Skip to 0 minutes and 15 secondsThe following section we provide the structures and details in Recommended Accreditation Standards. This recommendation was from a government-grant project and was completed in 2014. The project was sponsored by Taiwan Food and Drug Administration,

Skip to 0 minutes and 37 secondsimplemented by Taiwan Society of Health-System Pharmacists. Hopefully, the recommendation could added into official hospital accreditation criteria.

Skip to 0 minutes and 51 secondsIt is a consensus document

Skip to 0 minutes and 54 secondsand its contents cover 3 areas: including Total Parenteral Nutrition, Parenteral Chemotherapy Agents, and Patient Controlled Analgesia.

Skip to 1 minute and 11 secondsFollowing are the recommendation for Total Parenteral Nutrition. It recommended the role of a pharmacist should include participating the patient evaluation in a multidisciplinary team, preparing standard formula and prescriptions and should be a member of the nutrition committee.

Skip to 1 minute and 37 secondsThe primary and secondary engineer controll for Dispensing require the establishment of clean room, Horizontal Laminar Air Hood, and anteroom.

Skip to 1 minute and 54 secondsThe Testing frequency for HEPA filter and Horizontal Laminar Air Hood and dispensing machine is at least once a year.

Skip to 2 minutes and 6 secondsCleaning and disinfection should be done every day and using 70% alcohol.

Skip to 2 minutes and 17 secondsCheck list should be established to monitor whole dispensing processes.

Skip to 2 minutes and 25 secondsDouble check mechanism could be done either by human or by weight

Skip to 2 minutes and 35 secondsTraining and evaluation should be done as two types, that are Initial education and training when the personnel is about to start and continuous education and regular training for those who have been working for years.

Skip to 2 minutes and 56 secondsThe followings are for Chemotherapy preparation.

Skip to 3 minutes and 1 secondPrimary engineer controls are required, especially the appropriate types of biological safety cabinet for hazardous and sterile products are Biological Safety Cabinet type II B and Type III.

Skip to 3 minutes and 19 secondsThe Secondary Engineer Control for sterile and hazardous preparation require the establishment of clean room, anteroom, and transfer box

Skip to 3 minutes and 35 secondsPharmacists are required to perform tasks in dispensing of chemotherapy agents, including prescription verification, preparation procedure, double-check mechanisms, and labeling.

Skip to 3 minutes and 53 secondsIt is also important that the receiving processes and storing drug product in nursing area are monitored by pharmacists.

Skip to 4 minutes and 7 secondsBefore the dispensing of chemotherapy agents, the appropriate personal protective equipments need to be worn, including hair cover, surgical mask, gown, 2 pairs of sterile powderless chemotherapy gloves, and shoes cover.

Skip to 4 minutes and 31 secondsSpill management requires the hospital to have appropriate number of spill kits at those places with high risk of spills and regular training and drill.

Skip to 4 minutes and 46 secondsWaste management requires the labeling of all container with a sign of genotoxin and training provided to the cleaning personnel.

Skip to 4 minutes and 59 secondsQuality Assurance is important to check on the quality of prescribing and dispensing. The Quality Assurance plan could also cover the Primary and Secondary engineer controls.

Skip to 5 minutes and 17 secondsTraining and its evaluation on Chemotherapy also requires two types, one is the initial education and training before a person entering into the chemotherapy dispensing program

Skip to 5 minutes and 32 secondsand continuous education and regular training for every pharmacist who is involved in preparation.

Skip to 5 minutes and 43 secondsThe recommendations also require regular health checkup: Initial and Periodical, and the regular items and those items for extensive exposure to hazardous drugs, for example the large scale of spill.

Skip to 6 minutes and 5 secondsRecommendations for preparing Patient Controlled Analgesia are as following: The requirement for Primary engineer controls is the same as preparing parenteral nutrition, in terms of the type and the maintenance

Skip to 6 minutes and 25 secondsThe recommendations on Secondary engineer control require same level of establishment of Clean room and Ante room. Regular maintenance is also required.

Skip to 6 minutes and 42 secondsPatient Controlled Analgesia usually use pump for drug delivering,

Skip to 6 minutes and 48 secondstherefore the recommendations also require Periodical maintenance: in terms of frequency and contents are clearly indicated.

Skip to 7 minutes and 2 secondsDue to the medication used for Patient Controlled Analgesia is usually opioids, the dispensing process would involve the special steps in signing off for the opioids by pharmacists. Also, prescription of special form proposed by Drug Enforcement Administration need to be used by the hospital.

Skip to 7 minutes and 30 secondsStorage, delivery, and record keeping needs to be done according to the requirement of DEA

Skip to 7 minutes and 43 secondsDue to opioids’ status of high-alert and controlled medication,

Skip to 7 minutes and 49 secondsthe recommendations of Administration for Patient Controlled Analgesia as follow:

Skip to 7 minutes and 58 secondsPump needs to be set by two nursing staff and Record keeping on the use of controlled drug by every shift of nursing staff.

Skip to 8 minutes and 12 secondsDischarge home with Patient Controlled Analgesia needs a comprehensive evaluation.

Skip to 8 minutes and 20 secondsTraining and evaluation to the health care professionals

Skip to 8 minutes and 24 secondscould be two types: one is to provide initial education and training before the start of work,

Skip to 8 minutes and 34 secondsthe other is continuous education and training.

Skip to 8 minutes and 39 secondsThe quality of sterile product preparation is critically related to patient safety. There are consensus standards on TPN, chemotherapy, and PCA dispensing available. Finally, the hospital accreditation standards need to be updated to reflect the speed of emerging innovative therapies and new concept. Thank you for your attention.

Hospital accreditation standards in sterile products

There are various accreditation standards for hospitals. One of the most important missions of these standards is to enhance patient safety. In this video, Deputy Chiang will introduce 3 main standards related to sterile medications. These standards are implemented in Taiwan as a result of a government project in 2014.

  • Total parenteral nutrition(TPN)
  • Parenteral chemotherapy
  • Patient controlled analgesia

Share this video:

This video is from the free online course:

Essentials of Good Pharmacy Practice: The Basics

Taipei Medical University