Delaware



|Cannon Building |STATE OF DELAWARE |Telephone: (302) 744-4500 |

|861 Silver Lake Blvd., Suite 203 |DEPARTMENT OF STATE |Fax: (302) 739-2711 |

|Dover, Delaware 19904-2467 | |Website: dpr. |

| |DIVISION OF PROFESSIONAL REGULATION | |

MEMBERS PRESENT

Don Holst, R.Ph., Professional Member, Chair

Sebastian Hamilton, R.Ph., Professional Member, Vice Chair

Angelo Chiari, R.Ph., Professional Member

Sandra Robinson, R.Ph., Professional Member

Geoffrey N. Christ, Esq., R.Ph., Professional Member

David W. Dryden, R.Ph., J.D., Executive Secretary

MEMBERS ABSENT

David Bonar, Public Member

Robb Carter, Public Member

Carolyn Calio, Public Member

DIVISION STAFF/DEPUTY ATTORNEY GENERAL/COURT REPORTER

Chris Spizzirri, Deputy Attorney General

Judy Letterman, Administrative Specialist III

Nancy Fields, Administrative Specialist II

Jim Kaminski, Pharmacist Administrator

James Collins, Director, Division of Professional Regulation

Lorena Hartnett, Court Reporter

ALSO PRESENT

Joanne Krakowiak

Suzanne Raab-Long

Jack Murphy

Andrew Kennedy

Karen S. L. Yuen

Jennifer Eye

Sandy Zarogoza

Barbara Bonk

Al Helmeczi

Scott Samples

Ana D. Gonzalez

Vince Paul

Barry Phillips

Jeanne Chiguive

Debbie Hamilton

Julie Miro Wenger

CALL TO ORDER

Mr. Holst called the meeting to order at 9:36 AM

REVIEW OF MINUTES

The Board reviewed the minutes of the July 18, 2007 meeting. Mr. Chiari requested an edit. A motion was made by Mr. Chiari, seconded by Mr. Hamilton to approve the minutes as amended. The motion was unanimously carried.

UNFINISHED BUSINESS

District II Meeting Update

Mr. Dryden reported that the final package was sent out in September. The District II Group has completed the continuing education package. Mr. Dryden reviewed the District II agenda.

Immunization Review

Mr. Holst made reference to an e-mail received by the Board on September 11, 2007 from Walgreens. Walgreens was seeking clarification of the pharmacists’ ability to administer immunizations pursuant to standing orders from a licensed physician in Delaware. This is permitted.

Strategic Plan

Mr. Spizzirri prepared a Strategic Plan handout related to Board goals and objectives. The Board made a recommendation to amend the action under SB84 to relate that the Board would be participating in the DPS meeting. Mr. Hamilton made a motion to adopt plan as amended. The motion was seconded by Ms. Robinson and carried unanimously.

Temporary Licensures Review

Mr. Dryden provided a handout that showed the related statutory law to temporary licensures. Section 2513 relates to the temporary licensure of pharmacists; section 2526 relates to the temporary licensure of pharmacies; and section 2541 relates to the temporary licensure of distributors.

The Board determined the following policies pursuant to the above:

• The Executive Secretary may issue a temporary license to a pharmacist provided there is a complete package. The Executive Secretary will contact the President or Vice-President of the Board to review the licensure prior to issuance.

• The Executive Secretary may issue a temporary license to a pharmacy provided there is a complete package and all regulatory and statutory requirements have been met. The Executive Secretary will contact the President or Vice-President of the Board to review the licensure prior to issuance.

• The Executive Secretary may issue a temporary license to a distributor provided there is a complete package. The Executive Secretary will contact the President or Vice-President of the Board to review the licensure prior to issuance.

The Board reviewed whether a temporary license could be issued to Harris Teeter Pharmacy. The Pharmacy application had been submitted less that the required 15 days prior to the meeting regulation. The Board stated that the temporary licensure was not a tool to circumvent the 15 day requirement. The Board requested the application be part of the November meeting agenda.

Quality Assurance Data from PacMed Implementation

Al Helmeczi and Scott Samples appeared before the Board to present the quality assurance data from the PacMed implementation. Mr. Helmeczi and Mr. Samples reviewed error data and actions taken to circumvent future concerns. The Board approved a random 1% pharmacist check of all doses filled daily by the PacMed system at the Christiana Care Hospital Pharmacy. Of the 1% selected the check would be 100% of those doses checked.

