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

2. www.dhp.virginia.gov 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

3. www.dhp.virginia.gov 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. www.dhp.virginia.gov 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

5. www.dhp.virginia.gov Impact of New Laws Effective July 1, 2008

6. www.dhp.virginia.gov 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

7. www.dhp.virginia.gov 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.

8. www.dhp.virginia.gov 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.

9. www.dhp.virginia.gov 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.

10. www.dhp.virginia.gov 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.

11. www.dhp.virginia.gov 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.

12. www.dhp.virginia.gov 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.

13. www.dhp.virginia.gov 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.

14. www.dhp.virginia.gov 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 patient’s agent may donate eligible drugs to these drug donation sites. List of registered drug donation sites will be available online for consumer access.

15. www.dhp.virginia.gov 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.

16. www.dhp.virginia.gov 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 pharmacist’s professional judgment, experience, knowledge, or available references;

17. www.dhp.virginia.gov 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.

18. www.dhp.virginia.gov 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 patient’s agent, unless the patient resides in LTC or other setting where drugs are administered. Donor form shall include: Donor’s 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.

19. www.dhp.virginia.gov 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.

20. www.dhp.virginia.gov 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.

21. www.dhp.virginia.gov 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.

22. www.dhp.virginia.gov 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.

23. www.dhp.virginia.gov 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.

24. www.dhp.virginia.gov 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.

25. www.dhp.virginia.gov Nonresident Pharmacies Requires nonresident pharmacies that dispense >50% 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.

26. www.dhp.virginia.gov Amended Guidance Document

27. www.dhp.virginia.gov 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.

28. www.dhp.virginia.gov 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.

29. www.dhp.virginia.gov Periodic Regulatory Review

30. www.dhp.virginia.gov 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.

31. www.dhp.virginia.gov 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.

32. www.dhp.virginia.gov 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.

33. www.dhp.virginia.gov 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.

34. www.dhp.virginia.gov 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.

35. www.dhp.virginia.gov 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.

36. www.dhp.virginia.gov 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 Board’s 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.

37. www.dhp.virginia.gov 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.

38. www.dhp.virginia.gov

39. www.dhp.virginia.gov New Initiatives or Plans for the Future

40. www.dhp.virginia.gov 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 administration’s legislative package **Not known at this time if either of these proposals will go forward to the 2009 legislature**

41. www.dhp.virginia.gov 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

42. www.dhp.virginia.gov 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 CQI Program (for 2009 GA)

43. www.dhp.virginia.gov Board of Pharmacy website www.dhp.virginia.gov/pharmacy pharmbd@dhp.virginia.gov

44. www.dhp.virginia.gov Questions??