Virginia Board of Pharmacy Law Update

1
Virginia Board of PharmacyLaw Update

• VPhA Annual Convention
• August 5, 2008
• Caroline D. Juran
• Deputy Executive Director
• Board of Pharmacy

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Current Board Members

• David C. Kozera (Chair)
• Michael E. Stredler (Vice Chair)
• Gill B. Abernathy
• John Beckner
• Willie Brown

• Gerard Dabney
• Jennifer H. Edwards
• Bobby Ison
• Leo H. Ross
• Brandon K. Yi

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Program Objectives

• Review the impact of the new laws effective July
  1, 2008
• Anticipated changes to the expiration dates for
  facility permits and impact on the renewal cycle
• Board's new ability to require up to 2 hours of
  CE in a specific content area
• Proposed regulations for a prescription drug
  donation program
• New requirements for nonresident pharmacies
  to include a Virginia-licensed PIC and VIPPS
  certification

4
Program Objectives

• Review the revised date for enforcement of USP
  Chapter 797 standards and the possible monetary
  penalties associated with non-compliance
• Explain the status of the periodic regulatory
  review process highlighting examples of proposed
  regulatory amendments

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Impact of New Laws Effective July 1, 2008
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Expiration of Licenses

• HB 1129 passed in 2008 General Assembly.
• Removes the requirement that all licenses issued
  by Board expire on 12/31 annually
• Allows Board to establish in regulation annual
  expiration dates
• Legislation change was sought due to workload
  associated with approximately 25,000 licenses
  expiring on 12/31

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Expiration of Licenses

• 6/08- Board approved draft emergency amendments
  to regulations allowing
• Pharmacy permits and non-resident pharmacy
  registrations to expire April 30th annually
• All other facility permits (medical equipment
  suppliers, wholesale distributors, warehousers,
  etc.) to expire February 28th annually.
• Draft emergency regulations currently under
  administrative review.

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Expiration of Licenses

• Board anticipates regulatory changes to be
  approved this Fall.
• If regs approved this Fall, then changes will
  affect this upcoming renewal cycle.
• Notification letters will be sent this Fall
• If regulatory changes have not yet become final,
  then the letter will state that it is time to
  renew the pharmacy permit prior to 12/31/08
• If regulatory changes have become final, then the
  letter will indicate that the expiration date for
  the pharmacy permit has been changed to 4/30/09.

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Expiration of Licenses

• If expiration date is changed to 4/30/09, then a
  second notification letter will be sent in early
  March 2009 stating that it is time to renew the
  pharmacy permit prior to 4/30/09.

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Expiration of Licenses

• The regulatory changes will not affect the
  expiration date for a pharmacist license or a
  pharmacy technician registration.
• The expiration date for a pharmacist license and
  a pharmacy technician registration will remain
  12/31 annually.
• Notification letters will be sent in
  early-November indicating that it is time to
  renew your pharmacist license or pharmacy
  technician registration, and attest to completing
  the annual CE requirements.

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Continuing Education

• HB 1128 passed in 2008 General Assembly
• Amended 54.1-3314.1 to give authority to the
  Board to require 2 of the 15 hours of CE to be in
  a specific subject area
• If the Board designates a subject area for
  continuing education, it shall publish such
  requirement no later than January 1 of the
  calendar year for which the specific continuing
  education is required.

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Prescription Drug Donation Program

• HB 85 passed in 2008 General Assembly.
• Requires Board to promulgate and implement
  regulations within 280 days establishing a
  prescription drug donation program to
• Accept certain unused previously dispensed
  prescription drugs and,
• Re-dispense such drugs to patients of clinics
  serving the indigent.

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Prescription Drug Donation Program

• Current allowance in 54.1-3411.1 states
  hospitals or nursing homes may donate drugs under
  specific conditions.
• This allowance remains in effect until
  regulations become final, then new law will take
  over expanding the authority for drug donations.
• Draft regulations will be presented to the full
  Board for consideration at the September 3, 2008
  full Board meeting.

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Prescription Drug Donation Program

• Draft regs require pharmacies wishing to
  participate to register with the Board as a drug
  donation site - no fee.
• Patient or patients agent may donate eligible
  drugs to these drug donation sites.
• List of registered drug donation sites will be
  available online for consumer access.

