Making Drugs for Chemotherapy: Tips for Setting Up a Compounding Chemo Room
Whereas in the past many cancer centers outsourced their chemotherapy needs or had them dispensed from the general hospital pharmacy, more and more today are opting to create their own on-site compounding centers. This has many benefits, including:
- Cost savings
- Efficiency for staff
- Quality control
- Patient satisfaction
If you are considering the idea of or are in the planning stages for the development of your institution’s compounding center for chemotherapy, it’s important to purchase your products from a trusted source. Here are some ideas for making your center as effective as possible, based on your needs and assets:
The number and experience level of available pharmacy staff will have a big impact on how your chemo compounding center is set up. Compounding cytotoxic chemotherapy drugs needs to be done in a negative pressure hazardous drug room. Ideally, you want staff who have either already prepared chemotherapy drugs or who have at least had experience in sterile compounding. While the airflow direction is different (positive pressure being used for standard sterile compounding), staff already trained in compounding will be used to working under a hood. The only significant difference will be working under a containment hood as opposed to a standard horizontal hood.
Although it may be tempting to think that having a large number of staff members available to work different shifts is ideal, actually limiting the number of staff who compound chemotherapy drugs is best. Having a small number of pharmacists and technicians working in the chemo center means those staff members become experts at their jobs. Intermittent staffing can increase errors, as well as the amount of time for each medication to be prepared. Larger centers also often have an on-call pharmacist available 24/7.
One of the biggest issues in compounding, especially with chemotherapy drugs, is minimizing the number of times staff enter and leave the sterile environment, as each time means re-gowning and garbing. Some cancer centers have solved this problem with telepharmacy. While technicians remain in the clean room producing medications, the overseeing pharmacist can communicate with them and sign off on drugs via an audio-video system. Order instructions and other information can be implemented into the telepharmacy system as well.
Develop Rigorous Protocols
Even with a small number of staff members working in the hazardous drug room, strict protocols must be maintained for quality control. Periodic evaluations should be scheduled, and training updates must be provided for the addition of new drugs or equipment.
It is virtually impossible to remember all the steps and details for every chemotherapy preparation. Therefore, it is imperative to put together step-by-step checklists for technicians. These lists should cover everything from pulling the prescription and obtaining the ingredients to making the dose and checking the final IV bag.
Some institutions have also created reference charts for stability guidelines for all the drugs they commonly prepare. The USP General Chapter <797> serves as their source. These charts could also contain unusual delivery requirements as needed, such as special tubing for infliximab.
In general, documenting everything is of the utmost importance to reduce any opportunities for human error. The chemotherapy compounding center should be integrated with the institution’s EHR system as well.
Enlist Sophisticated Automation
Because the final IV bag volume for pediatric chemotherapy is vital, an automated compounder is best for centers with pediatric patients. An automated compounder can produce highly accurate volumes for patients as small as neonates while still filling normal size bags for larger children. Some centers have taken their automation to the next level with compounding robots.
More popular in Europe, the use of robotic machines to perform compounding is becoming more commonplace in the US today. The University of Colorado Hospital was the first in the country to implement a compounding robot in 2008. These robotic assistants weigh ingredients, confirm barcodes, and perform visual checks on drugs. The greatest advantages include:
- Eliminating human calculation errors (some by close to an order of one million)
- Decreasing exposure to needle sticks and to cytotoxic drugs that can cause burns and long-term health risks
- Creating an ISO 4 or 5 clean room environment in a small footprint
- Facilitating documentation and auditing
- Reducing repetitive use injuries
- Saving money and preserving pharmacy staff for other duties
Manage Therapy for Home Use
Pharmacists at cancer centers must also often compound anticancer medications, such as tamoxifen, for home use. Because many cancer patients cannot swallow pills, extemporaneous compounding of tablet or capsule formulations can b transform them into liquids. It is crucial that home care providers understand that this method is safer and therefore preferable to patients crushing or splitting tablets at home, where they may be exposed to chemotherapy agents.
There are numerous considerations in preparing oral chemotherapy drugs for home use:
- Dose uniformity
As there are dozens of anticancer drugs that could be compounded in liquid form, instructions for each one are beyond the scope of this post. We would like to stress, however, that the safety of the home caregiver is as important as any of the issues related to pharmacokinetics and efficacy. When possible, these agents should be compounded in a hospital or cancer center environment, versus in a community pharmacy.
With statistics of many cancers on the rise, and new chemotherapy agents being developed, the need for this special type of compounding is ever increasing. For more information about pharmaceutical compounding and purchasing bulk APIs, please contact Pharmaceutica North America, your trusted compounding resource.