Date of Adoption: May 17, 2000.

Purpose: To implement legislation concerning pharmacy ancillary personnel to enhance and promote public health and safety. The proposed changes redistribute duties within the pharmacy, register pharmacy assistants, and modify the pharmacist to pharmacy technician ratio.

Citation of Existing Rules Affected by this Order: Repealing WAC 246-901-110; and amending WAC 246-901-010, 246-901-020, 246-901-030, 246-901-035, 246-901-040, 246-901-050, 246-901-060, 246-901-065, 246-901-070, 246-901-080, 246-901-090, 246-901-100, 246-901-120, and 246-901-130.

Statutory Authority for Adoption: RCW 18.64.005, chapter 18.64A RCW.

Adopted under notice filed as WSR 00-08-101 on April 5, 2000.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 14, Repealed 1.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 14, Repealed 1. Effective Date of Rule: Thirty-one days after filing.

June 14, 2000

C. A. Leon Alzola

Board Chair

OTS-3698.5

(1) "Consultation" means:

     (a) A communication or deliberation between a pharmacist and a patient, a patient's agent, ((and/))or a patient's health care provider in which the pharmacist uses professional judgment to provide advice about drug therapy.

     (b) A method by which the pharmacist meets patient information requirements as set forth in WAC 246-869-220.

     (2) "Dispense" as defined in RCW 18.64.011(16).

     (3) "Intravenous admixture preparation" means the preparation of a drug product that combines two or more ingredients using aseptic technique and is intended for administration into a vein.

     (4) "Parenteral" as defined in WAC ((246-871-020)) 246-871-010.

     (5) "Pharmacy ((assistant)) technician specialized function" means ((a function that the board has determined does not require the supervision normally required by a Level A pharmacy assistant but does require additional training)) certain tasks normally reserved to a pharmacist according to WAC 246-863-095 that may be performed by a pharmacy technician who has met board requirements.

     (6) "Prescription" as defined in RCW 18.64.011(8).

     (7) "Responsible manager" as defined in WAC 246-869-070.

     (8) "Unit-dose" and "unit-dose drug distribution system" as defined in WAC 246-865-010.

     (9) "Unit-dose medication cassettes" means containers for a patient's medications into which each individually packaged and labeled drug is placed.

     (10) "Verification" means ((that)) the pharmacist has reviewed a patient drug order initiated by an authorized prescriber, has examined the patient's drug profile, and has approved the drug order after taking into account pertinent drug and disease information to insure the correctness of the drug order for a specific patient.      The verification process must generate an audit trail that identifies the pharmacist.      The pharmacist who performs the verification of a drug order is responsible for all reports generated by the approval of that order.      The unit-dose medication fill and check reports are an example.

     (11) "Immediate supervision" means visual and/or physical proximity to a licensed pharmacist to ensure patient safety.

[Statutory Authority: RCW 18.64.050.      94-08-097, § 246-901-010, filed 4/6/94, effective 5/7/94.]

(1) ((Level A pharmacy assistants may assist in performing, under the immediate supervision and control of a licensed pharmacist, manipulative, nondiscretionary functions associated with the practice of pharmacy.

     (2) Immediate supervision shall include visual and/or physical proximity that will insure adequate safety controls.

     (3) The following shall not be considered to be manipulative and nondiscretionary functions associated with the practice of pharmacy:

     (a) Consultation with the prescriber regarding the patient and his prescription.

     (b) Receipt of a verbal prescription other than refill approval or denial from a prescriber.

     (c) Consultation with the patient regarding the prescription, both prior to and after the prescription filling and/or regarding any information contained in a patient medication record system.

     (d) Interpretation and identification of the contents of the prescription document.

     (e) Determination of the product required for the prescription.

     (f) Extemporaneous compounding of the prescription, except in accordance with written policies and procedures in accordance with WAC 246-901-100, whereby the accuracy, correct procedure and preparation, and safety of pharmaceutical constituents can be verified by the pharmacist.

     (g) Interpretation of data in a patient medication record system.

     (h) Final check on all aspects of the completed prescription and assumption of the responsibility for the filled prescription, including but not limited to accuracy of drug, strength, labeling, and proper container provided that a Level A pharmacy assistant may perform specialized functions.      The employer and the responsible manager are responsible and liable for the acts performed by the Level A pharmacy assistant as set forth in WAC 246-901-100(2) board-approved utilization plan.

     (i) Dispense prescriptions to patient with proper patient information as required by WAC 246-869-220.

