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Maryland Board of Pharmacy
Public Meeting
MINUTES
May 19, 2010
Todays Attendance Year-to-Date Attendance
Name TitlePresentAbsent Present AbsentAnderson, C. CommissionerX101Bradley-Baker, L.CommissionerX110Chason, D.CommissionerX110Finke, H.Commissioner X101Handelman, M.Commissioner X101Israbian-Jamgochian, L.CommissionerX110Leandre, A. CommissionerX101Matens, R.CommissionerX92Souranis, M.Commissioner/TreasurerX92Taylor, D.Commissioner/PresidentX110Taylor, R.Commissioner/SecretaryX101Zimmer, R.CommissionerX101Bethman, L.Board CounselX110Gibbs, F.Board CounselX110 Banks, T.MIS Manager X65 Gaither, P. Administration and Public Support ManagerX110 Goodman, S.Licensing ManagerX74 Jeffers, A. Legislation/Regulations ManagerX110 Naesea, L.Executive DirectorX110Waddell, L. Executive Secretaryx92France, KCompliance Officerx21Seeds, JPIOX30
Subject
Responsible Party
DiscussionMotionACTION/RESULTSI. Call to Order
& Approval of
Minutes
Donald Taylor, Board President
A. D. Taylor called the Public Meeting to order at 9:00am.
B. D. Taylor requested all meeting attendees to introduce themselves and to remember to sign the guest list before they leave the meeting.
C. D. Taylor reported that guests will be given packets of materials so that they can follow meeting discussions. He requested that the guests please return the draft packets when they leave the meeting.
D. Members of the Board with a conflict of interest relating to any item on the agenda were advised to notify the Board at this time or when the issue is addressed in the agenda.
Introduction of pharmacy student on rotation with LaVerne Naesea at the Board: Mary Bales.
E. Revisions to Minutes: Approval of April 21, 2009.
Motion to accept minutes as amended: R. Matens
Second: R. Zimmer
Board Action: The voted to approve the minutes as amended.
II. Meeting Updates
Donald Taylor, Board President
A. Meeting Updates
1. R. Zimmer attended the ACPE Accreditation Review at the College of Notre Dame School of Pharmacy on April 27-29, 2010. He indicated that it was a very interesting and thorough process and that it appeared that the college would pass the second level of ACPE accreditation.
2. M. Handelman represented the Board at a meeting at OHCQ on bulk medications in Long Term Care on April 29, 2010. More information later.
3. L. Bradley-Baker attended the final APAP Coalition Meeting on May 12, 2010. Although the group will no longer meet, the Coalitions Facebook page will remain updated and active and any relevant information to the public regarding acetaminophen will be promoted through venues such as the Board of Pharmacys booth at the annual Baltimore City Flower Mart.
4. L. Bradley-Baker attended the Drug Therapy Management (DTM) Committee Meeting on May 12, 2010. The committee is currently reviewing the protocols from Peoples Community Center and the University Maryland, College Park. The Board of Physicians wanted the committee to omitted some information that it felt was not necessary under, though it is required under current DTM regulations.
5. L. Bradley-Baker attended the Maryland Pharmacy Coalition (MPC) meeting on May 13, 2010. The new chair of the MPC for the upcoming year is Chi Wang (University of Maryland School of Pharmacy Student Government). A review of the past legislative session as well as plans for the upcoming session was discussed.
6. R. Zimmer attended the Howard County CERN meeting on May 13, 2010. Discussions included:
a. BRAC effort to expand Ft. Meade and NSA facilities; and
b. Presentation by John Reginaldi about the Nuclear Detection Program
7. Home Infusion Workgroup met on May 5, 2010. Cindy Anderson indicated that the group should complete their charge within two more meetings. The next meeting will be held June 2, 2010.
8. Institutional Workgroup met on May 6, 2010. - Dave comments?
9. The Board Staff Retreat was held on May 17-18, 2010 at the Maritime Institute.
10. C. Anderson will be leaving tomorrow for a week working as a pharmacist in Haiti (from May 22-29, 2010).
11. The University of Maryland School of Pharmacy will hold their Honors Convocation ceremony on Friday May 21st at 9:30 am at the Sheraton Baltimore City Center Hotel. Don Taylor will present the Pharmacists Oath to the graduates.
12. NABP will hold its 106th Annual Meeting in Anaheim on May 22-25, 2010. L. Israbian-Jamgochian has been awarded a travel grant by NABP to represent the Board. Lenna asked the Boards opinion on a National License administered through NABP. The majority of Board members were not in favor of a national license. The concept of national standards for pharmacy technicians was also discussed. The majority of the Board members were in favor of this concept.
