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

Carolyn Calio, Public Member

Michael Hertzfeld, Public Member

Howard Simon, R.Ph., Professional Member

David Bonar, Public Member

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

MEMBERS ABSENT

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

DIVISION STAFF/DEPUTY ATTORNEY GENERAL

Chris Spizzirri, Deputy Attorney General

Nancy Fields, Administrative Specialist II

ALSO PRESENT

Dan Luce

Barbara Bonk

Erik Mabus

Ed Asare

Bruce Costa

Jeremy Kashuka

Lucy Somer

Lacy Weisenberg

Josephat Waigua

Chris Lowry

Joli Martini

Joanne Krakowiak

Suzanne Raab-Long

Debbie Hamilton

Georganne Bloch

Gaurang Gandhi

Kevin Musto

Hooshang Shanehsaz

Tiffany Sorey

Ajita Johnson

Rob Pinkerton

Tim O’Hea

CALL TO ORDER

Mr. Holst called the meeting to order at 9:30 a.m.

REVIEW OF MINUTES

The Board reviewed the minutes of the November 21, 2007 meeting. A motion was made by Mr. Chiari, seconded by Mr. Simon to approve the minutes with edits. The motion was unanimously carried.

UNFINISHED BUSINESS

Prescreening Assessment Tools for the In-State Stockpile (ISS)

Kevin Musto, Rob Pinkerton and Tim O’Hea presented an update of information related to the In-State Stockpile. The Board continued to have concerns with non-licensed staff distributing prescriptive medications. The presenters assured that pharmacists and other medically related licensees would be used if possible and that other means would only be utilized if the Governor issued an emergency situation and licensed staff was not available.

Legitimate Medical Purpose - Internet Pharmacy Proposal

Mr. Dryden had reported at the previous Board meeting that the Iowa Board of Pharmacy had adopted language in their Administrative Code that provided that “the pharmacist ensure the prescription drug or medication order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner acting in the usual course of the practitioner’s professional practice. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued solely on the basis of an internet-based questionnaire, an internet-based consultation, or a telephonic consultation and without a valid preexisting patient-practitioner relationship.” The Board last month further had requested Mr. Dryden to obtain information from other states. This information was distributed to the Board prior to the meeting for their review. Mr. Holst stated that he would be developing a Committee to review this issue for possible amendments to current law.

In addition to the above, Mr. Dryden alerted the Board to HB 270 that had been introduced at the close of the General Assembly Session last June 2007. A handout of this Bill was distributed. This Bill amends current Title 16 to address the prescription internet/patient /practitioner issue. The Board had numerous concerns with this Bill including it was placed in the wrong area of the Code, had administrative and current law conflicts and that many of its directives were not clear. The Board agreed and requested that Representative Hall-Long be informed that they thought the Bill should be completely stricken. The Board suggested a group comprised of all stakeholders be developed to review and develop ideas that would review and propose possible amendments to current law that would better handle the internet pharmacy issues.

Nursing Home Interim Box Update

Mr. James Kaminski presented an update of the nursing home interim box issue addressed in previous Board meetings. As requested, sample stock interim boxes/e-mail lists were collected from provider nursing home pharmacies. Mr. Kaminski requested guidance from the Board as to the direction the Board wished him to proceed. The Board determined to form a sub-committee to review lists to see if changes were needed.

A forty hour a week hospital pharmacy had approximately fifteen prescription medications stocked on the nursing units, in addition to a night cabinet stock area. The Board had no concerns and did not take any actions.

Happy Harry’s Walgreen Computer Systems

Dan Luce from Happy Harry’s Walgreens gave a presentation of their Pharmacy computer systems for processing prescriptions. The prescription is scanned whereby a technician would enter the prescription information into the computer system. This information is checked by a pharmacist. A label is printed and the medication is filled by another technician. This filling is checked by a second pharmacist who does not review the prescription but only the filled container and medication used for the filling.

5.4.3.2.3 requires that a “final check by the pharmacist is made after the medication is placed in the final container prior to dispensing and administration to the patient. There will be a final check by a licensed pharmacist prior to dispensing and administration, except where the Board of Pharmacy grants, in writing, an exemption for good cause shown.” Mr. Dryden stated that the Board had the following choices: to not accept the current procedure of Walgreens in accordance to present law; to amend the current regulation to permit the proposed procedure or; to authorize and grant in writing, an exemption for good cause shown. After much discussion Mr. Hamilton made the motion and Ms. Robinson seconded to grant an exemption to Walgreens once they had submitted their proposal/procedure in writing and to review current regulation for possible amendments that would better address this issue. Ms. Calio, Mr. Simon, Mr. Chiari, Mr. Hamilton and Ms. Robinson voted in favor of the exemption. Mr. Bonar and Mr. Hertzfeld opposed. Mr. Holst abstained. The motion carried.

NEW BUSINESS

Pharmacist-in-Charge Interviews

Mr. Hamilton conducted the pharmacist-in-charge interview for Paul Tribits, Erik Mabus, Lacy Weisenberg, Ajita Johnson, and Josephat Waigwa.

Review of Pharmacy Applications

Barbara Bonk appeared before the Board for approval of the floor plans for renovation pharmacy plans for the Rite Aid Pharmacy located in Milford. All building requirements were reviewed and agreed to by Ms. Bonk. Mr. Hamilton made the motion, seconded by Mr. Bonar to tentatively approve the pharmacy permit pending final inspection by the Board. Mr. Chiari recused himself from the vote. The motion carried.

