garret Cavanaugh. Topics discussed were the Opioid Crisis and Substance Use Disorder; Changing How the Pharmacist is looking at the Healthcare System, Prescriptive Authority. In the business session an update of NABP’s status was given. Three resolutions were presented by Anita Young, District I contact person. District II backed one of the District I proposed resolutions. District I will still submit the other two resolutions without the backing of District II. Garret Cavanaugh was nominated to be on the Resolutions Committee for the annual meeting to be held in May of 2016. Robert Carpenter of VT will be the alternate.

So noted

TOPIC VIII FLEX SESSION Time: 9:24am

Announcement of 10/14 Advisory Committee Meeting:Presented by: Dave Sencabaugh

The next meeting of the Advisory Committee will be held on Friday October 14, 2016. This meeting will be open to the public. The three main topics to be discussed will be:

1) Follow up and finish the protocol when a licensee receives an above action level notification (guidance for Board staff &/ registrant)

2) Scope of practice of technicians with regard to technology3) Telepharmacy-Chapter 159 will be addressed4)

TOPIC: IX File ReviewCase #1SA-INV-9196 Owens and Minor Distribution, WD53 TIME: 11:45 RECUSAL: NONEDISCUSSION: G. MELTON presented and summarized the investigation report that

pertained to these matters.

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Owens & Minor notified the MA Board on 1/25/16 of reciprocal discipline by the AL Board related to discipline by the VT board against their facility in TX.

Vermont Board disciplined Owens & Minor for failing to disclose all prior discipline in 6 states including their own ( for their facility in CA) in an application for out of state licensure for the TX facility

•The VT discipline resulted in reciprocal discipline in AL, HI, & WI •When the TX facility was originally disciplined in VT it was not licensed by the MA

board •The Franklin, MA facility was licensed in MA when the reciprocal discipline was issued in AL therefore reported to MA

ACTION: Motion by C. BASILE, seconded by T. FENSKY, and voted unanimously by those present, to close SA-INV-9196, no violation.

Case #2PHA-2016-0047 Ashburnham Family Pharmacy, DS3314 TIME: 11:46 AMRECUSAL: S. CORNACCHIO recused and was not present for the discussion or vote

on this matter.DISCUSSION: G. MELTON presented and summarized the investigation report that

pertained to these matters. A technician in training was observed working in excess of 1000 hours during retail

compliance inspections on 5/12/15 and 8/7/15. •The MORs plan of correction indicated that at the end of April 2015 he was aware the

technician trainee had exceeded 1000 hours. •At that time an application for licensure was completed but never submitted by

corporate. •MOR indicated the technician in training stopped working in that capacity after the

May inspection. Observations to the contrary were made during the follow up inspection in August

•MOR indicated he believed the application was in progress. Technician eventually licensed 10/13/15.

ACTION: Motion by A. STEIN, seconded by C. BASILE, and voted unanimously by those present, to dismiss PHA-2016-0047, no discipline warranted.

Case #3PHA-2016-0048 Michael Webb, PH18093 TIME: 11:46 AMRECUSAL: S. CORNACCHIO recused and was not present for the discussion or vote

on this matter.

DISCUSSION: G. MELTON presented and summarized the investigation report that pertained to these matters.

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A technician in training was observed working in excess of 1000 hours during retail compliance inspections on 5/12/15 and 8/7/15.

•The MORs plan of correction indicated that at the end of April 2015 he was aware the technician trainee had exceeded 1000 hours.

•At that time an application for licensure was completed but never submitted by corporate.

•MOR indicated the technician in training stopped working in that capacity after the May inspection. Observations to the contrary were made during the follow up inspection in August

•MOR indicated he believed the application was in progress. Technician eventually licensed 10/13/15.

ACTION: Motion by M. GODEK, seconded by G. CAVANAUGH, and voted unanimously by those present, to refer the matter to the office of the prosecution for the issuance of an order to show cause and to authorize resolution of the matter by a consent agreement for stayed probation with special terms to include reading, and attest to having read the following: 247 CMR sections 6, 8,9 as well as the Manager of Record Checklist. Furthermore, licensee must complete an additional 2 CEs in pharmacy law.

