Recently, I went on a fact-finding mission by performing an audit at our quality assurance chemical lab, DynaLabs, located in St. Louis, Missouri. It is an ongoing policy at Hartley Medical to perform due diligence on our suppliers, labs and other vendors to ensure that patient safety is continually at the forefront of our operations and that the highest quality is maintained throughout our organization.
Currently, the FDA is heavily scrutinizing compounding pharmacies and the laboratories providing services to compounding pharmacies. In August of this year, the FDA investigated a Colorado laboratory about which a report, dated August 30, 2013, presented the startling discovery that the FDA determined their “lab results” to be invalid. If the microbiology tests and quantitative tests are invalid, then the pharmacies that engaged with this lab could potentially experience compromised patient safety. The Colorado laboratory had to issue recalls and receive further inspections by the FDA.
Many compounding pharmacies across America submit samples to various analytical laboratories for sterility and other testing, and compounding pharmacists rely on the accuracy of these laboratories’ results to guarantee their products are safe for patient use. Over the course of many years, I have researched and queried many analytical labs for testing of compounded sterile preparations; and I have had in-depth conversations via telephone and in person with chemists and microbiologists to determine their competency. I have been pleased with my findings; however, after the aforementioned startling discovery, I chose to travel to the laboratory we use to ascertain their abilities and qualities with my own eyes. The extensive and expansive journey proved to be very educational and assuring – something that I highly recommend that all compounding pharmacies make a habit of doing at least annually.
I was very impressed with DynaLabs in a multitude of aspects. During my time there, I was able to tour the facility and interview many staff members. I was very pleased to find that many individuals held four-year degrees or higher, and that most of the senior staff had extensive Pharma backgrounds. These individuals understood qualitative and quantitative testing – and had significant experience dealing with FDA issues.
During the tour, DynaLab’s Director of Operations, Cindy Fowler, took me through the process of sample receipt and input into their systems while correctly routing samples to the appropriate departments. This was significant considering the amount of samples they receive on a daily basis, and their processes were strongly defined to maintain a chain of custody during the entire testing process. I observed their laboratory to be very clean and orderly, and they had just moved into a new facility that allows the opportunity to expand with the increasing demand of testing.
I inquired into the training of their technical staff, and Ms. Fowler was able to explain, at great length, the training processes for all employees involved with the testing of pharmaceutical preparations. I observed their employees in action and was impressed with their professionalism and skills. One particular technician was performing endotoxin testing and her skills in pipetting; and her precision and attention to detail was astonishing.
I was equally fascinated with DynaLab’s sterility testing processes. It was greatly assuring to observe this process performed by a properly gallant individual in a clean room that had filtration systems set up to provide 100 air changes per hour. The transfer of samples onto filtration systems are performed within a laminar airflow workbench, and the room is monitored for both viable and nonviable particulates. The technician involved displayed great care with each sample as he was performing the sterility test – which is reassuring because this individual is charged with a great responsibility for the outcome of the sterility test.
My final interview was with Brett Allen, DynaLab’s Method Development and New Business Manager. He and his team are responsible for developing methods for quantitative analysis of compounded sterile preparations. I was amazed to learn what these individuals do in developing analytical methods for the many non-sterile and sterile preparations. There is a plethora of compounded preparations that exist across the United States, and Mr. Allen’s team has the responsibility of developing methods to qualify and/or quantify such preparations. Truly impressive.
I wish to express my sincerest gratitude to the following: Jason McGuire, Brett Allen, Melissa Brereton, Cindy Fowler and Scott Glover. In addition, I tip my hat to Russell Odegard and Michael Pruett for creating a great company of true quality.
This trip has only solidified my belief that all compounding pharmacies need to perform due diligence, and healthcare providers who receive compounded preparations from pharmacies should ask their compounding pharmacist to speak on behalf of the quality of their analytical labs. As I have stated in the past, not all pharmacies or laboratories are the same … you can only know this by performing proper due diligence.