A Q&A with Patricia C. Kienle, RPh
Operations Director for the Pharmacy Management business of Cardinal Health

Q. Before the release of finished sterile preparations, what kind of checklist should people go through?
A. Checklists are important, especially for new staff members. First, the sterile preparation should be visually inspected. We’ve all seen things floating in an IV, such as particulate matter or even chunks of a vial stopper. People might try to hold the preparation up against a sheet of paper that is black on one side and white on the other. That’s a very good visual check. I also think the preparation should be visually inspected by someone other than the staff member who prepared it.

Q. Is there confusion between sterility and stability when it comes to beyond-use dating?
A. There’s still a good deal of confusion between sterility and stability. A preparation may be stable for 30 days, according to valued references, but USP may assert that it is sterile for only 14 days. Those sterility limits should be adhered to; use the lesser of the two time limits. Even for facilities that defer to that judgment, epidurals often seem to fall through the cracks. For some reason, many people use 30-day dating on epidurals, which exceeds USP’s current sterility requirements. In addition, people may make and freeze TPA or RPA syringes storing them for six months, because they are stable for that long. However, USP’s sterility limit is 45 days.

Q. How can pharmacists maintain control over preparations once they leave the pharmacy?
A. Pharmacy’s role differs, depending on the culture of the organization and the location of the pharmacy in relation to the patient care areas, but the most important things to monitor are the temperature and safety of your storage units on the floor. If something is guaranteed to be stable for 14 days if kept at a certain temperature, it should not sit out on a nursing unit floor for six hours at room temperature, because that compromises its stability and reduces the appropriate beyond-use dating. Furthermore, IVs should be stored where they will not have other fluids spilled on them. That’s no different from the way oral solids should be treated. It’s common sense.

In one facility, I was very comfortble with reusing preparations because pharmacists placed them in the nursing-unit refrigerators and we got them at the end of the shift. The nurses knew not to take them out and I never saw them on the counter. So I felt comfortable reusing those products, because I felt that they were under control. At another facility, there were more employees and the pharmacy was farther away from the patient care areas, so I felt uncomfortable. Part of it is a “gut” check. As the person responsible for the pharmacy department, do you feel that your system is comprehensive enough to ensure the proper storage of drugs? If so, you might feel comfortable re-dispensing drugs. If not, you shouldn’t reuse them.

Q. When is end-product testing required?
A. According to current USP regulations, end-product testing is required if you make a high-risk preparation in batches of 25 or more.

Q. Is it inappropriate to test randomly?
A. It is not inappropriate, but it’s not going to tell you anything. Running a random bag through the lab may make you feel as if you are completing a QA process, but it’s not doing a thing from a quality-assurance standpoint. A QA program and process needs to be based on scientific reasoning, and testing a random bag will not provide a complete process.

Q. How can you ensure that you’re properly testing your end products?
A. First, if you’re using growth medium to perform microbiological monitoring tests in your end products, make sure that the growth medium will actually allow contaminants to grow. Request QA documents from the growth-medium vendor to make sure the product is appropriate. Second, you need to consistently follow the manufacturer’s instructions when using the product.

Q. Is it important to establish an emergency plan for those cases in which a culture comes up positive?
A. I think so. It should be established upfront so that, even though people are bound to panic, there is, at least, a response plan in place. First, it’s important to segregate the product in question. Keep it; don’t discard it, because you need to trace all of the doses that were prepared. In some cases, you may even need to dig through the trash, but get your hands on the product if you can. Ask your organization’s risk-management team about chain-of-custody requirements, and consult with your infection control nurse or infection control committee for plan pointers. In addition, the National Coordinating Committee of Large Volume Parenterals published literature on this topic in the 1970s.

An employee of Cardinal Health since 1999, Patricia Kienle assumed her current position in July 2004. The recipient of an MPA in health service administration from Marywood College in Scranton, Pennsylvania, and a BSc in pharmacy from Philadelphia College of Pharmacy and Science, Kienle has more than 30 years’ hospital pharmacy experience.