WSR 08-09-102

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed April 21, 2008, 2:09 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 06-08-103.

Title of Rule and Other Identifying Information: WAC 246-901-030 Technician education and training and 246-901-060 Technician certification.

Hearing Location(s): Department of Health, 310 Israel Road S.E., Tumwater, WA 98501, on May 29, 2008, at 9:15 a.m.

Date of Intended Adoption: May 29, 2008.

Submit Written Comments to: Doreen Beebe, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, web site http://www3.doh.wa.gov/policyreview/, fax (360) 586-4859, by May 23, 2008.

Assistance for Persons with Disabilities: Contact Doreen Beebe by May 26, 2008, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule requires pharmacy technician candidates to take a standardized examination to evaluate their knowledge and skill level prior to certification in Washington state. By approving a standardized national examination, the board adopts a reliable tool for assessing a candidate's competencies.

Reasons Supporting Proposal: It is anticipated that the proposed rule will assure a reliable and consistent evaluation of the education and training of pharmacy technician applicants. The examination will help assure that technicians possess the basic skills to assist pharmacists in the practice of pharmacy in all practice setting[s] and will improve the quality of care for patients.

Statutory Authority for Adoption: RCW 18.64A.020.

Statute Being Implemented: RCW 18.64A.020.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington department of health, board of pharmacy, governmental.

Name of Agency Personnel Responsible for Drafting: Doreen Beebe, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, (360) 236-4834; Implementation and Enforcement: Judy Haenke, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, (360) 236-4828.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

1. Briefly Describe the Proposed Rule: The board of pharmacy is proposing to require pharmacy technician candidates to take a standardized examination to evaluate the knowledge and skill level of pharmacy technician candidates prior to certification in Washington state.

In recognition of the disparity in the current examination process, the proposed rule will require applicants for pharmacy technician certification to successfully complete a national standardized pharmacy technicians' examination approved by the board. This change in standards will provide a reliable tool for assessing a candidate's competencies. The proposed rule would also eliminate the need for individual pharmacy technician training programs from having to develop their own exams.

It is anticipated that the proposed rule will assure a reliable and consistent evaluation of the education and training of pharmacy technician applicants. The examination will help assure that technicians possess the basic skills to assist pharmacists in the practice of pharmacy in all practice setting[s] and will improve the quality of care for patients.

The proposed rule will require amending WAC 246-901-030 (3)(b), proof of successful completion of a "certification examination approved by the board" and WAC 246-901-060 Technician certification, to include the requirement for successful completion of a national standardized examination prior to certification in Washington state.

2. Is a Small Business Economic Impact Statement (SBEIS) Required for this Rule? The board of pharmacy assessed the impact of the rule on businesses subjected to economic impact analysis. The impacts to the majority of small pharmacy businesses are less than $66 and thus below the threshold amount defined as "minor costs" in RCW 19.85.020. However, there are a few small businesses for which the economic impact of implementation of this rule would exceed minor costs.

3. Which Industries are Affected by this Rule? The proposed rule can be expected to affect businesses identified by the United States North American Industry Classification System (NAICS) code: 44611 for pharmacies and drug stores; 61151 technical and trade schools; 62211 hospitals. Small pharmacy businesses are those businesses with fifty or fewer employees.

4. What are the Costs of Complying with this Rule for Small Businesses (Those with Fifty or Fewer Employees) and for the Largest 10% of Businesses Affected? In analyzing the possible costs, the board conducted a survey of active board-approved technician training programs. At the time of the survey, there were one hundred seventy-nine board-approved on-the-job (OTJ) training programs and twenty-three approved academic courses. The OTJ programs were broken down into practice sites to include: Community/retail pharmacies (fifty employees or less), long-term care pharmacies, hospital pharmacies, other (correctional/public health facilities or specialty pharmacies) and chain store pharmacies (more than fifty employees). Approximately 20% of each category was asked to participate in a survey to determine if the proposed rule would have a disproportionate impact for smaller businesses verses large businesses. Of the forty-five sites solicited sixteen responded.

Random samples of approximately 20% of pharmacies from each category were selected to participate in the survey.

The pharmacies were asked to evaluate their current training program on its ability to prepare an applicant to pass a national standardized examination. Each pharmacy was provided content outlines for examinations administered by the pharmacy technician certification board (PTCE) and of the exam content for the institute for the certification of pharmacy technicians (ExCPT).


Category Headings by Examination

PTCE - Pharmacy Technician Certification Board

1. Assisting the Pharmacist in Serving Patients (66% of exam).
2. Maintaining Medication and Inventory Control Systems (22% of exam).
3. Participating in the Administration and Management of Pharmacy Practice (12% of exam).

ExCPT - Institute for the Certification of Pharmacy Technicians

1. Regulations and Technician Duties (~25%of exam).
2. Drugs and Drug Products (~25% of exam).
3. Dispensing Process (~50% of exam).

Survey results: 63% of the pharmacies responding to the survey indicated that they use an examination developed by the program to assess a participant's knowledge and skill level in performing entry level pharmacy technician duties. Others use exams provided by the Michigan Pharmacy Association and the American Society of Health-System Pharmacists. Half of the programs responding to the survey indicated that their programs will need to change to prepare program participants to successfully pass a national standardized certification exam.

