Pharmacy Education Resources National Sterile Compounding Training Manual for Pharmacy Technicians” is a 40 hour ACPE accredited program available to technicians. The goal of this manual is to provide the technician with advanced information beyond the general basis of knowledge concerning sterile pharmaceutical products. This manual provides basic knowledge to develop an understanding of concepts, techniques and procedures related to the preparation of sterile and hazardous pharmaceutical products obtained from USP 795, 797, 800, 1163 and 1176. A set of 9 “Process Validation Checklists” have been included. This Checklist plus an additional 20 hours of Hands-on Supervised Practice are required when evaluating the reader’s ability to actually demonstrate sterile technique. Most state boards of pharmacy require process validation at least annually.

Education Procedure

This section details the step-by-step process from purchase to credit issuance.

1. A purchase is made
2. The individual is provided the initial Participant & Instructor (Evaluator) forms and instructions:
   
   1. Evaluator Instructions
   2. Participant Instructions
3. Pharmacy Education Resources provides TSHP approved participant information to leah.cody@tshp.org.
4. The Evaluator completes the Evaluator Approval Form here: http://bit.ly/PER-Evaluator
5. Once the Evaluator receives the official approval from TSHP, the participant may begin the program.
6. Participant reads the textbook materials and works their way through the chapter quizzes. Evaluators are to assist in this process as determined by the needs of the participant and facility.
7. Evaluator and Participant complete the Process Validation Evaluation Checklist portions of the program. Evaluators are required to supervise all portions of the experiential training required by this program. Evaluators must supervise technician participants a minimum of 22 hours; pharmacist participants a minimum of 2 hours.
8. Evaluator or Participant scan and submit the Supervised Practice Documentation Form and all Process Validation Evaluation Checklists to TSHP for processing via the online form here: http://bit.ly/PER-Form
9. TSHP will review the submitted documentation within 5-10 business days of receipt. Once approved; the participant (evaluator will be copied) will receive instructions to complete the online exam via email. Participants and Evaluators are instructed to complete the exam within 30 days of this notice.
10. Evaluator proctors the exam completion to ensure exam security. Participants will have 1 attempt to pass the exam.
11. Participants that pass the exam will have their credit transferred to the My CPE Monitor system (provided they have correctly entered their NABP ePID and date of birth into the education portal and no other errors are reported) within 72 hours.
12. On a monthly basis, TSHP will run reports to ensure no un-authorized exams were completed. Any identified will be removed from the system and any issued credit will be revoked.
13. On a monthly basis, TSHP will issue an invoice to Pharmacy Education Resources based on successful participant completions.

Failure Procedure:

1. Should a participant fail the electronic exam, they will receive notice that upon purchase of the $20 re-exam through the TSHP website, TSHP will send instructions on re-exam process.

Authors:
Liz Johnson Wilroy, M.A.Ed, BS, CPhT, PhTR
Daniel E. Garcia, Pharm.D, RPh
N. Pauline Thomas Parks, MS, RPh
Roderick L. Dunn, BS, CPhT, PhTR

The speakers have been determined to have no relevant financial conflict of interests.

The Texas Society of Health-System Pharmacists (TSHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. To receive credit for this activity the participant must provide all relevant participant registration materials, documentation of training hours, 9 Process Validation Evaluation Checklists with 100% accuracy supervised by a TSHP approved “Evaluator,” and pass one (1) written exam, via the PER Education Portal, with a score of 75% or greater. Participants will have one (1) exam attempt. All credit is issued through the PER Education Portal and transferred to the My CPE Monitor system. It is the responsibility of the participant to ensure their PER Education Portal profile is complete and that the My CPE Monitor Details provided are accurate. Participants that fail to provide this information (or provide inaccurate information) at the initial completion of the exam will not be issued credit and have a maximum of 60-days to update their profile with their NABP ePID and date of birth. Participants that fail to update their information within the 60-days will not be issued credit, regardless of program completion, and will not receive a refund for their program materials.

This activity is made possible through a joint-providership between TSHP and Pharmacy Education Resources.

For questions regarding program purchase, program content, participant validation or course materials, contact PER at customerservice@pharmacyeducation.ccor by phone at (281) 497-4742.

For questions regarding program accreditation or status of your submission, contact TSHP at tshp@tshp.org or by phone at (512) 906-0546.

Pharmacy Education Resources National Sterile Compounding Training Manual for Technicians
UAN: 0156-9999-20-220-B07-T
Live Credit Hours: 22.0 (0.22 CEUs)
Home-Study Credit Hours: 18.0 (0.18 CEUs)
Type: Practice-based
Initial Release Date: 07/07/2020
Planned Expiration Date: 07/07/2023

Course Objectives:

At the completion of this activity, the participant will be able to:

1. Duplicate appropriate calculations as required to prepare a variety of sterile compounded preparations. (recon, drug dose, iv flow rate, etc.)
2. Describe the various sterile compounding areas: anteroom, buffer room, clean room, and the compounding, storage, and cleaning requirements for each area.
3. Recall the various ISO Class 5 Hoods and Isolators to determine the appropriate method required for cleaning each.
4. List the proper methods for documenting environmental quality control in the Clean room.
5. Demonstrate @ 100% accuracy on Process Validation (PV) Checklist aseptic hand washing.
6. Demonstrate @ 100% accuracy on PV Checklist proper gowning and sterile gloving technique.
7. Demonstrate @ 100% accuracy on PV Checklist proper horizontal hood cleaning technique.
8. Demonstrate @ 100% accuracy on PV Checklist proper vertical hood or Barrier Isolator cleaning technique.
9. Demonstrate @ 100% accuracy on PV Checklist proper powder vial reconstitution technique.
10. Demonstrate @ 100% accuracy on PV checklist proper liquid vial and ampule technique.
11. Demonstrate @ 100% accuracy on PV Checklist proper hazardous drug preparation technique.

Statement of Topics Covered in Intravenous Training Programs

Pharmacy Education Resources Intravenous Training Programs for Pharmacists providing 20 hr ACPE and Technicians providing 40 hr ACPE since 1995 cover all topics listed in sub-section 4(D) of TAC 291.133 and includes instruction, experience and demonstrated proficiency in the following areas:

(i) aseptic technique;
(ii) critical area contamination factors;
(iii) environmental monitoring;
(iv) structure and engineering controls related to facilities;
(v)equipment and supplies;
(vi) sterile preparation calculations and terminology;
(vii) sterile preparation compounding documentation;
(viii) quality assurance procedures;
(ix) aseptic preparation procedures including proper gowning and gloving technique;
(x) handling of hazardous drugs, if applicable;
(xi) cleaning procedures; and
(xii) general conduct in the clean room.