Board of Pharmacy
Minutes – September 19, 2007
Page 5
Cannon Building / STATE OF DELAWARE / Telephone: (302) 744-4500861 Silver Lake Blvd., Suite 203 / DEPARTMENT OF STATE / Fax: (302) 739-2711
Dover, Delaware 19904-2467 / Website: www.dpr.delaware.gov
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
Michael Hertzfeld, Public Member
Howard Simon, R.Ph., Professional Member
Geoffrey N. Christ, Esq., R.Ph., Professional Member
David W. Dryden, R.Ph., J.D., Executive Secretary
MEMBERS ABSENT
Carolyn Calio, Public Member
David Bonar, Public Member
DIVISION STAFF/DEPUTY ATTORNEY GENERAL
Chris Spizzirri, Deputy Attorney General
Nancy Fields, Administrative Specialist II
James Kaminski, R.Ph., Pharmacist Administrator
Juli LaBadia, Court Reporter 11:00 – 1:15
ALSO PRESENT
Kelly Shanahan
Maz Emadi
Al Stointi
Vic Manuele
Wendy Destasio
Mitali Patel
Stephen Silver
Pamela Perza
Jason Wong
Gourang Gandhi
Georganne Bloch
Michelle Lauer
Suzanne Raab-Long
Barbara Gadbois
Edward Perkowski
Jacqueline Perkowski
Gary Stabley
CALL TO ORDER
Mr. Holst called the meeting to order at 9:32 a.m.
REVIEW OF MINUTES
The Board reviewed the minutes of the January 16, 2007 meeting. A motion was made by Mr. Hamilton, seconded by Mr. Chiari to approve the minutes with edits. Mr. Christ abstained. The motion carried.
UNFINISHED BUSINESS
Legitimate Medical Purpose - Internet Pharmacy Proposal
Mr. Dryden reported that the Internet Pharmacy Committee met on March 5, 2008. The Committee prepared and agreed to draft language that would cover the Internet issue under the Pharmacy Act. The Committee’s draft was distributed. The draft follows the NABP Model Rules which were agreed to by the AMA. The Board has numerous concerns with HB 270 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. The Board requested that Mr. Dryden provide copies of our draft to other practitioner Boards. A motion was made by Mr. Simon, seconded by Mr. Hamilton to accept the committee’s recommendations. The motion unanimously carried.
Gas Committee Report
Mr. Dryden reported that the Gas Committee had met on February 14, 2008. The Committee had developed a rough draft of regulation that would provide for this issue. The Committee requested another meeting to tighten up the rough draft. A final draft will be available for Board review at the May 21, 2008 meeting.
Nursing Home Committee Report
Mr. Kaminski reported that the Committee met on February 27, 2008. A handout of the Committee’s recommended draft regulation was distributed and reviewed by the Board. Minor amendments were made by the Board. Mr. Chiari made the motion, seconded by Mr. Christ to approve the draft with amendments for a regulatory hearing. The motion unanimously carried. Regulatory changes will be posted in the May Delaware Regulations register to have a public hearing on July 16, 2008.
Final Check Committee Report
The Committee met on February 14, 2008. The Committee analyzed the current Regulation 5. The Committee discussed error rates associated with workflow balances, the final check’s impact on patient safety, issues of tracking, and the verification of the prescriptive processes. The next Committee meeting is scheduled for March 19, 2008.
NEW BUSINESS
Pharmacist-in-Charge Interviews
Mr. Hamilton conducted the pharmacist-in-charge interview for Wendy DeStasio.
Review of Pharmacy Applications
Kelly Shanahan appeared before the Board for approval of the floor plans for renovation pharmacy plans for the Giant Pharmacy located in Millsboro. All building requirements were reviewed and agreed to by Ms. Shanahan. Mr. Christ made the motion, seconded by Mr. Hamilton tentatively approve the pharmacy permit pending final inspection by the Board. The motion unanimously carried.
Maz Emadi and Al Stainti appeared before the Board for approval of the floor plans for the Pathmark Pharmacy located on Lancaster Pike. All building requirements were reviewed and agreed to by Mr. Emadi. Mr. Christ made a motion, seconded by Mr. Chiari to tentatively approve the pharmacy permit pending final inspection by the Board paying particular focus on the counseling area. The motion unanimously carried.
Maz Emadi and Al Stainti appeared before the Board for approval of the floor plans for the Pathmark Pharmacy located in Newark. All building requirements were reviewed and agreed to by Mr. Emadi. Ms. Robinson made the motion, seconded by Mr. Hamilton to tentatively approve the pharmacy permit pending final inspection by the Board paying particular focus on the counseling area. The motion unanimously carried.