13. There will be a conference at the Baltimore Intercontinental Harbor Court June 28-29, 2010 titled Crossroads for Temperature Sensitive Drugs (USA). K. France, Pharmacist Compliance Officer, will be a panel speaker. The agenda is still in the planning stage, but the topic is timely from the Boards perspective.
14. The MPhAs annual conference will be held in Ocean City at the Clarion Resort Fountainebleau Hotel June 1215, 2010. The Board will host a booth at the event.
15. There will be a Summit for Healthcare Professionals held June 18, 2010 at the Turf Valley Resort in Ellicott City. The focus will be on Caring for Service Members, Veterans and Their Families.
16. There will be a MPVC training at BWI Weston on June 22, 2010 for all professional volunteers.
17. Deputy Secretary Frances Phillips has asked Don Taylor to participate in a Mid-Atlantic Region H1N1 Summit on June 24, 2010 at The Marriott Inn and Conference Center in Hyattsville, Maryland. Maryland, Virginia, and DC State Health Officers, their staffs and partners from the neighboring states of Pennsylvania, Delaware and West Virginia are invited.
18. National Conference on Quality Health Care for Culturally Diverse Populations will be held on Oct 18-21, 2010 at the Baltimore Renaissance Harborplace Hotel. L. Bradley-Baker will be attending to represent the Board.
19. NABP will be holding their District I and II Meeting in Cooperstown, NY October 29-31, 2010.
B. Introduction of Guest Presenter, Dr. Jennifer Thomas, who is the Project Manager of the Delmarva Foundation (Pharmacy Quality Improvement Community - PQIC).
Dr. Thomas gave an update on several medication safety projects. Two new potential areas of interest included oral anticoagulation and medication reconciliation. III. Executive Director
LaVerne Naesea,
Executive
Director
A. Staffing Updates: With the recent permanent hirings of a Pharmacist Compliance Manager and Public Information Officer, the Board is fully staffed with the exception of one inspector. The freeze exemptions to hire a Help Desk and temporary employee for the Licensing Unit were approved and the two seniors aides appointed from the Baltimore City Health Department were all filled in May.
B. Maryland Pharmacy Laws Book: The Board was requested to determine whether to continue amending to the State contract with Lexis/Nexis for the 2011 Lawbook or to consider issuing a bid in response to a request received from MPhA.
C. Legislation Affecting Board Budget: HB 114 - L. Bethman reported that under HB 114, all Boards will be required to adopt sanctioning guidelines, in addition to other requirements. The A.Gs office is working on a framework and set of general recommendations to assist Boards in developing the guidelines.
D.Receipt and Disposal of Prescription Medications----what was the issue discussed?
E. Staff Retreat Summary: L. Naesea presented a summary of the staff training meeting. Overall, it was a successful program.
F. Nomination of Board Officers: LaVerne will collect nominations for positions via email. Don recommended all Board members consider becoming an officer. Open nominations will be taken from the floor and the election conducted at the June 2010 board meeting.
G. UKs Council for Healthcare Regulatory Excellence (CHRE) has requested that the Board become a member by filling out a survey. We would then have access to surveys filled out by other member nations (i.e., Australia, Canada, Denmark, Germany).
B. Motion: D. Chason.
Second: L. Israbian-Jamogchian
D. Motion: D. Chason
Second: H. Finke
Motion:
Second:
B. Board Action: The Board voted to continue with Lexis/Nexis contract.
D. Board Action: Return letters to Practice Committee
G. Board Action: No Action
Will be presented to NABP by Lenna at the upcoming NABP meeting.
IV. PEAC ReportKathy Putz,
PEAC
A. PEAC monthly statistics for the Board.
See Attachment 1, Section D.
V. Legislation and
RgulationsAnna Jeffers,
Legislation and Regulation Manager A. Maryland 1. Legislation: Bill Signing for HB 233 Physicians and Pharmacists Therapy Management Contracts Extension of Law, will be May 2008.2. Regulations - Status:
10.34.03 Inpatient Institutional Pharmacy
To be presented at the May Practice Committee Meeting10.34.05, .07, .12, .13, and .15
Notice of Final Action published May 7, 2010 with an Effective Date of July 1, 2010.
NoFA 10.34.05,.07,.12,.13&.15 Md R. 05071010.34.18 Continuing Education
Notice of Final Action published May 7, 2010 with an Effective Date of July 1, 2010.