Emergency Box Issue

At the May 16, 2007 Board meeting, Mr. Kaminski had reported that the supply of emergency use medication has been increasing. A sample emergency drug use list was presented to the Board. As per Regulation 11.3.1, “emergency use medications are those which may be required to meet the immediate therapeutic needs of patients, as determined by the prescriber, and which are not available from any other authorized source in sufficient time to prevent risk or harm to patients by delay resulting from obtaining such drugs from other sources. After review, the Board was concerned that all medications may not be meeting the above Regulatory requirements. The Board had directed Mr. Kaminski and Mr. Dryden to ask providers to review their lists and justify any medications that may not meet the patient’s immediate therapeutic needs requirement.

Mr. Kaminski provided the Board with data requested. After review, the Board determined that inspections should continue to monitor the emergency box medication of facilities for safe numbers.

Pharmacist Renewal

Mr. Spizzirri presented a handout amending Regulation 1 to set the period within which a pharmacist license or pharmacy permit may be renewed after its expiration. The proposal also set requirements for late renewal, including mandatory audit of all late-renewed pharmacist licenses to verify compliance with the continuing education renewal requirement. Other grammatical, typographic, or stylistic changes were also included. A motion was made by Ms. Robinson, seconded by Mr. Hamilton to approve the Regulatory amendment, including a 60 day renewal cycle, for a hearing. The motion unanimously carried. A regulatory hearing will be scheduled accordingly.

NEW BUSINESS

Pharmacist-in-Charge Interviews

Mr. Hamilton conducted the pharmacist-in-charge interview for Andrew Kennedy, Karen S. L. Yuen, Jennifer Eye and Sandy Zarogoza.

Review of Pharmacy Applications

Barbara Bonk appeared before the Board for approval of the floor plans for remodeling plans to the Rite Aid Pharmacy Wilmington. All building requirements were reviewed and agreed to by Ms. Bonk. Mr. Hamilton made the motion and Ms. Robinson seconded to tentatively approve the pharmacy remodeling permit pending final inspection by the Board. Mr. Chiari and Mr. Christ recused themselves from the vote. The motion was unanimously carried.

Pharmacist Licensure Review

Mr. Chiari made a motion, seconded by Mr. Hamilton to approve licensure for the following individuals contingent upon candidates meeting all the requirements for pharmacist licensure:

Ainsley Norbert Gopie

Benjamin Charles Keller

Meghan Marie Yamamoto

Whitney A. Swears

Ravinda Muralishankar

Amy B. Desai

Bao Huynh

Steven A. Shipper

Beth Nicole Keller

Yves Brian Parker

John B. Pollock

Stella Yoshiko West

Melissa Ann McLean

Monica Pobee

Christy Ottavia

The motion was unanimously carried.

After review of additional information requested by the Board at the July meeting, Mr. Chiari made a motion, seconded by Mr. Christ to approve the application of Robert Alleavitch. The motion was unanimously carried.

The Board reviewed the application submitted by Luan Eifert Mundell. The Board office had been notified that Ms. Mundell’s license had been suspended in Pennsylvania in 1985. Ms. Mundell did not admit this fact in her initial application. Ms. Mundell had forwarded correspondence apologizing for her untruthfulness after being notified that the Board had received this information. The Board reviewed all related information. The Board found that Ms. Mundell had answered the ’Professional History” section of the application falsely. Ms. Mundell had answered question (2) that she had not been subject to a disciplinary action in any Board of Pharmacy. That was untrue since the Pennsylvania Board of Pharmacy reprimanded her October 15, 1985.

Mr. Hamilton made a motion, seconded by Ms. Robinson to propose to deny Ms. Mundell’s application. The motion was unanimously carried. Correspondence related to this decision will be forwarded from the Board office to Ms. Mundell.

Pharmacist Consultant Interviews

No interview was conducted.

Committee Reports

Joint Practice Committee – No report.

Physician’s Assistant Report – Sebastian Hamilton, R.Ph.: Mr. Hamilton reported that the committee met on July 24, 2007. The committee approved ten for licensure, seven for prescriptive authority and nine for controlled substance prescriptive authority. The committee also met on September 11, 2007. The committee approved one for licensure, five for prescriptive authority and six for controlled substance prescriptive authority. The next meeting is scheduled for October 2, 2007.

Newsletter – David Dryden, R.Ph., J.D, and Angelo Chiari, R.Ph. and Don Holst, R.Ph.: No report.

Legislative –David Dryden, R.Ph., J.D., and Don Holst, R.Ph., Geoffrey Christ, R.Ph., Esq.,: No report.

Continuing Education –Nancy Weldin and Don Holst, R.Ph., Geoffrey Christ, R.Ph., Esq.: No report.