     (j) Any duty required by law, rule or regulation to be performed only by a registered pharmacist.

     (4) Except for a specialized function approved by the board for the location, a Level A pharmacy assistant shall not release any drug ordered for a specific patient from the pharmacy or satellite pharmacy that has not been checked by a licensed pharmacist.)) Pharmacy technicians may perform certain nondiscretionary and specialized functions consistent with their training in pharmacy practice while under the immediate supervision of a licensed pharmacist.

     (2) The discretionary tasks reserved to a pharmacist are listed in WAC 246-863-095.

     (3) Unless authorized as a specialized function according to WAC 246-901-035, the pharmacy technician shall assist a pharmacist in the performance of all tasks except those reserved to a pharmacist in subsection (2) of this section.

     (4) Entry of a new medication order into the pharmacy computer system and retrieval of the drug product to fill a prescription are tasks reserved to the pharmacist and pharmacy technician.

     (5) The pharmacy assistant may assist a pharmacist in performance of all tasks except those reserved to the pharmacist and pharmacy technician.

     (6) Pharmacy ancillary personnel may record or provide medication data when no interpretation is required.

[Statutory Authority: RCW 18.64.050.      94-08-097, § 246-901-020, filed 4/6/94, effective 5/7/94.      Statutory Authority: RCW 18.64A.020 and 18.64A.030.      92-12-035 (Order 277B), § 246-901-020, filed 5/28/92, effective 6/28/92.      Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-020, filed 8/30/91, effective 9/30/91; Order 141, § 360-52-010, filed 12/9/77.]

(1) ((The education and/or training of Level A pharmacy assistants shall be obtained)) Pharmacy technicians must obtain education or training from one of the following:

     (a) Formal academic program for pharmacy ((assistant)) technician training approved by the board.

     (b) On-the-job training program approved by the board.

     (2) The minimum educational prerequisite for entering a training program shall be high school graduation or G.E.D.

     (3) ((Foreign trained applicants must earn five hundred twenty hours of supervised experience in an approved pharmacy assistant training program.      In addition,)) In order to receive certification as a pharmacy technician, the technician must send the board the following:

     (a) A state application indicating completion of board approved training program;

     (b) Proof of successful completion of a certification examination approved by the board.

     (4) An out-of-state pharmacy technician applicant must meet the same requirements as a pharmacy technician trained in this state. The board must approve training programs approved in other states.

     (5) Applicants whose academic training has been obtained in foreign countries shall meet certification requirements as listed below:

     (a) Foreign pharmacy school graduates.      Board approval of program completed for the degree.

     (b) Foreign medical school graduates.      Board approval of program completed for the degree.

     (((4))) (c) All foreign graduates for whom English is not the primary language shall provide proof of receiving a score of at least ((500)) 173 on the Test of English as a Foreign Language (TOEFL) and a score of 50 on the Test of Spoken English (TSE) prior to certification.

     (((5))) (d) Foreign trained applicants must earn 520 hours of supervised experience in an approved pharmacy technician training program.

     (6) Prior to performing specialized functions, ((Level A)) pharmacy ((assistants)) technicians shall complete specialized training and meet proficiency criteria set forth by the board.

     (a) Unit-dose medication checking.      The training proficiency criteria requires demonstration of 99% accuracy in medication checking.

     (b) Intravenous admixture preparation.      The training proficiency criteria requires demonstration of 100% accuracy in intravenous admixture preparation of a representative sample of preparations provided by the facility using aseptic technique.

[Statutory Authority: RCW 18.64.050.      94-08-097, § 246-901-030, filed 4/6/94, effective 5/7/94.      Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-030, filed 8/30/91, effective 9/30/91; Order 141, § 360-52-020, filed 12/9/77.]

A ((Level A)) pharmacy ((assistant)) technician who meets established criteria for employment, experience, training and demonstrated proficiency may perform specialized functions.      The criteria shall be specified in the utilization plan of the pharmacy for ((Level A)) pharmacy ((assistants)) technicians performing specialized functions required in WAC 246-901-100 (2)(b).      Records of ((Level A)) pharmacy ((assistant)) technician training and of demonstration of proficiency shall be ((kept on file in the pharmacy)) retrievable within seventy-two hours upon request of the board.      Specialized functions include the following:

     (1) Unit-dose medication checking.      Following verification of the drug order by a licensed pharmacist, a ((Level A)) pharmacy ((assistant)) technician may check unit-dose medication cassettes filled by another ((Level A)) pharmacy ((assistant)) technician or pharmacy intern in pharmacies serving facilities licensed ((pursuant to)) under chapter 70.41, 71.12, 71A.20 or 74.42 RCW.      No more than a forty-eight hour supply of drugs may be included in the patient medication cassettes and a licensed health professional must check the drug before administering it to the patient.