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Prescription Drug Donation Program

• Requirements for eligible drugs
• Official compendium storage requirements are
  assured and drugs are in manufacturers original
  sealed containers or in sealed individual dose or
  unit dose packaging that meets official
  compendium class A or B container requirements,
  or better and,
• Expiration date is not less than 90 days from the
  date drug is donated.

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Prescription Drug Donation Program

• Drugs which shall not be accepted
• Schedule II-V drugs, if such return is
  inconsistent with federal law
• Drugs which in the professional judgment of the
  pharmacist have been adulterated or misbranded
• Drugs determined to be hazardous for donation
  based on pharmacists professional judgment,
  experience, knowledge, or available references

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Prescription Drug Donation Program

• Drugs which shall not be accepted
• Drugs that may only be dispensed under a
  restricted distribution system for safety reasons
  to include drugs that may only be dispensed to a
  patient registered with a manufacturer and,
• Drugs that have been previously compounded.

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Prescription Drug Donation Program

• A pharmacist or a pharmacy technician under the
  personal supervision of a pharmacist may accept
  eligible donated drugs.
• A donor form must be completed by the patient or
  patients agent, unless the patient resides in
  LTC or other setting where drugs are
  administered.
• Donor form shall include
• Donors contact information and signature
• List of drugs donated
• Date of donation
• Statement attesting that drugs have been properly
  stored
• Statement that private health information will be
  protected
• Initials of receiving pharmacist, or of receiving
  pharmacy technician and supervising pharmacist.

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Prescription Drug Donation Program

• Drug donation site may either
• Re-dispense the donated drug pursuant to a valid
  prescription to a patient of a clinic serving the
  indigent or,
• Transfer the donated drug to a second drug
  donation site, such as a clinic, for the purpose
  of re-dispensing.
• Prior to re-dispensing or transferring, the
  pharmacist shall perform a final review of the
  drug for eligibility and shall ensure that
  patient specific information has been rendered
  unreadable. All other drug-related information
  must remain on the label.

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Prescription Drug Donation Program

• If transferring donated drug, the transferring
  site must provide a transfer record to the
  receiving drug donation site.
• Transfer record shall include
• Names, addresses of transferring site and
  receiving site
• Name, strength, quantity of drug being
  transferred
• Date of transfer.

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Prescription Drug Donation Program

• Original transfer record to be maintained at the
  transferring site.
• Copy of transfer record to be provided to
  receiving site. Copy shall be dated when
  received and maintained.

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Prescription Drug Donation Program

• When re-dispensing donated drug, recipient shall
  sign a form indicating that the drug has been
  donated pursuant to the prescription drug
  donation program.
• Form must be maintained by drug donation site.
• Site shall not charge the recipient for the cost
  of the drug, but may charge a dispensing fee, not
  to exceed the current Medicaid dispensing fee.

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Prescription Drug Donation Program

• All records pertaining to program shall be
  maintained for two years and separate from other
  records.
• Donated drugs shall be maintained separate from
  other drug inventory.
• Any drugs that expire or become ineligible shall
  be disposed of by the drug donation site.

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Nonresident Pharmacies

• HB 1147 and SB405 passed in 2008 General
  Assembly.
• Requires nonresident pharmacies, other than
  pharmacy benefit managers, to designate a
  Virginia licensed pharmacist-in-charge to be
  responsible for ensuring compliance with Virginia
  laws.

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Nonresident Pharmacies

• Requires nonresident pharmacies that dispense
  gt50 of its total prescription volume pursuant to
  an order received as a result of solicitation on
  the Internet, including solicitation by e-mail,
  that it
• Is credentialed and has been inspected and,
• Has received certification from NABP as a
  Verified Internet Pharmacy Practice Site (VIPPS),
  or has received certification from a
  substantially similar program approved by the
  Board.

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Amended Guidance Document
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Guidance Document 110-36 Sterile Compounding

• Formerly required all pharmacies performing
  sterile compounding to be in compliance with the
  physical standards of USP Chapter 797 by June 30,
  2008.
• Due to recent revision of Chapter 797 which
  became effective June 1, 2008, Board has allowed
  a one-time extension of the deadline to October
  31, 2008.

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Guidance Document 110-36 Sterile Compounding

• Board will begin enforcing physical standards
  after 10/31/08.
• Non-compliance may result in a monetary penalty
  of not more than 5,000 per violation.
• Each sterile preparation that is compounded under
  conditions not in conformity with 54.1-3410.2,
  and by reference USP 797, may constitute a single
  violation.