Consumer Affairs – Carolyn Calio, Nancy Weldin, and David Bonar: No report.

Professional Liaison – Angelo Chiari, R.Ph. and Sandra Robinson, R.Ph.: Ms. Robinson reviewed the future continuing education courses made available by DSHP.

MPJE Study Committee –Angelo Chiari, R.Ph., Sebastian Hamilton, R.Ph., Sandra Robinson, R.Ph. and James Kaminski: No report.

Public Hearing

The Delaware Board of Pharmacy, in accordance with 29 Del.C. Chapter 101 and 24 Del.C. §2509, proposes amendments to its regulation 3.0. Specifically, the proposed addition to 3.0 Pharmacy Requirements would require the pharmacist-in-charge at each pharmacy to develop written policies for situations in which a pharmacist's professional obligation to dispense certain pharmaceuticals may conflict with the pharmacist's personal beliefs, potentially causing the pharmacist to refuse to dispense the pharmaceutical. The Board's proposed regulatory changes do not specify how such situations should be handled. Instead, the proposed changes merely require the pharmacist-in-charge at each pharmacy to develop written policies for such situations.

The Board also proposes amendments to its regulation 16.0 and the addition of regulation 17.0. Specifically, the current regulation 16.0 Crimes substantially related to the practice of pharmacy would be renumbered regulation 17.0, and a new regulation 16.0 Automated Delivery Devices would be added. The new regulation 16.0 allows for and regulates the use of machines that are able to store and dispense medication to patients. The proposed regulations limit use of such devices to dispensing refills of non-controlled substances/medications. Refills would be completed by pharmacy personnel and placed in the machine for customer pick up. All such devices must be approved by the Board before they may be put into operation.

Mr. Holst called for public comment. There was one written comment from NACDS no verbal comments were received. Ms. Robinson made a motion to go off the record for deliberation. The motion was seconded by Mr. Hamilton and carried unanimously. The Board finds that adoption of the proposed amendments will aid law enforcement’s efforts to prosecute forged prescriptions, serving the interest of public safety. Mr. Chiari made a motion, seconded by Mr. Christ to adopt the regulations as presented, which was carried unanimously. The Board hereby adopts the proposed amendments to the regulations to be effective 10 days following final publication of this order in the Register of Regulations. Mr. Hamilton made a motion, seconded by Mr. Chiari to close the hearing. Motion was unanimously carried.

Inspection Report

Mr. Dryden reported that 7 pharmacies and 1 hospital were inspected in the month of July. There were 10 pharmacies, five hospitals and 1 nursing home inspected in the month of August. There were no new investigations opened during the months of July and August. All investigations are currently closed.

Board Correspondence

NABP e-News dated August 8, 2007 regarding the Washington Suit and Case over the State Requirement to Sell Contraception.

NABP e-News dated August 8, 2007 regarding CMS Guidance for Implementation of

Tamper-Resistant Prescription Pad Requirements.

NABP e-News dated August 8, 2007 regarding Survey of Online Pharmacy Spammers.

NABP e-News dated August 8, 2007 regarding Pro posed Legislation for More Effective Pain Management.

Correspondence from IACP dated August 8, 2007 regarding Pharmacy Compounding.

Other Business Before the Board (for discussion only)

Mr. Dryden provided a handout for the Board to review related to the suspension of the NAPLEX and Georgia MPJE examinations.

Mr. Dryden provided a handout for the Board to review related to the tamper resistant prescription pad federal legislation. Mr. Dryden relayed the fact that the prescription format is also an issue with the Office of Narcotics and Dangerous Drugs for diversion purposes.

Public Comment

Mr. Vince Paul made a public comment about the renewal issue and Regulation 1 proposal. Mr. Paul related the issue to his own Delaware licensure. Mr. Paul requested the Board be considerate to the issue of the ease of pharmacist licensure in Delaware.

Next Scheduled Meeting

The next meeting will be held on Wednesday, November 21, 2007 at 9:30 a.m. in Conference Room A, second floor of the Cannon Building, 861 Silver Lake Boulevard, Dover, Delaware.

Adjournment

Mr. Chiari made a motion, seconded by Mr. Christ to adjourn the meeting. The motion was unanimously carried. The meeting adjourned at 11:48 AM.

Respectfully submitted,

David W. Dryden, R.Ph., J.D.

Executive Secretary

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PUBLIC MEETING NOTICE: BOARD OF PHARMACY

DATE AND TIME: Wednesday, September 19, 2007 at 9:30 a.m.

PLACE: 861 Silver Lake Boulevard, Dover, Delaware

Conference Room A, second floor of the Cannon Building

APPROVED:

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