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DISCIPLINARY ACTIONS. The following disciplinary action was taken by the Board since the last newsletter.
Carlson, Robert J., License #112293-2. Licensee misappropriated controlled substance drugs from his place of employment for unauthorized personal use. Licensee was placed on probation with the Board.
PROPOSED RULE CHANGES. The Board of Pharmacy is proposing to make several changes to existing Board rules relating to a number of different subjects, and is proposing new rules relating to the registration of pharmacy technicians. Included here is a summary of the rule changes being proposed. Anyone interested in obtaining a copy of the actual language of the proposed changes may do so by contacting the Board of Pharmacy office.
Minn. Rule 6800.0100, Subpart 11. The Board is redefining "prescription drug order" to include an electronically transmitted order of a practitioner for a drug for a specific patient.
Minn. Rule 6800.0700. The Board is proposing to revise the size requirement for licensed pharmacies. The current minimum size for an area licensed as a pharmacy is 400 square feet. Oftentimes, licensees have included an office space, within the secured area, resulting in a dispensing area of substantially less than 400 square feet. The Board is proposing to reduce the minimum square footage for a licensed area to 250 square feet, but all of that 250 square feet must be in the dispensing and drug storage area. The prescription dispensing counter must be at least 18 inches deep, and provide two linear feet of space for each pharmacist and each technician working concurrently on compounding and dispensing activities. Additional counter space will be required for computers, reference materials, etc., that are used in the dispensing process. In addition, pharmacies will be required to provide an identifiable patient counseling area that provides an assurance of privacy for patient counseling services. Under the current reasonable expectation of privacy standard, the Board found many pharmacies providing patient counseling at a cash register location or in a nearby aisle of the pharmacy. This lack of regard for the patient's right to hold private conversations with the pharmacist must be addressed.
Minn. Rule 6800.1010. In Subpart 2, Item B, the Board is adding "chemicals" to the list of items which the pharmacist-in-charge, of a pharmacy that is closing, must dispose of properly.
Minn. Rule 6800.2250, Subpart 1, Item C. The Board is adding language that allows pharmacists to refuse to compound and dispense certain prescriptions based on moral objections to the use of certain drugs to induce abortions.
Minn. Rule 6800.2400. Responsibilities of the pharmacist-in-charge are being modified to include supervision of pharmacy technicians and the responsibility to ensure that all persons, working as pharmacy technicians, are registered with the Board. In addition, it will become a responsibility of the pharmacist-in-charge to maintain staffing of the pharmacy at a level sufficient to prevent harm to the public due to dispensing errors associated with prescription volume.
Minn. Rule 6800.2600. Any pharmacy utilizing automated dispensing equipment must notify the Board of the location of the automated system.
Hospitals may utilize automated medication management systems, as a primary drug distribution system, only if the system requires that drug orders be reviewed and electronically released by a pharmacist before hospital staff are allowed access to the drug.
The use of automated medication management systems, at sites remote from the location of the pharmacy responsible for the system, must be approved by the Board before installation and implementation.
Minn. Rule 6800.3100. This section addresses the role of the pharmacist in compounding and dispensing of prescriptions, and is being amended to require that those pharmacists, using automated medication management dispensing systems, develop written policies and procedures which provide that all certification steps are performed and documented before the medication is distributed to the patient, and that those policies and procedures be made available for inspection by the Board upon request.
Minn. Rule 6800.3120. This section deals with the transfer of prescriptions between pharmacies. The Board is proposing language which would allow the voiding of the electronic record of prescriptions being transferred to another pharmacy without the necessity of also having to void the original hard copy of the prescription.
Minn. Rule 6800.3850 Pharmacy Technicians. This rule establishes a registration system for pharmacy technicians. All pharmacy technicians will be required to register with the Board beginning in January of 1999. Re-registration will be required on an annual basis, and the registration fee is proposed to be $15.