     (2) Intravenous admixture and other parenteral preparations.      A ((Level A)) pharmacy ((assistant)) technician may prepare intravenous admixtures and other parenteral drugs.      ((Each parenteral drug prepared by a Level A pharmacy assistant must be checked by a licensed pharmacist.)) A licensed pharmacist must check each parenteral drug prepared by a pharmacy technician.

[Statutory Authority: RCW 18.64.050.      94-08-097, § 246-901-035, filed 4/6/94, effective 5/7/94.]

An individual enrolled in a training program for ((Level A)) pharmacy ((assistants)) technicians will perform ((Level A)) technician functions only under the immediate supervision of a pharmacist preceptor or a delegated alternate pharmacist.

[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-040, filed 8/30/91, effective 9/30/91; Order 141, § 360-52-030, filed 12/9/77.]

(1) Program standards.      The board will establish standards ((by which programs designed to train Level A)) for judging pharmacy ((assistants shall be judged)) technician training programs.

     (2) Approval.      In order for a program for training pharmacy ((assistants)) technicians to be considered for approval by the board, the director of the program, who shall be a pharmacist, shall submit to the board a description of the course of training offered, including subjects taught, method of teaching, and practical experience provided.      The director of the program shall also advise the board concerning the skills and knowledge which are obtained in ((such)) the course, and the method by which the proficiency of the pharmacy ((assistant)) technician in those skills and knowledge ((was)) is tested or ascertained.      The board may require such additional information from program sponsors ((as it desires)).

     (3) Program change.      ((The board shall be informed and shall grant approval before any significant change in program can be implemented.)) The director shall request board approval before implementing any significant program change.

     (4) Reapproval.      ((Each approved program will be reexamined at intervals to be determined by the board.      Approval will be continued or withdrawn following each reexamination.)) The director shall submit each approved program to the board for reapproval every five years.

     (5) Registry.      ((A registry of approved programs shall be maintained by the board which shall be available upon request to interested persons.)) The board will maintain a registry of approved programs. Interested persons may request a copy of the registry by contacting the board.

[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-050, filed 8/30/91, effective 9/30/91; Order 141, § 360-52-040, filed 12/9/77.]

((Any person completing an approved pharmacy assistant training program and who wishes to perform in that capacity shall apply to the board for certification as a Level A pharmacy assistant, on forms to be supplied by the board, which shall include a verification of program competency by a notarized statement of the program director and a declaration by the applicant indicating whether he or she has at any time been found guilty by any court of competent jurisdiction of any violation of any laws relating to drugs or the practice of pharmacy.)) To become certified as a pharmacy technician, an individual must:

     (1) Complete an approved pharmacy technician program;

     (2) Apply to the board for certification. The application must include a notarized statement of program verification signed by the program director.

     It is the responsibility of the pharmacy ((assistant)) technician to maintain a current mailing address with the board as required by chapter 246-12 WAC.      Pharmacy ((assistants)) technicians shall notify the ((state)) board ((of pharmacy)) of any change of mailing address within thirty days of the change.      ((The board may rely upon the last mailing address for purposes of service or delivery of any official board documents, including the service of adjudicative proceeding documents.      If, after a good faith but unsuccessful attempt to determine the actual address of a certificate holder, charges against the pharmacy assistant are mailed by certified mail to the address on file with the board and returned unclaimed or are unable to be delivered for any reason, the board may proceed against the assistant by default under RCW 34.05.440.))

[Statutory Authority: RCW 18.64.005.      93-17-097 (Order 387B), § 246-901-060, filed 8/17/93, effective 9/17/93.      Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-060, filed 8/30/91, effective 9/30/91.      Statutory Authority: RCW 18.64A.030.      88-14-043 (Order 217), § 360-52-050, filed 6/30/88; Order 141, § 360-52-050, filed 12/9/77.]

(1) If the technician license has expired for five years or less, the practitioner must meet the requirements of chapter 246-12 WAC, Part 2.

     (2) If the license has expired for over five years, the practitioner must:

     (a) Complete certification requirements within one year of application to the board for certification((, complete the certification requirements));

     (b) Meet the requirements of chapter 246-12 WAC, Part 2.

