Assistance in initiating a new sterile compounding service

[Rani Sudarshana]

We are considering the initiation of a new pharmacy-led sterile compounding service at our hospital.

Due to limited resources at this time and as a first step, we narrowed down the types of medications to be prepared in a hood to antimicrobials (antibiotics, antivirals, and antifungals), nutrition (total parenteral nutrition, and pediatric electrolyte solutions), ophthalmic products, +/- monoclonal antibodies. We then determined the overall daily number of preparations requiring sterile compounding as well as the number of hours needed to complete those preparations.

One of our main concerns is the fact that the current pharmacy operating hours are limited to 11 working hours on week days, 8 hours on Saturdays, and 3 hours on Sundays and holidays. This schedule, if maintained as such, prevents the pharmacy department from being able to cater for new orders requiring sterile compounding during pharmacy off-hours. The solution that we thought of would be to extend pharmacy operating hours to 24 hours.

However, if this is not feasible, are there any other recommendations that you may suggest, which could replace this solution and still allow the pharmacy department to initiate and lead this service in an effective way?

Thank you in advance for your time and help,

Best regards,

[Naveed Rivas]

Dear Rani,

The first advice to you, is to do the right thing at the beginning, otherwise you will suffer by the compromises forever..!! The right thing, in my opinion, is to have the sterile preparations as long as -out of the 24 hours- as possible.

However, here are some compromises if not 24 hours:

Some of these preparations can be done as batches, for example the TPN, and large volume parenteral solutions, you can make standardized preparations and keep them at the ward fridge. Some of the antibiotic/antifungals/IV preparations can be also done in the same way.

You can put also a laminar flow hood inside a segregated room at the hospital (as mentioned on USP 797), so you can prepare low risk preparations with BUD of 12 hours. You may let one on-call pharmacist (or more according to your production scale) to come to the hospital (if pharmacy is closed), so he/she can prepare the queue of medications which couldn’t be batched.

For STAT medications, it is not possible to cover them all if you don’t have 24 hour service. As for the USP 797, if low risk medications are prepared under non-sterile conditions, it can be used within one hour after preparing. But, again, it is still risky to standardize such a practice, and a nurse who will be the one who prepares them..!!

Keep in mind that all the above have much material and time wasting, which will raise the costs at your hospital, so I would better use this point to convince your administration to allow a 24 hour service, at least for some of the IV preparations.

I hope I helped you with my answers.

Best Regards,

[Nawal Schmitt]

I’d like to congratulate you for such initiative which I hope to see one day as a standard practice in my home country. However, I agree that some work and budget constraints put a limit to such practice for which I hope that the coming lines would provide a suitable and reasonable alternative for the time being.

Your choice for the items to be prepared is a wise one especially with TPN which is a medium risk preparation. Considering USP 797 and JCI 6th Edition standards:-

Low risk preparations include immediate use CSP with 1 hour beyond use date. This includes IV mixing with simple manipulations of adding a solution to vial which constitutes the majority of mixing practices. Such practice can be performed on site using aseptic technique.

Based on the logistics of service available for you I’d like to recommend the following:-

1- Developing an IV manual listing the standard dilutions that should be used to be familiar among the prescribing physician, pharmacy and nursing staff.
2- Priority for preparation in the pharmacy during the working hours to be for medium and high risk preparations as well as supplying the daily doses of all IV preparations.
3- Perform a hospital wide in-service training for the nurses regarding:-

A) Levels of risks associated with CSPs and those allowed to be prepared on site.
B) Proper use of ASEPTIC TECHNIQUE for preparing low risk CSPs on site in a dedicated area to do so.
C) Stress on the use of standard dilutions recommended by pharmacy so that the practice would be unified.

4- Use of premixes for medication with long refrigerator BUDs can save you a lot of effort, time and risk. This can be instituted for many commonly used antibiotics.

5- Proper recycling of the unused preparations.

In other words, that’s to utilize nursing staff to work with the same pharmacy standards so that it would be easy for you when you transfer to a full pharmacy lead IV service.

On the other side, you have to perform continuous quality checks that includes, but not limited to:-

1- IV order load outside the working hours.
2- Items that are commonly ordered out of working hours to be prepared as premixes, as possible.
3- Monitor any reported infections due to failure to follow standard aseptic technique.
4- Monitor the compliance with standard aseptic technique by nursing staff.
5- Reported error rate associated with preparation outside the pharmacy.
6- Wastage due to discontinued orders.

You can combine the above data in a way that will give you an insight about the efficiency of the service and a measure to convince your management about the importance of utilizing a 24 hrs service if it appeared to be more cost efficient.

[TDP]

We are considering the initiation of a new pharmacy-led sterile compounding service at our hospital.

1. If you have the budget, use it all ASAP or you will lose it.
2. Build the Clean Room as per available resources. Make sure you have the right space for the available workload> be strategic so no extension/construction for next 20 years.
3. Leave a space for future technologies i.e. Robots of the future, IV Workflow needs extra electric and network sockets, other compounding devices, etc.
4. Make sure the contractor has healthcare experience and knows a bit about USP 797
5. Horizontal LAFH ONLY for ordinary drugs (not vertical)

Due to limited resources at this time and as a first step, we narrowed down the types of medications to be prepared in a hood to antimicrobials (antibiotics, antivirals, and antifungals), nutrition (total parenteral nutrition, and pediatric electrolyte solutions), ophthalmic products, +/- monoclonal antibodies. We then determined the overall daily number of preparations requiring sterile compounding as well as the number of hours needed to complete those preparations.

1. Good strategy, although I feel it is important to give priority for non-antimicrobial agents since these drugs protect themselves naturally. Just theoretical judgement.
2. Work on standardization of doses then invest on batches- batches- batches

One of our main concerns is the fact that the current pharmacy operating hours are limited to 11 working hours on week days, 8 hours on Saturdays, and 3 hours on Sundays and holidays. This schedule, if maintained as such, prevents the pharmacy department from being able to cater for new orders requiring sterile compounding during pharmacy off-hours. The solution that we thought of would be to extend pharmacy operating hours to 24 hours.

1. Great thoughts by Naveed & Nawal as shown in previous replies
2. JCIA will mercy you if the nurses are well trained under pharmacy supervision in using aseptic technique (strict when needed especially in immunocompromised patients) when mixing/transferring parenteral drugs outside the duty hours.
3. Make sure there is a dedicated mixing Bench at the nursing medication room and away from traffic and bed side… I don’t favour LAFW hood in nursing units.
4. Have a pharmacist on call to answer nursing queries

 

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