Maz Emadi and Al Stainti appeared before the Board for approval of the floor plans for the Pathmark Pharmacy located in New Castle. All building requirements were reviewed and agreed to by Mr. Emadi. Mr. Chiari made the motion, seconded by Mr. Simon to tentatively approve the pharmacy permit pending final inspection by the Board paying particular focus on the counseling area. The motion unanimously carried.
Maz Emadi and Al Stainti appeared before the Board for approval of the floor plans for the Pathmark Pharmacy located on Kirkwood Highway. All building requirements were reviewed and agreed to by Mr. Emadi. Mr. Hamilton made the motion, seconded by Mr. Christ to tentatively approve the pharmacy permit pending final inspection by the Board paying particular focus on the counseling area. The motion unanimously carried.
Georganne Bloch appeared before the Board for approval of the floor plans for the Happy Harry’s Walgreens Pharmacy located on Kirkwood Highway. All building requirements were reviewed and agreed to by Ms. Bloch. Mr. Hamilton made the motion, seconded by Mr. Hertzfeld to tentatively approve the pharmacy permit pending final inspection by the Board. Mr. Holst abstained. The motion carried.
Victor Manuele and Stephen Silver appeared before the Board for approval of the floor plans for the NEW CASTLE RX Pharmacy. All building requirements were reviewed and agreed to by Mr. Manuele. 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.
Pharmacist Licensure Review
Mr. Sebastian made a motion, seconded by Mr. Christ to approve licensure for the following individuals’ contingent upon candidates meeting all the requirements for pharmacist licensure:
Nwakaego Chukwunenye
Ashley Hasulak
Laura Mandos
Michael Ilodigwe
Dino Martino
Nicholas Zener
Michelle Nunlee
The motion was unanimously carried.
After some discussion, Mr. Sebastian made a motion, seconded by Mr. Chiari to approve licensure for Luan Mundell contingent upon candidates meeting all the requirements for pharmacist licensure. Mr. Christ opposed approving this application due to previous issue, while the other members voted to approve her application. The motion carried.
Pharmacist Consultant Interviews
Mr. Hamilton conducted the pharmacist consultant interview for Pam Perza, Delaware Hospital for the Chronically Ill.
Consent Order Review 13-06-07
Barbara Gadbois, DAG, presented the consent order for Hugh O’Donnell, R.Ph. As an appropriate disciplinary sanction Mr. O’Donnell agreed to have his license placed on probation for a period of one year beginning on the date the Board accepted this consent order and enters it as an order of the Board. Mr. Christ made the motion and Ms. Robinson seconded to approve the consent order. Mr. Hamilton abstained. The motion carried.
COMMITTEE REPORTS
Joint Practice Committee – Mr. Holst read the Joint Practice Committee minutes that were submitted by Cal Freedman, R.Ph. The Joint Practice committee met on December 18, 2007 and January 29, 2008 at the Stanton Campus of Delaware Technical & Community College. They approved 18 people for independent practice or prescriptive authority. The next meeting was scheduled for February 26, 2008 with no report from that meeting.
Physician’s Assistant Report – Sebastian Hamilton, R.Ph.: Mr. Hamilton reported that the committee met on March 4, 2008. The committee approved four for licensure, two for prescriptive authority and two for controlled substance prescriptive authority. The next meeting is scheduled for April 1, 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 there are currently three bills affecting pharmacy. HB270 – Internet, HB260 – pharmacy benefit manager and HB207 –counterfeit. HB270 is being addressed. HB260 pertains to prescription payment issues and HB207 pertains to law enforcement, both are beyond the jurisdiction of the Board.
Continuing Education – Don Holst, R.Ph. and Geoffrey Christ, R.Ph., Esq. and Michael Hertzfeld: The Committee met on March 19, 2008 and approved 7.5 non ACPE Continuing Education credits for the NASCSA Convention held 2007. Mr. Hamilton made a motion, seconded by Mr. Christ to approve the Committee’s recommendation. The motion was unanimously approved.
Consumer Affairs – Carolyn Calio, Michael Hertzfeld, and David Bonar: No report.
Professional Liaison – Angelo Chiari, R.Ph. and Sandra Robinson, R.Ph.: Mr. Chiari attended two general Delaware Pharmacists Society meetings. The DPS convention is May
14 - 17, 2008.
Ms. Robinson stated that DSHP would be installing new officers in April.
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 will be developing new questions for the MPJE.
A motion was made by Mr. Chiari, seconded by Mr. Hamilton to adjourn for ten minutes to set up for hearing.