Pharmacy technicians will be required to report any changes in name, residence, or place of employment to the Board within ten days of the change. The Board will not allow the registration of an individual, as a pharmacy technician, if the individual is less than 16 years of age. Written procedures for the use of pharmacy technicians will continue to be required. A copy of the procedures must be given to each technician and the procedures must be kept on file in the pharmacy. Copies of the written procedures must be made available for inspection by the Board upon request. The policies and procedures will need to be updated every five years, but the policies and procedures will not be required to be submitted to and approved by the Board ahead of time. It will be the responsibility of the pharmacist-in-charge to make sure that the policies and procedures, being implemented, are in compliance with all laws and rules. The existing ratios of technicians-to-pharmacists, covered in part by Board rules and in part by statutes, remain unchanged.
Minn. Rule 6800.3950. Language is being proposed which would restrict third parties from capturing, editing, or manipulating electronically transmitted prescription orders being communicated to a pharmacy by a practitioner.
Minn. Rule 6800.4300. The Board is proposing language that will allow the partial dispensing of Schedule II controlled substances to terminally ill patients in conformity with DEA limitations on allowances.
Minn. Rule 6800.4800. The Board is proposing a requirement that any pharmacy, drug wholesaler, drug manufacturer, or controlled substance researcher, detecting the theft or significant loss of controlled substance drugs, must report the loss both to DEA and to the Board.
Minn. Rule 6800.5300. The Board is proposing two small changes relating to internship reporting, changing the reporting requirement from each "quarter" to each "segment" of internship, and is changing the requirement relating to a passing score on the Internship Competency Examination.
Minn. Rule 6800.5350. This section relates to duties of pharmacists acting as preceptors for pharmacist interns. The Board is eliminating the requirement that preceptors provide at least 12 hours, per calendar quarter, of scheduled, uninterrupted time, in segments of not less than 30 minutes with the intern, for purposes of education and discussion and, instead, is establishing a requirement that the preceptor spend an unspecified amount of time with the intern for the purpose of helping the intern meet the competencies of the internship manual.
Minn. Rule 6800.5400. This part, again, relates to internship, and the change is simply one of changing the term "guides and objectives" to "competencies".
In addition, the Board is making a minor modification in the hours of internship credit that may be acquired through Pharm D clinical rotations in recognition of the curriculum changes at the University of Minnesota College of Pharmacy.
Minn. Rule 6800.6700. This rule relates to drugs in nursing home emergency kits. Here, the Board is acting on a request from long-term care pharmacists to expand the number of oral medications that can be stocked in emergency kits in nursing homes. The Board is acting to allow an unlimited number of oral antibiotics, in 72-hour supplies of each, to be stocked in the emergency kit.
Minn. Rule 6800.6800. This is a new rule relating to protecting nursing home staff from HIV transmission. This rule allows a pharmacy to provide, to a nursing home, a separate supply of medications containing the Prophylaxis regimen, currently recommended by the Centers for Disease Control, for the prevention of HIV due to accidental contact with contaminated body fluids.
Minn. Rule 6800.8007. This rule incorporates new language allowing a hospital or home IV therapy pharmacy to provide an emergency kit for use by designated registered nurses employed in the hospice or home health care setting.
Repealer. In addition to all of the above, the Board is proposing
to repeal Minn. Rule 6800.0100, Subpart 10 defining "poisons", Minn. Rule
6800.3550 relating to the sale of poisons, Minn. Rule 6800.3650 relating
to the labeling of poisons, Minn. Rule 6800.3850, Subpart 8 relating to
the authority of a pharmacist-in-charge to petition the Board for use of
pharmacy technicians in ratios in excess of those specifically allowed
under this rule, Minn. Rule 6800.5100, Subpart 7 relating to the definition
of "quarter" as it relates to internship time gained during a three month
period of time, Minn. Rule 6800.6400 relating to the labeling of insulin
being dispensed to nursing home patients as an OTC drug, and Minn. Rule
6800.7600 relating to pharmaceutical service equipment and supplies in
hospital pharmacies.