Case #4SA-INV-9667 Lynnfield Drug, Inc/ Freedom Fertility Pharmacy, DS89717

TIME: 11:44 AMRECUSAL: NONE

DISCUSSION: J. SANTORO presented and summarized the investigation report that pertained to these matters.

•Timely self report of an abnormal result from 6/13/16 •Reduced BUDs following guidelines of draft regulations 247 CMR 17 •Remediation was completed; compounding resumed 6/24/16 after approval from

the board ACTION: Motion by T. FENSKY, seconded by C. BASILE, and voted unanimously

by those present, to close SA-INV-9667, no violation. Case #5PHA-2016-0060 Pharm Blue Mass, LLC, DS89961 TIME: 11:55 AMRECUSAL: NONE


•Regulatory code violation involving proper maintenance of records

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•The pharmacy scanned C VI prescriptions into the computer and then shredded the hard copies •The prescriptions were maintained in Docu Tract Software which the pharmacy thought met the requirements of the board •New policy implemented to comply with record retention requirements and

prescriptions were retrieved from the system, printed and filed on site. ACTION: Motion by C. BASILE, seconded by S. CORRNACHIO, and voted unanimously by those present, to dismiss PHA-2016-0060, no discipline warranted.

Case #6SA-INV-9016 Omnicare of Northern MA, DS89931 TIME: 11:57 AMRECUSAL: S. CORNACCHIO recused and was not present for the discussion or vote on

this matter.

DISCUSSION: J. TRAN presented and summarized the investigation report that pertained to these matters.

• DEA 106-8 hydromorphone 4mg tabs on or about 1/19/16• Discovered while performing weekly perpetual inventory count. • Possible contributing factors-human error, process error, inventory discrepancy• A review of perpetual inventory calculations, item usage report, drug verification error report, cancelled full report, duplicate label report and no discrepancies detected. Video surveillance reviewed as well with no evidence of suspicious activity.• Corrective action is to put medication on a daily count if shows a loss to look for trends or a pattern of no discrepancies

ACTION: Motion by C. BASILE, seconded by A. STEIN, and voted unanimously by those present, to close SA-INV-9016, insufficient evidence.

Case #7SA-INV-9662 CVS #1143, DS1713 TIME: 11:59 AMRECUSAL: S. CORNACCHIO recused and was not present for the discussion or vote on

this matter.


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•Staff Assignment opened due to an Inspectional deficiency of improper technician ratio •Technician trainee was assigned to this training store by the training department •The plan of correction indicated the ratio was exceeded because the technician tasked with training the trainee was not properly identified as "coach" via their name badge and absence of a white lab coat •Technician trainers were also reminded they will only observe and coach trainee and not engage in any technician duties while training

ACTION: Motion by G. CAVANAUGH, seconded by C. BASILE, and voted unanimously by those present, to close SA-INV-9016, and to send licensee advisory on staff ratios.

Case #8SA-INV-9739 CVS #1007, DS2629 TIME: 12:00 PMRECUSAL: S. CORNACCHIO recused and was not present for the discussion or vote on

this matter.


•DEA 106- 453 clonazepam 0.5mg tabs on or about 3/1/16 due to an incorrect 2015 biennial inventory •Loss was identified during corporate CS monitoring •A full investigation did not reveal any evidence of diversion or gross violation of current policy. An explanation of the loss was not uncovered. •Corrective action includes double counting of CS prior to dispensing, retraining of technicians who handle damage drug or outdates, coaching on importance of checking in CS inventory completely before an inventory check is entered into record

ACTION: Motion by T. FENSKY, seconded by G. CAVANAUGH, and voted unanimously by those present, to close SA-INV-9739, no discipline warranted.

Case #9SA-INV-9730 CVS #594, DS89964 TIME: 12:02 PMRECUSAL: S. CORNACCHIO recused and was not present for the discussion or vote on

this matter.


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•DEA 106-299 tramadol 50mg on or about 4/20/16 identified via corporate CS monitoring •Full investigation did not reveal any evidence of diversion or gross violation of current policy. An explanation of the loss was not uncovered.