Hearing Eric Assibey 13-07-07
A disciplinary hearing was held in reference to Complaint #13-07-07 against Eric Assibey-Marfo, R.Ph. (Respondent). Mr. Assibey-Marfo was not present at the hearing. Barbara Gadbois, D.A.G prosecuted the case for the Complainant. Verbatim testimony was taken. Gary Stabley, the Complainant’s treating Physicians Assistant (P.A) at the cardio surgery unit, was called as first witness. Mr. Edward Perkowski, the Complainant, was called as the second witness. Mrs. Perkowski, the Complainant/Patient, was called as the last witness and testified as to what how she felt about the incident.
Mr. Dryden testified that he spoke with the Respondent on June 11, 2007 during the investigation and at that time he admitted to his error. At that time, Mr. Dryden told him that due to the severity of the complaint, that a hearing would probably take place in the near future. When the Division tried to notify him of the hearing, the certified mail came back to us unsigned.
A motion was made by Mr. Hamilton, seconded by Ms. Robinson to go off the record for discussion at 12:25 p.m. The motion unanimously carried.
After discussing, a motion was made by Mr. Christ, seconded by Mr. Hertzfeld to go back on the record at 1:05 p.m. The motion unanimously carried.
A motion was made by Ms Robinson, seconded by Mr. Christ to approve Ms. Gadbois’s order that states that Mr. Assibey-Marfo, through his conduct, is guilty of violating the provisions of 24 Del. C. 2518(a)(5) in that he is guilty of gross negligence or incompetence in the practice of pharmacy. The Board determined that the penalties of this violation is that his license will be suspended for a minimum of six months, will have to pay a fine of $500, have to take 12 credit hours of prescription error prevention course and/or a patient communication courses, and issue writing a letter of apology to the patient/Complainant. After six months, if the Respondent would like to have his license reissued, he will have to submit a written request to the Board and must appear before the Board for a hearing. The Board will make the determination if they feel that they can lift the suspension at that time, based on his fulfillment of the Board’s requests.
Inspection Report
Mr. Dryden reported that 2 pharmacies, 1 hospital, 1 researcher, 1 clinic and 5 controlled substance inspections were performed in the month of January. Seven pharmacies and 7 controlled substance inspections were completed during the month of February. There is one open investigation currently.
Mr. Kaminski reported to the Board of Pharmacy that controlled substance prescribing has taken a huge leap since he was involved in controlled substance audits prior to the Board transfer to the Division of Professional Regulation. There is a problem out there and without the proper monitoring and education of health care practitioners through an inspection program, the problem will continue to grow. He reported that DEA also has expressed a similar concern. Jim stated to run even a standard inspection program with the current personnel is impossible. The Board of Pharmacy expressed concerns and wanted to contact the Governor’s office explaining that personnel is needed to help resolve the problem even though current State budget concerns exist.
Board Correspondence
NABP e-News dated February 7, 2008 regarding NABP Attendance at PhRMA Briefing.
NABP e-News dated March 5, 2008 regarding Proposed Federal Legislation Mandating Electronic Prescriptions.
NABP e-News dated March 5, 2008 regarding HMS Release of Proposed Rule on Patient Safety Reporting.
NABP e-News dated March 5, 2008 regarding Survey of Increased popularity of Mail-Order Pharmacies.
NABP E-mail dated February 27, 2008 regarding Pharmacy Curriculum Outcomes Assessment.
Correspondence to the Walgreen’s Company dated January 31, 2008 regarding their Final Check Exemption.
Public Comment
Michelle Lauer appeared before the Board and spoke about a planned take back program she wanted to do with law enforcement presence in April. Mr. Dryden advised that this was not permitted under current law, that there were accountability, adulteration and misbranding issues and that statute was needed for a take back program. Mr. Spizzirri thought that statutory approval was not required.
Pat Carroll Grant spoke to the Board regarding patient safety CE issues. In addition to immunizations and medication errors, she feel like non communicative error, such as behavior, follow up and cover up issues should be looked at more closely. The Board can discuss in Committee meeting.
Next Scheduled Meeting
The next meeting will be held on Wednesday, May 21, 2008 at 9:30 a.m. in Conference Room A, second floor of the Cannon Building, 861 Silver Lake Boulevard, Dover, Delaware.
Adjournment
Mr. Hamilton made a motion, seconded by Mr. Chiari to adjourn the meeting. The motion was unanimously carried. The meeting adjourned at 1:52 p.m.
Respectfully submitted,
David W. Dryden, R.Ph., J.D.
Executive Secretary