     (3) If the practitioner has been in an active practice in another United States jurisdiction with duties that are substantially equivalent to a ((Level A)) pharmacy ((assistant)) technician in Washington state, the practitioner must:

     (a) Submit verification of active practice from any other United States jurisdiction;

     (b) Meet the requirements of chapter 246-12 WAC, Part 2.

[Statutory Authority: RCW 43.70.280.      98-05-060, § 246-901-065, filed 2/13/98, effective 3/16/98.      Statutory Authority: RCW 18.64.005.      93-17-097 (Order 387B), § 246-901-065, filed 8/17/93, effective 9/17/93.]

((Level B)) Pharmacy assistants may perform, under the general supervision of a licensed pharmacist, all duties ((including typing of prescription labels, filing, refiling, bookkeeping, pricing or determination of cost or charge, stocking, delivery, nonprofessional phone inquiries, and documentation of third party reimbursements)) except those reserved to the pharmacist and the pharmacy technician.

     ((Level B)) Pharmacy assistants may:

     (1) Prepackage and label drugs for subsequent use in prescription dispensing operations.      ((However, they cannot))

     (2) Count, pour, ((or)) and label for individual prescriptions.

[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-070, filed 8/30/91, effective 9/30/91.      Statutory Authority: RCW 18.64A.030.      88-14-043 (Order 217), § 360-52-060, filed 6/30/88.      Statutory Authority: RCW 18.64.005(11) and 18.64A.030.      80-02-113 (Order 153, Resolution No. 1/80), § 360-52-060, filed 1/28/80.      Statutory Authority: RCW 69.50.201.      79-04-048 (Order 147, Resolution No. 3-79), § 360-52-060, filed 3/27/79; Order 141, § 360-52-060, filed 12/9/77.]

(1) Training.      No formal training or educational program will be required by the board, and there will be no age or educational restrictions.      The supervising pharmacist shall thoroughly instruct the ((Level B)) pharmacy assistant in the limitations of the functions he or she may perform.

     (2) ((Record of certifications.      All pharmacies employing Level B pharmacy assistants shall complete a certification application on a form approved by the board, such form to include a declaration by the applicant that he or she has never been found guilty by any court of competent jurisdiction of any violation of any laws relating to drugs or the practice of pharmacy, for each Level B pharmacy assistant employed.      The completed form will be witnessed by the responsible pharmacist for the pharmacy and will be produced for inspection on the request of the board or its agents.)) Registration of pharmacy assistants. Any person desiring registration as a pharmacy assistant shall apply to the board for registration on forms to be supplied by the board. The fee for ((certification)) registration will be included in the fee for authorization to utilize the services of pharmacy ((assistants)) ancillary personnel.

     (3) It is the responsibility of the pharmacy assistant to maintain a current mailing address with the board as required by chapter 246-12 WAC. Pharmacy assistants shall notify the board of any change of mailing address within thirty days of the change.

     (4) A pharmacy assistant registration must be renewed every two years on the assistant's birthdate. The fee for renewal is included in the fee the pharmacy pays to utilize pharmacy ancillary personnel.

[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-080, filed 8/30/91, effective 9/30/91; Order 141, § 360-52-070, filed 12/9/77.]

All ((Level A)) pharmacy ((assistants must wear badges or tags clearly identifying them as Level A pharmacy assistants while on duty.      Those pharmacy assistants)) ancillary personnel working within the pharmacy and having contact with patients or the general public shall wear badges or tags clearly identifying ((their status)) them as pharmacy assistants or technicians.

[Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-090, filed 8/30/91, effective 9/30/91; Order 141, § 360-52-080, filed 12/9/77.]

(1) Application.      All licensed pharmacies may apply on a form supplied by the board for permission to utilize the services of pharmacy ((assistants)) ancillary personnel.

     (2) Utilization plan for ((Level A)) pharmacy ((assistants)) technicians.

     (a) General.      The application for approval must describe the manner in which the pharmacy ((assistants)) technicians will be utilized and supervised, including job descriptions, task analysis or similar type documents that define the duties performed and the conditions under which they are performed, number of positions in each category, as well as other information as may be required by the board.      The board will be notified of all changes to the utilization plan.      A copy of the utilization plan must be maintained in the pharmacy.