•Corrective action includes double counting of CS before dispensing, retraining of technicians who handle damage drug or outdates, reviewed baseline loss prevention procedures with staff, specifically those that prevent drug diversion.ACTION: Motion by C. BASILE, seconded by G. CAVANAUGH, and voted unanimously by those present, to close SA-INV-9730, no discipline warranted.

TOPIC XEXECUTIVE SESSIONDISCUSSION: NoneACTION: At 1:10 pm President Taglieri called for a motion to enter Executive Session: Motion by T. FENSKY seconded by M. GODEK and voted unanimously by roll call to enter into Executive Session. E. TAGLIERI; yes, T. FENSKY; yes, P. BOUVIER; yes, C. BASILE; yes, S. CORNACCHIO yes, A. STEIN: yes G. CAVANAUGH: yes; A. RAJA; yes, M. GODEK; yes

At 1:47 pm motion by T. FENSKY seconded by C. BASILE, and voted unanimously by roll call to adjourn Executive session. E. TAGLIERI; yes, T. FENSKY; yes, P. BOUVIER; yes, C. BASILE; yes, S. CORNACCHIO yes, A. STEIN: yes G. CAVANAUGH: yes; A. RAJA; yes, M. GODEK; yes

TOPIC XIAdjudicatory SessionDISCUSSION: NoneACTION: At 1:48 pm, on a motion by T. FENSKY, seconded by C. BASILE, the members voted unanimously to enter into Adjudicatory session.

At 1:51 pm motion by G. CAVANAUGH seconded by C. BASILE, the members voted unanimously to adjourn Adjudicatory Session.

TOPIC XII.M.G.L. c. 65C SessionDISCUSSION: NoneACTION: At 1:52 pm motion by A. STEIN, seconded by A. RAJA and voted unanimously to enter into M.G.L. c. 65C Session. (Susan Cornacchio was not in the room for that vote)

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ACTION: At 3:16 pm motion by M. GODEK, seconded by G. CAVANAUGH and voted unanimously to adjourn M.G.L. 65 C.

TOPIC XIII.ADJOURMENT OF MEETINGDISCUSSION: NONEACTION: At 3:18 pm motion by G. CAVANAUGH, seconded by C. BASILE, and voted unanimously to adjourn the meeting.

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EXHIBITS USED DURING THE OPEN SESSION OF THE MEETING

1. Draft Agenda for the October 6, 2016, regularly scheduled meeting of the Board of Registration in Pharmacy.

2. Draft August 30, 2016 Open Session Minutes.3. Application for New Outpatient Retail Pharmacy Sturdy Memorial4. Application for Renovation / Expansion Keyes Pharmacy5. Application for Renovation / Relocation of Medminder Systems6. Application for Renovation New England Home Therapies7. Report of Applications approved pursuant to licensure policy 13-018. Report of Application information pursuant to licensure policy 16-019. Report from Probation Monitor 8/19/2016 – 9/27/201610. Board Delegated Compliant Review report 9/29/201611. Draft proposed changes to regulation 247 CMR 18.00: Non-Sterile Compounding per

public testimony. 12. Draft proposed regulation 247 CMR 19:00: Hazardous Medication12. Investigation report in the matter of Owens and Minor, WD353, SA-INV-919613. Investigation report in the matter of Ashburnham Pharmacy, DS3314, PHA-2016-004715. Investigation report in the matter of Michael A. Webb, PH18093, PHA-2016-004816. Investigation report in the matter of Lynnfield Drug Inc. / Freedom Fertility Pharmacy, DS89717, SA-INV-966717. Investigation report in the matter of Pharm Blue Mass, DS89961, PHA-2016-006018. Investigation report in the matter of Omnicare of Northern Mass, DS89931, SA-INV-901619. Investigation report in the matter of CVS #1143, DS1713,SA-INV-966220. Investigation report in the matter of CVS #1007, DS2629, SA-INV-973921. Investigation report in the matter of CVS #594, DS89964, SA-INV-9730

Respectfully submitted by:M. GODEK, R.Ph.

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