NoFA 10.34.18 Md R 05071010.34.20.01 - .04 Format of Prescription Transmission
Proposal anticipated to be published June 4, 201010.34.23 Pharmaceutical Services to Patients in Comprehensive Care Facilities
Proposal anticipated to be published June 4, 2010
There was a brief discussion whether a Director of Pharmacy should be full time. The issue will be revisited when the Official Comments are considered10.34.25 Delivery of Prescriptions
Proposal to be submitted to the Department of sign-off.10.34.28 Automated Medication Systems
Published 12/04/10
Reproposal submitted to the Department April 12, 2010.10.13.01 Dispensing of Prescription Drugs by a Licensee
Waiting to hear from Wendy Kronmiller
LaVerne will make this a priority now that the staff training meeting is complete.
Pharmacist non-CLIA testing
No action, waiting on State laboratory to respond.
VI. Inspection Program ReportKimberly France, Compliance OfficerA. Compliance monthly statistics for the Board.
See Attachment 1, Section C.
B. A Draft Quality Assurance Peer Review Proposal was reviewed by Cynthia Anderson.
Refer to compliance for consideration on a case-by-case basis.
VII. Management Information Services
LaVerne Naesea
A. MIS monthly statistics for the Board.
See Attachment 1, Section F.
MIS Updates- new help desk person has installed new printers and computers and performed other tasks as assigned. The MIS Manager is please with his performance.
Proposal for database system The Board is awaiting an itemized bid from Systems Automation.
VIII. Administration
& Public SupportPatricia Gaither,
Administration
and
Public Support
ManageA. Administration and Public Support monthly statistics for the Board.
See Attachment 1, Section G.
B. Staffing Updates
IX. Public Relations Committee Report
Janet Seeds, Public Information Officer
A. Public Relations Committee Report: J. Seeds reported that the Board of Pharmacy booth was the first place winner at the annual Baltimore City Flower Mart. It was a very successful event. She also thanked all the staff and Board members who attended and worked the booth at the event.
B. Acetaminophen Coalition Report: The coalition is formally dissolved as it has completed all of its stated goals to educate the public on the safe use of acetaminophen. The coalition will reconvene if the need arises.
C. DTM Committee report. Motion to send a letter to the Board of Physicians proposing to work together to revise the current DTM regulations.
D. Boards Emergency Preparedness Committee will hold a training and update meeting on November 21, 2010 at the BWI Weston. Attendees would include current volunteers and pharmacists, pharmacy technicians and those pharmacists, pharmacy technicians and pharmacy students who wish to become volunteers.
C. Motion: Lynette Bradley-Baker
Second: Dave Chason
C. Board Action: The Board voted to approve the motion. X. Practice CommitteeReid Zimmer,
Chair
Anna Jeffers,
Legislation and Regulation Manager
Letter to DEA. 2. Practice Responses to Public Inquiries:a. Martha Russell, Cardinal Health;b. Marie Mason, Carolina Pharmaceuticals, Inc.c. Ron Keech, Village Green Apothecary Public Inquiries:
1) Jenny Harrison, Hills Pharmacy verbal inquiry.
Response to Jenny Harrison-Pharm Techs-RxDrugRep Program
A repository shall designate a pharmacist who shall:
(1) Accept donated prescription drugs or medical supplies forwarded by:
(a) A drop-off site; or
(b) A manufacturer regulated by the U.S. Food and Drug Administration.
(2) Inspect donated prescription drugs or medical supplies;
(3) Accept donated prescription drugs or medical supplies that meet the requirements of Regulations .02 and .03 of this chapter; and
(4) Obliterate from the labels of donated prescription drugs or medical supplies patient specific information for which the donated prescription drugs or medical supplies were originally dispensed when it is placed in inventory. See COMAR 10.34.33.06B.
According to COMAR 10.34.33.05B, a pharmacist or health care practitioner accepting donated prescription drugs or medical supplies at a drop-off site may not delegate the initial step of acceptance of donated prescription drugs of medical supplies.
A registered pharmacy technician employed at a drop-off site may be involved in the drop-off site process, after initial acceptance of the drugs by the pharmacist, in accordance with COMAR 10.34.33.07:
A repository shall dispense donated prescription drugs or medical supplies in compliance with applicable federal and State laws and regulations for dispensing prescription drugs or medical supplies.