     (b) Specialized function.      The utilization plan for ((Level A)) pharmacy ((assistants)) technicians performing specialized functions.      The utilization plan must include:

     (i) The criteria for selection of ((Level A)) pharmacy ((assistants)) technicians to perform specialized functions;

     (ii) A description of the methods of training and of initial demonstration of proficiency;

     (iii) A copy of the part of the section of the pharmacy's quality assurance plan related to pharmacy ((assistants)) technician specialized functions;

     (iv) Other information that may be required by the board.

     (c) To gain approval for specialized functions, a pharmacy must follow board-approved guidelines regarding pharmacy ((assistant)) technician training, implementation and evaluation.

     (3) Utilization plan for ((Level B)) pharmacy assistants.      The application for approval shall list the job title or function of the pharmacy assistant.

     (4) The board may give conditional approval for pilot or demonstration projects for innovative applications in the utilization of pharmacy ((assistants)) ancillary personnel.

[Statutory Authority: RCW 18.64.050.      94-08-097, § 246-901-100, filed 4/6/94, effective 5/7/94.      Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-100, filed 8/30/91, effective 9/30/91.      Statutory Authority: RCW 18.64A.030.      88-14-043 (Order 217), § 360-52-090, filed 6/30/88; Order 141, § 360-52-090, filed 12/9/77.]

Pharmacy technician and assistant applicants must complete four clock hours of AIDS education as required in chapter 246-12 WAC, Part 8.

[Statutory Authority: RCW 43.70.280.      98-05-060, § 246-901-120, filed 2/13/98, effective 3/16/98.      Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-120, filed 8/30/91, effective 9/30/91.      Statutory Authority: RCW 18.64.005.      89-04-015 (Order 222), § 360-52-110, filed 1/23/89.]

(1) ((RCW 18.64A.040 establishes a ratio of pharmacists to Level A pharmacy assistants who are performing Level A functions.      This ratio is one pharmacist to one Level A pharmacy assistant in most pharmacies, including hospital outpatient activities and one to three in pharmacies associated with inpatient hospital services including those pharmacies operating in connection with facilities licensed pursuant to chapter 70.41, 71.12, 71A.20 or 74.42 RCW.

     (2))) A standard ratio of one pharmacist to a maximum of three technicians is established for each licensed pharmacy.

     (2) The pharmacist must be actively practicing pharmacy.

     (3) In determining which pharmacists may be included in the calculation of the ratio, the board will consider approval of pharmacy ((assistant)) technician utilization plans which include all pharmacists within the pharmacy who are engaged in the actual practice of pharmacy.      When the pharmacy provides service to inpatients of a hospital or extended care facility, pharmacists who are practicing pharmacy outside of the confines of the licensed pharmacy (((e.g.)) for example, performing nursing unit inspections, reviewing charts, consulting with health professional staff) may be included in the ratio, ((provided)) if:

     (a) There are sufficient numbers of pharmacists within the pharmacy to properly supervise the work of the pharmacy ((assistants)) technicians;

     (b) The pharmacy is not open to the public;

     (c) The medications are being checked by another health professional before being given to the patient;

     (d) Drug orders are not dispensed from the pharmacy without being checked by a licensed pharmacist or pharmacy intern except for board-approved ((Level A)) pharmacy ((assistant)) technician specialized functions provided a ((Level A)) pharmacy ((assistant)) technician may check unit-dose medication cassettes.

[Statutory Authority: RCW 18.64.050.      94-08-097, § 246-901-130, filed 4/6/94, effective 5/7/94.      Statutory Authority: RCW 18.64.005 and chapter 18.64A RCW.      91-18-057 (Order 191B), recodified as § 246-901-130, filed 8/30/91, effective 9/30/91.      Statutory Authority: RCW 18.64.005.      91-11-040 (Order 169B), § 360-52-120, filed 5/10/91, effective 6/10/91.]

A pharmacy may use more pharmacy technicians than prescribed by the standard ratio if the board approves the pharmacy's pharmacy services plan.

     (1) The pharmacy services plan shall include, at a minimum, the following information: Pharmacy design and equipment, information systems, workflow, and quality assurance procedures. In addition, the pharmacy services plan shall demonstrate how it facilitates the provision of pharmaceutical care by the pharmacy.

     (2) The board may require additional information to ensure appropriate oversight of pharmacy technicians before approving a pharmacy services plan.

     (3) The board may give conditional approval for pilot or demonstration projects.

[]

     The following section of the Washington Administrative Code is repealed:

WAC 246-901-110

Level A experience equivalency.

© Washington State Code Reviser's Office