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The history of sterile product preparation

The history of sterile product preparation - Taiwan's experience
Next section, we will share the history of handling sterile products in Taiwan For the non-hazardous products, the parenteral nutrition are mainly prepared by using commercial products as base, and other components were drawn into syringes and injected into the mixture. Many Taiwanese hospital pharmacies use compounding machine to prepare the TNA admixture, which is more accurate, but require the use of expensive axillary material. For example, the tubing. In 2014, Taiwan Society of Health-System Pharmacists recommended accreditation standard to the government in preparing parenteral nutrition, so far it is still under consideration by the government. The details will be discussed later.
Patient Control Analgesia is another very common used sterile products. It’s important because the drug in the device are opioids, which are both controlled and high-alert. Currently, the trend in preparation of PCA, that is Patient Controlled Analgesia is changing gradually from the anesthetic nursing staff prepared products to pharmacy-prepared products. So far it is still few hospital pharmacies dispense PCA in Taiwan.
In 2014, Taiwan Society of Health-System Pharmacists recommended accreditation standard to the government in preparing Patient Controlled Analgesia, so far it is still under consideration by the government. The detail will be discussed later.
Potassium-containing infusion solution was mainly prepared by nursing staff at the bedside. In 2006, Koo Foundation, Sun Yat-Sen Cancer Center, the hospital I work for, started the preparation of diluted potassium-containing infusion solution this is due to the requirement from Joint Commission International Accreditation. Since then, there are more and more hospital pharmacies having taken this responsibility.
For hazardous drugs preparation, physicians and nursing staff dispensed chemotherapy agents at bedside. At that time, these personnel ware not well-trained and do not withdraw drugs within biological safety cabinet.
The 1st Type IIB biological safety cabinet purchased by Koo Foundation, Sun Yat-Sen Cancer Center Pharmacy in 1990. Before 2006, Pharmacy spent time to dispense syringe and sent the syringe filled with cytotoxic agent to nursing staff and nursing staff inject the drug from syringe into an infusion bag and then started to infusion into patient’s body.
In 2006, Koo Foundation, Sun Yat-Sen Cancer Center Pharmacy started sending infusion bags with cytotoxic agents added and primed IV line to nursing staff.
2010 first Taiwan hazardous drug handling guideline was published by Taiwan Society of Health-System Pharmacists. 2011 two closed system drug transfer devices for infusion obtained National Health Insurance reimbursement and hospitals started to use them. 2012 Koo Foundation, Sun Yat-Sen Cancer Center started using 2 other closed system drug transfer devices which were not reimbursed by National Health Insurance. 2013 and 2015 we have the second and third versions of Taiwan hazardous drug handling guideline was published by 3 institutes, they are Taiwan Society of Health-System Pharmacists, Taiwan Oncology Nursing Society, and Taiwan Clinical Oncologist Society. In this section, we will share the sterile product related content in 2017 Taiwan Hospital Accreditation Standards, which is the current standard.
The basic requirements are: Number 1 : The dispensing of special sterile admixtures— for example, cytotoxic agents, Total Parenteral Nutrition, and Patient Controlled Analgesia should be performed by pharmacists.
There should be a appropriate facility to protect products and personnel.
Number 2 : The dispensing pharmacists should have knowledge in inventory control, contraindications, standard procedures. And they should know how to deal with critical situation and have been trained. Pharmacists should evaluate the appropriateness of chemotherapy orders. There should be standard of procedures and records of all routine processes. Before the administration of chemotherapy agents, pharmacists should verified patients’ medication history and organ functions, for example, renal and hepatic functions.
Medical and nursing staff should have been provided with references related to chemotherapy and other special sterile admixture, especially on the administration routes, timing, and precautions.
Following are the advanced requirements
Sterile product preparation should have standard of procedures which meet related regulation and are audited regularly. Pharmacists should discuss with patient care team and the documentation are kept.
After the completion of cytotoxic preparation, the final products should be kept in a concept concept of closed system, for example, use closed system transfer devices.
Institution should provide regular health checkup to those who dispense and administer cytotoxic agents

Massive sterile products are mainly the responsibility of pharmaceutical industries. However, due to the intensive care of complex diseases, such as cancers, there are certain type of medications needs to be prepared by pharmacists in hospitals.

In this video, Deputy Chiang will introduce the Taiwan experiences on those sterile medications prepared by pharmacists in hospitals and the requirements of them.

How does the Taiwan experience compare to your own? Are there similarities?

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