2) Jennifer Krusa, Omnicare
Omnicare - expiration dates on labels
Draft - Bd Response - Krusa Omnicare
Dave Chason suggested amendments that are consistent with the following response:
Thank you for contacting the Maryland Board of Pharmacy requesting clarification regarding expiration date labeling requirements on pharmacy prescription labels and "responsible pharmacist" duties of a Maryland licensed pharmacy. Below you will find responses to your inquiries.
Expiration date of medications
Omnicare Inc. asked if a pharmacy dispenses the manufacturer packaged or pharmacy repackaged medications, does the prescription label that is affixed to the manufacturer package or pharmacy repackaged product, require the expiration date to be printed directly onto the prescription label, or will wording on the prescription label, such as "Exp. date see package" suffice in meeting the requirements for determining the accurate expiration date of the manufacturer packaged or pharmacy repackaged product.
Wording on the prescription label, such as Exp. Date see package does not suffice in meeting the requirements for determining the accurate expiration date. The expiration date must appear on the prescription label.
Responsible pharmacist duties
Omnicare Inc. also requested clarification regarding the ability of a Maryland licensed pharmacist to be designated as the responsible pharmacist for more than one licensed pharmacy location in Maryland.
In a full service pharmacy "a pharmacist shall be immediately available on the premises to provide pharmacy services at all times the pharmacy is in operation." See COMAR 10.34.05.03A. If a pharmacist is full time at one pharmacy, that pharmacist may not be listed as full time at another pharmacy at the same time. If the pharmacist is listed as part time at two pharmacies then both pharmacies will have to list other pharmacists who will be working when the pharmacist in charge is not available. The hours of operation and the staffing of pharmacists must be consistent.
Whether or not a director of pharmacy at a comprehensive care facility may be a director of pharmacy for more than one licensed pharmacy location at a time is not currently addressed in COMAR 10.34.23 Pharmaceutical Services to Residents in Long-Term Care Facilities. The Board is in the process of revising COMAR 10.34.23 and this issue will be addressed after the anticipated publication of those revisions in the Maryland Register on June 4, 2010. A 30 day comment period follows. Please refer to HYPERLINK "http://www.dsd.state.md.us"www.dsd.state.md.us and click on Maryland Register on the left menu.
3) Joanne Hawana,, Arent Fox
Pedigree Question Private Label Distributors
Draft - Bd Response - Hawana - Arent Fox
The private label distributor you described in your e-mail would be required to be licensed as a wholesale distributor in Maryland because, as you indicated, it directs and controls the actual distribution of the product by the third-party logistics provider. Forms are available on the Boards website at: HYPERLINK "http://www.dhmh.maryland.gov/pharmacyboard"www.dhmh.maryland.gov/pharmacyboard
Pursuant to our phone conversations, your next concern was how a private label distributor would affect the normal distribution channel and who would provide the pedigree. The definition of normal distribution channel is narrow and is provided below:
(l)Normal distribution channel means a chain of custody for a prescription drug that, directly or by drop shipment, goes:
(1)From:
(i)A manufacturer of the prescription drug; or
(ii)The manufacturers colicensed partner, third party logistics provider, or manufacturers exclusive distributor; and
(2)To:
(i)A pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;
(ii)A wholesale distributor to a pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;
(iii)A wholesale distributor to a pharmacy warehouse to the pharmacy warehouses intracompany pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient;
(iv)A pharmacy warehouse to the pharmacy warehouses intracompany pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient; or
(v)An authorized distributor of record to another authorized distributor of record solely for distribution to an officebased health care practitioner authorized by law to dispense or administer the prescription drug to a patient.
Health Occupations Article, 12-6C-01, Annotated Code of Maryland
The scenario described in your e-mail of April 1, 2010, is outside of the definition of normal distribution channel because the third party logistics provider distributes to other wholesale distributors, so it does not fall under 12-6C-01l(2)(v).
Therefore, the private label distributor, of a prescription drug that leaves, or has ever left, the normal distribution channel shall provide, before each wholesale distribution of the prescription drugs, a pedigree to the person who receives the prescription drug. Health Occupations Article, 12-6C-10(a), Annotated Code of Maryland
Since this is outside the normal distribution channel, the first authorized distributor of record would authenticate the pedigree as coming from the initial manufacturer. In your e-mail the first authorized distributor of record is the private label distributor who holds title to the product.
4) Doug Haggerty, Walgreens
Haggarty - Schedule II prescription
Draft - Bd Response - Haggerty Walgreens
Returned to Practice Committee for further research and revisions.
