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Action Items

January 2001 BOARD MEETING

COMMUNICATION AND PUBLIC EDUCATION COMMITTEE

The board:

  • Reported on the development of Health Notes #7 on alternative medicines. The anticipated completion date is May 2001.
  • Reported that the 2001 Pharmacy Lawbooks have been updated and will be mailed to California pharmacies by February 2001.
  • Reprinted three issues of Health Notes to replenish board supplies. The issues are Women's Health, Anticoagulation Therapy and Developmental Disabilities.
  • Held a public committee meeting to receive comments on the revised wording of the Notice to Consumers and will recommend final wording at the April board meeting.

LICENSING COMMITTEE

The board:

  • Convened a Task Force on Pharmacy Manpower - a working group to ensure patient access to pharmacists' care and prescription services. The 16-member task force met on January 23, 2001 in Los Angeles. Proposed solutions were generated. Written documentation to support the solutions was requested and must be submitted to the board by March 1, 2001. The next meeting is scheduled for April 27, 2001, in Sacramento.
  • Heard a presentation from Danny Jordan, Self-Governance Coordinator and Director-Department of Commerce for the Hoopa Valley Tribal Council. The Hoopa Valley Tribal Council is sponsoring AB 108 that would authorize a non-California licensed pharmacist to operate a pharmacy on any tribal-owned land. These pharmacies would be authorized to serve all Californians. After considerable discussion, the board took an oppose position on AB 108.
  • Received a request from the Department of Consumer Affairs Director Kathleen Hamilton to seriously evaluate reciprocity.
  • Reviewed a final report on a study of technicians checking technicians in the inpatient setting of a hospital pharmacy. In May 1998, the Board of Pharmacy granted a wavier pursuant to CCR section 1731. This waiver was granted to the UCSF, School of Pharmacy, in conjunction with Long Beach Memorial Center (LBMC) and Cedars-Sinai Medical Center (CSMC) to evaluate technicians in unit-dose drug distribution systems to check the work of other technicians. The board moved to proceed with a regulation to support the practice of using technicians to check technicians in inpatient settings for 24-hour unit dose drug distribution systems with the following conditions:
    • the programs are conducted under the supervision of a pharmacist,
    • there is appropriate training of the checking technicians,
    • there is demonstrated proficiency in meeting the desired accuracy standards of the checking technicians
    • there is ongoing quality assessment of the checking technicians.

The board also extended the waiver for the study until the end of this Legislative Session, which is 2002, should legislation need to be pursued instead of a regulation.

  • Will sponsor legislation that authorizes a "remote pharmacy." The proposal would allow the pharmacy to use an "automated dispensing" device to dispense medications without a pharmacist being physically present. The legislation would specify the conditions for which the "remote pharmacy" could be licensed. Those requirements include a certification that there is a pharmacist shortage in the pharmacy's service area, the pharmacist provides consultation via a two-way audio and video device, a technician or licensed health care provider furnishes the dispensed medication and the pharmacist is responsible for stocking the device. If the legislation passes, the board would promulgate regulations to specify the documentation required for a pharmacy to certify that there is a pharmacist shortage in the pharmacy's service area and specify the other responsibilities of the pharmacist operating the "automated dispensing" device.
  • Will sponsor legislation to make a technical amendment to clarify Business and Professions Code section 4161 regarding the licensure of out-of-state distributors. This technical amendment would not change existing state requirements.
  • Will sponsor legislation that would make significant changes to the wholesaler and exemptee provisions. The board would eliminate the exemptee examination and require as a qualification one year paid work experience, completion of a training course and a high school diploma or general education development equivalent. The exemptee permit would no longer be tied to a specific wholesale facility and would require the wholesale facility to designate a pharmacist or exemptee in charge.
  • Approved legislative language to authorize "approved entities" pursuant to 340B of Public Law 102-585, the Veterans Health Care Act of 1992, to access statutory established drug prices and then contract with a licensed pharmacy to dispense these drugs to the covered patients.
  • Approved the request from Fresenius Medical Care Pharmacy Services to waive CCR 1717(e) to deliver Epogen prescriptions directly to a dialysis unit. This waiver was granted contingent upon Fresenius providing its policies and procedures for patient consultation. · Approved the request from Statscript Pharmacy for wavier of CCR 1717(e) to deliver dispensed prescriptions to AIDS clinics. This wavier was granted contingent upon Statscript providing its policies and procedures for patient consultation.
  • Approved proposed regulatory language to define wholesaling.

ENFORCEMENT COMMITTEE

The board:

  • Approved proposed regulatory language to authorize the board to issue citations and fines for violations of the Confidentiality of Medical Information Act (CMIA).
  • Approved proposed regulatory language to authorize the board to cite and fine an Internet pharmacy for violation of Business and Professions Code section 4067.

LEGISLATION/REGULATION COMMITTEE

The board:

  • Held an informational hearing on the proposed requirements for quality assurance programs. The regulation hearing for this (CCR section 1711) will be scheduled for the April board meeting.
  • Held a regulation hearing on the proposed amendment of CCR section 1760 regarding the disciplinary guidelines. The board adopted the guidelines with some modifications. The revised guidelines will be noticed for a 15-day comment period.
  • Amended CCR section 1715 regarding the self-assessment form for pharmacies. The board adopted the amended regulation with minor revisions. The revisions will be noticed for a 15-day comment period.
  • mended CCR section 1717.3 regarding preprinted, multiple, check-off blanks. The board adopted the amended regulations with minor revisions. These revisions will be noticed for a 15-day comment period.

ORGANIZATIONAL DEVELOPMENT COMMITTEE

The board:

  • Approved seeking a $400,000 deficiency budget change proposal to permit ongoing work at the Attorney General's Office for this fiscal year.