Barbara Bonk appeared before the Board for approval of the floor plans for new pharmacy plans for the Rite Aid Pharmacy located in Smyrna. All building requirements were reviewed and agreed to by Ms. Bonk. Mr. Bonar made the motion, seconded by Ms. Robinson to tentatively approve the pharmacy permit pending final inspection by the Board. Mr. Chiari recused himself from the vote. The motion carried.

Bruce Costa appeared before the Board for approval of the floor plans new pharmacy plans for the Renaissance Family Pharmacy located in Claymont. All building requirements were reviewed and agreed to by Mr. Costa. Mr. Hamilton made the motion, seconded by Mr. Chiari to tentatively approve the pharmacy permit pending final inspection by the Board. The motion was unanimously carried.

Ed Asare appeared before the Board for approval of the floor plans new pharmacy plans for the Bi-State Pharmacy located. All building requirements were reviewed and agreed to by Mr. Asare. Mr. Bonar made the motion, seconded by Mr. Simon, to tentatively approve the pharmacy permit pending final inspection by the Board. The motion was unanimously carried.

Pharmacist Licensure Review

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

John Dominic Caramanico

Joanne Fabiano

Chen Oeur

Patrick Joseph McNamara

Joseph James Perricone

Diedre Chante Mallika

Shivaji Gajanan Phadke

David Bruce Reinertsen

John Pollock

Edward Lee Fingers

Mary K. Koffer

Stella Y. West

Pooja Gupta

Saha, Sohodeb

Ho, Thanh-Thanh

Marilyn Rodriquez

Judy Crain

Cyprian Ume

The motion was unanimously carried.

Pharmacist Consultant Interviews

Mr. Hamilton conducted the pharmacist consultant interview for Joli Martini.

Public Hearing

The Delaware Board of Pharmacy, in accordance with 24 Del. C. § 2509, proposes amendments to its regulation section 1.0. Specifically, the proposed addition to 1.0 Pharmacist Licensure Requirements sets the period within which a pharmacist license or pharmacy permit may be renewed after its expiration. The proposal also sets the 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 are also included.

Mr. Holst called for public comment. There was no written or verbal comment. Mr. Hamilton made a motion to go off the record for deliberation. The motion was seconded by Mr. Bonar and carried unanimously. The Board finds that adoption of the proposed amendments will better serve the interest of public safety. Ms. Robinson made a motion, seconded by Mr. Hertzfeld to adopt the regulation as presented. The motion carried unanimously. The Board hereby adopts the proposed amendment to the regulation to be effective 10 days following final publication of this order in the Register of Regulations. Mr. Bonar made a motion, seconded by Mr. Hertzfeld to close the hearing. Motion was unanimously carried.

Request for Propose to Deny Hearing - Luan Mundell

The Board held a hearing for Luan Mundell regarding the Board’s proposal to deny. After discussion regarding issues of deceit, intent and the duration of time elapsed since the initial application filing, Mr. Hamilton made the motion, seconded by Mr. Bonar to deny the current application as written based on its falsehood, but advised that the Board will review and consider approving a new, corrected version of the application when submitted in the future. The motion was unanimously carried. The Board order was signed by the Board members. Mr. Chiari made a motion, seconded by Mr. Bonar to close the hearing. The motion unanimously carried.

Committee Reports

Joint Practice Committee – No report.

Physician’s Assistant Report – Sebastian Hamilton, R.Ph.: Mr. Hamilton reported that the committee met on January 8, 2008. The committee approved six for licensure, two for prescriptive authority and three for controlled substance prescriptive authority. The next meeting is scheduled for February 2, 2008.

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.,: Mr. Holst reported that he would be assigning members to a Committee to develop and review law that would address the monitoring and licensure for gases.

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 that DSHP would be installing new officers. The next meeting is on January 22, 2008.

MPJE Study Committee –Angelo Chiari, R.Ph., Sebastian Hamilton, R.Ph., Sandra Robinson, R.Ph. and James Kaminski: Ms. Robinson reported that she and Jim Kaminski had attended the question review session January 9-12, 2008. New questions were requested and will be written in the near future.

Inspection Report

Mr. Dryden reported that 4 pharmacies, 2 distributors, 2 clinics, 3 oxygen supply facilities and 1 researcher were inspected in the months of November and December. There were 3 investigations completed in the last two months. All investigations are currently closed. There were 19 total pharmacy related investigations for 2007.

Board Correspondence

NABP e-News dated December 12, 2007 regarding the Manufacturers agreement to Restrict Methadone.

NABP e-News dated December 12, 2007 regarding USP Publishing of Standards for Compounding Sterile Preparations.

Other Business Before the Board (for discussion only)

The Board would like to address the terminology in section § 4740 of the Delaware Code regarding Technicians dispensing pseudoephedrine products.

Public Comment

Hooshang Shanehsaz appeared before the Board in support of the grant of an exemption to Walgreens relevant to the final check issue and to review current regulation for possible amendments.

Next Scheduled Meeting

The next meeting will be held on Wednesday, March 19, 2008 at 9:30 a.m. in Conference Room A, second floor of the Cannon Building, 861 Silver Lake Boulevard, Dover, Delaware.

Adjournment

Mr. Bonar made a motion, seconded by Mr. Hertzfeld to adjourn the meeting. The motion was unanimously carried. The meeting adjourned at 12:45 pm.

Respectfully submitted,

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

Executive Secretary

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PUBLIC MEETING NOTICE: BOARD OF PHARMACY

DATE AND TIME: Wednesday, January 16, 2008 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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