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Periodic Regulatory Review
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• Overview of Status
• Identify potentially problematic regulations
  (cannot address statutes) via public comment and
  Board committee (done).
• Create Notice of Intended Regulatory Action
  (NOIRA)- list of all identified regulations
  (done).
• NOIRA was published 8/6/2007, public comment was
  accepted until 9/5/2007.

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• Proposed regulation amendments developed and
  Board adopted December 2007.
• Currently under administrative review, and once
  published 60 day public comment period.
• Board summarizes and responds to public comment
  and if no substantive changes are made, then can
  adopt final regulations.
• Administrative review again, and once published
  become effective within 30 days.

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Examples of Identified Regulations

• 18VAC110-20-111 Pharmacy technicians.
• May add requirement for pharmacies to maintain
  start date for each pharmacy technician in
  training program.

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Examples of Identified Regulations

• 18VAC110-20-180 Security System.
• Consider requiring capability of sending alarm
  signal to monitoring entity when breached even if
  communication line is inoperable.
• Clarify need that all alarms must be monitored.
• Consider changing exemption from having an alarm
  system to requiring installation of alarm prior
  to closing.

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Examples of Identified Regulations

• 18VAC110-20-240 Manner of maintaining records,
  prescriptions, inventory records.
• Consider requiring perpetual inventory for CII
  drugs, to include monthly count-back to reconcile
  count at least every 30 days.
• In lieu of perpetual inventory, may allow for
  electronic monitoring which alerts pharmacy of
  discrepancies between drugs received and drugs
  dispensed provided alerts are reviewed at least
  monthly.
• Clarify need that records may be stored within
  building where drugs are stored.
• Require maintaining CVI invoices.

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Examples of Identified Regulations

• 18VAC110-20-270 Dispensing of prescriptions
  supervision of pharmacy technicians.
• Consider eliminating ratios of pharmacist to
  pharmacy technicians in training, pharmacy
  technicians, and pharmacy interns.
• May allow pharmacist to determine how many
  individuals he can safely and competently
  supervise at one time.
• Consider requirement to retain knowingly forged
  prescription for 30 days prior to destroying or
  may give to law enforcement official.

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Examples of Identified Regulations

• Complete document of proposed regulations is
  attached to the full Board meeting minutes from
  12/31/07 which may be accessed from the Boards
  homepage by clicking on Meetings and Minutes,
  find the date for 12/12/07, and then click view
  minutes.
• Public comment may not be accepted by the Board
  until approval is given to publish the proposed
  regulations and the comment period begins.

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Regulatory Town Hallwww.townhall.virginia.gov

• May register online to receive email
  notifications regarding upcoming meetings and
  regulatory actions.
• Under Join the Town Hall community, click on
  Register as a public user.
• May set notification preferences.
• BOP is located within the Department of Health
  Professions within the Secretariat of Health and
  Human Resources.

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New Initiatives or Plans for the Future
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Legislative Initiatives

• Process
• Board adopts a proposal
• sent to associations/others for comment
• proposal may be revised by staff based on
  comments received
• Director DHP decides whether to submit the
  proposal
• Governor ultimately decides if the proposal will
  be part of the administrations legislative
  package
• Not known at this time if either of these
  proposals will go forward to the 2009
  legislature

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Voluntary Reporting (for 2009 GA)Change from
Handout

• BOP had voted to put forth a legislative proposal
  to require mandatory reporting or professional
  knowledge of
• Intentional or negligent conduct likely to cause
  harm
• Professional incompetence
• Unprofessional conduct
• Mental or physical impairment
• Substance abuse or diversion
• similar to current requirements for health care
  institutions
• Based on comments received, staff is suggesting
  change from mandatory to voluntary reporting
• would still provide civil immunity to persons
  making a good faith report

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CQI Program (for 2009 GA)

• Considering a legislative proposal requiring
  pharmacies to implement and maintain a continuous
  quality improvement program.
• Statute to be written very generally, and give
  the Board the authority to promulgate regulations
  specifying details.
• Idea is for each pharmacy to identify and analyze
  medication errors occurring at the individual
  site and to modify systems so to decrease chance
  of medication errors reoccurring.
• Language is currently being worked on to provide
  some protection against discovery

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• Board of Pharmacy website
• www.dhp.virginia.gov/pharmacy
• pharmbd_at_dhp.virginia.gov

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• Questions??