Cost estimates were assessed based on need to revise program curriculum and the cost of staff to provide additional didactic and experiential training.

Responses were received in the following categories:


Categories Surveyed #

Surveyed

#

Responded

Business #

Surveyed Reporting No Costs

Estimated Cost Reported Average Cost of Compliance Per Employee*
Large

> 50 employees

Small

< 50

employees

Chain Store Pharmacies 5 1 $2200 $13**
Community/Retail Pharmacies 26 9 3 $5665 $59
Other Pharmacies 2 0 -
Hospital Pharmacies 3 1 $31,060 $58
Long-term Care Pharmacies 4 3 $9135 $190
Academic/Vocational Programs 5 2 1 $200 $10
*Average cost per employee calculated based on total costs reported divided by the average number of staff per pharmacy reporting costs (average number of staff based on NAICS data).

**Average cost per employee was calculated based on actual staffing levels reported by the corporation responding to the survey.


Costs were primarily associated with providing the necessary instructions to pharmacy technicians to perform activities related to various pharmacy practice sites.

The content of two national standardized certification exams were reviewed and provided to the survey respondents for consideration when reviewing their current training plans.

5. Does the Rule Impose a Disproportionate Impact on Small Businesses? Yes, the cost for small businesses to enhance their technician training programs to prepare applicants to pass a national standardized examination on average is higher than those of larger businesses. However, based on the survey, four of the twelve small pharmacy businesses indicated no changes were needed. In addition, five of the sixteen respondents indicated that proposed rule may result in a cost savings to the program if the program was not required to provide a final examination.

6. If the Rule Imposes a Disproportionate Impact on Small Businesses, What Efforts Were Taken to Reduce That Impact (or Why is it Not "Legal and Feasible" to Do So) By:

a) Reducing, Modifying, or Eliminating Substantive Regulatory Requirements? The proposed rule does not reduce, modify, or eliminate substantive regulatory requirements. Reducing regulatory requirements would not result in reduced costs to the affected small businesses.

b) Simplifying, Reducing, or Eliminating Record-keeping and Reporting Requirements? Reducing or eliminating record-keeping requirements were not considered. Performance evaluations of program participants are required to be maintained for two years. This is consistent with all other record keeping required by these businesses. There are currently no reporting requirements related to pharmacy technician training programs.

c) Reducing the Frequency of Inspections? The proposed rule does not reduce the need for the board's inspection process. Reducing inspections would not be a viable way of reducing costs to affected small businesses. Conducting regular inspections is necessary to protect public health and safety.

d) Delaying Compliance Timetables? The board may consider delaying implementation of the rule to give affected businesses time to find ways they can comply. With the exception to the academic programs, OTJ training programs do not have a set start or completion schedule; therefore, it may be problematic to attempt to coordinate a compliance timetable.

The proposed rule exempts pharmacy technicians who are currently certified in Washington from having to meet the new standard. Although this does not provide a delay in implementation, it will minimize the impact on current pharmacy personnel.

e) Reducing or Modifying Fine Schedules for Noncompliance? The board has not considered assessing fines for noncompliance. Technician programs that are unable to meet the new standards for training will not be approved or reapproved.

f) Any Other Mitigation Techniques? No other mitigation techniques were considered. However, the board will make any necessary changes to the written guidelines for the implementation of pharmacy technician training programs.

7. How are Small Businesses Involved in the Development of this Rule? Small pharmacies were involved in the development of the proposed rule amendments through stakeholder meetings, letters and messages sent to the board and an invitation to participate in a pharmacy cost of rule survey.

A copy of the statement may be obtained by contacting Doreen E. Beebe, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, phone (360) 236-4834, fax (360) 586-4359, e-mail doreen.beebe@doh.wa.gov.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Doreen Beebe, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, phone (360) 236-4834, fax (360) 586-4359, e-mail doreen.beebe@doh.wa.gov.

April 21, 2008

Doreen E. Beebe

Program Manager

OTS-9390.2


AMENDATORY SECTION(Amending WSR 00-15-081, filed 7/19/00, effective 8/19/00)

WAC 246-901-030   Technician education and training.   (1) ((Pharmacy technicians)) Applicants must obtain education ((or)) and training from one of the following:

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

(b) On-the-job pharmacy technician 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) ((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)) Applicants must pass a board-approved national standardized pharmacy technician 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.

(c) All foreign graduates for whom English is not the primary language shall provide proof of receiving a score of at least 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.

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

(6) Prior to performing specialized functions, pharmacy 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 18.64.005, chapter 18.64A RCW. 00-15-081, 246-901-030, filed 7/19/00, effective 8/19/00. 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.]


AMENDATORY SECTION(Amending WSR 00-15-081, filed 7/19/00, effective 8/19/00)

WAC 246-901-060   Technician certification.   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)):

(1) A statement ((of program verification signed by the program director)) signed by the program director verifying the applicant has successfully completed the board-approved pharmacy technician training program.

(2) Proof of passing a board-approved national standardized pharmacy technician certification examination.

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

[Statutory Authority: RCW 18.64.005, chapter 18.64A RCW. 00-15-081, 246-901-060, filed 7/19/00, effective 8/19/00. 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.]

Washington State Code Reviser's Office