5) Marianna F. Miyazaki, Arent Fox
Vaccine distribution - Miyazaki - Arent Fox
Draft - Bd Response - Miyazaki - Arent Fox
Thank you for contacting the Maryland Board of Pharmacy concerning whether a company would need to be licensed by the Board if it purchases vaccines from a manufacturer/wholesale distributor for storage at one of the companys locations, and distributes to other of the companys locations, and then administered by a nurse pursuant to a physicians standing order.
Please be advised that the company would have to be licensed as a wholesale distributor in Maryland in order for it to purchase vaccines and then distribute the vaccines to the physician/nurse. A nurse would administer the vaccines to individuals under the authority of the physicians license.
1. Motion: Practice Committee
Second: Dave Chason
2. Motion: Dave Chason
Second: Harry Finke
3. Motion: Practice Committee
Second: Dave Chason
4. Motion: Practice Committee
Second: Dave Chason
5. Motion: Practice Committee
Second: Harry Finke
1. Board Action: The Board voted to approve the motion.
2. Board Action: The Board voted to return to practice
3. Board Action: The Board voted to approve the motion.
4. Board Action: The Board voted to return to Practice Committee
5. Board Action: The Board voted to approve the motion.XI. Licensing Committee
Mike Souranis,
Chair
A. Licensing Committee statistics for the Board.
See Attachment 1, Section A and E.
B. Letter for Out-if-State Wholesale Drug or Device Distributor Renewals
C. Approval of Repositories
1. Halethorpe Pharmacy
2. Joppa Road Pharmacy
3. Independent Pharmacy
B. Motion: Licensing Committee made a motion to approve letter.
Second: Harry Finke
C. Motion: Licensing Committee made a motion to approve all 3 Repository applicants,
Second: Mayer Handelman
B. Board Action: The Board voted to approve the motion.
C. Board Action: The Board voted to approve the motion.XII. Disciplinary
CommitteeLenna Israbian-Jamgochian,
Chair Compliance Committee monthly statistics for the Board. See Attachment 1, Section A and C.
XIII. Long Term CareMayer Handelman, ChairCommittee Report
Long Term Care letter should be drafted and sent to NABP for approval on controlled dangerous substance authority.
Motion: Mayer Handelmann
Second: Harry Finke
Board Action: The Board voted to approve the motion.XIV. InformationalDonald Taylor,
PresidentA. FDA has initiated a new program Bad Ad Program where they are asking physicians to report ads and sales pitches that violate FDA rules. They are also offering physicians training at medical conferences (providing funding). There is NO mention of pharmacist participation.
B. Tennessee allows vending machines in medical clinics. One company is installing Rx vending machines that dispense 60 different generics and can hold 1000 Rxs. Patients are given an ID # and can just pick up their medications on exit. The company states that they are not cutting out pharmacists, but are only dealing with acute medications and not chronic medications.
C. Pharmacists are increasingly finding a changed profession. Not only is the job market becoming wobbly, but the skill-set required has shifted. They now need to know how to work in different environments (retail clinics, mail-order businesses, nursing homes, consulting). They must also be comfortable with new technology, drug therapy management, changing issues/regulations related to Medicare/Medicaid and the new politics of health care reform.
D. AMA Seeks Limits to Pharmacists Scope of Practice:
1. AMA is arguing that collaborative therapy has the potential to lead us to independent authority for pharmacists to monitor and modify medication therapy.
2. They have issued the AMA Scope of Practice Data Series: Compendium on Pharmacists which states among other things:
a. Neither the Accreditation Council for Pharmacy Education nor
state licensing requirements mandate direct patient contact
for student practice experience, and
b. No evidence exists that the profession has modified the
quality or manner in which students are trained to provide
direct care to patients.
3. AMA introduced HR 2260 that would have required all health care
providers (other than medical doctors or doctors of osteopathic medicine) to issue disclaimers informing patients that they do not have the skills and training of MDs and DOs. That bill did not make it out of committee, but they are now introducing similar bills at the state level (3 billsat this point),A. Motion to send letter to FDA by Harry Finke
Second: M. Souanis
A. Board Action: The Board voted to approve the motion.XV. AdjournmentDonald Taylor,
Board PresidentA. D. Taylor asked for a motion to close the Public Meeting and open a Closed Public Session for the purpose of engaging in medical review committee deliberations of confidential matters contained in technician applications in accordance with State Government, Sect. 10-508(a)(13).
Motion: Richard Matens
Second: Dave Chason
The Public Meeting was adjourned at 11:48 am.
PAGE
PAGE 9
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